chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Retching
Clinical narrative: woke with the dry heavies; achy body; light headness; feel really bad today; Fever; tired; muscle pain; headache; This case was reported by a consumer via interactive digital media and described the occurrence of dry heaves in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (received 1st dose one nad half year ago from reporting date, refer case US2020AMR040791).   On 3rd March 2020, the patient received the 2nd dose of Shingrix. On 4th March 2020, 1 days after receiving Shingrix, the patient experienced dry heaves, general body pain, light headedness, feeling bad, fever, tiredness, muscle pain and headache. On an unknown date, the outcome of the dry heaves, general body pain, light headedness, feeling bad, fever, tiredness, muscle pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the dry heaves, general body pain, light headedness, feeling bad, fever, tiredness, muscle pain and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 64 years or 65 years. The patient needed second shot but the patient was very nervous about getting it due to adverse events experienced after 1st dose, so the patient received 2nd dose late, a year and half after the 1st dose. On the day of reporting, the patient woke with the dry heavies, achy body and light headness. The patient felt very bad on the day of reporting, had fever, tired, muscle pain and headache. The patient wanted to know how long thses side effect might last.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I'm experiencing fever; body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were unknown.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient had had 2nd shot on day before reporting around 2 pm and at the time of reporting all ready patient experiencing fever and body aches. The patient enquired could he or she took Motrin. The permission to follow up was denied.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix shot and the side effects were worse than what he/she thought. The patient wanted to know what are the chances of getting shingles if he/she did not receive 2nd shot.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: my arm at the injection site broke out in a red spotted rash; my arm at the injection site broke out in a red spotted rash; This case was reported by a consumer and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the injection site erythema and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The 1st dose of Shingrix was received on unknown arm. After Shingrix shot the patient's arm at the injection site broke out in a red spotted rash on the 3rd day. The patient asked about getting 2nd dose as it had been almost 6 months since 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper
Clinical narrative: first shot made my stomach upset; if there is anything I can take that will help with my stomach ache; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced upset stomach and stomach pain. On an unknown date, the outcome of the upset stomach and stomach pain were unknown.   It was unknown if the reporter considered the upset stomach and stomach pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The first shot made patient's stomach upset. The patient just wanted to know if there was anything he/she can take that would help with stomach ache. The patient was nervous about the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: pain in arm; tiredness; achy; mild headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, tiredness, general body pain and headache. On an unknown date, the outcome of the pain in arm, tiredness, general body pain and headache were unknown.   It was unknown if the reporter considered the pain in arm, tiredness, general body pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain in arm, tiredness, achy and mild headache. The patient asked how long do some of side effects generally last.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Headache
Clinical narrative: my joints starting aching; my muscles in my back and hubs starting aching; rarely ever have a headache by I got a severe one; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th March 2020, the patient received1st dose of Shingrix. On 18th March 2020, 7 days after receiving Shingrix, the patient experienced joint pain, muscular back pain and headache. On an unknown date, the outcome of the joint pain, muscular back pain and headache were unknown.   It was unknown if the reporter considered the joint pain, muscular back pain and headache to be related to Shingrix.  Additional details were provided as follows: On 18th March 2020, the patient joints and muscles in back and hubs started aching. The patient rarely had headache but he/she got a severe headache after Shingrix.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Tiredness; muscle pain,; headache; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced tiredness, muscle pain and headache. On an unknown date, the outcome of the tiredness, muscle pain and headache were unknown.   It was unknown if the reporter considered the tiredness, muscle pain and headache to be related to Shingrix.  Additional details were provided as follows: The reporter wanted to know that how long these typical side effects last.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain and soreness in my arm; Pain and soreness in my shoulder; impossible to use that arm for routine tasks, such as dressing or brushing hairs; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, for tolerance refer linked case US2020AMR050143).   On 20th February 2020, the patient received the 2nd dose of Shingrix. On 20th February 2020, immediately after receiving Shingrix, the patient experienced pain in arm, shoulder pain and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, shoulder pain and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient had pain and soreness in arm and shoulder since receiving vaccine. The 2nd dose had made it impossible, at times, to use that arm for routine tasks, such as dressing or brushing hair. The patient asked what would cause this, and what can he/she do to stop the pain.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: minor soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The vaccination caused minor soreness for a few days. For tolerance with 2nd dose of Shingrix, refer linked case US2020AMR050134.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Some pain at the injection site on her right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The patient felt some pain at the injection site on her right arm when she received the first dose in the end of October 2019. The pain lasted for a day or two. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020029108
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pyrexia, Reaction to preservatives, Rhinorrhoea
Clinical narrative: sick; snotty; fever; bad histamine reaction; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 52-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness, nasal mucus increased, fever and reaction to preservatives. On an unknown date, the outcome of the sickness, nasal mucus increased, fever and reaction to preservatives were unknown.   It was unknown if the reporter considered the sickness, nasal mucus increased, fever and reaction to preservatives to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. Caller states the first 5 to 7 years she got the flu vaccine, she got sick.   The reporter states it was not until later on that she realized it was probably due to the preservatives in the vaccine.   The reporter states she tries to get the preservative free vaccine now, but if she did have a reaction now it was much milder and shorter in duration.      The reporter was not able to provide specific time or product manufacturer.
Age: 66.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Nausea
Clinical narrative: experienced nausea; experience shivering; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included breast cancer. Previously experienced adverse reactions included shingles. Concurrent medical conditions included diabetes mellitus (had medical history of Diabetes Melatus Type 1.).   In January 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. In January 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced nausea and shivering. On an unknown date, the outcome of the nausea and shivering were recovered/resolved.   It was unknown if the reporter considered the nausea and shivering to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient received Shingrix on mid January 2020 and within hours on the same day she started to experience shivering and nausea that lasted for 7 hours and then resolved.  She stated that she ended up in the Emergency Room due to these symptoms because she did not know it would happen. The reporter consented to follow up. Emergency room visit was required. The consumer did not know the details of the vaccines for this adverse event.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Head cold; swollen, red, and hot injection site; swollen, red, and hot injection site; swollen, red, and hot injection site; golf ball sized knot developed at the injection site; Body aches; Chills; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 27-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number ZZ772, expiry date 30th June 2020) for prophylaxis.   On 26th November 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site swelling, injection site erythema, injection site warmth, injection site mass, general body pain, chills and head cold. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, injection site mass, general body pain, chills and head cold were resolved with sequelae.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, injection site mass, general body pain, chills and head cold to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were reported as follows: The reporter had a patient that reports having a swollen, red, and hot injection site after having the Fluarix vaccine.   A golf ball sized knot developed at the injection site.   All injection site symptoms resolved after one week.   The patient also developed body aches and chills that lasted for three days.   After that she developed a head cold.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Nasopharyngitis, Pain
Clinical narrative: Head cold; swollen, red, and hot injection site; swollen, red, and hot injection site; swollen, red, and hot injection site; golf ball sized knot developed at the injection site; Body aches; Chills; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 27-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number ZZ772, expiry date 30th June 2020) for prophylaxis.   On 26th November 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site swelling, injection site erythema, injection site warmth, injection site mass, general body pain, chills and head cold. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, injection site mass, general body pain, chills and head cold were resolved with sequelae.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, injection site mass, general body pain, chills and head cold to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were reported as follows: The reporter had a patient that reports having a swollen, red, and hot injection site after having the Fluarix vaccine.   A golf ball sized knot developed at the injection site.   All injection site symptoms resolved after one week.   The patient also developed body aches and chills that lasted for three days.   After that she developed a head cold.
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: sinus cold; This case was reported by a consumer via call center representative and described the occurrence of head cold in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2020, the patient received Shingrix. On 28th February 2020, 3 days after receiving Shingrix, the patient experienced head cold. On an unknown date, the outcome of the head cold was unknown.   It was unknown if the reporter considered the head cold to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient woke up with a sinus cold on day of reporting. His call was disconnected during the early phase of the conversation. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: didn't feel good; felt like they had the flu; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell and influenza like illness. On an unknown date, the outcome of the feeling unwell and influenza like illness were unknown.   It was unknown if the reporter considered the feeling unwell and influenza like illness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter stated that she had heard from couple people that had the luxury of getting Shingrix that they did not feel good after receiving Shingrix. They felt like they had the flu. The nurse reported that they just received Shingrix (US product) and did not administered any yet. No additional information was available for report.  The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction, Influenza, Vaccination failure
Clinical narrative: Suspected Vaccination failure; get the flu; have reactions; This case was reported by a nurse via call center representative and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and adverse reaction. On an unknown date, the outcome of the vaccination failure, influenza and adverse reaction were unknown.   It was unknown if the reporter considered the vaccination failure, influenza and adverse reaction to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Nurse, in conversation, states patients had reactions to flu shots (brand not provided) and still get the flu following flu vaccinations.  No further details provided. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for infuenza, time to onset for event and laboratory confirmation for influenza were not provided.
Age: 95.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: Shingles; Pain; Itching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in Novemebr 2019 and did not experience side effects).   On 7th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th March 2020, 1 days after receiving Shingrix, the patient experienced shingles, pain and pruritus. The patient was treated with antihistamine. Rechallenge with Shingrix was negative. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the pain and pruritus were unknown.   The reporter considered the shingles, pain and pruritus to be related to Shingrix.  Additional details were provided as follows: The following day after receiving Shingrix, the patient had pain and itching.  She said that she went to her doctor they told her that she has Shingles.  She said that her doctor gave her Antihistamines and a topical solution.  The patient stated that she never had shingles before and that she believes that the shingles vaccine vaccine caused the shingles. The patient was very frustrated that GSK would not compensate/reimburse for the Shingles vaccine and the cost of her medical bills.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: tiredness; low grade fever; body aches; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu unspecified (Flu vaccine).   On 8th October 2019, the patient received the 1st dose of Shingrix. On 8th October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 9th October 2019, the patient experienced tiredness, low grade fever and general body pain. On an unknown date, the outcome of the pain in arm, tiredness, low grade fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness, low grade fever and general body pain to be related to Shingrix.  Additional information was provided as follows: The symptoms began to resolve after the 2nd day of vaccine. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Felt sick; Fever; Achiness; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 21st September 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On 21st September 2019, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced feeling unwell, fever and pain. On 22nd September 2019, the outcome of the feeling unwell, fever and pain were recovered/resolved.   It was unknown if the reporter considered the feeling unwell, fever and pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix on left upper arm and she also received the flu vaccine that same day.  The patient reported that after receiving both vaccines, she felt sick in the middle of the night, she had fever and achiness.  She said all symptoms were resolved and gone in the morning.  The patient was not sure if the Shingrix or the Flu vaccine caused those symptoms. The patient consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: her right arm was sore for a day and a half; she felt aching in her joint for a couple of days /  the pain abated in her hip / intense 12 hours of pain in her right hip joint; pain worked its way out of her glute muscle; she was limping; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hip replacement (surgery done on 11th January 2019).   On 26th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th February 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity, pain in hip, muscle pain and limping. On an unknown date, the outcome of the pain in extremity was recovering/resolving and the outcome of the pain in hip, muscle pain and limping were recovered/resolved.   It was unknown if the reporter considered the pain in extremity, pain in hip, muscle pain and limping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her right arm was sore for a day and a half and then she felt aching in her joint for a couple of days. Then in 36 hours the pain abated in her hip. The patient reported that the pain worked its way out of her glute muscle but for two days it was painful in her hip joint and she was limping. She described it as an intense 12 hours of pain in her right hip joint and then the pain abated and resolved. The reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: vaccination site pain and limited arm motion; vaccination site pain and limited arm motion; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative.  A female patient of an unspecified age started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported.  On an unknown date the patient experienced vaccination site pain and limited arm motion on an unspecified date with outcome of unknown.    Information on lot/Batch number has been requested.
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pain, Pneumonitis
Clinical narrative: inflammation in my lungs; This is a spontaneous report from a contactable Other HCP.   A 55-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported she missed 14 days of therapy related to receiving the pneumonia vaccine. Adverse event of increased pain, stiffness in back, hips reported from missed doses. She had plan to restart therapy 24Mar2020. MD was aware. On an unspecified date the patient experienced inflammation in her lungs and started on breo inhaler per pulmonologist. The outcome of the events was unknown.   Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  Information on the batch number has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: redness, swelling and pain from the swelling down to her elbow; redness, swelling and pain from the swelling down to her elbow; redness, swelling and pain from the swelling down to her elbow; she was supposed to be given Pneumovax on 12Mar2020 not the Prevnar 13.; she was supposed to be given Pneumovax on 12Mar2020 not the Prevnar 13.; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 70-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) intramuscular on 12Mar2020 at 0.5 ml, single for immunization at the physician's office. Medical history included lung condition from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The nurse reported that they gave a dose of Prevnar 13 to a patient that was previously vaccinated with PREVNAR 13 and she had redness, swelling and pain from the swelling down to her elbow. She says she was given the PREVNAR 13 for the first time on 09Jul2018 and the most recent administration in which the patient experienced the adverse event was 12Mar2020. She says she was supposed to be given PNEUMOVAX on the 12Mar2020 not the PREVNAR 13. The redness pain and swelling started shortly after the injection a resolved shortly after the injection. She confirmed that the redness, pain, and swelling had resolved completely.  Information on the batch number has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Wrong product administered
Clinical narrative: Tubersol .5 as an IM and they were supposed to receive the Tetanus TD vaccine/no ae; Initial information received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient who received 0.5 mL TUBERSOL (TUBERCULIN TEST) (with an unknown batch number) for Tuberculin test via intramuscular route at an  unknown administration site instead of TETANUS TOXOID (Wrong vaccine administered)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error case due to Wrong vaccine administered.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old patient was accidentally given a 6th injection of Daptacel instead of Adacel, no AE; 11 year old patient was accidentally given a 6th injection of Daptacel instead of Adacel, no AE; 11 year old patient was accidentally given a 6th injection of Daptacel instead of Adacel, no AE; Initial information and additional information received on 05-MAR-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 11 years old female patient who was administered with 0.5 ml sixth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5281AA, expiration date- 05-Oct-2019) via an intramuscular route in the left deltoid on 06-Aug-2019 for prophylactic vaccination.  The patient's past vaccination(s) included series of 5 Daptacel injections at the correct times in childhood. The patient's past medical history, medical treatment(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered, extra dose administered and inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Teniviac expired on 08-Mar-2020 and was given to a patient on 09-Mar-2020; Initial information received on 09-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2020SA065407.  This case involves a 71 year old male patient who received 0.5 ml expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number- U5882AA, Expiration date- 08-MAR-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 09-Mar-2020.  Medical history, medical treatment, concomitant therapy, vaccination and family history were not provided.  It is a case of actual medication error due to expired vaccine used. It was reported that an expired dose of Tenivac was administered to a 71 year old male patient on 09-Mar-2020.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Teniviac expired on 08-march-2020  and was given to a 66 year old female patient with no AE; Initial information received on 09-Mar-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case is linked to case 2020SA065407 (same reporter).  This case involves a 66 year old female patient who received 0.5 ml expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number- U5882AA, Expiration date- 08-Mar-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 09-Mar-2020.  Medical history, medical treatment, concomitant therapy, vaccination and family history were not provided.  It is a case of actual medication error due to expired vaccine used.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 5 year old received Fluzone HD instead of Fluzone QD/no AE; 5 year old received Fluzone HD instead of Fluzone QD/no AE; Initial information received on 11-Mar-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age), (overdose) on 11-MAR-2020 for prophylactic vaccination via intramuscular route at the right leg [batch number: UJ310AB,dosing details 0.5 ml and expiry date: 30-JUN-2020]   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error case due to inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose of ActHib vaccine to a 4 month old, no AE; Initial information received on 11-Mar-2020 regarding an unsolicited valid non-serious case received from consumer or non-healthcare professional.  This case involves a four month old patient who was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] (lot number not reported, Exp. Date 29-Nov-2019) via an unknown route in an unknown administration site on an unknown date, for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: U
Vaccine: IPV
Symptoms: Unevaluable event
Clinical narrative: torage temperature reached a high of 70.42 degrees F for 7 hours/no AE; No human error involved and stability data not reported in source document and vaccine administered hence non-case
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3 patients under 65 received Fluzone High Dose, no AE; 3 patients under 65 received Fluzone High Dose, no AE; Initial information received on 16-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves three patients under 65-year-old (gender not reported) who were vaccinated with dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Batch number, expiration date, dose and site of administration was not reported) for prophylactic vaccination on unknown date (PT: Overdose, Product administered to patient of inappropriate age).   Medical history, past medical treatment, vaccination, concomitant therapy and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Erythema, Herpes zoster, Rash
Clinical narrative: 15 month old male patient brought to ED with rash to the right flank/right abdomen red raise area in clusters (coalesced erythematous vesicular, extending from the lower back T9 region to the flank and abdomen does not cross midline, non-weeping and crusting at this time).  The diagnosis Herpes Zoster.  The patient received the following on 6 December 2019:  Vaccines Viral Varicella (Active) ADDITIONAL PROVIDER(S): - Varicella; Series #: 1; 0.5 mL; SC; Left Thigh; Mfg: Merck; Lot: S012037; EXP: 04/17/21  VIS given (Ver: 8/15/2019).  The patient was treated appropriately with acyclovir.   The literature shows that some patients may present with Herpes Zoster after the administration/exposure to the Varicella vaccine.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: I had the old shingles shoT in March of 2011 wiTh no reacTion. over
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Hypersensitivity, Pruritus, Swelling, Urticaria
Clinical narrative: 3/8/20 patient developed diffuse erythema with swelling and itching. She was seen in a local ER and treated for severe allergic reaction - per patient description sounds like diffuse urticaria with possible angioedema
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: lhe patient was administered an improperly stored dose of Rotateq; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 24-MAR-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number: 1660112, expiration date: 18-OCT-2020) (exact dose and route of administration were not provided).   The vaccine experienced temperature excursion above 47 degree Fahrenheit 52.1 F for 15 minutes Previous temperature excursion was detected above 47 degree Fahrenheit 55 F for 21 minutes. Digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Pain, Rash
Clinical narrative: Shingles; get a rash on my left thigh and waist; extrem body aches; had side effects of chills; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, 14 days after receiving Shingrix, the patient experienced shingles, rash, general body pain and chills. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the general body pain and chills were unknown.   It was unknown if the reporter considered the shingles, rash, general body pain and chills to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. Less than 2 weeks after vaccination, the patient had side effects of chills and extreme body aches. The patien started to get a rash on left thigh and waist about 2 weeks later. The patient did not think it was Shingles but just a rash. The rash was on thigh but now was on waist . Reading the description of what shingles was, the patient believed it was Shingles.  The patient asked if an antiviral medication taken orally help at this time.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had a sore arm.  For tolerance after 2nd dose refer case US2020AMR044290. This is 1 of the 4 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Can side effects present themselves 4 days after receiving the vaccine; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient experienced side effects and enquired that side effects can present 4 days after receiving the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: How long do symptoms from Shingrix shot last; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient experienced adverse event and enquired for how long do symptoms last?