chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: soreness / injection site.; redness / injection site.; raised, swollen injection site.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and within hours of the injection she started having soreness, redness and raised, swollen injection site.  The patient stated that these symptoms persist. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Influenza like illness
Clinical narrative: Fatigue/tiredness; she had a rash that did not itch and was located at her right torso under her breast and under her arm; arm pain; warm to touch at the injection site; Chills; cold hands; ache on her back and hip; ache on hip; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix. On 1st September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and injection site warmth. On 2nd September 2020, the patient experienced fatigue and rash. In September 2020, the patient experienced chills, cold hands, back pain, pain in hip and influenza-like symptoms. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in arm and rash were not recovered/not resolved and the outcome of the injection site warmth, cold hands, back pain, pain in hip and influenza-like symptoms were unknown and the outcome of the fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injection site warmth, fatigue, chills, cold hands, rash, back pain, pain in hip and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and had arm pain and warm to touch at the injection site. The patient had fatigue, tiredness, chills and cold hands. The patient reported that she had a rash that did not itch and was located at her right torso under her breast and under her arm and ache on her back and hip. The patient taking Advil.  The patient reported it was like having flu like symptoms. The reporter did not consent to follow up. Lot and expiration date were unknown.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Peripheral coldness, Rash
Clinical narrative: Fatigue/tiredness; she had a rash that did not itch and was located at her right torso under her breast and under her arm; arm pain; warm to touch at the injection site; Chills; cold hands; ache on her back and hip; ache on hip; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix. On 1st September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and injection site warmth. On 2nd September 2020, the patient experienced fatigue and rash. In September 2020, the patient experienced chills, cold hands, back pain, pain in hip and influenza-like symptoms. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in arm and rash were not recovered/not resolved and the outcome of the injection site warmth, cold hands, back pain, pain in hip and influenza-like symptoms were unknown and the outcome of the fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injection site warmth, fatigue, chills, cold hands, rash, back pain, pain in hip and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and had arm pain and warm to touch at the injection site. The patient had fatigue, tiredness, chills and cold hands. The patient reported that she had a rash that did not itch and was located at her right torso under her breast and under her arm and ache on her back and hip. The patient taking Advil.  The patient reported it was like having flu like symptoms. The reporter did not consent to follow up. Lot and expiration date were unknown.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: sore arm; injections site reactions  / swelling; injections site reactions / area of redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th March 2020, the patient received the 2nd dose of Shingrix. On 11th March 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had injection site pain, area of redness and swelling was described as the size of the palm of his hand. The injections site reactions resolved within 2 days.  The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Incomplete course of vaccination, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: redness at site; pain at site; Arm felt so"painful could not lift".; Arm felt so"painful could not lift".; received the 1st dose of Shingrix on November 2019.; rash; flu like symptoms; bad headache; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 2nd November 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms and headache. On 4th November 2019, the patient experienced rash. On an unknown date, the patient experienced injection site erythema, injection site pain, mobility decreased, pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, headache, rash, injection site erythema, injection site pain, mobility decreased, pain in arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the influenza-like symptoms, headache, rash, injection site erythema, injection site pain, mobility decreased and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and woke up with flu like symptoms, bad headache, rash started on day 3, redness at site and pain at site.  The arm felt so painful could not lift.  The patient did not receive 2nd dose yet, which led to incomplete course of vaccination. No additional information was provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178062:same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Pain in extremity, Rash
Clinical narrative: redness at site; pain at site; Arm felt so"painful could not lift".; Arm felt so"painful could not lift".; received the 1st dose of Shingrix on November 2019.; rash; flu like symptoms; bad headache; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 2nd November 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms and headache. On 4th November 2019, the patient experienced rash. On an unknown date, the patient experienced injection site erythema, injection site pain, mobility decreased, pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, headache, rash, injection site erythema, injection site pain, mobility decreased, pain in arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the influenza-like symptoms, headache, rash, injection site erythema, injection site pain, mobility decreased and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and woke up with flu like symptoms, bad headache, rash started on day 3, redness at site and pain at site.  The arm felt so painful could not lift.  The patient did not receive 2nd dose yet, which led to incomplete course of vaccination. No additional information was provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178062:same reporter
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: achiness; tiredness; mild headache; general malaise; This case was reported by a consumer via call center representative and described the occurrence of pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd September 2020, 1 days after receiving Shingrix, the patient experienced pain, tiredness, headache and general malaise. On 3rd September 2020, the outcome of the pain, tiredness, headache and general malaise were not recovered/not resolved.   The reporter considered the pain, tiredness, headache and general malaise to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experiencing achiness, tiredness, mild headache and general malaise. Reviewed adverse effect section of PI to patient and offered a copy. The reporter did not consent to follow up. The reporter declined to provide HCP information.
Sex: F
Vaccine: VARZOS
Symptoms: Sinus congestion, Sinusitis, Vertigo
Clinical narrative: Sinus Infection; congestion; vertigo; This case was reported by a consumer via call center representative and described the occurrence of sinus infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced sinus infection, nasal sinus congestion and vertigo. On an unknown date, the outcome of the sinus infection, nasal sinus congestion and vertigo were unknown.   It was unknown if the reporter considered the sinus infection, nasal sinus congestion and vertigo to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sinus Infection two weeks after receiving initial Shingrix vaccine. The patient stated that it started with congestion and she also had vertigo. The reporter did not consent to follow-up.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Quadracel vaccine was given to a 3 year old patient, no AE; Quadracel vaccine was given to a 3 year old patient because the child was behind on her vaccinations, no AE; Quadracel vaccine was given to a 3 year old patient which had temperature excursion at 1.65 C due hurricane, No AE; Initial information received on 05-Aug-2020 regarding an unsolicited valid non-serious case received from a pediatrician. This case involves a 36-months-old female patient who experienced received a 0.5 mL dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5763AA and expiry date: 26-Aug-2022) via an intramuscular route in the right for prophylactic vaccination on 29-Jul-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and product storage error temperature too low.   It was also a case of off label use.  Description: Facility experienced a temperature excursion due to the Hurricane. Lowest temperature: 1.65 Celsius, Duration of status: 50 minutes for Quadracel vaccine which was given to a 3 years old patient. Quadracel is to be used in children between the ages of 4 and 6 which was know by nurse still she was persistent on wanting to give it (Quadracel) to the child because the child was behind on her vaccinations.  At the time of this 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 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: 5.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 5 year old child was given Adacel instead of Daptacel, no AE; Initial information received on 27-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 year old male patient who administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 24-Aug-2020, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5669AA and expiry date: 09-Oct02021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered.  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 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.
Sex: M
Vaccine: FLUR4
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; Initial information received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 70-years-old male patient who experienced allergic reaction, while he received vaccine QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV].  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUBLOK QIV lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On 27-Aug-2020, the patient developed a non-serious allergic reaction (hypersensitivity) unknown latency following the administration of FLUBLOK QIV. It was not known if it had been caused by the egg protein.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for allergic reaction.  There will be no information available on the batch number for this case.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Contusion, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Shot administered at the acromion area of the upper shoulder. immediate pain at the injection site with little to no blood once the needle was removed. Half dollar sized purple-blue bruising within an hour of injection, dull ache in the shoulder, and soreness of the joint. By 9/11/2020 bruise turning gray, but still sore and tender to touch. Complete rotation of the shoulder possible, but with slight pain when moving the left arm up and dorsal.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Shot administered at the acromion area of the upper shoulder. immediate pain at the injection site with little to no blood once the needle was removed. Half dollar sized purple-blue bruising within an hour of injection, dull ache in the shoulder, and soreness of the joint. By 9/11/2020 bruise turning gray, but still sore and tender to touch. Complete rotation of the shoulder possible, but with slight pain when moving the left arm up and dorsal.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt. received Dose of Varicella and dose of Proquad on the same date and time. Family has been informed and no report at this of any side effect.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Muscle spasms, Pain in extremity
Clinical narrative: swelling to left upper arm. after swelling resolved, muscle cramps to left upper arm. pain in left upper arm that radiates to lower arm and hand. pain is intermittent, lasts 2 hours, self- resolves or resolves with massage. pain waxes and wanes. no paresthesias, retains full range of motion to arm and hand
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This patient reported redness, heat, and swelling at the injection site.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Cardiac disorder
Clinical narrative: patient sought medical attention from ambulance due to cardiac distress.  she was taken to Hospital and stated the physician there does not feel this was related to the flu shot.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Malaise, Myalgia
Clinical narrative: Pt reports generalized muscle aches and malaise lasting about 24 hours after evening of vaccination.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: Pt came on 9/10/20 and informed the pharmacist that her arm was a little red. He asked her to observe it for 1 more day and report it to the pharmacist on duty if it isn't any better. She came back on 9/11/20 and told me that it was still itching and red.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediate swelling at injection site
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Rash, Rash erythematous
Clinical narrative: About 1 to 2 hours after her shot she had redness at the injection site and a rash developed on her leg. The rash was red and was about 8 inches long. It has since turned to a purple color. She was seen by her doctor on 9/10/20 and was given a steroid injection as well as an oral steroid. The rash is still there but she is doing better as of 9/11/20.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt has swelling and redness at injection site on left thigh. Recommends supportive care from clear triage, and to call back with further questions.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: experienced "significant swelling, redness, and severe pain in her arm" at the injection site; experienced "significant swelling, redness, and severe pain in her arm" at the injection site; experienced "significant swelling, redness, and severe pain in her arm" at the injection site; This spontaneous report was received from an unspecified reporter via company representative and refers to a 65 year old female patient. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medication were not provided. On an unknown date, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route of administration, lot # and expiration date were not provided), for prophylaxis. On an unknown date the patient experienced "significant swelling, redness and severe pain in her arm" at the injection site, for a couple of weeks before it subsided. The outcome of of the events was considered as recovering/resolving. The causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, in 2017, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequently to the vaccination, the patient was treated for shingles. The patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering ongoing injuries; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site swelling, Pain, Pruritus
Clinical narrative: Swelling were injection site, pain/soreness, tendernes headache and fatigue; itching and red rash Rx: cold compress and tylenol. Has lasted for 9 day currently.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Tenderness
Clinical narrative: Swelling were injection site, pain/soreness, tendernes headache and fatigue; itching and red rash Rx: cold compress and tylenol. Has lasted for 9 day currently.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Balance disorder, Chest discomfort, Eye pain
Clinical narrative: back pain,; she couldn't sleep; she couldn't lay on her left side; she lost her balance and sat down; fell down; neck started to hurt / she had a dull ache all of the time; left side hurt really bad / side pain; pain - into her rib cage on the left side / hurt to the touch / ribs felt like they were broken; uncomfortable on the left side of her chest; she felt miserable / she felt crummy; didn't want to do anything with fatigue; joint pain / her wrist is really bad; eyeballs hurt /both of her eyes hurt so bad / eye pain; she had a headache / had a headache above her eye; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 22nd April 2022) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 1 week after receiving Shingrix, the patient experienced eye pain, headache and joint pain. On 18th August 2020, the patient experienced feeling abnormal and fatigue. On 19th August 2020, the patient experienced chest discomfort. On 22nd August 2020, the patient experienced rib pain and pain localized. On 24th August 2020, the patient experienced neck pain. On 26th August 2020, the patient experienced loss of balance and fall. On 28th August 2020, the patient experienced sleeplessness and mobility decreased. On an unknown date, the patient experienced back pain. The patient was treated with ibuprofen, meloxicam (Mobic) and muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the feeling abnormal, eye pain, pain localized, joint pain and back pain were not recovered/not resolved and the outcome of the fatigue, chest discomfort, rib pain, neck pain, headache, sleeplessness, mobility decreased, loss of balance and fall were unknown.   It was unknown if the reporter considered the feeling abnormal, fatigue, chest discomfort, rib pain, neck pain, eye pain, headache, pain localized, sleeplessness, mobility decreased, loss of balance, fall, joint pain and back pain to be related to Shingrix.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Fatigue, Feeling abnormal, Headache, Insomnia
Clinical narrative: back pain,; she couldn't sleep; she couldn't lay on her left side; she lost her balance and sat down; fell down; neck started to hurt / she had a dull ache all of the time; left side hurt really bad / side pain; pain - into her rib cage on the left side / hurt to the touch / ribs felt like they were broken; uncomfortable on the left side of her chest; she felt miserable / she felt crummy; didn't want to do anything with fatigue; joint pain / her wrist is really bad; eyeballs hurt /both of her eyes hurt so bad / eye pain; she had a headache / had a headache above her eye; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 22nd April 2022) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 1 week after receiving Shingrix, the patient experienced eye pain, headache and joint pain. On 18th August 2020, the patient experienced feeling abnormal and fatigue. On 19th August 2020, the patient experienced chest discomfort. On 22nd August 2020, the patient experienced rib pain and pain localized. On 24th August 2020, the patient experienced neck pain. On 26th August 2020, the patient experienced loss of balance and fall. On 28th August 2020, the patient experienced sleeplessness and mobility decreased. On an unknown date, the patient experienced back pain. The patient was treated with ibuprofen, meloxicam (Mobic) and muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the feeling abnormal, eye pain, pain localized, joint pain and back pain were not recovered/not resolved and the outcome of the fatigue, chest discomfort, rib pain, neck pain, headache, sleeplessness, mobility decreased, loss of balance and fall were unknown.   It was unknown if the reporter considered the feeling abnormal, fatigue, chest discomfort, rib pain, neck pain, eye pain, headache, pain localized, sleeplessness, mobility decreased, loss of balance, fall, joint pain and back pain to be related to Shingrix.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal chest pain, Neck pain, Pain
Clinical narrative: back pain,; she couldn't sleep; she couldn't lay on her left side; she lost her balance and sat down; fell down; neck started to hurt / she had a dull ache all of the time; left side hurt really bad / side pain; pain - into her rib cage on the left side / hurt to the touch / ribs felt like they were broken; uncomfortable on the left side of her chest; she felt miserable / she felt crummy; didn't want to do anything with fatigue; joint pain / her wrist is really bad; eyeballs hurt /both of her eyes hurt so bad / eye pain; she had a headache / had a headache above her eye; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 22nd April 2022) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 1 week after receiving Shingrix, the patient experienced eye pain, headache and joint pain. On 18th August 2020, the patient experienced feeling abnormal and fatigue. On 19th August 2020, the patient experienced chest discomfort. On 22nd August 2020, the patient experienced rib pain and pain localized. On 24th August 2020, the patient experienced neck pain. On 26th August 2020, the patient experienced loss of balance and fall. On 28th August 2020, the patient experienced sleeplessness and mobility decreased. On an unknown date, the patient experienced back pain. The patient was treated with ibuprofen, meloxicam (Mobic) and muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the feeling abnormal, eye pain, pain localized, joint pain and back pain were not recovered/not resolved and the outcome of the fatigue, chest discomfort, rib pain, neck pain, headache, sleeplessness, mobility decreased, loss of balance and fall were unknown.   It was unknown if the reporter considered the feeling abnormal, fatigue, chest discomfort, rib pain, neck pain, eye pain, headache, pain localized, sleeplessness, mobility decreased, loss of balance, fall, joint pain and back pain to be related to Shingrix.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: body aches; chills; headaches; cold feet and hands; injection site was sore; fatigue; This case was reported by a other health professional and described the occurrence of general body pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number PR5B2, expiry date 8th November 2021) for prophylaxis.   On 1st August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st August 2020, less than a day after receiving Shingrix, the patient experienced general body pain, chills, headache, cold feet, injection site pain and fatigue. On an unknown date, the outcome of the general body pain, chills, headache, cold feet, injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, headache, cold feet, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix and experienced severe body aches, chills, headaches, cold feet and hands at night, her injection site was sore and she had fatigue.  These side effects started the same day that she received the vaccination. The patient spoke with the physician on 26th August 2020, and she explained that her side effects had improved. The reporter consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness
Clinical narrative: body aches; chills; headaches; cold feet and hands; injection site was sore; fatigue; This case was reported by a other health professional and described the occurrence of general body pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number PR5B2, expiry date 8th November 2021) for prophylaxis.   On 1st August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st August 2020, less than a day after receiving Shingrix, the patient experienced general body pain, chills, headache, cold feet, injection site pain and fatigue. On an unknown date, the outcome of the general body pain, chills, headache, cold feet, injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, headache, cold feet, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix and experienced severe body aches, chills, headaches, cold feet and hands at night, her injection site was sore and she had fatigue.  These side effects started the same day that she received the vaccination. The patient spoke with the physician on 26th August 2020, and she explained that her side effects had improved. The reporter consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: rash developed at the injection site with some swelling.; rash developed at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number C47FY, expiry date 16th September 2022) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th August 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site rash. On an unknown date, the outcome of the injection site swelling and injection site rash were unknown.   It was unknown if the reporter considered the injection site swelling and injection site rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced rash at the injection site with some swelling. The reporter did not consent to follow up.
Age: 16.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Pt fainted after receiving flu shot. Pt request water. After drinking water, pt felt better but went to ER as a precaution.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Employee reports she received her flu vaccine in her left deltoid on 9/8/20 from an immunization liaison. States she noticed some redness, swelling, and pain at the site a few hours later that continued to get worse. Reports she also developed a low grade fever of 99.6. Reports she went to urgent care today to be evaluated and was diagnosed with cellulitis.  States she was prescribed Cephalexin.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Chest pain, Dysstasia, Pain in extremity
Clinical narrative: On 9/10/20 at approximately 3:52pm, patient was given a flu shot (Fluad 2020-2021).  I advised him to remain at the pharmacy in case of an adverse event.  Approximately 5 minutes later, patient complained that his legs were hurting and that he was having difficulty standing.  In addition, he claimed to having chest pains.  I then helped him sit down while a nearby patient called 911.  I also gave the patient 4 baby aspirin.  The patient was conscious and aware.  Minutes later, EMTs arrived and measured the patient's vitals.  The patient did stand and seemed to feel better soon after the vitals were taken.  As a precaution, the patient left with the EMTs in an ambulance.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Diarrhoea, Nausea, Pyrexia
Clinical narrative: unsure whether got high dose or regular.  Low grade fever, weakness, diarrhea that was explosive, some nausea. but no vomiting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Muscle spasms, Pain in extremity
Clinical narrative: 48-72 hours after injection patient started to notice a rash around injections site. Patient also has pain and muscle cramping below site of injection.
Age: 73.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthenia, Dizziness, Fall, Head injury, Pain in extremity
Clinical narrative: PATIENT COMPLAINED OF HAVING SEVERE ARM PAIN (WOKE HIM OUT OF HIS SLEEP); DIZZINESS, FREQUENT URINATION (6 TIMES BETWEEN 10:30PM AND 6:30AM WITH FULL BLADDER EACH TIME), AND FAINTING (ONCE AT 6:30AM THE MORNING AFTER RECEIVING THE VACCINE-PT SAID HE HIT HIS FACE ON THE WALL FIXTURES AS HE FELL). SAID HE WAS STILL FEELING WEAK AND A LITTLE DIZZY AT THE TIME OF THE REPORT/COMPLAINT (NOON 9/11/20). HE WAS INSTRUCTED TO IMMEDIATELY SEE A PHYSICIAN.
Age: 73.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pollakiuria, Poor quality sleep, Syncope
Clinical narrative: PATIENT COMPLAINED OF HAVING SEVERE ARM PAIN (WOKE HIM OUT OF HIS SLEEP); DIZZINESS, FREQUENT URINATION (6 TIMES BETWEEN 10:30PM AND 6:30AM WITH FULL BLADDER EACH TIME), AND FAINTING (ONCE AT 6:30AM THE MORNING AFTER RECEIVING THE VACCINE-PT SAID HE HIT HIS FACE ON THE WALL FIXTURES AS HE FELL). SAID HE WAS STILL FEELING WEAK AND A LITTLE DIZZY AT THE TIME OF THE REPORT/COMPLAINT (NOON 9/11/20). HE WAS INSTRUCTED TO IMMEDIATELY SEE A PHYSICIAN.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes virus infection
Clinical narrative: Previous to receiving this vaccine I had only approximately 2 or 3 herpes outbreaks per year.  In the past 3 years, I have had 25 outbreaks.
Age: 83.0
Sex: M
Vaccine: FLUA4
Symptoms: Contusion
Clinical narrative: Patient saw MD on 9/11/20 for follow up and showed bruising of arm. Patient stated that MD said they were not worried about bruising on arm, but to show pharmacy. Patient presented to pharmacy to pick up medications and show bruising of arm.
Age: 0.58
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient given Flucelvax Quad on 9/10/2020 at 12:30pm by me. No signs or symptoms.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Irritable bowel syndrome, Migraine, Ovarian cyst, Small fibre neuropathy
Clinical narrative: None at time of injection.  Adverse events later in life- neurologist seen for migraines and diagnosis of small fiber neuropathy. Dr. seen for IBS.
Age: 37.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: About 24 hours post injection, the injection site is raised hard warm to touch and red covering a good portion of my upper arm . Also was accompanied by a severe headache for 12 hours with no relief from Tylenol, Motrin or ice on the injection site .
Age: 51.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Underdose
Clinical narrative: she was given the pediatric dose instead of the adult doses
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: reddish rectangular patch around area of arm; 3x 5 inches
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient stated that her arm became red, swollen, and tender for an area a couple of inches wide around the vaccine site.
Age: 2.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient given Flucelvax Quad on 9/10/2020 at 12:30pm by me. No signs or symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival disorder, Oral discomfort, Stomatitis, Throat irritation, Tongue disorder
Clinical narrative: Mouth sores and bumps on tongue and lower gums. Burning, sore and more aggravated when eating and drinking. Slight irritation of tonsils, throat and uvula. Duration: 8/15/2020 to date. Still have sores on lover gum and unable to wear my dental partial.
Age: 28.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Sore are, red, warm swollen injection site, low grade fever
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to get the MMR vaccine.  Pharmacist on duty injected Varicella instead of MMR.  Patient had already received the two doses of Varicella earlier in the year. Patient had no symptoms
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Rash
Clinical narrative: day following vaccine patient reported chills and diffuse rash on her arm- covering the upper half of the upper arm- resolved on it's own in 3-4 days
Age: 64.0
Sex: F
Vaccine: FLUA4
Symptoms: Pruritus, Swelling of eyelid, Urticaria
Clinical narrative: About 48 hrs after injection, started feeling itchy and noticed hives on face.  Took dose of Benadryl and hives abated somewhat.  The next morning, hives were now welts and were all over face and neck.  Eyes were almost swollen shut.  Took 2 more doses of Benadryl with little effect.  Went to Urgent Care and was given an injection of Prednisone.  Was also given Rx for Prednisone for a week and told to continue to take double doses of Benadryl.  The welts slowly abated and were gone within 8 days.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: pt had a 101 degree fever and her arm got red and swolen (she reported it we didnt see it)
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: MMRV was administered rather than MMR for a patient over the age of 12. Spoke to immunization registry, they stated that both doses will still count toward series and to not re-dose either. Pt shouldn't experience any adverse effects from MMRV.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: Rash all over shoulders and down back resembling shingles and low grade fever. Started the day after vaccine and the rash is still present almost 2 weeks later
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Inflammation, Nausea, Pain in extremity, Vomiting
Clinical narrative: Flu vaccine -  Arm pain/felt inflamed (afternoon) Headache (overnight) Nausea (next day) and throwing up
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: red,hot
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Electroencephalogram, Fall, Magnetic resonance imaging, Postictal state, Tonic clonic movements
Clinical narrative: Per Parent approximately 1 hour after injection, pt was dropped off at daycare there she had a episode with tonic-clonic movment. Event was witnessed by security camera and staff, when she fell forward and had tonic-clonic movement of her lower extremities and contractions of her upper extremities. Pt was post ictal  for ~ 20 min.  No bowel or bladder incontinence noted.  Pt was seen at ED
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Large welt oh right leg (size of a grapefruit) hot to touch
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Chills, Diarrhoea, Enuresis, Fatigue
Clinical narrative: - Chilling, diarrhea, abdominal pain, wetting at night, tiredness, body ache
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: - Chilling, diarrhea, abdominal pain, wetting at night, tiredness, body ache
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: The patient received the flu shot first and then waited in consultation room and watched her sister and father also receive a flu shot.  After they were done and the whole family was  going to leave the consultation room the patient fainted and hit her head on the wall (occurred a few minutes after she had received the shot).  She seemed to lose consciousness for a few seconds. 911 was called but then canceled because her father said she was ok.  We also gave her a bottle of water which she took with her when she left the building.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: localized redness and swelling of the left upper arm (6cm circumference). perfectly round skin nodule
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Chills, Diarrhoea, Enuresis, Fatigue
Clinical narrative: - Chilling, diarrhea, abdominal pain, wetting at night, tiredness, body ache
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, SARS-CoV-2 test negative
Clinical narrative: - Chilling, diarrhea, abdominal pain, wetting at night, tiredness, body ache
Age: 9.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None reported at moment. FluBlok for adult given to 9 year old
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: large swollen, hot, red area on arm. Ran fever since 9/9/2020
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: By morning after the injection, I was experiencing a severe headache, sore arm, muscles and a mild fever (99-101).   Headache and muscle soreness lasted until about 7 pm that evening - about 12 hours.    All symptoms, except for a sore arm near the injection site, were gone by the next morning.
Age: 24.0
Sex: M
Vaccine: ANTH, HPV9, JEV1
Symptoms: Loss of consciousness, Mydriasis, Oxygen saturation normal, Syncope
Clinical narrative: Patient develops syncope with bilateral symmetrical pupil dilation.  Duration aprox. 1 minute with return to consciousness in supine position.  Patient states no memory of adverse event.  Patient AO for place, time, name, and reason for medical encounter, but not oriented for period during loss of consciousness.  Patient instructed to stay in supine during medical assessment and assessment of vitals signs.  Patient examined by medical provider without any significant or adverse findings.  Patient left the facility without assistance once post medical observation period ended for adverse event.  Patient instructed by provider to follow-up with PCM for further evaluation.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Feeding disorder, Vomiting
Clinical narrative: Felt fine the next day - 9-8-2020,  On 9-9-2020 SEVERE  Diarrhea  (9 movements) and SEVERE Vomiting (4 )  This went on for 13 hours. On 9-10-20 could not eat a thing.  The above stopped but was completely wiped out.