chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: they received shipment not realizing it was a day late and gave one dose of Adacel; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 13 years old male patient who received 0.5 ml  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6273AA via intramuscular route in the left deltoid, on 01-Aug-2019. It was reported that they received shipment not realizing it was a day late and gave one dose of Adacel.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due incorrect product storage.  It was unknown whether the patient had any adverse event.  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.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered to a 6 month old patient on 02Aug2019; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who experienced inadvertently administered to a 6 month old patient on 02aug2019, while she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomintant medication included PCV13, Hepatitis B.  On 02-Aug-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5248AA via intramuscular route in the right thigh.  It was of actual medication error due to  inappropriate age at vaccine administration..  It was unknown if adverse event was experienced.  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.  List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Daptacel administered to patient; Initial information received on 05-Aug-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office Staff).  This case involves a five years old female patient who received expired 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5180BA and Exp. Date 06-Apr-2019) via intramuscular route in the upper left thigh, on 05-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), POLIO VACCINE INACT 3V (VERO) (IPOL) and HEPATITIS B VACCINE for Immunisation.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether the patients had any adverse reactions.  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.  List of documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: Pt started with facial swelling 24 hours after her MMR vaccine. At 48 hours the swelling was severe enough to warrant an ER visit and treatment.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Skin warm
Clinical narrative: 8 cm diameter warm rash, no pain, fever or complaints
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Blood glucose normal, Dizziness, Nausea, Pain in extremity
Clinical narrative: Please note the above Manufacturer for Bexsero is incorrect.  The correct manufacturer is GSK. After patient's clinic appointment, she went outside to wait in the family vehicle with the car off and the windows down while her Mother and sibling were in the clinic seeing another provider.   Patient's Mom notified me at 15:52 that patient had texted her from the car and asked if we had anything she could "throw up in".  I instructed Mom to have patient come back into clinic.  Patient was extremely pale.  Patient c/o nausea, dizziness/weakness and significant right arm pain.  BP:  70/42  P:  96 (Prior to vaccine administration BP: 102/62  P:  91 [which is what she normally runs]).  Glucose POC:  75. Pt was monitored, candy and Coca Cola provided to increase blood sugar.  Tolerated candy however, Coca Cola exacerbated nausea.  Pt was continually monitored in clinic until BP returned to normal (for her).  She continued w/dizziness and nausea.  Phenergan 25mg was administered IM @ 16:56.  Pt was monitored an additional 15 minutes.  Nausea improved; remained w/slight dizziness.  Pt was escorted to family vehicle.   Spoke w/at 17:51 and patient was sleeping. Spoke w/Mom @ 18:43 and patient was up, feeling better and eating. 8-8-19 @ 09:38 spoke w/Mom:  Patient was still feeling "woozy".  Blood glucose per Mom's glucometer was 124 and BP w/home monitor was 115/74   P:  95.  Continued to c/o right arm pain.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pallor
Clinical narrative: Please note the above Manufacturer for Bexsero is incorrect.  The correct manufacturer is GSK. After patient's clinic appointment, she went outside to wait in the family vehicle with the car off and the windows down while her Mother and sibling were in the clinic seeing another provider.   Patient's Mom notified me at 15:52 that patient had texted her from the car and asked if we had anything she could "throw up in".  I instructed Mom to have patient come back into clinic.  Patient was extremely pale.  Patient c/o nausea, dizziness/weakness and significant right arm pain.  BP:  70/42  P:  96 (Prior to vaccine administration BP: 102/62  P:  91 [which is what she normally runs]).  Glucose POC:  75. Pt was monitored, candy and Coca Cola provided to increase blood sugar.  Tolerated candy however, Coca Cola exacerbated nausea.  Pt was continually monitored in clinic until BP returned to normal (for her).  She continued w/dizziness and nausea.  Phenergan 25mg was administered IM @ 16:56.  Pt was monitored an additional 15 minutes.  Nausea improved; remained w/slight dizziness.  Pt was escorted to family vehicle.   Spoke w/at 17:51 and patient was sleeping. Spoke w/Mom @ 18:43 and patient was up, feeling better and eating. 8-8-19 @ 09:38 spoke w/Mom:  Patient was still feeling "woozy".  Blood glucose per Mom's glucometer was 124 and BP w/home monitor was 115/74   P:  95.  Continued to c/o right arm pain.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unspecified date in 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, lot #, expiration date and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions by a pharmacist in a pharmacy. Subsequent to the patient's inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   On an unspecified date in 2016, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequent to patient's vaccine inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 would continue to suffer such losses, and damages in the future.   The outcome of the events was considered not recovered. Causality assessment was related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and/or zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. As a direct and proximate result of patient' use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 would continue to suffer such losses, and damages in the future.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a  lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 24-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's  inoculation, patient was treated by a healthcare provide for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions or concomitant medications. On or about January 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose # and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient inoculation, the patient was treated for herpes zoster or shingles. As a direct and proximate result of the patient's use of the ZOSTAVAX vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs 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. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 5.0
Sex: F
Vaccine: MMRV, UNK
Symptoms: Expired product administered, Injection site rash, Rash
Clinical narrative: the patient had developed an unspecified rash on both arms after the administration of PROQUAD on the same day; inadvertently administered an expired dose of PROQUAD; This spontaneous report was received from a nurse refers to a 5 year old female patient. The patient's concurrent condition was not reported. The patient did not have any concomitant medications or pertinent medical history or drug reactions or allergies. On 01-AUG-2019, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R003294, expiration date: 31-JUL-2019, therapy type: recombinant human albumin (rha), in the left arm/deltoid (strength and route of administration was not reported) for prophylaxis (expired product administered). A sterile diluent was used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number: S018820, expiration date: 24-SEP-2019. On 01-AUG-2019, on the same day after the administration of the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), the patient had developed an unspecified rash on both arms. The outcome of rash was reported as not recovered. The reporter's causality assessment between the suspect products and rash was not reported. No treatment was given for treating rash. No lab diagnostics or studies were performed. No product quality complaints were involved. There were no intervention to prevent serious criteria.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019 15:00, the patient received the 1st dose of Shingrix. In July 2019, several hours after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. On the day of reporting in the morning, the patient had headache and fever. The patient enquired whether he/she should take something or let it to run the course. Also how long he/she should expect this to last. The patient enquired about to take second round.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: feet were swollen; This case was reported by a consumer and described the occurrence of swelling of feet in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019, the patient received Shingrix. On 30th July 2019, 1 days after receiving Shingrix, the patient experienced swelling of feet. On an unknown date, the outcome of the swelling of feet was not recovered/not resolved.   It was unknown if the reporter considered the swelling of feet to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and feet were swollen and they were, at the time of reporting. The swelling did not go down overnight.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Pruritus, Rash, Skin burning sensation
Clinical narrative: Shingles; Itching; Rash / Rash on back; Pain in lower chest on the left side; Burning; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2019, 1 days after receiving Shingrix, the patient experienced shingles, pruritus, rash, chest pain and burning skin. The patient was treated with valaciclovir hydrochloride (Valtrex), lidocaine hydrochloride (Lidocaine) and gabapentin. On an unknown date, the outcome of the shingles, pruritus, rash, chest pain and burning skin were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pruritus, rash, chest pain and burning skin to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the patient's wife. The patient received vaccine in left arm. The next day after vaccination the patient started experiencing pain in his lower chest on the left side. It became itchy, then broke out into a rash.  On saturday, 27th July 2019, patient went to the emergency room and was diagnosed with shingles. The rash extended from the center of his chest and all the way around to his back. The reporter stated that patient getting a rip roaring case of shingles from just having the first vaccine of the new shingles shot. The patient had been prescribed with Valtrex, gabapentin and lidocaine patches. The reporter gave permission to follow up. In the XML document outcome of events was reported as recovering, but in Argus its mentioned as not recovered, so kept as reported in Argus.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Night sweats, Pyrexia
Clinical narrative: flu like symptoms; chills; headache; Fever; Night sweats; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, chills, headache, fever and night sweat. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, chills, headache, fever and night sweat were unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, headache, fever and night sweat to be related to Shingrix.  Additional details were provided as follows: The patient experienced influenza-like symptoms, chills, headache, fever and night sweat. Fever reported was 102.4 F. Tylenol got the temperature down to 101.1 F. At the time of reporting the temperature was 100 F. The patient declined to provide demographics or follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: nausea; shivering; injection site very hot; injection site red; injection site swollen; fever blister; bumps which are itchy; bumps are scabby; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th July 2019, less than a day after receiving Shingrix, the patient experienced nausea, shivering, injection site warmth, injection site erythema, injection site swelling and fever blister. In July 2019, the patient experienced itchy rash and scab. On 12th July 2019, the outcome of the nausea and shivering were resolved with sequelae. On 16th July 2019, the outcome of the injection site warmth, injection site erythema and injection site swelling were resolved with sequelae. On 21st July 2019, the outcome of the fever blister was resolved with sequelae. On an unknown date, the outcome of the itchy rash and scab were recovering/resolving.   It was unknown if the reporter considered the nausea, shivering, injection site warmth, injection site erythema, injection site swelling, fever blister, itchy rash and scab to be related to Shingrix.  Additional details were provided as follows: On 11th July 2019, the patient received the 1st dose of Shingrix and experienced nausea, shivering, injection site warmth, injection site erythema, injection site swelling and fever blister. The patient stated that the nausea and shivering resolved the next day of vaccination. Injection site reaction took around 4-5 days to resolve. The patient stated that around two weeks later she started to notice bumps which are itchy located below the injection site on her left arm but around 2 inches above the elbow. The patient stated that the bumps were scabby, maybe because she was scratching it in her sleep. The patient consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Rash pruritic, Scab
Clinical narrative: nausea; shivering; injection site very hot; injection site red; injection site swollen; fever blister; bumps which are itchy; bumps are scabby; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th July 2019, less than a day after receiving Shingrix, the patient experienced nausea, shivering, injection site warmth, injection site erythema, injection site swelling and fever blister. In July 2019, the patient experienced itchy rash and scab. On 12th July 2019, the outcome of the nausea and shivering were resolved with sequelae. On 16th July 2019, the outcome of the injection site warmth, injection site erythema and injection site swelling were resolved with sequelae. On 21st July 2019, the outcome of the fever blister was resolved with sequelae. On an unknown date, the outcome of the itchy rash and scab were recovering/resolving.   It was unknown if the reporter considered the nausea, shivering, injection site warmth, injection site erythema, injection site swelling, fever blister, itchy rash and scab to be related to Shingrix.  Additional details were provided as follows: On 11th July 2019, the patient received the 1st dose of Shingrix and experienced nausea, shivering, injection site warmth, injection site erythema, injection site swelling and fever blister. The patient stated that the nausea and shivering resolved the next day of vaccination. Injection site reaction took around 4-5 days to resolve. The patient stated that around two weeks later she started to notice bumps which are itchy located below the injection site on her left arm but around 2 inches above the elbow. The patient stated that the bumps were scabby, maybe because she was scratching it in her sleep. The patient consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Nausea, Pain
Clinical narrative: Flu-like symptoms; Fatigue; Aches; Nausea; feeling "icky and blah; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms 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, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue, pain, nausea and feeling abnormal. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the fatigue, pain, nausea and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fatigue, pain, nausea and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The age group was captured as adult as per Shingrix indication.  The reporter reported that a number of patients (exact number unknown) had reported flu-like symptoms after having Shingrix.  The side effects include fatigue (feeling "icky and blah"), aches, and nausea that usually resolve about 48 hours after receiving the vaccine. The reporter gave permission to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; fever; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms 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, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms and fever. On an unknown date, the outcome of the influenza-like symptoms and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient took one dose of Shingrix and developed flu like symptoms and fever. This happened a few months ago and the patient was fine.  The patient had the dose at a pharmacy, it wasn't at reporter's office. The reporter gave permission to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: A little bruise at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising 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, 5 days after receiving Shingrix, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was unknown.   It was unknown if the reporter considered the injection site bruising to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient experienced "a little bruise" at the injection site five days after receiving Shingrix. The healthcare professional was in a hurry and could not share more information. The reporter did not give permission to follow up.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Hyperhidrosis, Palpitations, Pyrexia
Clinical narrative: On the evening after receiving the vaccination the patient became febrile (101.4), development weakness, chills, sweats, and heart palpitations. She did not go to ER, took tylenol (x 3) and attempted to "sleep it off". These symptoms continued to occur daily (less intensity each day). Seen again in clinic on 7/29/19. Pt slightly improved but concerned about reaction. Provided patient with prednisone burst and encouraged to follow up as needed.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Immediate post-injection reaction, Swelling
Clinical narrative: The pharmacy student that was working administered the vaccine. Less than 30 seconds after administration, bruising/swelling occurred. The bruise was marble-sized under the skin. I had the patient wait for at least 15 minutes so I could monitor her. During this time period, she felt fine and was not concerned. I think upon injection the pharmacy student hit a capillary or vessel causing the immediate bruising and swelling. About 4 hours after the patient left, I gave her a call to check on her. She stated that the swelling had gone down and her arm felt fine and similar to other post-vaccination periods.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Feeling cold, Headache, Oral pain, Oropharyngeal pain
Clinical narrative: After midnight   I felt VERY cold, had to wrap myself  in blankets;  for 6 hours,  later developed cough  and sore throat and mouth,  dull headache  which continued for 5 days.   I guess I am improving now but do not want to get the second shot  in October,  do not want to get sick again.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Malaise
Clinical narrative: became tired and sleepy  with increasing joint ache, headache, sore arm and redness in the area of the injection and  painful around neck and neck area.  Some muscle pain but the worst was the joint pain even in my fingers and a general malaise.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pain in extremity, Somnolence
Clinical narrative: became tired and sleepy  with increasing joint ache, headache, sore arm and redness in the area of the injection and  painful around neck and neck area.  Some muscle pain but the worst was the joint pain even in my fingers and a general malaise.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given the Pneumonia vaccine Friday 8/2/10 afternoon around 12:45. At the time of injection she had no reaction. Patient came into the office Monday with complaints of redness,swelling and heat at the injection site that traveled around the bottom of her arm that was present over the weekend. By the time she came in Monday the reaction was almost resolved. It was documented in the chart and physician has been informed.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's inoculation, patient was treated by a healthcare provide for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 reported as not recovered.   The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: Swelling at injection site; Redness at injection site; This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABX749AA, expiry date 29th February 2020) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Bexsero. On an unknown date, less than 2 months after receiving Bexsero, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Bexsero.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient had "quite an impressive amount of swelling and redness at the injection site. The patient was unsure how long the symptoms lasted but stated that she was better now. The reporter gave permission to follow up.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Granulocyte count, Haemoglobin normal, Platelet count decreased, Pyrexia, Rash
Clinical narrative: Fever rash S1. Low platelets, Granulocytes  & 1 wk after MMR
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Vertigo, Vomiting
Clinical narrative: ADVERSE EVENTS: VERTIGO, DIARRHEA, VOMITING, &  CHILLS  TREATMENT: OTC TYLENOL/ IBUPROFEN, MECLINIZE
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood magnesium, Chest X-ray, Culture throat, Diarrhoea, Differential white blood cell count
Clinical narrative: Low grade fever, nausea, diarreha, night sweats when Tylenol seemed to 'break' the fever...but did not actually end it.      Symptoms began late evening after the afternoon shot.     Were told to expect 1-3 days of "possible symptoms' so continued to treat with OTC meds  (Tylenol, pepto bisnol)...and bed rest.    Symptoms would moderate slightly but never went away.     Nausea and diarreha 'out ran' the ability to stay hydrated.     On the 6th day took my wife to ER.    She was given one bag of fluids and prescriptions.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Glomerular filtration rate, Metabolic function test, Microscopy, Nausea
Clinical narrative: Low grade fever, nausea, diarreha, night sweats when Tylenol seemed to 'break' the fever...but did not actually end it.      Symptoms began late evening after the afternoon shot.     Were told to expect 1-3 days of "possible symptoms' so continued to treat with OTC meds  (Tylenol, pepto bisnol)...and bed rest.    Symptoms would moderate slightly but never went away.     Nausea and diarreha 'out ran' the ability to stay hydrated.     On the 6th day took my wife to ER.    She was given one bag of fluids and prescriptions.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats, Pyrexia, Streptococcus test, Ultrasound scan, Urine analysis
Clinical narrative: Low grade fever, nausea, diarreha, night sweats when Tylenol seemed to 'break' the fever...but did not actually end it.      Symptoms began late evening after the afternoon shot.     Were told to expect 1-3 days of "possible symptoms' so continued to treat with OTC meds  (Tylenol, pepto bisnol)...and bed rest.    Symptoms would moderate slightly but never went away.     Nausea and diarreha 'out ran' the ability to stay hydrated.     On the 6th day took my wife to ER.    She was given one bag of fluids and prescriptions.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Product administered at inappropriate site
Clinical narrative: Patient was administered second dose in wrong location.  Pharmacist administered  too low.  Patient had large red skin reaction about 3 inches in size.  A follow up call 2 days later and patient is felling better.  Patient works at dr office and was looked at.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Tremor
Clinical narrative: Patient had extreme shaking and a bad headache. Patient thought she was having a stroke.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Varicella zoster pneumonia
Clinical narrative: varicella pneumonia; death; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to pt's inoculation, pt was treated by a healthcare provider for varicella penumonia. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had suffered serious injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses, 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. On an unknown date, the patient died due to unknown reason. It was not reported if an autopsy was performed. The outcome of varicella pneumonia was unknown.  The reporter considered varicella zoster pneumonia to be related to Zoster Vaccine Live (ZOSTAVAX). The causality between the Zoster Vaccine Live (ZOSTAVAX) and death was not provided.   Upon internal review, the event of varicella pneumonia was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's inoculation, patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 would continue to suffer such losses, and damages in the future. At the reporting time, the outcome of shingles was considered as not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 11-SEP-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patients inoculation, patient was treated by a healthcare provider for herpes zoster. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 would continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was considered as not recovered.  The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's inoculation, patient was treated by a healthcare provider for shingles.. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 would continue to suffer such losses, and damages in the future.   At the reporting time, the outcome of shingles was considered.  The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 41.0
Sex: F
Vaccine: PPV, UNK, UNK
Symptoms: Abdominal discomfort, Adverse drug reaction, Anaphylactic reaction, Peripheral swelling, Swelling
Clinical narrative: anaphylactic reaction described as "her entire arm swelled into her neck"; the steroids, "epi's, and Benadryl upset her stomach"; This spontaneous report was received from a currently 42-year-old female patient referring to herself, via a field representative. The patient's concurrent conditions included Addison's disease and autoimmune deficiencies. The patient received 13-valent pneumococcal vaccine in the past (reported as PCV13) without any reaction. On 27-SEP-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot# R000772 verified to be a non-valid lot number, expiration date 10-MAR-2020, (exact dose and route of administration were not reported) for prevention of pneumococcal disease. There was no information about the patient's concomitant therapies. On the same day, the patient experienced anaphylactic reaction described as "her entire arm swelled into her neck". She was hospitalized for three days at an unspecified facility, was given unspecified steroids, two doses of epinephrine (reported as "two epi's"), and diphenhydramine hydrochloride (BENADRYL). The reporter stated that the steroids, epinephrine and diphenhydramine hydrochloride (BENADRYL) upset her stomach and as treatment she was given an unspecified "stomach medication". The patient recovered "by the fourth day". The outcome of anaphylactic reaction and upset stomach was reported as recovered on approximately 30-SEP-2018 (by the fourth day). There was no causality assessment provided by the reporter.   Upon internal review, the event of anaphylactic reaction was considered to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-0095075143-1908USA001571: