chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Diagnostic procedure, Feeling abnormal, Generalised tonic-clonic seizure, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: After the first shot, August 18, 2016 she started to notice something randomly but after the second shot on August 29, 2017 she noticed that weird something was happening more often.  A few months after the shot, pt started to tell me something weird keeps happening to me.   She said her friend had noticed something weird happens to her too.  I still hadn't seen anything.  I tried to have her explain to me what was happening but  she couldn't.   It happened more frequently in the mornings.  Then on the day before Thanksgiving 2018 (over a year and a half after she was telling me something weird was happening) I saw it happened.  Pt had a seizure right in front of me.   It was a small seizure and from then we saw them often.   Doctors said she had absent seizures and started her on meds.   Within a few weeks they turned into Grand Mal Seizures.  Pt could not attend school from that Thanksgiving.   She was a very active child involved in sports and after school activities and her whole life stopped.   One of the seizures was so bad the Ambulance had to bring her to Hospital.   The meds have not cured her situation yet.  We are continually working on finding a way to stop the seizures and for  to go back to her normal life.   She took a sleeping test and it showed 29 mini seizures in 1 1/2 day period.   This is a child that NEVER had any problems until the HPV shot was given.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Petit mal epilepsy, Seizure, Sleep study abnormal
Clinical narrative: After the first shot, August 18, 2016 she started to notice something randomly but after the second shot on August 29, 2017 she noticed that weird something was happening more often.  A few months after the shot, pt started to tell me something weird keeps happening to me.   She said her friend had noticed something weird happens to her too.  I still hadn't seen anything.  I tried to have her explain to me what was happening but  she couldn't.   It happened more frequently in the mornings.  Then on the day before Thanksgiving 2018 (over a year and a half after she was telling me something weird was happening) I saw it happened.  Pt had a seizure right in front of me.   It was a small seizure and from then we saw them often.   Doctors said she had absent seizures and started her on meds.   Within a few weeks they turned into Grand Mal Seizures.  Pt could not attend school from that Thanksgiving.   She was a very active child involved in sports and after school activities and her whole life stopped.   One of the seizures was so bad the Ambulance had to bring her to Hospital.   The meds have not cured her situation yet.  We are continually working on finding a way to stop the seizures and for  to go back to her normal life.   She took a sleeping test and it showed 29 mini seizures in 1 1/2 day period.   This is a child that NEVER had any problems until the HPV shot was given.
Age: 11.0
Sex: M
Vaccine: HEPA, IPV, TD, VARCEL
Symptoms: Cellulitis, Injection site erythema, Vaccination site swelling
Clinical narrative: On 6/18/19 back of rt arm given VARIVAX sq pt re-visited clinic on 6/20/19 and vaccine site appeared red swollen about 7 am at 9 am. Pt referred to office at 11:30 am on 6-20-19. They were rx for cellulitis with cephalexin 250 mg 4 x daily/one wk.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; Patient was inadvertently administered one dose of expired VAQTA; This spontaneous report was received from a Registered Nurse concerning to a patient of an unknown age, race and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 14-JUN-2019, the patient was vaccinated with one dose of expired Hepatitis A Vaccine, inactivated (VAQTA) (expired product administered) 25/0.5 (units not reported) lot number R013858 with expiration date on 12-JUN-2019 (route of administration and frequency were not reported) for prophylaxis. The outcome of expired vaccine used was unknown.   No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-JUN-2011, the patient was vaccinated by a healthcare provider with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions prescribed by a healthcare provider. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by  pharmacist for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for the event. The outcome of the event  was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 60.0
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 currently 65-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 31-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for the event. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 52 year old female patient received a dose of GARDASIL 9; No adverse effects reported; This spontaneous report as received from a pharmacist refers to a 52-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical site, lot # and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events; improperly stored Proquad; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.    On 19-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R028531, expiration date 02-APR-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion from -14 to -10 degrees Celsius (-13.3 degrees Celsius) for 30 minutes and from 9 to 25 degrees Celsius (17.8 degrees Celsius, multiple) for 32 minutes. The data logger was involved. There were no previous excursions reported.     The outcome of product storage error was unknown.   This report is cross-referenced with MARRS # 1906USA008121 and MARRS #1906USA008290 (same reporter).; Sender's Comments:  US-009507513-1906USA008121: US-009507513-1906USA008290:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: it felt like she had the flu.; there was a red bump and the area was swollen for a week after.; there was a red bump and the area was swollen for a week after.; Sick; vomite; Aching; having no energy; sleeping all day; This case was reported by a consumer via patient support programs and described the occurrence of sickness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema. On an unknown date, the outcome of the sickness, vomiting, pain, asthenia, somnolence, injection site swelling and injection site erythema were recovered/resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient called and advise that the shingrix medication made her sick.  The patient stated that she had been vomiting, aching, having no energy, sleeping all day and the symptoms lasted 1 and half days.  The patient felt like she had the flu. The patient stated that where the pharmacist injected the vaccine, there was a red bump and the area was swollen for a week after.  The patient also stated the same thing happened both times she received the injections. For tolerance dose, reference case US2019GSK112613.; Sender's Comments: Patient called to advise that the shingrix medication made her sick. She stated she has been vomiting, aching, having no energy, sleeping all day and the symptoms lasted 1 ½ days. She stated it felt like she had the flu. Patient stated where the pharmacist injected the vaccine, there was a red bump and the area was swollen for a week after. Patient also stated the same thing happened both times she received the injections.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Somnolence, Vomiting
Clinical narrative: it felt like she had the flu.; there was a red bump and the area was swollen for a week after.; there was a red bump and the area was swollen for a week after.; Sick; vomite; Aching; having no energy; sleeping all day; This case was reported by a consumer via patient support programs and described the occurrence of sickness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema. On an unknown date, the outcome of the sickness, vomiting, pain, asthenia, somnolence, injection site swelling and injection site erythema were recovered/resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient called and advise that the shingrix medication made her sick.  The patient stated that she had been vomiting, aching, having no energy, sleeping all day and the symptoms lasted 1 and half days.  The patient felt like she had the flu. The patient stated that where the pharmacist injected the vaccine, there was a red bump and the area was swollen for a week after.  The patient also stated the same thing happened both times she received the injections. For tolerance dose, reference case US2019GSK112613.; Sender's Comments: Patient called to advise that the shingrix medication made her sick. She stated she has been vomiting, aching, having no energy, sleeping all day and the symptoms lasted 1 ½ days. She stated it felt like she had the flu. Patient stated where the pharmacist injected the vaccine, there was a red bump and the area was swollen for a week after. Patient also stated the same thing happened both times she received the injections.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis, Erythema, Feeling hot, Herpes zoster, Pruritus
Clinical narrative: shingles; large red patch on thigh and back; large puffy patch on thigh and back; large itchy patch on thigh and back; fever on patch; skin warm; inflammed patch; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 4 days after receiving Shingrix, the patient experienced shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation. The patient was treated with ethanol (Alcohol) and paracetamol (Tylenol). On an unknown date, the outcome of the shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation were unknown.   It was unknown if the reporter considered the shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left upper arm and experinced side effects similar to shingles. After vaccination with Shingrix, the patient experienced large red, puffy itchy pathech on both thigh and back. The patient reported that, the patch was not painful but had fever in it. Two days before the date of reporting, the patient experienced patch on thigh and one day before the date of reporting, the patch was developed on back of the patient. The patient reported that,the patches were not inflammed today, as she rubbed alcohol on it, and took tylenol to reduce hotness of the patch. The reporter reported that, the Shingrix was non live vaccine and could not cause shingles. The reporter called to physician
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: shingles; large red patch on thigh and back; large puffy patch on thigh and back; large itchy patch on thigh and back; fever on patch; skin warm; inflammed patch; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 4 days after receiving Shingrix, the patient experienced shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation. The patient was treated with ethanol (Alcohol) and paracetamol (Tylenol). On an unknown date, the outcome of the shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation were unknown.   It was unknown if the reporter considered the shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left upper arm and experinced side effects similar to shingles. After vaccination with Shingrix, the patient experienced large red, puffy itchy pathech on both thigh and back. The patient reported that, the patch was not painful but had fever in it. Two days before the date of reporting, the patient experienced patch on thigh and one day before the date of reporting, the patch was developed on back of the patient. The patient reported that,the patches were not inflammed today, as she rubbed alcohol on it, and took tylenol to reduce hotness of the patch. The reporter reported that, the Shingrix was non live vaccine and could not cause shingles. The reporter called to physician
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash generalised, Rash macular, Rash pruritic
Clinical narrative: shingles; large red patch on thigh and back; large puffy patch on thigh and back; large itchy patch on thigh and back; fever on patch; skin warm; inflammed patch; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 4 days after receiving Shingrix, the patient experienced shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation. The patient was treated with ethanol (Alcohol) and paracetamol (Tylenol). On an unknown date, the outcome of the shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation were unknown.   It was unknown if the reporter considered the shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left upper arm and experinced side effects similar to shingles. After vaccination with Shingrix, the patient experienced large red, puffy itchy pathech on both thigh and back. The patient reported that, the patch was not painful but had fever in it. Two days before the date of reporting, the patient experienced patch on thigh and one day before the date of reporting, the patch was developed on back of the patient. The patient reported that,the patches were not inflammed today, as she rubbed alcohol on it, and took tylenol to reduce hotness of the patch. The reporter reported that, the Shingrix was non live vaccine and could not cause shingles. The reporter called to physician
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Skin warm
Clinical narrative: shingles; large red patch on thigh and back; large puffy patch on thigh and back; large itchy patch on thigh and back; fever on patch; skin warm; inflammed patch; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 4 days after receiving Shingrix, the patient experienced shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation. The patient was treated with ethanol (Alcohol) and paracetamol (Tylenol). On an unknown date, the outcome of the shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation were unknown.   It was unknown if the reporter considered the shingles, skin red, swelling, pruritus, localized feeling of warmth, skin warm and skin inflammation to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left upper arm and experinced side effects similar to shingles. After vaccination with Shingrix, the patient experienced large red, puffy itchy pathech on both thigh and back. The patient reported that, the patch was not painful but had fever in it. Two days before the date of reporting, the patient experienced patch on thigh and one day before the date of reporting, the patch was developed on back of the patient. The patient reported that,the patches were not inflammed today, as she rubbed alcohol on it, and took tylenol to reduce hotness of the patch. The reporter reported that, the Shingrix was non live vaccine and could not cause shingles. The reporter called to physician
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: it felt like she had the flu.; there was a red bump and the area was swollen for a week after.; there was a red bump and the area was swollen for a week after.; Sick; vomite; Aching; having no energy; sleeping all day; This case was reported by a consumer via patient support programs and described the occurrence of sickness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on 2nd January 2019, refer case US2019AMR106750).   On 29th April 2019, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness, vomiting, pain, asthenia, somnolence, injection site swelling and injection site erythema were recovered/resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient called and advise that the shingrix medication made her sick.  The patient stated that she had been vomiting, aching, having no energy, sleeping all day and the symptoms lasted 1 and half days.  The patient felt like she had the flu. The patient stated that where the pharmacist injected the vaccine, there was a red bump and the area was swollen for a week after.  The patient also stated the same thing happened both times she received the injections.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Somnolence, Vaccine positive rechallenge, Vomiting
Clinical narrative: it felt like she had the flu.; there was a red bump and the area was swollen for a week after.; there was a red bump and the area was swollen for a week after.; Sick; vomite; Aching; having no energy; sleeping all day; This case was reported by a consumer via patient support programs and described the occurrence of sickness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on 2nd January 2019, refer case US2019AMR106750).   On 29th April 2019, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness, vomiting, pain, asthenia, somnolence, injection site swelling and injection site erythema were recovered/resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient called and advise that the shingrix medication made her sick.  The patient stated that she had been vomiting, aching, having no energy, sleeping all day and the symptoms lasted 1 and half days.  The patient felt like she had the flu. The patient stated that where the pharmacist injected the vaccine, there was a red bump and the area was swollen for a week after.  The patient also stated the same thing happened both times she received the injections.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: Inappropriate site of vaccine administration; shoulder pain; it may be affecting their shoulder movement as well; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced shoulder pain and joint range of motion decreased. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the shoulder pain, joint range of motion decreased and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain and joint range of motion decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The batch number was unknown. The patient received a dose of Shingrix too far above deltoid on 9th or 10th June 2019, which led to vaccine administered at inappropriate site. The patient experienced shoulder pain after this dose, and it may be affecting their shoulder movement as well.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Rash; Itchy; Warm to touch; Vaccine administered at inappropriate site as an event; This case was reported by a pharmacist via call center representative and described the occurrence of red rash in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2020) for prophylaxis.   On 9th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced red rash, itchy rash, skin warm and vaccine administered at inappropriate site. On an unknown date, the outcome of the red rash, itchy rash, skin warm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the red rash, itchy rash and skin warm to be related to Shingrix.  Additional details were provided as follows: The health care professional stated that the patient received Shingrix Injection administered on patient's back side of arm.  The front side had redness covering the whole bicep. The health care professional described it looked like a rash, warm to touch, little itchy, 4 inches long and 3 inches wide.  Pharmacist asked any information on Shingrix reaction on the opposite side of the arm.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Inflammation, Limb discomfort, Musculoskeletal discomfort, Pruritus generalised
Clinical narrative: leg itching/groin itching; groin itching and discomfort; legs discomfort; Jock itch; condition aggravated; systemic hives, itching, inflammation; systemic hives, itching, inflammation; Systemic itching; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th March 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th March 2019, not applicable after receiving Shingrix and immediately after receiving Shingrix, the patient experienced condition aggravated, hives, inflammation and generalized pruritus. On an unknown date, the patient experienced pruritus, groin discomfort, leg discomfort and tinea cruris. The patient was treated with antifungals for topical use. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pruritus, groin discomfort, leg discomfort and tinea cruris were not recovered/not resolved and the outcome of the condition aggravated, hives, inflammation and generalized pruritus were recovering/resolving.   It was unknown if the reporter considered the pruritus, groin discomfort, leg discomfort, tinea cruris, condition aggravated, hives, inflammation and generalized pruritus to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination for the 1st dose was not reported but it could be 61years or 62 years. At the end of summer of last year, the patient had his 1st dose of Shingrix. Within one week, the patient developed itching and discomfort throughout his legs and groin. He thought it was jock itch and treated with an anti-fungal spray but was not resolved.  On 14th March 2019, the patient received dose 2 of Shingrix and immediately the previous symptoms got worse. Additionally less than a day after 2nd dose, systemic hives, inflammation and itching started. These symptoms had improved but not resolved.  Emergency visit was required and the patient sought medical care for this. The patient consented to follow up and also provided healthcare professional's address. The patient did not have vaccine information and some details were missing which he did not know.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tinea cruris, Urticaria, Vaccine positive rechallenge
Clinical narrative: leg itching/groin itching; groin itching and discomfort; legs discomfort; Jock itch; condition aggravated; systemic hives, itching, inflammation; systemic hives, itching, inflammation; Systemic itching; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th March 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th March 2019, not applicable after receiving Shingrix and immediately after receiving Shingrix, the patient experienced condition aggravated, hives, inflammation and generalized pruritus. On an unknown date, the patient experienced pruritus, groin discomfort, leg discomfort and tinea cruris. The patient was treated with antifungals for topical use. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pruritus, groin discomfort, leg discomfort and tinea cruris were not recovered/not resolved and the outcome of the condition aggravated, hives, inflammation and generalized pruritus were recovering/resolving.   It was unknown if the reporter considered the pruritus, groin discomfort, leg discomfort, tinea cruris, condition aggravated, hives, inflammation and generalized pruritus to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination for the 1st dose was not reported but it could be 61years or 62 years. At the end of summer of last year, the patient had his 1st dose of Shingrix. Within one week, the patient developed itching and discomfort throughout his legs and groin. He thought it was jock itch and treated with an anti-fungal spray but was not resolved.  On 14th March 2019, the patient received dose 2 of Shingrix and immediately the previous symptoms got worse. Additionally less than a day after 2nd dose, systemic hives, inflammation and itching started. These symptoms had improved but not resolved.  Emergency visit was required and the patient sought medical care for this. The patient consented to follow up and also provided healthcare professional's address. The patient did not have vaccine information and some details were missing which he did not know.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Nausea, Pain in extremity
Clinical narrative: arm soreness; dull headache; nausea; today not feeling 100%; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2019, the patient received the 1st dose of Shingrix. On 14th June 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, headache dull, nausea and feeling unwell. On an unknown date, the outcome of the pain in arm, headache dull, nausea and feeling unwell were unknown.   It was unknown if the reporter considered the pain in arm, headache dull, nausea and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. on the day of reporting the patient not feeling 100 percent. He noted arm soreness, dull headache and nausea somewhat.  The reporter did not consent to follow up
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Upper respiratory tract infection
Clinical narrative: Upper Respiratory Infection; This case was reported by a pharmacist via call center representative and described the occurrence of upper respiratory tract infection in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced upper respiratory tract infection. The patient was treated with prednisone. On an unknown date, the outcome of the upper respiratory tract infection was unknown.   It was unknown if the reporter considered the upper respiratory tract infection to be related to Shingrix.  Additional details were provided as follows: The patient developed an upper respiratory infection after they received the dose of Shingrix. They were being treated with Prednisone, at the time of reporting.  No additional information was provided
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Blood culture, C-reactive protein, Erythema multiforme, Mycoplasma test, Pyrexia
Clinical narrative: Patient received both vaccines on 5/31/19 and on this same day she was diagnosed with an ear infection. Vitals for this visit appear normal however i suspect that Patient may have also had a fever that was being controlled by Tylenol. I asked the provider if it was ok to vaccinate under current circumstances (i.e. ear infection) and she said it was fine.  Therefore Patient was vaccinated and later that day began a 10-day treatment of antibiotics.   -6/9 was her last day of antibiotics (Amoxicilan) and then on 6/10 is when we began to see hives around her torso which later spread everywhere (except inside mouth) and the rash became worse between 6/10 and 6/13 leading to 2 doctor's visits and 1 ER visit.  During this time (6/11-6/14) she also had a high fever 100 to 103 in spite of Tylenol  -The primary diagnosis was Erythema Multiforme
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Urticaria
Clinical narrative: Patient received both vaccines on 5/31/19 and on this same day she was diagnosed with an ear infection. Vitals for this visit appear normal however i suspect that Patient may have also had a fever that was being controlled by Tylenol. I asked the provider if it was ok to vaccinate under current circumstances (i.e. ear infection) and she said it was fine.  Therefore Patient was vaccinated and later that day began a 10-day treatment of antibiotics.   -6/9 was her last day of antibiotics (Amoxicilan) and then on 6/10 is when we began to see hives around her torso which later spread everywhere (except inside mouth) and the rash became worse between 6/10 and 6/13 leading to 2 doctor's visits and 1 ER visit.  During this time (6/11-6/14) she also had a high fever 100 to 103 in spite of Tylenol  -The primary diagnosis was Erythema Multiforme
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Thur-Fri 6/6-6/7/19,  HIVES, left hip area.  Sat-Sun 6/8-9/19, back of top of both legs.  Mon-Wed 6/10-12/19, right hip area,                              Wed 6/12/19 inside (elbow bend) left arm.  Thu-Fri  6/13-14/19  inside right (elbow bend) arm.  Fri 6/14/19, left inside wrist.      Sat-Sun 6/15-16/19, left side back of head at hair line.  MONDAY 6/17/19 NONE to report.  Tue 6/18/19 over night, left forearm( stayed all day).  Wed 6/19/19 one starting, above belly button, 2nd top front of right leg, left side chin, backside right butt.  Thursday, Friday (until this point) NONE!!!
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash erythematous, Skin warm, Swelling
Clinical narrative: Red warm rash, swollen and hot with pain upon touch, occasionally itches. Rash occurred 48 hours post injection approximately 4 inches below injection site.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Generalised erythema, Rash macular, Skin warm
Clinical narrative: Patient broke out with blotches and redness all over his body the day after vaccine. Parent noticed it in the morning time. The pots were very warm to the touch.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Myalgia, Nausea, Pain in extremity
Clinical narrative: First Shingrix vaccine sore arm only.  Second 6 months later, severe flu-like symptoms including headache, muscle ache, nausea vomiting. Unable to hold anything down for 12+ hours so violent dry heaves.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching, Vomiting
Clinical narrative: First Shingrix vaccine sore arm only.  Second 6 months later, severe flu-like symptoms including headache, muscle ache, nausea vomiting. Unable to hold anything down for 12+ hours so violent dry heaves.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurt
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient states that top of arm is swollen and she has a fever. It start about and hour after the vaccination. She has been taking Tylenol
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Nasal pruritus, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: After injection I started to feel scratchiness in the back of my throat and nose.  By the bed time at 10pm I was congested and had an intermittent cough.  The following morning the symptoms were cough, runny nose, sore throat.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation
Clinical narrative: After injection I started to feel scratchiness in the back of my throat and nose.  By the bed time at 10pm I was congested and had an intermittent cough.  The following morning the symptoms were cough, runny nose, sore throat.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: Patient experienced shortness of breath an hour after injection was administered on 3/15/2019.  She took a Benadryl and did not seek medical attention at the time of event.  We did not learn of her reaction until following up for Shingrix booster on 6/4/2019, and deferred to her physician on whether to proceed with booster.  She was told not to get the booster by her physician on 6/19/2019.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, IPV, MMRV, VARCEL
Symptoms: Decreased appetite, Extra dose administered, Gait disturbance
Clinical narrative: Was given Pentacel and IVP, MMRV and Varicella vaccines resulting pt getting two IVP and two Varicella at the same time. Discuss with Vaccine unit. 06/21/2019 Father reports pt limping and not wanting to eat. No site reactions reported
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Eye pain, Feeling cold, Pyrexia
Clinical narrative: Fever, shivering, feeling cold in bed, eyes sore.  I think these are in line with the noted possible side effects.  I feel somewhat better today.  I don't have a fever today (June 21).
Age: 53.0
Sex: M
Vaccine: TD
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: I had a fever of 99.5 F the next day 5/27/2019 I felt very tired the next few days. I also had sore left arm for 5 days
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: 9:51am the vaccine was administered that corresponds to 4 years.  Patient did not present at the moment a reaction to them.   11:00am received a call from the mother of the patient, reporting that the girl has a rash on the body; she was given instructions to go to the ER.  She was taken to the ER and she was given treatment and she was discharged with medical instructions
Age: 0.75
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported.; an unspecified "9 month old male patient" received one dose of GARDASIL 9.; an unspecified "9 month old male patient" received one dose of GARDASIL 9.; This spontaneous report was received from a registered nurse regarding a 9 months old patient. There was no information reported about the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On 25-JUL-2018, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, anatomical site, lot number N022583 and expiration date 20-JUN-2020) intramuscularly for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: Almost like cellulitis; Had significant pain and swelling in their arm; Had significant pain and swelling in their arm; This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for 3 patients. This is 1st of 3 reports.   A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on an unspecified date for immunization.  Relevant medical history and concomitant medications were unknown.  On an unspecified date, after the vaccination, the patient experienced significant pain and swelling in the arm. The doctor reported "it was almost like cellulitis". Clinical outcome of the events was unknown at time of this report.  The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 might have played a contributory role towards the occurrence of significant pain and swelling in the arm like cellulitis.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2019267626 same reporter/drug/event, different patient;US-PFIZER INC-2019267627 same reporter/drug/event, different patient
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: Almost like cellulitis; Had significant pain and swelling in arm; Had significant pain and swelling in arm; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 3 patients. This is the 3rd of 3 reports.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced almost like cellulitis, had significant pain and swelling in arm all on an unspecified date with outcome of unknown.  The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 might have played a contributory role towards the occurrence of cellulitis like having significant pain and swelling in arm.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2019267621 same reporter/drug/event, different patient;US-PFIZER INC-2019267626 same reporter/drug/event, different patient
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Chills, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Immediate burning at shot site, within 15-20 minutes a pouding headache, chills, nasca, and lethargy. within the hour shoulder, neck & back tightness and pain. This lasted for about 24 hours. The following day the tightness moved from shoulder neck to elbows and knees; the following day it spread to my ankles toes and hands. On Saturday, June 8th, I started to feel better and but, I was not fully recovered until June 12th.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Joint stiffness, Lethargy, Muscle tightness, Musculoskeletal pain, Nausea
Clinical narrative: Immediate burning at shot site, within 15-20 minutes a pouding headache, chills, nasca, and lethargy. within the hour shoulder, neck & back tightness and pain. This lasted for about 24 hours. The following day the tightness moved from shoulder neck to elbows and knees; the following day it spread to my ankles toes and hands. On Saturday, June 8th, I started to feel better and but, I was not fully recovered until June 12th.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Neck pain
Clinical narrative: Immediate burning at shot site, within 15-20 minutes a pouding headache, chills, nasca, and lethargy. within the hour shoulder, neck & back tightness and pain. This lasted for about 24 hours. The following day the tightness moved from shoulder neck to elbows and knees; the following day it spread to my ankles toes and hands. On Saturday, June 8th, I started to feel better and but, I was not fully recovered until June 12th.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Hives; Hydroxyzine & Prednisone.