chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: It was a progression of redness that was like a welt at the injection site. I've never gotten anything like that before. It looked like a hive then it started to spread and became wider. It started to circle my arm. I started marking it over the next few days. I was told to take some BENADRYL and I started icing the area. I hadn't had it with any of the other vaccines. I had 3 Moderna vaccines with a fourth dose being Pfizer, then I had another Moderna vaccination. I'm curious to see if having another Moderna vaccine after that Pfizer vaccine caused me to have a reaction.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Dehydration, Fall, Hypotension, Influenza
Clinical narrative: I received my 4th Bivalent booster on 09/29/2022. On 11/10/2022 my Flu symptoms started in the morning around 08:00AM. I felt weak and I fell down on the floor while waking up. I had low blood pressure. After 1 hour I called the EMS  and they took me to the emergency room. They prescribed me with TAMIFLU for 5 days and lots of liquids since I was dehydrated. On the 3rd day of the medication I was feeling better than before.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Influenza virus test positive, SARS-CoV-2 test negative
Clinical narrative: I received my 4th Bivalent booster on 09/29/2022. On 11/10/2022 my Flu symptoms started in the morning around 08:00AM. I felt weak and I fell down on the floor while waking up. I had low blood pressure. After 1 hour I called the EMS  and they took me to the emergency room. They prescribed me with TAMIFLU for 5 days and lots of liquids since I was dehydrated. On the 3rd day of the medication I was feeling better than before.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 12/8/22 tested positive; took PAXLOVID for 5days; tested 10 days negative; then tested positive for 6 days.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Bivalent booster given erroneously as Primary series. Patient's and his caregiver notified. Primary care Provider notified.
Age: 11.0
Sex: U
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Grey bivalent given upon charting realized that orange should have been given. Provider and family notified.
Age: 1.75
Sex: M
Vaccine: HEPA
Symptoms: Hand-foot-and-mouth disease, Peripheral swelling
Clinical narrative: HIVES RASH TO NECK, TRUNK, EXTREMITIES  SWELLING TO HANDS AND FEET
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Abdominal distension, COVID-19, Chills, Decreased appetite
Clinical narrative: First day was Friday. I had a sore throat all day and took throat drops. In the evening I felt bloated and super full. At night I felt chills, and super hot. No thermometer available to take temperature. I went to restroom at 2AM and had a loose stool. I went about 2-3 times that night which was unusual. The next day cruise line medical staff came to do a COVID-19 test and test was positive. On and off during next few days chills, nausea, loss of appetite and stomach issues. Each day got to be a little better. The second week I was just really tired. I was getting like 12 hours of sleep per day. I was congested. I took DAYQUIL and NYQUIL. Today I took COVID-19 at home test and results were negative.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diarrhoea, Fatigue, Feeling hot, Hypersomnia, Nausea
Clinical narrative: First day was Friday. I had a sore throat all day and took throat drops. In the evening I felt bloated and super full. At night I felt chills, and super hot. No thermometer available to take temperature. I went to restroom at 2AM and had a loose stool. I went about 2-3 times that night which was unusual. The next day cruise line medical staff came to do a COVID-19 test and test was positive. On and off during next few days chills, nausea, loss of appetite and stomach issues. Each day got to be a little better. The second week I was just really tired. I was getting like 12 hours of sleep per day. I was congested. I took DAYQUIL and NYQUIL. Today I took COVID-19 at home test and results were negative.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: First day was Friday. I had a sore throat all day and took throat drops. In the evening I felt bloated and super full. At night I felt chills, and super hot. No thermometer available to take temperature. I went to restroom at 2AM and had a loose stool. I went about 2-3 times that night which was unusual. The next day cruise line medical staff came to do a COVID-19 test and test was positive. On and off during next few days chills, nausea, loss of appetite and stomach issues. Each day got to be a little better. The second week I was just really tired. I was getting like 12 hours of sleep per day. I was congested. I took DAYQUIL and NYQUIL. Today I took COVID-19 at home test and results were negative.
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Asthenia, COVID-19, Chills, Cough, Decreased appetite
Clinical narrative: I had chills, body aches, fever, cough, nasal congestion, fatigue, sore throat, and loss of appetite. I tested positive for COVID-19. My doctor put me on PAXLOVID, and I started to feel better. By 12/19/2022 I tested negative. I still don't have the same level of energy and a little cough.
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Fatigue, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: I had chills, body aches, fever, cough, nasal congestion, fatigue, sore throat, and loss of appetite. I tested positive for COVID-19. My doctor put me on PAXLOVID, and I started to feel better. By 12/19/2022 I tested negative. I still don't have the same level of energy and a little cough.
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had chills, body aches, fever, cough, nasal congestion, fatigue, sore throat, and loss of appetite. I tested positive for COVID-19. My doctor put me on PAXLOVID, and I started to feel better. By 12/19/2022 I tested negative. I still don't have the same level of energy and a little cough.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Pericarditis, Pleuritic pain, Troponin normal
Clinical narrative: Pericarditis Patient is current on Ibuprofen and Colchicine as per Cardiology recommendation  Awaiting Echocardiogram  clinically improved Patient presented with left sided chest pain, improved by sitting forward. Pleuritic-type chest pain
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Echocardiogram, Gait inability
Clinical narrative: Numbness on left side; Arm, Leg and Face, Started in afternoon, by evening I couldn't walk.  Went to ER, they determined it wasn't stroke, I was admitted, symptoms were gone next day and I was discharged.  Two days later, symptoms started coming back and with a severe headache.  Went to ER again and they treated me for the pain.  Most symptoms stopped after a few hours, but facial numbness remained and remains today.  It's never gotten better.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Magnetic resonance imaging, Pain, Ultrasound Doppler
Clinical narrative: Numbness on left side; Arm, Leg and Face, Started in afternoon, by evening I couldn't walk.  Went to ER, they determined it wasn't stroke, I was admitted, symptoms were gone next day and I was discharged.  Two days later, symptoms started coming back and with a severe headache.  Went to ER again and they treated me for the pain.  Most symptoms stopped after a few hours, but facial numbness remained and remains today.  It's never gotten better.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Amnestic disorder, Confusional state, Dizziness postural, Head injury, Headache
Clinical narrative: Patient was in office for medication check appointment. Patient received flu vaccination at conclusion of visit. Patient proceeded to checkout, accompanied by father. Patient then passed out while standing for checkout and hit back of head on floor. From progress note by PCP, "Patient seen and reassessed multiple times after having a syncopal episode immediately outside of the building after flu vaccine. He struck his head and had a LOC.   Initially confused and amnestic. This resolved after about 45 min. However continued to be somewhat pale with an escalating ha(no hx of migraine) where he became photophobic. He continued to have orthostatic dizziness and nausea and vomited about 2.5 hours after incident.   Got ibuprofen in the office about 45 min prior to emesis without sig improvement in ha.   Decision made to go to er -- dad to transport directly to hospital by car as is his preference.  agree that he is stale enough with stable VS.   Phone call placed to  NP in the er, who is expecting his arrival"
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Nausea, Pallor, Photophobia, Syncope
Clinical narrative: Patient was in office for medication check appointment. Patient received flu vaccination at conclusion of visit. Patient proceeded to checkout, accompanied by father. Patient then passed out while standing for checkout and hit back of head on floor. From progress note by PCP, "Patient seen and reassessed multiple times after having a syncopal episode immediately outside of the building after flu vaccine. He struck his head and had a LOC.   Initially confused and amnestic. This resolved after about 45 min. However continued to be somewhat pale with an escalating ha(no hx of migraine) where he became photophobic. He continued to have orthostatic dizziness and nausea and vomited about 2.5 hours after incident.   Got ibuprofen in the office about 45 min prior to emesis without sig improvement in ha.   Decision made to go to er -- dad to transport directly to hospital by car as is his preference.  agree that he is stale enough with stable VS.   Phone call placed to  NP in the er, who is expecting his arrival"
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient was in office for medication check appointment. Patient received flu vaccination at conclusion of visit. Patient proceeded to checkout, accompanied by father. Patient then passed out while standing for checkout and hit back of head on floor. From progress note by PCP, "Patient seen and reassessed multiple times after having a syncopal episode immediately outside of the building after flu vaccine. He struck his head and had a LOC.   Initially confused and amnestic. This resolved after about 45 min. However continued to be somewhat pale with an escalating ha(no hx of migraine) where he became photophobic. He continued to have orthostatic dizziness and nausea and vomited about 2.5 hours after incident.   Got ibuprofen in the office about 45 min prior to emesis without sig improvement in ha.   Decision made to go to er -- dad to transport directly to hospital by car as is his preference.  agree that he is stale enough with stable VS.   Phone call placed to  NP in the er, who is expecting his arrival"
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: NO ADVERSE EFFECT THIRD DOSE OF MONOVALENT MODERNA DOSE GIVEN INSTEAD OF BIVALENT BOOSTER
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: patient states she has pain and swelling in the axilla region of the arm she got her shot in.  It developed 2 days after the vaccine was given.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Epistaxis, Herpes zoster
Clinical narrative: Had a bloody nose in right nostril that took over an hour to stop; Then the next day got a nosebleed in the left nostril that took half an hour to stop; Went to doctor and had an exam a few days later; Was told that the nosebleeds could be due to the lack of humidity, was advised to use saline solution as needed; One month later had an outbreak of Shingles, though had Shingles vaccination June 20, 2020.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Data Quality Team contacted clinic staff at local Family Health Center informing staff that upon review of COVID-19 vaccine data. It was found that this child had documentation in their local records indicating that the child had received an adult Pfizer purple cap COVID-19 vaccine on 12/07/2021. Clinic staff was unaware of this incident until the Data Quality Team brought it to staffs attention on 12/19/2022.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 11/27/22 and was administered on 12/30/22, no adverse reactions, medical provider notified
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Neuropathy peripheral
Clinical narrative: Erectile dysfunction; peripheral neuropathy; patient still experiencing both symptoms as of reporting date, ED treatments (Viagra etc have not relieved symptoms.
Age: 70.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Dysgeusia, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: I had a headache, slight sore throat, fever of 101, and metallic taste. I tested positive for COVID-19. I spoke to my doctor, and he prescribed me an antiviral. 48 hours after I stop taking the antiviral I rebounded for about a week with headache and fever of 101. I just took ibuprofen.
Age: 70.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a headache, slight sore throat, fever of 101, and metallic taste. I tested positive for COVID-19. I spoke to my doctor, and he prescribed me an antiviral. 48 hours after I stop taking the antiviral I rebounded for about a week with headache and fever of 101. I just took ibuprofen.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired, no adverse event.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye pain, Facial pain, Headache, Ocular discomfort
Clinical narrative: On the 26th I woke up with pain behind my right eye/eyebrow. I had a headache there all day, and the pain hurt worse when I moved my right eye.  On the 27th the headache was gone, but  it still hurt to move my right eye. I took ibuprofen and scheduled an appointment to see my primary care doctor.  On the 28th, the eye pain had improved some, and my doctor said my eye looked fine. She said it could possibly be some facial swelling behind the eye. She said I can wait a week to see if it is still bothering me and then follow up with my eye doctor. In the meantime she recommended ibuprofen/Tylenol for the pain.  I was still worried, and having headaches so on the 29th I saw my eye doctor. She also said my eyes looked fine, but to follow up if the eye pain gets worse again, or if I notice any visual changes. I am still currently taking Tylenol/ibuprofen today for the headaches, and the lingering eye discomfort.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired, no adverse event.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Gave 0.3 ml from undiluted vial of Pfizer 5-11 bivalent covid vaccine. The wrong vial was used.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given adult strength Pfizer covid vaccine at 0.2ml pediatric dose.  Patient parent was informed after we got notification from Immunization Information System. Patient parent was informed no repeat or additional vaccine shots is needed.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Product administration error, Wrong product administered
Clinical narrative: Patient came for her Annual Well Child Visit. She was due for Meningococcal ACWY vaccine, instead I mistakenly gave her the MenB Trumenba vaccine. Doctor was notified and she called the patient's mother and told her about the administration error that occurred. Mother understood and per provider, she can still get the right MenACWY vaccine, so patient came back into clinic to receive the right vaccine. Patient was feeling fine and did not experience any symptoms.
Age: 34.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Arthralgia, Pain
Clinical narrative: Shoulder pain still feels like right after vaccination even though so much time has passed. If left arm is down by my side it's fine but if I lift it up it is painful. I do have an upcoming appoint with Dr. on January 4th, 2023.
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope
Clinical narrative: Pt had a TBI 4 months ago playing football.  He also gave a history of syncope with previous injections, as he had received multiple Metamizole  injections in the past with syncope.   After vaccination patient experienced syncope in few mints. We helped the patient to be stable and send him out emergency department for further evaluation  and care. At ED his diagnosis was vasovagal syncope. No further workup. No meds. In follow-up by a provider for vaccination site  staff the next day, he was stable and was advised to establish primary care , to have a full assessment.   Also, advised to seek medical attention if he experience any concerning symptoms.  patient was released from the emergency department  in stable condition with no adverse reaction.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Influenza like illness, Lethargy, SARS-CoV-2 test positive
Clinical narrative: DEVELOPED FLU-LIKE SYMPTOMS, LETHARGY, COUGH, SINUSITIS .
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: DEVELOPED FLU-LIKE SYMPTOMS, LETHARGY, COUGH, SINUSITIS .
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given adult strength Pfizer covid vaccine at 0.2ml pediatric dose. Patient parent was informed after we got notification from Immunization Information System. Patient parent was informed no repeat or additional vaccine shot is needed.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 11/27/22 and was administered on 12/30/22, no adverse reactions, medical provider notified
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 11/27/22 and was administered on 12/30/22, no adverse reactions, medical provider notified
Age: 1.0
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received rotavirus at 12 month wcc, along with 1 yr vaccines.  There was no treatment for it but did advice parents to check for blood in stool and or severe abdominal pain.  As of today 12/30/2022 pt is doing fine and neither one of those symptoms have been present.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion and reported PROQUAD that was stored improperly was administered to a patient; There was no adverse event; This spontaneous report was received from a medical assistant and referred to a currently 4-year-old female patient. Information about historical conditions, concurrent conditions, drug allergies/reactions and concomitant medications was not reported.  On an unknown date, there was a temperature excursion and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) (lot #W004029, expiration date: 02-AUG-2023, indication: prophylaxis; anatomical location, strength, dose, and route were not reported) that was stored improperly was administered to the patient (product storage error). There was no adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Caller stated that her brother's child received the PROQUAD vaccine intramuscularly instead of subcutaneously; No additional AE information provided; This spontaneous report was received from patient's family member and refers to a patient of unknown age and gender (age group - child). The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered intramuscularly instead of subcutaneously for prophylaxis (strength, lot #, and expiry date were not provided) (incorrect route of product administration). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE's and no PQC's were reported.; A pharmacist could not rule out that the pharmacy may administer two doses of VAQTA pediatric formulation to an adult patient; This spontaneous report was received from a pharmacist referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-DEC-2022, the patient may be administered 2 doses of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, pediatric formulation (strength, lot #, expiry date, and route of administration were not provided) as directed to prevent hepatits A infection (prophylaxis) (product administered to patient of inappropriate age). No additional adverse events (AEs) were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE information provided; HCP states that ROTATEQ vaccine, that underwent a supported temperature excursion, was administered to a patient on Dec 27, 2022; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-DEC-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), route of administration was defaulted to oral, lot #W010331 was valid, expiration date was 01-NOV-2023, for prophylaxis. The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a supported temperature excursion. Temperature was 8.9 Celsius degrees and time frame of excursion was 1 hour 49 minutes (product storage error). There was no previous temperature excursion.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine, got a bad case of shingles, Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-DEC-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The reporter reported that his/her sister-in-law had the vaccine and still got a bad case of shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available. This is 1 of 4 link cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR193098:Same reporter US-GSK-US2022AMR193110:Same reporter US-GSK-US2022AMR193112:Same reporter
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Got GBS, was on a vent for weeks, will always be a cripple & be disabled; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 25-Dec-2022. Reporter's Comment: This case was received from patient's friend via interactive digital media.  The reporter stated that got a friend (patient) that got it from Flu vaccine. Was on a vent for weeks.  The reporter stated this was years ago, the patient said she would always be a cripple and be disabled. The reporter also mentioned the Flu shot could also cause it and got a friend that would always be a cripple from the flu vaccine then got GBS (guillain barre syndrome). Additional Supportive Information: This case was one of 4 cases reported by same reporter. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR193091:Same reporter US-GSK-US2022AMR193110:Same reporter US-GSK-US2022AMR193112:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body aches; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-Dec-2022. Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter wanted to know what over the counter medication could he/she drink after getting 2nd dose of shingles vaccine for body aches. Follow-up would not possible as no contact details were available.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pruritus, Rash macular, Rash vesicular, Skin discolouration
Clinical narrative: injection site was a little sore; Near the brown spots about ½ an inch away there is one red pimple spot.; mild round chicken pox spots brown pin size on breast, legs and back/ I have like 8 to 9 different areas with the brown spots; red spots itches/ the itching last for about 2 days, and it has been more prevalent in the last 2 to 3 days; irritation; I had signs of mild round chicken pox spots. The spots are not like the normal chicken pox-; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had when patient as a child).   On 2nd December 2022, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2022, 1 days after receiving Shingrix, the patient experienced injection site pain. In December 2022, the patient experienced red spotty rash, skin discoloration, pruritus, skin irritation and varicella-like rash. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the red spotty rash, skin discoloration, pruritus and varicella-like rash were not recovered/not resolved and the outcome of the skin irritation was recovered/resolved.   It was unknown if the reporter considered the injection site pain, red spotty rash, skin discoloration, pruritus, skin irritation and varicella-like rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The reporter was a patient that had the Shingrix vaccine 2 weeks ago.  The reporter reported that patient had chicken pox as a child. The patient had no side effect the next day except the injection site was a little sore. 3 to 4 days after the vaccine patient had signs of mild round chicken pox spots. The spots are not like the normal chicken pox. They were no bigger than a pin head. At the begging it first starts with brown pin head size spots under the breast are and then it had been appearing in other areas of the body.  The reporter reported that near the brown spots about ½ an inch away there was one red pimple spot.  The reporter reported that the red pimple spot itches. The reporter stated that the brown spots do not itch only the red ones.  The patient had like 8 to 9 different areas with the brown spots.  After 28 to 48 hours the irritation disappears.  The spots were more prevalent now in other parts of the body, like the legs and back. The itching last for about 2 days, and it had been more prevalent in the last 2 to 3 days. Not all information was available.  The lot and expiration dates were unknown. The reporter did not consent to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: injection site was a little sore; Near the brown spots about ½ an inch away there is one red pimple spot.; mild round chicken pox spots brown pin size on breast, legs and back/ I have like 8 to 9 different areas with the brown spots; red spots itches/ the itching last for about 2 days, and it has been more prevalent in the last 2 to 3 days; irritation; I had signs of mild round chicken pox spots. The spots are not like the normal chicken pox-; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had when patient as a child).   On 2nd December 2022, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2022, 1 days after receiving Shingrix, the patient experienced injection site pain. In December 2022, the patient experienced red spotty rash, skin discoloration, pruritus, skin irritation and varicella-like rash. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the red spotty rash, skin discoloration, pruritus and varicella-like rash were not recovered/not resolved and the outcome of the skin irritation was recovered/resolved.   It was unknown if the reporter considered the injection site pain, red spotty rash, skin discoloration, pruritus, skin irritation and varicella-like rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The reporter was a patient that had the Shingrix vaccine 2 weeks ago.  The reporter reported that patient had chicken pox as a child. The patient had no side effect the next day except the injection site was a little sore. 3 to 4 days after the vaccine patient had signs of mild round chicken pox spots. The spots are not like the normal chicken pox. They were no bigger than a pin head. At the begging it first starts with brown pin head size spots under the breast are and then it had been appearing in other areas of the body.  The reporter reported that near the brown spots about ½ an inch away there was one red pimple spot.  The reporter reported that the red pimple spot itches. The reporter stated that the brown spots do not itch only the red ones.  The patient had like 8 to 9 different areas with the brown spots.  After 28 to 48 hours the irritation disappears.  The spots were more prevalent now in other parts of the body, like the legs and back. The itching last for about 2 days, and it had been more prevalent in the last 2 to 3 days. Not all information was available.  The lot and expiration dates were unknown. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Painful rash/ rash has improved slightly; Warm to the touch rash; Pinkish/red rash / rash has improved slightly; Arm soreness/ arm soreness is ongoing; Chills; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 559H5, expiry date unknown) for prophylaxis.   On 16th December 2022, the patient received the 1st dose of Shingrix. On 17th December 2022, 1 days after receiving Shingrix, the patient experienced chills, fatigue and nausea. On 18th December 2022, the patient experienced pain in arm. On 19th December 2022, the patient experienced painful rash, skin warm and red rash. On 17th December 2022, the outcome of the chills, fatigue and nausea were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the painful rash and red rash were recovering/resolving and the outcome of the skin warm was unknown.   It was unknown if the reporter considered the chills, fatigue, nausea, pain in arm, painful rash, skin warm and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The patient had received the first dose of Shingrix at a retail pharmacy, in the left arm. The patient had reported experiencing chills, fatigue, and nausea on Saturday morning, the patient had reported chills, fatigue, and nausea had resolved at the night of 17 December 2022.  The patient had reported experiencing left arm soreness starting on Sunday, 18 December 2022. The patient had reported arm soreness was ongoing at the time of reporting. The patient had reported she had noticed rash on left arm on Monday, 19 December 2022. The patient had reported that the rash was 2-3 inches below injection site and the rash was painful, warm to the touch, red and in a linear pattern. The patient had reported width of rash was approximately one and a half to 2 inches wide. The patient had reported rash had improved slightly, at the time of reporting had more pinkish, as opposed to red, appearance. The reporter consented to Follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Painful rash/ rash has improved slightly; Warm to the touch rash; Pinkish/red rash / rash has improved slightly; Arm soreness/ arm soreness is ongoing; Chills; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 559H5, expiry date unknown) for prophylaxis.   On 16th December 2022, the patient received the 1st dose of Shingrix. On 17th December 2022, 1 days after receiving Shingrix, the patient experienced chills, fatigue and nausea. On 18th December 2022, the patient experienced pain in arm. On 19th December 2022, the patient experienced painful rash, skin warm and red rash. On 17th December 2022, the outcome of the chills, fatigue and nausea were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the painful rash and red rash were recovering/resolving and the outcome of the skin warm was unknown.   It was unknown if the reporter considered the chills, fatigue, nausea, pain in arm, painful rash, skin warm and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The patient had received the first dose of Shingrix at a retail pharmacy, in the left arm. The patient had reported experiencing chills, fatigue, and nausea on Saturday morning, the patient had reported chills, fatigue, and nausea had resolved at the night of 17 December 2022.  The patient had reported experiencing left arm soreness starting on Sunday, 18 December 2022. The patient had reported arm soreness was ongoing at the time of reporting. The patient had reported she had noticed rash on left arm on Monday, 19 December 2022. The patient had reported that the rash was 2-3 inches below injection site and the rash was painful, warm to the touch, red and in a linear pattern. The patient had reported width of rash was approximately one and a half to 2 inches wide. The patient had reported rash had improved slightly, at the time of reporting had more pinkish, as opposed to red, appearance. The reporter consented to Follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Painful rash/ rash has improved slightly; Warm to the touch rash; Pinkish/red rash / rash has improved slightly; Arm soreness/ arm soreness is ongoing; Chills; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 559H5, expiry date unknown) for prophylaxis.   On 16th December 2022, the patient received the 1st dose of Shingrix. On 17th December 2022, 1 days after receiving Shingrix, the patient experienced chills, fatigue and nausea. On 18th December 2022, the patient experienced pain in arm. On 19th December 2022, the patient experienced painful rash, skin warm and red rash. On 17th December 2022, the outcome of the chills, fatigue and nausea were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the painful rash and red rash were recovering/resolving and the outcome of the skin warm was unknown.   It was unknown if the reporter considered the chills, fatigue, nausea, pain in arm, painful rash, skin warm and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The patient had received the first dose of Shingrix at a retail pharmacy, in the left arm. The patient had reported experiencing chills, fatigue, and nausea on Saturday morning, the patient had reported chills, fatigue, and nausea had resolved at the night of 17 December 2022.  The patient had reported experiencing left arm soreness starting on Sunday, 18 December 2022. The patient had reported arm soreness was ongoing at the time of reporting. The patient had reported she had noticed rash on left arm on Monday, 19 December 2022. The patient had reported that the rash was 2-3 inches below injection site and the rash was painful, warm to the touch, red and in a linear pattern. The patient had reported width of rash was approximately one and a half to 2 inches wide. The patient had reported rash had improved slightly, at the time of reporting had more pinkish, as opposed to red, appearance. The reporter consented to Follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue, Wrong technique in product usage process
Clinical narrative: A single drop came out while administering; Needle was not firmly attached to the syringe; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered and wrong technique in drug usage process. On an unknown date, the outcome of the incomplete dose administered and wrong technique in drug usage process were unknown.   Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The Pharmacist stated that while administering Shingrix a single drop came out due to a needle not being firmly attached to the syringe.  The reporter stated that the patient was waiting at the facility and the pharmacist did not have time to provide additional patient information. Permission for follow-up was not asked by reporter. Additional supportive information: At the time of reporting, while administering Shingrix a single drop came out due to a needle not being firmly attached to the syringe, which had led to incomplete dose administered and wrong technique in drug usage process.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received HBV (Engerix B) (batch number LM992, expiry date 13th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th December 2022, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 19th December 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-DEC-2022. Reporter's Comment:  The reporter stated that a patient received the second dose of Engerix-B, which expired on 13th December 2022, on 19th December 2022. This took place at the same site from which the reporter was calling.  Information for the adverse event was collected. Reporter asked to be contacted through e-mail only. The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive Information: The patient received the second dose of Engerix-B, which expired on 13th December 2022, which led to expired vaccine used.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st Pediarix-Rotarix-Hiberiix 2Dec22, 2nd 20Dec22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old male patient who received Hib (Hiberix) (batch number yn44n, expiry date 15th December 2023) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number n7hl3, expiry date 15th April 2024) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number z5r33, expiry date 23rd February 2024) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (HIBERIX), PEDIARIX and LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX).   On 20th December 2022, the patient received the 2nd dose of Hiberix, the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 20th December 2022, unknown after receiving Hiberix, Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:20-DEC-2022 Reporter's Comment: The reporter was practice manager. The reporter reported on 2nd December 2022 that, patient received the first dose of Hiberix , Pediarix and Rotarix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Hiberix , Pediarix and Rotarix below than the recommended schedule, which led to shortening of vaccination schedule.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 11/27/22 and was administered on 12/30/22, no adverse reactions, medical provider notified
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 11/27/22 and was administered on 12/30/22, no adverse reactions, medical provider notified
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chest discomfort, Computerised tomogram normal, Condition aggravated, Dyspnoea
Clinical narrative: I felt soreness, fever, aches, tight chest, joint swelling. I could not breath, I had shortness of breath. I had to go to the hospital on 07/01/2022. It triples my Arthritis. I had to see orthopedics. I had a fracture in your spine. They sent me home with inhaler and pain medications. I had to go back in and out the hospital on 07/03/2022 and 07/06/2022. I saw my PCP on 07/07/2022. I also had to see a cardiologist. I had to be out of work for two months and when I went back I had a really hard time.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Impaired work ability, Joint swelling, Laboratory test normal
Clinical narrative: I felt soreness, fever, aches, tight chest, joint swelling. I could not breath, I had shortness of breath. I had to go to the hospital on 07/01/2022. It triples my Arthritis. I had to see orthopedics. I had a fracture in your spine. They sent me home with inhaler and pain medications. I had to go back in and out the hospital on 07/03/2022 and 07/06/2022. I saw my PCP on 07/07/2022. I also had to see a cardiologist. I had to be out of work for two months and when I went back I had a really hard time.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Spinal fracture, Urine analysis normal
Clinical narrative: I felt soreness, fever, aches, tight chest, joint swelling. I could not breath, I had shortness of breath. I had to go to the hospital on 07/01/2022. It triples my Arthritis. I had to see orthopedics. I had a fracture in your spine. They sent me home with inhaler and pain medications. I had to go back in and out the hospital on 07/03/2022 and 07/06/2022. I saw my PCP on 07/07/2022. I also had to see a cardiologist. I had to be out of work for two months and when I went back I had a really hard time.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Feeling abnormal, Malaise, Oropharyngeal pain
Clinical narrative: I received my 5th booster shot on 09/23/2022. My COVID-19 Infection symptoms started on 11/27/2022 in the morning around 8:00AM. I had body aches, sore throat, congestions, and slight cough. On Sunday I called my doctor she prescribed me with PAXLOVID for 5 days. I took over the counter ADVIL, TYLENOL, MUCINEX and ZYRTEC as per needed. I tested negative on day 5. On day 7th tested positive for COVID-19 infection again this time I repeated the same over the counter medications. On 12/23/2022 I felt bad. I had low grade fever and I was vomiting. I tested negative for COVID-19  since I didn't test for Flu I wasn't sure what this was.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive, Vomiting
Clinical narrative: I received my 5th booster shot on 09/23/2022. My COVID-19 Infection symptoms started on 11/27/2022 in the morning around 8:00AM. I had body aches, sore throat, congestions, and slight cough. On Sunday I called my doctor she prescribed me with PAXLOVID for 5 days. I took over the counter ADVIL, TYLENOL, MUCINEX and ZYRTEC as per needed. I tested negative on day 5. On day 7th tested positive for COVID-19 infection again this time I repeated the same over the counter medications. On 12/23/2022 I felt bad. I had low grade fever and I was vomiting. I tested negative for COVID-19  since I didn't test for Flu I wasn't sure what this was.