chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness with both doses at the injection site / 1st dose; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but could be 51 or 52 years. The patient received her first dose of Shingrix in left arm. The patient experienced soreness at the injection site. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020AMR223832.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR223832:Same reporter
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: Bullous Pemphigoid on the skin; This case was reported by a physician via call center representative and described the occurrence of bullous pemphigoid in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix. In August 2020, 1 week after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was recovered/resolved.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and a week after or so patient developed Bullous Pemphigoid. On 3rd September 2020, patient went to dermatologist and after consulting with the dermatologist, it was stated that he developed a Bullous Pemphigoid on the skin which already went away.  The physician had questioned if 1st dose of Shingrix would be enough since patient was afraid to receive 2nd dose. Health care professional stated that no data of Batch Number or Expiration Date was available as patient got the shot at a different facility.  No further details were reported. The reporter consented to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: soreness at injection site has not yet resolved; shivering; fever came on last night; headache is mild; fatigue / more tired than normal; weird muscle pains; Aching all over; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th November 2020, less than a day after receiving Shingrix, the patient experienced shivering and fever. On 12th November 2020, the patient experienced injection site pain. In November 2020, the patient experienced headache, fatigue, myalgia and general body pain. The patient was treated with paracetamol (Acetaminophen) and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, fever, headache and fatigue were not recovered/not resolved and the outcome of the shivering was recovered/resolved and the outcome of the myalgia and general body pain were unknown.   The reporter considered the injection site pain, shivering, fever, headache, fatigue, myalgia and general body pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient himself. The age at vaccination was not reported. In morning of 11th November 2020, the patient received 1st shot of Shingrix intramuscularly in right deltoid.  The reporter did not have the lot number or expiration date. The patient's right arm where the injection was given was not sore or painful immediately but it was at the time of reporting. He said it was not red or swollen.  The reporter stated that not long after he received the shot he began experiencing weird muscle pains that come and go and then he began aching all over.  The patient experienced fatigue and said that he was more tired than normal. Also reported headache which was mild but had not resolved even after taking acetaminophen or Tylenol.  The patient had fever which came on last night from the day of reporting and recorded as 99 degrees.  It had not resolved even though he took acetaminophen or Tylenol.  He did experience a good deal of shivering as well which resolved after taking 3 Tylenol (acetaminophen) last night.  The reporter consented to followup.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: soreness at injection site has not yet resolved; shivering; fever came on last night; headache is mild; fatigue / more tired than normal; weird muscle pains; Aching all over; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th November 2020, less than a day after receiving Shingrix, the patient experienced shivering and fever. On 12th November 2020, the patient experienced injection site pain. In November 2020, the patient experienced headache, fatigue, myalgia and general body pain. The patient was treated with paracetamol (Acetaminophen) and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, fever, headache and fatigue were not recovered/not resolved and the outcome of the shivering was recovered/resolved and the outcome of the myalgia and general body pain were unknown.   The reporter considered the injection site pain, shivering, fever, headache, fatigue, myalgia and general body pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient himself. The age at vaccination was not reported. In morning of 11th November 2020, the patient received 1st shot of Shingrix intramuscularly in right deltoid.  The reporter did not have the lot number or expiration date. The patient's right arm where the injection was given was not sore or painful immediately but it was at the time of reporting. He said it was not red or swollen.  The reporter stated that not long after he received the shot he began experiencing weird muscle pains that come and go and then he began aching all over.  The patient experienced fatigue and said that he was more tired than normal. Also reported headache which was mild but had not resolved even after taking acetaminophen or Tylenol.  The patient had fever which came on last night from the day of reporting and recorded as 99 degrees.  It had not resolved even though he took acetaminophen or Tylenol.  He did experience a good deal of shivering as well which resolved after taking 3 Tylenol (acetaminophen) last night.  The reporter consented to followup.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pruritus, Pyrexia, Rash
Clinical narrative: PATIENT STATED HAVING CHILLS AND COULD NOT WARM UP. SHE HAD A FEVER OVER 100. PT STATED THAT BY 11/14/20 SHE FELT FINE OTHER THAN HER ARM WAS SORE AND BACK WAS ITCHING. HUSBAND STATED THAT PT'S BACK WAS COMPLETELY BROKEN OUT IN RASH. DR RECOMMENDED PATIENT TO TAKE BENADRYL AND MONITOR SYMPTOMS. PT STATES SHE TOOK THE BENADRYL, RASH IS SOME BETTER BUT STILL THERE, SHE WILL CONTINUE TO MONITOR SYMPTOMS AND NOTIFY US IF THINGS GET WORSE.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Headache, Induration, Injection site bruising, Injection site swelling
Clinical narrative: Dark bruising at injection site.  Localized swelling of upper arm at and below injection site to 3" above elbow. Area pink, hard, swollen, edematous, tender, mottled, and very warm to touch. Pain - arm and headache.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Livedo reticularis, Pain in extremity, Skin warm, Swelling, Tenderness
Clinical narrative: Dark bruising at injection site.  Localized swelling of upper arm at and below injection site to 3" above elbow. Area pink, hard, swollen, edematous, tender, mottled, and very warm to touch. Pain - arm and headache.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Swelling
Clinical narrative: Left arm swelling, itching.  Went to urgent care next day after vaccine and was given steroids and benadryl. Better now.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain, Pain, Pain in extremity
Clinical narrative: pain radiating from a lump at injection site upward to shoulder and, to a lesser degree, down through forearm limited range of movement with extreme discomfort when full movement is attempted This condition has continued without improvement for over a year.
Age: 1.25
Sex: M
Vaccine: FLU4, PNC13, VARCEL
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Endotracheal intubation, Intensive care, Lumbar puncture normal
Clinical narrative: 1 day post vaccines complex generalized seizure with fever 103 lasting 30 minutes requiring intubation and ICU admission to Med Ctr
Age: 1.25
Sex: M
Vaccine: FLU4, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: 1 day post vaccines complex generalized seizure with fever 103 lasting 30 minutes requiring intubation and ICU admission to Med Ctr
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Varicella
Clinical narrative: Patient reported a rash within 3 days of vaccine administration. Upon prompt evaluation by primary physician, it was determined to be an unusual case of chicken pox from the Shingrix vaccine.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: pt called an hour after the shot and said she started to experience blurry vision about a half hour after returning home. the blurry vision goes away when she closes her eyes. She stated no other side effects.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient had a sore arm for the first few days and the pain hasn't subsided still. Patient hadn't recovered the full motion of the arm.
Age: 2.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Thigh was swollen and was also red and hot for approximately 2 days.  There was also a bruise around the injection site.  This also happened last year when he received the flu shot.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, COVID-19, Chills, Fatigue, Influenza
Clinical narrative: Patient spouse called wanting to report husbands symptoms after receiving the HD flu shot the day before. She stated that every year he has gotten the high dose vaccine, he has reacted with minor body aches but this year seemed severe. She stated that he was experiencing "full blown flu symptoms" with aches, fatigue, chills, nausea, stomach pain, etc. She states he previously had COVID -19 and was sure he was reacting from the vaccination and wanted to let us know. I explained to the patient's spouse to keep an eye on his symptoms and if they worsen or do not improve to contact their doctor to be seen.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Pain
Clinical narrative: Patient spouse called wanting to report husbands symptoms after receiving the HD flu shot the day before. She stated that every year he has gotten the high dose vaccine, he has reacted with minor body aches but this year seemed severe. She stated that he was experiencing "full blown flu symptoms" with aches, fatigue, chills, nausea, stomach pain, etc. She states he previously had COVID -19 and was sure he was reacting from the vaccination and wanted to let us know. I explained to the patient's spouse to keep an eye on his symptoms and if they worsen or do not improve to contact their doctor to be seen.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Feeling abnormal, Pain, Pyrexia, Vomiting
Clinical narrative: * had vaccination 11/16/20 at about 4:30pm * Patient said she didn't feel good at about 7:30-8pm on 11/17/20 * head, knees, back, neck and arm are all in pain * has fever between 99.8 and 100.9 * threw up 2 times early this morning 11/18/20 * called doctor and was told if she throws up again to go to urgent care *** waiting to see what the doctor would like to do next and monitoring daughter
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Induration, Pain in extremity, Skin discolouration
Clinical narrative: Arm soreness, 3 days later 11/11/2020 red area on arm size of palm below the shot site 3-4 dime sized areas very red and other area pink flesh toned areas. Harden, very firm areas underneath skin in flesh colored red and pink areas more so in redden area. Discoloration still visible today 11/18/2020 in moderation. 11/12/2020 Left shoulder joint tender in certain positions.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Injection site pain, Injection site warmth, Muscle tightness
Clinical narrative: The patient developed injection site pain, warmth, "muscle tightness", intermittent numbness that waxes and weans. These symptoms started after the injection was given and persisted. Advised follow up with clinic  or PCP today for further assessment/treatment.
Age: 0.92
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Per website child was due for Polio-IPV and DTaP. I mistakenly gave the child Kinrix.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Feeling cold, Headache, Nausea
Clinical narrative: all over achy & tired for 3 days. cold chills, queasy stomach, fuzy head, left arm very sore. Left arm & left foot feel very hot from the inside but normal when touched from the out side. Last few days most pain is in the neck and arm had a very bad headache. It has been 6 days since shot and I feel 85% normal.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Skin warm
Clinical narrative: all over achy & tired for 3 days. cold chills, queasy stomach, fuzy head, left arm very sore. Left arm & left foot feel very hot from the inside but normal when touched from the out side. Last few days most pain is in the neck and arm had a very bad headache. It has been 6 days since shot and I feel 85% normal.
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Immediate post-injection reaction, Injection site inflammation, Mobility decreased, Pain, Pain in extremity
Clinical narrative: patient states sore arm deep inside with limited range of motion ( hurts to be raised) 30 days after vaccine given.  Immediately after vaccine he had inflammation at injection site which resolved in a few days but pain stayed.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Nurse called to report temperature excursion for VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 02-NOV-2020 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T006345, expiration date 20-FEB-2022 (route of administration was not provided) for prophylaxis.     The vaccine had a temperature excursion between 13.9 degrees Celsius (°C) and -14.7°C; -14°C to -10°C, with an average of -13.9°C for 30 minutes; -14°C to -10 with an average of -14.2°C fro 15 minutes; -14°C to -10°C with an average of -14.7°C for 20 minutes and -14°C to -10 °C with an average of -14.6°C for 5 minutes. There were no previous temperature excursions. The call was due to digital data logger.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC; dose of VARIVAX was administered today after the temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 03-NOV-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T012552, expiration date 10-APR-2022 (route of administration was not provided) for prophylaxis.  The vaccine had a temperature excursion of 7 degrees Celsius (°C) for 14 hours. There was no previous temperature excursion.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other AE reported; received a third dose of PROQUAD; This spontaneous report has been received from nurse concerning  a 6 years-old male patient. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.      On 02-NOV-2020, the patient was vaccinated with the third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)  formulation not reported but defaulted to subcutaneous injection,  Lot # T013541, expiration date 17-OCT-2020,  for prophylaxis (patient route of administration was not reported).        No other adverse event (AE) was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Temperature excursion; This spontaneous report has been received from licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.       On 02-NOV-2020,  the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) formulation not reported but defaulted to subcutaneous injection, 0.5 milliliter, Lot # reported as T016147, expiration date 07-NOV-2021 for prophylaxis (dosage regimen and patient route of administration were not reported).   The temperature was reported to had been at -13.9°Celsius (°C) to -14.7°C . For 30 minutes, the temperature was in between -14°C to -10°C (-13.9°C). For 15 minutes, the temperature was in between -14°C to -10°C (-14.2°C). For 20 minutes, the temperature was in between -14°C to -10°C (-14.7°C). For 5 minutes, the temperature was in between -14°C to -10°C (-14.6°C).There was digital data logger involved.   Lot # T016147 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported as 07-NOV-2021, but upon internal validation established as 11-JUL-2021.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: 17 people were given vaccines during improperly stored; This spontaneous report, as received from a nurse refers to a 5-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, concomitant medications and medical history was provided.  On 02-NOV-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml, lot # T006345, expiration date: 20-FEB-2022 (strength, dosing schedule and route of administration were not reported) for prophylaxis. Administered dose of vaccine was exposed to the following temperature excursions: -14 Celsius (C) degrees to -10 C (-13.9 C) for 30 minutes; -14 C to -10 C (-14.2 C) for 15 minutes; -14 C to -10 C (14.7 C) for 20 minutes and -14 C to -10 C (-14.6 C) for 5 minutes. The digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received improperly stored PROQUAD; This spontaneous report was received from a registered nurse regarding  to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 03-NOV-2020, the patient was vaccinated with  an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) lot # T020620, expiration date 13-DEC-2021 for prophylaxis (strength, dose and route of administration were not reported).     The improperly stored suspect vaccine experienced a temperature of - 10 to 8 degree Celsius (°C) ( Average of -5.4 °C) for 2 hours 50 minutes and - 10 to 8 °C ( Average of -5.3 °C) for 3 hours 20 minutes. No previous temperature excursion was provided.   The suspect vaccine was reconstituted with properly stored diluent. The call was made due to a digital data logger. No additional adverse effect reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: no additional AE/PQC reported; caller is reporting an expired VAQTA that was administered; This spontaneous report was received from an other reporter and refers to a patient of unknown age and gender. There was no information regarding the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-NOV-2020, the patient was vaccinated with a hepatitis a vaccine, inactivated (VAQTA) injection, 0.5 milliliter, lot # S020241 for prophylaxis (route of administration was not reported) that expired on 23-AUG-2020. No additional adverse event (AE) or product quality complaint (PQC) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020241; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: expired dose ofRECOMBIV AX HB was administered to a patient; administered vaccine had a previous temperature excursion; This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 12-NOV-2020, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (route and dosage information were not reported; lot # R021370 expiration date 07-NOV-2020) for prophylaxis.  It was also mentioned that, the administered vaccine had a temperature excursion of 46.1 °F for11 minutes, on 06-OCT-2020.    The reporting nurse wanted to know if the patient needed to be re-vaccinated.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Rash, Throat irritation
Clinical narrative: arm rash; itchy eyes; itchy throat; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 hrs after receiving Shingrix, the patient experienced rash, eye pruritus and itchy throat. On an unknown date, the outcome of the rash, eye pruritus and itchy throat were recovered/resolved.   It was unknown if the reporter considered the rash, eye pruritus and itchy throat to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Aftter receiving Shingrix, the patient experienced a rash on the arm, itchy eyes and itchy throat. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: achy; tired; sore left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number GM2Y4, expiry date 10th May 2022) for prophylaxis.   On 8th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 8th November 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 9th November 2020, the patient experienced pain and tiredness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm, pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The same day, after receiving Shingrix, the patient experienced sore left arm. The patient was also achy and tired. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix and experienced Shingles. Till the time of reporting patient had an active episode of shingles. The Vaccine Administration Facility is the same as Primary Reporter. No further details were reported.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: probably polycellulitis; The whole half of the arm was really red and swollen; The whole half of the arm was really red and swollen; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), intramuscular on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced polycellulitis, the whole half of the arm was really red and swollen on an unspecified date. The reporter mentioned that a patient developed something that the reporter thought was probably polycellulitis after shot of unknown pneumonia vaccine product; product might have been Prevnar 13 but reporter was not sure. The patient called the doctor who sent them to a clinic to be seen that day and think theirs was maybe 3 days since they had gotten the unknown pneumonia vaccine if the reporter remembered correctly. This occurred maybe 6 months ago. The reporter just remembered the whole half of the arm was really red and swollen. The outcome of the events was unknown. Lot/batch number has been requested.; Sender's Comments: A contributory role of PREVNAR 13 cannot be fully excluded in triggering the onset of probably polycellulitis with the whole half of the arm was really red and swollen.  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.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis, Wheelchair user
Clinical narrative: Guillain-Barre syndrome (GBS); paralyzed; Initial information received on 07-Oct-2020 regarding an unsolicited valid serious case from a consumer via social media.   This case involves female patient of unknown age had GBS (Guillain-Barre Syndrome) got paralyzed (paralysis) and was 10 years in a wheelchair, after vaccination with INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via unknown route in unknown administration site or prophylactic vaccination.  On an unknown date, the patient developed serious events of GBS (Guillain-Barre syndrome) and got paralyzed from flu (paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for both the events.  It was reported by the reporter, that the Guillain-Barre syndrome is listed on the flu vaccine side effects.  Information on the batch number was requested.  Follow up information received on 06-Nov-2020 regarding an unsolicited valid serious case from a consumer via social media.  Event: Guillain-Barre syndrome was added and the case was corrected to valid serious case as it was incorrectly captured as non-valid case considering Sanofi Product Not otherwise specified (NOS). Corresponding fields were updated.; Sender's Comments: Follow up information received on 06-Nov-2020 does change the previous assessment of this case. This case concerns a  female patient of unknown age who had Guillain-Barre Syndrome and paralysis, after vaccination with INFLUENZA VACCINE. The time to onset is unknown. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Diarrhoea, Malaise, Vomiting
Clinical narrative: continuous vomiting; diarrhea; was so sick; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient of unknown demography who experienced continuous vomiting (vomiting), diarrhea (diarrhoea) and was so sick (malaise), after he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, vaccinations, concomitant medication and family history were not provided.   On an unknown date in 1970 (Friday afternoon), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (until Sunday night), the patient developed non-serious continuous vomiting (vomiting) and diarrhea (diarrhoea) 2 days following the administration of INFLUENZA VACCINE. On an unknown date, the patient was so sick (malaise) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as non-serious.  Other case details: the patient reported that in 1970, flu shots did contain the virus. For a long time, the patient refused to take the shot and started taking it again after being in the hospital in December 2016 with a blood clot in each lung and pneumonia.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Quadriplegia
Clinical narrative: paralyzed from the neck down; Initial information was received on 05-Nov-2020 regarding an unsolicited valid serious social media case from the patient.  This case involves a female patient (age was not reported) who was paralyzed from the neck down (quadriplegia), after she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient was paralyzed from the neck down (quadriplegia), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  The patient was hospitalized for this event on an unknown date for 24 days.   Details of laboratory data were not reported.  It was not reported if the patient received any other corrective treatment.  At the time of reporting, the event outcome was not reported.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a female patient of unknown age who had quadriplegia after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, the patient's medical condition at the time of vaccination, concomitant medication and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Near death experience, Nervous system disorder, Respiratory disorder
Clinical narrative: flu nearly dead; Ended up with long term respiratory issues; Ended up with long term nerve issues; Initial information was received on 07-Nov-2020 regarding an unsolicited valid serious case from a consumer (patient) via social media.  This case involves a patient with unknown demography who took the flu shot and ended up in the hospital with the flu nearly dead (influenza) and ended up with long term respiratory and nerve issues (respiratory disorder) (Nervous system disorder), while the patient received INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced serious flu nearly dead (influenza), ended up with long term respiratory and nerve issues (respiratory disorder) (Nervous system disorder) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the events was unknown at the time of reporting.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly document case received from social media concerns a patient with unknown demography who experienced  flu nearly death and long term respiratory and nerve issues, after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Gait inability, Movement disorder
Clinical narrative: The patient cant walk move his arms and in a rest home; The patient cant walk move his arms and in a rest home; Initial information was received on 07-Nov-2020 regarding an unsolicited valid serious social media case from a consumer via social media.  This case involves a 69 years old male patient who cant walk move his arms and in a rest home (walking disability) (movement disorder), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient could not walk(walking disability), move his arms(movement disorder) and in a rest home  (unknown latency) following the administration of INFLUENZA VACCINE. These events were leading to disability.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the events were unknown at the time of reporting.  There will be no information on the batch number for this case.; Sender's Comments: This poorly document case received from Facebook concerns a 69 years old male patient who cant walk move his arms and in a rest home, after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: A week after receiving 2nd shot. I started noticing pain in my left arm at the injection site. Pain radiates to the back of my neck and the entire left shoulder.  Went to see my PCP. She requested I get an Xray. When I sit down in my recliner I do not feel pain. I'm still feel a dull ache. The pain comes and goes.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: developed  a rash on right arm, subjective fever, fatigue, body aches, HA, Nausea.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: developed  a rash on right arm, subjective fever, fatigue, body aches, HA, Nausea.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid area was swollen, warm to the touch, red and itchy. Her mom said she recalls it happening the last time the child got a flu shot. Symptoms & signs improved after one day.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: For 3-4 days after the vaccine, child had redness and swelling at the site. Also for two days after the vaccine, she had a fever of 100-102 and both of her ears had blisters.
Age: 62.0
Sex: M
Vaccine: FLUR4
Symptoms: Chills, Gastrointestinal pain, Myalgia
Clinical narrative: Pt explained he had intestinal cramps starting 2 days after injection, followed by shivers for 2 days, followed by myalgias for 2 days.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Patient reports fever, chills, and fatigue the evening following vaccination and for a day thereafter.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Nausea
Clinical narrative: Diarrhea, nausea, chills
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Pyrexia, Vomiting
Clinical narrative: Patient developed a temperature of 104 degrees at night he received FluLaval vaccination bilious emesis one time. Fever lasted until the next afternoon around 2 PM when it resolved.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Muscular weakness, Pain, Product administered at inappropriate site, Vaccination site induration
Clinical narrative: Weakness in L arm following day. Dull pain, radiates to L elbow. Sore, firm to the touch at vaccination site. Dr. recommended massaging site. Dr. also recommended on 10/06/2020 to attend PT. Zero change with PT as of current date. Dr. recommends referral to orthopedist. Dr. stated that the injection itself could be the cause of the adverse event as it was administered too low in the arm and not closer to the shoulder.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site pain
Clinical narrative: Weakness in L arm following day. Dull pain, radiates to L elbow. Sore, firm to the touch at vaccination site. Dr. recommended massaging site. Dr. also recommended on 10/06/2020 to attend PT. Zero change with PT as of current date. Dr. recommends referral to orthopedist. Dr. stated that the injection itself could be the cause of the adverse event as it was administered too low in the arm and not closer to the shoulder.
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Pharyngitis, Rash
Clinical narrative: rash on the trunk and the face; pharyngitis like reaction on the throat; erythema at the injection site; Route of Administration: IM; This spontaneous report as received from a physician refers to a 12 month old male patient. He had no known allergies.     On 16-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # T016145 has been verified to be a valid lot number, expiration date: 07-NOV-2021, recombinant Human albumin (rHA)), via intramuscular route (dose was not reported) for prophylaxis. On 17-OCT-2020, the patient experienced erythema at the injection site. On 27-OCT-2020, he experienced rash on the trunk and the face and pharyngitis like reaction on the throat. Medical attention was sought for the patient. He received a treatment with acetaminophen (TYLENOL).  The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain
Clinical narrative: Soreness at the injection site; Her arm was red; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 9th November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site pain and erythema of extremities were unknown.   It was unknown if the reporter considered the injection site pain and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and experienced Injection site soreness and next day arm redness. No other information was available. The reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site warmth, Lipoma
Clinical narrative: Injection site became red; Injection site became / warm; Has not received the second dose yet; Lump near her right breast / diagnosed to be a lipoma; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of lymphadenopathy (dose received 25 years ago).   On 12th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In January 2020, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced lipoma. On an unknown date, the patient experienced injection site erythema, injection site warmth and incomplete course of vaccination. On an unknown date, the outcome of the injection site erythema, injection site warmth, lipoma and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and lipoma to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and  and experienced injection site erythema, injection site warmth,lipoma. The patient did not receved the 2nd dose yet which led to incomplete course of vaccination. The patient stated that she received flu vaccine 25 years ago but did not remember the name of vaccine and after that never received any other flu vaccine. The patient stated that around the end of January 2020 she noticed a lump near her right breast and after ultrasound it was diagnosed to be a lipoma. The reporter consented to follow up. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia oral
Clinical narrative: Sore arm; Tingling around her lips/Tingling on the roof of the mouth; This case was reported by a consumer via call center representative and described the occurrence of tingling lips in a female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   Concurrent medical conditions included cancer. Concomitant products included linum usitatissimum (Flax Seed), cinnamomum verum (Cinnamon), colecalciferol (Vitamin D 3), calcium citrate (Citracal), ubidecarenone (Coq 10), vitamin B nos (Vitamin B), pravastatin, levothyroxine sodium (Synthroid) and amlodipine.   On 9th September 2020, the patient received Shingrix. On 9th September 2020, several hours after receiving Shingrix, the patient experienced tingling lips. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the tingling lips was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the tingling lips and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix and experienced tingling in lips and over the mouth, sore arm. She was cancer survival patient. The reported batch number 2ZN2 was not found in sales data sheet hence was updated to 2ZN2D. Concomitant medications reported were Synthroid, Amlodipine, Pravastatin, Vitamin B Complex , CoQ-10 Enzyme, Vitamin D-3 1000 units, Citracal (Calcium Citrate) , Cinnamon Pills, and Flax Seed. She did not know if she can get 2nd dose of shingrix. The reporter did not consent to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain barre syndrome; Initial information was received on 07-Nov-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves a 69 years old patient who experienced Guillain Barre Syndrome, while the patient received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious Guillain Barre Syndrome (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported as patient took one flu shot and got a virus from it called Guillain Barre Syndrome and had never took another dose.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a 69 year-old patient who experienced Guillain-Barre Syndrome after vaccination with INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.