chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BP 190/110; fainted; shortness of breath; severe pain to upper back; severe pain to upper back and shoulder; chest pain; Pain to sternum; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had pain began on 28Mar2021. This is severe pain to upper back and shoulder and chest pain causing shortness of breath and the patient fainted went to the emergency department and was ruled out stroke. 2 weeks later, the patient was still taking Ibuprofen for pain. The patient had pain to sternum on 28Mar2021. The patient has a history of hypertension and had BP 190/110 resolved only after taking Ibuprofen 800mg 3 times a day, otherwise the pain prolongs. The patient underwent laboratory tests and procedures which includes CT, blood work, EKG, Chest X-ray of chest of lung; all negative on unspecified date. The patient was reported to be hospitalized due to the events. The events were treated with Ibuprofen. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
This spontaneous report as received from clinical medical assistant refers to a patient of unknown age and gender. On 01-AUG-2013, the patient was vaccinated with GARDASIL first dose (dose unit, route, lot# and expiry date unknown). On 11-FEB-2014 today, patient visited office to receive the second dose (dose unit, route, lot number and expiry date unknown). the outcome of in the office today (11-FEB-2014) to receive the second dose was unknown. No other information to report. Additional information is not expected.
This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 16.5-month-old female subject who was vaccinated with Varicella vaccine (manufacturer unspecified) and Hepatitis B vaccine. This case corresponds to case 1 in the literature article. The subject's medical history included dehydration and jaundice (at 4 days old) thought to be secondary to maternal ABO blood type incompatibility. She responded well to the treatment. On an unspecified date, the subject received an unspecified dose of Varicella vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with Hepatitis B vaccine and Varicella vaccine, the subject experienced macrophagic myofasciitis with gross motor delay and inability to crawl and stand. Her physical examination, at 16.5 months, showed hypotonia with decrease of strength in arm and leg, decreased reflexes and inability to stand without support. She had failure to thrive, her height was at the 50th percentile with a weight at the 10th percentile. This case was assessed as medically serious by GSK. Her CK, serum carnitine, lactate and amino acid profile were normal. The electroneuromyography demonstrated reduced recruitment in the proximal left leg testing but normal in proximal arms and normal sensory and motor nerve conduction studies. It demonstrated evidence of impaired muscle function with lack of voluntary motor unit recruitment in the left quadriceps suggesting the muscle was electrically unexcitable, while the biopsy was performed on the right, suggesting that impaired muscle function was not limited to one muscle or limb. No other organ system involvement was described. No radiological evidence of central nervous system dysfunction or parental consanguinity, and all demonstrated significant improvement in motor function over time. At 17 months, her right vastus lateralis was biopsied. Clinical presentations were characterized by motor delay, hypotonia and failure to thrive with an unrevealing evaluation for central nervous system disease, congenital and mitochondrial myopathies. All muscle biopsy specimens were similar with stereotyped demonstration of epi- peri-, and endomysium macrophagic infiltrates without muscle fiber necrosis. There was no histopathological evidence of ragged red fibers, fiber type atrophy, grouping, or significant impairment of mitochondrial oxidative staining. By the age of 3 years and 9 months, she had improved, demonstrating normal cognition and language development, with ability to run and jump, climb stairs while holding a handrail, and rise from the floor without Gower's maneuver. The author considered that macrophagic myofasciitis was possibly related to vaccination with Varicella vaccine and Hepatitis B vaccine. This case corresponds to 1 of the   [Due to memory limitations, the remainder of this text could not be compared.]  1 of the 3 cases reported in the literature article.
This 75 year old white  female received the Moderna Covid shot on03/03/21    and went to the ED on  3/10/21     and was admitted  on 3/12/21 with the following diagnoses listed below. Thrombocytopenia, unspecified
Kinrix mixed up with another vaccine; Kinrix mixed up with another vaccine; received Kinrix, child is 11 years old; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were 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: 31-AUG-2022 Reporter's Comment: The reporter reported that the 11 years old patient received Kinrix vaccine which was mixed up with another vaccine and it was outside the indication. No adverse reaction occurred, just need to know what to be done. The reporter agrees to follow up from GlaxoSmithKline. Additional supportive information: The reporter gave Kinrix vaccine mixed up with another vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter reported that 11 years patient received Kinrix vaccine which is out of recommended age, which led to Inappropriate age at vaccine administration.
Injection site pain and swelling. Two days of high fever and profound body soreness/aching. Some mild wheezing and nausea.
Nausea, Vomiting, Fever, Rash at Injection Site, Chills, Stiff and Achy Body
This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. About two years ago (approximately February 2012) the patient was vaccinated with the first two doses of GARDASIL (dosing information not provided). The reporter stated that the patient still has not yet received the 3rd shot of GARDASIL. No adverse events were reported. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 31-year-old [non-pregnant] adult female received COVID-19 immunization with the first dose of a COVID-19 VACCINE (manufacturer unknown, unspecified formulation; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date; and the second dose of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 13Apr2021 (at 30-years-old). The patient had no relevant medical history and denied any known allergies or any other medications within two weeks of the vaccine. On an unspecified date in May2022, the patient experienced COVID-19. There was no laboratory testing reported. Treatment for the event included nirmatrelvir tablets; ritonavir tablets (PAXLOVID) from 17May2022 through 21May2022.  The outcome of the event was recovering.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Patient received vaccine, sat in vaccination room for about 90 seconds then walked over to the waiting area.  Patient sat next to his uncle and within 3 minutes leaned his head back, became rigid. Rph and patient's uncle lowered him to the ground, rolled him to his side and patient started to resist help. Patient appeared to be disorientated for a moment.  Paramedics arrived and assesed patient thereafter.
bad headache for 2 days, stomach ache for half day the first day , chills off and on the second day, muscular aches the second day, extreme fatigue for 2 days.
28 HOURS AFTER INJECTION, DEVELOPED BODY ACHES AND PAINS, 99.5 FEVER, CHILLS, SIGNIFICANT FATIGUE REQUIRING ME TO GO TO BED - SLEPT 12 HOURS
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-395985 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 63-year-old female patient who received FLUARIX. The patient's past medical history included tinnitus (did not experience for a long time). Concurrent medical conditions included asthma, drug allergy (causes tinnitus) and drug allergy (causes arm to become red and swollen). On 5th October 2015, the patient received FLUARIX (intramuscular) .5 ml. On 5th October 2015, 2 hrs after receiving FLUARIX, the patient experienced tinnitus. On 6th October 2015, the patient experienced feeling hot, rash, erythema and flushing. The patient was treated with prednisone. On an unknown date, the outcome of the tinnitus and feeling hot were not recovered/not resolved and the outcome of the rash was recovering/resolving and the outcome of the erythema and flushing were recovered/resolved. The reporter considered the tinnitus to be probably related to FLUARIX. The reporter considered the feeling hot and rash to be almost certainly related to FLUARIX. It was unknown if the reporter considered the erythema and flushing to be related to FLUARIX. Additional details were received as follows: The reporter stated that, she usually gets the Sanofi flu vaccine, and has noticed that FLUARIX contains gentamicin, while the Sanofi vaccine does not. She is very sensitive to ear side effects, and wonders if the small amount of gentamicin could have led to the tinnitus. While she has had tinnitus in the past, it has not been for a long time. On 6th October 2015, 1 day after vaccination, the patient woke up with redness or flushing on her arms that might be a rash and she was also feeling a bit hot. The flushing had about resolved at the time of reporting (today). The patient was treated with prednisone today and thought that it might have improved the reaction a bit. The patient had denied permission to contact her physician.
Chills, low fever, headache, fatigue Chills went away overnight Remaining symptoms lasted 24 hours
next day felt very tired, was fine 2 days until Monday-Wed got headache-pressure in head, felt woozy, stomach was queasy, very low energy, croupy cough, nose runny, no stamina for long walks Was ok 2 days and then it started again off and on till 3/31. Sometimes stomach felt sick, couldn't eat much. Finally feeling better in stomach but still getting headaches. Still have little stamina and very low energy and headaches make it hard to think, runny nose, croupy cough comes and goes. Teleconference with Dr. on 3/23/2021 Saw family Dr. 4/2/2021. Saw no urgent needs, just noted side effects
Ct obtained the prescription for the Oral Typhoid vaccine from the Health Dept on 6/15/09.  Ct started the capsules on Tuesday, 6/16/09.  Ct took her second capsule on Thursday, 6/18/09.  When ct woke up on Friday, 6/19/09 she was covered in a rash and welts.  Ct spoke with the pharmacist and the pharmacist told her to continue taking the capsules as prescribed because the rash was less of a problem than getting the disease would be.  Ct then consulted with her PMD who told her to continue taking the Ty21a, but gave her a medrol dose pack and informed her to go the ER if she experienced difficulty breathing.  Ct then called the Health Dept and I informed ct that our recommendation would be for her to stop taking the Ty21a, see her physician and if she still wants Typhoid prophylaxis that she could come into the health dept on Monday and obtain an inactivated Typhoid vaccination.  Ct did not state whose recommendation she would follow.
Guillain Barre Syndrome.  Tingling in fingers and toes. Progressed to muscle weakness.  Emergency room. IgG started. Respirator for 3 monthes. Coma for 1 month. Painful physical therapy until present.
RA flare up; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4172137-00 (RA).  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Feb2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 04Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 2019 (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "RA flare up". Causality as per reporter (Drug/Vaccine): Possible The reporter considered "ra flare up" related to bnt162b2.The reporter considered "ra flare up" not reasonably possible to adalimumab (HUMIRA). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided the causal association between the event rheumatoid arthritis flare up and the usage of the suspect vaccine BNT162B2 cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Limited ROM; Cannot move arm; Severe arm pain; sharp pain while at rest; This is a spontaneous report from a non-contactable consumer.   A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in the left arm, on 17Dec2020 at 11:00 (at the age of 26-years-old) at a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced limited range of motion (ROM), cannot move arm, severe arm pain, and sharp pain while at rest on 17Dec2020 at 11:45. No therapeutic measures were taken as a result of the events. The clinical outcome of limited ROM, cannot move arm, severe arm pain, and sharp pain while at rest was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vomiting, nausea, very sore arm, numbness in arm, redness  At Injection site,, swelling and hardness at site, numbness in arm., Injection site felt hot. Still very sore and red after more than a week.
Indicated throat swelling and trouble breathing about 2-3 hours after vaccination. Also had low-grade fever. Red eyes w/ discharge.
The shot was given 3/23/21 shortly after the shot the cough started and then progressed.  I thought it as bronchitis or pneumonia. I went to Dr and he did an exray and breathing test.  The cough attacks were so severe I thought I was going to throw up.  The cough gradually got better.
Headache, cold to the touch skin, pain in arm for one week and counting, cough, irritable, loss of appetite, tired and easily fatigued, loss of bladder control, bloody noses, diarrhea, stomach pain
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442, expiration date, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660:
soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 18-Mar-2021, PAIN IN EXTREMITY (soreness in arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment information was provided.   This case was linked to INC.-MOD-2021-053195 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: follow-up received on 09-AUG-2021 and contains no new information.; Sender's Comments:  INC.-MOD-2021-053195:Boyfriend's case
sick/very-ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "sick/very-ill".  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick/very-ill".  Additional information: The patient reported that "I'm seeking from Pfizer for the effects that its covid-19 vaccine had on me. Everyday I'm sick. I want to just settle this thing outside of court. I've been very-ill every since I got the two shots".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300088160 same reporter/ patient/ event, different dose;
The patient presented to the pharmacy with a red, inflamed rash on various areas including a small place on right cheek, both forearms, and both inner thigh areas. She stated the rash appeared within 48 hours of receiving her booster dose. The rash was itchy and had not resolved or progressed since initially presenting around 10 days ago. No other adverse effects were reported.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not reported.  Treatment details were not given.
Hives for 2-3 days on chin, neck, and buttocks. No tx for this reaction.
On Tuesday, January 12 at 1:30pm I felt the onset of chills, body aches, headache, fever, and  nausea. Additionally, the area where the vaccine was administered (left upper arm) was tender to the touch and red. On the same day, at 5:00pm all symptoms were at an extreme level where I had to lie down to rest, however, the pain of the body aches, headache, and chills made it difficult to rest (sleep) On the morning of Wednesday, January 13 and throughout the day all symptoms were still at an extreme level making it difficult to function (unable to get out of bed, no appetite to eat due to the nausea,  unable to sleep due to the headache, extreme discomfort) these symptoms continued on this level throughout the morning, into the afternoon and into the evening On the morning of Thursday, January 14 all symptoms with the exception of the nausea and headache had subsided The headache and nausea subsided by 11am on Thursday, January 14. I am now feeling better and could eat and function.