chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a 16 month old male patient received a Tripedia and an ActHIB vaccination on 3/28/00. Reportedly on 3/29/00, the patient's arm became swollen and red. On 3/30/00, the patient's lips and feet turned purple per patient's mother. The patient was brought to the physician's office for a visit in the late morning. The patient had a temperature of 102.5 F and was shivering, increased heart rate. The patient sent to the emergency room via ambulance, lips and feet blue. From correspondence received at manufacturer on 4/17/00, additional patient information was provided. Follow up #1 (6/14/02): during internal auditing of all fieles, it was deemed necessary to amend the report by updating the adverse event coding (added tachycardia, skin discoloration and chills). Additional also resulted in re-ranking of events which changed the AE onset date.
This spontaneous report as received from a licensed practical nurse 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 an unknown date, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB injection (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33 degrees Fahrenheit for 10 hours and 49 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Chills; fever; muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration, in left arm on 29Mar2021 at 08:45 (at the age of 48-year-old) at single dose for COVID-19 immunization. Medical history included Epstein-Barr and diagnosis of COVID-19 prior to vaccination. The patient did not receive concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient hasn't been tested for COVID-19. The patient experienced chills, fever and muscle soreness the night after the vaccine on 29Mar2021 at 22:00. He woke up with the same. The patient didn't receive any treatment for the events. Outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
first dose  before the pandemic, second dose has not yet been administered.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The patient received her first dose of Shingrix series before the pandemic began and did not follow through with receiving the second dose. The pharmacist did not have the date or lot number or expiration date of the first dose. The second dose had not yet been administered. The consent to follow up was given.
Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization.  Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68.  There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
I had been traveling and just got back. I was told that someone I was with on the trip was positive. I thought I had a summer cold and I noticed that I had lost my taste a bit. I ended up going and getting a COVID-19 PCR test at my pharmacy and that came back positive. I had a sore throat, was coughing, had congestion, and my sense of balance was off. I was given Benzonatate for the symptoms and also took Mucinex.
This spontaneous report was received from a patient of unknown age and gender referring to him/herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided refers to a female patient of unknown age. On unknown dates, at age 1 and 10 years old, the patient was vaccinated with unspecified doses of (wistar ra 27-3) M-M-R II (exact dose, roue of administration, lot# and expiry date were not reported) for prophylaxis. Other suspect therapies included sterile diluent. On an unknown date, the patient reported having postvaccination serologic testing with results that were not clearly positive. No adverse effects were reported. The outcome of the event was unknown. Causality assessment was not provided.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-APR-2021, the subject experienced suspected covid-19 infection. On 21-APR-2021, the subject experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was non-serious.; Sender's Comments: v0-Medical assessment comment not required as per standard operating procedures, as case was assessed as non-serious.
102 degree (F) fever beginning at 10 PM on Day 1 and lasting until 8 AM on Day 3. Headache, chills, muscle aches, joint pain, and vomiting on Day 2. Enlarged lymph nodes beginning on Day 3 and persisting through Day 4
Seen 11-8-07 D/T rash on chest, back & face that comes & goes for x3 weeks.
This spontaneous report was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot #: K026246, expiration date on 28-JAN-2017 or lot #: L045711, expiration date on 08-MAY-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. Temperature: 30.7F. Time frame: 20 hours. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Intense tingling in left hand after first dose 8/20/21, subsided after a few hours. Immediate right leg weakness on night of second dose- 9/10/21. Intense patasthesia on 9/17-9/18 in right leg and left arm. "Stiffness" and "weakness" sent to emergency room.
Multifocal muscle neuropathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  An 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 83 years as DOSE 2, SINGLE for covid-19 immunisation. Relevant medical history included: "Hyponatraemia" (unspecified if ongoing). The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication(s) included: NACL. Vaccination history included: Bnt162b2 (Dose Number: 1), administration date: 15Feb2021, when the patient was 83 years old, for COVID-19 immunization. The following information was reported: MULTIFOCAL MOTOR NEUROPATHY (hospitalization, disability, life threatening) with onset 15Apr2021, outcome "not recovered", described as "Multifocal muscle neuropathy". The patient was hospitalized for multifocal motor neuropathy (hospitalization duration: 40 day(s)). The event "multifocal muscle neuropathy" was evaluated at the physician office visit and emergency room visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
he has been feeling ill/feeling something was different; feeling something was different; fever; he loss his voice for a couple of days/voice comes and go; feeling his throat thick; a little of pain in the arm; a feeling of oppression in the chest/chest congestion; he's not blowing his nose; felt blah; coughing; he typically has sinus; nothing is going down the back of his throat; chest congestion; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 54-year-old male patient received bnt162b2 (PFIZER BIONTECH COBID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single (age at vaccination: 54 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He was administered with the first dose of the Pfizer's COVID-19 vaccine 2 weeks ago and he is still experiencing symptoms related with the vaccine. On an unspecified date, it was reported that he has been feeling ill, feeling something was different and he loss his voice for a couple of days, feeling his throat thick and a feeling of oppression in the chest/chest congestion, also had fever and a little of pain in the arm. The arm did not hurt like a lot of people and felt blah, feels like he had chest congestion, pressure on top of his chest and thickness of his throat, he was coughing. It was stated that it took him about an hour to get through. States he and his wife got the Pfizer shot 2 weeks ago today and when he first got the shot his arm did not hurt like a lot of people. States he has a 100 degree fever and feels something was different and he felt like that and it went away, it was a different feeling. Last Wednesday he lost his voice. On Thursday, he stayed home from work, he felt blah for several days after the shot, he feels like he has chest congestion but he does not have drainage, he's not blowing his nose, isn't digging hawkers out of it, and nothing is going down the back of his throat, his voice comes and goes. He typically has sinus and chest congestion and there is a difference and he knows, states this is not like an allergy kind. He does not wake up in the morning and blow his nose. And asking if what he is experiencing is symptoms of the shot and states he would like to talk to somebody and needs to find out. The Wife of the reporter also reported during the call that she has been experiencing pain in the injection site since the administration of the Pfizer's COVID-19 vaccine. The patient underwent lab tests and procedures which included fever resulted as 100 on an unspecified date 100 degree. The clinical outcome of the events feeling something was different, fever was resolved and rest of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax & 45mins p/vax exp sweating followed by chills;sx lasted 1hr & resolved w/o treatment;vax series was discontinued;
Sore arm; Slight feeling of fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm) and fatigue (Verbatim: Slight feeling of fatigue). The outcome of the pain in arm and fatigue were not reported.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and fatigue to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR051910, US2023AMR051911, US2023AMR051912   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient and her husband received the 2 shingles vaccines. neither of both had any side effects, other than a sore 3 arm and a slight feeling of fatigue the following day. The patient have heard many horror stories of people who have had shingles.  The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR051911:Same reporter - HUSBAND case US-GSK-US2023AMR051910:Same reporter US-GSK-US2023AMR051912:Same reporter - HUSBAND case
fell into his head; Little red bumps on chest, back,head,face; Looked like he had chicken pox; Bumps developed white pus on top; Little red bumps got bigger and bigger; White blood cells count was high; Fluid building up in his lungs; Weak; Kidney numbers were high; A spontaneous report was received from a consumer concerning a 79 year old male patient who experienced fluid building up in his lungs, weak, kidney numbers were high, fell into his head, back, head, face, little red bumps got bigger and bigger, bumps developed white pus on top, looked like he had chicken pox.   The patient's medical history included rheumatoid arthritis. Concomitant product include methotrexate indicated for rheumatoid Arthritis (He stopped taking that 2 weeks before the Moderna vaccine and hasn't taken it again since then), allopurinol, acetyl salicylic acid, folic acid, prednisone, hydroxychloroquine, amlodipine and Irbesartan, all were used for an unknown indication.   On 07 Jan 2021, prior to the onset of the event(s), the patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20A] intramuscularly in the arm for prophylaxis of COVID-19 infection.  On an unknown date, Approximately a week later, he started presenting little red bumps, that got bigger and bigger and developed white pus on top of every one of them. He had hundreds of bumps on his chest, back, head and face. On 06 Feb 2021, he was supposed to get the second, but previously to that he went to the MD and was told not to get it. That day he was feeling so weak that he fell into his head and had to get stitches, at the hospital. Tests were run and he was told that his kidney numbers were high, his white blood cells count was high and he had fluid building up in his lungs. He was hospitalized for seven days. It was reported that the bumps looked in appearance like he had chicken pox. He still had the bumps, but they were dry, not as big and have no pus.   Treatment information was not provided.  The seriousness criterion for the events weak, fell into his head, kidney numbers were high, white blood cells count was high and fluid building up in his lungs was considered as prolonged hospitalization.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, weak, fell into his head, kidney numbers were high, white blood cells count was high and fluid building up in his lungs was considered as recovered on 13 Feb 2021. The outcome of the event(s), little red bumps, bumps got bigger and bigger, bumps developed white pus on top, hundreds of bumps on his chest, back, head and face and looked like he had chicken pox was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Patient developed pain, swelling, and warmth < 24 hours after the vaccine was given. Induration of 9.5cm x 12 cm at 24 hours. No evidence of cellulitis.
Developed abdominal pain 12/4 with vomiting. Had surgery for SBO. Recovering well and then had acute onset of chest pain with tachycardia, hypotension, diaphoresis, and nausea. EKG suggested a MI, went to catherization lab and revealed normal arteries. NG placed, became unresponsive, CPR started and patient died.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender, however, it was reported that the patient was not pregnant. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient had anaphylactic reaction. It was reported that the patient was given epinephrine and sent to emergency room at an unspecified hospital. At the reporting time, the outcome of anaphylactic reaction was unknown. The reporter considered the event of anaphylactic reaction to be related to RECOMBIVAX HB. Upon internal review, the event of anaphylactic reaction was considered to be medically significant. Additional information has been requested.
Red, erythematous, swelling locally over injection (right SubQ). Also, deep nerve pain. C7 radiculopathy.
NO ADVERSE REACTION , IT WAS NOTED IN ENTERING THE VACCINE DATA THAT THE PATIENT HAD THE FULL SERIES OF  PFIZER DOSE ONE ON 04/08/2021 AND DOSE TWO ON 04/29/2021. THE PATIENT DENIED HAVING A COVID VACCINE IN THE PAST BOTH ON THE FORM HE SUBMITTED AND TO ME WHEN I ASKED. THE PHONE NUMER HE PROVIDED FOR A FOLLOW UP CONVERSATION IS NOT ATIVE
Hypotension 89/61, tachycardia, fever over 102 F, diaphoresis, diarrhea all for over 36 hours.
5min following administration of vaccine pt passed out. Within moments pt became responsive. Pt was pale and diaphoretic. Bp 76/54. HR 84. Pt was taken to hospital by ambulance.  Pt was d/c from hospital 2hrs later. Pt states he received iv fluids and ekg wnl. Pt states he feels much better.
Fever of 101.2 approx 10 bumps on back, leg and thigh, runny nose, felt tired, not eating.
pt recvd vax & exp inconsolable crying; pt was fussy & drew up leg as if in pain;
Was standing at check out to make her next appt, felt dizzy, dropped to the ground, was passed out for <1 min. No tonic-clonic activity.
A health professional report has been received. The report concerns a 10 year old, Female consumer who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on an unknown date. The reporter stated inadvertently GAVE EXPIRED FLUMIST QUADRIVALENT which started on 15-Dec-2013. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Increased heart rate, heart rate elevated to 171 bpm during my work day. Heart rate episode lasted an hour before going back down. Intense chest pains and sharp pain while breathing.  I now have a heart rate monitor for the next two weeks to ensure nothing else happens and if it happens the doctors will be able to track everything.
Initial case received on 04 November 2009 from a consumer, who is also the patient's parent. The reporter also noted that the patent's brother experienced a serious adverse event; this is captured in case number 2009-04731. A seven-year-old female patient was diagnosed with Fifth Disease after receiving H1N1 (lot not reported) on 24 October 2009. The patient had no reported medical history. One hour post-vaccination, she developed a rash at the injection site, which subsequently spread down her vaccinated arm and later to her other arm. The next day, after being in the sun, her face looked pinkish. She presented to the physician two days post-vaccination, and was diagnosed with Fifth Disease at that time. No additional information was reported. Follow-up information received on 03 December 2009 from a consumer, who is the patient's parent. The patient recovered from Fifth Disease. The symptoms lasted for five days. No treatment was required. No further information is expected. Documents held by sender: None.
day p/vax given started w/redness by 11MAR93; redness almost to elbow to shoulder; fever 101-102 for 2-3 days;
on 12/24/2020 the resident was sleepy and stayed in bed most of the shift.  He stated he was doing okay but requested pain medication for his legs at 250PM.  At 255AM on 12/25/2020 the resident was observed in bed lying still, pale, eyes half open and foam coming from mouth and unresponsive.  He was not breathing and with no pulse
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-000002852. A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; macrogol 3350 (MIRALAX), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION COMPLETED, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG HYPERSENSITIVITY, outcome "unknown", described as "developed an allergy to Miralax after getting the third dose". The action taken for macrogol 3350 was unknown. Adverse event information: On 03Aug2022 it was reported that a patient started treatment on an unspecified date with Pfizer Bion-tech Covid-19 Vaccine - third dose. It was reported the patient developed an allergy to Miralax after getting the third dose. No further follow up is anticipated. Reporter type: Consumer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness (R) arm began day after vaccination. Erythema 4 x 7 cm around injection site. Cool compresses / KEFLEX 500 Q 6 hours x 7 days.
23 year old S/P Smallpox, 13 days ago, now with 2-3 days of pimples of shoulders, neck and chest. Feeling well, no pain, no N/V/D. Chest has scattered punctate pustules 1-2mm surrounding hair follicles; right trapezius papule surrounding hair follicle and scalp has a few scattered 1-2mm papules. Care discussed and is to use non-perfumed soaps, no showering. Use Motrin/Benadryl for any itching. Follow-up with FPC for any problems. Dx: folliculitis.