chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headaches ever since vaccine; fever; Could not sleep; hurt like hell; This is a spontaneous report from a Pfizer sponsored program . A contactable female consumer (patient) reported for herself. Follow-up information received on 19Apr2021 from same reporter was processed together with initial information. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via intramuscular route in left arm on 13Feb2021 (at 62-years age) as single dose for covid-19 immunisation. Medical history included high cholesterol. Patient States her whole family was dead, and all died of cancer. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient has never been sick or had a headache in her whole life until after receiving 2nd dose of Covid19 Vaccine. Said has headaches ever since vaccine. Wants to speak to someone about this. She later clarified and stated she wanted to report that the headaches are happening daily. If she would have known, she would have not taken the vaccine, even if it was to be with her mother-in-law. A friend of hers works for a research company states she would not recommend that anyone get the vaccine. Then she states she was provaccine. When providing details about the first dose she states the vaccine hurt like hell. The pain started 20 minutes after the vaccine was given on 13Feb2021. It hurt all night and went away the next day. The second vaccine was given on 06Mar2021. Provides lot number as EL330. The vaccine was given in the upper left arm. The second one did not hurt. There is no expiration date or NDC number on the vaccine card for either vaccine. She had a headache the first night her and her husband had the shot on 0, and they could not sleep on 13Feb2021. They felt like they did a whole bunch of cocaine. Tossing and turning could not sleep. Her husband did not have headaches. She also had a fever and the headaches have been going on daily. The headaches come and go but gets it at least once a day and now she's getting them in the morning. After the first shot they could not sleep, but she does have insomnia. However, the issue of could not sleep that occurred with this occurrence has. Patient states today was the worst headache. She might call her doctor. Caller also mentioned she was sore as well. She just feels like the headaches are form the vaccine. She doesn't like to take Advil or any medication. Taking Tylenol really affects her. States she doesn't take any medication, and hopes no none else has headaches and needs to take Tylenol and Ibuprofen every day. It was awful. She will call her doctor if this keeps happening. She thinks it was crazy that all her life she has not had headaches, and now she gets them every day. The outcome of the events was not recovered for headache and resolved for other events.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from an unspecified report refers to a patient of unknown age and gender. On 13-FEB-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Ten days after receiving vaccine, patient developed high fever of 103. Second day developed rash on face and neck that spread to rest of body by day three. Severe lethargy persisted for six days. Rash lasted seven days and fever lashed four and a half days. Also had runny nose and redness in the eyes.
Tingling and numbness in right arm and right side of face started on drive home from clinic approximately 1 hour after vaccine administration.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In January 2022, between 5 and 6 months 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 provided as follows: The age at vaccination was unknown. The reporter reported that a patient needs to receive his second Shingrix shot by 8th February 2022 (6 months since first shot) as reported.  The reporter developed shingles 4 days prior to this report.  The patient currently had an active case of shingles. The lot number or expiry data available as the first dose was not administered at their pharmacy and the reporter did not know the exact date of the first dose.  The reporter stated that she needed to give a shot and not to log her out but then disconnected the chat.  The patient was unable to obtain permission for follow up due to this but an email was provided. The mailing address was listed in the reporter details section of the adverse event form but he/she was not able to confirm that this was the current address. Case US2022012215 was identified as a follow up of case US2022012210. Case US2022012215 was deleted due to being created in error. All future correspondence would be submitted to case US2022012210 (case of record). The case has been linked to US2018024303,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018024303:Same reporter
Patient was given undiluted dose of pediatric Pfizer Covid-19 vaccine. This was caught by the pharmacist on site after administration. Patient did well through observation period in clinic and did not have any immediate reaction. Patient's mother was notified and advised patient may have more impressive immune response due to this increased dose of vaccine.
and got the booster and got sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), 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: 2, received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke), for Covid-19 Immunization, reaction(s): "ischemic stroke"; Bnt162b2 (Dose: 1, received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke), for Covid-19 Immunization, reaction(s): "ischemic stroke". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "and got the booster and got sick".  Additional information:Caller stated that she read that the second dose of the Pfizer covid 19 vaccine was stronger and this could be why the patient had the stroke and stated she called a year ago and would not provide any demographics. Caller wanted to speak with someone in the lab. Caller wanted to know the data regarding a person in their early eighties that received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke and then got the booster. she heard that Pfizer and Moderna stopped doing trials on persons in their seventies. Caller asked if there were any specific trials for persons in their eighties. Caller wanted to know if there is any data on a person that had an ischemic stroke and got the booster and got sick, asking what is the adverse reaction and wanted to know if the vaccine is contraindicated in this person. Caller refused to be sent because she said it would not help and she is not here to help the company. Caller stated the patient would only agree to report to DSU if the patient got the information about persons having an ischemic stroke and then getting the booster. Caller stated the HCP does not have any information. That it is too bad that Pfizer does not have information about persons that are 65,75 or 85 because they are the ones in danger noting it is too bad that the trials were not done on the age group 80 and older. Caller stated this age group is the age group that needs the vaccine the most. Caller stated Pfizer has determined this age group to not be important because there is not any money in it. Caller stated that there were persons with autoimmune disease and still took the shot. Caller stated she was at ground zero because Pfizer did not have any specific information  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
irreg breathing-poss apnea was checked in ER-was OK place on home apnea monitor;
IgG test negative after two doses of vaccine; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (IgG test negative after two doses of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (IgG test negative after two doses of vaccine). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (IgG test negative after two doses of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
PT ADMITTED TO HOSPITAL FOR COVID PNEUMONIA ON 6/17/21. RECIEVED PFIZER VACCINES ON 1/29/21 AND 2/24/21 (UNSURE WHERE THESE WERE RECEIVED). 1.5 WEEK HISTORY OF DECLINE IN FUNCTION INCREASED CONFUSION, CHRONIC PAINS, DECREASED ENERGY, SUBJECTIVE CHILLS, CONGESTION AND DECREASED APPETITE. SAT 89% ON RA UPON ARRIVAL. PUT ON 8L/NASAL CANNULA. REMOTE HX OF LYMPHOMA S/P RADIATION AND CHEMO 3 YEARS AGO. WILL GET REMDESIVIR AND DEXAMETHASONE HERE
Monday, the day after the vaccine I had a lot of pain in my arm and I still have it. Vaginal bleeding and I'm still bleeding and pains that come and go, and it's still going down with clots.
First night (and next 5 days) - fever, chills, extreme pain at injection site. After 5 days, left with feeling of pressure in throat head and chest (like being strangled). This lasted unabated, 24/7 for three months. With acupuncture, is slowly getting better now.
Minutes after the pneumonia 13 shot she became "freezing" The following morning she felt nausea without vomiting which is coming and going. She had 1 day of loose stools only. The local arm pain was relieved with icings. Patient is very concerned.
1252 Resident rang with complaints of chest pain and shortness of breath.  BP 126/70, Temp 97.5, pulse 72, resp. 20, O2 sats on room air 90%.  While awaiting transport complained of increasing shortness of breath.  Resident transported to Community Hospital via Ambulance with 3L O2 .  Resident placed on ventilator and transported to Medical Center
Fever the following morning. Then, 38 hours after shot: abdominal cramping, rapid heart beat, dizziness while laying in bed. Then, upon standing, passing out with loss of bowels and bladder and a tonic response.
rash on his right forearm and on his left tight. The rash is  ulcerated and look like tiny suction cups. rash on his right forearm and on his left tight.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his right forearm and on his left tight. The rash is  ulcerated and look like tiny suction cups.) and VACCINATION SITE RASH (rash on his right forearm and on his left tight.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, ALBUTEROL [SALBUTAMOL], LISINOPRIL, MULTIVITAMIN [VITAMINS NOS], FERROUS SULPHATE [FERROUS SULFATE] and OMEPRAZOLE for an unknown indication.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on his right forearm and on his left tight. The rash is  ulcerated and look like tiny suction cups.) and VACCINATION SITE RASH (rash on his right forearm and on his left tight.). The patient was treated with CORTISOL [HYDROCORTISONE] for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (rash on his right forearm and on his left tight. The rash is  ulcerated and look like tiny suction cups.) and VACCINATION SITE RASH (rash on his right forearm and on his left tight.) outcome was unknown.            Concomitant medication also included Enludopin for unknown indication. Treatment also included aloe vera to little effect.
Chest pain, SOB, malaise. 25 mg BENADRYL IM, 20 mg prednisone PO.
I gave her Pfizer vaccine without knowing she got the Moderna vaccine at the pharmacy. I am reporting it. I know pt got COVID.
Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush face
Patient under 18 received dose; A spontaneous report was received from an HCP, concerning a 16-year-old male patient, who received Moderna's COVID-19 vaccine and patient under 18 years received the dose (Product administered to patient of inappropriate age).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Feb 2021, the patient received his first of the two planned vaccine doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis.   On 26 Feb 2021, the patient arrived at the health care providers clinic to receive second dose.   The HCP wants to know if the patient should receive second dose of the vaccine.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, product administration to the patient of inappropriate age, was considered to be resolved at the time of this report.; Reporter's Comments: This report refers to a case of, Product administered to patient of inappropriate age, for mRNA-1273, lot # Unknown,  with no associated AEs.
pain; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
This case was reported by a healthcare professional and described the occurrence of urticaria in a 29-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). There was no concomitant medication and no relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included MMR II (Merck, unknown) given on 6 July 2009; ADACEL (Sanofi Pasteur MSD, unknown) given on 6 July 2009. On 6 July 2009, in the morning (reported as possibly 11:00 hours) the subject received 1st dose of TWINRIX (1 ml, unknown route, right deltoid). On 6 July 2009, several hours after vaccination with TWINRIX, the subject experienced "horrible" urticaria, swollen eyes and trouble breathing. The subject immediately went to an urgent care. The healthcare professional considered the events were a systemic reaction. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL and ATARAX. At the time of reporting the urticaria and swollen eyes were improved. The trouble breathing resolved on an unspecified date. The vaccination course with TWINRIX was discontinued. The healthcare professional considered the events were probably related to vaccination with TWINRIX. The events occurred several hours after vaccination with TWINRIX, MMR and TDAP, but the healthcare professional only considered TWINRIX as the cause.
rash, a rash on her arms and back; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included methotrexate.   On 21st June 2019, the patient received the 1st dose of Shingrix. On 25th June 2019, 4 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient stated that late in the evening of 25th June 2019, she noted a rash on her arms and back. The patient would plan to discuss with her physician.  The patient did not consent to follow up and declined providing health care professional information.
PATIENT RECEIVED VACCINE ON 4/12/22 AND DID NOT REPORT ADVERSE EFFECTS DURING MONITORING PERIOID. FOAMING AT THE MOUTH AND UNCOORDINATED MOVEMENT REPORTED BY RESIDENTIAL FACILITY ON 4/13/22
On the day shots were given, mother called to report that that evening the child complained of charlie horses in both legs and muscle aches. He sounded hoarse the next morning. Stiff neck began the evening of 2nd day. Parent gave ibuprofen. Called parent and child is eating well again with good energy, but still some stiffness in neck.
I had my vaccination on 09/12/2022. On 12/25/2022 I started to have a sore throat which got worse over time and was the worst I have ever had. I started to cough every time I would speak which lingered for 7 days. I tested COVID-19 Positive on 12/26/2022 and 12/28/2022. I contacted my doctors office 12/26/2022 and prescribed an antiviral medication.  I have had no lingering affects.
This spontaneous report was received from a nurse referring 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 VARIVAX lot # M014908, expiration date 25-MAR-2018 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit (>14 but <16 degrees Fahrenheit) for 8 hours. Data logger was involved. It was also reported a previous temperature of excursion of 10 degrees Fahrenheit (>5 but <14 degrees Fahrenheit) for 2 hours. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA010414: US-009507513-1703USA006256: US-009507513-1703USA006254: US-009507513-1703USA006255:
1/3/2022- Present to ED with c/o SOB and chest pressure. Covid + test. On 4L o2 via NC, sat 94%. T-101.4 Admit with acute hypoxic respiratory failure secondary to Covid 19. IV Decadron, IV ceftriaxone and doxycycline. EGFR-49. Troponin-0.218. Chest x ray- persistent bilateral lower lung zone subsegmental atelectasis.   1/4/2022- TEE performed, no change from previous study. Afebrile. Bumex held due to hypotension. Hold doxycycline and ceftriaxone as prolacitonin was negative. Started on aspirin and continue on warfarin.  1/7/2022- T-97.6 and B/P 128/59. Troponin - 0.079, patient cough and sob improved.  1/8/2021-Afebrile, vitals WNL. Discharged to home.
2nd dose was scheduled and the patient missed his scheduled 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose was scheduled and the patient missed his scheduled 2nd dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose was scheduled and the patient missed his scheduled 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose was scheduled and the patient missed his scheduled 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
The child received his 1st injection of Engerix-B (lot ENG22439) on 5/29/97, at 1 month of age and his 2nd injection of Engerix-B (lot ENG229729) on 10/27/97, at 6 months of age. Other vaccines reportedly administered included combination diphtheria and tetanus toxoids and pertussis vaccine adsorbed and haemophilus influenza type b conjugate vaccine (Tetramune) on 6.26/97 and 10/27/97, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, lot 362AZ, see report 2001025030-2) on 8/19/98 and haemophilus influenza type b conjugate vaccine (MSD) on 10/22/99. The child's lawyer stated, "The concomitant and aggregated injections of vaccines has exposed him to mercury in excess of all known Federal safe limits. The total exposure to date, exceeds 187.5mcg." The child's attorney alleged that "At approx. 18 months of age, (the child) was neurologically devastated by the accumulation of Mercury in his body, having been exposed via IM vaccinations and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to, the following: a. He became withdrawn, unable to speak, unresponsive to his environment; and b. His injuries include the loss of language skills, motor skills and affect." The attorney alleged that the child "sustained severe devastating permanent neurological injuries." The lot numbers provided for Engerix-B and Infanrix are not valid lot numbers.