chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blister / Injection site blisters /Blister below injection site; Redness at Injection Site; Pain at the Injection Site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 47XJ3, expiry date 20th April 2022) for prophylaxis.   On 16th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 19th November 2019, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters and injection site erythema were not recovered/not resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site blisters, injection site erythema and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. Just underneath the injection site the patient noticed a blister on day of reporting. The patient also mentioned redness and pain at the injection site and that the patient still had a Band-Aid covering injection site. The reporter consented to follow up.
She got the vaccine and she immediately felt a warm flush in her left arm.  She was ok, and waited for a few minutes after.  An hour later she felt that her tongue was very heady and the inner sides of her cheeks in her mouth were numb.  She did not have problems with her throat, but the tongue was heavy.  She was extreme tired, very, very fatigued.  About 12 hours later her head started feeling dizzy like she was in a boat.  Yesterday morning, 3/31/21 her whole body was aching and in pain, and she took one regular Tylenol that helped her through the day and by the end of the day she was so tired and out of it, and had chills from about noon, so cold that she was trembling.  She also had warm feelings in her hand as well.  She went to bed early and slept for about 9 hours as she was extremely tired.  She feels a little better today, but not back to feeling completely well.
Tinnitus; It improved slightly a few weeks later but got worse again after the second dose; This is a spontaneous report from a contactable consumer (patient). A 29-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0182), via an unspecified route on unspecified date of 2021 as dose 2, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8731), via an unspecified route on unspecified date of 2021 as dose 1, single in the left arm for covid-19 immunisation experienced very loud tinnitus 3 days after the first shot. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Apr2021, the patient experienced tinnitus: Patient started getting very loud tinnitus 3 days after the first shot. Patient received an audiogram which showed no hearing loss in the tested frequencies. It improved slightly a few weeks later but got worse again after the second dose. It's been 5 weeks now and it hadn't gone away. Patient received sought treatment and was told there was none. The outcome of the events was not recovered.
Information has been received from a registered nurse concerning a 16 year old male with reflux disease, sensitivity to codeine and environmental allergies who on Sept 13 2005 was vaccinated with a first dose IM in the left deltoid with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). On Sept 15 2005, two days post vaccination, the patient called the office stating that he had pain in injection site, axillary, and chest wall which lasted 4 days. The patient had also difficulty raising arm. Unspecified medical attention was sought. The patient was treated with ibuprofen (Motrin). Subsequently, the patient fully recovered on 18-SEP-2005. The registered nursed requested a lot check. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. Pain at injection site, axillary and chest pain were considered to be disabling. Other business partner numbers included: E2005-05552. Additional information has been requested.
losing his hearing; This is a spontaneous report from two non-contactable consumers (one is patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer actually was calling on behalf of her boyfriend who received his second vaccine, they both did on Tuesday and patient was having as a side effects with his hearing- losing his hearing on an unspecified date. Outcome of event was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On 28th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 29th May 2018, the patient experienced general body pain, malaise and headache. On 30th May 2018, the outcome of the general body pain, malaise and headache were recovered/resolved. On 1st June 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm, general body pain, malaise and headache to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain in his arm and reported his arm was sore but not so severe that he could not do activities. It was sore but if someone hit him in the arm it would have really hurt. On 29th May 2018, 1 day after receiving vaccination, the patient also stated he experienced body aches, malaise, headache and would have wanted to stay home but he had to work.  The body aches, malaise and headache all resolved by 30th May 2018.
Headache, Abdominal discomfort, nausea, difficulty breathing, diarrhea.
Information has been received from a registered nurse concerning a 30 year old female with migraine headaches and a KEFLEX allergy who "in college" on an unspecified dates one month apart was vaccinated with first and second doses of Varivax. Subsequently the patient's titers were checked by her obstetrician/gynecologist and the results show that the patient is "not immune", the patient remains seronegative,. No adverse experience was related to this event and the patient was not on any medication at the time of the report. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. Additional information has been requested.
I was vaccinated with both a flu shot and a COVID-19 bivalent booster on 11/21. The symptoms started on 11/22, and at first, I thought it was because of the vaccinations. It began with a slight fever and a feeling of achiness. The fever dissipated by mid-day but the achiness increased. Toward the evening I had developed a cough. The following morning there was still a cough and body aches, but no fever. Overall, I felt worse than the day before so I took an at home rapid COVID-19 test, which was positive. For the next four or five days, there wasn't a whole lot of change. I was really fatigued and took a lot of naps. The cough went away but the aches never went away until after a week or so, but the fatigue stayed. By then my ears started to bother me, a ringing in the ears and the feeling that the inside of my ears were swollen. I went to see my doctor about my ears on 12/5 because it was the only remaining symptom. He gave me an antibiotic, there has been some improvement, but it is not entirely clear yet. The ringing has decreased but is not entirely gone. It started off in both ears but is now just in one.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/8/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 3/5/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/8/2022 MALIGNANT PLEURAL EFFUSION R09.02 HYPOXIA 3/5/2022 MALIGNANT PLEURAL EFFUSION
Chills: uncontrollable shivering for 2 hours (started  6 hours following vaccine)  103.6 fever max (fever varied) lasted 9 hours (started 7 hours after vaccine) Muscle/joint aches lasting for 16 hours (started 11 hours after vaccine) Severe migraine: extreme sensitivity to light and forehead pain lasting for 22 hours ( started 12 ish hours after vaccine) All symptoms disappeared in order of appearance 34 hours after vaccine.
I got the vaccine mid-morning on a Thursday. Early in the morning the day following the vaccine (Friday) I woke up with significant diarrhea. The diarrhea continued for the next 4 days, with the worst days being Friday and Saturday. I continued having diarrhea on Sunday, Monday, and Tuesday, though it did get less and less with each passing day. I also had the common issues of a sore arm, a headache, a slight fever, and a very runny nose. I would say all of those side effects were minor compared to the gastrointestinal issues.
while patient was being monitored after injection, patient become hot, diaphoretic - staff went to assist and patient went pale, non responsive with agonal breathing and flaccid.  Patient assisted to supine position and immediately regained consciousness.
Sick for a week; This is a spontaneous report from non-contactable consumer (patient mother). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sick for a week. It was stated that caller's son, 41 y/o was sick for a week after his pfizer vaccine dose. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected
Body ache (muscles), started with neck and right arm then spread to right and left legs and now also the calf areas. Taking Motrin but it is not helping. Took steroid shot on 01/04/2015. Felt better for just a few days but muscle ache still present. Backache post thigh & calf when bending. Took Motrin. 01/30/2015- Pain arms when lifting. Pain in back when walking. Also back of thighs/calf on bending, unable to pick up things from floor. The pain continues to spread. Still taking Motrin
After the first vaccine on 2/4/21  in left arm pain subsided on day 3   Mild pain appeared 2 weeks later.  After the second dose in right arm on 2/25/21 left arm pain rapidly intensified without physical Sxs, interfering with sleep and normal activity.  Worse  with sitting, lying on either side , radiating into the shoulder.  Nerve like pain but also point tenderness in several areas.  Present without change niw almost for one week.
tested positive for COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (tested positive for COVID) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2022, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2022, SARS-CoV-2 test: (Positive) positive at-home test.         Patient did not have any allergic condition. Concomitant medication details were not reported by the reporter. On 17-AUG-2022, patient received second booster dose of Moderna COVID-19 vaccine. After that, he was having cough and nasal congestion (symptoms of COVID-19). Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Treatment details was not reported by the reporter.  Company comment: This spontaneous case concerns a 65-year-old male patient with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, which occurred 5 days after fourth dose (reported as secondary booster) of mRNA-1273 vaccine. SARS-CoV-2 test was positive 5 days after fourth dose (reported as secondary booster) of mRNA-1273 vaccine. Patient experienced cough and nasal congestion. No further information on clinical course and treatment received was available in the report. The outcome of the events is unknown. Ongoing pandemic of Covid-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 65-year-old male patient with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, which occurred 5 days after fourth dose (reported as secondary booster) of mRNA-1273 vaccine. SARS-CoV-2 test was positive 5 days after fourth dose (reported as secondary booster) of mRNA-1273 vaccine. Patient experienced cough and nasal congestion. No further information on clinical course and treatment received was available in the report. The outcome of the events is unknown. Ongoing pandemic of Covid-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE, stop date: 10May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Negative, notes: Antigen had been only very slightly negative day 7 and 10; (20May2022) Negative, notes: Antigen had been only very slightly negative day 7 and 10; (unspecified date) Unknown result, notes: COVID 19 Treatment; (23May2022) positive, notes: tested5-23 w new onset worseningsymptoms and noted to be frankly positive within 2 minutes. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
2 days p/vax eyes appeared glazed, temples-warm, mom didn't check temp; pt hasn't been as active as usual; c/o headaches; 13SEP came home from school crying c/o h/a; treated w/APAP;
Following the vaccine, my herpes outbreak became much more aggressive and painful. Typically an outbreak will clear up within 5 days as I take medication for it, but I am currently on my 14th day with little to no improvement. I am not sure if this is the direct cause of it, but I can?t think of any other reason why it would last so long. My theory is that the vaccine weakened my immune system enough to cause the outbreak to become more violent.
Patient presented to clinic with large lump and redness around injection site.  Patient was prescribed Amoxicillin 400mg/5mL oral suspension.  Patient returned for evaluation and symptoms improved.
Shoulder injury related to vaccine administration  Severe L shoulder pain developed within hours of vaccination. Symptoms have improved significantly but persist since vaccination. I received a steroid injection in the L shoulder and saw physical therapy for 5 sessions. I do not have normal use of my left arm.
Sudden onset violent chills at 8pm lasting through night. Fever high of 104.9.
has a numb area on her tongue and there is a red patch on the area where it is numb; has a numb area on her tongue and there is a red patch on the area where it is numb; tongue is swollen; she is having a lot of mucus ever since the COVID vaccine; This is a spontaneous report received from a contactable consumer (patient's husband) via Pfizer sponsored program.  A 39-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: FA7485, Expiration date and NDC number was unknown), via an unspecified route of administration, administered on 26Jul2021 as dose 1, single (at the age of 39-year-old) for COVID-19 immunization. The patient had no medical history and did not receive concomitant medications. On 26Jul2021, patient's husband was unsure if this was relevant, but patient was having a lot of mucus ever since the COVID vaccine. On 27Jul2021, patient had a numb area on her tongue and there was a red patch on the area where it was numb, tongue was swollen, it had become slightly swollen. There were spots going around her tongue, all the way around it and it goes around the outside rim of her tongue and there was one spot on top of her tongue. The spot got bigger on the tongue. It was reported that numb area on her tongue and there was a red patch on the area where it was numb was worsened. They were worried about if it was going to be safe to get the second dose. Patient still has it now. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
My Ataxia has gotten a lot worse. Moved into my legs, arms and mid section. Muscle spasms, and loss of balance.
Approximately one month after my second shot, beginning around 5/20, I began to lose the sense of taste on the right side of my tongue. I thought it would go away but by 5/23 I had partial paralysis on the right side of my face. Fearing a stroke I went to the ER and after a full battery of tests I was diagnosed with Bell's Palsy. The symptoms worsened for a few days and I was unable to close my right eye, had difficulty breathing out of my right nostril and both eating and drinking were difficult because my lips would not close fully. The symptoms stabilized and then finally began to improve after steroid and antiviral treatment for a week, then on to regular aspirin.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a week after receiving BEXSERO, the patient experienced fever, stiff neck and headache. The patient was treated with methylprednisolone sodium succinate (Solu-Medrol). On an unknown date, the outcome of the fever, stiff neck and headache were recovered/resolved. It was unknown if the reporter considered the fever, stiff neck and headache to be related to BEXSERO. Additional details were provided as follows: The patient was 18 or 19 year old. The patient received her 1st dose of BEXSERO and within 72 hours, developed fever, stiff neck, and headache. The symptoms lasted for approximately 5 days. The patient was seen in the emergency room and was treated with solu-medrol. The reporter did not have any additional details regarding the event and the emergency room visited was visit required. The reporter agreed to follow up from GSK.
injection site raised; injection site is red; injection site is slightly tender; This spontaneous case was reported by a nurse and describes the occurrence of   in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    Treatment for the event included Benadryl topical solution/cream.   Reporter did not allow further contact