chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st shot made her seriously sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness (serious criteria other: Serious by reporter). On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-OCT-2022 Reporter's Comments:  This case was received from consumer via  interactive digital media. The reporter's wife had the first shot and made her seriously sick. Additional supportive information: The follow up would not possible as no contact details were available.
Following the shot, my face became hot, my ears were red, my tongue, arms, and legs tingled, heart rate increased.  This started shortly after the injection, It subsided after about 15 to 20 minutes. This is similar to reactions that I've had to flu vaccines when I last had one nearly 25 years ago.  It is also similar to my reaction to numbing shots where epinephrine is in the shot.
About three weeks later I developed 5 cm lump under the arm in which I received the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 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: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Booster; Unknown manufacturer). The following information was reported: VACCINATION SITE MASS (non-serious) with onset Oct2022, outcome "unknown", described as "About three weeks later I developed 5 cm lump under the arm in which I received the vaccine". The event "about three weeks later i developed 5 cm lump under the arm in which i received the vaccine" required physician office visit.  Additional information: The patient received the Pfizer second booster on 18Sep2022. About three weeks later the patient developed 5 cm lump under the arm in which the patient received the vaccine. Since then the patient's family physician authorized an ultrasound and a consultation with a surgeon. The surgeon said that it appears the patient had an overreaction to the vaccine. The surgeon said to return in 6 months if the lump hasn't resolved itself and they would do further tests. The patient was questioning if these procedures at all covered if the lump was caused by the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I started off with a sore throat and general fatigue. That lasted about 3 days and I treated myself with over-the-counter medications. I tested myself on December 12, 2022, and I was positive for COVID-19. I was prescribed PAXLOVID due to hypertension and hyperthyroidism. I have been taking this every since then. I have lingering congestion.
Patient said that her arm was swollen and red and hurt, no where she received the vaccine, but below it. She said it was almost like a half moon. She said it resolved tho.
low-grade fever (99.7degrees F), chills, achy, sweats, burning up (hot), headache, fatigue, not able to think clearly (out of sorts)
First, shock-like pains in leg for almost a month, then in same side developed numbness, tingling, other parasthesias, muscle pain, muscle fatigue, muscle shaking, general fatigue, sleepiness. After a couple of months I gradually developed a severe frozen shoulder, same side and other joint stiffness worsened as well. Almost a year later I continue to suffer and left side is also developing some symptoms now. Have had loads of tests done including MRIs, xrays, blood work, and they have not found any disease they (neurologist, rheumatologist, primary care) can diagnose, but I still suffer. This is not a complete list of symptoms -too long to remember them all.
There was no adverse side effect, needed to report that case was COVID positive and unaware at the time of vaccination. He did not find out that he was positive until the day after. He tested on 4/14, vaccine on 4/17, and found out he was positive on 4/18.
Pain at shoulder down to forarm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain at shoulder down to forarm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain at shoulder down to forarm). At the time of the report, ARTHRALGIA (Pain at shoulder down to forarm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       AE submitted. no concomitant medications and treatment medications are provided.   Reporter did not allow further contact
Significant swelling of lymph nodes under arm. No treatment. Visible swelling resolved within 7 days. Continue to have high neutrophil count through last test, 2 months after vaccine.   Burning tongue syndrome started around October 6, 2021.  Prescribed course of prednisone with no improvement resulting. No improvement as of 11/3/2021.  Missed period.  No treatment.  Period returned 11 weeks from prior period and 9 weeks from vaccine.
Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked with Case ID 2018SA201498, 2018SA201512, 2018SA201514 and 2018SA183350 (same reporter). This case involves a four-years old patient (gender not reported) who received a IPOL from a IPOL shipment should be returned due to it being in transport a day longer than it should have, no adverse event. This is the case of actual medication error as the vaccine was administered to the patient, which was incorrectly stored. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose 0.5 ml of suspect IPOL lot N1K92 via unknown route in unknown administration site. Caller reported that by the time they received notification that their IPOL shipment should be returned due to it being in transport a day longer than it should have, they had administered 5 doses to patients already. All of the patients were 4 years of age. It is unknown who administered each dose. There were no adverse reactions reported for any of the patients who received the doses. The doses were administered on June 8th, June 12th, June 13th, June 14th, June 18th and June 21st. Caller stated they were aware that the parents will have to be notified and the children will have to be re-vaccinated. Caller stated that she had already talked to someone about returning the shipment. Lab data and corrective treatment: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) via a contactable nurse. A female patient of an unspecified age and ethnicity received first dose of TRUMENBA (lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date (reported as 6 months ago) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a fever of 105 degrees at the first dose of meningococcal group b rlp2086 six months ago. The outcome of the event was unknown.
syncope and near syncope episodes; just being either close to blacking out or blacking out, or dizzy; just being either close to blacking out or blacking out, or dizzy; sick; gastrointestinal issues; lost 20 percent of his body weight in the same time period; feeling frequent chest pain; bad feeling in my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), in Aug2021 as dose 1, single (Batch/Lot number: unknown) and in Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "syncope and near syncope episodes"; LOSS OF CONSCIOUSNESS (medically significant), DIZZINESS (non-serious), outcome "unknown" and all described as "just being either close to blacking out or blacking out, or dizzy"; ILLNESS (non-serious), outcome "unknown", described as "sick"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "gastrointestinal issues"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 20 percent of his body weight in the same time period"; CHEST PAIN (non-serious), outcome "unknown", described as "feeling frequent chest pain"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "bad feeling in my head". The events "syncope and near syncope episodes", "just being either close to blacking out or blacking out, or dizzy", "sick", "gastrointestinal issues", "lost 20 percent of his body weight in the same time period", "feeling frequent chest pain" and "bad feeling in my head" required physician office visit.  Clinical course: The patient stated that he is trying to get information on adverse events from Pfizer Biontech COVID-19 vaccine. He stated that he had the vaccine several months ago and has been to several doctors. The last doctor he saw suggested he called Pfizer to see if he could get any information. He has been sick ever since he got the two doses of the first primary series on Aug2021. He has been going to doctors trying to figure out what is going on and cannot figure out anything. It all started after the vaccine. He stated that he has had gastrointestinal issues, namely nausea and stomach issues every single day for the last seven and a half months. He has lost 20 percent of his body weight in the same time period. Thats the mayor issue. He also reported feeling frequent chest pain and syncope and near syncope episodes. "patient have a really bad feeling in head of just being either close to blacking out or blacking out, or dizzy, its hard to explain". Patient asked does Pfizer have some kind of data that he can look at or somebody else he can talk to that has experienced this and is there some kind of treatment for the adverse events he was experiencing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fussiness for 4-5 hours beginning at time mentioned previously. Rash on torso-no new soaps, detergents or foods were introduced: still present at time of report. Loose stools.
Headache, myalgias, chills, 99.8 deg F elevated temp, fatigue. Tylenol was used. Resolved after 48hrs. Had to miss 1 day of work
Patient received vaccine around 3pm and felt normal. Around 11pm he woke up and had chills and vomited, which dissipated around 2am. Came into pharmacy next afternoon feeling well and normal.
Breastfeeding mom/nursed him multiple times right after I vaccinated; Had 99.6 F temperature/temperature went up/fever; Diarrhea; This is a spontaneous report form a contactable other Health Care Professional (mother). A 19-month-old male patient received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Lot number: En6199, Expiration date: was not reported) via transmammary on 10Mar2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 10Mar2021 18:15, reporter stated her son was 19 months old. He had 99.6 F temperature and diarrhea 4 hrs after she got vaccinated (I nursed him multiple times right after I vaccinated and when his temperature went up). She also stated I am breastfeeding mom. It looks like it was transitory as this morning he no longer had a fever. He was not sick from anything else as he was in good health prior to me vaccinated and he didn't present any other symptoms. I believe the vaccine made his body react (for a brief period of time). The patient mother was not diagnosed with COVID prior vaccination and was not tested post vaccination. The outcome of event fever was recovered while other events were unknown.  Follow-up (11Jun2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021287049 Mother/Baby case
On Wednesday 3/15/07 pt went to school nurse c/o HA.  On arriving home she continued to c/o HA and fatigue.  Took 2 children's Motrin and slept, giving some relief.  On Thursday 3/15/07 AM pt still complained of HA.  Slight fever (99.9 by mouth).  Administered allergy nasal spray, pt stayed home from school.  Encouraged fluids, and by afternoon pt states she feels much better and the HA only occurs when she rises quickly or bends over.
Nausea, Night sweats, Joint Pain in legs and lower back, Headache,  fever (99.3 to 100.9), fatigue. Treated with Tylenol , Naproxen ,  Lidocaine patch, fluids, heating pad and rest. Reduced fever, reduced joint pain, headache persisted. Time course: 24 hour period
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by  for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Callers nephew had a 26 year old friend of his that received the second dose of the vaccine. Died two days later; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Callers nephew had a 26 year old friend of his that received the second dose of the vaccine. Died two days later) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 26-May-2023 The patient died on 26-May-2023. The cause of death was not reported. An autopsy was not performed.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact; Reporter's Comments: This fatal spontaneous case concerns a 26-year-old patient of an unknown gender, with no medical history reported, who received the second dose of mRNA-1273 vaccine and died two days later (death and medically significant). No details of previous doses were provided. The reported cause of death was not reported. An autopsy was not performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
pt had a systemic rash noted under arms bilat, ears, face and pubic area. Pt was given Singulair 4 mg, PO x 1 , Benadryl 25 mg IM x 1 per Dr.
Injection site warmth, tenderness, erythema. Deltoid muscle is hard. Extremely painful. Can't lift arm or sleep on that side. Redness the size of a silver dollar that grew in size over several days and then subsided.
Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. The patient received 2 doses of the Moderna vaccine greater than 6 months ago and nowhas Covid-19  Company comment: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date, more than 6 months after the second dose of mRNA- 1273 vaccine. Schedule of vaccination was not reported. Very limited information is available regarding clinical manifestations and course of the disease. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date, more than 6 months after the second dose of mRNA- 1273 vaccine. Schedule of vaccination was not reported. Very limited information is available regarding clinical manifestations and course of the disease. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
01/03/2022 Began to feel unwell 01/04/2022 Positive rapid home test  01/05/2022 Positive rapid test and awaiting PCR test results
Developed a large blood clot in my leg; passed out before being hospitalized.; pieces broke off and traveled to my lungs.; One clot in particular was very large and my artery was dilated and one side of my heart was under a lot of stress.; I experienced difficulty breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. No Covid prior vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. No other vaccine in four weeks or other medications in two weeks. The following information was reported: THROMBOSIS (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "Developed a large blood clot in my leg"; LOSS OF CONSCIOUSNESS (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "passed out before being hospitalized."; PULMONARY THROMBOSIS (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "pieces broke off and traveled to my lungs."; CARDIAC DISCOMFORT (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "One clot in particular was very large and my artery was dilated and one side of my heart was under a lot of stress."; DYSPNOEA (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "I experienced difficulty breathing". The patient was hospitalized for thrombosis, loss of consciousness, pulmonary thrombosis, cardiac discomfort, dyspnoea (hospitalization duration: 8 day(s)). The events "developed a large blood clot in my leg", "passed out before being hospitalized.", "pieces broke off and traveled to my lungs.", "one clot in particular was very large and my artery was dilated and one side of my heart was under a lot of stress." and "i experienced difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of thrombosis, loss of consciousness, pulmonary thrombosis, cardiac discomfort, dyspnea with Catheter inserted in groin to deliver medication. Clinical course: Developed a large blood clot in the leg and pieces broke off and traveled to the lungs. One clot in particular was very large and her artery was dilated and one side of her heart was under a lot of stress. She experienced difficulty breathing and passed out before being hospitalized.   The lot number for bnt162b2 was not provided and will be requested during follow up.
03/13/20 at 0900 am :Received Varicella, Dtap +IPV, and MMR vaccines 04/06/20 at 0800 am : Mom noticed fluid filled bumps and redness during bath, mom brought child to clinic, provider applied PPE to self and staff, assessment, lab ordered: varicella IGM and Varicella IGG.  Patient sent home, instructed to keep papules covered, good hand washing and keep sibling away from new baby. 04/08/20 1000am:  mom states scabbing and itching and keeping away from newborn. 04/08/20 01:20 pm:  LAB RESULTS: Varicella zoster IGG 2974.00, varicella zoster IGM 0.91
Stuffy head; Sore throat; Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAD DISCOMFORT (Stuffy head), OROPHARYNGEAL PAIN (Sore throat) and MYALGIA (Body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 HEAD DISCOMFORT (Stuffy head), OROPHARYNGEAL PAIN (Sore throat) and MYALGIA (Body aches). At the time of the report, HEAD DISCOMFORT (Stuffy head), OROPHARYNGEAL PAIN (Sore throat) and MYALGIA (Body aches) 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.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Patient scheduled to take the second on 02-SEP-2021, and reported that this past weekend worked and had 3 patients test positive, she was feeling bad body aches, stuffy head and sore throat, she concerned about she should go ahead and get the second injection.