chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had PPSV on 3-11-15 with adverse reaction on 3-14, 3-15, 3-16, 3-17 with fever of 102 degrees, coughing spells constantly. Unable to leave house. Brought fever down with TYLENOL but would go up each night with night sweats.
Patient was administered second dose of Moderna CIVID-19 vaccine 03/01/2021, IM 0.5 ml in left deltoid.  According to the nurse administering the vaccine, a small drop of the vaccine came out of the syringe where the needle hub attaches to the syringe.  The patient was concerted that she did not receive the entire dose of vaccine.   Consult done it was suggested that the patient be offered a third dose.  Patient wanted a third dose and it was administered on  03/04/2021 without incident.  Dose # 1 administered on 03/03/2021
Complained of a "thick tongue" and tingling around the mouth.   Treated with 25mg of benedryl.  Symptoms resolved in approx. 20 minutes after receiving the benedryl.
pt recvd vax; pt devel rash x 10 days; fever x 5 days; URS x 5 days;
pt recvd vax; 12 cm diam erythema of upper lt arm; 8cm of induration; inj of demerol;
Pt was leaving the clinic walking out of store, his stepdad asked him "how was the shot" and pt immediately passed out. Was unconscious for just seconds, VS were stable, EMS was called and pt hit his head on the side of a metal shelf. Stepmother then admitted pt has history of extreme sensitivity to any medical procedures. He once threw up from an eye exam. They did not want to tell me before his shot as his father died 2 weeks before and "we didn't want any drama". I asked that in the future, they inform any provider of the possibility of his reaction to shots. He did require surgical glue at the local ER to close the 2 inch laceration above his right eye. No signs of head injury. No reaction at site of injection. Called 2 days later and was told by stepmother he was having no issues at all.
Information has been received from a pharmacist via a field representative referring to a 40 years old patient of unknown gender. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose, frequency and route were  unknown) at 40 years old, Inappropriate schedule of drug administration). The patient's concomitant medication was not reported. No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Congestion; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced NASAL CONGESTION (Congestion) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Congestion) and HEADACHE (Headache) had resolved.            Patient stated she usually takes an antihistamine (not specified) but did not take the dose prior to receiving the vaccine on 18-Feb-2021.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up document was received on 14-jul-2021. Reporter's contact information and event outcome updated.
15Aug96 Pt recv 1 dose vax. 17Jan98 Pt devel about 5 lesions on trunk & 1 on face.Pt afebrile.
Stomach cramps, Pain at the injection site, Fever, Headache, Tiredness, Nausea, Diarrhea, chills, swollen glands, fast heart rate.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on 06-SEP-2011. No other co-suspects were reported. No concomitant medications were reported. On 01-OCT-2012 the patient was in the office to receive dose 2 of GARDASIL which was late. No symptoms reported. Additional information has been requested.
During evening, patient laid down then felt clammy. Had transient episode in which she couldn't talk, as if she was having a stroke. This spontaneous resolved shortly afterward.
Rashes; really itchy; scalp and private area have been itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes), PRURITUS (really itchy) and PRURITUS (scalp and private area have been itchy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes), PRURITUS (really itchy) and PRURITUS (scalp and private area have been itchy). At the time of the report, RASH (Rashes), PRURITUS (really itchy) and PRURITUS (scalp and private area have been itchy) outcome was unknown.       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.   Patient reports taking Benadryl two weeks after her first dose and last night 25Mar2021. Patient started taking prednisone 50mg (daily for 5 days) on 25Mar2021, and she noticed improvement   Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Rash is consistent with the known safety profile of the vaccine.
After getting the 2nd shot, I had no issues other than arm pain. On the 3rd of May, about 3 days later, I started feeling a burning sensation in my chest. The sensation could be felt on the top left of my chest. It was an ongoing feeling. At times I also felt the same sensation at the injection sight. Sometimes there was an achy feeling but the burning was more prominent. On that wednesday, I decided to go to Urgent care as the symptoms did not stop. They had me do a chest xray but did not see any cause for concern and so I was sent home and told to keep an eye on it and that if I had any difficulty breathing or terrible pain in my chest, I should go to the ER. That Saturday, May 8, I went to my doctor's office because I was getting worried and the sensation was not going away. I had begun to feel some chest tightness every now and again. It had now been a week. I was seen by a doctor who said that the vaccine can cause lymph node swelling and that was probably what was happening to me. She felt my chest and arm and said that she could feel swelling. I could feel a bit of swelling in my arm but nowhere else. There were no visible lumps or anything like that. But she said not to worry about it and that it will go away. After another week, I went to my actual doctor for a check up (May 15). After explaining to her what was happening and the anxiety it was causing me, she did an EKG. Results of that were normal and she also did not see any cause for concern. By this time, the sensation had begun to subside. After that day, I did not feel the sensation any more. All and all, the whole ordeal lasted about 2 weeks after getting my second shot
Within a couple hours of Tdap administration, experienced uncontrollable, inconsolable, non-stop crying for ~4 hours.  Also experienced low grade temperature of about 100 with same onset.
RECEIVED THE VACCINE FROM A BATCH THAT WAS TO BE DISCARDED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 63 year old female. 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: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 22-APR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 63 years old. No concomitant medications were reported. On 2022, the patient experienced incorrect product storage. On 22-APR-2022, the patient experienced received the vaccine from a batch that was to be discarded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the vaccine from a batch that was to be discarded and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759289, 20220759337, 20220759052, 20220759222, 20220761815, 20220759160 and 20220759219.
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medication information was provided.  Total 77 Monovalent doses were administered after the BUD to patients 12 and up.37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A.  It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided.
she was "sick " for 16 days following covid vaccine; This is a spontaneous report from a contactable other HCP and a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date. It was reported that the patient was "sick " for 16 days following covid vaccine in Apr2021. Exact symptoms unknown, md aware. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
OCT95-MAY96 lt arm muscle feels funny, redness, no swelling feels like a nodule;no functional limitations;
After the first dose two to three weeks later I started experiencing vertigo symptoms. It incapacitated me for 20 minutes at a time. It was a happening from time to time not very often. I started having longer and more frequent episodes after receiving the other doses of the Pfizer vaccine. I am unable to maintain my balance and I can not turn my head to the right. I get a episode of vertigo, I have no way to tell which way is up down or spinning around. I feel terrible. I have had 4 doses of the vaccine and I feel they have made them worse, my booster dose has made it to where even lying down I can not turn to the right.  I saw a ENT specialist and have been now referred to see an Audiologist.  This issue is constant, I feel like this is permanent.
Dermatographia of the entire skin appeared 10 days after receiving the COVID-19 booster shot. It has persisted so far for at least 2 weeks. Hives appear on the skin when itched or rubbed, and remain for around 30 minutes before subsiding.
pain at injection; Loss of appetite; fatigue; headache; Leg muscle weak; Flushed; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain, appetite lost, fatigue, headache, muscle weakness lower limb and flushing. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the appetite lost, fatigue, headache, muscle weakness lower limb and flushing were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, appetite lost, fatigue, headache, muscle weakness lower limb and flushing to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's friend. The age at vaccination was not reported but could be 61 or 62 years. The patient experienced pain at injection site which resolved and also experienced loss of appetite, fatigue, headache, leg muscles weak, flushed. The patient had been seen by primary care nurse practitioner and has been referred to a rheumatologist for consult. This case has been linked with case US2020019997, reported for same reporter.
Headache, Myalgia, Fever & NauseaVomiting Narrative:  Developed Bodyaches, Headache,Nausea, fever and chills few hours after the shot then or the next 2-3 days after the shot and gradually resolving .  Other Relevant History:
started vomiting/diarrhea-couldn't keep anything down;got pedilite-popcycles;finally 16MAR97 @ 8:00 & kept down & slept til 11:00 17MAR97;no fever noted;not exposed to any stomach flu;instructed rxn to hep B-MD will not give another
Low-frequency tinnitus-like the rambling of a distant train.  Onset Fall 2002 and resolved by late summer 2003.  Return of symptoms fall 2003 roughly same time as flu shot this year.  Mostly resolved now-but not 100%.
I received my Pfizer booster shot on the morning of 2/28/22. I had zero signs of illness. However, by the evening of 2/28/22, I developed a sore throat. It worsened the following day, and I also had a slightly congested nose.  I did not have these symptoms after the second dose of the vaccine.  I wanted to report this because my mother experienced a sore throat and congestion after she received her Moderna booster in November 2021. For some background, we both tested positive for Covid-19 on 10/20/21.
Patient states that vaccine caused her skin to 'wrinkle' and has had itching since receiving vaccine.  She says she has not contacted her primary care doctor.
vomiting; nausea; diarrhea; This is a spontaneous report received from contactable consumer. A consumer (patient) reported for a herself that the 47-year-old female patient received first dose of bnt162b2 (BNT162B2), PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Deltoid Left on 20Apr2021 around 2:00-3:00PM (Batch/Lot Number: EK8733) as 1st dose, single for covid-19 immunization. The patient medical history was none. The patient's concomitant medications were not reported.  The patient experienced vomiting (medically significant) on 21Apr2021 with outcome of recovered on 21Apr2021, nausea (medically significant) on 21Apr2021 with outcome of recovered , diarrhea on 21Apr2021 with outcome of recovered on 21Apr2021. Therapeutic measures were taken as a result of vomiting, nausea.  The clinical course was reported as follows: After my first dose I had one episode of nausea, vomiting, and diarrhea. I am going for my second dose today. Is this something that is common that other people experience after the second dose? Seriousness criteria was other medically important condition. She received the first dose of the covid vaccine, and within 24 hours, she experienced vomiting and nausea. She could not put her finger on anything that she ate or drank. She took antiemetics. She only had the one moment of vomiting and nausea. She is getting ready to take the second dose of the covid vaccine. She is asking if this is something common with other people.  No follow-up attempts are needed. No further information is expected.
Starting April 27 (7 days after first dose) . Coincidentally , I had annual eye exam that day and doctor noted high eye pressure (24) which I have not had previously.  Also, starting that day was a dull headache that lasted for the next 5 weeks daily.   Additionally, starting in week 3 and lasting 3 weeks til end of May, I had neurological symptoms consisting of  dizziness most days and cognitive issues that I am noticing which was the worst in weeks 4 and 5.   Having to hold onto counters and chairs walking around my home and oddly keeping wide berth walking around objects. Forgetting my pills, couldn't recall if I had taken pill several hours earlier, names,, words,etc.   Felt to me like early dementia symptoms that started suddenly.  As of today, June 9,  the symptoms seem to have subsided.   I have a followup appointment to recheck my eye pressure later this month.     As of now, I am very concerned and hesitant to receive the second dose of this vaccine.
Approximately 33 hours after immunization, parents report patient in crib, cried out suddenly, then vomited followed by approximately two minutes of movement all four extremities and was non responsive.  Patient then arched back, stiffly then patient became responsive.  Taken to emergency department via ambulance for further evaluation. No history of fussiness or fever.
A few hours after receiving the vaccine at school, she developed sneezing and abdominal cramping. By the next day, symptoms had progressed to fever of 102 and mild diarrhea. Did not require medical evaluation; symptoms resolved after 4 days.
PAIN IN THE ARM SINCE VACCINATED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 15-MAY-2021, the subject experienced pain in the arm since vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the arm since vaccinated. This report was non-serious.
Vaccine administered without waiting fifteen minutes at room temperature; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and vaccine administered without waiting fifteen minutes at room temperature.   The patient's medical history was not provided. No relevant concomitant medications were reported.  It was not reported when the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   It was stated from the reporter, we had vaccine that had been completely thawed, and it was administered without waiting fifteen minutes at room temperature. This was at a Mas Vaccination site and we have no knowledge of how many were vaccinated prior to the vials being at room temperature. Reporter made an estimated guess of fifteen to twenty individuals who have been vaccinated prior to the vaccine coming to room temperature. Reporter was looking for clarification on if the vaccine always needed to be brought to room temperature and why. She stated if we need to always have the vaccine at room temperature before vaccinating, that it was not clear in the instructions. No further information was provided.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was not applicable.  The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 with no associated AEs.
Itching which then became hives all over my body.  Was given a steroid shot and attarax.
Severe generalized pruritis alleviated by 900mg Gabapentin & prescriptions of topical corticosteroid preparations.
I had a red rash around injection site which felt warm/ a red blotch around the injection site; It is 3 inches around swollen and itchy; It is 3 inches around swollen and itchy; The injection site is swollen mainly on Tuesday.; headache; antitrypsin deficiency; tired and weak/ Fatigue; tired and weak; the injection site was a little swollen and itchy.; My doctor said I had Lyme's disease and I got it from a tick.; Monday my arm became sore.; I had a red rash around injection site which felt warm; This is a spontaneous report from contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), dose 3 via an unspecified route of administration on 03Oct2021 14:00 as dose 3 (booster), single for covid-19 immunisation. Medical history included sepsis (she was hospitalized a few years ago with a blood infection). The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date and then second dose of bnt162b2 on an unspecified date for covid-19 immunisation with reported reactions of headache, fatigue, asthenia, feeling abnormal. The patient experienced my doctor said i had lyme disease and i got it from a tick, monday my arm became sore, i had a red rash around injection site which felt warm on 04Oct2021; i had a red rash around injection site which felt warm/ a red blotch around the injection site, it is 3 inches around swollen and itchy, the injection site is swollen mainly on Tuesday, headache, antitrypsin deficiency, tired and weak/ fatigue, tired and weak, the injection site was a little swollen and itchy on 05Oct2021. The outcome of events was recovering.  Follow up(07Oct2021): no new event   Follow up(07Oct2021): new events (rash, swelling, soreness, itchy)  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Stated felt burning sensation Pneumovax immunization in right arm. On 11/02/2005 had soreness, redness and swelling shoulder, elbow also had rash near elbow area (but not at injection site) Saw MD 11/02/2005 RX Benadryl, Hydrocortisone cefadroxil 500 mg, TC to client states decreased soreness and redness.
Redness, warmth, pain, swelling, and "knot" left upper arm. Pt instructed to apply ice to site, and return to clinic pm.
This spontaneous report received from a consumer via a company representative concerned a female 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: Unknown) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced debilitating migraines. On MAR-2021, the subject experienced aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, debilitating migraines, aches, and chills. This report was non-serious.