chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TERRIBLE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the subject experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible headache was not reported. This report was non-serious.
Horrible heartache, heart rate stayed at 145 bpm overnight according to apple watch, muscular aches throughout body, mild nausea, extreme tiredness.
Rash itching started shortly after vaccine was given, then a painful rash started to show, Now is red, painful, elevated.
covid test result Positive; covid test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood, pressure. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; BUDESONIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Apr2022, outcome "unknown" and all described as "covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient complained of pain at the injection site while the shot was being administered. Later that day her arm started to get swell up around the injection site.
This case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 26th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. It was reported that the patient was feverish after recevining SHINGRIX dose. The reporter declined consent for follow up. For tolerance to next dose, refer case US2019GSK040791.
This is a spontaneous report from a contactable Physician via Pfizer sales Representative. This Physician reported similar events for two patients. This is 2nd of two reports. This Physician reported for a patient that of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced vomiting on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017360415 same reporter/drug/event, different patient.
Fatigue, cold sore, unexplainable small bruise on opposite arm with no injury, pain at site of metal plate in leg (which is really odd and does not happen normally)
Below notation copied from  a verbal communication NP, had with student, chart note on 3/8/2021 Tetanus given on Friday Friday night fever chills vomiting Ok since but now with palpable left cervical lymph node--tetanus shot given on left No problem with previous tetanus shots
MENACTRA dose was given sc instead of recommended route of IM. Box label reads "polysacchaide DTD " and further reads "conjugate".  Subcutaneous is the route recommended for "polysaccaride MPSV". Label was confusing. Call to manufacturer stated that a study by CDC determined that despite misadministation, persons vaccinated by the sc route were sufficiently protected and revaccination was not necessary.
Rash after second dose (10 days after vaccination) on left arm and legs. The rash continued to spread for 3 weeks and would not subside with any treatment options (hydrocortisone, benadryl cream, calamine lotion). Had to see dermatologist to get put on a steroid to get rid of the rash after a skin biopsy determined it was spongiotic dermatitis (he suspects a medication).
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 64 hours and the lowest recorded temperature reported was 33 Fahrenheit (F). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Severe restless leg syndrome. Weak legs and arms. Pain in joints and muscles. Swelling lower extremity. L>R
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-JUL-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 09-FEB-2018 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
patient was given an expired Daptacel, no AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from consumer or non-healthcare professional.  This case is linked to case 2019SA327223 (same reporter).  This case involves 4 year old female patient who received a dose (fourth in series) of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]  lot C5307AA expiry date: 23-Oct-2019 via unknown route in unknown administration site on 15-Nov-2019.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was of actual medication error case due to expired vaccine used.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Bad heart rate; sore arm; A spontaneous report was received from a nurse who was also a 77-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and bad heart rate.  The patient's medical history was not provided. No concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient developed a sore arm. No treatment was administered.  On 10 Jan 2021, the patient experienced bad heart rate and had to go to the emergency room (ER).   On 21 Jan 2021, the patient had a second visit to the ER, where she required a cardioversion for the bad heart rate.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event, sore arm, was resolved on an unknown date. The outcome for the event, bad heart rate, was resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 77-year-old female patient, who experienced a medically significant unexpected event of Heart rate abnormal and unexpected non-serious event of Pain in extremity. The medical history is not provided. The event of Pain in extremity occurred on the same day after receiving their first of two planned doses of mRNA-1273 (Lot # 025L20A). The event of Heart rate abnormal occurred approximately five days after receiving their first of two planned doses of mRNA-1273 (Lot # 025L20A). Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Same day vaccine second dose given March 4. Between 15 minutes reaction was dizziness, difficulty breathing. Went into adverse reaction. Did not wake up - moved to ER
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 71-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6207), at the age of 71, in left arm, on Mar 15, 2021, single dose, for COVID-19 immunization. Medical history included psoriasis (unspecified if ongoing); and psoriatic arthritis (unspecified if ongoing). Concomitant medications not reported. The patient had influenza-like illness (flu-like symptoms), onset 2021, with outcome of recovered (2021). Additional information: Prior to the vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. First only flu-like symptoms for a couple days. Psoriasis became much more severe. Psoriatic arthritis more intense. No follow-up attempts possible. No further information expected.
2 days post vaccine significant swelling and pain in right axilla, unable to put arm down completly due to pain.  swelling and pain lasted approx 72 hours from start of swelling.  right arm at injection site was tender but not warm/raised.
PT WAS GIVEN PFIZER SHOT EXPIRED BY 1 DAY.  NO ADVERSE REACTION AT THE TIME OF REPORT.
2 weeks out. Severe pain in neck and back. June 26 went to ER. Pain in back cramping in legs. Giving pain medication sent home . Referred to rheumatology.  June 29 return to ER. For severe pain in legs. Numb right side of face, double vision, difficult speaking loss of balance. July 6 return to ER. Diagnosed with thrush Gillian Barre Syndrome. Acute Demyelinating Polyneuropathy.Admitted to hospital
Developed Type 1 Diabetes approximately one month after HEP vaccination. No other family history or illness during the time of first onset. Had Blood Glucose level tested at 199 the following month with no recommendation for continued care until labs one year later. First A1C at 9.7 nearly a year later. Large study confirms incidence rate of Type 1 Diabetes and HEP B vaccination push in the early 1990s. What's worse is that this hospital has no record of the vaccination given though I have numerous witnesses and co-workers receiving the same vax on the same day.
Body aches; fever; headache; chills; lethargy; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received dose 2 of BNT162B2 via an unspecified route of administration on 22Feb2021 at 12:00 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient did not receive any other vaccines within 4 weeks of the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient did not have allergies to medications, food, or other products. The patient previously receive dose 1 of BNT162B2 on 02Feb2021 as a single dose in the left arm for COVID-19 immunization. After dose 2 of BNT162B2, on 23Feb2021 at 00:00 the patient experienced body aches, fever, headache, chills, and lethargy. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of body aches, fever, headache, chills, and lethargy were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Information has been received from a nurse concerning a teenage patient who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On approximately 16-FEB-2007, the patient experienced a reaction at the injection site". The nurse reported that the area felt hot and had redness and swelling. There was no product quality complaint. The patient's status was not reported. Additional information has been requested.
Pt. had worsening hives on arms, EMS called. Pt. denied shortness of breath. Benadryl 50mg IM given in the left deltoid. EMS arrived and assumed care of the patient. Pt. released from EMS to go home without transport to hospital. Pt. reported to ED 2 days later reported rash on face and arms is worse than before. Pt. reports taking Benadryl with good relief of symptoms. Pt. given Methylprednisolone IM and sent home with hydroxyzine, Medrol Dosepak, and famotidine. Pt. given instructions to follow up with primary care in 1 week.
severe shooting pain with motion, decrease in range of motion/inability to lift arm over head without severe pain. slight numbness down arm. "normal" injection site pain.
dehydration; dizziness; weakness; This is a spontaneous report from a contactable consumer. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Mar2021 (Lot Number: EN6208) at age of 87-year-old as 2nd dose, single for COVID-19 immunization.  Medical history included ongoing cognitive impairment. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 19Feb2021 (Lot Number: EN6201) at age of 87-year-old for COVID-19 immunization.  He provided the first Covid 19 vaccine was given on 19Feb2021. Second Covid 19 vaccine given on 20Mar2021. The third Covid 19 vaccine was given on 07May2021. The patient has some cognitive impairment. The patient was recently admitted to hospital for dehydration. That was a week or so ago. He was admitted for dehydration that caused some dizziness and weakness. This hospitalization occurred after the second Covid 19 vaccine and prior to the third Covid 19 vaccine. The patient was better now, he was receiving some physical therapy. The patient had a Covid 19 virus test that was negative. He also had some medical tests that were all negative. He had some blood work, urinalysis, CT scans to rule out anything else. The doctor determined the patient was dehydrated. The events require a visit to emergency room and no physician office. There was no prior vaccinations (within 4 weeks) received and no events following prior vaccinations. The patient underwent lab tests and procedures which included blood work, CT scans, urinalysis: unknown results; Covid 19 virus test: negative; medical tests: all negative.  Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.
Tingling throat; This is a spontaneous report from a contactable physician. This physician reported same event for two patients. This is second of two reports. A patient of unspecified age and gender started to receive bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; unknown lot number, NDC number and expiration date), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that it was unknown if other products were received or if an investigation assessment was performed. On 16Dec2020, the patient experienced tingling throat (non-serious). The physician called regarding COVID 19 vaccine since they had two events that happened yesterday (16Dec2020), however, the physician stated that she needs to ask a question before speaking with DSU and reporting the events. the physician mentioned that two patients complained of tingling in their throat during the observation period after the vaccine was administered. The physician thought "they just panicked and overreacted " and she did not think they had a reaction. The patients did go the ER (emergency room) and were discharged the same day. The physician wanted to be able to give the second dose. The physician wants to ask about the side effects of the vaccine. The outcome of the event was unknown.  The following information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020502608 same reporter/event, different patient
Woke up on 4/22/21 and the entire room was spinning out of control. I was nauseous and had diarrhea.  I could not move without getting dizzy.  I took anti diarrhea medication a few times in order for the diarrhea to  stop.  Felt miserable. Was able to sleep on my stomach that night without being dizzy. 4/23 I did not wake up with the room spinning but when I sat up I was dizzy. Still could not bend over or I was get extremely dizzy and nauseous.  Was able to eat this day. 4/24 was still pretty much a repeat of the previous day.  The dizziness has decreased but it's still there occasionally.
Fatigue that has been chronic and effecting quality of life.  Chronic arthralgias continuing to the present.  Chronic unrefreshing sleep, chronic post-exertional malaise after exercise.  New onset migraine headaches, now resolved.  Vertigo episodes - now resolved.
6om leg and knee on L swollen and hot. Hurts to touch walks with temp. Given Benadryl, Tylenol and ice TID.
On April 14, 2022, I began having body aches, fever, chills, cough, shortness of breath. My fever peaked at 103.1 degrees on April 16, 2022.
This spontaneous report was received from a registered nurse refers to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 14-MAR-2016 (today), the patient was inadvertently vaccinated with PROQUAD lot # L040414, expiry date 13-APR-2017, 0.5 ml, subcutaneously. No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Stomach Cramps Loose bowels Chills Total body ached Symptoms ended after 24 hours
Patient had returned to work post vaccination. Approximately 90 minutes later patient brought to medical at plant and sent out via ambulance.
Information has been received from a physician via a company representative concerning a female patient who was vaccinated with the first dose. 0.5 ml, IM, of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient "developed hives all over her body." At the time of this report, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
CHILD TOO YOUNG TO RECEIVE VACCINE.  DATE OF BIRTH WRITTEN AS 08/29/2009 ON CONSENT BUT AGE WRITTEN AS 12.
(L) upper arm started swelling & getting red & warm area got worse as weekend progressed & area felt hot. Area measured approx. 5x5" of redness/swelling. Pt taken to ER on 11/22/09 for treatment.
Pt recvd 1st dose of Hep B vax 30OCT91 & on 5NOV91 pt exp nausea, vomiting, abd cramping & pain; presented to MD 7NOV91 & was placed on Compazine & Levsin; dx gastroenteritis & stayed home fr work 4 days; 5DEC91 pt cont to exp stiff neck;
My menstrual cycle has started 13 days early! I just had a week long cycle Aug 9th.
24hr p/vax felt discomfort & warmth @ site of inj;swelling & pain cont over next days;pt seen on 5JUN96 for erythema & induration of approx 120mm x 70mm;no fever;no other sx;
Pt arrived due to confusion. Pt admitted due to acute hypoxic respiratory failure secondary to COVID-19 pneumonia.
Patient came in for Flu vaccine and Covid-19 vaccine 10/05. During the process of retrieving the moderna from the fridge, the wrong moderna for pediatric use was chosen. The vaccine was not verified when drawing up that it was the adult dose of Spikevax. The patient was then administered the pedicatric Moderna. The patient was informed over the phone of the incident. He is reporting no side effects or adverse events at this time of this report.
Expected headache, chills, muscle/joint soreness... and sudden increase in urinary frequency, urgency, and volume?!
Patient presented to the ED and was subsequently hospitalized for pyelonephritis, renal cyst, stage 3 renal disease within 6 weeks of receiving covid booster vaccination.
acute pain in shoulder after vaccination, getting worse over the days after vaccination. Pain in shoulder for about 5 weeks after vaccination. Not able to lift up arm, not able to sleep on right shoulder. Having to take Ibuprofen for weeks, do exercises. Condition improved after 5 weeks. Visit to doctor's office on March 5.
11/24/21 the day after the shot I had a persistent fever of 103 F not made better with tylenol; pcp notified and no remedy prescribed. Bruise on left arm size of a 50 cent coin. Flu like symptoms continued until Sunday 11/28/21. On 11/29/21 Acute pain on right flank/ ribs began but due to a history of slipped disk I thought this pain was muscular. On 11/30/21 at 9am I flew to visit family and by 10pm I became unable to breathe so I went to Emergency Room. MD and RN suggested my experience was a vaccine reaction.
Erythema/ Induration around injection site approx. 3" wide. Skin warm to touch. C/o pain. Tylenol, Benadryl, ice pack to site.
Admitted 12/14 with acute myocardial infarction, STEMI, required PCI to the left circumflex artery.  Hospital course complicated by acute ischemic stroke 12/15 with severe cerebral edema and herniation syndrome
First dose received on 4/18/2021, second dose received 5/9/2021.  Admitted to Hospital on 5/21/2021 with large pulmonary embolus and bilateral DVT.  Patient became short of breath 3 days prior to admission, and the day of admission developed left sided pleural pain.  Physical exam revealed a friction rub in left posterior chest. Patient was initially heparinized, then switched to oral apixaban bid and is being followed up as an outpatient.  As of this day 5/31/2021 patient is asymptomatic at rest but still has dyspnea on exertion.
Pt reported on 3/8/21 with concerns of chest pains r/t the covid immunization he had previously received. Pt had F/U apt to discuss this with PCP. Advised per DO to report the possible reaction.