chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the ED for evaluation of intermittent chest pain over the past week. Initial troponin negative, patient admitted for observation. Cardiology does not believe cath is warranted at this time. Patient remains hospitalized. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
on 6OCT arm swollen @ site warm very tender unable to sleep noc of 5OCT; p/working 6hrs arm ached from wrist, lt shoulder & lt shoulder blade back arm; T100.0 @ 5PM 6OCT; went to ER
Dizziness for two hours.  Around 7 p.m. I fell deathly Ill. Temperature was 102 degrees farenheit; complete exhaustion; chills; headache; no energy; body aches. Took tylenol.  The symptoms Lasted for about 6 hours. Around 1 a.m. I woke up burning hot (like I had heat stroke) my temperature was a 103 degrees farenheit. Took tylenol. Temperature was fine when I woke up. About three to for hours later  I felt freezing cold, I took my temperature it was about 95.5 degrees farenheit. My temperature fluctuated between 103-95.5 degrees for the next 24 hours.
Patient was scheduled physical. Provider ordered six vaccines. Clinic was out of Hep A adult. Hepatitis ped/Adolescent was placed in adult basics. Expiration of vaccine checked not adult/ped on vial. 0.5 mL given instead of. No reaction noted. Patient doctor and charge noticed. Patient rescheduled for adult dose #1.
Broke out in cluster of raised red nodular lesions near injection site 7 days after MMRV injection
inability to move/unable to move; congestion; tired/exhausted; Bell's palsy; pain on her right arm; swelling; sick; flu like symptoms; fever; sore throat; headache; ear pain; numb tongue; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy (diagnosed with a very bad case in 2005).   On 26th February 2020, the patient received the 1st dose of Shingrix. On 28th February 2020, 2 days after receiving Shingrix, the patient experienced swelling arm and pain in arm. In March 2020, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced sickness, influenza-like symptoms, fever, sore throat, upper respiratory tract congestion, headache, ear pain, numbness of tongue, tiredness and mobility decreased. On an unknown date, the outcome of the bell's palsy, sickness, influenza-like symptoms, fever, sore throat, headache, ear pain and numbness of tongue were recovered/resolved and the outcome of the upper respiratory tract congestion was not recovered/not resolved and the outcome of the swelling arm, tiredness, pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the bell's palsy, sickness, influenza-like symptoms, fever, sore throat, upper respiratory tract congestion, headache, ear pain, numbness of tongue, swelling arm, tiredness, pain in arm and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in right arm. Exactly 14 days after receiving Shingrix, the patient awoke with Bell's palsy.  Less than 3 weeks after receiving Shingrix, the patient was sick with flu like symptoms, had slight fever and sore throat with congestion. Over the weekend following vaccination, the patient had a lot of Bell's Palsy symptoms and experienced a headache, pain in her left ear and a numb tongue.  The patient was extremely tired and exhausted and was unable to move for days after the vaccine.  She also experienced swelling and pain on her right arm.  Within 24 hours, the patient's symptoms cleared up. The reporter consented to follow up.
Expected mild covid symptoms after the vaccine, so not sure if delayed reaction of a whole week, or have gotten covid...cough, congestion, sore throat, loss appetite, bad headache, low grade fever
Patient took 1st oral typhoid pill in a.m. Reported a rash, and within 3 hours had trouble breathing. Called 911. Paramedic gave BENDARYL. ER gave pt. IV steroid. Placed on BENADRYL of 80 and discharged.
Vaccine given 5pm. around 8 pm hives/rash slow. Took BENADRYL 50 mg at 9:30p. Full body hives and itchy lips/tongue rash itching continued until 11/16/13 10:30 pm.
Headaches, back pains, sweating, fever, stomach aches, coughing a lot, spitting up while salty spit.  Eyes hurting.  Fast heartbeat.  Diarrhea.  My side hurts feeling weak.
COVID Vaccine Breakthrough Case  J&J dose 3/31/21 (lot not listed in database) COVID Positive 10/16/21  10/23/21: Patient is a 52-year-old gentleman with history significant for gout who presented to the ED with worsening shortness of breath, cough, and fatigue for the last several days.  Patient tested positive for COVID-19 approximately 6 days ago last Sunday.  He did receive the Johnson & Johnson vaccine several months ago.  He does have 1 sick contact approximately 2 weeks ago.  He has been symptomatic for 11 days.  He endorses worsening cough with activity, dyspnea on exertion, loss of taste and smell, fevers, and generalized muscle aches.  He has not taken anything other than DayQuil, NyQuil, Tylenol, and ibuprofen for pain and symptomatic relief.  He denies hemoptysis, chest pain, palpitations, changes to bowel or bladder function.   In the ED, patient was found to be saturating in the 90s on room air.  He did get up to walk and his saturations dropped to approximately 88. He was also slightly hypertensive to 157/108.  His respiratory rate was also slightly elevated in the 20s.  His lab workup was notable for an ESR of 25, a CRP 8.2, and a D-dimer of 0.92.  There was no leukocytosis or electrolyte abnormalities and troponin was negative at less than 0.01.  CT chest showed no evidence of pulmonary embolism.  There was scattered bilateral areas of airspace disease in all 5 lobes consistent with a viral pneumonia.  He received a DuoNeb treatment, azithromycin, Rocephin, and a dose of Solu-Medrol 125 mg. He was subsequently admitted to our service for management of COVID-19 infection.  10/26/21: Patient is a 52-year-old gentleman with history significant for gout who presented to the ED with worsening shortness of breath, cough, and fatigue for the last several days.  Patient tested positive for COVID-19 approximately 6 days prior to admission.  He did receive the Johnson Johnson vaccine several months ago.  At time of admission he had been symptomatic for 11 days.  In the ED, he was found to be hypoxic with walk test, he was started on supplemental oxygen.  D-dimer was 0.92, CTA chest showed no evidence of pulmonary embolism.  CT findings were consistent with viral pneumonia.  Due to need for supplemental oxygen patient was treated with remdesivir and dexamethasone.  Due to elevated D-dimer he was also started on prophylactic Lovenox daily.  Over the following 3 days patient's symptoms greatly improved, he was able to be weaned to room air and pass O2 walk test without difficulty.  He felt comfortable returning home.  He did not need further treatment with remdesivir dexamethasone, VTE risk factor score did not qualify him for home anticoagulation.  He was hypertensive throughout his hospitalization, he was started on losartan 25 mg. A1c was also noted to be 6.1, putting him in the pre diabetes range.  At time of discharge vitals were stable.  He is to follow-up with his PCP.
Vaccine was given 3 weeks apart from Monovalent Pfizer Covid Vaccine, not 60 days apart like instructed on the vaccine schedule.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th April 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. In April 2018, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site erythema and influenza-like symptoms were unknown. The reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. The reporter considered the influenza-like symptoms to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In April 2018, less than a week after receiving SHINGRIX, the patient experienced redness and swelling at the injection site and began to develop flu-like symptoms. The reporter was unable to provide additional details at the time of the call.
Information has been received from a woman in a physician's office  concerning a 4 year old male who on05/05/98 was vaccinated in the left arm with a first dose of Varivax. On 01/09/02, the patient developed chickenpox. It was reported that there were "14-20 of them'. The lesions were pruritic and scattered over the body. Unspecified medical attention was sought the patient's brother (WAES0201USA00773) also developed chickenpox following exposure to Varivax. Additional information has been requested.
Patient complains of subjective significant word-finding (cognitive) difficulties that developed shortly after receiving her first dose of Pfizer covid vaccine (at another facility) in March, with continued symptoms after second dose of vaccine on 4/6/21. She is still having symptoms now.  Patient has a neurological condition and medication that could contribute to symptoms, and we are evaluating for other possible contributors with labs (just ordered), but given the temporal relationship to vaccine administration, we have opted to report to VAERS. Patient reported symptoms, has not had in-person evaluation since symptoms developed.
Arm is hot , hard and sore around the injections site and this spread to other parts of the injection arm. A little itchy and rash like.
extreme fatigue; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (extreme fatigue) and HEADACHE (headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extreme fatigue) and HEADACHE (headache). At the time of the report, FATIGUE (extreme fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient spoke to the physician and everything was fine and it was taken care of. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information
2:33 pm: mother reports pt vomited, pt reports feeling faint and nauseous. Pt is perspiring. Vomit is on the floor. Pt assist to room, helped to laying position with feet elevated. Cold washcloth placed on forehead. Given cold water to sip. 2:40 pt feels better and leaves clinic.
When printing the vaccine administration record for the patient in August, it was noticed that a 3rd Shingrix vaccine was given. We filled out the error report. It seems the patient had requested another vaccine but it was missed that two doses were given the year before due to multiple billing attempts until the prescription went through. No adverse event occurred to the patient.
Mother reports same evening patient had 102 fever and body aches.  off work/school following day 3/9/21
Information has been received from a pharmacist who reported that multiple patients of an unspecified number received an improperly stored dose of GARDASIL 9 (lot # L038917, expired date 20-FEB-2018, route and dose not reported). These vaccines were under 50 F for 9 hours. There was no previously temperature excursion. Additional information has been requested.
Monovalent pfizer vaccine was given isntead of bivalent pfizer, no immediate risk at the moment will notify patient and offer a bivalent in two months. PCP has reviewed her chart
In the summer of 2000, the patient developed a mild breakthrough case of chickenpox. The patient sought unspecified medical attention. Follow up information received from the RN indicated that the patient's unimmunized 2 year old sister had a "heavy" case of chickenpox in June of 2000 and the patient came down with a "mild" case of chickenpox after that. It was reported that the patient subsequently recovered. No further information is expected.
tested positive for COVID-19; pain in her back; This is a spontaneous report from a contactable other healthcare professional (patient) via the Pfizer-sponsored program. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received her first dose of the Pfizer BioNTech COVID-19 vaccine on 12Mar2021 and stated that 9 days after, on 21Mar2021, she tested positive for COVID-19. The patient added that today (unspecified date) is her 11th day of quarantine and was told by her doctor that she only needed to quarantine for 10 days. She would like to know if she will be able to get her second dose of the vaccine which is due on Friday 02Apr2021. She reported that she is feeling better but "not 100%" as she stated that yesterday (unspecified date) and today (unspecified date) she was experiencing pain in her back that she thinks is actually related to her lungs, and is thinking about going to get an X-ray for it. The outcome of event Covid-19 was recovering; outcome of event back pain was unknown.   Information on lot number/batch number has been requested.
RESIDENT RECEIVED PFIZER VACCINE ON 1/21/22  WHEN RESIDENT DISCHARGED FROM HOSPITAL. WHEN RESIDENT ADMITTED TO FACILITY DAUGHTER SIGNED CONSENT FORM FOR VACCINE AND REPORTED THAT RESIDENT DID NOT RECEIVE VACCINE. ON 1/26/22 RESIDENT WAS GIVEN MODERNA VACCINE. RESIDENT DOES NOT HAVE ANY ADVERSE REACTIONS AT THIS TIME.
In addition to pain at the injection site, the gland on the left side of my body by my collarbone has swollen considerably (size of an egg) and is very painful.
since I began taking my first Covid vaccine, i began getting rash, thought just getting the hives from something; since I began taking my first Covid vaccine, i began getting rash, thought just getting the hives from something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 1, 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: RASH (non-serious), URTICARIA (non-serious), outcome "unknown" and all described as "since I began taking my first Covid vaccine, i began getting rash, thought just getting the hives from something". The event "since i began taking my first covid vaccine, i began getting rash, thought just getting the hives from something" required physician office visit. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PVSame product and patient; different dose and events Same product and patient; different dose and events;
Infection on the finger; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events infection on the finger.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Infection on the finger.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), infection on the finger was unknown.
Adverse reactions; A spontaneous report was received from a pharmacist concerning unspecified patients, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced adverse reactions.   The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.   On an unknown date, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Lot number: unknown) via an unknown route for prophylaxis of COVID-19 infection.   On an unknown date the patients experienced adverse reactions.  Treatment for the events were not reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, adverse reactions were unknown
blood sugar level is over 400; This is a spontaneous report from a contactable consumer who reported for herself.  A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN5318) on 09Feb2021 at 15:00 (at 74 years) at single dose in left arm for covid-19 immunisation. Medical history included type 2 diabetes mellitus, high blood pressure.  Concomitant medication included metformin and diphenhydramine hydrochloride (LURISPAN). Patient was not pregnant.The patient previously took epinephrine and had drug allergy. The patient blood sugar level was over 400 on 10Feb2021. No treatment given for the event. The final outcome of the event was not recovered.
This is a spontaneous report received from a contactable reporter(s) (Physician). A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 as dose 3 (booster) , single (Lot number: FD0809) at the age of 62 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "lichen sclerosis et atrophicus" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "atrophic vaginitis" (unspecified if ongoing); "penicillin" (unspecified if ongoing), notes: known allergies: dairy, codeine, penicillin, scallops; "scallops" (unspecified if ongoing), notes: known allergies: dairy, codeine, penicillin, scallops; "known allergies: dairy" (unspecified if ongoing), notes: known allergies: dairy. Concomitant medication(s) included: COMBIPATCH; CLOBETASOL; METRONIDAZOLE; VIT D [VITAMIN D NOS]; CALCIUM; PATANOL. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: dairy, codeine, penicillin, scallops. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "joint motion limitation"; JOINT SWELLING (non-serious), JOINT WARMTH (non-serious) all with onset 16Jun2022 at 03:00, outcome "unknown" and all described as "joints very painful, hot, swollen"; ARTHRALGIA (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "severe arthralgia/ joints very painful". The events "severe arthralgia/ joints very painful", "joint motion limitation" and "joints very painful, hot, swollen" required physician office visit. Therapeutic measures were not taken as a result of arthralgia, joint range of motion decreased, joint swelling, joint warmth. Additional information: No other vaccine in four weeks: No If other vaccine in four weeks. No covid tested prior or post vaccination. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202200887057 Same patient and drug, different event;
Headache; This is a spontaneous report from a contactable Health Professional, the patient. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. The clinical outcome of the event headache was not recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.
Patient reports started having weakness and numbness in feet in mid March 2021. She reports she saw a neurologist and was diagnosed with Guillian Barr Syndrome on 06-15-2021. She reports her weakness is improving with Physical Therapy. She received her first dose of COVID 19 Pfizer vaccine on 01/25/2021.
On Thursday, 6/3/2021 received her second dose of Pfizer Covid-19 vaccine (LOT #: EW0187, exp.: on 8/2021) at 9:28 am on her left deltoid. During assessment questions, client states her underlying medical condition includes hypertension and currently takes Atenolol and Losartan. Client denied any other heart or respiratory diseases. Client also states she experiences "severe allergic reaction" to Bactrim and Sulfa and exhibits "anxiety and confusion" and requires a place to sit if standing for long period. At 10:00 am, while waiting in Observation Area, client stated to EMTs, "I'm feeling very tired." EMT's responded immediately and provided a quiet environment and helped client in anti gravity chair. Vital signs were taken every 5 minutes. At 10:00 am: BP: 181/115 sitting, O2 sat: 99% with no respiratory distress noted, skin was warm to touch bilaterally, no skin rashes or swelling noted. Patient was alert, oriented X4 with clear, slow speech. At 10:07am, client was responsive to stimuli but was not verbally responsive with noted body guard; BP: 177/104 lying, HR: 56, O2sat: 99%. Upon further assessment, client complained of "the same 7/10 lower back pain that happened 3 weeks ago" and "feeling nauseous and fatigue". Client also stated she took her BP medications at 8:30 am. Client told the EMTs she did not follow up with her primary care provider after her first Pfizer dose. Client was also offered an ice pack to apply on her neck and encouraged to take deep breaths by EMT. At 10:15 am, BP: 201/121 lying, O2 sat: 99%, RR: 14, HR 59. Client was encouraged to drink water. At 10:17 am, client reported she felt "tension in the back of head and headache. Vitals: BP: 189/114 lying, HR: 67 bpm. Staff encouraged client to change positions in gravity chair for comfort however client reported "no improvement of the symptoms." EMT offered EMS service to which the client requested. At 10:22 am, EMS was activated by Lead RN. Client was educated by EMT and RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe and importance of following up with her primary care physician. At 10:26 am, care was turned over to paramedics. At 10:30 am, client was verbally responsive, alert, oriented X4. Vitals: BP: 181/115 lying, HR: 80, O2 sat: 99%, Temp: 98.1. Client was transferred to a gurney with assistance from 4 AMR staff. At 10:36 am, client left facility to be transported to hospital for further assessment.
This spontaneous report was received from a health care worker regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (dose and route were not reported, lot # L004014 with expiration date or lot # L013429 with expiration date 21-JUL-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information is not expected as there is no permission to contact the physician.
Hepatitis A vaccine expired 5/20/2022 but was administered to patient on 7/19/2022