chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed a severe headache, fatigue, body aches that lasted 2 1/2 days.  I had facial swelling and hand swelling.  on the 7 day I developed a rash all over my back, rash on both forearms and developed a localized red, warm, painful itching area at the injection site.
Examination of the left arm shows a tender, erythematous, somewhat indurated area centrally where the shots were given and is tender in this particular area. He also has redness spread down to just above his olecranon process. The other areas of erythema are not particularly tender, however, especially the margins of the erythema. The rest of the hand and arm are normal; neurovascular is intact.
Hepatitis A Vacine administedred by Erie County DOH due to possible exposure from produce employe at Wegmans grocery store on Sheridan Dr in Williamsville, NY.  Vaccine administered at 6:30 PM with no immediate reaction.  Lethargy set in approximately 3 hours later.  By early morning it was difficult to take a deep breath, and had aches and pains similar to the flu.  No fever or nausea.  Benadryl provided some relief from difficult breathing.  Thus far no need for an ED visit.
pt recv vax 27MAR96 & mom found baby dead 29MAR96;
It was quick onset; I had aching in my right hand and my pointer finger and both my hips. I felt the same way for a while. I thought it was arthritis but then I thought it might be connected to the vaccine. I went to the doctor, and he is unsure of what it could be caused by. He told me to do stretches. I go back for a physical in October.
Urinating more than usual; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Urinating more than usual) and HEADACHE (Headache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced DYSURIA (Urinating more than usual) and HEADACHE (Headache). At the time of the report, DYSURIA (Urinating more than usual) and HEADACHE (Headache) outcome was unknown.            Concomitant medications were not reported. Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Action taken with the mRNA-1273 in response to the event is not applicable.   Reporter did not allow further contact
approx 4-5 hrs post vax pt awoke from nap w/fever of 106.6; mom sponged pt & gave APAP; t103 approx 45 mins later t106 sponged again & temp 104; pt taken to ER; exam WNL; given ATB;
sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
measles-like rash p/vax w/bacterial superinfection requiring ATB lasted 5 days;
lower back and up to shoulder were killing me/hurting/Back pain; shoulder were killing me; Chills; Started coughing, coughed and cough and it wouldn't let up; Sinus were just draining; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Started coughing, coughed and cough and it wouldn't let up), SINUSITIS (Sinus were just draining), BACK PAIN (lower back and up to shoulder were killing me/hurting/Back pain), ARTHRALGIA (shoulder were killing me) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism (being treated in the past for hyperthyroidism). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) and CICLOPIROX for an unknown indication.    On 24-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COUGH (Started coughing, coughed and cough and it wouldn't let up), SINUSITIS (Sinus were just draining) and CHILLS (Chills). On 24-Jan-2022, the patient experienced BACK PAIN (lower back and up to shoulder were killing me/hurting/Back pain) and ARTHRALGIA (shoulder were killing me). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at a dose of Tylenol around 10pm. and Bed rest (Laid down got some relief) for Back pain. At the time of the report, COUGH (Started coughing, coughed and cough and it wouldn't let up) had not resolved, SINUSITIS (Sinus were just draining) and ARTHRALGIA (shoulder were killing me) outcome was unknown and BACK PAIN (lower back and up to shoulder were killing me/hurting/Back pain) and CHILLS (Chills) was resolving.            Sinus were just draining went through a whole box of Kleenex.   This case was linked to MOD-2022-461617, MOD-2022-461572 (Patient Link).
Pt recvd 3 Hep-B vax on 27JUL89, 29AUG89, 25JAN90 & following these, titer=35; one yr later titer=6; pt was given a 4th dose of vax 23JUL91;
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 05-AUG-2015, the patients were vaccinated  with unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L004754, expiration date 10-NOV-2016) (dose, strength and route of administration were not reported). It was reported that the doses were exposed to temperatures outside of the recommended range. There was not concomitant medication reported and no adverse effects were reported. Additional information has been requested. This is one of four reports received from the same reporter.
Started with visual disturbance in left eye 1 week after vaccine. Prism like effect in left visual field and blurriness. Seen by ER, then by my OD which referred me to neuro ophthalmology which ruled out neurological cause, then sent to Ophthalmology. IVP dye test reveals a dark spot in left eye which Dr. characterized as a virus in the left eye. Right eye not affected. No illnesses prior to vaccine or after with the only exception being the left eye. Still on this date of report still having the same visual disturbance that has not gotten any better.
Cold, sinus, stuffy.   Sore throat Fri. - Sat, stuffy/runny nose, watery eyes. Eyes feel heavy and want to close, wheezing, sneezing, productive cough, backache from sneezing and coughing, no fever, no taste or smell, glands hurt, face hurts from sinus, clear and yellow mucus, ears feel plugged, sore on right side of tongue.
TWO DAYS AFTER VACCINES ADMINISTERED DEVELOPED NUMBNESS AROUND RT EYE WITH DIFFICULTY CLOSING RT EYE, DIFFICULTY MOVING RIGHT SIDE LIPS, DISCOMFORT RIGHT TEMPORAL AREA -NO HEADACHE OR LOSS CONSCIOUSNESS. 11/3/08-records received for office visit 10/24/08-Presented with numbness and difficulty to close his right eye. Cannot move well his right side of lips. Discomfort in right side of temporal ear. Possible Bell's Palsy. Office visit 10/30/08-C/O pain severe earache in right ear. Right eye slow movement eye lid, right lip muscle no movement.
Patient developed non-cardiac chest pain after first COVID vaccine which was determined to be GERD. He then developed DVT approximately 1 year after his second COVID vaccination.
Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise arm without significant pain), left wrist pain
He is positive for corona/got Covid; He is positive for corona/got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FD7218) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He is positive for corona/got Covid ". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.
p/vax lab eval revealed lack of seroconversion;pt recv 3rd dose of vax & again failed to seroconvert (dates unk);medical attention sought;
A couple of hours later noticed shoulders and neck getting stiff and sore. Stiffness progressed to other sites - to other shoulder and down back; whole body was hurting to the point that was not able to sleep last night. Blood pressure spiked to 172/102, normally usually at 130/80. BP stayed up until bedtime and back to normal this morning. Did not take any over the counter medication. This morning feeling better, got a quick back massage and hot shower. Pt. feels 95% better now. At site, soreness but not hard, doesn't hurt to move it anymore, more like a bruise. Husband received same vax with no problem.
Covid; Covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4272717 (Abbvie).  A 50-year-old female patient received BNT162b2 (BNT162B2), on 15Jun2021 as dose 1, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free), every 2 weeks), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causalities: The reporter's causality for the event(s) of Covid with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Covid with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not ProvidedAbbVie's opinion was that the causality for the event(s) of Covid respiratory infection with Adalimumab Solution for Injection was Not Provided. companies opinion was that the causality for the event(s) of Covid with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided Assessment Results: - Humira 40MG/0.4ML - COVID-19, Market Authorization Holder (MAH)- COVID-19, Non-Health Care Professional, Global Introspection, Not ReportedPfizer/BioNtech Covid-19 Vaccine - COVID-19, Market Authorization Holder (MAH.  Pfizer/BioNtech Covid-19 Vaccine - COVID-19, Non-Health Care Professional, Global Introspection, Not Reported  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / Suspected COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202300069763 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-PV202300029663 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Minor arm aches; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st February 2020, 1 days after receiving Shingrix, the patient experienced pain in arm and tiredness. On 22nd February 2020, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter reported for his Wife. The patient experienced minor arm aches and tiredness one day after receiving the Shingrix injection. The arm aches and tiredness lasted one day. The reporter consented to follow up. This case has been linked with wife's case   US2020093436, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020093436:same reporter
Nearly 1 week after, I developed a rash, redness, and swelling at injection site.  I also experienced a low grade fever ( 99.7) with chills, muscle and joint aches.
Red sores first a few than massive. Doctor issued presc. I presently being treated by my doc. Still in pain been on meds for 2 1/2 month. Have difficulty in walking am using cane to prevent a fall.
ACHY ALL OVER; FELT TERRIBLE; This spontaneous report received from a female patient 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, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 08-MAR-2021, the patient experienced achy all over and felt terrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy all over, and felt terrible. This report was non-serious.
Allergic reaction to the sun; Red rash on exposed skin that was itchy; Red rash on exposed skin that was itchy; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, allergy to cats and overweight. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), topiramate (MANUFACTURER UNKNOWN) and montelukast sodium (SINGULAIR); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 09:30 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. On 13Apr2021 at 14:00, few hours after receiving the second dose, the patient had an allergic reaction to the sun within two minutes of exposure and also had red rash on exposed skin that was itchy. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events allergic reaction to the sun, red rash on exposed skin that was itchy was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 13:30 as dose 2, single (Lot number: EN6203) at the age of 68 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Mild PVCs" (unspecified if ongoing); "Mild PACs" (unspecified if ongoing); "Infrequent SVT" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Contrast dye" (unspecified if ongoing). The patient had mild PVCs, PACs and 3 occasions of SVT in the past 30 yrs. so on Acebutolol. Concomitant medication(s) included: ACEBUTOLOL; ALENDRONATE. Other medications in two weeks were Acebutolol, Alendronate. Vaccination history included: BNT162b2 (Dose:1, Dose administration time: 14:30, Vaccine location: Left arm, Lot number: EL9267), administration date: 11Feb2021, when the patient was 68-year-old, for Covid-19 immunization. Facility type vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient did not have Covid prior vaccination. The patient was not tested for Covid post vaccination. The following information was reported: CONDITION AGGRAVATED (medically significant), HEART RATE IRREGULAR (non-serious) all with onset Mar2021, outcome "recovering" and all described as "About 3 weeks after 2nd dose felt extreme increase in frequency, duration and intensity of arrhythmias"; ARRHYTHMIA (medically significant) with onset Mar2021, outcome "recovering", described as "About 3 weeks. After 2nd dose felt extreme increase in frequency, duration and intensity of arrhythmias"; PALPITATIONS (non-serious) with onset Mar2021, outcome "recovering", described as "Heart thumping kept me awake. Abated some by 6 months when I got 3rd. 15 days later it all started again. Abating some now but still more frequent and intense than before shots." The events "about 3 weeks after 2nd dose felt extreme increase in frequency, duration and intensity of arrhythmias", "about 3 weeks after 2nd dose felt extreme increase in frequency, duration and intensity of arrhythmias" and "heart thumping kept me awake. abated some by 6 months when I got 3rd. 15 days later it all started again. Abating some now but still more frequent and intense than before shots". Required physician office visit. Therapeutic measures were not taken as a result of arrhythmia, condition aggravated, palpitations, and heart rate irregular.
Tiredness; sore shoulder; Swelling; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced shoulder soreness and swelling. On 9th July 2019, the patient experienced tiredness. On 10th July 2019, the outcome of the tiredness was resolved with sequelae. On 12th July 2019, the outcome of the shoulder soreness was resolved with sequelae. On an unknown date, the outcome of the swelling was resolved with sequelae.   It was unknown if the reporter considered the shoulder soreness, swelling and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient recevied Shingrix vaccine on right arm. The patient reported swelling, shoulder pain and feeling tired after receiving vaccine. The patient consented to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019169168.
Pt vaccinated with MMR/DTP/OPV developed fever 101(R), swelling lt arm. Administered Tylenol; Arm twice usual size at site of injection. No other symptoms.
Patient reports that she had a red welt the afternoon of 7/22/17 and for most of 7/23/17. She had been counseled that an injection site reaction could occur and she was not alarmed. The evening of 7/23/17 her red welt started to blister and feel warm to the touch. She called the pharmacy the morning of 7/24/17 to report the reaction. The patch is raised and about the size of a silver dollar right over the injection site. She reports that she is otherwise feeling well- no fever.
Resident presented with stroke like symptoms on 2/27/21 and was transferred to the emergency room.  She was diagnosed with Bell's Palsy and sent back to the facility.  Resident received 1st dose of Pfizer vaccine on 1/24/21 and 2nd dose on 2/14/21.
HCP said that 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. No adverse events were reported. Vials were placed in refrigerator on 21-Sep-2021. No temperature excursion was reported.
Pt stated that her arm started to swell and was red. Swelling started to go down within a week.
Patient received Moderna vaccine, first dose. After approximately 5-10 minutes she was observed itching her arms and she had asked for some benadryl. 50 mg oral benadryl was given and pt was taken to a room in adjoining medical clinic for observation. Patient stated back of throat was scratchy. Provider on duty administered 125 mg SoluMedrol, itchiness continued, patient had history of anxiety and laryngospasms so provider administered 1mg lorazepam. After another 1 mg dose of lorazepam pt appeared to calm down, vitals were stable and pt was discharged home with husband.
Approximately 3 years post vax, pt experienced greater than 50 varicella lesions.
CHIEF COMPLAINT/REASON FOR VISIT Fall     HISTORY OF PRESENT ILLNESS  a 74 year old male with asymptomatic COVID-19 infection (positive PCR 10/21), diabetes mellitus II, hypertension, hyperlipidemia, and Parkinson's disease who presents to the Emergency Department for evaluation following a fall. The patient states that he was repositioning himself when he accidentally fell out of bed onto his back. He denies hitting his head or loss of consciousness. He endorses mid thoracic back pain that is not present at rest, but gets up to 10/10 with movement. The patient denies other injuries or complaints. He is not anticoagulated. There are no other complaints at this time.
Patient was given a pediatric covid vaccine for children ages 5 to 11 years of age.  This type of vaccine was not approved for his age of 12 years.
went to clinic with flu sx and headache .  A covid test was done _Neg. my blood pressure was 148/103, then by end was 168/109 was told to go to er. in er my BP was 187/119. er Dr told me it was an immunity reaction to the Covid Vaccine.
Extreme body aches, chills and shaking lasting for a period of 24 hours.  Heart racing and chest pain for 5 hours.  Symptom free 54 hours after injection.