chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the morning of Friday, Feb 5, I had a shaking chill and headache, and my blood pressure was 206/78, pulse 93.  I did not have a fever.  I went to the emergency room, and by the time I got there and was examined, my blood pressure was down to about 175/ 90.   After the brief exam and blood draw / EKG, I was left in the waiting room.  After about 3 hours, I felt better, and asked the nurse about leaving.  She took a final blood pressure, which was about 165 / 90, and I left.     I had a similar, slightly less severe episode a week later, Thursday, Feb 11, and went to urgent care.  Additional testing, including thyroid hormone was all normal.
lt upper arm around inj site, red itching & warm also red rash on lt shoulder, scapula & neck;started last noc
soreness; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date refer case US2021AMR162106).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine when it came out, the patient thought she had soreness and she made sure to hydrated before and after each vaccine. The patient did believed hydration lessen and reaction symptoms.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR162106:same patient/reporter - 1st dose
Client received Moderna vaccine (1st dose) on 3/11/21. States arm has been sore since day 2 post vaccine. States 3-4 days ago (from today 3-24-21), she felt her upper Left arm getting tight/swollen and feverish. There is a visible red ring around her entire upper arm. Client states has not taken ibuprofen/Tylenol or Benadryl yet. Advised to take Ibuprofen for inflammation and non-drowsy Benadryl for redness/rash/allergic reaction. Client advised to visit ER if worsens or call PCP.
Dysphagia, facial swelling, abdominal pain and nausea. Given BENADRYL, PEPCID, and IV SOLO-MEDROL. Send home w/prednisone burst.
A few weeks after vax i developed severe leg pain on walking/ weight bearing.  It began in the right leg, was diagnosed as hamstring injury.  Could not walk without severe pain.  Used crutches and took pain meds.    About one month later the pain switched to the left leg.  If the right leg still hurt it was minimal compared to the left leg.  About one month later the pain greatly subsided but is now localized IN BOTH legs between the mid calf and mid thigh - mostly around the knee area.  It has now been 5 months.  I still have pain on walking, standing and cannot walk distances.  Although the pain is greatly reduced.  I have pain on lying down with legs out straight.
This spontaneous report was received from a registered nurse concerning an unspecified number patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On approximately 22-JAN-2017 (reported as "between 22-JAN-2017 and 20-FEB-2017"), the patients were vaccinated with improperly stored doses of PROQUAD (lot # M035690, expiration date: 06-FEB-2018) for prophylaxis (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: refrigerator: 49.8 Fahrenheit for 2 hours 30 minutes; freezer: 30.3 Fahrenheit for 4 hours. The previous temperature excursion reported was: refrigerator: 49.6 Fahrenheit for 31 minutes; freezer: 11.2 Fahrenheit for 48 minutes. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009653: US-009507513-1702USA009654: US-009507513-1702USA009133:
No additional adverse event reported; Caller reports administering pediatric dose of RECOMBIVAX HB to an adult; This spontaneous report has been received from a licensed practitioner nurse, regarding a patient of unknow age and gender (reported as adult). The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 20-APR-2022, the patient received a pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0.5 milliliters intramuscularly as prophylaxis (lot number T032918, which was determined to be a valid lot number for a vial formulation, expiration date: 12-NOV-2022) (anatomical location not reported) (Incorrect dose administered). No additional adverse event was reported.
This spontaneous report as received from a physician refers to an approximately 22 years old female patient. The patient was vaccinated when she was 14 years old with a dose of GARDASIL (lot #, dose and route not reported) on an unspecified date and was vaccinated with dose 2 of GARDASIL (lot #, dose and route not reported) on 18-OCT-2012, No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient had a positive PAP smear about 6 months ago (approximately in April 2012). A repeat PAP smear performed about 3 weeks ago (approximately in September 2012) was negative. No treatment was given for the event. The relatedness for positive PAP smear was not provided for GARDASIL. Additional information has been requested.
left lower leg paresthesia in the left lateral sural nerve dermatome / felt like a tingling sensation localized to dermatome lateral to shin; felt like a burning sensation localized to dermatome lateral to shin; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: E51685), via an unspecified route of administration on 17Dec2020 05:45 (at the age of 33-years old) as a single dose in the left arm for COVID-19 immunization. Medical history included penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included an unspecified multivitamin received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient experienced left lower leg paresthesia in the left lateral sural nerve dermatome which felt like a tingling/burning sensation localized to dermatome lateral to shin on 18Dec2020 08:00 (reported as about 12 hours after injection). There was no loss of sensory, "temp" or pain detected, as reported. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the lower leg paresthesia in the left lateral sural nerve dermatome which felt like a tingling/burning sensation localized to dermatome lateral to shin was not resolved.
Received immun on 8/7 @1400 and 8/8 @ 0200. Mother noted poor perfusion, acrocyanosis and cool extremeties.  On 8/8 1030 began having desaturations and bradycardia requiring B&M ventilation and progressed to acute decompensation and respiratory failure requirng intubation at 2300.
Five minutes post vax the pt slumped over and was cold and clammy. The health care professional described a vasovagal response and noted the pt did not lose consciousness.
After the second dose in February 2021, my menstrual cycle became irregular and erratic. Bleeding between periods, periods every other week, some periods super heavy for 5-7 day, other periods light for 3 days. My menstrual cycle was regular before the shot and has been irregular ever since.  After the booster, I have been cramping for two weeks straight since the shot. I have been spotting blood, tired, and PMSing. I feel awful and cannot make the cramping stop.
nauseas; fevers; chills; generalize weakness; heart rate elevated; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 17:15 (Lot number: FC3180) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 13Aug2021 18:30, outcome "not recovered", described as "nauseas"; PYREXIA (non-serious) with onset 13Aug2021 18:30, outcome "not recovered", described as "fevers"; CHILLS (non-serious) with onset 13Aug2021 18:30, outcome "not recovered", described as "chills"; ASTHENIA (non-serious) with onset 13Aug2021 18:30, outcome "not recovered", described as "generalize weakness"; HEART RATE INCREASED (non-serious) with onset 13Aug2021 18:30, outcome "not recovered", described as "heart rate elevated". The events "nauseas", "fevers", "chills", "generalize weakness" and "heart rate elevated" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, pyrexia, chills, asthenia, heart rate increased.  Additional information: Vaccination facility type was Pharmacy or Drug Store. Patient had no known allergies. The patient had neither received any other vaccine in four weeks prior to vaccination nor received any other medications within two weeks. The patient started experiencing symptoms on 13Aug2021 one day after getting the vaccine. However (today) 18Aug2021 was day 6th of having nauseas, fevers, chills and generalize weakness. The patient's heart rate had been elevated since Friday. She had to go to the Emergency department and urgent care since she did not feel okay. The patient took treatment for AE IV fluids, Tylenol and Motrin. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Felt sicker; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (Felt sicker) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt sicker). At the time of the report, MALAISE (Felt sicker) outcome was unknown. No concomitant medication was reported.  No treatment medication was reported.
Female  became dizzy and passed out for 23 minutes after vaccination.  Vital signs  105 over 70, heart rate 66, respiratory rate 16.  She was complaining of dizziness for the next 80-90 minutes. Her vital signs were stable.  She was discharge home.
13 Year old patient was given the wrong covid vaccine 0.5 ml of Moderna were given when the patient should have been givenj0.3 ml of Pfizer. No adverse effects have been reported.
Moderca Covid-19 Vaccine EUA Started like a stiff neck mainly on the left side ( Sunday Morning), Mon-Thursday especially in the morning ( Left side only) neck, top back, and the whole left arm hurt and I was not able to move or get up from bed ( very bad muscle pain).
Dizziness, Fever, Headache, Irregular Heartbeat, feeling like you are going to pass out, rolling chills, swollen and pain in injection site
9MAY92 t105 R pt was given APAP & taken to ER; mom denies any redness to inject sites; mom stated noted during sleep pt jumpy, but not sure if convuls or what;
Influenza Vaccine given in Right Deltoid. Approximately 30 minutes post vaccine administration, redness, swelling and fine rash to upper arm and vaccine site developed. Severe headache, neck and jaw pain also developed. All symptoms lasted approximately 12 hours. Pt reported she took ibuprofen and BENADRYL for symptoms.
Had breakthrough menstral bleeding this morning. I am 2 weeks away from menstration. Very light spotting.
Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: DEATH (death, medically significant), outcome "fatal", described as "Die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: it was reported patient died in the first day of trials. One died instantly.  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-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: Die
Shivers; muscular pain; This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd April 2019 03:30, the patient received Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced shivering and muscle pain. On an unknown date, the outcome of the shivering and muscle pain were unknown.   It was unknown if the reporter considered the shivering and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix vaccine on left arm. Within 12 hours of vaccination the patient awoke to shivering and muscular pain.
Duplicate doses of DTap and IPV were given on 12/8/08 to this patient due to confusion re contents of new combination vaccine being used at Clinic (Pentacel).  The combo vaccine was given, and single doses of DTaP and IPV were also given.
This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck was stiff on one side/ Mine went up my neck and was kind of below my ear), OROPHARYNGEAL DISCOMFORT (I could feel one side of my throat like my jaw is stiff or something), JOINT STIFFNESS (I could feel one side of my throat like my jaw is stiff or something), MASS (The middle of the night I had a lump there below my ear, and above my lower jaw/ When I laugh stuff I feel it in my jaw) and EXTRA DOSE ADMINISTERED (Patient had 5 shots of the Moderna vaccine at this time) in a 70-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. No Medical History information was reported. On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck was stiff on one side/ Mine went up my neck and was kind of below my ear), OROPHARYNGEAL DISCOMFORT (I could feel one side of my throat like my jaw is stiff or something), JOINT STIFFNESS (I could feel one side of my throat like my jaw is stiff or something) and MASS (The middle of the night I had a lump there below my ear, and above my lower jaw/ When I laugh stuff I feel it in my jaw). On 09-Sep-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient had 5 shots of the Moderna vaccine at this time). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck was stiff on one side/ Mine went up my neck and was kind of below my ear), OROPHARYNGEAL DISCOMFORT (I could feel one side of my throat like my jaw is stiff or something), JOINT STIFFNESS (I could feel one side of my throat like my jaw is stiff or something), MASS (The middle of the night I had a lump there below my ear, and above my lower jaw/ When I laugh stuff I feel it in my jaw) and EXTRA DOSE ADMINISTERED (Patient had 5 shots of the Moderna vaccine at this time) outcome was unknown. No concomitant medications were provided. On an unknown date, patient had received 5 shots of the Moderna vaccine. Patient reported that she experienced neck stiff on one side. It went up her neck and was kind of below her ear. Patient felt one side of her throat like her jaw was stiff or something. Patient took Tylenol last night. The middle of the night patient had a lump there below her ear, and above her lower jaw. At 4:00 AM took another Tylenol. When patient laugh and stuff patient felt it in her jaw. 70 years old. No difficulty breathing. This case was linked to MODERNATX, INC. (E2B Linked Report). Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC :Husband case.
Fever; Joint Pain; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (Joint Pain), FATIGUE (fatigue) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Spondylitis ankylosing.    The patient's past medical history included Ankylosing spondylitis relapse from 2019 to 2020. Concurrent medical conditions included Non-smoker, Abstains from alcohol and Drug allergy (sulfa allergy associated manifestation for the hives). Concomitant products included MELOXICAM, DROSPIRENONE, ETHINYLESTRADIOL (OCELLA) and ACYCLOVIR [ACICLOVIR] for an unknown indication.   In August 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PYREXIA (Fever), ARTHRALGIA (Joint Pain), FATIGUE (fatigue) and HEADACHE (Headache). In January 2021, PYREXIA (Fever), ARTHRALGIA (Joint Pain) and HEADACHE (Headache) had resolved. In February 2021, FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.   This case was linked to MOD-2021-082584 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Non significant followup received on 1-Jun-2021 and it contains no new information.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Return of Covid symptoms and positive test; Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Treatment of COVID-19; received bivalent as dose number 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 14:00 as dose 1, single (Lot number: gj6665) at the age of 65 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 20Oct2022 at 14:00, outcome "unknown", described as "received bivalent as dose number 1"; COVID-19 (non-serious) with onset 24Oct2022, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Additional information: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. COVID-19 Treatment was Paxlovid which received from 24Oct2022 to 29Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A couple of days after the Pizer Booster, my left hand and finger joints were EXTREMELY painful to move.  24/7 my left hand had zero relief from just day to day activities.  On December 22 the same pain from my hand and finger joints moved to my right hand and finger joints.   I had a hard time even sleeping, throbbing's pain went through my hands.   One year later I am better, but still have hand pain in both left and right.  That is why I am contacting you today.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 16-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: right deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805467 was crossed linked to original cases 201804863 due to same reporter.
The patient stated that she felt a tingling sensation down her arm. The clinical staff attended to her. They took her vitals. She was cleared by the staff. (SPo2 97, Pulse 81, resp 19, B/P 123/97).