chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt some fluttering in her heart; heavyness on her chest; Feeling strange; feeling funny; was so fatigued; had shortness of breath; whole body was so sore and hurt so bad; started runnning a low grade fever; was freezing; uncontrollable shaking; whole body was jerking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (uncontrollable shaking), DYSKINESIA (whole body was jerking) and CARDIAC FLUTTER (felt some fluttering in her heart) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020. Family history included Hair loss in December 2020. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Allergy, LISINOPRIL for Blood pressure, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for Stomach ulcer, VITAMIN D3 and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TREMOR (uncontrollable shaking) (seriousness criterion intervention required), DYSKINESIA (whole body was jerking) (seriousness criterion intervention required), FREEZING PHENOMENON (was freezing) and PYREXIA (started runnning a low grade fever). On 03-Apr-2021, the patient experienced DYSPNOEA (had shortness of breath), FATIGUE (was so fatigued) and MYALGIA (whole body was so sore and hurt so bad). On an unknown date, the patient experienced CARDIAC FLUTTER (felt some fluttering in her heart) (seriousness criterion medically significant), CHEST DISCOMFORT (heavyness on her chest), FEELING ABNORMAL (Feeling strange) and INAPPROPRIATE AFFECT (feeling funny). On 02-Apr-2021, TREMOR (uncontrollable shaking), DYSKINESIA (whole body was jerking), FREEZING PHENOMENON (was freezing) and PYREXIA (started runnning a low grade fever) had resolved. On 04-Apr-2021, MYALGIA (whole body was so sore and hurt so bad) had resolved. On 05-Apr-2021, DYSPNOEA (had shortness of breath) and FATIGUE (was so fatigued) had resolved. At the time of the report, CARDIAC FLUTTER (felt some fluttering in her heart), CHEST DISCOMFORT (heavyness on her chest) and FEELING ABNORMAL (Feeling strange) had not resolved and INAPPROPRIATE AFFECT (feeling funny) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-067382 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-067382:first dose of vaccine case
shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2021, the patient received Shingrix (intramuscular). On 6th October 2021, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by health care professional for himself. The patient received Shingrix vaccine in left deltoid and developed shingles just under the injection site. The patient was unaware if it was first or second dose. Till the time of reporting, the patient still had shingles. The reporter consented to follow up.
Vaccines given at 10:30 am. Child awakened after 2:30pm with temp 101.8 and "limp", moaning. Did not become active for 1 hour after awakening. Tylenol was given at 2:30pm child was re-examined in office at 4:00pm, exam was WNL. Awakened at 3am with temp 103, still with fever next day. 6/23/06 now continues with fever to 100.5, diarrhea for 3 days.
The pt had a febrile seizure and a Todd's paralysis which resolved in less the 4 hours.
Quick pain to wrists like pinches. Headache that worsen by day. Fever that lasted 12 hours after the initial fever started 12 hours after shot. Chills with fever. Vomiting and nausea lasted late evening after shot.  Slight pain in abdomen with slight varicose veins that occur occasionally.
No other AE reported; gave PNEUMOV AX 23 vaccine yesterday, 10/15/2020 and it expired 9/17/2020; This spontaneous report was received from a pharmacist who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 15-OCT-2020, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, intramuscularly (anatomical location and strength were not provided; lot number S026366 was confirmed to be valid, expiration date 19-SEP-2020, was also confirmed) for prophylaxis.  There were no other adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I have been having numbness my tongue, lips, both side of fingers and both side of toes. The symptoms level is same since o noticed them. Mean not getting worse or better.
This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 07-DEC-2016, the patient was vaccinated with a dose of improperly stored MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Left deltoid redness, swelling, pain, started about dime size, next day silver dollar size, by day 5 had spread to 3in by 5in. Telehealth visit with Dr. who prescribed increase in Famotidine and Ceterizine doses to BID and Benedryl to continue QHS for next 9 days (through 2 weeks post-vaccination. Rest ice and elevate as needed
Patient had a sore, red arm at site of injection. It was sore to the touch. Skin turned red
Onset of high fever (103) severe chills, body aches, soreness about  18 hours after shot. Intermittent fever, continuous body aches continued with use of Tylenol for 28 more hours, followed by rapid improvement.
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 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 15:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Negative, notes: Tested Positive 29Dec2022 after 2 negative tests on 21Dec2022 & 24Dec2022; (24Dec2022) Negative, notes: Tested Positive 29Dec2022 after 2 negative tests on 21Dec2022 & 24Dec2022; (29Dec2022) Positive, notes: Tested Positive 29Dec2022 after 2 negative tests on 21Dec2022 & 24Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid treatment from 16Dec2022 to 21Dec2022. . The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient got second shot of Pfizer today. After receiving her vaccine, she complained that her throat felt like it was swelling, but not difficulty breathing. Vital signs were checked and they were normal - BP was 153/85, HR 63, RR 18-20, Ox 100% at room air. She took Benadryl 25 mg at home around 8:15 AM prior to showing for app. Patient was given a second dose of Benadryl inside of observation room by nurse after she complained that her throat was swelling. Around 10:00 AM she was given a second dose of Benadryl at observation room. At 10:15 AM patient said that she was feeling better and she was allowed to leave. Member was not driving and was taken home by UBER.
Developed pain during the administration, later experienced body aches and a mild headache that started a couple of hours later.  A red rash appeared from the beginning and progressed to a deeper red circle, warm to the touch. Body aches and low grade headache lasted a couple of days. Still with persistent red raised rash, was very itchy, relieved with triamcinolone ointment with zyrtec. Took tylenol for her body aches and headache.
Information has been received through the Merck pregnancy registry, from a physician, concerning a 19 year old female who in March 2007, was vaccinated with a second dose of Gardasil. Subsequently the patient received her two doses of the vaccine and then became pregnant. Unspecified medical attention was sought. Follow up information received from the mother of the patient, indicated that in September 2006, her daughter received the first dose of Gardasil, on an unknown date the second dose, and in February 2007 the third dose of Gardasil (lot #'s not provided). She reported her daughter became pregnant in April 2007. In November, when 7 months pregnant, her daughter was admitted to the hospital for abdominal pain, and on 04-NOV-2007, she "lost her baby." The child "had no heartbeat and was dead for a week in her womb. The child was not fully formed." She added that the fetus's eyes, ears and nose were not fully developed. Her daughter remained in the hospital for "about a week." At the time of this report, she was recovering from the event. Additional information has been requested.
Patient presented as a walk up at a flu drive. Patient tolerated injection well, initially. Patient's mother returned to the clinic with him about 10 minutes later, stating that she "thinks he had a seizure in the car". She states that he lost consciousness and "shook" and was incoherent for about 30 seconds before waking back up.
After 30 min obs, attempted to stand and walk to desk. unsteady gai, walked into tent walls grabbing to brace herself. Assisted w/c and transported to healthcare facility with complaints of dizziness
Two days post first vaccine onset of early, heavy bleeding. Stopped after 7 daysTwo days after second vaccine, extreme bleeding for 3 full weeks so heavy; received dose1 and dose 2 on 08Apr2021; This is a spontaneous report from a contactable consumer (patient).  A 37-years-old female patient (not pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 13:00 at the age of 37-years-old(Batch/Lot Number: EW0179) as 2ND DOSE, SINGLE, dose 1 via an unspecified route of administration, administered in Leg Left on 08Apr2021 at the age of 37-years-old (Batch/Lot Number: EW0151) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included covid-19 from an unknown date, Prior to vaccination, the patient was diagnosed with COVID-19. IUD from an unknown date, having little to no period with IUD. Concomitant medication included bupropion hydrochloride (BUPROPION) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient stated despite having little to no period with IUD, two days (as reported) post first vaccine onset of early, heavy bleeding on 01May2021 08:00. Stopped after 7 days. Two days (as reported) after second vaccine, extreme bleeding for 3 full weeks so heavy that her body expelled her IUD. Sought treatment from OBGYN. Had to take four progesterone pills a day for four days to get bleeding to stop and was still taking them 6 weeks after vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event bleeding included progesterone and scheduled uterine ablation. The outcome of the event heavy bleeding was resolving.
2 Days after the shot patient reported soreness in the arm.  Patient is now reporting a shooting pain on the arm as of 6/19/23
Seen for 5 yr WCE on 7/10/14. Rec'd KD immunizations. S/S began eve. 7/11/14. Seen for s/s on 7/12/14. 5 inch x 4 inch area erythema, mod. edema, mild warmth and TTP to Lt arm at site. Tx with ibuprofen and ice packs.
On 23 July he received his annual Anthrax vaccine booster (dose #6) and over the next 48 hours noted gradual onset of localized swelling, redness, and tenderness affecting his right deltoid and upper arm. He denies chest pain, fever/chills, arthralgias, myalgias, generalized cutaneous symptoms, and systemic symptoms. He reports similar, albeit less marked, swelling and redness affecting the vaccination site with prior Anthrax vaccine doses but denies other adverse vaccine reactions. Mild (3/10) pain at site but has not affected his ability to perform his daily activities.
This spontaneous report was received from a 57 years old female patient with diabetes and fibromyalgia, who was reporting on herself. The patient had no drug reactions or allergies. The patient's medical history was not reported. On 21-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (lot #, expiration date, dose, route of administration and anatomical location were not reported). No concomitant therapies were reported. On 21-AUG-2015, immediately after vaccination, the patient "could feel the vaccine going through her body". The pharmacist told the patient to take ibuprofen to treat his symptom. The patient administered ibuprofen 200 mg and the feeling went away. On an unknown date in 2015 (reported as "a coupled days ago"), the patient developed rash on both legs "that did not look like chickenpox". The patient stated that "the rash was itchy, like a mosquito bite and somewhat painful". The patient had been applying an unspecified analgesic cream and mupirocin 2% to the rash. No lab diagnostic studies were performed. The outcome of the events was reported as recovering. The patient did not seek medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Shortness of breath with tachycardia lasting 6 weeks plus. Felt that heart had not enough room to beat properly.
Dose 2:  Sore arm muscle, large swollen and red area around injection site. Chills, headache, body aches, tired and loss of appetite. Began 12 hours after vaccination and continued for 24 more hours. Symptoms worse than first vaccination.  Dose 1: Sore arm muscle. Chills, headache, body aches, tired and loss of appetite. Began 12 hours after vaccination and continued for 24 more hours.  Patient previously had Covid-19 in March 2021.
Received vaccines on 07/29/09, Varicella on the right arm. 07/31/09 right arm is red, hot, swollen and painful, patient vomited, dizzy and started to faint, she caught self with right arm and possibly dislocated shoulder which she has had surgery on it in the past. Went to ER received joint reduction for the right shoulder dislocation and antibiotic medication for right shoulder cellulitis.
Presented with chest discomfort, palpitations and tachycardia. Symptoms occurred at about 7:30 pm and lasted throughout the night.
Beginning approximately 12 hours after the shot the following symptoms occurred and became progressively extreme throughout the night, causing an inability to sleep until the next day; Sweating; Fever; Headache; Chills; Nausea; Fatigue; Inability to sleep due to extreme side effects; Pain at injection site; Pain in arm muscles; Decreased arm mobility; The day following the shot the symptoms continued at an extreme intensity, until becoming less extreme but still disruptive in the evening. That night I was able to sleep and the next day the fever, sweat, and chills were gone. That day the rest of the symptoms continued in a milder way and by the day after I was feeling nearly normal again.
Fever (101.0 F) mild headache mild fatigue mod. R arm rain (inj site)
rash; rash in upper chest and shoulders in both sides; A spontaneous report was received from a consumer concerning an unmentioned-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced two small rashes and rash in upper chest and shoulders in both sides.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 21-JAN-2021, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch: unknown for prophylaxis of COVID-19 infection.  On 22-JAN-2021, The patient experienced two small rashes and rash in upper chest and shoulders in both sides.  No Laboratory details provided.  No treatment information provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s) was unknown.  The reporter assessed the event(s), [rash and rash in upper chest and shoulders], as listed to study drug.
achy soreness in muscle below injection site; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number TZ9L5, expiry date 22nd November 2020) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (the patient received 1st dose on 30th April 2018, refer case US2019125918).   On 28th July 2018, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received her second dose, and was still having an achy soreness in the muscle below the injection site. The reporter was unable to provide any additional information. This case has been linked with cases US2019125918 and US2019125917, reported by the same reporter.
15 year old with c/o 1 mo history mild arthralgia of knees when came in to office 3/6/13 for well care. Child and mom note worsening knee pain and milder upper back pain since vaccine. Using NAPROSYN. Rash noted at same time over knees.
Two hours post vax, the pt states "I had cramps and started period. This happened after both shots. I had my period for one complete month including cramps. I do not get cramps normally or have an abnormal menstrual cycle."
On or about Nov. 1st, 2022, I started experiencing diarrhea. I don't remember having this before, except possibly as a child. So far, I have had diarrhea for about 8 days, and I'm wondering how long it will continue. It is controllable, but still, not usual for me at all. I can't think of any other causal reason for this condition.
Doctor office notified the pharmacy that the patient had a reaction to the vaccine and was hospitalized. Per doctor office, it was due to incorrect administration of the vaccine too high in the deltoid and into the joint space instead. Patient was evaluated for DVT while in the hospital but has since been discharged.
sore arm after first booster dose; fatigue after first booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm after first booster dose) and FATIGUE (fatigue after first booster dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm after first booster dose) and FATIGUE (fatigue after first booster dose). At the time of the report, PAIN IN EXTREMITY (sore arm after first booster dose) and FATIGUE (fatigue after first booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications was reported.   This case was linked to MOD-2022-638961, MOD-2022-638962, MOD-2022-638950 (Patient Link).
Nausea, hard to breathe, headache, soreness, redness, swelling of left arm, fatigue.
I have had my period for 3 weeks, it is never irregular and now i am experiencing long term heavy bleeding
Same day as immunization, site very painful. Bump at site remained palpable for at least six months, continuous. After that time bump at site returned occasionally. When it returned it was itchy and red.