chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Normal chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Normal chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Normal chills) and HEADACHE (Headache). In March 2021, CHILLS (Normal chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient experienced normal chills and headache for a day or two after the first dose.   This case was linked to MOD-2021-395644, MOD-2021-395645 (Patient Link).
PATIENT REPORTS THAT HE HAS HAD A ITCHY SINGLE SHINGLE APPEAR ON HIS ABDOMEN. HE SAW THE DR WHO CONFIRMED IT WAS A SHINGLE. THIS WAS REPORTED TO ME 5-19-2008.
Started having a dry cough and nose was itchy; Took a home COVID-19 test and it was positive. Saw doctor and was prescribed molnupiravir. After finishing round of medication, started to get cough back.
generalized myalgia; fatigue; low grade fever with low grade temps like 100-101; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients. This is 2nd of 3 reports. A 16-year-old patient of unspecified gender received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date, at 0.5 mL, single for routine vaccination for 16-year-old (immunization). Medical history included confirmed COVID-19, months prior and recovered. There were no concomitant medications. The patient had significant systemic reaction to his/her first dose of meningococcal group b rlp2086. On Aug2020, the patient had generalized myalgia, fatigue, low grade fever with low grade temps like 100-101. The patient also experienced severe local reactions with pain, redness at site also described as a pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms. The events were reported as serious, medically significant. The physician considered the events to be related to meningococcal group b rlp2086. The patient recovered from the events in Aug2020.  Information on the lot/batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the PFIZER product is evaluated as part of PFIZER procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.,Linked Report(s) : 2020314784 same reporter, suspect drug and adverse events in different patient; 2020315028 same reporter, suspect drug and adverse events in different patient
Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VARIVAX (lot # M035688 with expiration date: 10-AUG-2018, 1 dose and lot# M041080 with expiration date 06-OCT-2018, 17 doses) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than -10°C but less than -14°C for 15 hours and 40 minutes with previous temperature excursion: temperature greater than -9°C but less than 8°C for 3 hours and 10 minutes; this information was registered in a digital data logger. No adverse effects were reported.   This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA013899:
The pt was satisfying a job requirement. Received MMR on 4/23/00, she started with pain in feet and ankle area and states she could not walk. She did not go to work, was taking Advil. She was feeling better the following day. Her feet were better but now her knees are bothering her. She could not bend her knees (hard to bend). The hands and wrists were painful with left index finger very swollen. The MD gave her a prescription for Vioxx and Tylenol.
Patient was vaccinated with a Moderna injection at 16 years of age. At the time of this VAERS being submitted, Moderna is only authorized for 18 years of age and older.
Pt reports that the day she received vaccines, left arm was red and itching on entire upper arm, and she became nauseated and had a headache when she got home. The day after, she started itching all over entire body and itchy rash developed on bilateral lower arms. Did not go to UC or ER, and did not take any medications. Stated that she thought it would go away on its own, so she didn't seek treatment. Currently, pt reports that itching and rash is worse and she feels dizzy. Provider advised pt to take Bendaryl at nights. Provider sent Prednisone to pharmacy for pt to start taking. ER precautions given for worsening symptoms.
Moderna COVID-19 Vaccine EUA    I woke up this morning with  diarrhea, and the frequency is getting shorter between episodes.
received adjuvant only; received adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number DA32Z, expiry date 30th May 2023) for prophylaxis.   On 22nd June 2022, the patient received Shingrix (intramuscular). On 22nd June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's comment: Pharmacy Technician reported that a the patient from a care facility received the adjuvant only of the shingrix vaccine into the left deltoid, without it being mixed with the antigen powder. The nurse form the care facility also participated in the call to provide further information. The reporter consented to follow-up. Additional Supportive Information: The patient received only the adjuvant of shingrix vaccine, without it being mixed with the antigen powder, which led Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 06-Dec-2021, lot 012H21B vials were kept in refrigerator. Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2022-449524 (Patient Link).
Information has been received from a medical assistant concerning a 6 year old female patient who on an unknown date was vaccinated with varicella virus vaccine live.  It was noted that on 04/24/2004, the patient developed breakthrough varicella.  There was no product quality complaint reported.  No additional information was provided.  Unspecified medical attention was sought.  Additional information has been requested.
tested positive COVID19 after vaccination; diarrhea; congestion; nausea; tiredness; A spontaneous report was received from a Healthcare Professional concerning a patient aged between 30-50 years who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced covid19, nausea, diarhoea , fatigue and congestion .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number not provided ) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date patient experienced covid19, nausea, diarrhea , fatigue and congestion.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of covid19, nausea, diarrhea , fatigue and congestion was not reported.
Information has been received from an Immunization Office concerning an unknown number of patients who, on unspecified dates might have received a dose of MMR II (dose, route and lot # not specified), which had been exposed to 11 degrees C for 137 hours. No adverse effects reported. This is one of five reports from the same source. The other linked reports are: 1211USA005919, 1211USA006715, 1211USA006716 and 1211USA006717. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
approx 8hr p/vax pt devel irritability, fever;temp reported by mom as 100, tx w/Ibuprofen;temp persisted into next day;pt taken to another MD for care;
The vaccine made me sick with chills, fever and body aches for three days. In 10/2022, I began having very irregular menstrual cycles. I am unable to take hormones as I have bad side effects. I will start my period between 7 to 8 days early and my cycle will last nine days. At this time, I am waiting or my system to self-regulate.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2015, the patient was treated by a Hospital for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Lightheaded, fuzzy feeling. Seen by EMS on site. Discharged home at 12:38 p.m.
Patient developed right V3 Shingles.  Viral culture positive for Varicella Zoster.
This case was reported by a lawyer and described the occurrence of Bell's palsy in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. At an unspecified time after vaccination with Lymerix, the subject experienced Bells palsy, joint pain and swelling, flu-like symptoms, fatigue, rashes, tingling in his extremities, headache, visual problems, cognitive problems, memory loss, joint stiffness, sleep disorder, sinus problems, dizziness, ear ringing, muscle pain and weakness, numbness, decreased activity of daily life, rheumatologic, neurologic and or cognitive impairment of an autoimmune mediated, or other mechanism. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-APR-2015 or 01-MAY-2015, the patient was vaccinated with either improperly stored (Merck) VARIVAX (strength, dosage, frequency and route unspecified) (Lot reported as K015375 with expiration date 18-SEP-2016, Lot reported as K018990 with expiration date 15-OCT-2016, Lot reported as K011317 with expiration date 13-AUG-2016 and Lot reported as K016153 with expiration date 24-SEP-2016) or improperly stored MMR II rHA, (strength, dosage, frequency and route unspecified) (Lot reported as K021930 with expiration date 10-NOV-2016, Lot reported as K021487 with expiration date 03-NOV-2016 and Lot reported as L001329 with expiration date 13-JAN-2017) (incorrect product storage). It was unspecified exactly which the lot % vaccine the patient was given. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Product and narrative were updated.
pt recv vax 9MAR99 & 10MAR exp swelling & redness of entire lt legs, this was gone by 11MAR;a couple days p/that the leg started peeling including the entire foot (plantar area);
The patient misinformed medical staff upon arriving claiming he had not be vaccinated yet and requested to be given J&J. Upon entering the patient information to system it was discovered he had already received both doses of Pfizer.
Extra menstrual cycle; felt dizzy; face tingling; tasted metal; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), PARAESTHESIA (face tingling), TASTE DISORDER (tasted metal) and MENSTRUAL DISORDER (Extra menstrual cycle) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included Intra-uterine contraceptive device (Patient had liletta IUD for 5 years.) since an unknown date. Concurrent medical conditions included Migraine since 1995 and Thyroid cancer (Start date 09-???-2015.) since 2015. Concomitant products included IBUPROFEN for Headache, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 2000 to an unknown date for an unknown indication.   On 14-Apr-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (felt dizzy), PARAESTHESIA (face tingling) and TASTE DISORDER (tasted metal). On 25-Apr-2021, the patient experienced MENSTRUAL DISORDER (Extra menstrual cycle). On 14-Apr-2021, DIZZINESS (felt dizzy), PARAESTHESIA (face tingling) and TASTE DISORDER (tasted metal) had resolved. On 28-Apr-2021, MENSTRUAL DISORDER (Extra menstrual cycle) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient visited her gynecologist for her extra menstrual cycle, and she suggested that the IUD has run its course and suggested to replace it. Patient stated that the adverse events were most likely caused by mRNA-1273.  "Follow-up received on 14 Jun 2021 included no new information.   This case was linked to US-MODERNATX, INC.-MOD-2021-140965 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Reporter's address and email id, Patient's demographics, Patient's  medical history, second dose details,  concomitant medications, new event, outcome of events were added. On 14-Jun-2021: Follow up received and contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-140965:Fi
Information has been received from a healthcare worker (immunization official) referring to a 4 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K015970(expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Presented 3/21/22 with acute onset left sided weakness and slured speech. CTA demonstrated right M1 occlusion. CT perfusion was favorable. She received TNK and underwent thrombectomy, TICI 2b. Despite these interventions, she has persistent severe deficits including left facial droop, slurred speech, and paralysis of her left arm and leg.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L031272, expiration date 19-NOV-2016, route and dosage not specified). No symptoms reported. It was reported that the vaccine was improperly stored at 32 degrees F for 20.5 hours and 15 F for 11 hours. Additional information has been requested.
When I removed the bandaid the day after the injectin (8/3/07) I noticed reddness, swelling and itching covering 1in above and to both sides of injection site and 3in below it. Blisters formed within a 1in radius of injection site. On 8/4/07 I started using 1% hydrocortisone cream to help with the itching. By 8/6/07 the swelling, reddness and itching have reduced to about a 1in radius around the injection site. The blisters still persist within a 1in radius of the injection site.
Patient received moderna vaccine on 2/13/21, 3/13/21 and 11/15/21. Presented to ER on 6/15/22 for transient ischemic attack for observation. FOund to be COVID19 positive as well. Admitted. No COVID19 symptoms or treatments. Discharged on 6/16/22
1st dose Moderna: 5hrs: injection site is tender and swollen. Arm muscle pain. 24hrs: Injection site still swollen and tender.  Injection arm muscle pain.  Hypothermia symptoms (92F- 95.4F), followed by feverish feeling at 99.2F. Intense headache especially when sitting down/ standing up.  Took 2x500mg Tylenol.
Headache; body aches; sore arm; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient herself). A 36-years-old female (Non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 22Feb2021 at 14:00 (Age at time of vaccination 36-years-old) as unknown single, dose for covid-19 immunization. The patient medical history, concomitant medications were not reported.  The patient has not covid tested before vaccination and after vaccination. No treatment received. The patient had no other vaccine in four weeks. On an unspecified date the patient experienced Headache, body aches, sore arm. The outcome of event was recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Upper arm was red and painful like she had a sunburn. She had chills and felt "wiped out" for 2-3 days. She took TYLENOL as needed. By Friday. 1/30/15 she felt fine.
Fever Nausea Feeling of potentially throwing up Dehydration Exhaustion Zoned out
A non-serious spontaneous report of fever of 104 has been received from parent/health professional concerning a six-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Nov-2009, the patient received H1N1, Intranasal, for an unknown indication. On 13-Nov-2009, after 12 hours of vaccine administration, the patient developed a high fever of 104. Ibuprofen was administered, fever subsided, with no problem or symptoms to report. The outcome for the reported adverse events was resolved.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose in September 2018 and had no side effects afterwards). On 18th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th February 2019, less than a day after receiving SHINGRIX, the patient experienced headache, general body pain, sleep disturbance and rem sleep abnormal. On 19th February 2019, the patient experienced dry mouth, sniffles, renal pain and injection site pain. On an unknown date, the outcome of the headache, general body pain, dry mouth, sniffles and renal pain were not recovered/not resolved and the outcome of the sleep disturbance, rem sleep abnormal and injection site pain were unknown. It was unknown if the reporter considered the headache, general body pain, sleep disturbance, rem sleep abnormal, dry mouth, sniffles, renal pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: A day before reporting, the patient received 2nd dose of SHINGRIX and started experiencing a headache and body aches that evening. The patient kept waking up through the night and he used a device to monitor rapid eye movement (REM) sleep and he did not have any episodes of REM sleep through the night. 1 day after receiving SHINGRIX, the patient had some soreness at the injection site, a terrible headache, severe dry mouth and pain in the area of his left kidney. The patient also had some sniffles. The patient was not sure if it was actually kidney pain, or related to the general body aches he was experiencing. The reporter consented to follow up.
This case was reported by a other health professional via sales rep and described the occurrence of headache in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced headache and feeling abnormal. On an unknown date, the outcome of the headache and feeling abnormal were unknown. It was unknown if the reporter considered the headache and feeling abnormal to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The GSK MSL received call from unknown person, who stated that the 2 teenage patient received BEXSERO (dose unknown) and experienced headache and feeling out of it. The person asked about mental status changes with BEXSERO. The MSL was not aware if the representative to the practice had or had not reported these events already. The reporter also noted that she received the call on 18th July or 20th July. The reporter had very limited information. This case has been linked with case US2017115591, as reported by same reporter.
I have had heavy menstrual bleeding since 8/29, large blood clots, cramps.  I have seen Nurse practitioner twice and see the Doctor on 10/29.  They prescribed me  Provera 10mg  to slow the bleeding for 10 days, did not work.  Then prescribed Megestrol 40mg for 30 days, did not work as well. Makes me nauseous.
Sore arm and hard to the touch. Not warm or red and could not lift arm. Symptoms improving and able to lift arm 3-26-2018 but not fully yet.