chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/6/22 8:30 pm- received booster at drug store, bled a lot.  1/7/22 7 am- sore arm; 10 am- slight headache; 12:30 pm- took Tylenol; 3:30 pm- tired leaving work; 4:30 pm- not feeling well with chills; 6:15 pm- temperature rose to 101.2 with body aches, took Tylenol; 11:45 pm- temperature 101.8   1/8/22 7 am- temperature at 101.3, took Tylenol; 9:30 am-fever went down, but lymph node under left arm pit was swollen, and sore to move arm; 11:30 am- joints ached, hurt to walk, headache/teeth ache; 12:45 pm- temperature was at 101.5, took Advil; 1:30 pm- temperature still at 101; 8:30 pm- fever down to 100.1 but sweating at night  1/9/22 9 am- no fever but rash on L arm from the injection area; 11:30 am- did not attend church, thought fever broke at 98.3 with no achiness but just a slight headache, harder breathing when walking; 5:00 pm- fever back with sweating, took Advil, rash went further down arm towards elbow  1/10/22 6am- rash from left arm spread to front neck area with low grade fever, rash on left arm holding heat, permitted to go into work; 7:30 am- sweating just sitting down; 12:45 pm- stiff neck, rash going to right arm area, called into family doc office; 1:45 pm- doc via phone visit instructed me to use Benadryl and if it didn?t improve/worsened then I would have to go to Urgent Care, 2pm- left work early, from doctor?s advice; 2:45 pm- took Benadryl; 7:30 pm- took another Benadryl, body itching  1/11/22 6:30 am- rash still with heat but no stiff neck; 4:30 pm- tired and resting at home, not better but not worse, VERS rep called to advise me to report concerns   Continued to feel tired and have small rash on left arm near injection site for rest of the week
Stroke; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that he was "a guy sitting in a chair" and "he was a genius". On an unspecified date after vaccination, the patient had a stroke "and now is just a regular guy". The event outcome was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 2:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 80.18 for batch number 035C21A administered on 27-Oct-2021 and age reported as 79.38 for batch number 027L20A.  No concomitant medications were reported.  Batch number 035C21A administered on 27-Oct-2021 with temperature between 29 to 32 from 09:00 AM to 10:00 AM. This vial was moved to fridge on 29-Sep-2021 and 05-Oct-2021 and beyond use date for the vial was reported as 29-Oct-2021 and 04-Nov-2021. Product moved to clinic on 27-Oct-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 07-APR-2015, the patients were vaccinated with ROTATEQ orally (dose, Lot# and expiration date not reported), which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
RAPID HEARTBEAT; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 165 pounds, and height was not reported. The patient's pre-existing medical conditions included the patient had no known allergies illness at the time of vaccination: no past history of similar event? no pre-existing acute illness 30 days prior to vaccination? no family history of any disease (relevant to vaccination) or allergy? no. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced rapid heartbeat. On 20-MAR-2021, the subject experienced injection site swelling. Laboratory data included: Heart rate (NR: not provided) 100 beats per min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, and rapid heartbeat. This report was non-serious.  Additional information received from patient on 31-march-2021 The following information was updated and incorporated into the case: patient weight added.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Patient received double the dose of Casirivimab via IV and no allotment of the Imdevimab - Nothing more to follow
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been been requested.
SWOLLEN LYMPH NODE; THROAT FEELING A LITTLE NUMB; SWEATING A LITTLE; HEART BEATING REALLY FAST; TROUBLE SLEEPING; SORENESS IN LEFT ARM; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced trouble sleeping. On 05-APR-2021, the subject experienced soreness in left arm. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced heart beating really fast. On 06-APR-2021, the subject experienced swollen lymph node. On 06-APR-2021, the subject experienced throat feeling a little numb. On 06-APR-2021, the subject experienced sweating a little. Laboratory data included: Heart rate (NR: 66 - 82) 91 beats per minute, 145 beats per minute, and Heart rate 91 beats per minute, 145 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness in left arm, had not recovered from chills, headache, heart beating really fast, swollen lymph node, throat feeling a little numb, and sweating a little, and the outcome of trouble sleeping was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Covid (minor); The vaccines have been difficult; shingles outbrakes / small breakouts of shingles; shingles outbrakes January 2023; scars remain; This spontaneous report was received from a consumer and refers to currently 71-year-old patient of unknown gender. On an unknown date in 1982, in the middle 30s, the patient had shingles outbreaks. The patient was not immune compromised. There was no information about the patient's concurrent conditions or concomitant therapies provided.  On an unknown date in 2013, at the age of 59, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (formulation, dose, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with 1st and 2nd dose of varicella zoster vaccine rge (cho) (SHINGRIX) (formulation, dose, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with all covid-19 vaccines (formulation, dose, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient stated that the vaccines were difficult, but the patient repeated them (ill-defined disorder). On an unknown date, the patient had minor covid-19 infection. On an unknown date, the patient reported that continued to have small breakouts of shingles. On an unknown date in January 2023, the patient stated that had the worst shingles outbreak ever, in both sides of the body, heavy on shoulder to shoulder, light breakout down arms and full breakouts on chest. On an unknown date in 2023 (reported as after 6 weeks), the patient noted scars, but stated that it was clearing. The patient received valaciclovir (VALTREX) 500 mg as a maintenance. The outcome of covid-19, herpes zoster, scar and ill-defined disorder was unknown. The outcome of herpes zoster reported on an unknown date in January 2023 was considered as recovering/resolving.  Causal relationship between covid-19, herpes zoster, scar, ill-defined disorder and zoster vaccine live (ZOSTAVAX) was unknown.
1 of 4 pts vaxed from the same vial who had an adverse event;pt exp a rxn following vax;no further details available;sxs unspecified;
Information has been received from a woman in a physician's office concerning a 5 year old male who on 07/01/97 was vaccinated SC with a first dose of Varivax. Concomitant vaccinations that day included a first dose SC  in the arm of MMRII and a fourth dose IM in the deltoid of Tripedia. On 02/09/02, the patient was seen in the office and diagnosed with chickenpox. The office reported the chickenpox as a case of vaccine failure. The patient recovered on an unspecified date. No further information is available.
One and half weeks after vaccination he had a seizure, then 2 weeks later he had another seizure.
MODERNA VACCINE ADMINISTERED TO PATIENT UNDER THE AGE OF 18. NO ADVERSE REACTION
1 of 3 pts immunizedd from the same lot number (same vial) who exp fever & crying; temp not taken for this pt; reaction treated w/APAP & DPH;
four month old male patient administered QUADRACEL vaccine in the thigh left with no reported AE; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case from a other health care professional via Medical Information (Reference number- 00727886).  This case involves a four month old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] at the left thigh (product administered at inappropriate site).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 16-Aug-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5763AA and expiry date: 26-Aug-2022) (Frequency: once) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to Vaccine administered at inappropriate site (latency on same day).  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1 week after my second Covid Vaccine I developed sudden bilateral foot and hand tingling and numbness . This occurred around Jan 30th/ my second Covid was given on 01/22/2021.  The numbness and tingling in my hands has resolved but my toes remain numb.
mom called 24JUL92 stated next day p/shots pt got a rash above both knees but not @ inject site; no other sx;
ADMITTED. Patient is an 89 y.o. male with h/o chronic pulmonary fibrosis, chronic diastolic CHF, chronic A-Fib on Coumadin, stage 3 CKD, gout and morbid obesity, presenting to the local ER on 1/27 with c/o dyspnea.  He was seen by his outpatient pulmonologist earlier in the day, reporting increasing dyspnea, cough and leg swelling over the past 2 days.   Cough is dry and non-productive.  Dyspnea is worsened by exertion and laying flat.  He reports chronic intermittent chest and back ache which has not changed significantly, and no other associated symptoms.  He is prescribed home supplemental oxygen but does not typically need it.  Over the past few days, he has been on the road a lot and has halved his dose of torsemide from 40 mg daily to 20 mg daily to reduce the amount of stops he'd need to take while driving.  He was once on as high a dose as 60 mg daily but this has been weaned by his cardiologist with the  local Clinic.  Plan late last year was for cardioMEMS implantation, though this was ultimately abandoned and not pursued since due to a procedural complications.  Pulmonology note from earlier today suggests plans for repeat HRCT to evaluate extent of pulmonary fibrosis and discussion regarding anti-fibrotics once past this episode of suspected volume overload.  They recommended he be admitted to the hospital for IV diuresis and directed him to the ER for this purpose.   In the ER, he was febrile, normotensive to moderately hypertensive, with normal HR, mild tachypnea and hypoxia to 86% on RA alone.  He was placed on 2L via NC.  Initial labs are notable for elevated proBNP and initial troponin, renal dysfunction, mild AST elevation with otherwise normal LFT?s, normal CBC and lactate, and positive COVID screen.  BCx were collected.  EKG shows rate controlled A-Fib, incomplete RBBB, and non-specific ST-T changes.  CXR showed retrocardiac opacity reflective of either atelectasis or consolidation, superimposed on underlying interstitial lung disease.     He was ordered IV fluids, but given less than one liter.  He was ordered antibiotics, but these were not given.  He will be given an initial dose of IV Lasix and dexamethasone following my conversation with his ER provider.  Admission was requested for workup and management of acute hypoxic respiratory failure.
fever,  skin peeling off my hands ever since second dose, rash on stomach, lips are chapped,
My initial COVID-19 vaccinations were on 4/1/2021 (age 55, Johnson & Johnson) and 1st booster on 11/5/2021 (age 56, Moderna).  On 5/13/21, I became ill with COVID-19.  My husband had become sick 2 days before.    Also, each time I had a vaccination, and again when I became ill, the fingers of my left hand (only) become mostly numb, and each time this has taken several weeks to mostly fade.  They are still numb today from my illness last week, and have not been completely normal since my initial vaccination on 4/1/2021
6 weeks 2 days pregnant for second shot - due date Nov30, 2021 mild morning sickness until vaccine reaction day, then severe nausea and vomiting the day of vaccine reaction day - return to low morning sickness symptoms day after vaccine reaction day. Other vaccine reaction day symptoms: nearly fainted (panic attack?) 35 minutes after receiving shot,  next day I had low fever, chills and muscle/joint aches for 12 hours. Note: After 1st shot I also nearly fainted (panic attack?) about 35 minutes after shot; had pain at injection site and neck ache that lasted 30 hours.
the vial was initially stored in the refrigerator 23Jul2022; We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 23Jul2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 23Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 23Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   The vial was initially stored in the refrigerator on 23-Jul-2022. The vial did not undergo any temperature excursions.     No treatment information was provided by the reporter.
Swelling at site with redness and itching initially. Currently small lump in (L) arm and slight discoloration. Marked improvement. No s/sx of anaphylactic allergy.
Vial initially stored on 31-JAN-2022 and then administered on 17-MAR-2022; received dose after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 17-MAR-2022) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2022 at 7:51 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Mar-2022 at 7:51 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 17-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 17-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Patient had received first booster dose. Reporter provided doses of moderna COVID 19 vaccine after the beyond use date as reporter did not know that the vials should not be used past 30 days from thawing the vials. Date vials were initially stored was reported as 31-Jan-2022. Thaw expiration date was reported as 2-Mar-2022. Total twenty doses were given. Total fifteen vials were used. Vial did not undergo any temperature excursion. No treatment medication were provided.
Pt received her primary smallpox vaccination (WAL 4020071) on 10/23/2003. That evening while out to dinner with her family, she complained of a headache, fever 103-104, and multiple red itchy bumpy skin patches and lesions (she called hives) all over her body. She reported being taken to near-by hospital where she was treated with BENADRYL, NSAIDs, and TYLENOL. She said her diagnosis was a reaction to her vaccination. All symptoms resolved within 24-48 hours. She also stated her SPV developed a pin size vesicle one day after vaccination that resolved by day 3. She remembers no scab or scarring experienced by others (her husband got vaccine at same time). [A request for any medical records between 2002-2004 at area hospital found no medical records for this time period (she was unable to remember name of hospital or if went to an urgent care facility). ] No JENNERIAN (smallpox vaccination) scar was visible to either deltoid on exam despite documentation of receipt in 10/2003. On 11/20/2003 she received her annual influenza vaccination (split - IM unknown manuf). Approximately 24 hours later she complained of a fever to 101, nausea, headache and red dots (she calls hives) to her chest. These dots were similar to SPV reaction but not as pronounced or severe as they were localized to chest only. She went to nearby ER being told it was a reaction to the vaccine and given oral BENADRYL and TYLENOL. All symptoms resolved within 1-2 days. Medical records of this event were requested from ER; however there were no records of any visit from Oct-Dec 2003. There were 4 visits earlier that year ending in September 2003 for other medically related issues (c/o fever, nausea, chills, back pain and diagnosed with kidney infection and treated with MOTRIN and CIPRO).