chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to a 61 year old male patient. The patient had no drug reactions/allergies. The patient was vaccinated with RECOMBIVAX HB (dose and route unspecified), dose 1 on 22-JUN-2012 (lot # was reported as 152AA, expiry date unknown), dose 2 on 14-AUG-2012 (lot # 0021AE, expiry date unknown) and dose 3 on 14-JAN-2013 (lot # and expiry date unknown), for prevention of Hepatitis B. After administration of the 3 doses of RECOMBIVAX HB, the patient "had titers drawn (on an unspecified date of 2013) which did not register", therefore the patient was also administered 2 booster doses of RECOMBIVAX HB (dose 4 on 09-APR-2013 (lot # H018691, expiry date unknown) and dose 5 on 24-APR-2013 (lot # 0021AE, expiry date unknown), but when his titers were drawn again, recently (in approximately 2015), on an unspecified date, "his titers still did not register." The outcome of the events was not provided. Additional information has been requested.
Erythema and induration of Left upper arm with vesicular rash seen 6/21/06 and treated with Keflex for possible cellulitis. Returned 6/22/06 with worsening erythema and edema (10cm x 11cm area of induration) with multiple vesicles over entire region (fluid filled). Prednisone started x 3 days.
Pt received dose#2 and c/o allergic reaction with faster onset. Pt reported dizziness/neck stiffness and right sided headache, nausea. States feels weak on the right side but no numbness. No slurred speech. No facial asymmetry. Pt denies any SOB/throat tightening. Dizziness less severe this time per patient. She was dizziness for 3 days with dose #1. Patient was discharged at 2112.
Received flu shot on 9/19/18 in (L) deltoid IM. On 9/20/18 at 8:00 AM experienced pain redness, heat at an area below where the shot was given. Employee put ice pack on it and took TYLENOL.
Right inner thigh with erythematous swelling measuring 10cmx12cm, slight edema noted. Ice over area TID, Ibuprofen for pain, BENADRYL for swelling.
Sudden Hearing loss in ear and tinnitis (80% hearing loss in one ear) Took a course of steroids for a week and some hearing came back Some hearing loss and constant tinnitis currently
Itchy rash developed at the injection site 1 week after administration of vaccine. Later it spread to the whole arm, the area was warm and inflamed. Patient also developed mild fever.
Pain traveling from collar bone, to shoulder and elbow. Pain has been ongoing since 08/13/2021.
patient was vaccinated by a technician who inadvertently selected an expired vial and adminstered an inert dose.
Administered Covid-19 Series 3 in the right arm. The injection created a red dot that started a month later. I will get pain that feels like the needle is inside of me injecting for about 30 minutes. The spot has grown and became more visible. The spot is numb but feels slight tender around when pressure is applied.
CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 05-AUG-2021, the patient experienced chills. On 05-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever was not reported. This report was non-serious.
mom called @ 430PM-9AUg93 & reported from rash on chin, lt ear & forehead; no fever;
Caused hard changes in my period also in both my daughters periods age 12 and 13; Caused hard changes in my period also in both my daughters periods age 12 and 13; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "Caused hard changes in my period also in both my daughters periods age 12 and 13".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. The patient was not tested post the vaccination. The patient had no covid prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110519 Same reporter/SD/AE, Different patient;US-PFIZER INC-202101110602 Same reporter/SD/AE, Different patient;
red  swollen  hot to touch  numbness down arm and up arm  into shoulder and down rib cage
This spontaneous report was received from a licensed practical nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On 18-APR-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot#: M020926, expiry date: 11-AUG-2018 (dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion with temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008154: US-009507513-1705USA000206: US-009507513-1705USA000207:
Blisters on Forehead; arm pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm pain) and BLISTER (Blisters on Forehead) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 10-Mar-2021, the patient experienced BLISTER (Blisters on Forehead). At the time of the report, PAIN IN EXTREMITY (arm pain) and BLISTER (Blisters on Forehead) outcome was unknown. Not applicable          No relevant concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up contains second dose details.
Had minor ache in lower back (left side) on Thursday afternoon which stayed as an ache all night but I couldn't get out of bed Friday morning.  Finally able to leave bed on Monday with help but sore all that week and extremely tender.  Two weeks later nearly today and still feeling it but mild.  (light tingling on butt and outer thigh too).  Maybe it was me and maybe it was exercise related but I did find a couple of people mentioning it on yahoo so thought I would mention it.
3mins post vaccination pt had a sudden onset of nausea and vomiting x2. Vitals: 14:40 97/68, 76, 18, 100% -- > 14:55 99/63, 72, 18, 100% Pt had skinny body structure. Denies unusual symptoms.  Pt instructed to drink water. Pt stable and released from the vaccination site, accompanied by boyfriend
The patient called about an hour ago and stated she was experiencing severe arm pain and was unable to lift her arm last night.  She stated she fell and couldn't get back up because the injection site was so sore and painful.  She did not experience this with her first dose at all.  She stated she's taken tylenol and it has helped somewhat.  She was about to try using a warm compress on the site when I spoke to her about an hour ago.  I told her I would report the incident and then reach back out to her to follow up.  She stated she has an appointment on Monday with her doctor, so she plans to mention it then.  I also called the doctor's office to notify them of the occurrence.
tender discomfort @ inj site immed;1wk later discomfort persists enough to awaken pt & prevent sleep;low grade fever persists 99;no axillary adenopathy or overlying erythema or induration;
Swollen glands after 3rd full shot; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Swollen glands after 3rd full shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia since 2012.   In May 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced LYMPHADENOPATHY (Swollen glands after 3rd full shot). At the time of the report, LYMPHADENOPATHY (Swollen glands after 3rd full shot) outcome was unknown.            No concomitant drug information was provided.  It was reported that had received 3 full doses and 1 half booster dose. Patient didn't experience any side effects after first two doses and half booster dose.  No treatment drug information was provided.
Site of injection became inflamed; Entire L arm was painful; Hot to the touch; This case was reported by a consumer via patient support programs and described the occurrence of injection site inflammation in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced injection site inflammation, pain in arm and skin warm. On an unknown date, the outcome of the injection site inflammation, pain in arm and skin warm were unknown.   The reporter considered the injection site inflammation, pain in arm and skin warm to be possibly related to Shingrix.  Additional information was received as follows: Patient had a reaction to the Shingrix Vaccine. Site of injection became inflamed, entire L arm  was painful for 24 hours. It was also painful and hot to the touch. Pharmasist told patient that this was a normal reaction. No other information provided.
the second vaccine was inadvertently administered on day 21 , I let the patient know that even though it was administered early it does not need to be readministered
Had a reaction to the vaccine; A spontaneous report was received from a Consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a reaction to the vaccine (PT: Anaphylactic reaction).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, Had a reaction to the vaccine (Anaphylactic reaction). Anaphylactic reaction was deemed medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   On an unknown date the outcome of event, Had a reaction to the vaccine was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient is fully vaccinated.  COVID + on 12/8/2021.  ED visit on 12/8/2021. Pt c/o abdominal pain, diarrhea, sob that is worse with exertion, bodyaches X5 days.60-year-old male with history of diabetes, hypertension, CVA, myocardial infarction presents to the ED complaining of COVID 19 symptoms. Patient states that he has been experiencing diffuse body aches, intermittent fevers, chills, and mild shortness of breath for the past 3-4 days.Patient denies any history of DVT/PE. Positi ve for cough too. BP 111/65  | Pulse 58  | Temp 97.9 °F (36.6 °C) (Oral)  | Resp 16  | Ht 182.9 cm (6')  | Wt 92.5 kg (204 lb)  | SpO2 94%  | BMI 27.67 kg/m² CXR: Chest appears as stated without evidence of a suspicious pleural or parenchymal abnormality.Imaging revealed gallbladder sludge without any evidence of acute cholecystitis. Treatment:  Toradol, potassium bicarbonate. His oxygen saturation has remained stable throughout his time on room air. Patient will be discharged at this time and has been advised to follow-up with his primary care physician and general surgery soon as possible. He was given strict return precautions. Discharged.
Vomiting (4), Diarrhea (6), headache, shaking, slight fever, rash blotches down my arm, red and sore vaccination site, fatigue (slept 36 hours), brain fog, no energy, continued nausea.
Left shoulder felt like lead was on it. It turned red and was so hot it melted ice on my shoulder. After a few days. I had red shoulder or arm with streaks. I was itchy. I was told by a nurse friend to take Benadryl so I did, I felt tired.
Pt developed fever about 3 days after vaccine administration in getting of new URI sx. On 11/3/09 had witnessed GTC seizure taken to ER. Febrile 10 100.6 F. Sz x 2 min, self resolved, pt quickly back to baseline with nl exam.  11/9/09:  Vaccine record received, VAERS updated.  11/05/09 and 11/09/09 Medical records recieved.  FInal DX Febrile seizure. Three days s/p vacccine. Seizure while sleeping. Jerking arms and legs. ED visit s/p convulsion. Fever, cough. constipation. H/O febrile seizures. D/C to home.
pulmonary embolism started on apixaban 5 mg po bid started on 11/1/22 during hospitalization after collapse in home due to unknown cause after receiving booster of covid vaccinations 2 days prior
This is a spontaneous report from a contactable consumer. This consumer (Patient's wife) reported for a 60-year-old male patient (Reporter's husband) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0183; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 25Aug2021 12:30 (at the age of 60-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient's medical history was none. There were no concomitant medications were reported. Patient had not other relevant medical history, other products and Illness/AE. Patient's family medical history relevant to AE(s) was none. Patient had not AE(s) following prior vaccinations. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FA7484; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 04Aug2021 (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date in Aug2021 patient experienced I have a magnetic reaction in both arms, it also happened to her husband too, after the second dose, but for him only in one arm the left arm on injection side and states it should not be doing that, it's not normal. AE(s) did not require a visit emergency room or physician office. Relevant tests was none. The outcome of events was not recovered. Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110375 Same reporter, different patient, same drug/event (split);US-PFIZER INC-202101110878 Same reporter, different patient, same drug/event (split).
On first day of injection, developed extreme fatigue, fever, chills, and the following day cellulitis on her arm, surrounding the injection site.
Onset 12 hours after vaccination of severe body and joint aches, fever, chills, hyperventilaion.
Approximately 8 hours after receiving vaccine on 6/3/21, pt experienced body aches, weakness, loss of bladder control, vomiting, severe cough, throat swelling, loss of appetite, crushing chest pain, severe arm pain that limited motion, and fever.  Also reports weakness so severe that she "could not lift a glass to her lips to drink water."  Pt took Tylenol with no resolve.  Reports symptoms lasted 7 days.  Reported event 6/17/21.
mom states pt had DTP apporx 10Am; 330PM w/t103 ax, aching legs, felt awful; taken to ER on 19AUG93;
Numbness of lips and chin bilaterally, left greater than right. Lasted 1 hour.
was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure; chills; Fever; Headache; body aches; Cold symptoms; congestion ST; This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (Cold symptoms), NASAL CONGESTION (congestion ST), EXPOSURE TO SARS-COV-2 (was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure), CHILLS (chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced NASOPHARYNGITIS (Cold symptoms), NASAL CONGESTION (congestion ST), CHILLS (chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure). At the time of the report, NASOPHARYNGITIS (Cold symptoms), NASAL CONGESTION (congestion ST), EXPOSURE TO SARS-COV-2 (was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure), CHILLS (chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Patient became weak . diaphoretic and was observed to have full dilation of pupils.  Patient became unresponsive, un able to obtain a pulse.  Patient lowered to the floor.  Patient became responsive but remained disoriented.  Paramedics were called. Patient had orthostatic hypotension and became bradycardic.(NR 30 BPM)   He was transported to ED of Hospital.      Patient indicates that he has a fear of needles and got "woozy" after immunization.  Patient had two syncopal episodes.  Patient reports having similar episodes in the past with blood draws.    BP in ED was 113/61 and 111/60, EKG normal
An 18-year-old male patient with a history of seasonal allergies received initial doses of ADACEL, lot number C2766AA, administered intramuscularly in the right deltoid, and MENACTRA, lot number U2614AA, administered intramuscularly in the left deltoid on the afternoon of 30 July 2008. The vaccines were administered with 1 inch needles and 3cc syringes. The patient also received a tuberculin skin test with APLISOL (manufacturer Parke Davis), lot number 62418, on the same date. The patient complained of feeling tired at the time the injections were administered. Hours later, at 2:00 am on 31 July 2008, the patient developed shaking, was weak and vomited twice. He also felt that his "skin was hurting everywhere." He was seen by a physician at 11:15 am on 31 July 2008. His temperature was recorded as 96.7 Fahrenheit and no other vital signs were available. No laboratory work was completed. The patient called the physician's office at 1:00 pm that same day and reported that he was "feeling better." His recovery status was reported as unknown.
c/o severe leg cramping. Went to PCP. Rest-Aleve-Heating Pad.
Soreness, pain throughout arm. Difficult to raise arm over head. Been going on for a few weeks. Very painful. Feels like a pulled muscle.
administered after improper storage of product; This spontaneous report was received from a medical assistant referring to a 4-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 07-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T022314, expiration date 30-JUN-2022, at a dose of 0.5 milliliter for prophylaxis  (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 7 degree Fahrenheit (°F) for 80 hours as recorded by a data logger. There was no previous temperature excursion reported.
Rapid heart beat; Chest discomfort; Slight breathing problems; Soreness and pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), CHEST DISCOMFORT (Chest discomfort), DYSPNOEA (Slight breathing problems) and VACCINATION SITE PAIN (Soreness and pain at the injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness and pain at the injection site). On 29-Apr-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat), CHEST DISCOMFORT (Chest discomfort) and DYSPNOEA (Slight breathing problems). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Rapid heart beat), CHEST DISCOMFORT (Chest discomfort), DYSPNOEA (Slight breathing problems) and VACCINATION SITE PAIN (Soreness and pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-098626 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098626:Same reporter
Tested NAAT positive for COVID 10/30/21 after being fully vaccinated.