chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant when vaccinated; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant when vaccinated) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast feeding (nursing baby).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant when vaccinated). The delivery occurred  and was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. On 05-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant when vaccinated) had resolved.            Relevant concomitant medications were not reported.  It was reported that patient  was pregnant when she had both of her Moderna vaccine and at the time of reporting she was a nursing mom.  The treatment information was  not provided.
migraine; Couldnt get out of bed; Injection site raised; Body ache; Non serious rash at injection site; 102 temperature; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (migraine), MOBILITY DECREASED (Couldnt get out of bed), VACCINATION SITE PAPULE (Injection site raised), PAIN (Body ache) and VACCINATION SITE RASH (Non serious rash at injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    The patient's past medical history included Tobacco user (Half of pack of cigarette per day) from 1993 to 2013, Bone fistula in 2011, Bone spur in 2011 and Meniscus tear in 2011. Concurrent medical conditions included Alcohol use in 1999, Osteoarthritis in 2011 and Allergy to allopathic drugs (Sulfa allergy manifested by ill/nauseous/dizzy).   In 2018, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 milligram per millilitre. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. In March 2021, the patient experienced MIGRAINE (migraine), MOBILITY DECREASED (Couldnt get out of bed), VACCINATION SITE PAPULE (Injection site raised), PAIN (Body ache), VACCINATION SITE RASH (Non serious rash at injection site) and PYREXIA (102 temperature). In March 2021, MIGRAINE (migraine), MOBILITY DECREASED (Couldnt get out of bed), VACCINATION SITE PAPULE (Injection site raised), PAIN (Body ache), VACCINATION SITE RASH (Non serious rash at injection site) and PYREXIA (102 temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature (97-99): 102f (High) 102F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications include Singulair and Tylenol.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted and woke up within seconds. Father was with 18 year old patient and stated patient had not eaten nor drank anything that day. Vaccine was given around 4pm. Patient immediately instructed to sit down with head between legs and drank some orange juice. Patient immediately felt better. Emergency personel was called to check patient blood pressure, sugar and heart rate. All was within normal limits. Patient doing just fine after resting 20 minutes.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a male patient who experienced ear infections. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was unspecified (intramuscular). Concomitant medications were not reported. The patient received 2 of the 4 doses of the Prevnar vaccine and experienced ear infections. The patient required implantation of ear tubes. The patients brother also experienced ear infections and required implantation of ear tubes (See case HQWYE499103MAY05 adverse event non expedited). No additional information was available at the time of this report.
Rash within four days at site of injection.  It was the size of a half dollar.  The rash was red and raised with a very hard lump underneath the skin.  It was warm to the touch and very sensitive.  It lasted 10 days.
Patient call OCHM about 2-3hrs after receiving immunization. Complained of heart racing and tightening of chest. Advised to go to ER. Patient called later stating ER stated it was a reaction, no treatment ordered. Patient requesting OCHD to pay for ER visit. SPHN explained patient is counseled about possible s/e, Her signature accepts this as a possibility.
Hair loss, "shedding pretty bad", right side is thinner then left side of head hair; Refused to get 2nd dose due to continuous shedding; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss, "shedding pretty bad", right side is thinner then left side of head hair) and INTENTIONAL DOSE OMISSION (Refused to get 2nd dose due to continuous shedding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair loss, "shedding pretty bad", right side is thinner then left side of head hair) and INTENTIONAL DOSE OMISSION (Refused to get 2nd dose due to continuous shedding). At the time of the report, ALOPECIA (Hair loss, "shedding pretty bad", right side is thinner then left side of head hair) outcome was unknown and INTENTIONAL DOSE OMISSION (Refused to get 2nd dose due to continuous shedding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided  No treatment medication information was provided
Severe nausea and headache, dizziness, continually rising fever (currently 101.7 F by 7:00 pm the next day), exhaustion, swollen painful arm -  red spot has grown from about 1" to 2".   Treatment: ibuprofin at 8:30 am; acetaminophen at 7:00 pm; sleep; cool compress
Presented w/ n/v/d, sore throat, cough. Dx Covid+ X 1 wk prior in ED but left AMA. Tx w/ Zinc, IV, Remdesivir and steroids.
SORENESS IN ARM; LIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 10-APR-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 11-APR-2021, the subject experienced light headache. On 12-APR-2021, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in arm and light headache was not reported. This report was non-serious.
This spontaneous report Was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided.     On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II, for prophylaxis, that underwent a temperature excursion of 9 degrees Celsius during a time frame of 1 hour, (dose, route, dose number, lot number and expiration date were not provided). No adverse effects were reported, no product quality complaint (PQC) was involved. There was no previous temperature excursion and the call was not because a digital data logger. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1706USA005170: US-009507513-1706USA001148:
Pt recvd vax 5AUG92 & 7AUG92 devel diffuse erythema multiforme; No further details were provided;
Information has been received from an RN concerning a 44 year old white female who on 7/19/00 was vaccinated with Hep-B. On 7/19/00, the pt experienced sore left arm, 5" below injection site. The pt was instructed to use a warm compress and Tylenol. As of 7/31/00, the pt continued to have pain and soreness in the left arm below the injection site. On 5/12/01, the pt developed severe pain in left arm that included tingling in the digits of the left hand and numbness in the left hand. In follow-up, the RN reported that on 7/12/01, the pt was dx'd with "spurring". The physician felt that the spurring was not related to the vaccination with Hep-B. Upon internal review, spurring was considered to be an "Other Medical Event". No further information is expected.
Chest pain; felt really bad; Death; Vomited that night; Sore arm and pain in both arms; A spontaneous report  was received from a consumer concerning a 83-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and pain in both arm /pain in extremity, felt really bad/feeling abnormal, chest pain and the patient died.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Mar 2021, patient experienced sore arm and felt bad. The patient vomited that night. On an unknown date patient reported chest pain and pain in both arms. On 05 Mar 2021, at 12:46pm the patient died.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient died on 05 Mar 2021. The cause of death was reported as unknown. Plans for an autopsy were unknown.; Reporter's Comments: This is a case of death in an 83-year-old male subject with unknown medical history, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death
Pain, swelling, redness, tender to touch to the (L) upper dorsal arm at 9:15 am.
The pt experienced acute pain in the left arm in the area around the elbow. This is the same arm the vaccine was given.
PT REPORTED TO THE PHARMACY SHE HAD A RED, RAISED AREA SURROUNDING THE INJECTION SITE OF HER SECOND INJECTION.  SHE SAID SHE NOTICED IT THE SAME DAY AS HER VACCINATION.  SHE ALSO REPORTED ACHINESS THRU HER WHOLE BODY THE DAY FOLLWOING THE VACCINE. SHE CALLED THE PHARMACY 5 DAYS AFTER VACCINE TO REPORT THE RASH. SHE WAS INSTRUCTED TO DRAW A CIRCLE AROUND THE AREA TO WATCH FOR AN INCREASE IN SIZE. SHE WAS INSTRUCTED TO USE ICE AND IF ITCHY TO APPLY HYDROCORTISONE CREAM.  SHE COULD ALSO USE APAP OR IBUPROFEN FOR PAIN AND SWELLING.  I DID CALL PATIENT BACK THE NEXT DAY AND SHE SAID THE AREA APPEARED IMPROVED.
had fever the week before; she had a wound; passed away from Covid; passed away from Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP).  A 98-year-old female patient received BNT162b2 (COMIRNATY), as single dose (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "the nursing home had positive cases" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), COVID-19 (death) all with onset 06Jun2022, outcome "fatal" and all described as "passed away from Covid"; PYREXIA (non-serious), outcome "unknown", described as "had fever the week before"; WOUND (non-serious), outcome "unknown", described as "she had a wound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) positive. Therapeutic measures were taken as a result of wound included bleach solution. The patient date of death was 06Jun2022. Reported cause of death: "passed away from Covid". It was not reported if an autopsy was performed. Clinical course: patient was in nursing home, the nursing home had positive cases. Patient died that day, after she tested positive 06Jun2022. She had fever the week before, but they thought it was because she had a wound. They were cleaning her aunt's wound with bleach solution and it was painful.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: passed away from Covid; passed away from Covid
Received full dose of Moderna booster I/O half dose, no adv rx to pt
Throat swelling up, difficulty swallowing, cough and hoarseness, itchy lips. At 3 PM of same day I called pharmacy and took one Wal-Dryl gel on her recommendation.
Swelling, itching, redness, warm to touch; recommended acetaminophen, cool compress.
Vaccine vial was thawed on 11/10/21. Vaccine administered 4 days after the beyond use date.
Patient received 1st dose of Moderna vaccine on 22Jan2021, second on 01Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 22Jan2021, second on 01Apr2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 22Jan2021, second on 01Apr2021). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 22Jan2021, second on 01Apr2021) had resolved.            No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-435504, MOD-2021-026441 (Patient Link).
Information has been received from a case in litigation from a pediatrician concerning a 15-1/2 year old male patient who birth day was complicated by cesarean section and a lack of breathing for about one minute who at the birth day was vaccinated with the first dose of RECOMBIVAX HB. The patient was also vaccinated with the second and third doses at 2 and 7 months of age respectively. The pediatrician noted concerns with delayed speech and motor development and sensitivity to food textures, all of which were signs of autism. At the time of reporting the patient's outcome was unknown. The petitioner alleged that the hepatitis B vaccine had caused autism. Upon internal review autism was considered to be an other important medical event. Additional information has been requested.
Numbness in lips and tongue, tingling and numbness in right arm and 3rd and 4th fingers on both hands, raised blood pressure, broke out in hives all over body. Two weeks later and still no feeling in tips of fingers
Arm was achy and warm for 24 hrs; Arm was achy and warm for 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was achy and warm for 24 hrs) and FEELING HOT (Arm was achy and warm for 24 hrs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was achy and warm for 24 hrs) and FEELING HOT (Arm was achy and warm for 24 hrs). At the time of the report, PAIN IN EXTREMITY (Arm was achy and warm for 24 hrs) and FEELING HOT (Arm was achy and warm for 24 hrs) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-353625, MOD-2021-353625 (Patient Link).
sharp pain in her left shoulder; sharp pain in her back; first dose of shingrix in August of 2020; had itching / at the injection site; also had / warmth at the injection site; also had pain/at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In August 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site itching, injection site warmth and injection site pain. On an unknown date, the patient experienced shoulder pain, back pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site itching, injection site warmth and injection site pain were not recovered/not resolved and the outcome of the shoulder pain and back pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site itching, injection site warmth, injection site pain, shoulder pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not applicable for 2nd dose of Shingrix. In August 2020, The patient received 1st dose of Shingrix in left arm. The patient experienced sharp pain in left shoulder and back which resolved without intervention in few days. The patient also had itching, pain and warmth at the injection site which had not resolved since getting the injection. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient stated that, there was no rash present. No other information obtained. The reporter did not consent to follow up.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # L011084, expiration date 01-APR-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of 12 degree centigrade for 10 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Area warm to touch, red, sore. Larger than half-dollar size.  Also c/o nausea.
anaphylaxis; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event anaphylaxis and BNT162b2.,Linked Report(s) : US-PFIZER INC-202200681973 Same article/ drug/event and different patient:
About one hour after the vaccinations, patient had returned to school and had an episode where she became disoriented. Her friend said her eyes went off to the side, and this lasted about 2 minutes. Patient was then a little bit confused afterwards.
Headache described as worse then a regular headache, vertigo and temperature of 102.1, exhaustion started the night of the shot and headache, temperature, and vertigo started early AM following day.  Temp decrease to low grade Saturday Night, and headache and vertigo finally subsided that night exhaustion continued until Monday morning. Temperature and all other reactions had subsided.
Chest pains, heart fluttering, dizziness, unusual heart rhythm  First admission:  Diagnosed with Atrial fibrillation Second admission: Pericarditis and a pacemaker was administered