chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per vaccine administrator, pt has an local reaction on lt arm, redness, tenderness, and swelling at site.
Second dose greater than 6 months; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2020 on an unknown date).   On 23rd September 2021, the patient received the 2nd dose of Shingrix. On 23rd September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received 2nd dose of Shingrix greater than 6 months after 1st dose, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Given the second dose of the vaccine a week early; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the second dose of the vaccine a week early) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the second dose of the vaccine a week early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the second dose of the vaccine a week early) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up document received on 28/5/2021 does not contain any new information
Caller reported temperature excursion / Caller reported multiple administrations of both products / Temperature -13.3 C; This spontaneous report was received from a registered nurse and refers to a 2-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 07-DEC-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T017688, expiration date 21-MAY-2022, 0.5 milliliter for prophylaxis (anatomical location and route of administration were not reported).  Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.3 degrees of Celsius for 4 hours and 15 minutes. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013093: US-009507513-2012USA013532: US-009507513-2012USA013501: US-009507513-2012USA013524: US-009507513-2012USA013533: US-009507513-2012USA013539: US-009507513-2012USA013584: US-009507513-2012USA013585: US-009507513-2012USA013592: US-009507513-2012USA013594: US-009507513-2012USA013596: US-009507513-2012USA013598: US-009507513-2012USA013603: US-009507513-2012USA013601: US-009507513-2012USA013501: US-009507513-2012USA013095:
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included Omeprazole, FOLIC ACID, IRON (PRENATAL [FOLIC ACID;IRON]), Insulin, METFORMIN, MONTELUKAST SODIUM (SINGULAIR), ACETYLSALICYLIC ACID (BABY ASPIRIN) and FERROUS SULFATE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 14-Oct-2020 and the estimated date of delivery was date. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.
SkinRash, Rash & ErythemaMultiform Narrative: saw NP at Facility for steroidal cream.
Chief Complaint  via EMS patient reports increased weakness today after outpatient MAB infusion at LMH, unable to stand on own.  COVID+ on Saturday.  38.8 in triage, hx of HTN.  + generalized aching, chills.  History of Present Illness  88yo woman with h/o HTN, paroxysmal afib, 2015 TIA, OSA, prior DVT, obesity, who had COVID vaccination with Moderna earlier this year.  Was in usual state of health until trip to another state, last week.  Then 3 days ago tested positive for COVID after feeling like she had a head cold.  Received antibody infusion yesterday, and weakness became so profound that she went to her knees.  Some DOE and cough that is minimally productive as well with no bloody component.  Did not really feel the fever she had on arrival.  No GI symptoms.  No syncope, rashes, other pain.  Was surprised that she was hypoxic on ED arrival.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 30Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Still's disease" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 28Jun2022, stop date: 06Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive, notes: Antigen test pos on 28Jun (lHealth brand); (04Jul2022) Negative, notes: Neg antigen test on 04Jul (Abbottt brand); (06Jul2022) Positive, notes: Symptoms returned on 06Jul, Tested pos again (Abbott antigen kit). Therapeutic measures were taken as a result of vaccination failure, covid-19.; included Paxlovid from 28Jun2022 to 03Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Vaccination failure.
Received vaccine 12/01/09 4pm. Woke up 12/2/09 approximately 0700 am with sore throat. 12/2/09 afternoon approximately 1500 had chills, headache, nausea/vomiting and fever till 12/3/09 Thursday. Took TYLENOL every 4 hours. Today 12/4/09 with slight headache.
Shot #3 tolerated better (no nausea, fever or swelling) but was sore.
The evening of the 2nd dose, I had a fever of 100.4, the next day both my sciatic nerves felt like they were on fire. I couldn't even type an email, my hands and fingers hurt so bad. Strong fatigue, nauseous, headaches. On the Feb of 17th, my lymph nodes got swollen and they are still swollen.  My head was light headed.   Lymph nodes were so swollen in my arm pits that I had to lift my arms above my head to breathe. Experienced high blood pressure
patient was given the shot after about 5 minutes she had flushing arms and legs were tingling short of breath has pain in hips she called ambulance by time they got here she was feeling better and refused transport to emergency room
Large local reaction to right arm reported to extend from upper arm to proximal forearm, with redness, warmth and induration, improved on evaluation today in clinic. No systemic symptoms.
Received Tdap on 2/8/12, (R) upper arm swelled, reddened and very itchy. Same reaction several years ago following dT. No fever; sxs occurred on 2/9/12 and pt placed on MEDROL pack on that day.
This is a spontaneous report from a contactable other hcp. A patient of unspecified age, race and gender received PREVNAR 13, via an unspecified route of administration at single dose on 16Nov2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced "redness, warm to touch, swollen and tenderness" at the injection site on an unspecified date with outcome of unknown.
Patient developed chest pain with rising troponin. Required 3 days of hospitalization. No cardiac dysfunction by echocardiogram
Severely itchy papular/eczematous skin eruption. Tx with Systemic steroids and antihistamines.
pt recvd vax 9OCT92 & started to cough, vomited 1 time, eyes turned red & tearing; cont to cough, return to clinic exam area on re-exam was wheezing, nasal flaring retracting;
swelling of opposite hand (left) and swelling of upper lip about 15 minutes after the vaccine
a patient received Imovax which was administered subcutaneously rather than intramuscular; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves a female patient (age at the time of vaccination) who received a dose of RABIES (HDC) VACCINE [IMOVAX RABIES] lot N1K30, expiration date: 28-Oct-2019 via subcutaneous route in the right arm on 09-Apr-2019.  The patient had monkey bite.  The patient's other past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  It was an actual medication error due to inappropriate route of vaccination. A patient received Imovax which was administered subcutaneously rather than intramuscular.  It was unknown whether patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.  List of documents held by sender: none.
Immediately upon administration of vaccine, patient had quarter size lump at the injection site. Patient was observed for 15 minutes with no other symptoms.
Patient developed chronic right facial neuropathy from Bell's Palsy and Ramsay Hunt Syndrome on 3/20/07. 10/22/07-records received for DOS 4/2-10/8/07-seen for right sided facial pain, ear pain, neck spasm, throat irritation and facial droop. Symptoms began on 3/20/07-. Pain lancinating shocks over right side of face and scalp tenderness along with few vesicles around right ear preauricularly. Bells's Palsy. Visit on 4/3/07-tongue aphthous like ulcer and continues with facial pain. 4/5/07-Geniculate herpes with cluster of lesions in front of right ear. Difficulty keeping eyes shut. Systemic drug reaction due to carbamazepine. Herpes Zoster and facial nerve palsy. Symptoms continue 4/25/07-trigeminal neuralgia. 10/8/07-visit lid lag status post Bell's palsy with weight and postherpetic neuralgia. Confusion secondary to polypharmacy now improving. Refused influenza vaccine. 1/11/2010 Still has facial weakness and pain.  02/02/2010 Residual eye lid droop, facial droop and pain.
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 19-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 10-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
About 12 hours after 2nd dose of Modern Covid 10 vaccination, severe chills and fever of 101.5* lasting over 24 hours. Injection site is very red, very swollen, hard, and itches even 2 days later. Notable muscle aches throughout body and extreme fatigue. Headaches even 2 days later.
Woke up every night with bloody left nostril; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Woke up every night with bloody left nostril) and PAIN IN EXTREMITY (Arm soreness) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN from 22-May-2020 to an unknown date for Hypercholesterolemia, METOPROLOL for Hypertension, DOXEPIN HCL from 16-Mar-2021 to an unknown date for Sleep disorder, LEVOTHYROXINE from 31-Mar-2021 to an unknown date for Thyroid function decreased, MULTIVITAMIN [VITAMINS NOS], OMEGA-3 NOS, CALCIUM, ACETYLSALICYLIC ACID (ASPIRIN 81) and SERTRALINE HCL from 31-Mar-2021 to an unknown date for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced EPISTAXIS (Woke up every night with bloody left nostril) and PAIN IN EXTREMITY (Arm soreness). In January 2021, EPISTAXIS (Woke up every night with bloody left nostril) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for event epistaxis was humidifier.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information was received and processed with initial report. Patient demographics and concomitant product used were updated. Second dose information was provided. Event outcome for epistaxis was updated.
Post vaccination patient had syncopal episode shortly after receiving vaccine. Mom supported the patient to the floor and several seconds later he is responsive. Feet was raised and checked vitals  At 12:25pm vitals, Pulse 88 BP 99/67 RESP 16. 12;45pm vitals Pulse 88 BP 98/74 RESP 17. Kept patient for a hour monitoring regularly.Gave patient juice and cookies. Patient is stable after one hour and ten minutes  and is released from facility with mom
Pt states he fell asleep around 10 in the evening with chills, he slept for 36 hours with vivid dreams and hallucinations, He recalls waking up a few times to use the bathroom and thought he slept for 8 hours. Upon awaking he realized the amount of time that had passed. His right arm swelled up and was hot and hurt for several days following the vaccine.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient received an improperly stored dose of VARIVAX from lot # N022977 with expiration date 23-AUG-2019 or Lot # N023958 with expiration date 01-SEP-2019, for prophylaxis, (strength, dose, frequency and route of administration were unknown); which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The storage temperature was reported as 6 to 14 degrees Fahrenheit (F) for a time frame of 180 minutes. There was a previous temperature excursion of 6 to 14 degrees Fahrenheit (F) for 222 minutes. Digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004551: US-009507513-1802USA004552: US-009507513-1801USA005336:
This spontaneous case reported by a consumer, describes the occurrence of muscle swelling (swelling in the muscle area) and product/dose omission issue (wanted to know if he should restart or get second dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031A21A) for COVID-19 immunization. No medical history reported. On May 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced muscle swelling (swelling in the muscle area) and product/dose omission issue (wanted to know if he should restart or get second dose). At the time of the report, muscle swelling (swelling in the muscle area) and product/dose omission issue (wanted to know if he should restart or get second dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
T-979, RR18 BP 168/99 HR 100 pruritis, urticaric itching, sob, hives two hours after receiving flu vax. Has had multiple anaphax reactions to various meds. pr pas med hx.
Patient collapsed after vaccination, hitting her head.  She remained unconscious while vomiting.  We administered epi-pen 0.3mg once and contacted 911.  Patient was transported to nearest hospital.
DIED; CATASTROPHIC INJURY; This spontaneous report received from a consumer via a company representative concerned multiple (48 patients) of unspecified race and ethnic origin. No past medical history or concurrent conditions were reported.  The patients received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  It was reported by the reporter that, "I personally know of 48 people who have either died from the experimental drug or who have suffered catastrophic injury from the experimental drug". On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patients died of death on an unspecified date, and the outcome of catastrophic injury was not reported.  This report was serious (Death).  This case, from the same reporter is linked to 20211260743, 20211261168 and 20211261664.; Sender's Comments: V0:20211260953-COVID-19 VACCINE AD26.COV2.S-Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Vaccinated patient at 11:38am after going to the observation area she started to feel weakness in her body, lost of vision and chills. She verbalizes I'm going to pass out. We proceed to identify the vagal vessel and proceed with treatment. Vitals were taken and she was transferred to an ambulance for recovery. After half and hour she made full recovery and left at her own risk. She verbalizes talking to her doctor who said to go home.
Severe weakness in upper left arm. Cannot lift arm above head. Weak, limited use pain is also in armpit and pec. Completely NOT normal for me...I understand a swollen injection site but this is not the case.
Muscular pain similar to hard work out. Walking stride greatly reduced. Aug 22, 2022 admitted to ER with Rhabdomyolysis. Later diagnosed with Polymyalgia Rheumatica.
Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Pt developed hives. NO: labored breathing/wheezing/worsening cough/vomiting/diarrhea/fever.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent  conditions and concomitant therapies were not provided. On multiple dates between 20-APR-2016 and 20-MAY-2016, the patients were vaccinated with incorrect stored doses of GARDASIL 9 (strength, dose, lot# and expiration date were not provided) for prophylaxis. On an unspecified date in 2016, the doses of GARDASIL 9 underwent a temperature excursion from 47 Fahrenheit degrees to 77 Fahrenheit degrees along 32 minutes. The call was placed because of a Digital Data Logger. The GARDASIL 9 had not experienced previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008180: US-009507513-1709USA008179: US-009507513-1709USA008178:
12/24 Vaccination Thursday after, 12/30th, I woke up. Felt arm was itchy. Large, oval shaped, size of a baseball red mark. Slightly raised, warm, very itchy. The redness spread when itching, spread with welts on upper torso. Lasted for 4days. I tried anticortisone cream but didn't help.
pt recv vax & failed to seroconvert;it was noted in f/u that wrong lab test was performed;pt was inadvertently tested for HBsAg initially;f/u testing was performed which indicated the pt had seroconverted & therefore WAES94120294 is deleted