chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN60207), in left arm and on 09Apr2021 as dose 2, single (Lot number: EN60207) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 3, (booster), single (Lot number: Moderna/030H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Just nature" (unspecified if ongoing), notes: Known allergies: Just nature. Concomitant medication(s) included: ZYRTEC R. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive; (03Aug2022) Negative; (05Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had received other medication in 2 weeks. The patient had tested positive on 25Jul2022- took Paxlovid by 2pm for COVID 19 Treatment. Finished treatment on 29Jul2022. Tested negative on 03Aug2022. Symptoms resumed and tested positive on 05Aug2022.  Follow-up attempts are completed. No further information is expected.
Vaccine expired in refrigerator on 9/25/21, but vaccine was administered on 9/26/21 (vaccine is stable undiluted in the refrigerator on-label for a duration of 31 days, 9/25/21 would have been the 31st day). Vaccine had not been pulled from the refrigerator the day that it expired on 9/25/21, hence accidental continued use by another pharmacist on 9/26/21. Pfizer med info reported that, based on physical stability data, there is an extended excursion time of +1 day for a total stable undiluted refrigerated time of 32 days, but to still file reports due to off-label use.
Chills, fatigue, headache, muscle aches, nausea vaccination 2:50 pm- Symptoms began 3 am
Patient reporting itching, hives, and rash on same arm as injection. Hives resolved with benadryl and time, however, rash is still present.
Patient had vaccine on 03/15/2021.  Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU.  Patient further declined while admitted having multiple system failure and passed away on 03/25/2021.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US013357 (RA). A 56-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; eltrombopag olamine (PROMACTA), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: STEVENS-JOHNSON SYNDROME (medically significant), outcome "unknown", described as "Stephen-Johnson syndrome"; BURNS THIRD DEGREE (medically significant), BURNS SECOND DEGREE (non-serious), outcome "unknown" and all described as "having 2nd and 3rd degree burns"; SKIN INJURY (non-serious), outcome "unknown", described as "has lost septum due to the skin burns from SJS". The action taken for eltrombopag olamine was unknown. Clinical Course: Product: COVID-19 Vaccine. Relationship to patient: Self. Event: Reports to having Stephen-Johnson syndrome, which happened after getting the Pfizer COVID Booster while on Promacta, reports having 2nd and 3rd degree burns from SJS and has lost septum due to the skin burns from SJS. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
has needle phobia per report, received vaccine, moments later felt nausea and "seeing stars", assisted to floor to place feet on chair. assisted to stretcher and brought to obs, vss throughout episode and through transition to standing. 1045 in Trendelenburg bp 124/74 hr 69 rr 18 sats 100%, to standing bp 123/75 hr 65 rr 18 sats 97% on ra. water and crackers given, feeling back to baseline per patient report, escorted with father to appropriate location with no issues.
Client needed to complete primary series by 4/20 due to requirements. Unable to receive monovalent vaccine due to FDA no longer authorizing it as of 4/18/23. No current guidance to switch to administering bivalent vaccine issued yet, received verbal order from medical director to administer.
This spontaneous report as received from a physician assistant refers to a 72 years old female patient with no drug reactions or allergies and no pertinent medical history. In 2006, the patient was vaccinated with first dose of PNEUMOVAX 23 (dose, route and lot # not reported). On 09-NOV-2012, the patient was vaccinated intramuscular with second dose of PNEUMOVAX 23 (lot # H013399 exp: 07-MAR-2012) (dose not reported). No concomitant medications were reported. The physician assistant stated that, a patient who received PNEUMOVAX 23 on 09-NOV-2012, developed an injection site reaction and generally did not feel well. The patient did not seek medical attention. No treatment for the adverse event was given. Lab diagnostics studies were not provided. The outcome of generally did not feel well and injection site reaction was reported as not recovered/not resolved. The relatedness for generally did not feel well and injection site reaction was unknown for PNEUMOVAX 23. This is one of the several reports from the same source. Additional information has been requested.
8 days after injection and about two inches below injection developed large, 6 inches long, 3 inches wide red raised oval, itching and hot, last 4-5 days
RIGHT ARM PAIN; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced nausea, and right arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the right arm pain and nausea was not reported. This report was non-serious.
Patient complained of feeling hot and mild shortness of breath @14:03. Pulse ox 98% on RAD pulse 99-102bpm. Lungs clear to auscultate, he said his breathing got better but started feeling dizzy & swelling. Sent to ER
Lower lip paralysis. Went to doctor next day. Seems to be subsiding after 10 days. Concern for 100% cure.
Child started with fever around 4:45 pm on 2-18-08. Loose stools with mucous and pink tinged started approx at 7:00pm. Went to emergency room 9:15pm due to fever and loose stools. ER didn't check stool for blood. Sent home no treatment except Tylenol for fever. Seen in our 2-19-08 at 4:00pm. Stool hemocult negative for blood. Abdomen soft. Still having loose stools. No treatment needed other than Tylenol for fever. Instructed to return to office if blood noted in stool and have stool tested.
Patient was given the flucelvax shot. Described experiencing arm pain, neck pain, nausea, and general malaise.
I've had my first seizure 3 weeks later after recieving the vaccine. Went to the ER and was diagnosed with Epilepsy. And was placed on KEPPRA medication. Where as I had my second seizure May 22
Chills, aches, muscle pain, upset stomach, Diarrhea and cramps, tiredness, pain and redness at injection site, headache
Skin discharge, breakout on under arms, groin and upper thigh, upper thigh open and draining; Fatigue; Skin breakout, breakout on under arms, groin and upper thigh; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCHARGE (Skin discharge, breakout on under arms, groin and upper thigh, upper thigh open and draining), FATIGUE (Fatigue) and RASH (Skin breakout, breakout on under arms, groin and upper thigh) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 10-Sep-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISCHARGE (Skin discharge, breakout on under arms, groin and upper thigh, upper thigh open and draining), FATIGUE (Fatigue) and RASH (Skin breakout, breakout on under arms, groin and upper thigh). At the time of the report, SKIN DISCHARGE (Skin discharge, breakout on under arms, groin and upper thigh, upper thigh open and draining), FATIGUE (Fatigue) and RASH (Skin breakout, breakout on under arms, groin and upper thigh) outcome was unknown.            No concomitant medications were reported.  Reported that On unknown dates, the patient experienced flare up or Condition aggravated, fatigue and breakout on under arms, groin and upper thigh/ upper thigh was open and draining.  The reporter causality for flare up with humira (adalimumab) was a reasonable possibility and fatigue with humira (adalimumab) was no reasonable possibility, for skin breakout and skin discharge unknown onset was not provided.  No treatment medications were reported.
Pain in arm and slight swelling in arm started the evening the day dose given. The next by noon, had severe generalized aching and fatigue - had to leave work. The following day severe aching and fatigue continued but developed a fever and anorexia, arm had some swelling and hot to touch. Could not raise her arm above her shoulder. The third day same symptoms. The fourth day showed some improvement and the fifth day she was able to return to work. She remembered after the symptoms started that 10 years before, she had gotten a Td and her whole arm down to her fingertips had swollen, red, hot and painful. She said she called the clinic and reported it but did not see the doctor. She used Ibuprofen alternating with Acetaminophen for the aching and fever, Benadryl to try to decrease the reaction and ice pack to arm.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. During the time period of 03-FEB-2013 through 13-FEB-2013 the patients were vaccinated with a dose of PROQUAD. Dose, route and lot number were not provided. The nurse reported that the patients received improperly stored PROQUAD. No adverse event reported. Additional information has been requested.
pt stated her right leg has swelling and hardness in between knee and groin area (middle of leg). Pt stated it was itchy when it started to swell but has subsided.
ELEVATED BLOOD PRESSURE; CHEST PAIN; RASH ON HER FACE THAT WAS BURNING AND SWOLLEN; RASH ON HER FACE THAT WAS BURNING AND SWOLLEN; RASH ON FACE AND RASH ON ALL OVER LEGS AND KNEES; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination on Left Deltoid. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chest pain, elevated blood pressure, rash on her face that was burning and swollen, rash on face and rash on all over legs and knees and headache. She had went to the hospital twice but was not admitted both were the outpatient visits.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on her face that was burning and swollen, and rash on her face that was burning and swollen on 11-MAR-2021, and rash on face and rash on all over legs and knees on MAR-2021, and had not recovered from elevated blood pressure, chest pain, and headache. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210333394-COVID-19 vaccine Ad26.COV2.S-elevated blood pressure. This event is considered unassessable. The events have 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.
Muscle pain in ribs; Cramps; Pain at the injection site; A spontaneous report was received from consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain, muscle pain in the ribs and cramps.   The patient's medical history was not reported. No relevant concomitant medications were reported.   On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient began to experience pain at the injection site, muscle pain in the ribs and cramps. Patient reported experiencing a lot of pain.     Treatment for the event included a heating pad.     Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Reporter's Comments: This case concerns a 60-year-old female who experienced nonserious events of unexpected musculoskeletal chest pain and muscle spasms and expected vaccination site pain.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event ongoing. Based on 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.
vertigo onset 1 day after receiving vaccination. Symptoms ongoing but improving as of 3 days post vaccination.
Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.
Vomiting (6 times in 12 hours) Chills Headache Fatigue
Was admitted 9/28/2021 to 10/1/2021 received 3 doses of Remdesivir. Pt was readmitted 10/6/2021 where he progressively worsened, pt was in ICU. Pt then put into hospice care and passed away 10/12/2021 at 1949
Four months after the second injection I was awakened after midnight by a painful red rash from my neck to my feet  that burned and itched for about 2 hours.  I put a wet towel on my chest and neck, but it did not stop the pain and the redness.  I began rubbing my body from my neck down to my waist.  After about 20 minutes the pain and redness began to disappear very slowly.  I then began to rub my chest and legs for another 20 to 45 minutes and the pain and redness begin to be releaved.    Last night (7/23/2021) I awoke at 1:30 AM with a painful red rash on both legs that itched like mosquito bites. The rash was primarily on the inside of both legs and down to my feet.  I started using Cortizone 10 (it did not help), then I switched to Triamcincolone Acetonide Cream USP, 0.1% (that did not help) and then Halonate .005% (that did not help).  It took almost an hour of rubbing my legs before the itching and burning subsided.
hip began to hurt; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hip began to hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M2OA) for COVID-19 vaccination.     Concurrent medical conditions included Pain in hip. Concomitant products included MELOXICAM for Pain in hip.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (hip began to hurt). At the time of the report, ARTHRALGIA (hip began to hurt) outcome was unknown.            Treatment medication was not reported
PATIENT BROUGHT TO CLINIC FOR BOOSTER BY CARETAKER, NOT REALIZING PATIENT HAD ALREADY RECEIVED BOOSTER ON 11/08/21. PFIZER CALLED AND SAID TO MONITOR INJECTION SITE AND PATIENT FOR SIGNS/ SYMPTOMS SIMILAR TO PREVIOUS DOSES. AS OF THIS REPORT PATIENTS INJECTION SITE IS NORMAL AND NO REPORTED ADVERSE EFFECTS OR SYMPTOMS YET
potential administration of improperly stored VARlVAX, MMR II, and PROQUAD; potential administration of improperly stored VARlVAX, MMR II, and PROQUAD; No additional adverse events reported; This spontaneous report was received from a nurse referring to some patients of unknown age and gender. The patients' pertinent medical history, concomitant drugs and drug allergies were not reported.  The reporter reported potential administration of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot #: T010312, expiration date: 24-MAR-2022; lot #: T024284, expiration date: 15-JUL-2022; lot #: T012550, expiration date: 10-APR-2022; lot #: S025913, expiration date was reported as 28-AUG-2021 (upon internal validation established as 20-AUG-2021), dose, strength, and route were not reported), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live, albumin status recombinant Human albumin (rHA) (M-M-R II) (lot #: S039316, expiration date: 04-DEC-2021; lot #: S037497, expiration date: 20-NOV-2021; lot #: S037501, expiration date: 20-NOV-2021, dose, strength, and route were not reported), Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, albumin status recombinant Human albumin (rHA) (PROQUAD) (lot #: T013540, expiration date: 17-OCT-2021, dose, strength, and route were not reported) for prophylaxis.  Temperature excursions of these vaccines were -10.9 degrees Celsius (C) for 25 minutes, -13.6C for 23 minutes, -14.7C for 7 minutes, -12C for 20 minutes, -13.9C for 14 minutes, -12.4C for 24 minutes, -14.2C for 11 minutes, -14.6C for 11 minutes, -11.2C for  29 minutes,-14.2C for 10 minutes, -14.7C for 7 minutes, and 3.8C for 1 hour and 11 minutes without any previous temperature excursion. The digital data logger was not involved.  This case was non-valid due to no specific patient identifier.
This spontaneous report was received from a registered nurse and refers to a 1 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 29-AUG-2016, while attempting to administer VARIVAX (lot # M000761 and expiration date 06-JAN-2018, dose and route of administration were not reported) to the patient, they received an invalid dose because they kicked, the needle came out of their leg and some of the vaccine leaked out. It was also reported that when the patient kicked and the needle came out, they received a scratch on the leg from the needle. The patient received treatment (unspecified) for the event. The outcome of the event was not reported. The relatedness between the event and VARIVAX was not reported. Additional information has been requested.
patient cannot stop vomiting after receiving the second dose on Friday; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (patient cannot stop vomiting after receiving the second dose on Friday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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. On an unknown date, the patient experienced VOMITING (patient cannot stop vomiting after receiving the second dose on Friday). At the time of the report, VOMITING (patient cannot stop vomiting after receiving the second dose on Friday) outcome was unknown.            No concomitant medication was reported No treatment medication was reported
hives on left arm at injection site; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th June 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On 5th July 2019, the patient experienced injection site hives. On 30th June 2019, the outcome of the injection site pain was recovered/resolved. On 8th July 2019, the outcome of the injection site hives was recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving vaccine had immediate injection site pain that lasted for 1 to 2 days. The patient one week after receiving vaccine noticed hives on her left arm at the injection site that lasted for 2 to 3 days. The patient consented to follow up.