chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible cough; Little bit of headache; Fever; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patients husband) via the Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 01Apr2021 (Lot Number: ER8732) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that the patient tested positive for covid on 06Apr2021. On an unspecified date the patient experienced terrible cough, fever, little bit of headache. The husband clarified that his wife was tested positive for COVID on 6Apr2021 and he had symptoms and tested positive on 9Apr2021. So, both of them out of 10 days so fever is gone "and everything" (not clear nor clarified) but they still have like a cough and little bit of headache.  The patients husband reported that their second dose was scheduled for tomorrow but they both have terrible cough and they wanted to know if they should go take the second vaccine tomorrow, or should reschedule it for I don't know when after one month or whatever. The patient had lab tests which included sars-cov-2 test: positive on 06Apr2021.  The clinical outcome of fever was recovered. The clinical outcome of terrible cough and little bit of headache was not revered. The clinical outcome of tested positive for COVID was unknown.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 17-OCT-2018 or 22-OCT-2018 the patient was vaccinated with improperly stored VARIVAX (lot # N029628 and expiration date 23-NOV-2019, route, strength, dose and frequency were not reported) for prophylaxis. Medical assistant also reported the MERCK STERILE DILUENT (lot # M041989 and expiration date 03-JUL-2019) used to reconstitute VARIVAX did not undergo a temperature excursion. No adverse effects were reported. The temperature excursion was 6 Fahrenheit to 14 Fahrenheit (also reported as 12 Fahrenheit) for 1 hour and 59 minutes. The previous excursion was 6 Fahrenheit to 14 Fahrenheit for 47 hours and 57 minutes and 15 Fahrenheit to 46 Fahrenheit for 39 hours and 57 minutes. The call was because of a data logger. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1810USA010189: US-009507513-1810USA012249.
Developed hives, nasally congested, within 1 hour of immunization. No wheezing.
No additional AE; patient was scheduled to receive MMR II and received a dose of VARIVAX instead; This spontaneous report was received from a medical assistant and referred to a 16-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 23-SEP-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On 27-DEC-2022 (when the patient was 16 months old), the patient was scheduled to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) instead (indication: prophylaxis; strength, dose, lot #, expiry date, and route of administration were not provided) (wrong product administered). The reporter stated the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) was administered too early. No additional adverse events (AEs).
Hot, itchy sore red rash over injection site; Raised hot spot over injection site: 4"X4'; Mild tendon pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TENDON PAIN (Mild tendon pain), INJECTION SITE WARMTH (Hot, itchy sore red rash over injection site), ARTHRALGIA (Joint pain) and INJECTION SITE SWELLING (Raised hot spot over injection site: 4"X4') in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Tendonitis and Arthritis. Concomitant products included APIXABAN (ELIQUIS), CARVEDILOL and HYDROCODONE;PARACETAMOL for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced TENDON PAIN (Mild tendon pain) and ARTHRALGIA (Joint pain). On 05-Mar-2021, the patient experienced INJECTION SITE WARMTH (Hot, itchy sore red rash over injection site) and INJECTION SITE SWELLING (Raised hot spot over injection site: 4"X4'). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Adverse event NOS, at a dose of 500 mg and TRIAMCINOLONE (topical) for Itch and Ache, at a dose of UNK, tid. On 04-Mar-2021, TENDON PAIN (Mild tendon pain) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, INJECTION SITE WARMTH (Hot, itchy sore red rash over injection site) and INJECTION SITE SWELLING (Raised hot spot over injection site: 4"X4') outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Additional information received on 08-Mar-2021 added new event and outcome On 07-Jul-2021: Follow up contains information about second dose events, new case created and action taken for dose 1 updated to no change
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit ; 32 to 35 degrees Fahrenheit for 64 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA010513: US-009507513-1703USA012528: US-009507513-1703USA012526.
I21.4 ACUTE NON ST ELEVATION MI 11/18/2021 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 12/22/2021 ATHEROSCLEROSIS OF AORTA I21.4 ACUTE NON ST ELEVATION MI 11/18/2021 ASTHMA, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 12/22/2021 ASTHMA, UNSPECIFIED
Bell?s palsy,  onset 21 days after vaccination, symptoms still ongoing since, on day 2 of prednisone and valtrex, started treatment about 24 hours after symptom onset, pending Lymes test
Received Pneumovax 10/7/2005 at 10PM same night woke up with severe pain in injection arm (rt) arm was red/warm went to ER for tx.
This spontaneous report as received from an unknown age, male physician, who is also the consumer, reporting on himself with a history of shingles that goes back 20 years (unspecified date) and no known allergies. In January of 2006 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route unspecified) for vaccination, no other suspect therapies or concomitant medications were reported. The patient reported that approximately in July 2007 (reported as "about a year and a half later" he developed a case of shingles that continues to present with short periods of remission. The patient reported that during a period of remission in early 2011, he received another dose of ZOSTAVAX, but the shingles outbreaks were now worse (lasted longer and did not respond to treatments). The patient reported that he had been taking Acyclovir ointment (manufacturer unspecified) and Acyclovir orally (manufacturer unspecified) as treatment for the shingles outbreaks. The patient reported that his current outbreak had lasted for about 3 months without remission. The outcome for the shingles outbreak has been reported as not recovered. The reporting physician did not assess the relatedness between ZOSTAVAX and the shingles outbreak. Additional information has been requested.
Delayed Cutaneous Hypersensitivity Reaction Narrative: Rash onset 1 day post vaccination; duration 7 days.
This spontaneous report was received from a physician who heard from an unspecified source via company representative referring to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL injection (dose, route and frequency unspecified). Concomitant therapy was not reported. On an unknown date the representative reported that a patient who received an unspecified number of doses of GARDASIL 9 and then the patient no longer got her period. No further information provided. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
The school called the mother to report that the child was having difficulty breathing, with dizziness. When she arrived, the pt was gasping. She took her to the ER and she developed hives while there. Dx was adverse reaction to Hep-B. She had complained in the night of her arm hurting and had not experienced that with previous immunizations. However, she does have some congestion in her chest now but is probably unrelated.
Pain when raising arm above shoulder. Pain lasted from Sept 20 to Nov 1, 2016. It started to improve after that. Put ice on shot site after shot and next few days. No improvement. Did less lifting. no improvement.
Information has been received from a physician concerning a patient who on 20-JAN-2009 was vaccinated with third dose of GARDASIL (Lot # not reported) Intramuscularly.  The patient received less than half her third dose because the patient jerked her arm away during administration of the vaccine.  No adverse effect was reported.
Within 12-24 hours, swelling, redness, itching approximately 2 inches around administration site.
Narrative: 7/30- COVID positive, reports cough 8/3- reports chills and fever
Vaccine admin at pharmacy appx. 10:40 AM on 12/10/14. Pt went home at appx 10:50 AM, and reports that at appx 1 PM she felt her throat "thickening" and difficulty breathing/swallowing. She went to ER, at approx. 5 PM that evening she came back to the pharmacy and told us what happened, she was treated and feeling better.
dehydration; vomiting; diarrhea; This spontaneous report has been received from a physician via Company representative, concerning a 6-year-old male patient. His concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient received the "complete series" of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered orally as prophylaxis (dosage regimen, lot number and expiration date were not provided).   On 30-APR-2023, the patient presented to the ER for dehydration, vomiting and diarrhea. On 01-MAY-2023, the patient was admitted to the hospital. Outcome of the events was not provided.   Causal relationship between Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and the events was not reported.   This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2305USA000844:
a patient received MMRII and VARIVAX after they had been stored outside of the recommended storage range; This spontaneous report as received from  a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drug reaction or allergy, and concomitant medication were not reported.  On 23-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dose (strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number was reported as s020961,  but upon internal validation established as S020961, expiration date reported and validated as 07-JUL-2021) and varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose (strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number reported as t010310,  but upon internal validation established as T010310, expiration date reported and validated as 24-MAR-2022) for prophylaxis (Improper storage of product in use). The vaccine was exposed to the following temperature excursions: 19.32 degrees for 7 hours and 45 minutes. There was no previous temperature excursion. Data logger was not involved.
day of vax pt exp flu like sx. persistent vomiting, fever 101f, very sleepy. 22 hrs. later still sleepy w/fever.
Teen fainted, recovered, then fainted again in office after receiving her 3rd GARDASIL (HPV). Teen ate breakfast before office visit.
Flu vaccine given in left deltoid. One day later injection site and surrounding area red and swollen. Painful to touch.
p/vax pt could not walk w/o assistance; weak, did not have strength to go to school; slow movement; lost sense of direction; disoriented;
fever; fatigue; vomiting; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), FATIGUE (fatigue), VOMITING (vomiting), CHILLS (chills) and PAIN (body ache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2OA) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), FATIGUE (fatigue), VOMITING (vomiting), CHILLS (chills) and PAIN (body ache). At the time of the report, PYREXIA (fever), FATIGUE (fatigue), VOMITING (vomiting), CHILLS (chills) and PAIN (body ache) outcome was unknown.
pt had 1st moderna vaccine on 8/14/21 L arm and reported to rx on 8/24/21 that the day after the shot she developed rash, welps, had chest pain, headache, dizziness and swollen lymph nodes. pt instructed to follow up with dr.
Headache, fever, joint pain, muscle pain, from 7 PM through 7 AM, now feeling tired, achy and light headed.
Fever, chills, night sweating, body aches, arm pain, swollen lymph node
Received an email from the patient on Monday 8/30 stating: Friday and my right arm was so sore that I took 2 pain pills before going to bed. When I got up at 1:30 for a bathroom trip, I just got a sip of water and was going to get my husband to get me a sip of 7 up since my stomach was upset. The next thing I knew, my husband was trying to get me to come to after fainting. I landed with my head in the shower and the door off the track. I have lots of bruises and a big know on my head and still not feeling well. Was running a little temp yesterday and going to try and get into the doc today since I?m still not feeling well".  In follow up w/patient, "pain med" was 50mg of Tramadol.
Lungs filling up with fluid; Cannot move; Uncontrolled diarrhea and uncontrolled bowel movements; Vomiting; A spontaneous report was received from a consumer concerning a 61-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lungs filling up with fluid/pulmonary edema, uncontrolled diarrhea/diarrhea, vomiting, cannot move/mobility decreased, uncontrolled bowel movements/bowel movement irregularity.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 16 Mar 2021, prior to the onset of the events, the patient received their doses of mRNA-1273 (Batch number:unknown) for prophylaxis of COVID-19 infection.  On 16 Mar 2021, within 12 hours of vaccination, the patient experienced lungs filling up with fluid, uncontrolled diarrhea, vomiting, cannot move and uncontrolled bowel movements.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of events, lungs filling up with fluid, uncontrolled diarrhea, vomiting, cannot move and uncontrolled bowel movements, were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a reported normal healthy 12 month old female pt with no known drug allergies, no immunosupression and no recent exposure to varicella or other viruses and reported significant medical history for the fact that the pt's mother reported the pt first walked at age 10 months however between age 10-12 months had a noted "change and widening" of her gait who on 3/20/03 was vaccinated with a dose of varicella virus vaccine live (641162/0797M). Concomitant therapy given during the same visit on 3/20/03 included MMR and HIB conjugated vaccine (manuf unk). It was noted on either 3/26/03 or 3/27/03 the pt developed a fever of 101.7, vomiting, and cereebellar ataxia. It was noted as of 4/1/03 the pt could not walk or crawl and was experiencing "truncal symptoms." It was noted there was no rash. It was noted the pt was not hospitalized and the physician reported that "at least for now" the pt could be handled as an outpatient. It was noted a complete blood count was ordered and on 4/1/03 the pt was scheduled to have a MRI of the brain to rule out presence of a tumor. It was noted the physician indicated that as of 4/1/03 a lumbar puncture had not been done, and "as of right now it is not in the plan." The physician did indicate that depending on what the MRI revealed and how the pt's condition was that a lumbar puncture may be done. It was noted, no prescription drug was required. Upon internal review cerebellar ataxia was determined to be an other important medical event (OMIC). Additional info has been requested.
arm is hot; arm is swollen; arm is hard; red patch / red patch is traveling down to the elbow/patch from side of arm all the way around; rash a little bit below injection site; scratching/itching area is larger; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (scratching/itching area is larger), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE ERYTHEMA (red patch / red patch is traveling down to the elbow/patch from side of arm all the way around), VACCINATION SITE RASH (rash a little bit below injection site) and VACCINATION SITE SWELLING (arm is swollen) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163(0orG)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), LAMOTRIGINE (LAMICTAL) and BUSPIRONE for an unknown indication.    On 24-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Sep-2022, the patient experienced VACCINATION SITE PRURITUS (scratching/itching area is larger), VACCINATION SITE ERYTHEMA (red patch / red patch is traveling down to the elbow/patch from side of arm all the way around) and VACCINATION SITE RASH (rash a little bit below injection site). On 26-Sep-2022, the patient experienced VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE INDURATION (arm is hard). The patient was treated with HYDROCORTISONE on 25-Sep-2022 for Scratch, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (scratching/itching area is larger), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE RASH (rash a little bit below injection site), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE INDURATION (arm is hard) outcome was unknown and VACCINATION SITE ERYTHEMA (red patch / red patch is traveling down to the elbow/patch from side of arm all the way around) had not resolved.            It was reported that patient was advised to take Benadryl by the pharmacist.  The patient took first dose on March-2021, second dose on 12-April-2021, first booster on Oct-2021 and second booster on 25-Apr-2022.
she received her first dose of the vaccine on 16Mar2021 but never received her second dose due to contracting COVID-19; she received her first dose of the vaccine on 16Mar2021 but never received her second dose due to contracting COVID-19; This is a spontaneous report from a contactable consumer. This 54-years-old female consumer (patient) reported for herself that she received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on 16Mar2021 as DOSE 1, SINGLE for covid-19 immunization(at the age of 54-Years). Medical history included she was diagnosed with a rare form of Lupus which affects the skin in Dec2020. She stated that she had been good since the diagnosis, allergic reaction to the shingles vaccine. The patient's concomitant medications were not reported. She stated that she received her first dose of the vaccine on 16Mar2021 but never received her second dose due to contracting COVID-19. She stated that during March (Spring Break) she contracted COVID. She wore masks and was very angry that she got COVID because she was so safe. She had recently seen a Rheumatologist for her Lupus. When she was diagnosed with COVID, the doctor at the urgent care told her that she needed to wait 90 days to get her next vaccine and she needed to start the series over. She told this to her rheumatologist and her rheumatologist stated that she did not think that the vaccine series needed to be repeated and that she should call Pfizer to get clarification. She had to wait thirty minutes after getting the first dose because she had an allergic reaction to the shingles vaccine in the past but she had no symptoms from the first COVID-19 vaccine not even a sore arm. Her 90 days would be over on 15Jul2021 and she would be getting the vaccine then and wanted to know if she should repeat the series or just get the second vaccine. Caller stated that since she didn't have any issues from the first shot that getting the series over again probably wont hurt her. The outcome of events was unknown.  Information on the lot/batch number has been requested.