chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 101°C; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101°C) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (Fever of 101°C). At the time of the report, PYREXIA (Fever of 101°C) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, SARS-CoV-2 antibody test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.
Vesicular lesions over entire trunk, body, all, anal area 7 days post vaccine. No treatment given.
Approximately 24 hours after receiving the first dose of the COVID vaccine, patient fell ill with extreme tiredness, profuse vomiting and loss of consciousness.  Patient never regained consciousness, pronounced brain dead after AVM rupture and died on 3/8/21.
Developed Covid-19 symptoms on 3/31/2021.  Tested positive on 4/2/2021.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 22Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma but currently not taking any treatments" (unspecified if ongoing); "Prescription antacids" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound Covid symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received COVID 19 treatment (Paxlovid from 03Jul2022 to 07Jul2022, Lot number=Unknown). No other medication in 2weeks. Adverse event: Rebound Covid symptoms and positive test (start date: 11Jul2022 at 04:00 PM), If patient recovered: Recovering, If treatment ae: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report received from contactable pharmacist, consumer or other non-HCP. A 56-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD7218, expiration date: Feb 28, 2022), at the age of 56, in left arm, on Jan 19, 2022, single dose, for COVID-19 immunisation. Medical history included migraines (unspecified if ongoing), notes: patient usually suffers from migraines before the vaccine. Concomitant medications not reported. The  patient had gait disturbance (needed a cane to walk for more than 2 weeks), arthralgia (arthritis pain, worse after the vaccine/knee pain), onset 2022, outcome of unknown; headache (bad headache; couldn't fall asleep until 4 am) and insomnia, onset Feb 5, 2022, with outcome of recovered (Feb 5, 2022). No follow-up attempts possible. No further information expected.
Got COVID-19 Disease a few days after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19 Disease a few days after vaccination) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (Got COVID-19 Disease a few days after vaccination). At the time of the report, COVID-19 (Got COVID-19 Disease a few days after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient Received Monoclonal Antibody infusion.  No concomitant medication was provided by reporter.
Pt given INFLUENZA vaccine. Called EHS c/o upper arm tenderness, erythema, edema, warmth and pruritus. C/O dizziness 9/19/11.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient's wife. In 2018, the patient received Shingrix on the left arm. The patient's arm was sore. This case was linked to the case US2018158194, reported by the same reporter.
Day of vaccine - vaccine given at 3pm, and at 7 pm she started feeling lightheaded, dizzy, nauseous, headache, body ache. Came on gradually throughout evening. 5 days later still having symptoms - mainly dizziness, nausea and headache.
Patient received the COVID Pfizer (lot #ER8732, exp 7/2021) dose 1 and reported to EMT that he felt nauseous 10 min after vaccination. At 955 EMT alerted PHN who responded. Vital signs at 955: blood pressure 130/100, pulse 74, O2 98%, respirations 18. Patient reported allergies to penicillin, medical condition to include asthma. Patient reported medications: albuterol, fenofibrate, synthroid. Patient denied dizziness, tingling, pain. PHN offered Benadryl but patient declined. PHN assessed for swelling, none noted. Vital signs at 1000: blood pressure 136/94, pulse 76, O2 97%, respirations 16. Patient reported his nausea had resolved. PHN advised to follow up with provider within 24 hours and when to call 911. Vital signs at 1015: blood pressure 132/98, pulse 72, O2 97%, respirations 18. Vital signs at 1025: blood pressure 144/92, pulse 69, O2 98%, respirations 16. Patient reported he thought the room was hot and he felt anxious before the vaccination. Patient left at 1027 with steady gait.
This spontaneous report was received from a medical assistant and refers to an unspecified number patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # M036059 and expiration date: 03-JUN-2019. The GARDASIL 9 was reconstituted with sterile diluent (STERILE DILUENT) which did not undergo a temperature excursion. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA010646: US-009507513-1708USA010647: US-009507513-1708USA010656:
Delayed itchy rash; Fever that went awat overnight; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Delayed itchy rash) and PYREXIA (Fever that went awat overnight) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (Fever that went awat overnight). On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Delayed itchy rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Delayed itchy rash) had not resolved and PYREXIA (Fever that went awat overnight) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: not provided results not provided. She had a covid 19 test that came back a week earlier.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter.
Patient was seen and given vaccine at 10:39 am.  Patient remained for evaluation post vaccination due to history of anaphylaxis.  At 11:10 am, patient reported a tingling sensation to upper lip and requested 12.5mg of Benadryl.  Patient received medication and feeling resolved by 11:20 am.  SPO2 remained steady at 98%-99% on room air.
Fever and irritability, down appetite, x 2 days.  "heart racing" (? 2in to mild dehydration)
Information has been received from a pharmacist concerning a patient of unknown age or gender. On unknown dates, the patient received an unspecified number of doses of either GARDASIL or GARDASILL 9 (lot #, dosage and route not provided). The patient was late to receive the remaining dose or doses. It was not able to confirm whether the patient received GARDASIL or GARDASIL 9, however the patient would now like to complete the vaccines series. No adverse symptoms were reported. Additional information has been requested.
Site: Pain at Injection Site-Severe, Additional Details: patient states that the covid vaccination (1st booster) that was administered on 11/11/21 had given him the adverse reaction of a sore arm that started 05/01/22. states that it is due to the needle hitting the bone upon injection and the pain started 6 months after. He is currently using tramadol 50 mg twice a day and gabapentin 600 once a day for other pain ailments and does not alleviate the pain in his arm which is described as excruciating and wakes him up while asleep.
This spontaneous report was received from a healthcare professional refers to a patient of unknown age. On 14-JUN-2013, the patient was vaccinated with a dose of M-M-R II, (lot # H010135, expiry date 17-MAY-2014, route was not reported) which may have been improperly stored at 8.5 degrees Celsius and 9.1 degrees Celsius for 720 hours. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt had reported following administration of booster dose. she developed flushing and throat itchiness. was sent to ED for additional evaluation.  Pt was monitored and given benadryl 50 mg PO x1 and was discharged after pt was stable from ED.
Patient reports tenderness and redness that started in the evening on 4/25/2016. She came to the pharmacy on 4/27/2016 to report the reaction. At that time, the margins were marked. The red area extended from her shoulder area to just above the inner part of the elbow. I followed-up with the patient on 4/28/2016 via telephone and the patient reports improvement in the redness and it is all confined to the pen marks on her arm.
Patient had a tingling in the rt arm about 15 minutes after the shot.  Pain and tingling started to go up her right arm after we had continued to moniter.  Initial BP was 137/97, with no history of high BP, pulse was 81,, no breathing issues or swelling or redness.  Pt. indicated she stopped feeling pain and just had the tingling.  After the 30 minutes she sat with us her BP was 124/97.  BP upon leaving was 119/100 before the associate left for the day and still complaining of the tingling but no redness or swelling.
t39.5(r) 1hr p/immun & one episode of convuls other sx hypotonic, hyporesponsive episode;
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Mild, Additional Details: Patient reported a sharp pain and burning sensation strong enough for her to cry out when administered the shot, and the patient reported a radiating pain in the arm/shoulder after administration.
got backache; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection,Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient got backache got 1st vaccine shot and got backache and asking if naproxen is okay to take. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
COVID/respiratory acidosis/pneumonia/COVID-19 pneumonia; COVID/respiratory acidosis/pneumonia/COVID-19 pneumonia; Acute hypoxic respiratory failure; Congestive heart failure; This is a spontaneous report from a contactable other healthcare repofessional (LPN, but was the patient's domestic partner). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 55-year-old) as single dose for COVID-19 immunization. Medical history included diabetes, diagnosed with this over 20 years ago when he was in his diabetes. None prior vaccinations within 4 weeks. Family history included diabetes that ran in the family and cardiovascular disease. Concomitant medication was reported as none. Patient passed away on 15Sep2021 and he was vaccinated with the Pfizer COVID vaccines and he ended up getting COVID. He was placed on a ventilator on 13Sep2021 and then passed away on 15Sep2021. He had both doses of the Pfizer COVID vaccine in Apr2021. Patient didn't have a primary care provider but he was admitted to the hospital for pneumonia and they had found out that he had COVID when they were going to transfer him to a nursing home for physical therapy but at that time he didn't have a primary care provider. The patient was admitted to the hospital from 26Aug2021 to 15Sep2021. He had developed respiratory acidosis on 13Sep2021 and then placed on the ventilator. He was admitted to the hospital due to pneumonia and then they had discovered he had COVID while there. The patient's death certificate said that the cause of death was COVID-19 pneumonia, acute hypoxic respiratory failure, congestive heart failure. The patient underwent lab tests and procedures which included weight: 170 to 180 lbs on an unspecified date. The patient died on 15Sep2021 due to drug ineffective, COVID-19 pneumonia, acute hypoxic respiratory failure and congestive heart failure. An autopsy was not performed.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events drug ineffective, COVID-19 pneumonia, acute hypoxic respiratory failure and congestive heart failure and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Congestive heart failure; COVID/respiratory acidosis/pneumonia/COVID-19 pneumonia; COVID/respiratory acidosis/pneumonia/COVID-19 pneumonia; Acute hypoxic respiratory failure
Itchy, scratchy throat; hives; coughing; "lump in throat". Seen in ER, BENADRYL, prednisone.
31 YEAR OLD MALE COMPLAINED THAT HE WAS EXTREMLY HOT. HE WAS SWEATY AND HE SAID HE WAS FATIGUED. ON SITE EMS RESPONDED. NO SIGN OF ANAPHYLAXIS HIS VITAL LISTED BELOW. HE REFUSED ADDITIONAL EVALUATION OR CARE.
This spontaneous report as received from a granddaughter refers to her 67 year old grandfather with none medical history. Approximately in December 2014 (also reported as some time last month and within 1 month), the patient was vaccinated with a dose of PNEUMOVAX 23 (1 shot, route of administration, lot# and expiration date were not reported). On an unknown date, the patient was feeling anxiety, he developed pneumonia-like symptoms such as chest pain, pressure on his chest, trouble breathing, a lot of mucous and was hospitalized (on an unknown date, also reported as one week after receiving the PNEUMOVAX 23 injection). It was also reported that the patient was hospitalized again on 21-JAN-2014 (also reported as two days ago). The outcome of the adverse events was not reported. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information is not expected, because there are no contact details.
At 6 hours feeling unusually fatigued and within 12 hours experienced problems with equilibrium, significant mylagias, arthralgias, headache, fever of 101.4, nausea.  Symptoms subsided in about 36-48 hours.
Case number PHEH2015US000672, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 54-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 11 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladmistration. No further information was provided.
A report was received from a health care professional on 25 November 2003, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 07 November 2003. On 07 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.
First symptom: pain in muscle and joints from the waist down still present. Took ibuprofen with some relief.   Lower mid abdominal pain off and on.  Tired and weak.  Some days worse than others. Diarrhea 2-4 bowel movements per day since 6/18/14.
His CDC shot card only indicated he had received Covid vaccinations.  No indications he had received a shot dated 9/12/2022, which was a bivalent. When charting today?s vaccination it was noticed he had received a Covid vaccination 9/12/2022-bivalent, there was no other Covid vaccinations charted. NO adverse reaction-no symptoms, no signs , no treatment, no reaction
Sudden onset. No injury, right hand/right ankle, swelling, pain, limited range of motion, difficulty ambulating. Symptoms have continued to this date including various joints of all extremities, requiring steroid, anti-inflammatory and chemo-therapy medication.
pt recvd vax for pre-exposure prophylaxis;p/ dose 3/exp pain at inject site persisting x 6 wks;
Rash on cheese and upper arms 7 hours after receiving vaccine.; This is a spontaneous report from a contactable consumer (patient).A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in right arm on 06Mar2021 at 02:15 (at the age of 51-years-old) as 1st dose,single dose for COVID-19 immunization. Patient's medical history included hypothyroidism, penicillin allergy and depression. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. Patient received concomitant medications within two weeks included Synthroid.75, Wellbutrin 300, vitamin D and biocell. The patient had not been tested for COVID19 nor before neither since the vaccination.On 06Mar2021 at 20:45,The patient experienced rash on cheese and upper arms 7 hours after receiving vaccine . The event was not treated. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Pt  had orders to receive the Rabies Vaccine series. Instead of receiving day 14 dose on 9/9/22, patient received this dose on day 11. (9/5/22)
Numbness in her arm; nauseas; She felt faint like she was going to fall over; she felt swelling in that area; she got pain so bad in her arm it hurt any which way she moved it/ Pain in arm; sore throat; a lot of saliva; she felt light headed; Feeling of hotness; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient)   A 28-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), on 11Jul2021 at 11:00 via an unspecified route of administration, administered in Arm Left (as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications.  The patient received received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0181) on 20Jun2021 on arm left. The patient received Flu vaccine on an unspecified date and experienced site swelling. On 11Jul2021 immediately after vaccination patient felt swelling in that area. Patient also had swelling and numbness in her arm that continued throughout that day and in the middle of the night she was awakened by the pain in her arm that hurt any which way she moved it, extending or reaching for anything hurt. About 15 hours later that night patient got pain so bad in her arm it hurt any which way she moved it. Patient woke up the next morning and that pain was gone but then she was nauseated. Patient also informed she was walking with her dog that morning and had to sit on the sidewalk as she felt faint like she was going to fall over, she felt light headed and spitting helped her feel better. She spitted a few times in a bag and the nausea went away and she was able to get up and walk back home (as reported). Patient also had a feeling of hotness but no fever on the thermometer, she felt very hot but didn't register a fever and that started on the 2nd day with the nausea. She also informed the hotness was more the full day and the nausea was a little less but worse in the morning for some reason on the 2nd day. On days 3 and 4 patient had no nausea but had a sore throat. She had no fever or fatigue just an isolated sore throat and a lot of saliva. AT the time of the reporting outcome for She felt faint like she was going to fall over, she felt swelling in that area', she felt light headed', Feeling of hotness' was unknown. The patient recovered from Numbness in her arm, nauseas' on an unspecified date in Jul2021, while had not yet recovered from other reported events.  The information on the lot/batch number has been requested.