chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority.. The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: ep7534), in left arm, on 10Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 31 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Test: (2022) unknown result, notes: went to a "Test to Treat" site at a "withheld''; SARS-CoV-2 test: (29Jun2022) Positive; (04Jul2022) Positive, notes: Faint positive; (05Jul2022) Negative; (06Jul2022) Negative; (08Jul2022) Positive; (08Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received antiviral treatment with Paxlovid from 29Jun2022 to 03Jul2022. Patient did not received any other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.
chills; body aches; upset stomach; tired for two days; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness, chills, general body pain and upset stomach. On an unknown date, the outcome of the tiredness, chills, general body pain and upset stomach were recovered/resolved.   It was unknown if the reporter considered the tiredness, chills, general body pain and upset stomach to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received the dose of Shingles vaccine other day and was tired for two days, with chills, body aches and an upset stomach.  The patient stated that so glad that was gone. The patient was not looking forward to the next shot, but so grateful that he/she had gotten at least one. The patient reported hope they felt better soon. The pharmacist told him/her people typically felt bad for just two days. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case had been linked with case US2022AMR148248, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR148248:Same reporter
This is a spontaneous report from a contactable consumer via Pfizer sales representative, who reported same event for the four patients . This is the fourth of four reports. A female patient (age range reported as 50-70) receive a single dose of PREVNAR 13 , on an unspecified date as vaccination. The patient medical history and concomitant medications were not reported.  On an unknown date, few days after vaccination, the patient complained of soreness between the elbow and shoulder. There was redness as well.The outcome of the events was unknown; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016487623 same reporter/drug/event, different patient.
swollen inguinal lymph nodes; bilateral leg swelling; This is a spontaneous report from a contactable consumer or other non hcp. A 68- Years-old  female patient of received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:45 (age at vaccination:67 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Medical history included surgery from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809, Expiration: unknown) via unspecified route of administration on 09Feb2021(age at vaccination: 67Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received pneumovax vaccine on 2014 for pneumonia. The patient experienced swollen inguinal lymph nodes on 01Jul2021, bilateral leg swelling on 2021. The patient underwent lab tests and procedures which included computerised tomogram: unknown result on unspecified date, computerised tomogram: the bilateral saphenous veins valves are shut on unspecified date, CT scan for something else and was more of a vascular CT to see if anything could be done with the veins in her leg on unspecified date ultrasound doppler: unknown results on 01Jul2021.Patient stated that the product complaint was patient had other vaccine pneumovax on 2014 and had no complications but had injection site reaction and  had fever of 100 degree and 2020 and had no reaction  The outcome of peripheral swelling was recovered, the outcome of the events lymphadenopathy was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Onset 2 days after vaccination of pruritic vesicles on bilateral arms. Treated with FAMVIR 500g TID x 5 days.
Fever, headache and fatigue.    January 5, 2022 - tested positive for COVID.   Fever, headache, body ache, fatigue for 5 days.
The day after vaccine I felt like I had a medium case of flu. Very weak, headache, a little nausea, and mild sweating. Today  (2 days after vaccine) I'm not as weak but still have a headache, mild diarrhea and extreme sweating off and on.  My bed sheets were damp enough at 4 am to have to sleep on the other side of the bed. When I awoke at 7 am the bed sheets were again to damp to lay back down on them.  At this time the sweating has abated and doesn't seem has often.
This spontaneous report was received from a nurse prescriber and refers to a pediatric patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 13-AUG-2018, the patient was vaccinated with a first dose of VAQTA (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On 14-NOV-2018 , the patient received a second dose of hepatitis a vaccine, inactivated (VAQTA) lot # R013857, expiration date 22-APR-2019 (dose and route of administration were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). No adverse effects were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1811USA009086.
Chills; Fatigue; Nausea; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect received from a contactable consumer. A male patient of an unspecified age started to receive bnt162b2 (BNT162B2 reported as COVID vaccine; lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that he had chills, fatigue and nausea and also "on that form, that talks about day 1 and other dates throughout the week". The patient stated that he is cautious of heavy side effects in the future and he did not explain any of those because he thought he would have to call every day. The outcome of the events was unknown.  Information about batch/lot number has been requested.
ACHINESS; CHILLS; MILD FEVER; HEADACHE; 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: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced achiness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced mild fever. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, chills, mild fever, and headache on 09-APR-2021. This report was non-serious. This case, from the same reporter is linked to.
no discernible antibody response to pneumococcal vaccine;   This literature marketed report has been received from the authors of a published literature article, and refers to 2 female patients of an unknown age. The retrospective study of 136 patients in antineutrophil cytoplasmic antibodies (ANCA) database was conducted to identify patients with recurrent infections and hypogammaglobinemia who were subsequently treated with the novel subcutaneous IgG SQIG. Of the 136 patients, 4 were treated with SQIG.    On unknown dates, the patients had proteinase 3 (PR3) antibody positive and immunoglobulin (Ig) levels (G and M) were reduced. CD19/20 cells were depleted and CD3/4/8/ natural killer (NK) cells were preserved in all patients.   On unknown dates, the patients were vaccinated with pneumococcal vaccine (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis.  On unknown dates, the patients had no discernible antibody response to pneumococcal vaccine (specific pneumococcal serotypes measured pre and post vaccine). The outcome of the event was unknown.  The authors of a published literature article considered the event of no discernible antibody response to pneumococcal vaccine to be related to the suspect vaccine.  A copy of the published article is attached as further documentation of the patients' experience.  This is one of two reports derived from the same literature article (cross referenced with # 1908USA004919).; Sender's Comments:  US-009507513-1908USA004919:
Only had one hour of sleep after the COVID-19 shot and couldn't sleep from it; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "Only had one hour of sleep after the COVID-19 shot and couldn't sleep from it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Acute pancreatitis; Acute renal failure; Low blood pressure; Weakness; Decreased appetite; Fatigue; Alanine aminotransferase increased; Aspartate aminotransferase increased; Troponin increased; Lipase increased; Blood bilirubin increased; A spontaneous report was received from a physician concerning an 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an odd presentation of acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue.  The patient's medical history included advanced dementia, heart disease, pulmonary embolism and possible leukemia. Concomitant product use was not provided by the reporter.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 08 Jan 2021, three days after vaccination, the patient developed symptoms of weakness, decreased appetite, and fatigue.   On 11 Jan 2021, the patient was admitted into the hospital with a diagnosis of low blood pressure,acute renal failure,acute pancreatitis,alanine aminotransferase increased,aspartate aminotransferase increased, troponin increased,lipase increased and blood bilirubin increased. Abnormal lab results included "significantly elevated" aspartate transaminase, alanine transaminase, bilirubin, lipase up to 1900, and "slightly elevated" troponin of 0.079.  On 13 Jan 2021, the patient's symptoms had improved, and he was discharged. Treatment for the event included two liters of intravenous fluid and supportive care.   Action taken with the second dose of mRNA-1273 in response to the event was not provided.    The events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, were considered resolved on 13 Jan 2021.   The physician assessed the events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, as not related to mRNA-1273. The physician's rationale was that the patient may have had a gallstone obstructing the pancreatic duct and once the stone passed, the patient got better with supportive care and slow administration of fluids.; Reporter's Comments: This case concerns a 81-year-old male patient with medical history of dementia, heart disease, pulmonary embolism, and possible leukemia, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of acute pancreatitis, acute renal failure, low blood pressure, the non-serious listed event of fatigue, and the non-serious unlisted events of weakness, decreased appetite, elevated aspartate transaminase, elevated alanine transaminase, elevated bilirubin, elevated lipase, and elevated troponin.  Very limited information regarding these events has been provided at this time.  Based on the current available information and in agreement with the physician reporter's assessment, the events are assessed as unlikely related to mRNA-1273, noting the rapid improvement after administration of IV fluids.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient received the first dose of GARDASIL on 16-MAY-2008 and the second dose on 04-OCT-2012. No adverse effect reported. The outcome was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
The night after the shot, I started feeling some pain in my right leg from about the hip down the thigh. It got progressively worse and I was actually having difficulty standing. It peaked around Monday, but as of today (Friday 4/16/2021) it is definitely still there. However, it is diminishing in pain. I think it will go away with time so I haven't seen a doctor yet. I don't experience leg pain so this was a surprise. I thought maybe I perhaps slept in a wrong position but I would assume it would go away. I don't see any discoloration in the area.
Information has been received from a physician's employee concerning a female who on unknown date was vaccinated intramuscularly with the first dose 0.5 mL of GARDASIL (LOT # was not provided). The patient passed out after she was given GARDASIL. The patient recovered from passed out on the same day she got the vaccination. She sought unspecified medical attention. Additional information has been requested.
First Pfizer dose: A few mins after receiving my first dose, my tongue went numb for a few mins and then healed. 1 week after receiving my first dose of the Pfizer shot, I developed a splotchy skin rash on my right/left arms, belly, and back. I then developed a red itchy scalp that still flares off and on after my second dose. My scalp still remains red and the itchiness flares up at odd times. Mind you, I don't have and have never had Psoriasis nor any other skin conditions. All of the flaring rashes on my body started right after I received the first dose of Pfizer.   Second Pfizer dose: A few mins after,  my tongue when numb again for a few mins and healed. After that, the first day was fine. the second day on the second does (9/27), I developed (5) red itchy spots that appear to look like Chicken Pox on my right arm only, and are still there. These (5) red round rash dots flare up every now and then and itch. Again, my scalp is still red from the 1st dose. Lastly on 9/27/2021- I developed a foul chemical after taste when eating food and drinking liquids. The taste is not metal-like, and it's more of a chemical taste that resembles bitterness. The closest thing that I can compare the taste to is Nail Polish Remover. It's almost as if I am taking a compound of the vaccine itself. I still have the after-taste and it is day 3 of the second dose.
mental fogginess; blurred vision; Feverish/a fever of 102; Muscle ache; pins and needles in her upper arms and legs; Headache; This is a spontaneous report from a contactable healthcare professional (patient) received by Pfizer from Medical information Team. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. She had previously received the first dose of BNT162b2 for COVID-19 immunisation and experienced a little blurred vision. The patient's concomitant medications were not reported. A few hours after the second dose, the patient experienced a fever of 102. The fever went through the night and all though the next day and through the next night. She took tylenol and advil for the fever but the fever did not go away but did slightly reduce the fever. She had muscle aches when she had a fever. She had been feverish for two days and after that had blurred vision. She also experienced pins and needles in her upper arms and legs. She stated she had a mental fogginess that barely went away yesterday (unspecified date). At the time of reporting, the the blurred vision was still occurring. The patient went to an optometrist but they did not have an answer for her. The patient also reported a headache but said it could be due to trying to study with blurred vision. The event blurred vision was not resolved. The outcome of the other events was unknown.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported event mental fogginess  and BNT162b2 (PFIZER-BIONTECH COVID-19 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.
very mild COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (very mild COVID-19) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy, Blood pressure high (improving with medications), Hypercholesterolemia and Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (oesophageal), VALSARTAN for Blood pressure high, SIMVASTATIN for Hypercholesterolemia.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (very mild COVID-19). At the time of the report, COVID-19 (very mild COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Positive.         It was stated that the patient was not able to read the dates written in her vaccination card. After 1st, 2nd and 1st booster dose she did not experienced any symptoms.  It was not stated weather the patient received treatment for COVID-19 or not. Company comment: This spontaneous case concerns an 84-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event was reported with no date; hence, latency to the primary schedule and to the third dose (first booster) of mRNA-1273 vaccine cannot be assessed. As per source document, she had a positive test, and she experienced a very mild case of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-580975 (Patient Link).; Sender's Comments: This spontaneous case concerns an 84-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event was reported with no date; hence, latency to the primary schedule and to the third dose (first booster) of mRNA-1273 vaccine cannot be assessed. As per source document, she had a positive test, and she experienced a very mild case of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Wrong dose was given- patient received 0.5ml dose instead of 0.25ml dose.
Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 (Lot number: FF2588) at the age of 82 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, lot no unknown), administration date: 04Feb2021, when the patient was 82 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, lot no unknown), administration date: 25Feb2021, when the patient was 82 years old, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 02Oct2021 06:00, outcome "not recovered", described as "Dizziness". Therapeutic measures were not taken as a result of dizziness.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not received any other medications within 2 weeks of vaccination. Patient not had covid prior vaccination and had not covid tested post vaccination. Patient not any known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. Patient reported other drug as Suspect Batch/lot number: EN6200 Date of start of drug 28Sep2021.  No follow-up attempts are possible. No further information is expected.
Erythema slight warmth and swelling about 2 inches from injection site on left deltoid within 24 hrs of injection.