chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 days went by, no reaction, thought I was home clear.   I woke up on the 6th day ON FIRE.  Not one part of my body that wasn't screaming.  I popped Acetaminophen like Tic Tacs for 2 days.  Initially, I thought I was going to die, then I was afraid I wouldn't.  Never been through anything like that.  I don't think I'll get the second dose.  I've heard the second is far worse than the first.
68-year-old gentleman presented with dyspnea and found to have bilateral PE, right lower extremity DVT. He was started on IV heparin, Coumadin. Patient was found to have acute kidney injury and urinary retention, bilateral hydronephrosis. Foley catheter was placed, this resulted in improvement in renal function and resolution of hydronephrosis. First cath urine was bloody but subsequent urine has been clear. A CT urogram did not reveal any other abnormality of the urothelial system. Prostate is enlarged.
Fever; Headache; This is a spontaneous report received from Pfizer-Sponsored Program. A non-contactable consumer (patient) reported for himself that 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), via an unspecified route of administration on 05May2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient received Pfizer Covid-19 vaccine first dose on 05May2021 and experienced fever and headache for 3 days on an unspecified date in May2021. He was confused if he would take the 2nd dose of the vaccine because of the side effects he experienced. The 2nd dose would be on the 27May, which is 22 days prior to 1st dose. Outcome of the events was recovered on an unspecified date in May2021.  Medical Information: No: Customer and/or medical inquiry was not forwarded or referred to MI  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199) at the age of 92 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: diabetes (controlled by diet and exercise no medicine). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received BNT162b2 (BNT162B2) on 27Mar2021 as DOSE 2, SINGLE; Lot Number: ER8730; Anatomical location: left arm), when the patient was 92-year-old, for COVID-19 immunization; The patient also received BNT162b2 (BNT162b2) on 05Jan2022 as DOSE 3 (BOOSTER), SINGLE; Lot Number: 33025BD; Anatomical location: left arm), when the patient was 93-year-old, for COVID-19 immunization.
Fatigue, headache, took Tylenol. Chills, coughing.
PE/DVT.  Pt had BL PE around 5/1/21 demonstrated on CT Angio Chest 5/12/21.  Workup to ID source included BL LE ultrasound on 5/26/21 which was positive for "chronic DVT" in L femoral, popliteal, and gastroc.  Pt had no symptoms of that so onset is unclear but "chronic" implies it was there at least by February.  Pt had no risk factors whatsoever - non-smoker, trim, exercises regularly, no travel.
This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT). On 19-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N019825 with expiration date 09-JAN-2019 (strength, dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The reporter also stated that the temperature excursion occurred in between 15 Fahrenheit degrees (°F) and 46 Fahrenheit degrees (°F) with a time frame of 45 minutes. The call was because of a data logger and there was no previous temperature excursions.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 23-JAN-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017,. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.  Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
24 hours after,  a small red papule and surrounding redness developed at injection site.  48 hours after, vesicular papules on an erythematous base developed on left thigh.  72 hours later, redness and vesicles spread to left groin and down left leg.
Tired/chills/weakness beginning at 9PM on day of shot - next day increased chills/fatigue - numbness and tingling of limbs, swelling of Tongue & Throat and Difficulty breathing with chest pain -was seen in ER - given Benadryl which relieved swelling symptoms - had low fever as well.
COVID-19; This spontaneous report received from a consumer concerned a 6 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. Age at time of vaccination 56 years old. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient was recovering from covid-19. This report was non-serious.
High fever (103-104); body aches & nausea; lasted 2 days then felt absolutely fine
began w/fever 101 last noc, this AM fever w/APAP 102, swelling @ site of inject down to toes; pt refuses to walk on affected limb;
no other adverse event occurred. No other AE; patient received his first dose of MMRII and VARIVAX on 2/10/2023. The caller said the patient received his second dose of MMRII and VARIVAX on 3/3/2023; patient received his first dose of MMRII and VARIVAX on 2/10/2023. The caller said the patient received his second dose of MMRII and VARIVAX on 3/3/2023; This spontaneous report was received from a medical assistant, regarding a 4-year-old patient with unknown gender. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.   On 10-FEB-2023, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, anatomical location, lot number and expiration date were not provided) (product administered to patient of inappropriate age) and varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 03-MAR-2023, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot # w007180 has been verified to be a valid lot number, expiration date was reported as 01-MAR-2024, dose, route and anatomical location were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # w022825 has been verified to be a valid lot number, expiration date was reported as 18-JUL-2024, dose, route and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). No other adverse event occurred (no adverse event).
Patient states that almost immediately after vaccine injection she became constipated and had little to no bowel movement for over a month. Patient states that if she did have a bowel movement then it would be very little and it would be about 1 1/2  weeks apart from each other. Patient stated that she tried drinking laxative and that didn't work.
got the 1st dose of the vaccine then tested positive after; got the 1st dose of the vaccine then tested positive after; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the 1st dose of the vaccine then tested positive after. She was asking if she can get the 2nd dose even if she is tested positive. She asked if it can cause to have a false positive result if she received the vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Woke up in middle of night with sensation of throat tightness, intense itching, and hives.
I had been tested prior to surgery on 09/09/2021 and tested Negative. I had knee surgery and was admitted to the Hospital from 09/13/2021-09/15/2021. I started to have some Nausea and vomiting symptoms on 09/18/2021. I went to the ER on 09/20/2021 and I was extremely dehydrated. I was tested for Covid-19 and it was Positive. I had no other symptoms except for the GI symptoms. I was hospitalized and I got an antibody infusion on 09/21/2021. I was discharged on 09/22/2021. No one else that I had been around had tested positive. I had to quarantine and I could not get the Physical Therapy for my knee until I was cleared.
second dose received apparently not effective due to a temperature excursion; prickly; stinging; itching; Extra Dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 3rd dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In JAN-2023, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tingling (Verbatim: prickly), stinging (Verbatim: stinging), pruritus (Verbatim: itching) and extra dose administered (Verbatim: Extra Dose). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: second dose received apparently not effective due to a temperature excursion). The patient was treated with desonide. The outcome of the tingling, stinging and pruritus were not resolved and the outcome of the extra dose administered and incorrect storage of drug were unknown.   It was unknown if the reporter considered the tingling, stinging and pruritus to be related to Shingrix.     It was unknown if the company considered the tingling, stinging and pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 22-Jun-2023 The patient was fully vaccinated with 2 doses of Shingrix. The patient was notified by the pharmacist that the 2nd dose received apparently not effective due to a temperature excursion. The patient went to pharmacy and received a third dose. The event happened around 5 months ago.  Since then, the patient has been feeling itching, stinging and prickly in the skin under her right breast by the liver area. The physician prescribed Desonide to alleviate the symptoms. The patient not recovered yet. Patient did not recalled any vaccination dates, stating she would callback to provide that information. The pharmacist informed that the 2nd dose received apparently not effective due to a temperature excursion, which led to incorrect storage of drug. The patient received 3rd dose, which led to extra dose administered. The reporter consented to follow up.
First dose- soreness to unknown arm at injection site; This is a spontaneous report from a contactable consumer or other non-HCP (Patient).    A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm on 05May2021 (Lot Number: EN6205, expiry date was not reported) as single dose for COVID-19 immunisation. The patient's medical history included ongoing hypothyroidism stated that she has had it since she was a child. The patient's concomitant medication included levothyroxine taken for hypothyroidism from an unspecified start date (Started when she was 8 years old) and ongoing; liothyronine taken for hypothyroidism from an unspecified start date and ongoing. On 05May2021, after first dose, the patient had soreness to unknown arm at injection site. It was reported that, dates for stated that the second dose was given closer to four weeks than three weeks after. She took the Pfizer vaccine first and second dose and had no symptoms prior to it. Stated that after approximately two weeks that she had a metallic, salty taste a lot of times not all of times. Stated that when she was not eating that the taste was on the tip of her tongue. She was not sure if it was from the vaccine, but she was reporting it due to the timing. Was getting feedback. Clarified that it was for Pfizer COVID vaccine. Stated that she had soreness to her unknown arm at injection site. Later clarified it as Pfizer BioNTech. Wanted to see if they can help her in any way. Stated that she hoped that this helped someone in some way. Stated that she went to the withheld and there were doctors there. Stated that the soreness to the injection site lasted the first day and was gone. Stated that the second dose was given closer to four weeks instead of three weeks because she could not go on that date. Stated that the metallic taste started on 17Apr2021 or 18Apr2021. Treatment reported as none. Did not have the NDC or expiration date for the second dose. Provided a lot number of EN6207. Stated that it was an unknown dose injection into the arm. Stated that it was for the prevention of COVID. Advised caller that she might speak with Medical Information and they might be able to provide her with medical information based on literature from research or studies. They could not provide recommendations. They could only provide information based on what she provided or were experiencing. They might refer her to the healthcare provider that was medically overseeing them. The outcome of the event was recovered on 06May2021.   Information on Lot/Batch number was available. Additional information has been requested.
lymphadenopathy; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymphadenopathy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cholesterol high and Thyroid disorder.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced LYMPHADENOPATHY (lymphadenopathy). At the time of the report, LYMPHADENOPATHY (lymphadenopathy) had not resolved.            Concomitant product information included unspecified medications for high blood pressure, cholesterol, and thyroid.  No treatment had been used.
Muscle/joint pain, fever, chills, nausea, shortness of breath, headache
Presented to the ED from group home due to change in mentation and behavior, nausea, vomiting.  Per EMS patient was hypoxic and hypotensive with blood pressure 88/54.  Patient unable to contribute to history.  Patient with reported history of recent COVID-19 infection.   - ED workup significant for oxygen saturation 88% on room air, RR 21, WBC 2.67, positive COVID-19 and bilateral pneumonia on chest x-ray - Patient with hypotensive episodes 86/64 prior to sepsis fluid administration. Tested positive on 01/15/2022   Presented to the ED from group home due to change in mentation and behavior, nausea, vomiting.  Per EMS patient was hypoxic and hypotensive with blood pressure 88/54.  Patient unable to contribute to history.  Patient with reported history of recent COVID-19 infection.   - ED workup significant for oxygen saturation 88% on room air, RR 21, WBC 2.67, positive COVID-19 and bilateral pneumonia on chest x-ray - Patient with hypotensive episodes 86/64 prior to sepsis fluid administration.
Delayed reaction at injection site. Rash, itching, hardness started approximately 9 days after vaccine shot. Rash was 3 inches by 2 inches. Resolved complyin 3 days.
Terrible diarrhea; patient feels awkward and she going to die; acting very puny; bit of lethargic; This is a spontaneous report from a contactable consumer or other non-health care professional. An 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. On an unspecified date, reporter mentioned patient got terrible diarrhea, patient feels awkward and she going to die, she was acting very puny and bit of lethargic. Reporter wanted to know if it was something that could be bothering her four days after or three days after she had the treatment. Reporter also wanted to know if it could be because of the vaccination and how much should they worry about it. Outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Return of same symptoms as when she had covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Return of same symptoms as when she had covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (Return of same symptoms as when she had covid). At the time of the report, COVID-19 (Return of same symptoms as when she had covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.; Sender's Comments: Based on the 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.
Pfizer Bivalent LOT GL0087 placed in the freezer upon receiving in clinic 12/7/22. Vaccine thawed and administered to patient 3/1/23. No signs or symptoms of reaction or issues from patient.
Received Moderna COVID-19 vaccine on 1/27/21 in the am.  At 11:30 pm, pt started to feel sweaty and went to the bathroom.  She passed out and fell to the floor.  Woke up on the floor.  Incontinent of stool.  Had scratches on forehead and nose from the fall.  Called her daughter who took her to emergency room. She was not admitted.  She was not given any treatment.  Stated they checked her vitals and drew some blood work.  She stated that she was told it was due to her blood pressure dropping. Discharged home with no further problems. Reported this on 1/12/21.
Information has been received from a physician concerning a 19 year old female who on 04-MAR-1992 was vaccinated with the first dose of MMR II (HSA) (route, site and lot number not reported). On 26-JUL-1995, the patient was vaccinated with a second dose of MMR II (HSA) (route, site and lot number not reported). On 22-NOV-2009, the patient experienced mumps (diagnosis date on 24-NOV-2009). The patient was afebrile and had right parotitis. On 24-NOV-2009 the patient had his 1st blood work and showed: serum measles immunoglobulin M antibody test: 0.32, serum measles immunoglobulin G antibody test: 5.36 and serum amylase test: 226. The outcome for the mumps was not reported. This is one of several reports from the same source. No further information is available.
Left arm pain/extending to left hand; Neck pain; Swollen lymph node in left neck area; Tingling in hand; Tired; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to contrast dye, latex and neoprene. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 the patient experienced left arm pain, neck pain within 1 week of 2nd dose, swollen lymph node in left neck area, continuing pain in left arm, extending to left hand, tingling in hand, tired. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events left arm pain/extending to left hand, neck pain, swollen lymph node in left neck area, tingling in hand and tired were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.