chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a currently 45-year-old female patient who was referring to herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JUL-2021, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (formulation, dose, site and route of administration, lot # and expiration date were not provided) for prophylaxis. On 22-DEC-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (formulation, dose, site and route of administration, lot # and expiration date were not provided) (inappropriate schedule of product administration). The caller reported a missed dose and she believed that she received the 2-dose regiment. No further information was provided, no additional adverse event / product quality complaint (AE/PQC) was reported.
07/27/2003: Fever to 102F, fine erythematous macular/papular rash starting at ears, scalp face, proceeding gradually.  No eating, drinking well.  07/28/2003: Fever continues, rash on face to conjunctivitis (+) A/P nasal DC, cough, sick, looking like "measly" looking.
Around the beginning of February I noticed more frequency of headaches, nausea and vomiting. I saw my doctor and an eye doctor. The medical doctor, we talked about a form of migraine medicine. And I received a prescription for Ubrelvy 50 mg, as needed. I would say unknown about recovering from the AEs, I am still having a lot of headaches and nausea and vomiting out of the blue.
INJECTION SITE ITCHING; injection site swelling; injection site rash; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (INJECTION SITE ITCHING), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE RASH (injection site rash) and INJECTION SITE PAIN (injection site soreness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and Flexural for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE PRURITUS (INJECTION SITE ITCHING), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE RASH (injection site rash) and INJECTION SITE PAIN (injection site soreness). At the time of the report, INJECTION SITE PRURITUS (INJECTION SITE ITCHING), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE RASH (injection site rash) and INJECTION SITE PAIN (injection site soreness) 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.   No treatment information was provided   Reporter did not allow further contact
COVID-19; COVID-19; rheumatoid arthritis symptoms flared up; FACILITATED COLLECTED  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4289039-00.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Oct2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single, intramuscular, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), first regimen oral (Batch/Lot number: unknown) and second regimen oral since Feb2022 (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "rheumatoid arthritis symptoms flared up". The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of rheumatoid arthritis.  The reporter causality of BNT162B2 in respect to the event Covid-19 and Rheumatoid arthritis flare up (Rheumatoid arthritis) was not reported, Vaccination adverse reaction (Vaccination complication), and Sleepy (Somnolence) was probable. The reporter causality for Rinovaq COVID-19 (COVID-19) was No reasonable possibility, Vaccination adverse reaction (Vaccination complication) and Sleepy (Somnolence) was not reported and Rheumatoid arthritis flare up (Rheumatoid arthritis) was not applicable.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.
Left shoulder pain at the lateral aspect that started the evening after the vaccine causing difficulty and painful ROM that has persisted, but improved.
10 mins p/flu vax c/o dizziness, shaking, confusion, weakness, progressing to inc pulse, inability to stand or walk; Epi given; In ER DPH & Cortisone were administered;
Pt recvd 2 doses of Hep B vax & exp fever, achiness & malise p/1st &/or 2nd dose; seen by MD; 10JUL92 some were still not feeling well;
dizziness; really not feeling well; nausea; vomiting; 101° F fever; off label use; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MALAISE (really not feeling well), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (101° F fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DIZZINESS (dizziness), MALAISE (really not feeling well), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (101° F fever) and OFF LABEL USE (off label use). In 2021, OFF LABEL USE (off label use) had resolved. At the time of the report, DIZZINESS (dizziness), MALAISE (really not feeling well), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (101° F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 (High) 101° F fever.         No concomitant drugs were reported.  Patient took the 3rd shot two weeks ago from the time of reporting.   Doctor advised the patient to take rest.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021 at 12:20 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021 at 12:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 07-Oct-2021 at 12:20 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Information has been received from a physician concerning a 22 year old female who experienced abdominal pain prior to receiving her second dose of GARDASIL (Lot # was not reported). The date of the abdominal pain began was not specified by the reporter. The patient sought medical attention in physician's  office. The outcome was unknown. Additional information has been requested.
I experienced a herpes outbreak on my left hand (had it for about 13 years). It was an immune system reaction to the vaccine. My PCP confirmed that it was no doubt some inflammation or immune reaction to the vaccine. She prescribed medication to treat the adverse event.
Patient has gastritis, fatigue, headache, unable to eat meals x 1 week.
sore throat, fever, headache, fatigue, SOA admitted to hospital 2/1- placed on 3L O2, started on decadron and remdesivir
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported) vial. On an unknown date, the patient experienced injection site reaction of redness and bumps. Varicella-like rash was not present. Patient sought medical attention (went to see the pharmacist). No treatment was given. On an unknown date, the event of injection site reaction of redness and bumps was recovered/resolved without treatment. Additional information has been requested.
Within 5min of the vaccine my mouth tasted like metal. It tasted like I was eating pennies and there was drainage in my mouth. It has been 1 week and nothing tastes normal, it is all metal tasting still. I also got a blood clot in my right calf. It was not a DVT but one closer to the skin. I have horrible calf pain and get Charlie horses nightly. Neither of these were an issue before the vaccine
I had received my 2nd covid shot on May 20th I was 38 weeks 4 days pregnant with my 5 pound 14 ounce son and that night I lost my mucus plug and went into labor. I was due May 30th.
Raised erythematous somewhat confluent papules that covered anterior upper chest only-itchy. OTC steroid cream.
my left eye, is in fact dry; Eye injury; some of the diluted vaccine ended up getting squirted in her eye; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 14Dec2021, this case now contains serious adverse reaction.  This is a spontaneous report received from contactable reporter (nurse) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 15Oct2021 (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: OCCUPATIONAL EXPOSURE TO PRODUCT (medically significant) with onset 15Oct2021, outcome "unknown", described as "some of the diluted vaccine ended up getting squirted in her eye"; EYE INJURY (medically significant) with onset 15Oct2021 16:00, outcome "recovering", described as "Eye injury"; DRY EYE (medically significant), outcome "unknown", described as "my left eye, is in fact dry". The event "eye injury" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of occupational exposure to product, eye injury, dry eye.  Additional information: Nurse Practitioner said before she administered the Pfizer-BioNTech Covid-19 Vaccine. As she was drawing up diluted vaccine, some of it ended up getting squirted into her left eye. She flushed my eye with water. It felt uncomfortable for several days. It stills feels uncomfortable at times (dry). She saw an ophthalmologist on 22Nov2021 who examined her and he said that her left eye, is in fact dry. He advised her to apply warm compress to my eye and if no improvement, he Rx'd eye drops to apply.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Occupational exposure to product, dry eye, and eye injury and BNT162B2.  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.
About 24 hours after receiving the booster shot patient experienced confusion, difficulty walking, dyslexia
04/30/2021 Before the vaccine, Patient had a small rush on her face-right cheek.  05/01/2021 12:30 am, the same rush on her face expanded, and appeared a big rush on her left leg.  8:am, her face was warm, swollen, red, and itching. A big rush on her lower and upper back; the rush on her leg expanded and is very red.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, route and dose was not reported). After receiving GARDASIL injection, the patient felt faint and dizzy when walking to her car on an unknown date. She was walked back into the office where it was confirmed by HCP (health care professional) that the situation was "not an asthma attack". The outcome of the felt faint and dizzy was unknown. Additional information is not expected.
Started with swelling on the thigh. Mother described the area as red, swollen and purple. Swelling of the thigh was started at the middle thigh and reached to the knee.
Could not sleep; I had redness to my eyes; Hand swelling; Warm spots at temper lobe; Redness issues in her left and right temporal lobe; Headache; Fever spiked/spikes in her body temperature of 100-102 F; Tenderness at injection site; This spontaneous case was received on 26-Jan-2022 from other non-healthcare professional (consumer) via regulatory authority (reference number: SEQW22-00403) and concerned 57-year-old female patient.  The patient's concurrent conditions included hypertension. The patient's concomitant medications included hydrochlorothiazide used for unreported indication.  On 19-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported), for prevention of seasonal influenza. The batch number was not reported, and expiry date was 30-Jun-2022.  On the same day, by 11:00 p.m., after receiving Flucelvax Quadrivalent, the patient had tenderness at injection site, headaches and warm spots at temporal (reported as 'temper') lobe. In addition, the patient experienced hand swelling, fevers, redness of eyes and could not sleep. She also had redness issues in her left and right temporal lobe. The patient thought that she was having a massive heart attack.   On 24-Nov-2021, the patient went to Urgent Care. She was discharged on the same day and was advised to contact her physician. The patient had a followed up with her physician and performed  blood tests, but no further details provided. Additionally, the patient visited a specialist for an eye examination, but no further details provided as well.  At the time of initial reporting, the patient had not recovered from the events of ' localized erythema' and 'fever'. The patient stated that she was still experiencing fever spikes in her body, temperature of 101-102 F and had redness issues in her left and right temporal lobe.   The outcome of other events was not reported.  The reporter assessed the events as related to Flucelvax Quadrivalent as they were adverse reactions to the vaccine.  The reporter assessed the events as serious.  Company comment: A 57-year-old female patient developed vaccination site pain, pyrexia, headache, ocular hyperemia, localised feeling of warmth, hand swelling, erythema and insomnia on the same day after vaccination with Flucelvax Quadrivalent. Causality for insomnia is assessed as not related due to biological implausibility. Causality for all the other events is assessed as possibly related due to plausible temporal relationship.; Reporter's Comments: Adverse reactions to the vaccine; Sender's Comments: A 57-year-old female patient developed vaccination site pain, pyrexia, headache, ocular hyperemia, localised feeling of warmth, hand swelling, erythema and insomnia on the same day after vaccination with Flucelvax Quadrivalent. Causality for insomnia is assessed as not related due to biological implausibility. Causality for all the other events is assessed as possibly related due to plausible temporal relationship.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Swollen lymph node under breast and arm pit; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and LYMPHADENOPATHY (Swollen lymph node under breast and arm pit) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for an unknown indication.    On 26-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 PERIPHERAL SWELLING (Swollen arm). On 28-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under breast and arm pit). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Pain, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swollen arm) had resolved and LYMPHADENOPATHY (Swollen lymph node under breast and arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a health professional concerning a a 13-year-old female with a history of rhinitis allergic and scoliosis who on 02-OCT-1995 was vaccinated with a first dose of VARIVAX (Merck). There was no illness at the time of vaccination. On 01-APR-2008 the patient experienced a vesicular, papular rash on her face, trunk and back. The patient was seen by a physician. Subsequently, the patient recovered on 07-APR-2008. Additional information has been requested.
Vaccines administered after more than 1 temperature excursion; Vaccines administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 10:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 10:31 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 65.53 years. No concomitant product use was reported. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. On 12-Feb-2021, Excursion temperature at 9 am was 29, at 10 am was 35 and 11 am 35, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 12-Feb-2021. 3 vials were moved to clinic. Vaccine BUD date was 10-Mar-2021. Vial was stored in cooler 1, on 12-Feb-2021, excursion temperature at 9 am 29, at 10 am 35, at 11 am 35, at 12 am 39, at 1 pm 42, at 2 pm 43, at 3 pm 40, and at 4 pm 39. Temperature recordings were taken by using a traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 24-OCT-2021.  The vial did not undergo any temperature excursions. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.