chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-May-2021, 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 product use was reported. No treatment information was provided. Vaccine administration date was on 18 Nov 2021. Assessment use by date  was 28 Apr 2021. Days post expiry was 14 Company comment- This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report
Fast heartbeat; Dizziness; Weakness / no energy; Diarrhea; Itch; Chills; Headache; Nausea; Eating any little food made me feel as if the food is at the top of my throat; Bodyache; This is a spontaneous report received from a contactable consumer or other non-health care professional (Patient). A 48-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 15Apr2021 08:30 (at the age of 48-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing. The patient previously took COMPAZINE [prochlorperazine edisylate] for hypersensitivity and experienced drug hypersensitivity. The patient received anti depressant within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The patient experienced fast heartbeat, dizziness, weakness / no energy, diarrhoea, itch, chills, headache, nausea, eating any little food made me feel as if the food is at the top of my throat, bodyache on 15Apr2021. The events outcome was recovered with sequel on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site wheal in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site wheal, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site wheal, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site wheal, injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The sales representative believed that the flu vaccine received by the patient was the FLULAVAL QIV Pre Filled Syringe. The patient complained of a 2 inch welt, soreness, and swelling at the injection site. The sales representative had no patient identifiers or lot and expiration date of the vaccine. The health care professional could be contacted directly for further information. This was one of the 5 cases, reported by the same reporter.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like he was going to pass out/Felt like  had gotten over something), DYSPNOEA (Short of breath/Like not getting enough air coming in/Gasping/Starving for air), COUGH (Cough) and PERIPHERAL SWELLING (Right leg started swelling/Foot was really swollen, especially on top/Toes were like balloons) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030MZ0A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (Cardiac history significant for bypass surgery 20-30 years ago.).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (Felt like he was going to pass out/Felt like  had gotten over something), DYSPNOEA (Short of breath/Like not getting enough air coming in/Gasping/Starving for air), COUGH (Cough) and PERIPHERAL SWELLING (Right leg started swelling/Foot was really swollen, especially on top/Toes were like balloons). At the time of the report, FEELING ABNORMAL (Felt like he was going to pass out/Felt like  had gotten over something), DYSPNOEA (Short of breath/Like not getting enough air coming in/Gasping/Starving for air), COUGH (Cough) and PERIPHERAL SWELLING (Right leg started swelling/Foot was really swollen, especially on top/Toes were like balloons) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Swallow study: normal (normal) normal. On an unknown date, Viral test: negative (Negative) negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that he actually thought he had the virus, but he tested and his test was negative. Treatment medication was Decongestant/Cough Medicine that may have had codeine in it. No concomitant medication reported.
Patient had 3 episodes during afternoon and evening after vaccines of quivering/shaking of arms and legs lasting 10-30 seconds. Then we observed similar episode 9/10 or 9/11 and two more on 9/13.
DVT Left leg and b/l PE,  Left leg symptoms began 3 days after booster.  Medical treatment sought on 10/21/21 -- US and CT chest done confirming dx.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer-BioNTech Vaccines on 2/26/2021 and 3/19/2021. Patient's wife reported patient tested positive for COVID on 1/24/2022. Admitted for NSTEMI and acute hypoxic respiratory failure 2/2 COVID-19 infection. Patient received: vitamin C and zinc. Patient's respiratory status continued to decompensate and patient was transitioned to DNR/AND. Patient expired 2/3/2022.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 06-Oct-2021, vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C. Concomitant and treatment information was not reported.
feels very stressed; feeling bloated; Abdominal pain / cramping x 3 days; constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Lot number: EN6200) at the age of 65 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Cardioversion Procedure", start date: 01Jul2020 (unspecified if ongoing), notes: Transesophageal Echocardiogram and Cardioversion Procedure; "Interventional radiology procedure", start date: 31Dec2020 (unspecified if ongoing), notes: Interventional radiology procedure note; "ascites", start date: 31Dec2020 (unspecified if ongoing); "5.0 liters of yellow fluid obtained from the right abdomen", start date: 07Feb2021 (unspecified if ongoing), notes: Another 5 liters of yellow fluid removed. The patient's concomitant medications were not reported. The following information was reported: CONSTIPATION (non-serious) with onset 26Feb2021, outcome "unknown"; ABDOMINAL PAIN (non-serious) with onset 07Mar2021, outcome "unknown", described as "Abdominal pain / cramping x 3 days"; ABDOMINAL DISTENSION (non-serious) with onset 07Mar2021, outcome "unknown", described as "feeling bloated"; STRESS (non-serious), outcome "unknown", described as "feels very stressed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient thinks his abdomen cramping and constipation is due to stress. He is in the process of buying a house in and feels very stressed. He denies any fever, vomiting or urinary symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200103560 same patient, different dose/AE;
States that within 24 hours of receiving the injection she could not move her left arm. Pt states she also noticed pain. She states that the range of movement improved over the next few weeks but 'joint pain' persisted. She was seen in health service and physical therapy was ordered. With physical therapy treatments the joint pain resolved but muscle pain persists although has decreased minimally.
REGULAR REACTIONS; CANNOT CONCENTRATE; TINGLING IN FEET, MOVED UP THE LEGS, UPWARDS INTO THE FACE AND REST OF THE BODY; TIRED; BRAIN FOG; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cigarette smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-AUG-2021, the patient experienced brain fog. On 12-AUG-2021, the patient experienced cannot concentrate. On 12-AUG-2021, the patient experienced tingling in feet, moved up the legs, upwards into the face and rest of the body. On 12-AUG-2021, the patient experienced tired. On an unspecified date, the patient experienced regular reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from regular reactions, and had not recovered from tired, tingling in feet, moved up the legs, upwards into the face and rest of the body, brain fog, and cannot concentrate. This report was non-serious.
mom states that the pt closed eyes & would not open them for 25min;denies pt sleeping;no tx @ ER-pt was responsive in ER & alert;dx was made as acute adverse drug reaction;pt released to see MD 22JUL97;
4/21/2004: Reported red, swollen area on left leg at injection site. 4/21/2004: Called back c/o: child's eye swollen
The pt experienced a local reaction to the typhoid vaccine he received on 5/30/00. The pt experienced redness, induration of 5 x 6 cm which became cellulitis. The pt was treated with Keflex. The symptoms became worse and the pt was admitted to the hospital from 6/2/00 through 6/5/00 for IV antibiotic therapy. The pt was discharged on 6/5/00 with a prescription for Cipro.
Pain immediately, with swelling developing over the next several hours.  Next day malaise, fever 99.5 with warmth at vaccine site and limited range of motion.  Vaccine site visualized as and confirmed to be correct placement in right deltoid muscle.  Discussed with patient this is likely a vaccine reaction, however due to upcoming trip and concern for early cellulitis began antibiotic treatment along with supportive care for pain and swelling.
Localized erythematous, pruritic skin eruption; recommended OTC ibuprofen; fully resolved: 72 hours.
The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a Pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician, for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
zoster -related skin conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), for the long term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by a healthcare-provider for zoster-related skin conditions. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Patient was given the Pfizer Booster vaccination 5 days prior to the "5 month" period. No adverse event was reported from receiving the vaccination early.
Patient was admitted to the hospital 2 weeks following first Moderna Vaccine for COVID.  Diagnosed with pericarditis/myocarditis.  No other clear preceeding illness or precipitant.
pt admit with COVID 2/22/22 s/p 2 doses Pfizer (4/8/21 & 4/29/21, no booster). pt ended up w/ DVT that was likely COVID related
This spontaneous report as received from a medical assistant and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, (which had a lot # of M019691 and an expiration date of 02-NOV-2017; however, dosage number and route of administration were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. It was unknown the temperature excursions for vaccines, however it was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports recevied from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA002672.
abruptly loss consciousness; extremely dizzy; fell hitting back of head on floor; fell hitting back of head on floor; cuts to both legs; hearing buzzing noise in ears; Dose number=3/third dose; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in arm right on 06Nov2021 12:30 (at the age of 58-years-old) (Batch/Lot Number: ER8732) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The vaccine was given in the workplace clinic. Medical history included osteoarthritis, NMH (Hypotension), TMD (Temporomandibular joint syndrome), known allergies to citrus, shrimp, scallops, walnuts, pecans, portabella/cremini and cilantro. The patient's concomitant medications were not reported. The patient previously took and had allergies to thimerosal and neomycin. Historical vaccine included BNT162B2 dose 1 administered in the right arm on 27Mar2021 12:15 PM (at 57-years-old) (lot number: FN8030) and BNT162B2 dose 2 administered in the left arm on 17Apr2021 12:00 PM (at 57-years-old) (lot number: ER8731) for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccines in four weeks. The patient had no covid prior vaccination. She had not been tested for covid since vaccination. Approximately 22 hours, on 07Nov2021 10:30 AM, after receiving the third dose, felt extremely dizzy.  While trying to pour water in the kitchen, abruptly loss consciousness and fell hitting back of head on floor. After getting up to walk to another room, abruptly lost consciousness and fell again, resulting in cuts to both legs, lay down on sofa after hearing buzzing noise in ears. Waited a few minutes, then returned to the kitchen to finish retrieving water and abruptly lost consciousness for a third time again falling to the floor. Drinking water seemed to help alleviate dizziness. Had experienced a similar reaction after receiving an MMR vaccine several decades ago. The patient was recovering from the events without any treatment.   Follow-up attempts are completed. No further information is expected.
Woke up with redness at the injection site; It was itchy at the injection site; a little warm on the injection site; a little swollen at the injection site; fell down because she tripped; arm hurt; a little headache but it was mild; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell down because she tripped), PAIN IN EXTREMITY (arm hurt), HEADACHE (a little headache but it was mild), VACCINATION SITE ERYTHEMA (Woke up with redness at the injection site) and VACCINATION SITE PRURITUS (It was itchy at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Lung disorder NOS. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FALL (fell down because she tripped), PAIN IN EXTREMITY (arm hurt) and HEADACHE (a little headache but it was mild). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Woke up with redness at the injection site), VACCINATION SITE PRURITUS (It was itchy at the injection site), VACCINATION SITE WARMTH (a little warm on the injection site) and VACCINATION SITE SWELLING (a little swollen at the injection site). In January 2021, HEADACHE (a little headache but it was mild) had resolved. On 19-Jan-2021, FALL (fell down because she tripped) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt) had resolved, VACCINATION SITE ERYTHEMA (Woke up with redness at the injection site), VACCINATION SITE PRURITUS (It was itchy at the injection site) and VACCINATION SITE SWELLING (a little swollen at the injection site) had not resolved and VACCINATION SITE WARMTH (a little warm on the injection site) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.