chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concomitant products included PREDNISONE for COVID-19 vaccination.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2020, the patient experienced TACHYCARDIA (Tachycardia). At the time of the report, TACHYCARDIA (Tachycardia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Red blood cell sedimentation rate: Increased.         No medical history was reported by the reporter .  Treatment medication information was not provided by the reporter.  In December 2020, the patient experienced tachycardia. On 28-Oct-2021, the patient experienced increased sedimentation rate. In November 2021, the patient experienced achy, inflammation, could not get out of bed for one day and fever. On 01-Nov-2021, the patient experienced very sick after covid booster. In 2021, the very sick after covid booster resolved. The patient had tachycardia after first covid vaccination in Dec 2020. On 28-Oct-2021, blood work showed increased Sedimentation rate. She gave shot of prednisone and her inflammation was better. On 28-Oct-2021 she had taken flu shot. She got sick due to covid booster shot taken on 1-Nov-2021 and could not get out of bed for one day. She was also achy and had fever. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-628641, MOD-2021-628642 (Patient Link).
This is a spontaneous report from a contactable other hcp (registered nurse). A 30-years-old adult female patient of received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number and expiry date was not reported) via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient experinced fainting and she lost consciousness and abdominal pain. Event Verbatim included, She had a fainting and she lost consciousness as one of the staff reporter was asking her question that fainting event occurred on Friday April 16th and so reporter was asking her if she has Vaccinated and she has received her second Pfizer vaccination on prior Thursday which was on April 8th so it was of Pfizer. reporter wish if had more information to provide you. She was taken by ambulance and reporter found out about her six hours later occurred at 9hr in the morning and reporter found out about that by clinical manager that she is in surgery for two hours, So reprter found out that she has an emergency surgery. Reporter was told an identifiable drug identifiable patient and identifiable reaction, So unfortunately, They would not tell me what precipitated the emergency surgery. So reporter know that it's not a lot information but reporter wanted to report it with all the information. Reporter said that morning was that she fainted had a lost consciousness and she said that she has had prior episodes of something that as prior has affected, may be related to food although they tested her and could not figured out what food it was. She was complaining of severe abdominal pain and when EMT scan was done, she said she did want to go to the hospital and like, reporter said all reporter knew 6hrs later that the clinical manager said that she has been in surgery for two hours and that did occur. That reporter do not know. The outcome of the events was unknown.  Follow up attempts needed. Further information is expected.; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded/assessed.  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 RAs, Ethics Committees, and Investigators, as appropriate.
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 29 out of 50 patients   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Hard lump at injection site and patch of red, somewhat itchy skin several inches in diameter, continuing 1 week after injection. Had fatigue and muscle pain for several days after the injection.
tested + PCR and neg CXR; tested + PCR and neg CXR; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), on 16Mar2021 as dose 2, single (Lot number: EL3247) and on 10Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovering" and all described as "tested + PCR and neg CXR". The events "tested + pcr and neg cxr" required physician office visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (18May2022) Negative, notes: 18May2022 tested +PCR and neg CXR; SARS-CoV-2 test: (18May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment ae: Unknown. It was unknown whether the patient had covid prior vaccination. She tested covid post vaccination.  Clinical information: Adverse event: attended a funeral 14May2022, then sx cough, moderate aches, congestion and chills on 16May2022 and on 18May2022 she tested positive PCR and negative CXR.  Investigation results: This was a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in PQS Q1215 and/or Q1252.  Lot (CR): EL3247 and FF2589: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer-BioNTech covid-19 vaccine lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223 and FE5318. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow up attempts are possible; No further information is expected; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
After leaving the immunization room the patient got lightheaded and sat down for a moment until he regained his composure. He is doing fine now.
Patient reported a mild headache after receiving the Moderna COVID vaccine in the Right Deltoid. patient's vitals stable.
Little welts on the body/They are on the back of the leg, are all on the back/There are 10 welts on the back, 8 on one leg, 3 on the ankles, they are multiplying; itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Little welts on the body/They are on the back of the leg, are all on the back/There are 10 welts on the back, 8 on one leg, 3 on the ankles, they are multiplying) and PRURITUS (itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03142A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMIN B12 [VITAMIN B12 NOS], MACROGOL 3350 (MIRALAX) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Little welts on the body/They are on the back of the leg, are all on the back/There are 10 welts on the back, 8 on one leg, 3 on the ankles, they are multiplying) and PRURITUS (itchy). At the time of the report, URTICARIA (Little welts on the body/They are on the back of the leg, are all on the back/There are 10 welts on the back, 8 on one leg, 3 on the ankles, they are multiplying) had not resolved and PRURITUS (itchy) outcome was unknown.            No treatment information was provided by the reporter.
Vaccine was picked up on 12/07/2021 to be stored in fridge and used by 01/07/2022. Patient received this dose eleven days past the vaccine usage date. Patient reported no known symptoms.
Acute sensory neural hearing loss, 2 week after initial injection, occurred in an ear that already had some symptoms; This is a spontaneous report from a contactable physician (patient). A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EH9899), via an unspecified route of administration, administered in Arm Left on 17Dec2020 at 13:00 (age at time of vaccination was 63-year-old) as single dose for COVID-19 immunisation. The patient's medical history included Known allergies of Penicillin. The patient's concomitant medications were not reported. No other vaccine in four weeks were taken by patient. No other medications in two weeks. No covid prior vaccination. On 29Dec2021, the patient experienced acute sensory neural hearing loss, 2 week after initial injection, occurred in an ear that already had some symptoms. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures post vaccination which included Nasal Swab unknown results. The patient received unspecified steroids as corrective treatment for the event. The outcome of event was not recovered.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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
covid arm: redness and itching starting 9 days after vaccination. lasted about 7 days
Swelling of L deltoid with associated pain. Edema of L deltoid to 8X8cm. Pt instructed to place warm compresses BID and motrin for pain.
Headache - started one hour after vaccination. Feeling of "unwellness", "not feeling like himself". Shortness of breath approx. 10 days after vaccination. Poor concentration, difficulty focusing. Light bothering eyes.
high temperature; short of breath; hotness; pain in the bones; HEADACHE; pain in the arm; swelling in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high temperature), DYSPNOEA (short of breath), FEELING HOT (hotness), BONE PAIN (pain in the bones) and HEADACHE (HEADACHE) in a male 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.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PYREXIA (high temperature), DYSPNOEA (short of breath), FEELING HOT (hotness), BONE PAIN (pain in the bones), HEADACHE (HEADACHE), MYALGIA (pain in the arm) and PERIPHERAL SWELLING (swelling in the arm). At the time of the report, PYREXIA (high temperature), DYSPNOEA (short of breath), FEELING HOT (hotness), BONE PAIN (pain in the bones), HEADACHE (HEADACHE), MYALGIA (pain in the arm) and PERIPHERAL SWELLING (swelling in the arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: high (High) high temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.
Day 1 after vaccine,  fever. day 10 after vaccine, rash covering abdomen and back, slightly on face an limbs
L facial paresthesia, injection site warmth, redness, firm nodule approx. 2.5 cm enduration.
Client received H1N1 in a mass vac's clinic and woke up next morning with jaw pain and neck swelling on the same side as the injection arm (Left). Called H.D. to report and we referred her to her physician (reported fatigue and chills to.) Client seen and tk with Benadryl for II weeks.
This spontaneous report as received from a nurse refers to a 12 months old female patient. The patient was vaccinated with VARIVAX (merck), 0.5 ml, on 05-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 20-JUL-2012 the patient developed a mild case of chicken pox. The patient has sought unspecified medical attention. No treatment information was reported. The outcome of mild case of chicken pox was unknown. This is one of several reports received from the same source. Additional information has been requested.
Really bad headache/it has worsened; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 21Jan2021 14:15 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included fluoxetine hydrochloride (FLUOXETINE). The patient had a small headache in the morning on 22Jan2021, he ignored it, but now it was getting worse. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    This case contains information of the 17th patient out of 20 patients.  No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:Master case
I had a subchorionic hemorrhage of placenta in the first trimester. This was confirmed with an external and internal Ultrasound. I had an additional external ultrasound last week confirming the pregnancy is still active. I also have an additional internal ultrasound tomorrow to evaluate if I still have a subchorionic hematoma. The hemorrhaging stopped on its own while at the hospital and left a hematoma which will be evaluated in tomorrows ultrasound.
Oral Rotavirus vaccine was given IM inadvertently; the following day there was swelling redness and induration at the injection site.
nurse accidentally gave Ipol to patient instead of Prevnar with no reported adverse event; Initial information received on 21-Jun-2023 regarding an unsolicited valid  non-serious case received from a Non-health professional.  This case involves an unknown age and unknown gender patient and is reported patient were given IPV (VERO) [IPOL] instead of pneumococcal vaccine CONJ 13V (CRM197) [prevnar 13] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site  On an unknown date, the patient received a dose of suspect IPV (VERO) Suspension for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) instead of PREVNAR 13 (wrong product administered) latency on the same day. Information on the batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No additional AE; received a 4th dose of ROTATEQ on 8/22/2022. Caller reports the 3rd dose was administered on 7/14/2022.; This spontaneous report has been received from a physician concerning a 6-month-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 22-AUG-2022, the patient was vaccinated with the 4th dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (ml) (lot # 1879861, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent [ROTATEQ], expiration date reported and upon internal validation established as 20-OCT-2023) (anatomical location and route of administration were not reported) for prophylaxis (Extra dose administered). The 3rd dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered on 14-JUL-2022.  No adverse event was reported.