chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
FELT SO AWFUL LIKE GOING TO DIE; SEVERE SIDE EFFECTS; This spontaneous report received from a consumer concerned a multiple patients of unspecified age and sex of unknown race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported.  The patients was previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, frequency one total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). It was unknown whether patients had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were unknown ) dose, frequency one total, start therapy date were not reported for prophylactic vaccination. (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients felt so awful like going to die, and unspecified severe side effects (event occurred in dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt so awful like going to die and severe side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211240244.
Chills; headache; fatigue; body aches; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730) via an unspecified route of administration in left arm on 26Mar2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history reported as none. The patient had no allergy to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other medications within 2 weeks of vaccination. 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. The patient previously received first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: EN6205) via an unspecified route of administration in the left arm on 05Mar2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 27Mar2021, at 01:30, the patient experienced chills, headache (appeared to be mainly in sinuses), body aches, and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcomes of the events chills, headache (appeared to be mainly in sinuses), body aches and fatigue were resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
The first month following injection, pt complained of itching. Started taking BENADRYL. Then it progressed to transient linear rashes all over her body. Her primary MD gave her prednisone, but it is still occurring.
fever since 12 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever since 12 weeks ago) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Diabetes. Concomitant products included ATENOLOL, PANTOPRAZOLE, FLUOXETINE HYDROCHLORIDE (PROZAC), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and INSULIN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (fever since 12 weeks ago). At the time of the report, PYREXIA (fever since 12 weeks ago) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include diabetes medications. The patient did not receive treatment medications. Patient went to her endocrinologist and urgent care and they haven't been able to advise her on what to do.; 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.  However, additional information has been requested regarding the event that continued 12 weeks after the first dose of vaccine.
Raised area 4 inches in diameter on Lt thigh-red and warm to touch-saw doctor on 1-6-05, treatment- Keflex, Prelone, Motrin and heating pad.
Max/low temperature reached: 20.7 F( -6.2C) for 71 hours 30 minutes with no reported AE; ADACEL was administered to one patient post excursion with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old female patient who was administered Adacel post excursion with no reported adverse event and max/low temperature reached: 20.7 f( -6.2c) for 71 hours 30 minutes with no reported adverse event, while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) for Immunisation.  On 08-Aug-2022, the patient received a  dose number 1 of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE( lot U67093AA and expiration date: 18-Jun-20223) at a dose of 0.5ml via intramuscular route in the left deltoid for immunization.  On an unknown date, the reporter stated that refrigerator malfunction and vaccine max/low temperature reached: 20.7 f( -6.2c) for 71 hours 30 minutes with no reported ae (product storage error).   On 08-Aug-2022 (latency: same day),the patient developed a non-serious event of  adacel was administered post excursion with no reported adverse event (poor quality product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: Unknown   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.; Sender's Comments:  01228270:
Post vax, the medical assistant reported that on 12/12/2000, the patient "broke out with chicken pox". In follow up, the physician reported that on 11/30/2000, the patient "developed clinical varicella". Unspecified medical attention was sought. The physician reported that the patient recovered. The patient's siblings had a similar experience following exposure to varicella virus vaccine live. No further information is available.
white blood cell count was very high; death; This is a spontaneous report from a contactable consumer (ex-spouse) via medical information team. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 at a single dose (at the age of 52-years-old) for COVID-19 immunisation. Medical history included back pain: At some point before the vaccine was administered, he had a telehealth visit for reported back pain. Concomitant medications were not reported. The patient died on 05Mar2021 at his home. The patient received the first dose of COVID vaccine at a hospital on 02Mar2021. The patient was a fairly healthy active 52-year-old. At some point before the vaccine was administered, he had a telehealth visit for reported back pain. He was instructed to get blood work/labs done. A letter was received the day of his death that states his white blood cell count was very high and with it a recommendation that he seek medical attention. She (ex-spouse) reports the autopsy results won't be complete for a few months. The cause of death is unknown. The outcome of white blood cell count was very high was unknown.   Information on the lot/ batch number has been requested.; Reported Cause(s) of Death: Death
07:00 - Lethargy, mild muscle pain, mild headache - could not sleep in bed or chair.  Concentration was poor - so wandered around the house slowly.  (1 tablet of Naproxen Sodium 220 mg)  11:00 - Chills/Shakes, very tired could not wander, heavy fleece garments in chair with heating pad for back muscles, and fleece blanket.  Continuous chills/shakes, drifted in and out of sleep but often woken by chills/shakes.  14:00 woke to use restroom - chills/shakes ongoing.  Filling out this form while shaking. Muscle aches continue.  (1 table of Acetaminophen 250/asprin 250/caffeine 65
After administration of the second vaccine(Flucelvax), the baptist, accompanied by his wife,  walked to the waiting area to sit down.  His pupils became dilated and he reported that he was unable to see.  He was slurring his speech but still able to have a conversation.  I advised (pharmacy tech) to call 911.  Patient ate a granola bar and drank a Cherry Coke.   He said he skipped lunch that day.  As the minutes passed, he regained his vision, began sweating, and became more comfortable.  He was assessed by the responding medics and walked out of the store on his own.
tongue swelling; This is a spontaneous report from a contactable nurse. This 47-years-old female nurse reported that she received BNT162B2 (lot EL0140) 1st dose intramuscular at Left Deltoid on 28Dec2020 9:38 for COVID-19 vaccination. Medical history was none. Concomitant drug was not provided. The patient reported in the evening on 28Dec2020, she noticed her tongue swelling. She started to notice her tongue swelling shortly after dinner, probably around 6:30-7 in the evening. She was a little bit on pins and needles regarding this reaction. It happened quite a few hours later after receiving the vaccine. She was thinking should she go to urgent care or emergency room or not. Her tongue was still swollen but it seemed like over the week, the swelling had gotten better. However, the swelling came back. So really overall, the swelling hasn't gotten much better. She hasn't been drooling due to the swelling. She hasn't had issues with eating, drinking, swallowing or breathing. She just had ridges around her tongue. Her tongue felt a little bit heavy. The question she had was how long was this going to take before the swelling went away and was it safe her to take the booster shot (second vaccine)? The swelling was still persisting.  The outcome of the event was not resolved.
It began as a severe headache. I went to the ER and I was treated with Toradol, Tylenol, Ketamine, Decadron, Morphine, Zofran, and Phenergan. I followed up with a neurologist and was treated  with Depakote. I was sent to a pain clinic. I was diagnosed with occipital neuralgia and was given an occipital nerve block.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
did not receive second dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive second dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: No specific follow-up information recorded.
Swelling upper posterior arm soft tissue subq hard area 3-4 cm erythema 8 x 4 cm. Pt given cool soaks BENADRYL crm for pruritus. AUGMENTIN for 10 days.
I only got a bruise at my injection spot when everyone else I know that got it the same day has a red welt. I don?t think it was injected properly
Guillain Barre, ICU for 2 weeks, rehab 3 months; Still have issues with walking; Still have issues with standing a long period of time; Had to learn how to walk,write, eat,and all the basic things in life; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), walking difficulty, difficulty in standing and activities of daily living impaired. On an unknown date, the outcome of the guillain barre syndrome and activities of daily living impaired were unknown and the outcome of the walking difficulty and difficulty in standing were not recovered/not resolved.   The reporter considered the guillain barre syndrome to be related to Flu vaccine. It was unknown if the reporter considered the walking difficulty, difficulty in standing and activities of daily living impaired to be related to Flu vaccine.     Additional Information: GSK receipt date: 17-MAY-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got Guillain Barre from get the flu shot.  The patient ended up in ICU (intensive care unit) for 2 weeks and then ended up in a rehabilitation for 3 months.  The patient had to learn how to walk, write, eat and all the basic things in life.  2 years later, the patient still had issues with walking and standing a long period of time. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Missed period. Menstrual cycle very regular prior to the vaccine, occurring every 27-28 days. Now two weeks late; no pregnancy.
At time of vaccination, patient had a temperature of 98.2 degrees Farenheit. Less than 24 hours later patient caregiver reports temperature of 102 degrees Farenheit. Monday morning, was notified that patient's spouse found the patient unresponsive during the day after complaining about stomach pains on Sunday 5/9/2021.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 21-AUG-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
After the vaccine administration, redness, swelling occurred at the injection site. Pain in the left arm. Symptoms resolved after 3 days. At day 9 new symptoms surged, such as rash, redness and swelling of the injection site area. The pain in the arm is worse than the pain at the day of vaccination. Had to take acetaminophen to relieve the pain. A physician prescribed Augmentin 875 mg 1 po q 12 hours/7 days.
Chills and fever started about 11 hours after the shot.  Took Tylenol and went to bed.  Those symptoms gone next morning. About 36 hours after shot right shoulder which got the shingrix has a red rash about 3 inches in diameter.  Shoulder still tender to touch after 48 hours.
Limits on movements of the arm; Pain in the arm; Swelling in the arm; Redness in the arm; This is a spontaneous case, initially received from a pharmacist on 12-Oct-2018, concerning a 56-year-old, adult, female patient.  The patient's medical history and concomitant medications were unknown.   On 28-Sep-2018 (reported as two weeks ago), the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: YF39207 and expiry date: 30-Jun-2019] for protection against seasonal influenza.  On 28-Sep-2018, same day after vaccination, the patient experienced swelling, redness and pain in the arm. The patient did not receive any of the treatment measures associated with the events. It was reported that, two weeks after vaccination, the patient was still experiencing swelling, redness and pain in the arm. On an unspecified date, the patient also experienced limits on movement of the arm. The patient confirmed that she wants to seek a second opinion with a new doctor.  On an unspecified date, the outcome of the events swelling arm and redness was resolved and the events (pain in arm and mobility decreased) was not recovered.  The reporter assessed the case as non-serious.  Non-significant case amendment (12-Oct-2018): The onset latency was added in the case comment. No changes were made in the narrative.  Follow-up received from the reporter on 29-Nov-2018: The patient's initials and age (56 years) were added in the patient tab. The vaccination date (28-Sep-2018), route of administration (intramuscular), anatomical location (left arm), batch number (YF39207) and expiry date (30-Jun-2019) of the vaccine were added in the product tab. The event onset date of the was added (28-Oct-2018). The outcome of the events peripheral swelling and erythema was changed from not recovered' to recovered'. The new event mobility decreased' was added in the event tab. The narrative was amended accordingly.  Significant case amendment (29-Nov-2018): Event onset date was deleted for the event mobility decreased from the event tab.  Significant case amendment (29-Nov-2018): The description to be coded for the event verbatim 'Limits on movements of the arm' was changed from 'mobility decreased' to 'joint range of motion decreased' in the event tab. The narrative and case comment was amended accordingly.; Reporter's Comments: A 56-year-old, female patient experienced swelling arm, redness and pain in arm on the same day after administration of suspect vaccine Afluria Quadrivalent. The patient also experienced Joint range of motion decreased on an unspecified date after vaccination. The causality of the events assessed as related to the suspect vaccine due to the plausible temporal relationship between the events and the suspect vaccine.
Low oxygen/oxygen dependent; Persistent dry cough; After covid booster shot had pain in arm; Rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (Low oxygen/oxygen dependent), COUGH (Persistent dry cough), VACCINATION SITE PAIN (After covid booster shot had pain in arm) and VACCINATION SITE RASH (Rash in the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included COVID-19 from December 2020 to January 2021.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In October 2021, the patient experienced VACCINATION SITE PAIN (After covid booster shot had pain in arm) and VACCINATION SITE RASH (Rash in the injection site). On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Low oxygen/oxygen dependent) and COUGH (Persistent dry cough). At the time of the report, OXYGEN SATURATION DECREASED (Low oxygen/oxygen dependent) and VACCINATION SITE RASH (Rash in the injection site) was resolving and COUGH (Persistent dry cough) and VACCINATION SITE PAIN (After covid booster shot had pain in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: low.         No concomitant medications were provided. No treatment medications were provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of low oxygen/oxygen dependent, persistent dry cough and COVID 19 with Humira was not provided. 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.