chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has covid; Not feeling well; Sick; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Has covid), MALAISE (Not feeling well) and ILLNESS (Sick) 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.   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 an unknown date, the patient experienced COVID-19 (Has covid), MALAISE (Not feeling well) and ILLNESS (Sick). At the time of the report, COVID-19 (Has covid), MALAISE (Not feeling well) and ILLNESS (Sick) had not resolved.            No Concomitant product use was reported.  The patient reported that they had Covid, was not feeling well, and was sick. The patient also reported that they completed their Moderna Covid-19 vaccination series in 2021. It was mentioned that the patient was looking for monoclonal antibodies.  No treatment information was provided.  Company Comment - This case concerns a female patient of unknown age with no relevant medical history, who experienced the non-serious unexpected events of COVID-19, malaise and illness. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the non-serious unexpected events of COVID-19, malaise and illness. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  No treatment drugs were reported.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
This spontaneous report as received from a healthcare worker refers to a 4 year old female patient. The patient's pertinent medical history, drug reactions/allergies were not provided. On 02-JUN-2014, the patient was vaccinated with an expired dose of PROQUAD (merck), 0.5 ml, SC, left upper thigh, (Lot # H021361, expiry date on 29-MAY-2014). No adverse effects reported at this time. Additional information has been requested.
Vaginally bleeding x4 days; diarrhea x 2 mornings; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0179 and expiration date was not reported), via an unspecified route of administration in right arm, on 13May2021 at 10:30 (at the age of 46 years old) as 1st dose, single for COVID-19 immunization in a hospital. Medical history included colon polyps, bipolar II disorder, inattentive add and early cardio disease. Concomitant medications included sertraline hydrochloride (ZOLOFT); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); sulfamethoxazole (+) trimethoprim (BACTRIM) and ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient experienced vaginal bleeding for 4 days and diarrhea for 2 mornings on 15May2021 at 10:00. The events were assessed as non-serious by the reporter. No treatment was received by the patient regarding these events. The outcome of these events was recovering at the time of report.
This spontaneous report was received from a healthcare worker referring to an unknown number of patients that may have been vaccinated with a dose of ROTATEQ (dose, route and lot # not reported). The healthcare worker reported that on unknown number of doses of ROTATEQ that were exposed to 10 degrees C for 1 hour and 17 minutes then exposed to 8.7 degrees C for 28 minutes may have been administered. No adverse effect reported. This is one of two reports from the same reporter source. Additional information is not expected due to no other information was available at the time of the report.
PFIZER SHOT GIVEN WAS EXPIRED 1 DAY BUT PATIENT HAS NO ADVERSE REACTION AT THE TIME OF REPORT.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-JUL-2016, the patient was vaccinated with an improperly stored dose of VAQTA 50 U/1ML (lot # L048460, expiration date 14-JAN-2017). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were 144, 12 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Polymyalgia Rheumatica; other zoster-related conditions; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On or about April of 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, route of administration and anatomical location were not provided), as prescribed and/or administered by a pharmacist at a pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination, the patient was treated by a physician for polymyalgia rheumatica and other zoster-related conditions (ill-defined disorder/herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of those 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 polymyalgia rheumatica, ill-defined disorder and herpes zoster was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the polymyalgia rheumatica was considered to be medically significant.
The day of the first injection I noticed a little swelling under my eyes where fillers were 2 years ago.  The next day after the vaccine I felt very drowsy and tired, chills, body aches.  After the second vaccine I felt flu like symptoms for two days. Body aches, fever, chills, headache.  I had fillers done on my lips the week prior to the 1st vaccine and they started to get lumpy. 6/28 my lips got very lumpy and swollen. The next day my eye was swollen and left side of face. I went to urgent care where I was given Prednisone for an allergic reaction. The swelling continued. Contacted primary care Dr who prescribed Medrol. While taking medrol  and 10mg or zyrtec or Benadryl the swelling lessened. After medrol  was done swelling continued along with inflammation. I went to the ER because my life side started feeling tingly, swelling continued  and started having inflammation throughout. Lab Work showed some things off like glucose and kidney. Prescribed more prednisone, Pepcid, hydrooxyzine. Saw the Allergist  who recommended I take 40 mg daily of zyrtec. I than put myself on an anti inflammatory diet. Developed a sensitivity to certain foods like nuts and tomatoes. Caused lots of headaches and inflammation and swelling. Took zyrtec and had my fillers dissolved. Gradually with time I started feeling better, swelling went away. August 5 is when I started feeling better.
Pt. developed hives, rash over entire body, itching. Within 12 hrs developed shortness of breath, facial edema. Mother gave BENADRYL PO x 3-4 doses. Took to ED 4 P 10/24. Given IV steroids. Given IM BENADRYL. Improved immediately. Sent home after 2 hrs. Improved.
I received my first injection of the Moderna Covid-19 vaccine on Monday evening (1/25/2021) and my arm became very sore. The next day, I could not lift my arm. By Wednesday (1/27/2021) morning, I had a terrible migraine type headache, chills, muscle aches and nausea. I went to bed and sleep the whole day. I took ibuprofen which helped ease symptoms. The headache went away by Friday but I had lingering nausea & tiredness for several days and food tasted strange to me. I felt better by Monday, Feb 1, but then on Tuesday, February 2 in the evening, I developed a large hive and swelling on my left arm where I had received the injection. I also had smaller hives on my chest and neck. I took Benadryl and the swelling went down and by Wednesday morning (2/3)- the hives were gone and feel somewhat normal again.
Dizzy, Lightheaded, weakness, swelling at injection site, redness at injection site, shortness of breath
GI Gas; bloatedness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received BNT162B2 (PFZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 14Jan2021 08:00 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: I just take medications to manage hypertension. Concomitant medication(s) included: AMLODIPINE (ongoing); IRBESARTAN (ongoing). Vaccination history included: BNT162B2 (1st dose, muscular injection, event onset: 26Dec2020 21:00 ), administration date: 24Dec2020, when the patient was 66 years old, for COVID-19 immunisation, reaction(s): "Abdominal cramps", "GI cramps", "Diarrhea", "Chills". The following information was reported: FLATULENCE (non-serious) with onset Jan2021, outcome "unknown", described as "GI Gas"; ABDOMINAL DISTENSION (non-serious) with onset Jan2021, outcome "unknown", described as "bloatedness".  Additional Information: The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient did not undergo any relevant tests. The patient had been taking the concomitant medications for couple of years with no reaction. The patient did not use antipyretic around the dates of vaccination. The events did not result in emergency room or physician's office visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
it felt like her bones got beaten with a stick; different parts of her back were hurting; This is a spontaneous report from a Contactable Consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number, expiry date, NDC number were not reported) via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history included osteoarthritis and compression fracture. Patient concomitant medications were not reported. The patient reported 09Feb2021; that night it felt like her bones got beaten with a stick. She said the next day she did not feel so bad. She said about a week after that (on an unspecified date in Feb2021), different parts of her back were hurting. She said she received her second COVID-19 Vaccine dose on 04Mar2021. She said 2 weeks before she received her second COVID-19 Vaccine, she was hurting real bad, she said she told the lady who was giving her the second COVID-19 Vaccine what had happened to her after the first COVID-19 Vaccine, She said the lady told her she had a reaction (unspecified) from the first COVID-19 Vaccine shot, she said after her second COVID-19 Vaccine shot, things went downhill from there, she said she had osteoarthritis her pain got so bad she went to her doctor, she told her doctor she thought she had a compression fracture, she had x-rays of her back (on an unspecified date), and her doctor told her she had degenerative joint disease, which was osteoarthritis. She said she can only take Tylenol, and she had been to a massage therapist, and had used ice packs, but was still in pain, she knew who had the COVID-19 Vaccine said they did not have any problems with pain after they got the vaccine. The patient took treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
fluzone high dose was given intravenously with no reported adverse event; Initial information received on 10-Nov-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 68 years old female patient who reported  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was given intravenously with no reported adverse event    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Osteoporosis.    On 10-Nov-2022, the patient received a 1X  0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE once (lot number not reported) via intravenously route in unknown administration site for immunization.  On 10-NOV-2022 same day, the patient reported a non-serious event INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (fluzone) high dose was given intravenously with no reported adverse event.  Action taken: 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 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.
No additional AEs; Caller reported expired dose of PNEUMOVAX 23 was administered; This spontaneous report has been received from other health care professional referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-NOV-2023, the patient was vaccinated with an expired dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 0.5 mL intramuscularly on right deltoid (lot number W004863 which was verified to be a valid lot number with an expiry date of 21-AUG-2023) administered for prophylaxis (strength was not reported) (expired product administered). No additional AEs (no adverse event) or PQC were reported.
Pt. received Moderna 1/15. Got contrAst for MRI 1/18, developed severe allergic rxn to contrAst. Both Moderna VAx and Gadavist contain TromethAmine. She probably got sensitized to Tromethamine by Moderna VAX. Improved with steroid IV & BenAdryl in ER, now resolved.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 17-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
The patient experienced aching/cramping/stiffness in her legs, left nonpulsatile tinnitus, and tingling in her face.  The tingling soon resolved.  She experienced the tinnitus and a sense of stiffness/myalgias in her legs intermittently for several weeks, ultimately resolving entirely about 10 weeks after the vaccination.  She has declined to get dose #2.
Breakthrough case admission after 4 vaccines Pfizer 2/23/21 Lot# EN6200;  Pfizer 3/16/21 Lot# EN6207;  Pfizer 10/4/21 Lot# 301358A;  Pfizer 4/8/22 Lot# FK9893
My symptoms began with all-over body-aches, chilling and fever on the night of April 22. The adverse event that I feel is noteworthy to report is I had chest pain that began on April 23 in the afternoon and became more severe throughout the night and the entire next day on Saturday, April 24th. The chest pains were accompanied by a fever of 102.3. The chest pains were milder on Sunday and resolved by Monday, April 26, 2021.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 05-NOV-2012 at 08:44, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
I have only recently discovered that I have very high blood pressure. I am young and eat a very healthy diet of mostly vegetables and whole grains with very little meat and dairy. I exercise regularly and have no other health issues, i am convinced that this is related to the vaccine,. I only discovered it after the booster but I bet it was going on for a while now.
Auditory changes - change in perception of pitch. Everything sounds weirdly discordant. I am also experiencing some inner-ear pain
Received  Vaccine on 12/19/20 around 5pm.  next day Sunday on 5/20/20  in the evening had, nausea, abdominal pain, headache, fatigue symptoms worsened to include chills and fever went to Emergency room 12/21/20 evening, had high Blood pressure and fever. had labs done, bedside ultrasound, and Abdominal CT. was diagnosed with Acute Appendicitis.  I just learned that Appendicitis was one of the serious adverse side effects of the Pfizer Vaccine.
I'm currently nursing. My son was only 4 weeks old and experienced a fever of 101° around 12am 6/12/2021 and fever wouldn't lower even with Tylenol. He also had nasal congestion and wouldn't eat. He was taken into Hospital the same day but no source to the fever etc. was found.
e had a bad reaction where she she had a whopping COVID arm; Purple arm that lasted for a week; Felt terrible; Flu-like symptoms; lethargy; mild upset stomach; Headache so bad that she could hardly lift her head off the pillow; Was a tad nauseous but not enough to vomit; Had a little fever but nothing crazy/101+ degrees; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and LETHARGY (lethargy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included IBD, Migraine, Seizure since an unknown date, Myocardial infarction (Myocardial bridge), Tachycardia, Lymph node abscess (with lymph node dissection ) on 26-Jan-2021, St. Louis encephalitis (when she was 15 years old and had a high fever and was in a coma for 5 days. ) and Radiation therapy. Concurrent medical conditions included Blood pressure high and Cancer since December 2020. Concomitant products included PARACETAMOL (TYLENOL) for Pain, LETROZOLE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (lethargy), ABDOMINAL DISCOMFORT (mild upset stomach), HEADACHE (Headache so bad that she could hardly lift her head off the pillow), NAUSEA (Was a tad nauseous but not enough to vomit) and PYREXIA (Had a little fever but nothing crazy/101+ degrees). At the time of the report, VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (lethargy), ABDOMINAL DISCOMFORT (mild upset stomach), HEADACHE (Headache so bad that she could hardly lift her head off the pillow), NAUSEA (Was a tad nauseous but not enough to vomit) and PYREXIA (Had a little fever but nothing crazy/101+ degrees) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received: Added new events.