chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, SARS-CoV-2 test: positive (Positive) positive test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-030804 (Patient Link).
mom states pt had h/a, stomach ache & generally felt ill 4 days p/vax;
wiped out sense of smell; wiped out sense of taste; This spontaneous case was reported by a non-health professional and describes the occurrence of ANOSMIA (wiped out sense of smell) and AGEUSIA (wiped out sense of taste) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (wiped out sense of smell) and AGEUSIA (wiped out sense of taste). At the time of the report, ANOSMIA (wiped out sense of smell) and AGEUSIA (wiped out sense of taste) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient had the first two shots starting in January 2021 and this year the patient received two booster shots.  No treatment information was provided by the reporter.  The patient needed information on how to get the smell and taste and back.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious ADR of Anosmia and Ageusia unspecified days after receiving the third (first booster) dose of mRNA-1273 vaccine. Its reported that patient had two shots starting in Jan2021 and this year received two booster shots, but the first shot wiped out sense of smell and taste. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious ADR of Anosmia and Ageusia unspecified days after receiving the third (first booster) dose of mRNA-1273 vaccine. Its reported that patient had two shots starting in Jan2021 and this year received two booster shots, but the first shot wiped out sense of smell and taste. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Information has been received from a Licensed Practical Nurse (L.P.N) concerning a 19 year old female patient with no pertinent medical history and no known drug allergy/drug reactions who on 03-JUN-2008 was vaccinated with the first dose of GARDASIL (lot # 655604/0052X); on 04-AUG-2008, the patient received her second dose of GARDASIL (Lot # 0250X) and on 18-DEC-2008, the patient was vaccinated with her third dose of GARDASIL (Lot # 0947X). Concomitant therapy included hormonal contraceptives (unspecified), ZOLOFT and MOBIC. It was reported that the patient developed rheumatoid arthritis in the fingers of her right hand, feet and legs after vaccination with GARDASIL. The patient was diagnosed in June 2009. It was reported that the patient was seen in the office. A blood work was performed on an unspecified date (results not provided). At the time of the report the patient had not recovered. Follow up information was received from the Licensed Practical Nurse (L.P.N) who reported that the AE onset date was in June 2009; the rheumatoid arthritis was diagnosed through blood work (results not available). It was reported that there were no concomitant vaccines, only concomitant therapy which included birth control pills and ZOLOFT which was prescribed at the end of August 2009. It was also reported that the patient was first seen in another office in September 2009. It was reported that MOBIC was prescribed for the treatment of rheumatoid arthritis. The patient was referred to the rheumatologist. The patient was doing well on MOBIC, ZOLOFT and PLAQUENIL. Follow up information was received from the Licensed Practical Nurse (L.P.N) who reported that the patient a 19 year old female student, received the three doses of GARDASIL intramuscularly on 03-JUN-2008, at 11:20 am in left gluteus; on 04-AUG-2008, at 12:57 pm in right gluteus and on 18-DEC-2008, at 11:18 am in left gluteus. There were no illnesses at the time of vaccination. At the time of the report the patient had not recovered. The reporter considered rheumatoid arthritis to be an other important medical event. No further information is available.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 27-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because their facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient.  No treatment information was provided.   This case was linked to MOD-2022-501575 (Patient Link).
530PM SOB, dizzy, rash over body; DPH & cool baths @ home; Decadron in ER & observation; advised not to take any more Hep B vax;
Narrative: Prior to receiving the vaccine, the Patient expressed concern about vaccine administration and reported that he did not want to get the vaccine. He stated that he only got the vaccine after his family pleaded with him to get it.
Within 24hrs fever of 101.5. Red circle that grew for 72hrs. Antibiotics given. Dizzy. Fever resolved day 4 continuing to see reduced redness.
This is a spontaneous report from a contactable other health care professional (patient). A 34-year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 02Mar2021 at 12:00 as UNKNOWN, single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient had no known allergies. Concomitant medications included citalopram (CITALOPRAM); alfetamines aspartate, amphetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. On 03Mar2021, patient experienced small patch of rash on left upper chest. The patient did not received treatment due to the events. The outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dizziness; Headache; Chills; Muscle Aches; Pain in right arm; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via an unspecified route of administration on 02Feb2021 at 12:45 PM (at the age of 20-years-old) at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Public Health Clinic/Administration facility. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. Medical history includes insomnia and migraines. Concomitant medications included eszopiclone (LUNESTA), melatonin, ibuprofen, bismuth subsalicylate (PEPTOBISMOL). On 02Feb2021 at 15:00 the patient experienced dizziness, headache, chills, muscle aches, pain in right arm. No treatment was given for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
That night while watching television, right eye started tearing up, watery, glazed, eyeball felt sore. On Sunday morning had redness like hemorrhage, in the eye.  She had no swelling or pain. The eye looks unsymmetrical.
Urticaria: Rash/hives 10 days after shot. Very itchy especially on palm of hands and scalp. Urgent care doctor put me on prednisone and Benadryl but the allergist changed it to Montelukast 10mg 1 tablet at night, fexofenadine 1180 mg 1 tablet a day, carbinoxamine 4mg 1 tablet at night, and famotidine 40mg 2 times a day.
6 month old daughter, was accidentally administered the GARDASIL vaccine instead of his 12 year old daughter; 6 month old daughter, was accidentally administered the GARDASIL vaccine instead of his 12 year old daughter; No additional adverse effects to report; This spontaneous report was received from a consumer and refers to his 6-month-old daughter. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  The reporter stated that on 24-AUG-2020, the patient was accidentally administered with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) first dose (dose, lot#, expiration date were not provided) intramuscularly, instead of his 12-year-old daughter (product administered to patient of inappropriate age,  wrong patient received product). No additional adverse effects were reported.
After the first dose 1/21/21, my period started 1/27/21, 4 days earlier than the earliest expected (1/31/21). Usually the shortest time between my periods is 24 days (and up to 30 days) and this time it was just 20 days. After my second dose 2/11/21, my period started the next day - 2/12/21 with the time between periods 16 days only. It also was heavier than usual and lasted for 5 days (usually it is 4 days). The bleeding then stopped.
5 minutes post vaccination client felt dizzy & confused  assessed by MD; assessed by paramedics client verbalized she has not slept well or care n since last night mother verbalized she was weaned off Zoloft and had first dose of Effexor today client refused to go to the hospital assisted by paramedics & family to car
Patient started having cold sweats and dizziness few minutes after having the vaccine around 1:30 pm. Patient was still seated on the chair and pharmacist was standing by there with her and asked her if she wants to call 911 for her which patient said no as she just wanted to sit down and have some water. Store management helped pharmacist to bring cold water and a fan for the patient. After 20-25 minutes patient was feeling normal and she said she  will be ok to leave for home (time was 2:05 pm). Patient was advised to use cold packs on injection site and take Ibuprofen or Tylenol in case of any pain or fever.  Store manager escorted patient to her car . Pharmacist called patient an hour after she left the store to check if she got home ok which she did and was feeling well, no more dizziness or any other side effects.
Headache, Arthralgia, Fever, Chills, Lost Voice Narrative:
collapses on the golf course after a heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp via public post.  This case involves a patient of unknown demographics who collapsed on the golf course after a heart attack while receiving vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, frequency, lot number, route, administration site) for prophylactic vaccination. Information on the batch number was requested.  On an unknown onset and unspecified latency, the patient "collapsed on the golf course after a heart attack" (myocardial infarction) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses on the golf course after a heart attack).  At time of reporting, the outcome was Unknown for the event collapses on the golf course after a heart attack.; Sender's Comments: Sanofi Company Comment dated 08-Feb-2022: This case involves a patient of unknown demographics who collapsed on the golf course after a heart attack while receiving vaccine INFLUENZA VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Originally came on as extreme brain fog with discomfort under left arm pit. Slowly progressed to tingling in lips, teeth and right hand thumb. Two weeks after the vaccine I experienced a panic attack. Prior to the vaccine I had never had a panic attack. In the coming weeks Cognitive thinking was a lot harder. I also experienced blurred vision in the inability to focus on any task. I also a sensation like Novacaine coming into my mouth over the course of a couple days. After the advisement of two of my doctors, I went ahead and got the second shot . Two days after the second shot, I experienced TMJ in my jaw that was so severe I could hardly chew for a month. This sensations in around the face neck, chest area in increased, and are prevalent every single day since the vaccination. I have gone to every doctor I could think of. These doctors include primary care, neurologist,  MS clinic, long, Covid clinic, cardiology, psychologist, and infectious disease. I keep being diagnosed with anxiety and stress. I have taken numerous SSRI?s, and other anti-anxiety and depression drugs. I?ve never taken any of these prior to vaccine. None of them have ever taken away any of the symptoms. I?ve also tried acupuncture and holistic purchase, such as breathing exercises and meditation.
reported not feeling well for about 2 weeks. Presented to the ED on 11/27/21, with room air SpO2 at 82%, cough, shortness of breath and nasal congestion. She was hospitalized 17 days from 11/27/21 - 12/13/21 then discharged home with home healthcare.
This spontaneous report as received from a registered nurse refers to an unspecified number patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that the patients received doses of (Oka/Merck) VARIVAX INJ (lot numbers, doses, and route not provided), on unspecified dates, that were exposed to temperatures outside of the proper storage range. No adverse effect reported. Additional information has been requested.
DTAP on 3/9/06. On 3/11 had fever 104. 3/13 developed 3 episodes of crying, kicking lasted about 20 minutes each.
Initial case was received on 05 August 2010 from a healthcare professional. A 14 year old male patient received on 04 August 2010 an injection of MENINGOCOCCAL VACCINE (manufacturer and lot not reported) and an injection of TETANUS (manufacturer and lot not reported). On 05 August 2010 the patient presented to the emergency room (ER) with fever (NOS), chills, shaking and back pain. The ER physician stated that it appeared to be meningococcemia and labs were pending. No further information was provided and the outcome of the adverse event was unknown. List of Documents held by Sender: None.
Admit for COVID pneumonia. Treated w/ remdesivir, tocilizumab, steroids, vit-c, zinc, high-flow O2, plasma, rocephin/doxy. Developed RLE DVT, started Eliquis. DC on 5L home O2.
fever 101 , ongoing heavy nasal congestion, coughing ,sneezing, no appetite
itchy skin in general, a couple small itchy rashes on right side of neck and left rib cage,  Trying not to be hypochondriac and was pretty relaxed about getting the vaccine but realized a couple days after I had started feeling itchy all over
Patient recieved flu shot on 9/30/09 at approximately 1pm.  Approximately 30 mintues after recieving the shot the patient reported to the nurse that her arm felt cold and numb (like it was asleep).  The nurse inspected the arm and noted no redness, edema, ecchymosis or other abnormalities.  Patient was asked if she would like to be seen by a physician and she declined.  Patient was instructed to contact facility if symptoms worsened.  Patient was contacted on 10/1/09 for follow-up on symptoms and reported that the feeling in her arm has returned to normal and she is just a little sore at the injection site.
Within 24 hours of vaccination patient had acute, severe (8-9/10) knee arthralgias and swelling for 3-4 days, with pain persisting for 2 weeks but slowly decreasing in severity.  Patient reported the reaction in early January 2020 during a routine health screening (PHA) and said he realized he didn't seek care initially, but was embarrassed.
Initial symptom was tingling then loss of feeling in both lower legs. Happened a few times over several days. Lasted for several minutes each episode. Also had involuntary muscle tightness and pain in left upper thigh (quads) and left biceps.  These episodes also happened several times, but not concurrently.
Starting at least 12 hours after vaccination, patient began to experience nausea, vomiting, anxiety, and numbness in the hands.
Patient complained of arm hurting - very sore and not able to lift very high the morning after injection.
Guillian-Barre syndrome, loss of sensation in extremities and motor movement coordination 10 days after influenza vaccination.  Treated with IVIG 24 gm x 1 then 42 gm x 4 doses.  12/29/06 Received partial medical records from hospital with note that d/c summary not available at this time.  Admitted on 12/13/06.  H&P indicates patient with increased back pain, numbness of hands & feet, facial numbness, headaches & frequent falls prior to admit.  Consults by neurosurg, neuro.  Admit Dx: carpal tunnel syndrome, polyneuropathy possible Guillain Barre Syndrome  2/2/07 Received additional records from hospital which reveal patient experienced lower extremity weakness & falls from 12/13-12/21/06.  Also had weak cough & poor swallowing but did not require ventilator.  Day before d/c, developed fever & CXR showed LLL infiltrate.  Started IV antibiotics & was to continue oral antibiotics upon transfer to rehab facility. FINAL DX: Demyelinating polyneuropathy, c/w Guillain Barre Syndrome; HTN; poorly controlled diabetes; chronic pain; & pneumonia.
Hospitalization 12/21/21-12/25/21 for acute hypercapneic/hypoxic resp. failure/COVID19. Treated with dexamethasone 12/20-12/22, zinc 50 mg daily 12/21-12/25, vitamin D3 50 mcg daily 12/21-12/25 and vitamin C 1,000  mg 12/21-12/25.
No true adverse event product was sent short dated from the manufacturer. Expiration date of the LOT was 09/30/22 but Pfizer determined that the stability data supported immunization with this lot through 10/19/22 and we were instructed that re immunization was not recommended or needed.
Pt. developed generalized papular rashes on 8/10/14, 2 days after receiving Hep A vaccine. No fever. No lethargy. No vomiting. No difficulty breathing. Appetite normal.
Initial case was received on 29 September 2010 from a healthcare professional. A 55 year old female patient received an injection of ADACEL in March 2008. On an unspecified date, the patient experienced shortness of breath and a rash on the chest. No pre-existing medical conditions, no known allergies and no concomitant medications were reported. No further information was provided. The patient recovered on an unspecified date. Follow-up information was received on 01 November 2010 from a healthcare professional. The reporter could not provide additional information. The patient was not seen in the reporter's clinic until 2010. Documents held by sender: None.
Fever 7 days after vaccine, swollen suboccipital lymph nodes, rash 10 days after vaccine, sore throat, cold symptoms.