chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling terrible bad; Pounding head ache; no appetite at all.still persisting until the day of the call; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite at all.still persisting until the day of the call), FEELING ABNORMAL (Feeling terrible bad) and HEADACHE (Pounding head ache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 002B21A) for COVID-19 vaccination.     No medical history was provided.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced DECREASED APPETITE (no appetite at all.still persisting until the day of the call) and HEADACHE (Pounding head ache). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling terrible bad). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 mg and NAPROXEN SODIUM (ALEVE) for Headache, at a dose of 200 mg. At the time of the report, DECREASED APPETITE (no appetite at all.still persisting until the day of the call) had not resolved and FEELING ABNORMAL (Feeling terrible bad) and HEADACHE (Pounding head ache) outcome was unknown.                Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Significant follow up: Event outcome updated. Patient states:I still have and no appetite
1/11 vaccination By 10pm, started to feel achy, HA. Went to bed 1/12 woke up with dry cough, chills, no fever, achy.  took some medication, went to work. Informed staff. Took Rapid test; negative. Was not feeling well. Took rest of the day off. Tested again the following day; standard and rapid covid test; negative.  Employee health consulted.  Symptoms lasted for 48 hours.
I tested positive for Covid on 01/02/2022 at urgent care. Symptoms began on 12/30/2021. Mild dry cough, drainage, and sneezing 01/04/2022 losing taste and smell. Taking Coricidin. Exposed from family who went to a party prior to coming to my house
Day of injection, 6pm discomfort by 9pm the pain in my left arm was on a scale of 1-10 was a 13-15 the worse pain I have ever had in 77 yrs, now two days later quite a bit of discomfort and swelling from my left shoulder down my arm within 5 inches from my wrist, with a considerable amount of redness on the site of the swelling.
Initial report was received on 24 July 2014 from a health care professional. Verbatim from the report: "Background: The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, used for monitoring the safety of all licensed vaccines. In March 2008, ACAM2000 replaced DRYVAX as the only licensed smallpox vaccine and is administered to all persons entering military service and certain civilian researchers. In 2011, routine data mining of VAERS identified a vaccine safety concern resulting in acute ischemic cardiac events (ICE) following ACAM2000. Methods:  During March 1, 2008 through June 30, 2013, we reviewed all serious reports received following ACAM2000 and classified them by diagnostic category. We identified possible ICE cases by searching the Medical Dictionary for Regulatory Affairs (MedDRA) terms for "myocardial ischaemia," "acute myocardial infarction," "myocardial infarction," and "ischaemia," and applied standardized surveillance case definitions. Results: VAERS received 1149 reports following ACAM2000 administration; 169 (14.7%) were serious (resulting in permanent disability, hospitalization or prolongation of hospitalization, life-threatening illness or death), including one death. The two most frequent diagnostic categories for serious reports were cardiovascular and other infectious conditions. The MedDRA search found 31 reports of possible ICE after receipt of ACAM2000 vaccine. Of a total 30 possible ICE cases with demographic information, all but one was male; the age range was 20-45 years (median 32) and median interval to onset of symptoms was 12 days. On clinical review there were 16 cases of myocarditis/pericarditis and 15 ICE cases. Conclusions: Our review of the data mining signal did not substantiate the concerns about ICE after ACAM2000. Our study also suggests that with current pre-vaccination screening, cardiac morbidity in generally healthy vaccinated populations remains uncommon." This case pertains to the unidentified patients in the article who experienced adverse events but did not have fatal outcomes. The two deaths described in this article have been previously reported; details are captured in case numbers 2012-00924 and 2009-00544. Documents held by sender: none.
FATIGUE; MUSCLE PAIN; CHILLS; This spontaneous report received from a patient concerned a 70 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue, muscle pain, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, muscle pain, and chills. This report was non-serious.
Very Uncomfortable; Sore Throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Very Uncomfortable), OROPHARYNGEAL PAIN (Sore Throat) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced DISCOMFORT (Very Uncomfortable), OROPHARYNGEAL PAIN (Sore Throat) and HEADACHE (Headache). At the time of the report, DISCOMFORT (Very Uncomfortable), OROPHARYNGEAL PAIN (Sore Throat) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Patient states that she received COVID-19 vaccine on 1/7/2021. After the vaccine she became light-headed and blood pressure of  186/103.      As per patient she does not have history of elevated blood pressure. She was followed-up with her PCP and prescribed two medications.  She tested negative for COVID-19. She went to Ed and was sent home.    (After further discussion, pt stated that she has been told in the past that she has HTN, was started on medication but discontinued it because "my blood pressure returned to normal."  )
fever of 101.4°F; Chills; Body ache; Headaches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), HEADACHE (Headaches), FATIGUE (Fatigue), PYREXIA (fever of 101.4°F) and CHILLS (Chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (Body ache), HEADACHE (Headaches) and FATIGUE (Fatigue). On 18-Mar-2021, the patient experienced PYREXIA (fever of 101.4°F) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache and Ache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever and Chills, at an unspecified dose and frequency. At the time of the report, PAIN (Body ache), HEADACHE (Headaches), FATIGUE (Fatigue), PYREXIA (fever of 101.4°F) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101.4 f (High) 101.4 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified vitamins.
Moderna covid-19 monovalent booster administered after 9/2/22.  On 9/16/22 monovalent booster administered, no adverse reactions noted, pt informed.
Generalized pruritis without a rash. More predominant to perioral area, tongue, palate, and to hands.
Per provider, no adverse effects noted at this time from receiving Janssen Covid Vaccine 3/11/21 and then Moderna # 1 vaccine on 9/2/21.
Began needing to urinate in the evening constantly, with little to no output. No night waking. No UTI. Symptoms are better than they were, no increase of symptoms after second dose on 12/04/21.    Patient did also begin having diarrhea and vomiting on 11/24/21. Symptoms resolved on 11/30/21.
Left arm redness, swelling and rash around the injection site. Bodyaches and nausea for 2 - 3 days.
very irritable for 48 hrs following vax; unconsolable, poor appetite; exam on 23MAY nl-ears were better;
1 day after shot: Extreme headache, fatigue and body aches. 3 days after shot: Headaches off and on 3 days after shot: Sweating profusely, fatigue, and headaches off and on 4 days after shot: Headaches off and on 5 days after shot: Broke out in hives and very itchy, felt tingly and off and on headaches, fatigue
swollen, red patch about an inch in diameter at the injection site, warm to the touch, uncomfortable/slightly painful when pressure is applied to it and slightly itchy. Not severe. Noticed discomfort about a week after injection, fairly high up on arm, so it wasn't noticed prior although may have been present. No treatments, just giving it time.
Next morning after injection, woke up not feeling well. Temperature, shakes, internal quivering, chills, tired, aching joints. This went on for 2 more days. Temperature ranged from 100.2 to 101.6.  Friday morning (2/5) woke with fever of 101 but soon dropped down to 99. As the day went on temperature became normal and has stayed that way. Lost 3 pounds and still feeling very tired.  Arm at injection site was swollen and very hard.
Patient arrived to recieve the third dose of the Pfizer vaccine series. Patient has hx of syncopy to the first dose, so she drank gatorade in preparation of third dose, as per MD orders. After vaccination, patient began to droop and lose consciousness, so we responded immediately by taking vitals and lying patient in supine position. Patient was breathing slowly and systolic BP was 110.  Team then called 911 and assessed vitals periodically until paramedics arrived. 5 minutes later, the paramedics arrived and patient was AO x3. Patient was then transferred to Hospital, and a nurse from our team accompanied her. Patient is currently in hospital and all vitals are OK.
Recipient came in to POD clinic on 3/16/2021 for her 2nd Moderna vaccine dose.  Per recipient, she had an immediate reaction 20 minutes after the 1st vaccine.  She experienced itching of the lips and cheeks.  She reported to an observation staff and apparently was told that it was ok to return for her 2nd dose but would be monitored longer.  The assigned Vaccine Team Leader nor the Clinic Manager that day was not made aware.  Reviewed screening questions with recipient.  Informed that she is unable to receive the 2nd dose of the Moderna vaccine at the clinic.
Severe headache and mild nausea started ~ 3 hours after injection. Joint pain and muscle aches started ~6 hours after injection. 1000 mg of Tylenol taken twice over the next 24 hours with some relief. Work was missed the day following injection due to inability to perform daily functions. Mild residual muscle aches 2 days after injection (today).
Patient with no prior otologic history notes onset of bilateral hearing loss ~ 10 days after first dose of vaccine. She notes associated non-pulsatile tinnitus and aural fullness AU. Currently treated with oral steroids
canker sore/ unable to eat or drink  Patient reports she developed canker sores on her gums, her tongue, and on the inside of her cheeks a few days ago. The sores on her tongue seem to be disappearing, and she hasn't noticed any new sores forming yet. Gums have been red & inflamed. Patient has been eating soft foods such as applesauce or else it is painful. She has used warm salt water rinses & has helped but not enough relief.  **FYI- Patient did recently get her Moderna COVID vaccine on 4/30/2021**  She recalls that the mouth sores began shortly after she received the vaccine.  Started CMPD- Magic Mouthwash (Lidocain Vic 2%/Benadryl Elix/Antacid 1:1:1)
devel varicella as did brother, both of whom recvd same lot of vax w/o resulting protection
This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. No information regarding the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX dose reported as 19400 PFU (plaque forming units) (lot number and expiration date were not reported) for prophylaxis. The dose of ZOSTAVAX was reconstituted with sterile diluent (MERCK) (dose, lot number and expiration date were not reported). On an unknown date, the patient experienced injection site rash and injection site swelling. The outcome of the events was unknown. The relatedness between the events and the suspect therapies was not reported. Additional information has been requested.
arm was sore; Headache; Lightheadedness; Fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6202; Expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at the age of 70-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. It was reported that patient received her second shot of the Pfizer BioNTech COVID-19 vaccine last week and on the way to the vaccination appointment, she reported she took one Tylenol. She stated it was then about a half hour later that she received her vaccine and would like to know if this affected her vaccine in any way. Caller did report after her second shot on an unspecified date her arm was sore "for maybe an hour" and then went away. She received 2nd dose of vaccine. Was stuck in traffic and got a headache so she popped an Tylenol not thinking about vaccine. So when she got shot, arm was little sore in the beginning like when she was walking back to her car and then it went away. She didn't have any symptoms other than lightheadedness and little fatigue. She was so scared that she knocked out the second shot with that one Tylenol. She was thinking as - What did I do? Did I ruin the second shot by taking that Tylenol? I get that some time, I feel protected. Therapeutic measures were taken as a result of headache as patient took Tylenol. The outcome of arm was sore was resolved on an unspecified date while it was unknown for all other events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580889 same patient/drug, different dose/event.
pt recv vax 29OCT98 & the next day devel swelling around eyes, lips & face & was feeling poorly;pt was seen by MD & tx w/DPH;
loose stools (bowels); has not been able to eat anything; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (loose stools (bowels)) and FEEDING DISORDER (has not been able to eat anything) in an 80-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 DIARRHOEA (loose stools (bowels)) and FEEDING DISORDER (has not been able to eat anything). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (loose stools (bowels)) and FEEDING DISORDER (has not been able to eat anything) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Reporter stated that his aunt received the second dose of the Moderna COVID-19 vaccine about 3-4 weeks ago. And  stated that his aunt has already seen two doctors and is also going to see a third one on Friday 23-APR-2021.  Concomitant medications not provided.
Red, swollen, deformed, pt refused to walk (left leg)- cried for 5 hours- inconsolable. On Benadryl, ice, Advil per PMD
This spontaneous report was received from a Registered nurse regarding a 14 year old patients of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
I have genital herps which rarely flares. One day after my first and second dose of Zoster vaccine I had a flare of the genital herps with mild bumps, no pain or burning.
Ten hours after administration, patient complained of abdominal pain.  This continued for the next 16 hours.  Twenty hours after administration, patient had chills, and within the hour started to get a fever.  Fever started at 99.1F and one hour later it was 103.6 F.  Motrin was administered to reduce fever.  Patient slept for several hours. Twenty eight hours after administration and continuing, patient has a low grade fever that is not being treated.
This is a serious study case, initially received from Physician on 26-Jan-2018, concerning an elderly, male patient in his 80's, enrolled in market research study. The patient's relevant medical history and social history was not reported. On an unspecified date, the patient was administered with Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: injection (as reported), anatomical location, batch number and expiry date: not reported) for influenza vaccination. On an unspecified date, the patient diagnosed with Flu. The patient died due to flu over Xmas week, between 24-Dec-2017 and 31-Dec-2017. It was unknown, whether the autopsy performed. The reporter assessed the event (flu) as serious (death). Significant case amendment (26-Jan-2018): The as determined listedness' of the event 'Flu' was corrected from listed to unlisted in event assessment tab.; Reporter's Comments: A male patient of unspecified age was diagnosed with flu (influenza) which resulted in fatal outcome, unspecified period after receipt of Flu Vaccine Cell Subunit QIV NVD.The causal role of study vaccine for influenza can not be assessed, as minimal information is available regarding vaccination date, onset latency, clinical presentation, detailed investigations (swab and blood culture, immunological tests), immune status of the patient prior to vaccination, concurrent conditions and relevant medical history. Similarly, since the strain and type of influenza is not known, vaccination failure cannot be considered.; Reported Cause(s) of Death: Flu.
Woke from sleep at 12:45 a.m. on 3/19 with severe pain at injection site. Got up to urinate and take Tylenol. While in bathroom, became dizzy, broke into sweats, and felt I was about to faint. I went to my knees holding onto counter. My wife came in to help me in bathroom. She observed I was incoherent but uttering moaning sounds and breathing heavily. She called 911. While on phone I came to and vomited into sink. It appeared I had not digested anything from dinner that night. After vomiting (1x) I felt much better.  First responders reported normal vital signs. I did not go to E.R. that night but went to Urgent Care later that morning and all seemed fine.
Fever of 102 next day and migraine from 1/17-present. Unsure of when migraine will stop. A migraine lasting more than 12 hrs has never happened to patient. Prescribed medication (Imitrex) not working. Nausea and vomiting occurred 1/20 and again today, 1/22.
Pt. received influenza vaccination by injection. Pt was ok immediately after injection but about 5 minutes later lost consciousness while standing and was helped to ground. Within 30 seconds pt. had regained consciousness and complained his "heart felt funny" before loss of consciousness. Pt. remained sitting until EMS arrived.
10-21-09 2 hrs after injection L arm red and itching. 10--209 redness, swelling, itching spread/ L arm, throat tight went to PMD. Tx DECADRON 8mg IM. 10-22-09 AM BENADRYL 50mg po. Felt better 10-22-09 PM.
Left arm became bright red, hot and hard from shoulder to elbow. Reaction began 2 days after shot was given.
23OCT severe h/a, migraine-like x 1 day; hematoma @ site of inject; pt has taken flu shot previously; soreness @ site, sore to touch;
Started seeing black spots like she was going to pass out; Dizzy/light headed; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Started seeing black spots like she was going to pass out) and DIZZINESS (Dizzy/light headed) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PRESYNCOPE (Started seeing black spots like she was going to pass out) and DIZZINESS (Dizzy/light headed). On 30-Apr-2021, PRESYNCOPE (Started seeing black spots like she was going to pass out) and DIZZINESS (Dizzy/light headed) had resolved.            After the second dose the patient was sitting for a few minutes at the site, a minute or 2 after getting the shot she put her head down to look at her phone and soon she got dizzy and light headed and started seeing black spots like she was going to pass out. They gave her water and a few minutes later she felt better. Her HCP told her it could be a side effect or an allergic reaction. No concomitant medications were mentioned. Treatment mentioned water.