chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash nearlbelow injection site on left arm. Suddenly hot and itchy, as though rash suddenly appeared covering an area of about 4x4 inches. Rashy area felt hard to the touch. I applied topical benadryl lotion and cold packs to alleviate the discomfort. Lasted about 3 days.
Gotten 5 flu shots and got the flu every time; Initial information was received on 16-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved an unknown age patient who had gotten 5 flu shots and got the flu every time (Influenza), while being received with INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency following the administration of INFLUENZA VACCINE, the patient got the flu every time (Influenza).  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Came into ED on 4/14/21 reporting Vague chest pain x 2 days (starting 4/12/21) after receiving J&J vaccine x 3 days ago (4/10/21) at church.  No available lot#. Pt monitored and discharged from ED as patient did not appear distress and HR & respiratory normal. Pt advised to monitor and seek medical attention is symptoms worsen.
still hurts/arm and shoulder always hurts; problem in my arm/came back/then stopped/pain lasted for the first two weeks/pain never went away/worse/never goes away/From shoulder down to my finger; From shoulder down to my finger; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (still hurts/arm and shoulder always hurts), PAIN IN EXTREMITY (problem in my arm/came back/then stopped/pain lasted for the first two weeks/pain never went away/worse/never goes away/From shoulder down to my finger) and ARTHRALGIA (From shoulder down to my finger) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021921A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE PAIN (still hurts/arm and shoulder always hurts), PAIN IN EXTREMITY (problem in my arm/came back/then stopped/pain lasted for the first two weeks/pain never went away/worse/never goes away/From shoulder down to my finger) and ARTHRALGIA (From shoulder down to my finger). At the time of the report, VACCINATION SITE PAIN (still hurts/arm and shoulder always hurts), PAIN IN EXTREMITY (problem in my arm/came back/then stopped/pain lasted for the first two weeks/pain never went away/worse/never goes away/From shoulder down to my finger) and ARTHRALGIA (From shoulder down to my finger) had not resolved.            No concomitant medication reported.  The patient reported the third vaccine was hurt in Dec-2021 and continued.  The patient stated had a problem in arm and the pain never went away.  The pain lasted for the first two weeks, then stopped. But it came back and it was worse. It was from shoulder down to finger.  No treatment medication reported.   Reporter did not allow further contact
Nausea, vomiting, severe stomach cramps, fever, chills, hot flashes, dizziness.
Symptomatic with runny nose and HA since 12/23/21.  In quarantine. Tested Covid positive on 12/23/21. Isolation x 10 days then she needs to f/u with the hotline.
pharmacist administered an expired dose ofGARDASIL 9 to a patient; This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-NOV-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter dose, lot # N017832, expiration date: 16-NOV-2019 (number of dose and route of administration were not reported) for prophylaxis.
changes in my menstrual cycle/my period was due to start on May12. However, I did not start my period until today, May26; abnormal spotting for 5 days straight; heavier flow; stronger cramps than usual; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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. On 05May2021, the patient experienced changes in her menstrual cycle, not related to any other changes made in her personal life. Patient experienced abnormal spotting for 5 days straight, which was a brownish/red color. Very abnormal for the patient to have that for more than the occasional 1 day before or after an actual period. This started on May 5, a week before her period was due to start on May 12. However, Patient did not start period until today, May 26, making it 2 weeks late. Patient was also experiencing a heavier flow and stronger cramps than usual. It is not a huge cause for concern, as patient believe it will resolve itself, and patient don't want this to dissuade anyone from being vaccinated, but think women should know what to expect, especially because patient heard similar stories from many other women who have been vaccinated. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of event abnormal spotting was resolved on 10May2021. The clinical outcome of events "changes in my menstrual cycle/my period was due to start on May12. However, I did not start my period until today, May26"; heavier flow; stronger cramps than usual was unknown at the time of report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 10May2021 as a single dose for COVID-19 immunisation.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.
Moderately severe pain  at injection site for 36 hrs Headache, moderately severe body aches, chills starting 12 hours after injection and lasting 24 hours
Expired doses administered to 13 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. It was unknown if the patient experienced any symptoms.  No treatment medication information provided.
eczema welts; swollen lymph nodes in neck; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema welts) and LYMPHADENOPATHY (swollen lymph nodes in neck) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ECZEMA (eczema welts) and LYMPHADENOPATHY (swollen lymph nodes in neck). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of UNK dosage form. At the time of the report, ECZEMA (eczema welts) and LYMPHADENOPATHY (swollen lymph nodes in neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Entire right arm swollen, red, itchy, warm to touch followed by extreme chills and fever
This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot# N013992); expiration date 27-JAN-2019 orally (dose not reported) for prophylaxis, which had a temperature excursion of 47 degrees F to 77 degrees F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996; US-009507513-1809USA006251; US-009507513-1809USA006252; US-009507513-1809USA006253; US-009507513-1809USA006254; US-009507513-1809USA006255; US-009507513-1809USA006256; US-009507513-1809USA006257; US-009507513-1809USA006258; US-009507513-1809USA006259; US-009507513-1809USA006260; US-009507513-1809USA006261; US-009507513-1809USA006263.
Four weeks after I was BOOSTED with the Pfizer Vavination I wokeup in the morning at 08:00 am and found my right arm was frozen. It was painful to move it at all. My first thought was " could I have had a mild STROKE while I was asleep?" At 09:00 I called the Surgery and reported my condition to the Doctor. I was told to contact the Vacine Inquiry Line straight away. There, I was told to go on line. So I did but I didn't know how to report my situation. It will soon be a month andmy life has been turned upside down.
fluid in pericardium on 8/4/21 CT scan.  not there on previous scan in 10/20
Patient is a 88 y.o. male patient of MD with history of HTN, HLD, COPD, chronic hypoxemic respiratory failure, who presented to Hospital with SOB.   Acute CHF: Elevated troponin: Type II Demand ischemia secondary to hypoxia from COVID, MI ruled out CAD: HTN: HLD: Troponin 326 Pro-BNP 534 CXR demonstrates changes consistent with COPD and scarring involving the left costophrenic angle. IV Lasix Nitropaste Plavix, statin Heparin infusion for 48 hour  Continue home spironolactone Seen by cardiology " Patient without chest pain.  Can continue heparin gtt for 48 hrs post peak troponin.  Confirmed that patient is DNR CCA as documented in the ED admission notes. Suspect troponin type II leak from the hypoxia and COVID infection.  No additional testing needed . Continue current medical management, plavix and statin. "        COPD Chronic hypoxemic respiratory failure: COVID-19 pneumonia Low flow oxygen protocols Spiriva and Dulera Albuterol PRN Consult ID, started on remdesivir Start on dexamethasone 6 mg IV daily, received for 5 days we will discontinue at  discharge    Generalized weakness and Debilitation  PT/OT consult  DC to ECF
Initially presented as a blurry patch in my right eye visual field but has progressed into bilateral optic neuritis and low vision impairment in both eyes.
Eight hours after  vaccine I developed terrible chills fever, terrible myalgia and weakness .   The pain was terrible as was the fatigue and fever .  I used Ibuprofen.  48 hours later I felt almost completely normal- no pain etc .   Then 56 hours later resumption of chills fever for 4 hours .  At 64 hours and after ibuprofen feeling better
This spontaneous report was received from pediatrician referring a currently 6 weeks old male patient. The patient's medical history included family history of supraventricular tachycardia (SVT) in a  grandparent. On 29-SEP-2016, the patient's mother was vaccinated with the first dose of GARDASIL 9 (Lot # M016193, expiration date was not reported). The patient's mother was also using prenatal vitamins (reported in MARRS case #1702USA001555). On an unspecified date in 2016, the patient experienced fetal tachycardia. On 21-JAN-2017 (at one month of age), the patient developed SVT with cardiac arrest, renal and hepatic failure. At the time of the report, the outcome of tachycardia foetal, SVT with cardiac arrest, hepatic failure and renal failure was reported as recovered/resolved. But the patient remained on therapy with Sotalol. Upon internal review the adverse events cardiac arrest, tachycardia foetal, hepatic failure, renal failure and supraventricular tachycardia were considered medically significant. The reporter did not assess the causal relationship between the adverse events and the vaccination of the patient's mother with GARDASIL 9. This is one of two cases received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA001555.
1. SM reports worsening of tinnitus; onset JUN 2021. 2. SM reports multiple warts appearing on body; onset APR -MAY 2021. Initially noticed first wart on right foot, then noticed on back and penis. 3. SM reports frequent headaches with associated light sensitivity; onset MAY 2021. 4. SM reports prior wrist injury and back pain but states that he noticed both wrist ache, low back, and both knees ache. SM reports bilateral knee pain, right knee worse than left; onset July 2021. SM denies direct trauma to affected areas. 5. SM reports tongue with greyish/white build up, painless; states that he tried to scrape off tongue but unable to; onset MAY-JUN 2021. 6. SM reports frequent trouble sleeping and excessive worry; onset MAY 2021.
Baby's mother stated patient/baby had purple discoloration of feet and face ---> forehead - for 10 minutes. It happened about 4 hours after the vaccinations. No breathing or feeling difficulty or seizure activity noted. 1 Hour after the episode patient was seen in our office. Vital signs stable. Pulse Ox - 97%. He was clinically stable. He was then evaluated at ER.
On 3/4 approximately 24 hours after receiving first dose started shaking while standing as if I had parkinsons disease. The heaviest shaking was of the right arm and hand which was where the vaccine was administered. Made my way to bedroom on my walker to tell hubby I was not feeling well,  Took blood pressure which was elevated and my heart felt like it was beating out my chest, Bllod pressure was elevated and so was pulse. Shaking continued and breathing was shallow, Waited 10 minutes and retook vitals, BP and pulse up more, Called 911, Paramedics came and monitored my vitals several times which after 20 minutes started declining, Could not say conclusively if was vaccine related. Elected due to Covid not to be transported to hospital and signed off on declination, Was told by paramedics to call 911 again if symptoms reoccurred and go to hospital,  In successive days I still continue to have pin-prick feelings and numbness in my right fingers, More difficult to walk than usual,
pt says after a couple of weeks after taking the vax.  Her left arm became very hot, red, inflamed, and very sore and was spreading.  She contacted her PCP.  She was instructed to use hydrocortisone cream.  On 4/7/2021 she went to Urgent Care.  She was told she had an infection and put on antibiotics cephalexin 500 mg x 4 daily for 10 days and told to FU if it doesn't get better.  She still has these symptoms but seem to be getting better.
Headache, Myalgia, Arthralgia, NauseaVomiting, chills/ pain inj site
Information has been received on 15-FEB-2019 regarding a case in litigation concerning a 66 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In December 2015, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a health provider. In 2016, the patient was treated by a physician for pneumonia as a result of vaccination with ZOSTAVAX. The outcome was not provided. Upon internal review pneumonia was considered a medically significant event. Additional information has been requested.
my first does was 4/2/21 can I get the seco; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (my first does was 4/2/21 can I get the seco) 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.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (my first does was 4/2/21 can I get the seco). At the time of the report, PRODUCT DOSE OMISSION ISSUE (my first does was 4/2/21 can I get the seco) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
ACHES; DEHYDRATION; A BAD FEELING; CHILLS; FEVER; HEADACHE; LOW ENERGY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced aches, dehydration, a bad feeling, chills, fever, headache, and low energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, headache, chills, low energy, dehydration and a bad feeling was not reported. This report was non-serious.
pt recvd 3rd dose of vax; found to have elev liver enzymes p/ 3rd dose;sxs cont
Patient states that on day after subq Zoster immunization she noticed a "red area 2"x4" round" and "felt fluid" at the injection site. On 11/6 in AM it was replaced with "bigger than an egg" size "knot"  and was warm to touch. Denied fever or malaise.
9-15-08, 8:45 - 09:00pm a little lightheaded. 9-15-08 temp 101 degrees F at 9pm, Tylenol at 9:10pm and fell asleep at 11:00pm and awoke with no sx.
BELLS PALSEY; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. Patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, frequency time 1 total was administered on 30-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 27-OCT-2021, the patient experienced bells palsey and went to urgent care (Emergency room). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bells palsey on 29-OCT-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211133835-covid-19 vaccine ad26.cov2.s-bells palsy .This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Bilateral hip bursitis, right greater than left, exacerbated by flexion and extension of hip, pain controlled easily with ibuprofen 200 gm po, acute onset and lasted approximately 18 hours with slow improvement.
Local rxn redness & swelling 8NOV91; hives; SOB; went to ER put on DPH 9NOV; swollen tongue; SOB Tues called MD; given DPH 12NOV91;
30JUL97 pt called to say arm red, hot, sore 2inches larger than other arm;recv vax 29JUL97;pt advised to see MD:MD prescribed antibiotics therapy;pt to call if necessary;
1st dose 07/26/2019, didnt get the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th July 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter called and stated that he received the first dose of Shingrix but did not follow up and get the second dose.  The reporter stated he plans on getting the second dose as soon as possible.  The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
This spontaneous report was received from a medical assistant referring to a 7 year old female patient. The patient's relevant medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent. On 02-MAY-2018, the patient was vaccinated with VARIVAX lot number: N022978, expiration date: 23-AUG-2019, for prophylaxis (strength, route and dosage schedule were not reported). On the same day, the patient was also vaccinated with PROQUAD (rHa/HSA) lot number: N022954, expiration date: 02-MAY-2019, subcutaneously, for prophylaxis (strength and dosage schedule were not reported). No adverse effects were reported.
first vaccinations, including rotateg, received on 1/26/09 at 2mo. of age. mother called clinic to report that baby had 8 episodes of diarrhea 1/28/09 and continues to have diarrhea today.
PT PHONED ON MONDAY (7/13/09) MORNING AND SAID THAT SHE AWOKE ON SUNDAY (7/12/09) WITH A "BREAKOUT" ON HER STOMACH AND UPPER LEGS IN THE "AREAS WHERE IT'S WARMER". PT STATED THAT SITES DID NOT ITCH. SAID THAT WHEN SHE AWOKE ON MONDAY MORNING THAT IT "LOOKS LIKE CHICKEN POX". PT WAS ADVISED TO SEE THE PRESCRIBING PHYSICIAN.
Started with an intense scratchy throat and then it completely closed up. This lasted about 5-seconds & the itchyness is not as intense but has never gone away.