chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach pain; Back pain; Diarrhea; Low appetite; Was in bed for two days; He wanted to know after passing 42 days is it worth to receive the 2nd dose and can he still get that.; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIARRHEA (Diarrhea), DECREASED APPETITE (Low appetite) and BEDRIDDEN (Was in bed for two days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIARRHEA (Diarrhea), DECREASED APPETITE (Low appetite), BEDRIDDEN (Was in bed for two days), PRODUCT DOSE OMISSION ISSUE (He wanted to know after passing 42 days is it worth to receive the 2nd dose and can he still get that.) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIARRHEA (Diarrhea), DECREASED APPETITE (Low appetite), BEDRIDDEN (Was in bed for two days), PRODUCT DOSE OMISSION ISSUE (He wanted to know after passing 42 days is it worth to receive the 2nd dose and can he still get that.) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Fever body aches chills fatigue starting 16 hrs after vaccine.   Symptoms continued for 4 days after vaccine before reducing in severity.   All symptoms still present today, 5th day after vaccine  .   Max temp recorded 100.7
*Patient received Shingrix series at Pharmacy* Patient had 2nd Shingrix August 5, 2019 and had achiness (first one was 6/3/19), HA Skin tingling, couldn't regulate body temperature and had fever; went to Hospital and was admitted 08/15/19-08/17/19; back to ER 08/23/19; given Fioricet, and subsequently Ketorolac 10mg q 8 hours, and then Zofran ODT (but made him more nauseous); not currently with HA; but taking Ketorolac q 7.5 hours; decreased appetite, started eating 08/26/19;  couldn't practice guitar for 3 weeks as guitar "too heavy"; just started driving again 08/26/19.
Patient received her second Pfizer vaccine on 4/12/2021.  On 4/19/2021 patient had a localized right sided tonic-clonic seizure, evaluated at local ER.  Patient has no prior history of epilepsy or seizure disorder.  Patient has no history of drug/alcohol use.
Seizures post MMRV with MRI evidence of brain stem ischemia. Residual spasticity onset fever 10 d past dose MMRV, Prevnar, Hib, Influenza 03/15/07-records received from facility for DOS 11/14-11/28/06 DC DX: respiratory syncytial virus bronchiolitis, resolved. Encephalopathy with basal ganglia lesions of unknown etiology. Seizure disorder. Dysphagia. mild spasticity. PMH:no significant medical history.  Developed fever and neurologic changes 11/14/06 approximately 10 days after vaccinations. initial symptoms included stiffening of legs, sucking type action of tongue and temperature to 104 and somnolence.  Remains with cognitive delays including Language, social, and reston  Follow-up: Pt has a confirmed diagnosis of: Complex I deficiency Mitochondrial Encephalomyopathy. This is an inherited metabolic defect, and the direct cause of her seizures and brainstem atrophy. The seizures were likely triggered by fever from the MMR vaccine, but not causally related otherwise. Formal report will be forwarded if requested, and approved by pt's parents.
I had vomiting; diarrhea and body aches. I had those symptoms for about 8 hours.  I was taking Tylenol. The following day, I had what seemed to be like a sinus infection. That lasted for about a week.  Was prescribed Prednisone and something else.
first dose of Shingrix back in 2019 / did not receive second dose of Shingrix; difficulty walking; blurred vision; lethargy; This case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced walking difficulty, blurred vision, lethargy and incomplete course of vaccination. On an unknown date, the outcome of the walking difficulty, blurred vision and lethargy were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the walking difficulty, blurred vision and lethargy to be related to Shingrix.  Additional details were provided as follows: The reporter reported for herself. The age at the vaccination was not applicable for the 2nd dose. The patient received 1st dose f Shingrix in 2019, and experienced lethargy, blurred vision, and difficulty walking the evening of the day the first dose was received. The reporter stated that, all symptoms lasted approximately 2 days. The patient was past due for dose 2 of Shingrix and till the time of reporting, did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Information has been received from a health professional concerning a 12 yr old pt who a long time ago was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Recently, in approx Nov 2005, the pt experienced a full blown case of chickenpox. It was noted that the pt improved but the current status is unk. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (05Dec2022) Negative, notes: negative test; (13Dec2022) Positive, notes: positive Covid test on day 15. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: vaccine received and no other medication in 2weeks. Paxlovid rebound, positive Covid test on day 15 after starting Paxlovid, and 8 days after first negative test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
"I received the flu shot yesterday at around 4:15pm. I felt fine, but around 8:00 my arm started hurting in the spot where the shot was administered on my right, upper arm. Pain where I have received a flu shot before is normal, but this kind of pain with it is not normal. The pain on the shot area started hurting around 8pm and through the night it got worse, and this morning it hurt very bad, too much to even touch it. Whenever I move my arm, it hurts to move it, so I thought I'd try to maybe break up the acid (this was my thought as to maybe why it was hurting) in the arm, so I forced myself to rub the area to see if that might help. Since then, I have been dizzy, and shaky and have felt like I might pass out." from employee report.  employee went to urgent care 10/19. symptoms resolved by 10/23/2023
I thought I had a cramp in the right calf on 2/27/2023. By that night, it became more and more painful. I tried walking it off and drinking pickle juice, but nothing worked. On Thursday, I could hardly walk. At about 1:00PM on 3/3/2023, I noticed that I had a large bruise on the back of my leg, just below the knee on the calf. By about 6:00 PM, the bruised extended from the bottom of the thigh to just above the crook of the knee; it had gotten larger. At about 7:30PM ET, I went to the ER. I underwent an ultrasound, which indicated that I had a deep vein thrombosis within the right distal superficial femoral vein and the popliteal vein. An eight-millimeter swollen inguinal lymph node was also indicated in the right leg. I was given a LOVENOX injection. They also prescribed me 15 mg of XARELTO, which I am to take twice a day for 21 days. After that, the dosage will be 20 mg twice a day for 30 days. At the time of this writing, it's still very painful. It's not as bad as it was before, but at this point, the pain is about a 7 on a scale from 1 to 10.
in  Health Unit 5-11-07 for immunization reported that on 10-31-06 child received immunizations and had rash on upper/lower gums and around mouth after receiving immunization; no increased temp. was given Benadryl per MD orders-No further problems.
2 days ago started all over with the redness at the site, raised area, warm to touch, itching, pain, slight headache,
Client received Children Pfizer vaccine not appropriate for her age for the first dose.  The right Pfizer vaccine was administered and they parents were inform about the error.
Fever off and on 3/15, 3/16, 3/17. Left elbow pain 4/12 & 4/13 - screaming 5 to 10 sec. Noticed eye lid droop 4/12 - present (optic palsy) (ocular palsy or cranial nerve palsy). Possible eye alignment off 4/16 - present Second dose of mmr, but first dose of varicella.
Tetanus Toxoid given left deltoid 06/20. 06/23 7 x 10 cm red, raised area.
Flushed, heart racing, pressure on arm, anxiety. EMS attended and cleared patient.
Urticarial-type rash (serum sickness like) that started 1 1/2 days after immunizations and recurred X 2. After 2/14/01 and 4/18/01 immunizations had concomitant shots on these 2 dates which were Hib and Prevnar. No respiratory symptoms.
Patient found on floor, taken to ER via ambulance, placed on ventilator, MRI determined patient suffered a stroke and had zero brain activity or chance of recovery.
Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated intramuscularly with a first dose of Gardasil. The next day, the patient developed a high temperature of 103 degrees F. Unspecified medical attention was sought. Subsequently, the patient recovered. The physician plans to continue the series of Gardasil. Additional information has been requested.
Symptoms started about 7-10 days after shot, symptoms were worse around a month after shot. Symptoms started wearing out around 8/31/06. Symptoms included irritability, fatigue, swelling at injection site, malaise, nausea and vomiting, vertigo and dizziness, shoulder pain, neck pain and stiffness, liver enzymes elevations, jet lag like effect and light headedness. No treatment. Episode lasted around 2 months.
adult patient was given a pediatric dose; adult patient was given a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 46-year-old female patient who received HBV (Engerix B pediatric) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   On 13th December 2021, the patient received Engerix B pediatric 10 mcg. On 13th December 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The clinic supervisor reported that, an adult patient was given a pediatric dose of Engerix-B during a visit, which led to underdose and adult use of a child product. The reporter consented to follow up.
Within 48 hours she was feeling palpatations that came and went up to 120's, some SOB and mild left leg numbness, at 72 hours she also was  feeling a chest pain.  She was seen in the ER  and labs EKG reported as normal.  She was given fluids and ibuprofen.  Seen one week after vaccine and still having numbness of left leg that seems to occur right before the sensation of palpatations and SOB (never over 120) chest pain is no longer as bothersome.
Vaccine stored in freezer but 2 degrees F high -1 degrees F low; Vaccine administered to patient past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past the expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in freezer but 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 021F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in freezer but 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past the expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in freezer but 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. The vial was stored in standard freezer on 30-Nov-2021 at 2 degrees F high and -1 degrees F low. Treatment medications were not provided. The case is reported for the 10 of 45 patients.
Redness with induration 5 x 6 cm and inflammation. On (R) deltoid region.
She got her vaccine, she checked with her PCP and her pharmacist and was told that she could get the 4th one as she is immunocompromised.   She had a mammogram a day after the 1st vaccine and told her to look at the pictures and that the Pfizer vaccine had changed her lymph nodes, and that they had seen a pattern with the Pfizer vaccine.  She did not feel well that day and then by Wednesday she was completely laid out.  Her joints hurt, had no equilibrium, no balance, and stayed in bed for a week or so.  she called her PCP a couple of times and was informed it was probably a reaction to her vaccine.  Tuesday a week ago she saw a doctor and ran tests, and had a pretty severe UTI and some other infections as well.  She was put on antibiotics and did not help.  She went back on Monday for the FU and she had told her that her GI doctor had a special IV to combat a really strong UTI like she had, had this for 3 weeks.  She went to see her GI doctor who admitted her and was on 2 days of IV antibiotics, and got out yesterday and is very weak right now.   The infection has now cleared.
Sore arm at injection site; Fatigue; aches; fever; chills; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old male patient received BNT162B2 (BIONTECH COVID 19 vaccine, Formulation: Solution for injection, Batch/Lot Number: EP6955) via an unspecified route, administered in Arm Left on 13Apr2021 at 17:30 (age at vaccination 49-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); atorvastatin calcium (LIPITOR); psyllium hydrophilic mucilloid (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]), omeprazole (PRILOSEC [OMEPRAZOLE]) and eszopiclone (LUNESTA). Historical vaccination included first dose of BNT162B2 (BIONTECH COVID 19 vaccine, solution for injection, Batch/Lot Number: EP6955) via intramuscular route, administered in Left arm on an 23Mar2021 at 17:45 as dose 1, single for COVID-19 immunization. Facility type Vaccine was workplace Clinic. The patient did not receive any other medications within 4 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to and Post vaccination. On 14Apr2021 at 10:00 the patient experienced sore arm at injection site, fatigue, aches, fever and chills. No treatment was received. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Dr. saw patient on 8-14-08 due to red swollen left arm.  Swelling extended from shoulder to elbow.  No fever.  No drainage.  Patient placed on AUGMENTIN.  Dr. saw patient on 8-15-08 for follow-up.  Arm no longer red.  Swelling down a bit.
Pale; had what looked like seizure and kept going in/out of consciousness; drop in BP.
This is a spontaneous report from a contactable consumer. A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient previously received dose 1 of  BNT162B2 on 19Mar2021. Reporter stated she did not have the typical reactions but she had dizziness, weakness, and overall not feeling well. She saw in the FactSheet that this was an allergic reaction to the vaccine. She reported her dizziness only occurred when she was walking and not sitting. She did not have a fever and she did not drive at first but she was driving now. The dizziness was starting to go away but then came back and intensified after she received the second dose on 10Apr2021.  She called her primary care doctor and she also went to a neurologist who did not know what to do about it, but the neurologist would like to do some test for some things that have been on her brain for 30 years. She has had many CT scans in the past. She will be going to an allergist on Monday who also told her prior to receiving the COVID vaccine that she would have a reaction to any COVID vaccine due to her list of other allergies. She was thinking of putting off her neurologist test until after she sees the allergist. The outcome of the events was not recovered. She would like to know how long will this dizziness last and what should she do about it.
Arm swelling/soreness, nausea, chest was hurting (found spot on the lung), coughing hard causing blood to come out
No additional AEs; MMR II administered after reconstitution with expired diluent; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant therapies provided.  On 11-APR-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot# reported as T012860 (lot number T012860 was an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)), expiration date reported as 14-APR-2022, 0.5 ml, subcutaneously (anatomical location not provided) for prophylaxis. The vaccine was administered after reconstitution with an expired Sterile Diluent, lot# S024969, expiration date 17-MAR-2022. No additional adverse events and product quality complaints reported.
Off label dosing; Fatigue; Diarrhea; Hypertension; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label dosing), FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and HYPERTENSION (Hypertension) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer.    The patient's past medical history included No adverse event.   On 01-Feb-2021, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced OFF LABEL USE (Off label dosing), FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and HYPERTENSION (Hypertension). At the time of the report, OFF LABEL USE (Off label dosing), FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and HYPERTENSION (Hypertension) had not resolved.            No treatment information provided.
Nausea Vomiting Day 1, fever started 11:30 PM, Hives began Day 3, Respiratory Distress night of Day 3, Nausea now subsiding, Hives and Respiratory distress are still going on.
low grade fever 100.8 for 3 days Cold feet and hands for 7 days Slept for most of the day for 7days
A report received on 10/30/2001, concerning an 85 year old male pt who experienced pneumonia which was considered to be medically significant, 1 day after receiving the fluvirin vaccine on 10/04/2001. relevent concomitant medications taken include bisoprolol fumarate and leuprorelin acstate. On 10/05/2001, the patient experienced pneumonia, which was considered to be medically significant 1 day after receiving the fluvirin vaccine on 10/04/2001. The pt has recovered without sequelae. There was insufficient info to determine the reporter's causality assessment. Follow-up report received on 02/28/2002 indicated that the pt was diagnosed with left sided lobar pneumonia, viral. There were no results of investigations documented. The pt had a history of prostatic carcinoma. The pt was treated with levofloxacin and augmentin for the event. OMIC
Swelling and redness at injection site - right arm for 4 days, No treatment given
had local rxn. to shot, swelling on (R) thigh where PENTACEL was given at 2 mo shot that resolved with warm compression.
Pt developed a red rash on both thigh, calves and feet which resolved without treatment in approx 20 minutes.
Patient was vaccinated with two doses of Moderna COVID-19 vaccines on 4/1/2021 and 4/29/2021, then subsequently diagnosed with positive COVID PCR on 9/30/2021 in the ED but was subsequently sent home. Patient then re-presented to the same hospital and this time was admitted on 10/4/2021.
rash on both legs 24hr p/vax; T100.6 R on 3rd day;not rxn to ETOH;tx DPH 3 days p/vax;
When administered, the shot burned  I have been taking ibuprofin for pain. generally feels like a bruise & irritating nerve pain to sleep. the 21st & 26th I experienced nerve pain going from my shoulder down my arm, up my neck and across my chest 21st-went to ER, 26th came to urgent care