chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 17-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002980: US-009507513-2104USA002978: US-009507513-2104USA002981: US-009507513-2104USA002976: US-009507513-2104USA002983: US-009507513-2104USA002974: US-009507513-2104USA002982: US-009507513-2104USA002973: US-009507513-2104USA002975: US-009507513-2104USA002963: US-009507513-2104USA002985: US-009507513-2104USA002971: US-009507513-2104USA002984: US-009507513-2104USA002972: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Intense chills, insomnia, nausea, headache, stiffness in neck/lower back.
Multiple sclerosis exacerbation causing hemiplegia of left side. Initial symptoms started 02/04/2022 as mild tingling of left limbs, & progressed to total loss of control of left side, including face, arm, & leg by time of emergency room admittance on 02/08/2022. MRI results at time of admittance confirm active lesion in the right corona radiata. Five doses of intravenous Solumedrol were administered for treatment during in-patient stay from 02/08/2022 to 02/12/2022.
From May 14, 2021, I have started experience dizziness and weakness in my body. There has been slight fever during the initial days but the weakness and mild headache is still there till today i.e. June 9 2021. I do experience a little shortness of breath and chest pain (on both sides) sometimes but that is not continuous and remains normal most of the time. I have got stomach infection and constipation too during these times and I have taken a pill of Prilosec upon prescription of doctor. Stomach looks good and bowel movement is fine as of now. I have been monitoring my blood pressure and body temp during these days and they all were normal.    Apart from that I experience chills more than anyone around me and don't know if that is related to vaccine effect.  Currently, my main concerns are - mild headache, weakness in body and dizziness which is happening for almost a month now.
Red knots over all injection sites. Prescribed Mometasone Furoate 0.1% topical ointment to affected areas BID for 7-10 days.
patient was administered an expired dose of Vaqta; Improperly stored and administered vaccine; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-AUG-2019, the patient was vaccinated with an improperly stored and expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R018775, expiration date 09-AUG-2019 (exact dose, injection site and route of administration were not reported) for prophylaxis. There were no details about improper storage provided.
She said that she has a pretty swollen black eye that is really red too; She said that she has a pretty swollen black eye that is really red too; She said that she has a pretty swollen black eye that is really red too; Blacked out; severe stomach cramps; Nausea; Diarrhea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18Mar2021 at 09:55 (Lot Number: ER2613, unknown expiration) as a single dose for COVID-19 vaccination.  Medical history and concomitant medications reported as none. The patient received the first shot of COVID-19 vaccine in the morning of 18Mar2021, and after supper, she experienced severe stomach cramps, nausea, diarrhea, vomiting, and stated that she blacked out. She mentioned that she is just taking it slow and eating broth. She confirmed that blacking out has only happened to her 2 other times in her life. She said that it usually happens with the cramping and the vomiting in this same kind of situation. She plans to follow up with the physician. She said that she has a pretty swollen black eye that is really red too (unspecified date). She is putting ice on it. It did not seem like she ate anything that would cause this reaction. She has no other reason to think her reaction could have been caused by anything else. She called the pharmacist and they told her to report it to Pfizer. No additional vaccines administered on the same date of COVID-19 vaccine. No prior vaccinations within 4 weeks.  The patient recovered from events blacked out, severe stomach cramps, diarrhea, and vomiting on 18Mar2021; recovering from nausea; while unknown outcome for the remaining events.   No follow-up attempts are possible. No further information is expected.
On 02/19/20221 Reported to Primary Physician of increased blood pressure, night sweats and coughing. On 05/02/2021 reported to ER and reported Chest pain  and vomiting, On 05/05/2021 reported back to ER for Acute Chest pain Acute Abdominal pain and nausea (diagnosed with Acute Pericarditis) tHrough out the last nine months she has been to the E.R. 10 times and Hospitalized 5 times under the care of Dr.  also Pericarditis caused various bout of AFIB.
Initial report received from physician on 14 Jan 2010: A dose (0.25 ml) of H1N1 (batch no. unknown) was administered to a child younger than 4 years during the week of 04 Jan 2010. The reporter was away from her clinic at the time of report and no additional information was not provided.
Pt's right thigh is quite swollen (almost double the size of her left thigh). It is very red and hot to the touch. Mom states that the pt has been itching and scratching at the site since vaccine was given. Tylenol and Tempra given - cool compresses. Dx cellulitis and given antibiotics.
Moderna COVID-19 Vaccine EUA  after 10 days, a raised red patch at the injection site.  Itchy and achy. Still there 4 days.  approx 2" diameter.
Fatigue and brain fog started 9 hours after injection and are still present 6 days later
Immediate feeling of fainting 5 minutes after administration. Later in the day the following symptoms: nausea, fatigue, fever, severe chills, stomach pains.
Itchy rash all over body, no fever. Noticed rash @ 12:30 pm  Receiving immunizations the day before received #5 DTaP, #4IPV, #2 MMR, No signs illness.
Received MMR 5-5-10. had (L) axillary adenopathy, fever 99-102, rash, stiff joints-sudden onset-5-14-10.
Pt to ED 8/14 for weakness/fatigue/chills/fever for several days. Pt COVID+ 8/15, rx for Decadron/remdesivir. 8/16 pt a+Ox4, denies any pain, pt repositioned for comfort, no sob noted. 8/17 pt blood pressure is 84/48., , Pt denies any pain, pt A & O x 4. 8/19 Pt "I don't feel good" and then complained of left chest pain that radiates down side and dizziness. 8/20 pt remains A&Ox4.  8/25 pt Aox3, sepsis BPA firing score 7. Vital signs stable. 8/26 Pt cleared for discharge. IV removed, no complications. Pt discharged 8/26.
Vaccine given 9/6/10 in PM - on 9/7/10 - AM patient had soreness - on 9/7/10 in PM patient experience tingling - to elbow - and from elbow to head (like funny bone) 9/8/10 "elbow is sore - left hand numb - tingling.
Started with a headache,  from approx. 10pm 11-3  and the whole next day I ran a fever of 101.6 orally- which would come down with Tylenol but then if went up again when the Tylenol was due, I ached all over!! I felt terrible.  I spent the majority of my day on 11-4 in bed and did sleep a lot.. I had a head ache the first evening. This was a nasty nasty  shot!! I was fortunate to have the day off work or I would have missed a day.  I am concerned about the booster shot. My PCP is telling me that he has not heard of this reaction BUT I talked to a employee at work that had a similar experience.
Luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine that patient got; Luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine that patient; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine patient got and leaked down the patient's arm.  The patient's medical history was not provided. No concomitant product use was reported.  On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On the unknown date, the luer lock between the syringe and the needle came undone. Some of the vaccine leaked down the patient's arm and was unknown how much of the vaccine the patient actually received. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, the luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine patient got and leaked down the patient's arm, was considered resolved.; Reporter's Comments: This spontaneous report concerns a female patient who experienced a non-serious event of luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine patient got and leaked down the patient's arm (Syringe connection issue and incomplete dose administered ).  The event occurred during the administration of the first dose of the mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown).  There were no reported AEs associated with the events of syringe connection issue and incomplete dose administered.
On Dec 20, 2020, (3rd day post injection) sudden onset of fatigue, malaise, mild sore throat, mild-mod headache, and lymphadenopathy cervical.  All the above waned over 48 hours, much in the 12 hours post onset.
Pt described itching ears and had slight flushing of skin on chest area. Benadryl given and symptoms resolved. Symptoms developed 33 mins after vaccine given. Symptoms resolved within 30 minutes.
Typical injection site pain that has steadily gotten worse since April 2021. It's almost impossible to lift my arm more than a few inches from my side. That injection was given improperly .. the nurse entered my arm at an angle or something and when she withdrew the needle, very thin blood ran down my arm. I say thin because I'm guessing it was mixed with the vaccine.
Patient was vaccinated with M-M-R II and subsequently became pregnant; This spontaneous prospective pregnancy report was received from a medical assistant referring to a currently 31 year old female primigravida patient, with no drug reactions/allergies.  Concomitant therapies included docusate sodium (COLACE), ferrous sulfate and prenatal iron.   On an unspecified date, the patient underwent an insertion procedure with etonogestrel implant (NEXPLANON), subdermally, for an unknown indication (strength, frequency, lot number and expiration date were not reported) (events capturen in case 1908USA002450).   On 19-JUN-2019, the patient had her last menstrual period (LMP).  On 22-JUN-2019, the patient had the etonogestrel implant (NEXPLANON) rod removed.  On the same day, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA (recombinant human albumin), lot # R029513, expiring on 14-OCT-2020, dose 1, subcutaneous for prevention due to high local outbreak of measles.    On 20-JUL-2019, the patient saw an unspecified doctor, for medical attention, because she was not getting her menses and it was determined during the office visit that the patient was pregnant (unspecified method) (drug exposure before pregnancy).  On an unspecified date, a urine pregnancy test was performed (result not provided).   The patient's estimated due date (EDD) was of 25-MAR-2020.    At the time of the report, the pregnancy outcome was pending.  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-1908USA002450:
Patient's arm was sore, red and "broke out" down to her elbow. She also had itching. Symptoms lasted for 4 days. No other symptoms.
Four years in a row eye infections after the flu shot; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient of an unknown demography who experienced four years in a row eye infections after the flu shot (eye infection), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, concomitant medications and family history were not provided.  Patient received flu vaccine in past with no side effects, except the last 4 years.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced four years in a row eye infections after the flu shot (eye infection), (Unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory details reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Stomach Pain/cramps; stomach pains/cramps; felt as if she wanted to throw up; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach Pain/cramps), MUSCLE SPASMS (stomach pains/cramps) and NAUSEA (felt as if she wanted to throw up) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Pain/cramps), MUSCLE SPASMS (stomach pains/cramps) and NAUSEA (felt as if she wanted to throw up). At the time of the report, ABDOMINAL PAIN UPPER (Stomach Pain/cramps), MUSCLE SPASMS (stomach pains/cramps) and NAUSEA (felt as if she wanted to throw up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
Office practice was to draw up all doses from vial at the beginning of the day. They discarded vial w/o a double check. They had bivalent NDC, lot and expiration on a sticky note and used this as source of data for database. At some point the realized that some days they had pulled monovalent vaccine and administered instead of the intended bivalent vaccine.
This spontaneous report was received from a nurse and refers to a currently 17 years old female patient. No medical history and concurrent conditions were reported. The patient had no drug reactions or allergies. Approximately in May 2015 (reported as "two months ago"), the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose, route of administration and anatomical location were not reported). Concomitant therapies included LOESTRIN. Approximately in May 2015, the patient experienced rash on her face and swelling of lymph nodes in her neck. No treatment was given and no lab diagnostic studies were performed. The patient sought medical attention, the patient's mother called the office. The outcome of the events was recovered on an unknown date in May 2015 (reported as "within 4 unspecified days after GARDASIL was administered). The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Patient called on 2/3/2020 reporting the reaction to Shingrix. She had redness, throbbing, and swelling circumference of a 'softball'. She said she discovered the reaction late in the evening (around 8 pm on 2/1/2020).
Client has history of syncope with injections/blood draws. Client warned vaccinator she would pass out. Client experienced syncope within 1 minute of vaccine administration. Client recovered completely within 40 minutes.
pt recv vax & devel chickenpox, 30-50 lesions mainly on trunk, face & back;3/19/98 pt devel a secondary bacterial infect;
Patient was admitted to Facility on 2/14/2022 as inpatient due to Upper GI bleed due to erosive gastropathy. Chart review indicates patient had a welfare check initiated by his Family Care team. Patient reports he fell last night and has fallen 5-6 times within the last month.   Tested positive for COVID while admitted on 2/20/22.
Adverse reaction to Tdap vaccine (local) (marked pain; swelling and warmth and erythema).
Acute Cerebellar Ataxia for 12-24 hours - my daughter woke up from a nap, she was ill from cold/flu and could not sit independently.  She was walking just fine before the nap and then for about 24 hours she slowly regained her ability to walk without falling over.
A)Patient diagnosed with Crohn's Disease in Aug 2005. B)Patient went into remission Dec 12, 2005( No diarrhea, no blood in the stool with anti-inflammatory medications. C)Patient administered a Typhoid shot on Jan 19, 2006 before an Overseas trip. D) Blood and diarrhea returned on Jan 26, 2006 indicating Crohn's Disease Flare Up. This flare up lasted for 2-3 days(minor) and subsided. 05/01/07-records received from PCP  Pancreatitis 3/07. Hospitalization in 3/07.
HCP reported inadvertent administration of expired VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported.      On 06-NOV-2020, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, frequency and strength were not reported; lot # was R031626 and expiration date was 01-NOV-2020) (Expired product administered) for prophylaxis. The reporter stated that the varicella virus vaccine live (oka/merck) (VARIVAX) has had no prior temperature excursions.  The outcome of the event was unknown.
Soreness in the right arm; Her skin felt like it was burning up; Could not go to sleep; A raging fever of 104F/the fever was not responsive to Tylenol & Aspirin; This spontaneous case was reported by a physician and describes the occurrence of SKIN BURNING SENSATION (Her skin felt like it was burning up), INSOMNIA (Could not go to sleep), PYREXIA (A raging fever of 104F/the fever was not responsive to Tylenol & Aspirin) and VACCINATION SITE PAIN (Soreness in the right arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 022C21A and 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, the patient experienced SKIN BURNING SENSATION (Her skin felt like it was burning up), INSOMNIA (Could not go to sleep) and PYREXIA (A raging fever of 104F/the fever was not responsive to Tylenol & Aspirin). On 28-Jan-2022, the patient experienced VACCINATION SITE PAIN (Soreness in the right arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN BURNING SENSATION (Her skin felt like it was burning up), INSOMNIA (Could not go to sleep) and PYREXIA (A raging fever of 104F/the fever was not responsive to Tylenol & Aspirin) was resolving and VACCINATION SITE PAIN (Soreness in the right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   This case was linked to MOD-2022-467238 (Patient Link).
Information has been received from a physician concerning a female pt with no prior medical history and no known drug allergies who was vaccinated "in the past" with a dose of MMR II. The pt developed a "severe local reaction (sterile abscess). It is unknown if medical attention was sought. The pt subsequently experienced a localized reaction and flu like symptoms following vaccination with varicella virus vaccine live (WAES0207USA00452). Additional info has been requested.
Constant moderate to severe headache for a week starting 5 days after 2nd dose of Moderna COVID vaccine. Treated at home with rest, ice, ibuprofen, acetaminophen, aromatherapy. Symptoms resolved after 7 days
Pt recv vax on 7/2/84; on same day pt exp fever and seizures, pt afterward recv DT instead of DTP for vax, still has seizures and mental retardation