chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/8/21 at 8PM Chills started and then they kept me up half the nigh and headache the next day I still had chill but not that bad then SOB began and had no energy I had to take the day off and I got a cough with the SOB I had achy joint through out the body. By Monday the 15th I felt back to normal.
A little bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of sore arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little bit of sore arm). In February 2021, PAIN IN EXTREMITY (A little bit of sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
broke out in hives all over body.  called dr and was advised to take zyrtec and dr called in a topical steroid to another pharmacy
Haven't got the flu since we stopped getting the shot; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves an adult patient with an unknown demographics who reported hadn't got the flu since they stopped getting the shot (influenza), while he/she received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patient reported hadn't got the flu since they stopped getting the shot (influenza) (Unknown latency) following the administration of Influenza Vaccine.  Details of laboratory data were not reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
Early vomiting with severe ab pain, temp 103 with fever over at least a week, continuing fatigue, worsening cough with elevated heart rate
flublok administered to pediatric patients with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA402510(CLUSTER), 2022SA402707(CLUSTER), 2022SA402396(CLUSTER), 2022SA402443(CLUSTER), 2022SA402500(CLUSTER), 2022SA402436(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402505(CLUSTER), 2022SA402704(CLUSTER), 2022SA402707(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER) and 2022SA402530(CLUSTER).  This case involves a 11 years old female patient and it was reported that Influenza Quadrivalent Recombinant Vaccine [Flublok] administered to pediatric patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI); and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9).  On 23-Sep-2022, the patient received suspect Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation unknown) (lot UJ887AA, expiry date: 09-Jun-2023) standard strength, via intramuscular route in the right  deltoid for immunization at 11 years of age with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 10-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017 (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
No adverse effects; pregnant patient received VARIVAX; a pregnant patient received VARlVAX; This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to an 18-year-old female patient. Her pertinent medical history included asthma and obesity. The patient did not have any concomitant medications, drug reactions or allergies. On 15-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot # R034392 has been verified to be a valid lot number, expiration date 27-NOV-2020) for prophylaxis (exact dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent diluent (STERLIE DILUENT) injection (lot # has been verified to be a valid lot number, expiration date 04-AUG-2020 (formulation, strength, dose, frequency and route of administration were not reported).  On an unknown date, the patient had unspecified pregnancy test performed (result not provided). On an unspecified date in 2019, the patient became pregnant with last menstruation period (LMP) of 21-JUL-2019 and estimated due date (EDD) of 26-APR-2020. The patient was vaccinated at 3 weeks of gestation. The patient sought medical attention and visited an unspecified office. She did not receive any treatment.  At the time of the report, the pregnancy outcome was pending and the fetal outcome was unknown. No adverse effects were reported.
After taking the 1st dose, it helped with wheezing that he was experiencing; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After taking the 1st dose, it helped with wheezing that he was experiencing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient was sick for almost 8 months and was constantly on low dose Medrol pack + doxycycline.) in 2020 and Wheezing.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After taking the 1st dose, it helped with wheezing that he was experiencing). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After taking the 1st dose, it helped with wheezing that he was experiencing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-390861, MOD-2021-390908 (Patient Link).
About 2"x2" edematous erythematous area on right deltoid, minimal tenderness, no fever, adenopathy or streaking.
Still came down with them/ Suspected vaccination failure; Still came down with them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: still came down with them/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still came down with them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he or she got the shot and still came down with them and was going in to get the two shot injections. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up was not possible, as no contact details were available.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients might have been vaccinated with improperly stored dose of LIQUID PEDVAXHIB. Dose, lot and expiry date were unspecified. No adverse effects were reported. This is 2 of several cases from same reporter. Additional information has been requested.
Pt reports (R) shoulder pain started day after shot. Faded 1-2 weeks. Flared up again approximately 10 days later. When shoulder used pain 4-5/10. Experiences no pain when relaxed, laying down, not using arm/shoulder. Also has decreased ROM. Unable to sleep at times. MD at hospital did exercise at clinic increased pain 8/10 is continued. Patient report (R) shoulder pain level = 3-4/10 when inactive/relaxing - increased to 7/10 when reaches to grab something or carries something with weight. Denies numbness or tingling. No response to Ibuprofen and/or TYLENOL. At night, feels like dull, aching pain - no noted weakness.
No additional AE; products that experienced temperature excursion were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 17-JUL-2023, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (lot#: X004813, expiration date: 28-JUL-2024; strength, dose, and route of administration were not reported); and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (rHA) (lot#: W017556, expiration date: 07-JAN-2024; strength, dose, and route of administration were not reported) both for prophylaxis. The vaccines administered experienced temperature excursion before with temperature above 46.7 degree Celsius for 25 minutes (product storage issue). No additional adverse events (AE) (no adverse event).
This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 12-year-old female patient who received BEXSERO (batch number 15B201, expiry date October 2017). On 1st December 2016, the patient received the 1st dose of BEXSERO .5 ml. In December 2016, less than a month after receiving BEXSERO, the patient experienced injection site swelling and injection site induration. On an unknown date, the outcome of the injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the injection site swelling and injection site induration to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO (left deltoid) and experienced swelling and hard lump at injection site. This case has been linked with the case US2016GSK187851, reported by the same reporter.
Large hot, red, raised oval shaped swelling; Large hot, red, raised oval shaped swelling; Large hot, red, raised oval shaped swelling; This is a spontaneous report from a contactable consumer. A 74-year-old female non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL9263), via an unspecified route of administration in the left arm on 02Feb2021at 09:00 AM (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included patient had Codeine allergy. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), ciclopirox, calcium, vitamin d nos, vitamin b complex (VITAMIN B) (all received in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration in the left arm on 12Jan2021 at 09:00 AM as a single dose for COVID-19 immunisation. On 03Feb2021 at 08:00 AM, patient experienced Large hot, red, raised oval shaped swelling. No treatment was received for adverse events. Outcome for the events was recovered on an unspecified date in 2021.
Pt became diaphoretic following1st dose of  Pfizer vaccine.  Medics placed pt on cardiac monitor. Cardiac rhythm was ST, then pt went into A-fib. VS: BP=184/100, HR= 128, RR= 22, 02 sat= 98% RA.  Pt stated he had not taken his BP med today.  911 called and pt transported to hospital.  VS at transport: BP= 165/122, HR= 130, RR= 22, 02 Sat= 99%.  Cardiac rhythm: A-fibrillation  Medics placed an 18G L AC prior to departure.
anaphylaxis. 8 days in ICU on Epi due to rebounding anaphylaxis. then 2 weeks on a critical care floor before d/c. still regaining my full strength .
First started noticing signs of sore throat and lump in throat at end of June, beginning of July 2021. My thyroid is swollen. They have diagnosed me with subacute thyroiditis. They took me off my lithium a couple weeks ago, so far no change. Doctors keep saying I should be on steroids, but no one is prescribing them.
Caused me to go into Atrial Fibrillation Emergency room visit, Hospitalization, Cardiac  Conversion
p/vax devel pain under lt axilla & on chest around pectoral muscle;no fever or skin changes;seen by MD w/2-3 swollen nodule lymph node along anterior lt axillary line;mildly tender, no red or warm o/w normal w/other lymphadenopathy;
Fever 104 resolved after 1 or 2 days. Injection site reaction with redness and warmth in the middle third of the arm. I confirmed with the patient the injections were given in the upper arm deltoid.
Laid down due to fever and started having palpations and feeling my heart beat irregular. Then 10/2/2015 arm is very swollen and welped and warm to the touch and very sensitive. Still having palpitations and having a little discomfort in my sternum area, but its tolerable. Definitely second guessing getting the shot.
4 days after receiving Gardasil vaccine 1st injection patient c/o red, hot rash on both hands and upper thighs, rash on thighs with small blisters lasted approx 1 hour then subsided this went on daily for the next 10 days each time lasting 1 hour.
shot made patient very sick; Initial information received on 17-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  This case involves a patient (unknown age and gender) who had INFLUENZA VACCINE which made him/her very sick (Illness).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (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, the patient was very sick (Illness), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was 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.
Hives to arms, trunk and face within 8 hours of receiving vaccine.  No swelling to lips or eyes, no wheeze.  Hives improved with antihistamines.
This spontaneous report as received from a health care professional refers to 2 unspecified patient of unknown age and gender. The patients concurrent conditions and medical history were not reported. The healthcare worker reported that on 22-SEP-2015, 2 different unspecified patients were vaccinated with an improperly stored, VARIVAX (Merck) lot # L006386; expiry date: 25-FEB-2017 (dose and route not reported). No adverse effects were reported. No further information was provided. This case is one of the several reports from the same reporter. Additional information has been requested.
10SEP93 pt recvd vax & cried for 3 hrs straight beginning 2 hrs p/got shot;
Patient was accidently given the flu shot with her other 2 month vaccinations. No adverse reaction has been noted. Discussion of the error was had with the mother. Documenting due to vaccine administration error (age not appropriate).
Patient presented to the vaccination site on 11/01/21. The client notified RN that he received single dose of (Cansino) COVID vaccine in another country in April 2021. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Pfizer. Per CDC guidance, approval to proceed with COVID vaccine Pfizer was obtained from medical consult team, Vaccine Operations Lead via text message. Client received COVID vaccine Pfizer LOT#: FF8839 on 11/01/2021. The client did not report any symptoms during the observation period. The client left the vaccination site at 1353.
Patient reported loose stools day after vaccination and they lasted for 2 days declined hives dehydration. Pt also experienced fatigue and head ache. NP on site spoke to patient agreed for VAERS to be submitted.
Received MMR #2 on 5/15/03. Awoke this AM (6/6/03) with right neck swelling, extending from jaw to lower neck; tender to touch. Also pain while attempting to move her head from left to right. Pt advised to see MD.
Anaphylaxis occurring approximately 3 hours after vaccine administration. Patient reported to emergency room.
Information has been received from a nurse concerning a 14 month old patient. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, lot# and route were unknown), and a dose of PROQUAD (Merck) instead of M-M-R II, as prescribed at the office visit (Overdose, Drug prescribing error). No adverse effects were reported. Follow-up information has been received from a nurse. It was unknown if the patient had any allergies, birth defects, medical conditions or illness at the time of vaccination. It was reported that on 27-JAN-2015, female patient was vaccinated with the first dose of VARIVAX (Merck) subcutaneously into the left leg, lot number J006358, expiration date 23-MAY-2015 and with the first dose of PROQUAD (Merck) subcutaneously into the right leg, lot number K005644, expiration date 17-OCT-2015. Concomitant therapies included: the second dose of Influenza virus vaccine (manufacturer Sanofi), intramuscularly into the left thigh, lot number was reported as 44983PH, administered on 27-JAN-2015 and the fourth dose of PREVNAR intramuscularly into the right thigh, lot number was reported as J16883 (date of administration was unknown). The patient did not seek medical attention. Additional information is not expected as no further information is available. Product information, event information and the narrative were updated.
has ?flu like sx?, chills, red face, when sitting ?feels like a pill is stuck in her throat?. Had Covid one month ago.  Sx resolved today (1/14/21)
not feeling well overall; nausea; redness at injection site; widespread pain throughout entire body; Left arm pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (widespread pain throughout entire body), PAIN IN EXTREMITY (Left arm pain), MALAISE (not feeling well overall), NAUSEA (nausea) and INJECTION SITE ERYTHEMA (redness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and CELECOXIB (CELEBREX) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (widespread pain throughout entire body), PAIN IN EXTREMITY (Left arm pain) and INJECTION SITE ERYTHEMA (redness at injection site). On 05-Mar-2021, the patient experienced MALAISE (not feeling well overall) and NAUSEA (nausea). At the time of the report, PAIN (widespread pain throughout entire body), PAIN IN EXTREMITY (Left arm pain), MALAISE (not feeling well overall) and NAUSEA (nausea) outcome was unknown and INJECTION SITE ERYTHEMA (redness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received treatment for the events - muscle relaxer, Bayer and Diclofenac potassium 50 mg tablets.
broke out in systemic red raised itchy rash, c/o sore throat with difficulty swallowing
Has history of allergic reaction to wine and wine vinegar. Reported puffiness of face, tightness in throat and visual changes. Came to occupational health service area immediately. Benadryl given (25mg) with response. Returned to work. Shot given at 12:55; symptoms began at 2:15pm.
a 6 years-old child patient received Flublok with no AE; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 6 years old male patient who received an 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: UJ448AA, expiry date: 22-Mar-2020) via intramuscular route in right arm site on 26-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No concomitant therapy was given.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  No adverse effects have been reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.