chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received Shingrix (intramuscular). On 23rd July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that the day before reporting he received his Shingrix injection in his right arm and developed soreness in the right arm. The reporter did not consent to follow-up. The reporter declined to provide treating physician's contact information and his DOB.  The reporter did not have the lot number or expiration date. The case has been linked to the case US2019134711, reported by same reporter.
Narrative: COVID infection following COVID vaccine series 01/04, Pfizer, dose #1 01/25, Pfizer, dose #2 08/11 pt cc: cough, rhinorrhea, dyspnea, headache, sore throat, fatigue, exposure: unknown 08/12- 08/31 pt symptoms continue 08/21 clinically resolved 08/16 COVID swab, result: detected 08/30 COVID swab, result: detected clinically resolved
Next day: chills, achiness, headache, fatigue. Very sore arm, swelling of arm. 12-1-07 Arm still very sore and inflamed-swollen and 2 large red splotches. Went to doctor at medical center-Blood tests, taken, Prescribed Amoxicillin for 10 days.
First vaccine she had a little bit of pain in arm; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8729, Expiration date: 31Jul2021, Pfizer NTEC), via an unspecified route of administration in left arm on 11Apr2021 09:15 as 1st dose, 0.3 ml single dose for covid-19 immunization (at the age of 63-years-old). The patient medical history was not reported. Concomitant medication(s) included telmisartan (TELMISARTAN) taken for hypertension, she started taking it about 7 years ago. They lowered her dosage because she lost so much weight and then they removed HCT- she was no longer taking that anymore. She used to have a little elevated blood pressure but it was not high, and that is why they gave her the medication On an unknown date, the patient experienced a little bit of pain in arm after the first dose. The clinical outcome of the event was unknown.  No Information on Lot/Batch has been requested.
Patient received Moderna for 3rd dose booster instead of Pfizer as patient had completed the 2 series of Pfizer vaccine. Patient waited for 30 minutes post vaccine and did not experience any of the following: wheezing; chest tightness; rashes; swollen lips, tongue, eyes or face.
@ site of inject reddened, inflamed & tender 2 days p/inject; 3 days: looks & feels better than day 1 & 2;
This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender.No concurrent or historical condition was reported. On 29-JUL-2015, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB lot # K010535, expiration date: 27-AUG-2016, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality was reported. This is one of several cases received from the same source (MARRS numbers 1508USA003819, 1508USA005117, 1508USA005118, 1508USA005119, 1508USA005120, 1508USA005122, 1508USA005123, 1508USA005124, 1508USA005125). Additional information has been requested.
This spontaneous report as received from a physician refers to a 15 year old female patient. On 31-OCT-2012 the patient was vaccinated with the first 0.5 ml dose  of GARDASIL for prevention of HPV. On approximately 18-JAN-2013 (about two weeks before adverse event onset), the patient was vaccinated with the second 0.5 ml dose of GARDASIL. On 01-FEB-2013, the patient experienced being tired and sleeping all the time. The patient did not seek medical attention, but treated by herself with herbal supplements. After taking supplements, the patient's adverse events improved. At the time of report, the patient was recovering from tired and sleeping all the time. Additional information has been requested.
p/vax pt very fussy p/got up was grasping for breath, was shaky & weak;afternoon was very weak & quit breathing for a short time;
45 minutes after vaccine administered client c/o L side pain and not feeling well- dizzy and wanting to go to sleep
Vaccine was expired on 10-March-2022 and was stored in the freezer before administration; Doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 10-March-2022 and was stored in the freezer before administration) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 10-March-2022 and was stored in the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 10-March-2022 and was stored in the freezer before administration) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
an expired dose of IPOL was given to a patient, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 6 years old male patient who received a 0.5 mL dose of expired vaccine IPV (VERO) [IPOL] (4th dose in series) lot N1J451M and expiry date: 05-Oct-2019 via intramuscular route in the left deltoid on 09-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was 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.
Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Apr-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Non-significant follow up appended
first dose of moderna vaccine (1/13 on L arm), admitted 1/24/2021 with progressive fever sore throat and odynophagia found to have RIJ lymphadenitis. Now persistently febrile, hypotensive, tachycardic
Comes to clinic on 11/15/07 with rash over stomach, back and arms times 2 days.  Given Benadryl by school nurse yesterday felt better.  This am rash is returned increasing itching.  Instructed to call parents and talk to PCP ASAP.  Student believes rash is due to HPV #2.
patients were given shots during excursions.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 02-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions.). On 02-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Treatment medication were not reported.
3 minutes after, patient fainted. We received vitals, which were already stable by that point.  Hit left upper eye. Pale. Neurological check 10 mins: normal. Nausea, headache, pupils (PERRLA) and bilateral equal strength.
Information has been received from a physician concerning a 9 year old female patient who in approximately 1999 was vaccinated SC with first 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On 08-MAY-2007, the patient was supposed to receive the second dose of varicella virus vaccine live (Oka/Merck), but the physician found out that the patient's dermatologist had diagnosed the patient with shingles. The patient's mother stated that the patient recovered "a while ago." Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age. No current condition was reported. No historical medication was reported. Approximately in 2014, the patient was vaccinated with PNEUMOVAX 23 lot # J004387, expiration date- 04-JAN-2015 (dose strength and route was not reported). No concomitant medication was reported. Nurse stated that an unspecified number of patients received (unspecified doses in series) PNEUMOVAX 23 that was stored at 47F for 120 hours. Nurse also reported that temperature issue occurred on 29-JUN-2014 through 03-JUL-2014 so doses administered somewhere after 04-JUL-2014 and 23-SEP-2014. The outcome of PNEUMOVAX 23 stored at 47F for 120 hours was unknown. This is one of the several reports. Additional information has been requested.
Pt received DTaP 9/1/09 came into clinic on 9/3/09 c/o redness,swelling, warm to touch on injection site.
extreme fatigue; slight fever; cough; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old male patient received bnt162b2 (BNT162B2, Lot Number: ER8735), dose 1 via an unspecified route of administration, administered in left arm on 20May2021 17:30 (at the age of 49-year-old) as dose 1, single for COVID-19 immunization. Medical history included Covid-19. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. On 20May2021, the patient experienced extreme fatigue, slight fever and cough. The events lasted for about 32 hours. The patient received no treatment for the events. The outcome of the events recovered in May2021.    No follow-up attempts are possible. No further information is expected.
headache and fatigue for 24 hours Pain in my underarm for 5 days Injection site pain for 2 days muscle sorness for 3 days
vomiting, diarrhea, chills and body aches. Treatment: Phenergan, advil Time Course: 36 hrs.
Headache; Fever 100°F; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever 100°F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever 100°F). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) fever 100°F.         No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-367562 (Patient Link).
Atrial Fibrillation. HR 140+. Return to normal sinus rhythm in 12 hours. Heparin and beta blocker.
myoclonic convulsions, high heart rate, high blood pressure, arrhythmia,  dyspnea, vertigo, trembling, lots of panic attacks and stress crisis and intense itching
bruised looking, swollen w/hard area size of dime or nickle noted on 20NOV92; 21NOV92 itching, redness, swelling inc began taking DPH; also c/o nausea & feeling tired;
itching; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2019, the patient received the 1st dose of Shingrix. In November 2019, 3 weeks after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved.   The reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. About 3 weeks after vaccination, the patient experienced itching. This case is linked to case US2020AMR023925 reported for the same patient for 2nd dose.
Intense arm pain during the night after vaccine.  Next day my arms and body and thighs were covered in deep red hives.  Hives still on arms after 10 days
Cold like symptoms such as sore throat and weakness.  Patient saw Dr. again and was ordered to take Mucinex. Symptoms resolved for a few days and then returned. Patient is still complaining of fatigue, weakness, heavy arms.
2 days p/vax leg began to hurt & became red; pt brought into clinic started on Augmentin orally; came back 15MAY94 advised to cont w/augmentin; no change from prev day;
This is primarily to report rash that appeared on left arm all over bicep area, noticed first at 6:00 a.m. 3 days after injection. Rash continued to worsen in intensity with pain (felt under skin, different from the muscular aching), burning, and itching. Rash was smooth, red, and raised like a large welt. Rash spread around to the inside of the arm, but stopped there. Rash visibly resolved 12 days after it appeared. Continued itchiness on the inside of arm where the rash border extent stopped and two small spots in the middle of bicep. This itchiness continues to persist as of today, which is 16 days after the injection. Other symptoms following this injection began at 4:00 a.m. the day following the injection. Fever of 101.2, muscle aches, headache, nausea, sore injection arm. Symptoms were somewhat relieved by 600 mg ibuprofen every 6 hours and 1000 mg acetaminophen every 12 hours. Fever persisted for 4 days, some achiness, arm soreness, headache and dehydration for an initial two days.
Information has been received from a physician concerning an adult patient who was vaccinated with a dose of varicella virus vaccine live. The reporter stated the patient received two doses of varicella virus vaccine live and had a negative titer. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Five days post vax, pt experienced severe constant pain which developed in his left knee, with swelling. Warm to touch, unable to  bear weight on knee for 4-5 days. Treated with ibuprofen. Seven days post vax, knee mildly painful, swelling had subsided.
Patient started feeling not good after 15+minutes administration, while sitting on a chair patient becoming weak, slided down slowly to the floor, and breifly fainted. Had him lay down with emergency spine position, and immediately took his vital sign (100/52) while had technician call 911 for paramedics. Small alcohol pad was opened to had him hold and put it close to his nose breiefly. Patient was conscious yet slightly shaking. He could answer all the questions without problems such as if he's diabetic or not. He is not diabetic, no medical history/condition yet did not eat meals nor drink water for the morning and/up till vaccination time. He insisted that he's fine and did not want us to call 911. Paramedics arrived shortly and took over for through examination. By then he was back to normal and his vital sign was back to 120/70. Paramedic highly recommended him to follow up with a doctor to see what's going on as he insisted that he did not go to ER/hospital/check in.
mom states 9OCT96 approx 7AM pt devel fever, vomiting, sl diarrhea;mom states pt very limp & t102;seen in office 7PM t98.4;pt was alert & active, good muscle tone dx mild systemic rxn to vax;tx clear liquids until morning, APAP;
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 20-JUN-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
sinus infection; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 18-Jan-2021 for Sinus infection and Fever, at a dose of UNK dosage form; DOXYCYCLINE on 18-Jan-2021 for Sinus infection and Fever, at a dose of UNK dosage form; MONTELUKAST on 18-Jan-2021 for Sinus infection and Fever, at a dose of UNK dosage form and ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]) (nasal) on 18-Jan-2021 for Sinus infection and Fever, at a dose of UNK dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.    This case was linked to MOD-2021-012744 (Patient Link).
10 days after the vaccine, I develop gives/urticaria all over my body from head to toe. Its been over 6 weeks since the hives first started and I'm still suffering from it daily. I'm not zyrtec daily to manage the itching, but no sight of it improving. I've never had hives in my life before. I've gone to the doctor several times.
after the third vaccine of GARDISIL i stoped getting my period, now if i dont take birth controls i wont get my period.
Pt received vaccine, after 30 minute wait period left the facility feeling fine. Later that day nose and throat started feeling strange. looked in mirror  and saw swelling under bottom lip. Went to see PCP who gave her injection Benadryl and steroid  Advised to continue with Benadryl for several days. While at PCP blood pressure was noted to be high. Placed on hypertension medications., pt reacted to BP meds and was then placed on anxiety meds. To see allergist on May 11,2021. States feeling much better now.
4/11/03 Parent called about 9:30am-stated child had rash yesterday-discription was macpular papular- this morning woke up with large area of confluent rash and whelps.  Advised to take to see her doctor.  Dr's office called back-Put on Ped pred. not to have any Varicella, Hib, or PCV-7 again.
The expired vaccine was given past the 30-day recommendation. No s/s of any adverse event at this time.
No additional AE; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-SEP-2022, improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status: recombinant human albumin (rHA) subcutaneous injection lot #W019623, expiration date: 19-DEC-2023 (dose, route of administration and anatomical location were not provided) was administered for prophylaxis. The vaccine experienced a temperature excursion of -11.8 degree Celsius for 1 hour and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Mild fever; Headache; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (patient). A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 59267-1000-01), second dose via an unspecified route of administration, administered in left arm on 28May2021 at 15:00 as dose 2, single for COVID-19 immunisation at pharmacy or drug store. Medical history included asthma from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITINE) taken for an unspecified indication, start and stop date were not reported; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 59267-1000-01), second dose via an unspecified route of administration, administered in left arm on 07May2021 at 15:00 as dose 1, single for COVID-19 immunisation at pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of COVID vaccine included Allergy Shot, Singular, Allegra, Claritin, Fish Oil. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced mild fever, headache on 29May2021 at 09:00. The events had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. No treatment was received for the events. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
pt recv vax; 15may95, noted sl sore throat & sl T; on 18may95 noted bilateral swollen glands in neck;
Fever of 101, body aches chills for three days.  Extreme soreness of entire arm, Blotchy redness and swelling on arm.  Swelling and pain moving down arm into elbow.
Fatigue, fever x 4 days. Advil Q10 x 3 days.
pt recvd vax & w/in 24hrs p/vax exp muscle & joint aches & nausea;these sx were not treated & lasted 4 days;