chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sore on lip) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LISINOPRIL, CARVEDILOL, ALLOPURINOL, FINASTERIDE and LOVASTATIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ORAL HERPES (Cold sore on lip). The patient was treated with BENZOCAINE, WHITE SOFT PARAFFIN (CARMEX COLD SORE) at an unspecified dose and frequency and BENZOCAINE, WHITE SOFT PARAFFIN (CARMEX COLD SORE) for Cold sores lip, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Cold sore on lip) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
low grade fever; fatigue; mild body aches; swelling at the injection site; redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (low grade fever), FATIGUE (fatigue), MYALGIA (mild body aches), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, LISINOPRIL, METFORMIN, LIRAGLUTIDE (VICTOZA), ATORVASTATIN, FUROSEMIDE, FAMOTIDINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (low grade fever), FATIGUE (fatigue), MYALGIA (mild body aches), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 10-Jan-2021, VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved. At the time of the report, PYREXIA (low grade fever), FATIGUE (fatigue) and MYALGIA (mild body aches) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-013466 (Patient Link).
About a week after my vaccination, I was getting sharp headaches on the left side of my head. I went to bed, woke up and I noticed the side of my face was numb, like I got a NOVOCAIN shot. I was so numb that I couldn't feel my ear. I was also numb from my shoulder to the left of my breast. I took some aspirin because I thought was having a stroke. I sat there until I was able to feel my face. I went back to bed and when I woke up, I wasn't numb anymore. My husband wanted me to go talk to the doctor, so I did. My doctor wanted me to go to the Cardiologist. I went to the Cardiologist, and she wanted me to the Neurologist. I was supposed to get an MRI and another test before I went to the Neurologist, and I haven't had the test done so I haven't seen the Neurologist yet. I am having Migraines now and I have never had them before. My primary care doctor told me that I had a mini stroke.
The Left side of my face is swollen from the neck up to check bones.      No treatment - no other adverse effects as of yet.  Just swollen face (one side)
Experienced in her words cold sore/fever blister on mouth the next day and lasted for approximately 7 days. Had no other side effects.
Information has been received from a physician, via a company representative, concerning an 18 year old female patient with a "lengthy medical history" (details not provided), who on 29-MAR-2007 was vaccinated with the first dose of Gardasil (lot #657006/0188U).  Concomitant therapy included a "lengthy medication list" (medications not provided).  On 13-APR-2007, 15 days after vaccination, the patient experienced symptoms of Guillain Barre syndrome.  On 14-APR-2007, she was admitted to the hospital, and was discharged on 22-APR-2007 (details not provided).  On 25-APR-2007, the patient was again admitted to the hospital, and released on 27-APR-2007 (details not provided).  At the time of this report, the patient was recovering from the event.  Additional information has been requested.  02/29/2008 Per email from CDC:  CDC's CISA staff has determined this case to be GBS Brighton level 2. 02/29/2008 MR received from CDC for visits from 5/2007 to 7/2007 from multiple sources including neurology. DX: Guillain-Barre Syndrome. Pt presented to ER 4/12/2007 with c/o leg weakness with PE suggestive of GBS (bilateral ascending paresthesias and weakness).  LP defered due to hx of spinal subdural hematoma.  Txd with IVIG. Admitted until 4/23/07.  Re-admitted 4/25/07 unable to walk and with c/o throat tremors, hand tremors,  difficulty lifting objects, and increased fatigue.  DTRs in lower extremities absent and decreased vibratory sensation.  Improvement noted by 7/2007 OV with new c/o headaches.
A 38 year old male patient experienced a unique high level of aching in the rib area while being treated  with RabAvert for post exposure prophylaxis after questionable exposure to a bat on 07/28/04. He received his first dose of RabAvert on 08/1/04. Concomitant medications included Protonix and nasal steroids. On 08/01/04, after the first dose of of RabAvert, the patient experienced a unique high level of aching in the area where th ribs come together. He described it as a headache in the chest, which he could feel all the way to the surface. The event was ongoing at the time of the report. Follow up information received on 08/10/04: The patient experienced muscle pain in the elbow of his left arm after the 3rd dose of RabAvert. The pain was described as an inside of the elbow muscle spasm almost like a tennis elbow. He also stated that it felt like he had been punched. The patient received the 1st and 2nd dose of RabAvert in the left arm and the 3rd dose in the right arm. Follow up information received 12/15/04: In September 2004 the patient saw a neurologist for an evaluation of muscle vibrating and twitching which had been occurring ever since stopping the RabAvert series. The vibrating and twitching were intermittent and appeared at any location of his body including eyelids and legs. The neurologist performed a physical exam and told the patient that he had fasciculations and myokymias. A MRI and electromyelogram were performed and were reportedly normal. The patient also had a rabies antibody titer test, which was reported as ok. The patient had an follow up examination one week prior to 12/15/04. He had another physical exam. An electroencephalogram was ordered. The results were reportedly normal.
pt went to ER 17SPE97-vax recv 15SEP97;upper arm red, hot & swollen;generalized erythema;macular rash of almost entire arm;medicated w/ATB & DPH;
Jynneos vaccine was administered beyond expiration date; Jynneos vaccines went beyond the 8 weeks in the refrigerator; Jynneos vaccine was administered beyond expiration date; Case reference number US-BN-2022-004198 is a spontaneous case report initially received on 12-Oct-2022 from other health care professional via Communication (reference number: USBAV22-1694) and concerns one patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 26-Sep-2022, Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) was administered beyond the expiration date and the eight weeks for refrigerating (explicitly coded as 'expired vaccine used', 'product storage error' and 'product administration error').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  The case is linked with US-BN-2022-004198 and US-BN-2022-004196.  Non-significant case correction performed for information received 28-Oct-2022 to include local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.
Pt had few seconds loss of consciousness with clonic movement of arms & legs. Pt pale with some circumanal cyanosis. Nml B/P & pulse after event. Pt had large local rxn at site of DTAP. Pt's LOC occurred 1-2 seconds after vax.
16 year old client received 1st dose of Moderna series, which is outside of recommended age range.
Fatigue, aches,  mild confusion, extreme arm soreness initially which went away by Monday, then came back 2 days later with extreme swelling, heat, and large hard knot where vaccine had been given.
Pt vax /w Flushot, B/P was 124/76, that evening @ 6:00 felt nauseated, @ 11:00 pm body ached all over, next day felt fine. Tues eve/Wed morn - he died
Leg pain on April 10th (7 days post vaccine injection, gone by April 11th), Abdominal pain on April 11-12th (8-9 days post vaccine injection, slightly better on April 13th, but not fully better).
Right after the vaccine developed severe arm pain, dizziness and headache. That same night of the dose I developed a high fever, severe muscle aches pains, bad sore throat, severe cough and chest pains, with my oxygen dropping to 88-91%. These symptoms lasted up to ( ? days and was not able to even get out of bed. It felt like catching COVID all over again.
1:00 incontrollable shaking and chills, excessive sweating fever,  diarrhea, brain fog severe headache most only lasted about 24 hours  the headache is on going as is the sweating
Patient developed left shoulder pain a few hours after receiving the SHINGRIX vaccine. She was evaluated the next day at an urgent care center. She was prescribed hydrocodone and ibuprofen 800 mgs there and was provided with an arm sling. On 6/1/2018 she had intact sensation FROM fingers, wrist, elbow, strong pinch/grip of her left hand. Left arm and elevation forward and laterally to 35 degrees, posterior arm movement with hand to L5.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient was immediately very dizzy and lighthead after 2nd injection (flu first, covid booster 2nd).  Remained sitting in vaccination chair.  Took at least 20 minutes to clear.  Patient stayed an additional time to ensure it did not return.
Didnt get 2nd dose, Dr never scheduled it; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mother had shingles in 70s) and shingles (Family History) (patient's daughter just had a significant episode of shingles last month at age of 37 year). Previously administered products included Zoster vaccine (received Zoster vaccine in 2014) and Shingrix (received first dose in January 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-Feb-2023 Reporter's comment: The patient stated that he/she did not get the second dose of Shingrix vaccination.  The patient's physician never scheduled it. The patient asked he/she should get the second vaccination now, get both by starting over or do nothing. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The intermediary for this case was conservatively captured as call center representative based upon the reference classification and details and for the same follow-up request was raised.
Several minutes after receiving Moderna vaccine, experienced numbness, tingling in left face and lips Hx of previous similar  reaction to Moderna booster vaccine last year, not disclosed at time of injection. Reports it went away after 2 hours that time Elevation in BP, patient reports did not take BP medication today  slight dullness of sensation in left face and tingling of lips
I was lethargic following this vaccination.  For the following month, I experienced 'brain fog'.  During this time I forgot where I worked, I missed 3 meetings or commitments and did not realize it for a few days after each one.  Up to this point, I had never done any of those things.  The brain fog has mostly lifted, but I still have trouble remembering words and am still lethargic.
This spontaneous report as received from a pharmacist refers to an about 80 year old male patient. About a week ago, approximately on 08-JAN-2014 the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose and route unknown). The pharmacist reported that the patient developed a varicella like rash on his stomach about 3 days after vaccination with ZOSTAVAX, approximately on 11-JAN-2014. The patient contacted pharmacist. The outcome of varicella like rash on his stomach was reported as not recovered. Additional information has been requested.
2m - 7-18-07 - after shots that Night - pt broke out in Rash - was taken to E.R. - rash 4-m - 9-18-07 - after Shot's - this time more severe Large area over body - taken to E.R.
Patient had started the BEXSERO meningococcal B series on 11/16/18 and needed her 2nd vaccine in the series. She received TRUMENBA which was the wrong vaccine. She did not have an adverse reaction.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 27-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
pt recv vax & exp chickenpox;@ time of report pt had three lesions on face, three on neck & two on buttocks;it was reported that lesions on buttocks were the only ones that were vesicular;
No additional adverse effects reported; A dose of PNEUMOVAX 23 was administered intravenous push; This spontaneous report was received from a pharmacist concerning a 44 year old male patient. There was no information regarding the patient's medical history, concurrent conditions, drug reactions/allergies or concomitant medications  On 08-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), via intravenous route for prophylaxis (dose, frequency, anatomical location, lot number and expiration date were not provided).
It was reported that a pt (no specifics provided) received a 4th post-exposure dose of Rabies Imovax IM vaccine (actual vaccination date not provided). Reportedly, sometime, post vax, the pt complained of swelling at the injection site and swelling of the eyes. Additional information is expected. From additional information received, the same day, the patient, vaccine, reporter and responsible physician information was provided. Reportedly, the pt recovered from this experience. Additional information was received on 8/12/99. This correspondence provided the date of vaccination as 8/5/99. The adverse event was also described as, "redness and swelling in arm with eyelid swelling." No additional information was available as reported on 10/25/99.
A total of 101 persons in seven states were reported to have received Menactra SC in error instead of IM route. The lot numbers and dates of administration were not reported. Of the 101 persons, 100 were contacted by their health care providers and advised of the administration error. Twelve non serious adverse events were reported among 54 persons from whom providers solicited such information. Eleven events were local reactions including injection site rash, tenderness, swelling, induration, or pain. One pt experienced a fever of one days duration. No additional information was provided regarding the individual pts or the reported adverse events. Further information is not expected.
Note PNEUMOVAX was the 3rd I have had since 2013 - they put PNEUMOVAX (PPSV23) on report given to me. Rx was very painful shoulders, neck and upper back and fever of 100.6 and chills; this first reaction was 3 days beginning on day of vac 1/25/19. I had what appeared to be 2nd reaction on 2/8/19, the same pains only worse and lasted 6 days, fever 6 days. Went to an after hours clinic; they blew me off as "neck strain" - original office ordered blood work which was negative done on 2/14; then Inf Dx blew me off too!
About 6 x 6 erythamatous rash with local temperature up and mild swelling left thigh.  Non tender.  No fever.  Treated: Tylenol/Benadryl as needed.
Immunology 3/3/2020 for PCV23 injection to right arm, after injection fever and mild erythema to right arm.  3/4/2020 small local redness to right arm, tmax 103.8F   3/5/2020 increased area of redness- continued fevers, tmax 101F, increased tenderness to right arm, favoring arm. Large erythematous inflammatory reaction to right shoulder extending down upper arm to just above elbow.
Chills and headache at 2:30 PM. At 6:00 PM experienced fever of 100.6, body aches, chills and extreme overall trembling (Rigors) which prevented me from walking normally. Took Tylenol for fever, aches and trembling. About midnight the trembling began again; I called the Dr. on call at my medical facility to see if I should call 911; she said I was suffering from "rigors" and should alternate Tylenol and Ibuprofen for the chills and rigors; continued with the Tylenol and Ibuprofen for aches and fever through Oct. 12. I felt better the morning of Oct. 13 but the 100.4 fever returned at 6:15PM; took Ibuprofen. I felt better the morning of Oct. 14 but a 100.2 fever returned at 4:30PM; took Ibuprofen. I felt better on Oct. 15 and and the fever did not return. I have never received the Fluzone High-Dose injection until this year. The pharmacist said it had better protection for people over 65. I will NEVER get that injection again!!!
N/A; administration error; patient was administered on 1 dose that was sitting at room temperature more than 2 hours.
Blurred vision, eyes crossed, Face swelled, Face broke out with rash, Headache, Nauseous, All happened within 30 minutes.  Next  day backaches and feeling tired. Dr. gave me Pepcid and Xyzal. Most all thru Sunday, Still not 100%.
Sudden Hearing loss/ ringing in left ear. Beginning mid June. Following vaccine. Hearing loss has not resolved and is only present in left ear.  Diagnosed by Doctor via audiology exam and treated with high dose prednisone.
Patient came into pharmacy today and informed that after she had the vaccine that day , her whole arm was sore and inflamed. Also couple days later she felt a sharp pain for few seconds in her back and down to her leg. She is feeling ok now, but she just wanted to inform us. She thought it was the flu vaccine but she also had Pnuemovax 23 which usually painful.
This case is linked to the case 2014SA009417. Initial report received from a health care professional on 17 January 2014. A female patient had received a dose of FLUZONE ID (lot number, route and site of vaccination was not reported on an unspecified date in 2013. On 28 January 2013, the patient experienced vomiting for 3 times, syncope attack for 3 times, hot flush and nausea. It was reported that the patient had experienced softball size swelling of arm immediately after vaccination. Laboratory details and corrective treatment was not reported. The outcome of the adverse event was unknown. Documents held by sender: none  Follow-up received on 24 March 2014. No additional information to add. Documents held by sender: none
This spontaneous report as received from a pharmacist refers to a 60-year-old female patient. The patient's medical history was not reported. On 07-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose and site of administration were not reported) and it might be administered intramuscularly instead of subcutaneously. On 08-APR-2016, the patient experienced redness, swelling and welt that localized at the injection site. The patient sought medical attention and came in to the pharmacy. No treatment was given for the adverse events. The outcome of redness, swelling and welt that localized at the injection site was reported as recovering/resolving. The relatedness between redness, swelling and welt that localized at the injection site and ZOSTAVAX was not reported. Additional information has been requested.
dizziness, cough, myalgia, sob Pt with active COVID19 infection on RA, being monitored inpatient
The first dose to phfizer I had bleeding 6 days after. I have pcos and do not have periods... it?s been 3 years. Then 5 days after my second dose I start bleeding again.