chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning at the injection site as dose was being administered; flu like symptoms; feeling sluggish; This case was reported by a other health professional via sales rep and described the occurrence of injection site burning in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date). Concurrent medical conditions included breast cancer.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site burning, influenza-like symptoms and sluggishness. On an unknown date, the outcome of the injection site burning, influenza-like symptoms and sluggishness were unknown.   It was unknown if the reporter considered the injection site burning, influenza-like symptoms and sluggishness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient had both doses of the Shingrix and experienced burning at the injection site as dose was being administered, flu like symptoms and feeling sluggish. The reporter gave permission to follow up.
Periorbital edema and itching started at 7:00 AM the following day (about 20 hours after immunization) improved with Benadryl
Mistrual isses; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MENSTRUAL DISORDER (Mistrual isses) in a 14-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Mistrual isses). At the time of the report, MENSTRUAL DISORDER (Mistrual isses) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720710 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live Non significant follow up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720710:Reporter case
developed shingles; rash on his chest; BUMPS ON NECK; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th March 2022, the patient received the 2nd dose of Shingrix (intramuscular). In March 2022, less than a week after receiving Shingrix, the patient experienced shingles, rash and papular rash. On an unknown date, the outcome of the shingles, rash and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's Comments: The patient self-reported this case. The reporter declined to give any contact information including patient demographic information. The reporter disconnected the call and agent was unable to obtain additional adverse event information and was offered (package insert) PI or transferred call to after call survey.  Additional Supportive Information: The patient experienced bumps on his head and neck and a rash on his chest (onset of adverse events not known). The reporter would like to know if Shingrix could cause these reactions. The reporter reported that he spoke with his pharmacist and he developed shingles.
injection site warm; injection site itchy; injection site red; injection site slightly raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site slightly raised) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VERAPAMIL for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site slightly raised). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) for Itching, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site slightly raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient kept Cold compresses.
Information has been received from a pharmacist referring to a currently 43 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. On unknown dates the patient was vaccinated with two doses of M-M-R II (dose, route, lot # and expiration date were unknown). There was no concomitant medication. The patient was seen for a routine examination by an unspecified physician on an unknown date. The patient was informed by the physician that his titers were low for measles, mumps, and rubella. No treatment was given for the adverse events. Outcome of the events was not reported. Additional information has been requested.
PATIENT RECEIVED IN LEFT DELTOID HEP A AND HEP B ON RIGHT DELTOID GARDASIL VACCINE. PATIENT GOT UP AND SAT DOWN IN ANOTHER CHAIR AT WHICH POINT STARTED TO BREATHE HEAVY AND THEN HIT HIS HEAD ON SIDE WALL OF IMMUNIZATION DESK. PATIENT WAS COMPLETELY PASSED OUT, UPPER BODY STIFF/RIDGID, PALE, EYES OPEN NOT BREATHING. PATIENT ASSISTED TO FLOOR AND BEGAN TO DO STERNAL RUB AND AND HIT SHOULDER CALLING OUT TO PATIENT ARE YOU ALRIGHT. PATIENT GASPED AND CAME TO QUICKLY. IMMEDIATELY SAT UP AND BEGAN TO REPLY WHAT HE FELT AND WHAT HAPPENED JUST PRIOR TO PASSING OUT. PATIENT WAS PALE AND SWEATY AND TAKEN TO TREATMENT ROOOM. PROVIDER NOTIFIED.
Approximately 24 hrs after I received the Moderna booster shot (3rd dose) in my left upper arm, a 1? diameter red swollen spot developed around the injection site.  I experienced mild side effects of muscle aches, chills, and fatigue the day after the shot. By 8:00 PM 2 days after the shot, the red swollen spot on my left arm around the injection site had grown to 3?x2? big. I also noticed at 8:00 PM 2 days after the shot that I had a red rash on my chest and torso. Part of my chest was solid red like a sunburn, and other parts were blotchy/spotted red, with more red spots on the side of my left chest that was closer to the injection site. The rash was not itchy or painful. I called a 24/7 nurses hotline and spoke with an RN regarding the swollen spot on my arm and rash.  She asked a lot of questions and determined that it was not an imminent risk, but advised me to see a doctor in the morning.  In the morning at 7:00 AM the red swollen spot on my arm was not as dark, and the rash was much lighter.
I got a sudden BAD red hot itchy rash 3 nights after my injection - Was near injection site, but not on...Felt & still feels like someone hit me with a hammer on my arm. Arm is still slightly red, but no longer is hot/itchy.  I also got a Headache 3 hours after shot was administered & woke with cold/flu-like symptoms the following day that kept me home from work with sore throat, runny nose, diarrhea/nausea...  Headache lasted approx. 2.5 days. Cold Flu symptoms went away in approx. 10 hours
Patient began noticing swelling of her left arm and redness on Thursday, March 19, 2020. Applied cool rags off and on and took ibuprofen. Left arm continued to swell and spread so she came to the health department on March 24, 2020. Left arm was swollen, warm to touch, and looked pink. Right arm measured 14 1/2 inches, left arm 15 1/2 inches. Called her primary doctor. I sent pictures to her and the arm measurements per her request and with permission from the patient. Dr send an order of Bactrim twice a day for 5 days and Diflucan 150mg (2 pills...take one on 1st day of Bactrim and 2nd one on last day of Bactrim) to patients pharmacy Dr will see the patient in her office on Thursday, March 25, 2020. Patient is to begin antibiotics today.
Headache, rash, defuse myalgias 1 day after administration, Myalgias began less than 12 hrs after administration.
SICK; SYMPTOMS RETURNED; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, emphysema, autoimmune disease, and hypothyroidism. The patient was pregnant at the time of vaccination. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, and batch number: 1805020, expiry: Unknown) dose was not reported, 1 total, administered on 06-MAR-2021 at 10:45 on left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, and batch number: 1822809, expiry: Unknown) dose was not reported, 1 total, administered on 02-NOV-2021 at 10:30, on right arm for covid-19 prophylaxis. Age at time of vaccination 61 years old. Concomitant medications included opioids used for allergy, ascorbic acid/calcium carbonate/calcium pantothenate/calcium phosphate/chromium/cyanocobalamin/folic acid/magnesium carbonate/magnesium hydroxide/manganese gluconate/nicotinic acid/potassium bicarbonate/potassium carbonate/potassium phosphate dibasic/pyridoxine hydrochloride/quercetin/riboflavin sodium phosphate/sodium bicarbonate/sodium phosphate/thiamine hydrochloride/thioctic acid/zinc ascorbate and guaifenesin used for unknown indication. The patient was prescribed with treatment drug Paxlovid (form of admin and route of admin were not reported, batch number: unknown, expiry: Unknown) dose not reported, administered first dose on 07-JUL-2022 and last dose on 12-JUL-2022 for covid-19 treatment .  On 11-JUL-2022 at 07:00, the patient experienced sick and had suspected covid-19 infection, the reporter started feeling better after finishing the Paxlovid and six days later symptoms returned and were worse than the original symptoms (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid drug discontinued. The patient had not recovered from sick, symptoms returned and suspected covid-19 infection. This report was non-serious.
She then had to return to a different location missing out on her second dose of the Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She then had to return to different location missing out on her second dose of the Moderna vaccination) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A214) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She then had to return to a different location  missing out on her second dose of the Moderna vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (She then had to return to a different location missing out on her second dose of the Moderna vaccination) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: No new information.
accidentally received an overdose of the Pfizer covid vaccine; accidentally received an overdose of the Pfizer covid vaccine; joint issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing), notes: Verbatim: Ulcerative colitis; "Anxiety" (unspecified if ongoing), notes: Verbatim: Anxiety. There were no concomitant medications. The following information was reported: ACCIDENTAL OVERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown" and all described as "accidentally received an overdose of the Pfizer covid vaccine"; ARTHROPATHY (non-serious), outcome "unknown", described as "joint issues". The lot number for bnt162b2 was not provided and will be requested during follow up.
Fri 2/1 heart racing, tired  Sat. 2/2 achiness, fever, chills, sweating that soaked sheets.  Sun. 2/3  Dr. told me it wasn't a reaction to the vaccine--that it must be the flu.  Mon 2/4 stayed home from work, more flu-like symptoms.  Tues. 2/5 fever subsides but still cold hands and feet.  7 PM Heart Attack.  2/12/08 Reviewed medical records from 2nd hospital which reveal patient experienced flu like s/s including muscle aches, fever, chills, midsternal chest pressure w/SOB.  Seen at outlying ER, tx w/anti-clot med & transferred to higher level of care for emergent coronary angiography.  Admitted 2/5-2/8/2008. FINAL DX: acute coronary syndrome, unclear whether vasospasm or clot disolved.  2/14/08 Reviewed ER medical records of 2/5/08 which reveal patient experienced substernal chest pressure, heaviness & pain which radiated to both jaws with diaphoresis, nausea & flu-like symptoms x 3 days.  Tx w/meds including anti-clot med & transferred to higher level of care.  FINAL ER Dx: myocardial infarction.
She started to have uneven elevated heartbeat since getting the second dose of vaccine. Initially, it was getting like 150. Now she suddenly gets in 120 , 100 even when sitting and resting.
I have redness, swelling and itching at the injection site/pretty red around where she got the shot; I have redness, swelling and itching at the injection site/swollen; I have redness, swelling and itching at the injection site/itches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Patient stated, "I had the 1st Pfizer COVID vaccine on the 07Jan2021; symptoms began on Saturday, 09Jan2021: I have been putting on peroxide on the area. I have redness, swelling and itching at the injection site. Am I doing the right thing?" Her side effects have subsided some, but she still has redness and itching passing. She had her first shot last Thursday and it is pretty red around where she got the shot. It was swollen and it itches. She wanted to know if that was normal. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.  Information about batch/lot number has been requested.
Soreness, slight fever, muscle weakness, tingling in left arm's fingers, lightheadedness. Onset of symptoms unknown.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 02-DEC-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
tingling and burning of tongue started 2 hours after injection and subsiding without intervention 4 hours after injection
Was seen at hospital on 8/4/09 for Intussusception, was discharged the same night after reduction.  9/14/09 ER/Hospital Records received DOS 8/4/09 to 8/5/09. Assessment: Ileocolic Intussusception. Patient presented with a 1 day history of lethargy, malaise, and fussiness, followed by a 5 hour history of persistent vomiting. Palpable mass in right lower abdominal quadrant. Currant jelly stool. Barium Enema Air Contrast - Intussusception reduced.
developed shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and after that developed shingles. The health care professional was not willing to provide patient's identifiers, dates, lot number nor expiration date. The reporter did not consent to follow up.
Patient developed painless red nodule that has not gone away even 4 months after the immunization.
Fatigue; Sensitive skin; Chills; Body aches; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176), intramuscular in the left arm on 11Jan2021 12:30 at a single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730), intramuscular in the left arm on 12Dec2020 11:30 at the age of 28 years old for COVID-19 immunization. The patient had not been tested for COVID-19 since the vaccination. On 11Jan2021 20:00, the patient experienced fatigue, body aches, sensitive skin, and chills. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 09-JAN-2017 at 14:51, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457
1645- I felt normal. 2330- I was awake. Sudden onset of dizziness that progressively got worse.  2400- My boss drove me to Rapid City Hospital ED. I was admitted to ED. I received 2 or 3 bags of saline. Labs were drawn. CXR done.  CBC, CMP, MG, PHOS. I was released at March 25 @0330. I was dx with dehydration.
5 min after receiving flu mist, pt went unconscience for aprox 45 sec. due to vasovagal episode.  Pt was given O2 and fully recovered.
Information has been received from a registered nursery referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with unspecified doses of improperly RECOMBIVAX HB (dose, route and dose number were not provided) (lot # L008660, expiry date 10-NOV-2016) (lot # L004754, expiry date 10-NOV-2016). No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
On 06/2021 through end of July the adverse event happened. I have used an IUD for birth control and I didn't have period for 1 year which is normal but a month later I noticed spotting. I contacted my Gynecologist and scheduled an appointment. I did read online that vaccines can interrupt period cycle. I took the IUD out after 4 months. My Gynecologist prescribe hormone to control my spotting which helped. When the spotting was gone, I had to choose another birth control method instead. It created breakthrough bleeding. On March 18/2023 my Gynecologist took out the IUD. I am now using a new birth control as of now and everything is normal.
Patientdescribed fever, chills, "blah" feeling, loss of appetite that developed around 6pm 11/4/08 in a phone call to pharmacist on 11/5. I tried to follow up on 11/6 & she returned my call 11/7 in am. She is still having cold symptons but is feeling better. Also reported to me that her eyes became red in the pm on 11/4.