chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 16FEB98 & 7MAR98 pt presented to MD w/a rash on legs, arms, face for several months;the rash had been seen to come & go;pt dx w/Gianotti-Crosti Synd & referred to dermatologist who confirmed dx;
Information has been received from a physician assistant concerning a 22 year old female with penicillin allergy who on 20-FEB-2007 was vaccinated with a first dose of HPV. On 20-FEB-2007 she developed itching, erythema and swelling at the injection site. On 21-FEB-2007 she developed hives on her abdomen, thighs and chest upon awakening. When she was seen by the physician assistant on 21-FEB-2007 the swelling and redness at the injection site was gone and the patient commented that the hives were less than before. Her prescriber put her on Zyrtec (10 mg) daily for the hives. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a 25 year old male patient. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 14-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not provided). On 17-JAN-2017, the patient was vaccinated with the second dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not provided). No adverse effect was reported. Product quality complaint was not involved. Additional information has been requested.
pain in inj site approx 3hr p/vax;swelling inc lt arm the following day;no tx x/ice packs;
1) Significant sore arm beginning within 3 hours of shot. Resolved over 2-3 days. Prevented usual activities, but did not require treatment. 2) Community acquired pneumonia. Onset of cough, increasing runny nose, fatigue ~5/30/22. Health COVID antigen tests negative  6/1, 6/3, 6/5. Cough worsening ~6/5/22. Diagnosed at urgent care 6/7/22. Abnormal chest x-ray - focal R upper lung lesion. COVID NAAT negative. Being treated with amoxicillin/clavulanate and doxycycline.
Side effects started around 15 hours after vaccine was administered. Started having extreme chills and severe body aches and a headache. Next morning I had severe fatigue, body aches, headache, nausea which very slowly dissipated throughout today. Woke up the next day feeling better but still a little nauseous and having joint pain
big red bump, like a big giant hive; itchy at the injection site; swollen at the injection site; red at the injection site; arm was itchy in my sleep; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (arm was itchy in my sleep) and FURUNCLE (big red bump, like a big giant hive) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart failure. Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE), METOPROLOL and DIGOXIN for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PRURITUS (arm was itchy in my sleep). On 29-Mar-2021, the patient experienced FURUNCLE (big red bump, like a big giant hive). At the time of the report, PRURITUS (arm was itchy in my sleep) outcome was unknown and FURUNCLE (big red bump, like a big giant hive) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included an unspecified medication for heart failure.  No treatment was received for the events.
Patient came in two weeks after administration stating that the night she got a vaccine she got a rash on her arm and stomach- the rash on her hand looks like brown freckles on her wrist.
One week post vaccine administration, the site has erythema (east/west in orientation, about 2.5" in diameter), warm to the touch and tender.  Tenderness started 1/21/21 but I didn't not look at it until this morning and saw the change in color and temperature of skin.
This spontaneous report as received from a other registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II (dose, route and lot # not reported). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient  did not have any reaction, however an expired vaccine was administered. Moderna Vial was punctured on 9/13/21 a little after 1:13 PM. Dose was given  a little after 12:04 PM on 9/14/21
Vaccines were administered following a temperature excursion; there were no adverse reactions; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose number, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003600: US-009507513-2110USA003601: US-009507513-2110USA003602: US-009507513-2110USA003603: US-009507513-2110USA003604: US-009507513-2110USA003599: US-009507513-2109USA001290:
Sweating; Flushing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) and FLUSHING (Flushing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating) and FLUSHING (Flushing). At the time of the report, HYPERHIDROSIS (Sweating) and FLUSHING (Flushing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. No treatment was reported.
Pt came in for Hep B #3 around 9:30 am-Returned to office approximately 1:00 pm with dizziness, Dry mouth, myalgias, disoriented sensation. Pt received 2 pediatric doses of Hep B on 1/2/07 & 1/3/07 by error. 2nd ped dose was given after contacting manufacturer about 1st dose Hep ped dose. Pt had shoulder infection after 2nd peds dose but wasn't specific or suspicious for reaction
This case was reported by a consumer via call center representative and described the occurrence of sickness in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of malaise (1st dose received in April 2018, refer case US2018178351). On 28th September 2018, the patient received the 2nd dose of SHINGRIX. On 29th September 2018, 1 days after receiving SHINGRIX, the patient experienced sickness, chills, headache, fever, tremor and hypersomnia. On 1st October 2018, the patient experienced skin peeling. Rechallenge with SHINGRIX was positive. On 30th September 2018, the outcome of the fever was recovered/resolved. On 1st October 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the sickness and hypersomnia were unknown and the outcome of the skin peeling was not recovered/not resolved and the outcome of the chills and tremor were recovering/resolving. It was unknown if the reporter considered the sickness, skin peeling, chills, headache, fever, tremor and hypersomnia to be related to SHINGRIX. Additional information was received as follows: At 3:00 pm in the afternoon, the patient received SHINGRIX on the left arm. The patient got sick again but the symptoms were more intense than sickness after the 1st dose of SHINGRIX. On Saturday, she woke up with fever, chills, shaking and a headache. She slept most of the day. It felt as if her fever was gone by Sunday and her headache was gone in morning of the reporting day. However, she noticed at work in morning of the reporting day, that her skin was peeling on the palm and inside of her fingers of her left hand. The contact details of the physician was provided.
Patient had no symptoms but a medication error has occurred. The Dtap and IPV liquid of pentacle has been given to the patient but the vaccine was not mixed with the Hib portion.
Information has been received from PharmD concerning a 42 year old female patient who on 04/20/01 was vaccinated IM with MMRII. On 04/22/01, the patient developed a possible abscess at the injection site accompanied by erythema and swelling at the injection site. Unspecified medical attention was sought. FOLLOW UP information has been received from a health care professional who states the employee started to complain of pain above the shoulder, not at the injection site. It was reported that the physician thinks that there could be sterile abscess and he does not think that this is an adverse event from the vaccine. He feels it is a problem with the injection itself. The employee is reportedly receiving hydrotherapy and physical therapy and complains of discomfort at night. FOLLOW UP information has been received from a health care provider who reports the patient had right arm, chest and shoulder aching starting on 04/15/01, previously reported as 04/22/01 There were no diagnostic tests done, but the patient received hydrotherapy and physical therapy and took NSAIDS. The recovery status was reported as unknown. FOLLOW-Up information has been received from a health professional who reports the patients did, in fact, receive the MMRII on 04/20/01. The patient has fully recovered.
The only immediate reaction to the vaccine was soreness in my arm. On March 11, I woke at 3:30 AM and had almost total hearing loss in my right ear along with some unsteadiness. I have also experienced unusual neurological symptoms like burning, tingling and numbness in my right foot, leg, hand and face. My second vaccine was delayed because I was taking steroids to help with hearing loss. I had my second shot on March 31 with no side effects to date.
Patient had injection site reaction and a fever on 10/28/17.  Went to the ER around 2am on 10/29/17. Followed up with PCP on 10/31/17. Prescribed diphenhydramine.
My arm felt more sore; It is just pinky red and sometimes it feels warm/there is a rash around it is 3 inches now round; It is just pinky red and sometimes it feels warm/there is a rash around it is 3 inches now round; This is a spontaneous report from a contactable consumer (patient herself) .  An 80-years-old female received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ENV202, Expiry Date-Unknown) via an unspecified route of administration on 04Mar2021 as DOSE 2, SINGLE (at the age of 80-years-old) for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On 10Mar2021 (6 days after the vaccination), patient experienced arm felt more sore, It is just pinky red and sometimes it feels warm/there is a rash around it is 3 inches now round. Patient got her second shot on 04Mar2021 and yesterday noticed that her arm felt more sore and there was a rash around it was 3 inches now round but today it was pink. Last night it was more red. Patient did not had a temperature and is this was normal reaction. Patient stated height was 5 and may be one quarter. Patient stated it does not hurt or anything. It is just pinky red and sometimes it feels warm. Otherwise it does not bother her but it is like okay. The outcome of arm felt more sore was recovered on an unspecified date in Mar2021 and remaining events outcome were unknown.  No follow-up attempts are possible. No further information is expected.
Middle Ear Infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 19-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2022 13:15 (Batch/Lot number: unknown) at the age of 18 years as dose 3 (booster), single for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 10Sep2021, when the patient was 18 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: Oct2021, when the patient was 18 years old, for Covid-19 Immunization. The following information was reported: OTITIS MEDIA (non-serious) with onset 30Mar2022, outcome "unknown", described as "Middle Ear Infection". The event "middle ear infection" was evaluated at the physician office visit. Therapeutic measures were taken as a result of otitis media.  Additional information: Patient used facility where the most recent COVID-19 vaccine was administered as Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Reported Event: Middle Ear Infection 2 days after 3rd shot. The events did not result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was antibiotics. Prior to the vaccination, the patient was unknown diagnosed with COVID-19. Since the vaccination, the patient had unknown been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report has been received from a pharmacist referring to a 68 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 08-MAY-2017 the patient was vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. The pharmacist stated that the vaccine was cleared, so they had vaccinated patients since the excursion. This is one of several reports from the same reporter.  Additional information is not expected as all the information has been received. Sender's Comments: US-009507513-1704USA006516: US-009507513-1705USA013607: US-009507513-1705USA013606: US-009507513-1705USA013608: US-009507513-1705USA013609:
Patient reported pain on 12/17/15.  She went to primary care physician on 12/22/15 and she was diagnosed with shingles.
Monday - vomiting & body aches. Tuesday- sore arm, itching skin & redness at injection site (took Benadryl). Wednesday- arm tenderness.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-FEB-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 670799/0975AA, expiry date 17-JUN-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Back ache; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back ache), CHILLS (Chills) and VOMITING (Vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011320A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back ache), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, BACK PAIN (Back ache), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided but mentions being on a blood thinner, of unspecified type.  Treatment medications were not provided by reporter.
SOB, chest discomfort, fever, chills, severe myalgias & arthralgia & coughing;onset w/in 3hr of vax;
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received SHINGRIX (batch number 4LP5Y, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 14th May 2018, refere case US2018GSK154593).  On 15th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 17th August 2018, the patient experienced weakness, sniffles, dizziness, headache and nausea. On an unknown date, the outcome of the pain in arm, weakness, sniffles, dizziness, headache and nausea were recovering/resolving. It was unknown if the reporter considered the pain in arm, weakness, sniffles, dizziness, headache and nausea to be related to SHINGRIX. Additional information was received as follows: The case was reported by the physician for himself. The patient received SHINGRIX on the left deltoid. With the second shot of the SHINGRIX vaccine, he experienced a sore arm on a scale of 8 out of 10. After 48 hours it was 70 percent better and the soreness was on a scale of 3 out of 10. He also experienced headache, weakness, nausea, sniffles and dizziness which started on day 2 post vaccination. No further details were provided.This case has been linked to the case US2018GSK154593, reported by the same reporter for the same patient.
Following receiving her vaccination, patient began feeling  a sharp type pain at her shoulder, running down her arm, experienced mainly with movement. No swelling, redness or warmth. She reports no specific injury, with a gradual onset of pain.
13yr 7month old female received the first Pfizer vaccine on 3/17/2021. mother came back for the second dose and we informed them Pfizer has not received the EUA for minors under 16. We advised the mother that when Pfizer receive the EUA she can bring her daughter back for the second dose.
Patient reports that she felt dizzy unless lying down; also fatigue and shakiness. These symptoms have lasted for 6 days.
"Stripe" inch away from injection site of PNEUMOVAX  (RD). Developed fever. Pt took OTC TYLENOL, relieved pain and fever.
A report has been received from a Pharmacist concerning a 3 year old, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The child received two doses of FLUMIST one month apart which started on 04-Nov-2013. The outcome of the event of received 2 doses of FLUMIST is unknown. The report was considered to be non-serous by the reporter.
pain fluttering in the neck behind the ear that comes and goes away; Little pain on the neck; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old female patient received bnt162b2 (BNT162B2 Formulation; solution for injection, Lot Number: 301558A; Expiration Date: 31Dec2021), dose 3 via an unspecified route of administration, administered in Arm Left on 11Oct2021 as DOSE 3 (BOOSTER), SINGLE (at the age of 79-year-old) for COVID-19 immunisation. Medical history included heart beat and all that (on unspecified heart medications) from an unknown date and unknown if ongoing. There were no concomitant medications (no other product). Historical vaccine included first dose of bnt162b2 06Feb2021 (Batch/lot number: EL9265, right arm) and second dose of bnt162b2 on 02Mar2021 (Batch/lot number: EN6200, right arm) (at the age of 78 -year-old) for covid-19 immunisation. It was reported that the patient did so good after first two shots. The patient experienced pain fluttering in the neck behind the ear that comes and goes away and little pain on the neck, behind the ears, but down a little bit on 12Oct2021 (about an hour or two ago). The patient stated it would come again in a little bit, but it has been doing that for a couple of hours. The caller wanted to know what she should do about the side effects she experienced after getting the Pfizer vaccine. The patient had a little fluttering pain which only lasts about 30 seconds. At the time of this report, the patient not experiencing fluttering pain. The patient stated since it started it comes and goes. The outcome of events reported as not recovered.  Follow-up activities closed. No further information is expected.
patients husband is stating there is significant hearing loss after the fourth vaccine, He states he has not had this ruled out by exam that he is sure that it is neurological
wrist to shoulder, up to the neck and back hurting; cold arm; wrist to shoulder, up to the neck and back hurting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (wrist to shoulder, up to the neck and back hurting), PERIPHERAL COLDNESS (cold arm), PAIN (wrist to shoulder, up to the neck and back hurting) and VACCINATION SITE PAIN (sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04M2DA) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included TELMISARTAN, CALCIUM, MELOXICAM, GLUCOSAMINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 21-Mar-2021, the patient experienced BACK PAIN (wrist to shoulder, up to the neck and back hurting), PERIPHERAL COLDNESS (cold arm) and PAIN (wrist to shoulder, up to the neck and back hurting). The patient was treated with MIGRAINE RELIEF at a dose of 220 mg and PARACETAMOL (TYLENOL) at a dose of 650 mg. At the time of the report, BACK PAIN (wrist to shoulder, up to the neck and back hurting), PERIPHERAL COLDNESS (cold arm), PAIN (wrist to shoulder, up to the neck and back hurting) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.