chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 16:00, the patient experienced left arm pit pain and swelling of lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm pit pain and swelling of lymph nodes was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
She mentioned that a dermatologist has prescribed GARDASIL 9 to a 5 year old due to reoccurring genital warts which have been unsuccessfully treated with laser therapy and freezing.; No adverse event; This spontaneous report was received from a nurse, concerning a 5-year-old female patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date, the patient's dermatologist prescribed her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) ast treatment for genital warts which had been unsuccesfully treated with laser therapy and freeezing (strength, dose, frequency, route of administration, lot number and expiration date were not reproted).   At the time of reporting, the patient had nto received the vaccine yet, however once she receive the vaccine it would be considered as an off label use. No additional adverse event was reported.
Extreme body aches, has to stay in be, severe headache, eyes hurt, swollen lymph nodes under right arm, fever to 99.2
No additional AEs reported; Vaccine experienced temperature excursion and was administered; This spontaneous report was received from a physician (also reported as a site manager) and refers to a patient of an unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 19-JAN-2021, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0.5 milliliter, lot # R028528 was confirmed to be valid, expiration date 04-JUN-2021, (route and site of administration were not provided) for prophylaxis. The administered dose was exposed to the temperature of 31 degrees Fahrenheit for 1 hour and 15 minutes. There was no previous temperature excursion. The call was because of a digital data logger. No additional adverse event was reported.
some shakiness in her left arm and hand which stopped for a few days after receiving the first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (some shakiness in her left arm and hand which stopped for a few days after receiving the first dose of vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arm injury (She walked around the corner into the kitchen where her arm caught on an electric wheel chair and injured that arm.). Concurrent medical conditions included Shakiness, Depression and Tremor limb (started after she was taking care of her son who had cancer) since 2013.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRE-EXISTING CONDITION IMPROVED (some shakiness in her left arm and hand which stopped for a few days after receiving the first dose of vaccine). At the time of the report, PRE-EXISTING CONDITION IMPROVED (some shakiness in her left arm and hand which stopped for a few days after receiving the first dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additionally after receiving the vaccine she has felt good, rested up, and like the depression she had was gone. She also felt that she could have gotten up and walked, though she was bedridden. Concomitant medications were not provided. The patient did not receive any treatment medications.
Other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to an elderly patient (pt) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 06-OCT-2014, the pt was administered the zoster vaccine live (ZOSTAVAX) (route, dose, lot number and expiration date were not reported) by a healthcare provider at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a healthcare provider for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
It was like every injury in her body was letting her know; could not function a 100% after first and second dose; but after the second dose her hands specially in pain; rash after the second dose; exhausting tiredness after first and second dose/after dinner she had to go straight to bed after first and second dose/she still does not feel fully recovered but is not tired anymore; joint pain in her hands after the second dose; muscle pain in her hands after the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (It was like every injury in her body was letting her know), MALAISE (could not function a 100% after first and second dose), PAIN IN EXTREMITY (but after the second dose her hands specially in pain), RASH (rash after the second dose) and FATIGUE (exhausting tiredness after first and second dose/after dinner she had to go straight to bed after first and second dose/she still does not feel fully recovered but is not tired anymore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Radiation therapy. Concomitant products included LOSARTAN for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (It was like every injury in her body was letting her know), MALAISE (could not function a 100% after first and second dose), PAIN IN EXTREMITY (but after the second dose her hands specially in pain), RASH (rash after the second dose), FATIGUE (exhausting tiredness after first and second dose/after dinner she had to go straight to bed after first and second dose/she still does not feel fully recovered but is not tired anymore), ARTHRALGIA (joint pain in her hands after the second dose) and MYALGIA (muscle pain in her hands after the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (It was like every injury in her body was letting her know), MALAISE (could not function a 100% after first and second dose), PAIN IN EXTREMITY (but after the second dose her hands specially in pain), RASH (rash after the second dose), ARTHRALGIA (joint pain in her hands after the second dose) and MYALGIA (muscle pain in her hands after the second dose) outcome was unknown and FATIGUE (exhausting tiredness after first and second dose/after dinner she had to go straight to bed after first and second dose/she still does not feel fully recovered but is not tired anymore) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-348194, MOD-2021-348232 (Patient Link).
Patient received MMRV subq and HepA IM in Rt arm. KINRIX was given IM in left deltoid. After administration of HepA and MMRV pt developed erythema in spots around where vaccines given, area warm to touch. Ice pack applied. No redness noted on Lt. arm. FNP instructed mother to give BENADRYL at home.
This spontaneous report was received via a company representative, from a 34 year old female pharmacist, reporting on herself. The patient presented no drug allergies/reactions. She had chickenpox when she was younger and in 2011 (reported as 5 years ago), the patient was tested for immunity titer and the test was positive. On 22-JUN-2016, while reconstituting ZOSTAVAX 19400 PFU, (route reported as subcutaneous) (dose and lot number were not reported) and trying to get bubbles out, somehow a small amount, 1/100th ml, landed in the patient's left eye. Concomitant medications were not reported. The patient did not seek medical attention, no treatment was given and no lab diagnostic studies were performed. Furthermore, it was reported that the patient at the time of reporting, was suffering from cardiac arrhythmia and she was taking metoprolol for it. At the time of reporting, the outcome of arrhythmia and its causal relation with ZOSTAVAX was not reported. No product quality complaint was involved. Upon internal review, cardiac arrhythmia was determined to be medically significant. Additional information has been requested.
I received the Pfizer Bivalent COVID-19 booster and a flu shot on 9/15/2022. On 12/11/2022, I had nasal congestion, a pounding headache, and a mild cough that took place mainly in the morning. I was also extremely fatigued and lacking in energy. On 12/12/2022, I took a home antigen test, which yielded a negative result. I tested again on 12/13/2022 and got a positive result. I called my PCP, who prescribed me a 5-day course of Paxlovid, which I began taking on 12/14/2022. After I started taking the Paxlovid, I saw some relief, though the medicine left a horrible aftertaste. I still had a headache and sinus pressure, but they weren't as severe and did not impede my ability to function. I finished taking the Paxlovid on 12/18/2022. On 12/19/2022, I went to a pharmacy to undergo a PCR test, which yielded a negative result. The pharmacy staff detected that I had some wheezing, so they gave me an albuterol inhaler to use for 4 days. At the time of this writing, I still feel tired and have to blow my nose in the morning. I feel better than I did at the beginning of the illness, but I still don't quite feel normal. Before COVID-19, I wasn't tired during the day, but now I am.
The patient's right upper arm had diffused induration, 100mm long x 40mm wide. The patient developed inflammation, redness and tenderness. The patient was treated with ice packs.
Patient was mistakenly given HPV vaccine instead of TDAP vaccine by nurse. Patient is pregnant at the time, expected due date of 12/22/23 and pregnancy complications of uterine fibroid, joint inflammation, antepartum maternal obesity, and anemia affecting pregnancy. Patient was educated that vaccine is not recommended but that limited studies have shown that vaccine does not typically cause complications for newborn. Patient still received TDAP vaccine after education and counseling. No other immediate events or outcomes noted after giving the HPV vaccine.
This spontaneous report was received from an administrator refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies were not reported. Concomitant therapies included sterile diluent. On 02-AUG-2018, the patient was vaccinated with improperly stored M-M-R II injection, lot # N009800, expiration date 24-MAR-2019 (dose and route of administration were not provided) for prophylaxis. Diluent was stored properly. No adverse effects were reported. The vaccine was stored between 0 and 1 (1.4) Celsius degrees for 4 hours and 18 minutes (multiple excursion). Previous temperature excursion was reported as 9 to 25 (8.7) Celsius degrees for 69.49 hours (multiple excursion). Digital data logger was involved.
Janssen COVID-19 Vaccine EUA 101 degree Fahrenheit fever, shaking from chills, nauseous, headache.  Injection occurred 9:40am. Symptoms began 6 hours after injection (4:00 pm). Got better with some Tylenol. Symptoms came back just as bad 5 hours later (9:00pm). Took more Tylenol at 9:30 pm.
Vaccine was administered without issue in clinic, patient did not complain of dizziness/lightheadedness. About 15 minutes later mom reported that child had passed out and had a "seizure" in the store, EMS was called patient was alert, oriented and without injury, was released from EMS - pediatrician notified.
Information has been received from a healthcare worker concerning an 89 year old female patient with no drug reactions/allergies, who in October 2004, was vaccinated with a first dose of PNEUMOVAX 23 (Lot #665402/1339Y) (Exp 22-MAY-2011), SQ. The healthcare worker reported that the patient had complained of a very sore arm and feeling very sick after receiving second dose of PNEUMOVAX 23 (Lot # 665402/1339Y) on 19-OCT-2010. Pain in her arm had kept her up all night. At the time of the report the patient was recovered. This is one of several reports from the same source. Additional information is not expected.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history provided).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced ARTHRALGIA (sore arm). On 12-Jan-2021, ARTHRALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
-Fever, chills/feeling of being cold, fatigue, soreness of arm -Treated via taking Tylenol and Advil
pt recv vax & was found to have neuroretinitis (close to optic neuritis);further details have been requested;
First shot on 10/2. After shot felt ill, sore and tired. On 10/3 developed rash on back of the neck. Rash continued to get worse that week until I went to doctors 10/7 and was prescribed triamcincolone. Which eventually got rid of rash. Second shot 10/23. Once again felt ill sore and tired. No rash this time.  However concerning reaction, I have not revived my period since my first shot. It is now 12/4. My cycle was normal before this and I am actively trying to get pregnant, so have been tracking my cycles? however all pregnancy tests are negative (including blood tests) and still no period. Went to OBGYN  11/30 blood tests were taken of which per the doctor all came back normal and hormones were at good levels.  Was prescribed medroxyprogresterone (started 12/2 on medication) still have not received a period since my vaccinations (today is 10/4), last cycle was 10/28.
has not had a period since her shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 15-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2022 at 11:00 as dose 2, single (Lot number: FL3209) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: FJ8762, Administration time: 11:00 AM, Vaccine location: Left arm), administration date: 05Jan2022, when the patient was 15-year-old, for Covid-19 Immunization, reaction(s): "has not had a period since her shots". The following information was reported: MENSTRUATION DELAYED (non-serious), outcome "not recovered", described as "has not had a period since her shots". Therapeutic measures were not taken as a result of menstruation delayed.  Additional Information: Facility type vaccine was reported as Doctor's office/urgent care. Additional information: Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. The patient had no known allergies.
pt rcvd vax; pt devel sore arm w/ knot at inject site; taken to ER for tx; 3 lot # reported even though only 2 doses administered;
Had vaccine, came home, went to bed, and has had a runny nose since.  Took a dose of Benadryl and still continues to have the runny nose, but has not continued with that.  She also has a sore throat, no temperature, no dizziness, weakness or anything other than the runny nose and sore throat.  Is not going to take 2nd vaccine due to this severe reaction.   Has been using saline, iodine and peroxide in her vaporizer to keep her lungs open.   Has not called her doctor.
It made me sick; Got nervous; Back ache; Felt weak; laid back; Felt she had a cold; Running a temperature/fever; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (It made me sick), NERVOUSNESS (Got nervous), BACK PAIN (Back ache), ASTHENIA (Felt weak) and FEELING OF RELAXATION (laid back) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR4504B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Echocardiogram (leaky heart valve go every 6 months and they do echogram.). Concurrent medical conditions included Drug allergy (Hydrochlorothiazide), Blood pressure high, Hypercholesteremia and Heart valve disorders. Concomitant products included CARVEDILOL, IRBESARTAN, NIFEDIPINE and ATORVASTATIN for an unknown indication.    On 14-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced ILLNESS (It made me sick), NERVOUSNESS (Got nervous), BACK PAIN (Back ache), ASTHENIA (Felt weak), FEELING OF RELAXATION (laid back), NASOPHARYNGITIS (Felt she had a cold) and PYREXIA (Running a temperature/fever). At the time of the report, ILLNESS (It made me sick), NERVOUSNESS (Got nervous), BACK PAIN (Back ache), ASTHENIA (Felt weak), FEELING OF RELAXATION (laid back), NASOPHARYNGITIS (Felt she had a cold) and PYREXIA (Running a temperature/fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2022, SARS-CoV-2 test: (Negative) Negative.         The patient had Dose 1(unknown date) with lot number 032L20A, dose 2 was on 22-Feb-2021 with lot number 030M20A and first  booster dose was on 04-Nov-2021 with lot number 076C21A.  Patient stated that she had the 2 shots and one booster and she never had any problems with them.  Patient never had COVID + test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. AE did not cause patient to seek medical care. The patient did not experienced a similar event in the past.  No treatment medications were reported.
Immediately following the vaccination I didn't notice any reaction or effect, but by a few days afterward the injection site began to itch and to be hard like a bad bee sting.  It itched and I refrained from scratching, put up with it for a couple days, but finally got so annoyed by it I looked at the site and saw a large angry red area around the site, covering much of my upper arm.  I put Neosporin on it to try to take out the sting, and the next two days I put on hydrocortisone cream, which seems to take most of the sting away.  But the area of red on my upper arm has become even larger now at the 11th day after vaccination.  I presume I must have some reaction to a component of the vaccine that is causing a very localized topical reaction.  I have never had a reaction to any vaccination before in my life aside from muscular soreness.
Pt got chills, muscle aches, 103 fever, pt could not eat and passed out. Pt was ill for 5 days.
Discomfort started around 2pm. Slight swelling. Hurts to move arm. Ibuprofen and ice the shoulder/arm. 2/13/09 doing much better.
About 18-20 hours after the immunization I felt achy.  At 6pm evening of the Jan. 8th I ached all over and temp. of 99.6.  Took Tylenol 650mg and went to bed.  Up and down most of evening / night, hot and cold, sweating and at 11pm temp. of 100.6 and took Ibuprofen 400mg.  Miserable at 3:30am with temp. 101.4 and took Ibuprofen again.  Slept well until 9:30am when I awoke with no temp. and feeling great.   Temp.s were taken orally.  Moderately sore arm.  No nausea
received Treatment of COVID-19; received Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 11Jul2022 at 12:45 as dose 5 (booster), single (Lot number: Pf7150) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Nov2022 at 14:30 as dose 6 (booster), single (Lot number: 023h22a), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) positive, notes: tested positive after 9 days of completing of stopping Poxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.