chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who on an unspecified date, was vaccinated intramuscularly with a first dose of Gardasil. Subsequently the patient experienced a rash and redness around at the injection site. Subsequently, the patient recovered. Additional information has been requested.
09-17-09 Within a few minutes of vaccine administration, client lost consciousness. After being placed in recumbant position, consciousness regained. After 15 minutes left clinic with mother. Mother reported H.A., nausea and tiredness in afternoon. During a visit to the optometrist the next day, lost consciousness again and transported to ER.
VACCINE EXPOSED TO TEMPERATURE OUTSIDE OF RECOMMENDED STORAGE RANGE.  UNKNOWN VIABILITY AND POTENCY PER MANUFACTURER.
his heart is now very weak and not as strong as it used to be; he does not have a vision and he does not know what he is looking at; I can't function regularly due to the head injury that I got from the vaccine; problems with vision and coordination and speech; he has been having severe headache; he gets too exhausted right away unlike before; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (his heart is now very weak and not as strong as it used to be), VISUAL IMPAIRMENT (he does not have a vision and he does not know what he is looking at), HEAD INJURY (I can't function regularly due to the head injury that I got from the vaccine), SPEECH DISORDER (problems with vision and coordination and speech) and HEADACHE (he has been having severe headache) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (his heart is now very weak and not as strong as it used to be), VISUAL IMPAIRMENT (he does not have a vision and he does not know what he is looking at), HEAD INJURY (I can't function regularly due to the head injury that I got from the vaccine), SPEECH DISORDER (problems with vision and coordination and speech), HEADACHE (he has been having severe headache) and FATIGUE (he gets too exhausted right away unlike before). At the time of the report, CARDIAC DISORDER (his heart is now very weak and not as strong as it used to be) had not resolved and VISUAL IMPAIRMENT (he does not have a vision and he does not know what he is looking at), HEAD INJURY (I can't function regularly due to the head injury that I got from the vaccine), SPEECH DISORDER (problems with vision and coordination and speech), HEADACHE (he has been having severe headache) and FATIGUE (he gets too exhausted right away unlike before) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Moderna COVID-19 Vaccine EUA - Second dose - Slight fever 99.8 waking on morning after, 17 hours post vaccine. Fatique and Increasing fever and flu-like symptons as day went on. At 1:00pm fever of 101.8, went to bed. Stayed in bed except for got up for water at about 2:00am (now 2/14) - very weak and almost could not walk - poss Low BP - husband helped me back to bed.  Slight naseau and mild headache. Slept off and on until morning 7:30am 2/14. Woke feeling much better with 99.4 temp.  98.3 temp and much better by 10:00am, but still fatigued and rested remainder of day.
My wife was pregnant 23 weeks. The baby died and the time of death was around the 15th of Dec. The doctor said that there is no way that the vaccine could have caused it. I am reporting this on my wife's behalf as I thought we should report it either way. Just in case some statistics are collected and help some one in the future.
Patient developed area of redness and induration, approximately 8cm x 8cm and was evaluated in clinic. It was painful to palpation. Diagnosed as cellulitis by primary care provider.
Generalized itching and erythema occurring minutes after injection, despite premedication with benadryl 25 mg orally 2 hours prior.  No SOB, wheezing, hives, throat/tongue swelling/itching, CP, LH, palp, N/V, abd pain, diarrhea. Vital signs stable. Improved with additional benadryl 25 po.   Similar reaction to first dose, at which time benadryl 50 IM given.  Had seen her allergist who cleared her for 2nd dose with premedication with benadryl 50 (pt took 25 due to concern for drowsiness). As pt had systemic reaction which broke through premedication, rec further monitoring in ER, but pt refused.   Discussed with her allergist who recommended benadryl 50 mg q6 hrs x24 hrs, and if progressive sxs, epipen and call 911. Pt agreeable with this plan and will make f/u appt with allergist.
Its kind of a mild nausea that I get daily, it does not go away. This is why I went to the doctor. It was nausea to the point of a dry heave, a mild headache and a tightness in my jaw or throat region. Today I had a CT scan and I have not gotten the results yet.
Patient arm was red and swollen from the shot from Saturday afternoon. She went to the doctor on Tuesday morning as swelling and red did not go down. Doctor told her it was a localized infection from a flu shot, for her to take benadryl, ice the area, and rest. If the area expanded or patient developed fever she was to return to the doctor. We called the patient back on Thursday 10/8 and she was doing much better and did not need to return to the doctor.
3 days after the injection on 1/15/21, I developed hives on hands, feet, and backside.  I wasn't sure if it was the vaccine or something I ate or some other irritant.  On the morning of 1/16/21, I noticed redness all around the injection site (sort of like a donut with no redness in the middle where injection took place) and a couple hives forming on right arm and now ears.  I took Zyrtec (don't have Benadryl on hand).  Symptoms are just itchy and mildly irritating at this time.
still feel lousy / feel bad; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient experienced very mild case of shingles 3 or 4 years ago from reporting date).   On 9th December 2021, the patient received the 2nd dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine 2 days ago from reporting date and still feel lousy. The patient stated that she did not want to imagine what a bad shingles case would feel like. Gladly feel bad for a couple days to hopefully never get it again. The follow-up would not possible as no contact details were available. The case had been linked to US2021AMR254583, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR254583:same reporter
3 days after receiving the smallpox vaccination the patient developed nausea and vomiting.  This persisted for 4 days. On the 4th day she was seen in the clinic and rehydrated and given phenergan.  She returned to work for 2 days then developed nausea, vomiting, RLQ pain and diarrhea.  She was seen in the ER and received 4 liters of IV fluids.  She was seen the following am and was still orthostatic so she was admitted to the hospital for IV hydration.  She remained in the hospital for 2.5 days.  At the end of her hospitalization all symptoms had resolved.  Her injection site had a normal appearance for small pox.
Dizziness upon returning home  where I thought I would pass out.  Fever 101, chills, headache,  Dizziness continues.  Today I am 2 weeks post vaccination and still too dizzy to drive.
Severe migraine, swollen face, left eye was irritated, extreme fatigue, left arm tingling from injection site to entire hand, where injection placed a dark bruise. Migraine continued for 6 days. Swollen face continued for 1 week, red eye continued for 1 week, fatigue for 3 days, left arm tingling 7 days, dark bruise I still have to this day.
pain and a tingling on her left knee -the back side- and her feet; not able to sleep; pain and a tingling on her left knee -the back side- and her feet; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pain and a tingling on her left knee -the back side- and her feet), INSOMNIA (not able to sleep) and PAIN (pain and a tingling on her left knee -the back side- and her feet) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     No medical history reported.  Concomitant products included AMLODIPINE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PARAESTHESIA (pain and a tingling on her left knee -the back side- and her feet), INSOMNIA (not able to sleep) and PAIN (pain and a tingling on her left knee -the back side- and her feet). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (pain and a tingling on her left knee -the back side- and her feet), INSOMNIA (not able to sleep) and PAIN (pain and a tingling on her left knee -the back side- and her feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
ADMINISTERED PAST THE CURRENT REFRIGERATION BEYOND THE USE DATE AS LINKED IN EUA
Pt had dental work right after getting her flu shot and said that her oral surgeon noticed herpes blisters in the back of her throat. Pt states she has never had any type of cold sore before and believes she got it from the flu shot. She mentioned that her son also had a flu shot around the same time and he got a cold sore on his lip for the first time ever.
c/o drooling, drowsiness, arms & face turning blue @ approx 10:30-11AM;color nl on arrival;no resp distress given DPH
After the first dose there was minimal side affects with some fatigue and joint pain.  The second dose side affects started 2 days after the injection.  There was a fever, abdominal rash and joint pain.  The fatigue lasted 2 weeks.  The tinnitus started about 2 days after the second injection and still persist with no improvement.
About 30-45 minutes after the vaccine was administered, I began to experience a thickening of the mucus in my throat and some slight+ wheezing, perhaps an increase in heart rate.  This lasted for about 10-15 minutes.  Next day very mild flu symptoms and lack of energy--this continued through the following day but milder.
Chest pain, heart pain, heart flutters, chest tightness, can't take full breath
itching at the injection site; Injection site swelling; redness at the injection site; Vaccination site pain; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (Vaccination site pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 immunisation.     No Medical History information was reported.    On 10-Mar-2021 at 12:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (Vaccination site pain) 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.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: The follow-up was received on 14-MAY-2021.  Patient demographics, Product route of administration, was updated. New event was added.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD (incorrect product storage) (lot #, expiry date unspecified) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 6 Fahrenheit (F) for 1 hour. Previous temperature excursion was reported on an unknown date, at a temperature of 22.6 F, for a duration of 13 hours. This case was reported because of a data logger. No product quality complaint (PQC) was reported. This case is linked to case number 1611USA011550 via same reporter link. Additional information has been requested.
This spontaneous report as received from a nurse refers to two patients of unknown age and gender. On unknown dates, the patients were vaccinated with incorrectly stored doses of VARIVAX lot # N002204 for prophylaxis. Concomitant therapies included sterile diluent (manufecturer unknown). Sender's Comments: US-009507513-1708USA013407.
Client was in for second dose of Janssen as booster, instead of client receiving Janssen, client received Pfizer Pediatric unknown if dose was diluted since Janssen is NOT a vaccine to dilute.  Client has had no reaction to dose and is aware of what was given but unknown is the amount and if diluted or not.
This spontaneous report was received from a licensed practical nurse referring to a 6 months old infant patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The patient did not have any brothers and sisters. On 13-APR-2018 (reported as today), the patient was in the office and was vaccinated with M-M-R II injection (strength and dose were not reported) (lot number N013296 and expiry date was not reported) (dose 1) subcutaneous in the left thigh for prophylaxis. The vaccine M-M-R II was reconstituted with sterile diluent injection (manufacturer unknown) (lot number and expiry date were not reported). The reason M-M-R II being given early because the family would be travelling internationally (drug administered to patient of inappropriate age). The reporter informed that the patient would also receive ROTATEQ today (13-APR-2018). However, due to lack of information regarding concomitant administration of ROTATEQ with M-M-R II, the provider and parents chose to wait 4 weeks to give ROTATEQ vaccine. On an unknown date, the patient was also vaccinated with PENTACEL (strength and dose were not reported) (lot number C5454AA and expiry date was not reported) (dose 3) intramuscularly in the right thigh, ENGERIX-B (strength and dose were not reported) (lot number L594L and expiry date was not reported) (dose 3) intramuscularly in the right thigh, and PREVENAR 13 (strength and dose were not reported) (lot number T62563 and expiry date was not reported) (dose 3) intramuscularly in the left thigh for prophylaxis. No adverse effects were reported with the given dose of M-M-R II. No further information was available. There was no product quality complaint (PQC) reported.
Hot to touch red lump at injection site. Very painful to touch. Fever. Verge of chills. Headache. Sore arm pit.
Rash started on 4/12/14, vaccine administered (MMR) on 4/4/14, no fever, rash started on the trunk, then spread to the face, neck, back and lower extremity, no itching. No treatment given.
This spontaneous report was received from a medical assistant concerning a 17-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L016429, expiration date: 09-AUG-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
ABOUT 9:30 P.M. ON THE 7TH OF FEB.  STARTED FEELING EXTREMELY DIZZY TO THE POINT OF ALMOST FAITING, ALSO STARTED TO VOMIT. LASTER ABOUT 2 HOURS.
One painful white patch showed up on uvula; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the right arm on 05Apr2021 at 13:15 (at the age of 34-year-old) as a single dose and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8735) via an unspecified route of administration in the right arm on 26Apr2021 at 13:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple mouth ulcers and a painful white patch in the throat from 03Apr2021 at 06:00. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN), vitamin d not otherwise specified (NOS) (MANUFACTURER UNKNOWN), ultra nutrient multivitamin (MANUFACTURER UNKNOWN), all drugs used for an unknown indication from unknown dates. The patient previously took amoxicillin on an unknown date for unknown indication and experienced drug allergy. The patient was treated with a steroid for multiple mouth ulcers and a painful white patch in the throat which went away after two weeks in Apr2021. After the steroid treatment, on an unknown date in Apr2021, one painful white patch was showed up on the uvula. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 28Apr2021, the patient underwent a rapid COVID test and the result was negative. The clinical outcome of the event one painful white patch showed up on uvula was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
POSSIBLE CLOGGING; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 7 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccine, patient had nothing out of the normal. The patient went to get annual physical done (gets physical done routinely). The physician heard something that might indicate some clogging so wanted to make sure that everything was okay with circulation of the patient. The physician listened to heart then ordered a CTA (computerized tomogram angiography) for patient. On an unspecified date, the patient felt a little bit of chest tightness after seeing the physician. The patient was generally healthy (not diabetic). On an unspecified date, the patient got blood work (blood counts were normal and nothing stood out), CT and physical examination were done and reports not reported. It was not sure whether something was wrong with patient and wanted to wait until the CTA scan result came out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest tightness and possible clogging was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210918545- COVID-19 VACCINE AD26.COV2.S- possible clogging. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Pt recvd Heptavax series (AUG88, SEP88, & FEB89) & tested neg 1JUL89; Engerix-B booster was given 23APR91 & 23MAY91 it was determined that pt tested neg & remained a non-responder;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 01-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: L003855 and Expiry: 05-FEB-2017). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mom came in today with client. Mom states client got immunizations on 06/15/10. She said "my son complained that evening of itching on his left arm." She said when she looked at it she saw nothing except where the needle went into his arm. She then stated on 06/16/10 he complained of itching again on his left arm where he got his shot. She stated "when I looked at it I saw nothing except a dot where the shot went into his arm." She said that evening they went swimming & she happened to notice his arm as they were getting out of the pool. She stated "I saw pus running out where the shot had went into his arm." She said she cleaned it with warm water & a little bit of soap & put a bandaid on it. She said she cleaned it again later on last night & when she looked at the bandaid there was a little bit of pus on it. She said that she then decided to call & come up here today for us to look at it. Both the nurse and I looked at the injection site of the left arm. It was slightly warm to touch. Very small amount of redness noted around the injection site. No discharge was noted. There was a small scab over the injection site. Patient was moving his arm without difficulty. When I asked him if his arm hurt he said "it is a little sore." Told Mom to give him something she usually gives for a fever or soreness such as TYLENOL or MOTRIN to help with the soreness of his arm. Told her to call us back if symptoms worsen or to see private doctor. She verbalized understanding. Called this morning to follow-up on patient. Mom brought him into the health department on 06/18/10 for us to look at his left arm where he received an injection on 06/15/10. The progress note for 06/18/10 visit is in the encounter screen under the note section. When I spoke with mother this morning she stated "the arm is better. There is only a little bit of drainage, not much at all." She also said "I'm not giving him any TYLENOL and he is not complaining about his arm." I told her if he continues to have even a small amount of drainage to see her private provider & to let us know." She said she would and thanked me for calling.