chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the first shot on 04/19/21 and the second shot on 05/10/21. On the 05/28/21 - my menstrual cycle arrived 6 days  early  (day 19 of cycle). This is unusual for me and my normal cycle.
I have had a non-stop pressure headache since the second dose. I drink plenty of water. I take Tylenol / Ibuprofen daily. Nothing helps. Laying down makes it worse. It throbs in the roof of my mouth and my nose. It is nauseating. I feel like someone is squeezing my brain. My blood pressure, pulse, and oxygen are fine.   I did reach out to a neurologist about this. I was thought to have IIH over two years ago when I was 70 lbs heavier, but I have not had a symptom since losing weight. Opening pressures and scans show no evidence of it. The headaches I am having now are significantly worse than that was. It hurts down my neck as well.  The headaches began approximately 18 hours after the second dose. I was nauseated. I had chills. I had a temperature. My joints ached. My muscles ached. My body ached I was seen at the hospital twice for the seemingly common and expected side effects. I received IV medication for nausea and plenty of fluids. The headache, however, did not let up. 60ish hours after the second dose and all other symptoms ceased. The headache, however, remained. It persists. The headaches get so intense sometimes that my body feels like it needs to jerk, or twitch. I honestly cannot explain this sensation. I feel like I have to really focus to keep my body from moving impulsively.  It is bothersome, but I am concerned with how long it is lasting, especially with reports of strokes following the vaccination.
Information has been received from a registered nurse concerning a 14 month old female female with no known drug allergies who on 11/07/2001 in the AM was vaccinated with the first dose of varicella vaccine in the right thigh. Concomitant therapy included the first dose of MMR vaccine in the left thigh and the third dose of Prevnar in the right thigh. There was no illness at the time of vaccination. On 11/07/2001, the pt developed swelling at the injection site, described as being "about the size of an almond, about 2 inches in length within five minutes of the injection." Follow-up info described the reaction as "redness and warm to touch with firm induration size of a quarter" at injection site. The pt was given a half teaspoon of Benadryl and was observed for twenty minutes. The redness appeared gone, however itchiness adna "firm lump" remained. It was also noted that on 10/24/2001, the pt received the fourth dose of HibTITER in the left thigh. It was reported that the pt did not experience any adverse events following previous vaccinations. It was also reported that another one year old female had a similar reaction. No further info is expected.
This spontaneous case, received from pharmacist on 03-Oct-2017, concerning a female patient of unspecified age. On 20-Sep-2017, the patient was vaccinated with FLUAD (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid and Lot no: 178701 and expiry date: unspecified date in April 2018). On an unspecified date, after vaccination, the patient experienced bruise that keeps getting bigger (1 inch) in size at the injection site and it was green in color. Greenness came right away and increasing in size. It was reported that, there was no sore and everything was fine. On an unspecified date, the patient was recovered from the event. As per the reporter, it was "just a little bit green and had resolved". The reporter assessed this case as non-serious. Follow-up received on 11-Oct 2017: Outcome of the events were updated to recovered/ resolved from not recovered. Narrative was amended accordingly. Non-significant case correction received 11-Oct-2017: Narrative was amended with relevant information.
improperly stored then administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drugs reactions or allergies, and concomitant medications were not reported.  On 16-NOV-2020, the vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had a temperature excursion. The vaccine was exposed to the following temperature excursion: 46.9 degrees Fahrenheit for 15 minutes as recorded by a data logger. There were no previous temperature excursions. On 17-NOV-2020, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml (strength, vaccination scheme and anatomical site of vaccination were not reported, lot # 1684152, expiration date reported and validated as 19-JUN-2021) orally for prophylaxis.
I got my first menstrual cycle 11/28/2013. Prior to receiving the vaccination, my period came every 28 days, and was of normal consistency and amount. Two weeks and a day after receiving the vaccination, I was supposed to start my period. I did not begin my cycle again until 06/2015. That period was incredibly painful, heavy and abnormal for me. Every period after that was only heavy, of weird consistency and my cycle ranged from 14 days to 60 days until 2018. Beginning in the later months of 2018, my period became incredibly painful in addition to the odd cycle length and amount/consistency that had been occurring since 2015. I finally saw my PCP in November of 2020 to address the periods. He put me on birth control which made my symptoms even worse. My period would be practically absent, and then would come for 15-20 days. I self-discontinued the birth control in 04/2021, and since then my periods have continued to be painful and heavy.
pt recvd DTP/OPV/MMR on 30JUL92 & mom reported fever intermittently for next 10 to 11 days; 9AUG92 10 days post vax began breaking out in urticaria from head to toe;
Numbness and burning down ulnar portion of arm into hypothenar area for one week. And down back of both legs for 3 days.
Rash appeared 1 day post administration along with patient reported total body joint soreness and fever. Patient reports self treatment with oral diphenhydramine, oral ibuprofen and APAP, topical cortisone and topical diphenhydramine.
High fever; Extreme shaking; Sore arm; Extreme chills; Swollen lymph nodes under arms; This is a spontaneous report received from a contactable consumer. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 22Mar2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, the consumer would like to report an adverse event for the COVID-19 vaccine (dose 2). Stated that, this was reported last night by the patient to the reporter. Stated that, she did not report adverse side effects with dose 1. On 23Mar2021 (starting 24 hours after treatment), the patient experienced high fever, extreme shaking (starting 24 hours after injection, subsided after overnight rest) and sore arm, extreme chills, swollen lymph nodes under arms starting (24 hours after injection, ongoing). The outcome of the events for high fever, extreme shaking was recovered on an unspecified date in Mar2021 while for the other events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
c/o pain lt deltoid beginning 2wk p/vax;states pain has affected mobility of arm;has not sought medical care (prior to 13MAR97) & did nothing to help alleviate discomfort;reported to this office 13MAR97;
Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but captured as an adult as per vaccine indication. The patient had sore arm post vaccination. The patient stated that the sore arm was way better than shingles. For tolerance of 2nd dose refer case US2021AMR104421.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104421:Same patient, 2nd dose
Report #2000028194-1 describes hives in a pt who rec'd Engerix-B for the prophylaxis of hepatitis B. The pt is allergic to commercial fabric softeners (skin irritation) and is obese. She takes over the counter weight reduction medication NOS). On 4/27/00 (IM), 5/25/00 (IM), and 9/14/00 (IM L deltoid), the pt rec'd her first, second, and third adult pre fill doses of Engerix-B, respectively. Two days after the third dose of Engerix-B, in the afternoon of 9/16/00, the pt experienced itching, burning (sensation), and hives on her abdomen, chest, arms, and legs. An emergency room visit was required. She missed four days of work. She was treated with epinephrine, diphenhydramine hydrochloride (Benadryl) PO. and Prednisone (from 9/16/00 to 9/20/00). the pt reported that the hives continued. The pt's symptoms resolved as of 9/21/00. this case is considered serious due to the medical intervention required. As of 12/14/00, the outcome of the event is resolved.
pt started having pain in his left foot.   He now has to limp since he has trouble putting any weight on it.  He has some pain in the calf and chin also.  He states he has never had any pain or problems with this foot in the past.  Pt will make an appt to see a doctor regarding his foot.
Patient noticed a mouth lesion/ulcer that came about approximately 4days post vaccination this is a painful spot that was starting to go away until I received my second dose and it cause what would almost be considered a flare up as it became more painful and enlarged again.   Saltwater rinses and otc pain reliever and ibuprofen seem to be helping the  discomfort
This spontaneous report as received from a physician via field representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with the second dose of VARIVAX (Merck). On an unknown date the patient developed chicken pox after the second dose of VARIVAX (Merck). The outcome of chicken pox was unknown. The patient did not seek medical attention. Additional information has been requested.
PAIN AT THE INJECTION SITE AND ABOUT 2 INCH ABOVE AND BELOW THE SITE OF THE FLUZONE INJECTION SITE.  THE PAIN WAS INTENSE ENOUGH THAT IS EFFECTING SLEEP.  PATIENT ALSO REPORTS FEVER REDNESS, AND WEAKNESS.
MODERNA bivalent booster dose was given to patient for quantity of 0.3 ml, instead of 0.5 ml.
swelling of the hands and tongue; swelling of the hands and tongue; some injection site redness; This is a spontaneous report from a contactable consumer. A 69 old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine on 12Jan2021 and developed swelling of the hands and tongue as well as some injection site redness on unspecified dates. Pharmacist gave her Benadryl and symptoms resolved. Her doctor has advised her not to receive the second vaccine. She had previous history of having an allergic reaction to the tetanus shot and was unable to receive the shingles shot. The patient recovered from the events on unspecified date.   Information about lot/batch number has been requested.
chest pain; diarrhea; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), DIARRHOEA (diarrhea), CHILLS (chills) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), DIARRHOEA (diarrhea), CHILLS (chills) and HEADACHE (Headache). At the time of the report, CHEST PAIN (chest pain), DIARRHOEA (diarrhea), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.            Patient felts throwing up and hit by a truck after getting her third dose Concomitant product was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-311093 (Patient Link).   Reporter did not allow further contact
PT WHO IS A NURSE RECEIVED PNEUMONIA VACCINE ON 11/20/07. PT HAD SOME TENDERNESS AT INJECTION SITE THAT EVENING. FOLLOWING MORNING, PT HAD MORE TENDERNESS AT SITE AND SOME SWELLING. FOLLOWING MORNING ON 11/22/07 PT HAD LOW GRADE TEMPS ALL DAY, SWELLING OF UPPER RIGHT ARM WHERE INJECTION WAS GIVEN, TENDERNESS (PT COULD BARELY LIFT UP ARM) AND SLIGHT REDNESS, PT TOOK TYLENOL. 11/23/07 PT HAD TEMP OF 102 AND HIGHER, DIZZINESS, NAUSEA, VOMITING, CHILLS, MORE TENDERNESS OF RIGHT UPPER ARM (PT COULDNT LIFT UP ARM WITHOUT EXCRUCIATING PAIN, AND REDNESS OVER ENTIRE RIGHT UPPER ARM FROM INJECTION SITE TO ELBOW, PT TOOK TYLENOL. PT TAKEN TO ER AND GIVEN ANTI NAUSEA MEDICATION, MOTRIN, AND ANTIBIOTICS, AND PRESCRIPTION FOR ANTIBIOTICS. PT GIVEN DIAGNOSIS OF CELLULITIS DUE TO PNEUMONIA VACCINE!
Received vaccines at PCP on morning of 1/27/23. Developed Hives on 1/27/23 in the evening. Took Benadryl. Had nausea and hives the morning of 1/28/23. Went to Urgent Care. Was given a prescription of Prednisone. Had one 20mg tablet of Prednisone. Hives proceeded to worsen. Came to our center at 1830 on 1/28/23. Nausea has resolved, but still having hives.
This spontaneous report was received from a nurse refers to 5 unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L032396, exp. 26-AUG-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link. Additional information has been requested.
She got her vaccine, her arm hurt for a day or two.   The following  Monday she was brushing her hair and had to empty it as it was so full.  She has been shedding her hair and has been gentle with washing her hair and coming and it continues to come out.  She can now see what looks like a receding hair pattern around her forehead and has baby hairs on the sides of hair above her ears/temple region and it's getting thinner.   She googled hair loss and it showed that it was due to the vaccine, and got the pamphlet from the pharmacy and called us.
Nausea; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Throwing up) in an elderly female patient who received mRNA-1273 (Spikevax) for an unknown indication.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and VOMITING (Throwing up). At the time of the report, NAUSEA (Nausea) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No treatment information was provided.
She stated that she was having burning and limited movement of her arm.  She said she went to a doctor, has had to have 3 x-rays, and has had to go to 8 sessions of physical therapy.
Suspected vaccination failure; Now has active shingles; Painful rash on back, rash on head and face; Painful rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a history of shingles for most of in her adulthood).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. On an unknown date, the outcome of the vaccination failure, shingles, rash and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The patient stated that, she had received both the doses of Shingrix around 4 years before the date of reporting.  The patient stated that, she now had active shingles with a painful rash on back, rash on head and face, referred her to health care professional. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided
Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Follow-up information received on 25-Apr-2021 contains non-significant information.
Patient started to develop tingling in the face and eventually turned into a shingles rash on face and scalp.
The pt experienced a generalized seizure lasting under 10 minutes at home approximately 2 hours post vax.
This spontaneous report as received from a registered nurse refers to unknown number of patients of unknown age and gender whom in January 2014 were vaccinated with VAQTA (dose, route and lot# not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from same reporter. Additional information has been requested.
Breakthrough case admission after 2 vaccines Moderna 2/28/21 Lot# 004M20A;  Moderna 3/8/21 Lot# 003A21
Slight headache/rash face, neck and head. Tx: Rx for hydrocortisone cream. Call PCP if not better in 5-7 days.
PATIENT AND SPOUSED ADVISED PATIENT FAINTS POST-VACCINES. VACCINES ADMINISTERED. 5 MINUTES POST VACCINE ADMINISTRATION, PT. STATED DID NOT FEEL WELL SKIN COLOR PALE THEN FAINTED BILATERAL UPPER EXTREMITIES EXHIBITED POSTURING. PATIENT REGAINED CONSCIOUSNESS WITHIN 20 SECONDS POST ADMINISTRATION OF AMMONIA INHALANT NEAR NOSTRILS.
kept sleeping; no appetite; real tired; fever; body aches; chills really bad; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (kept sleeping), DECREASED APPETITE (no appetite), FATIGUE (real tired), PYREXIA (fever) and MYALGIA (body aches) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (had an heart attack). Concurrent medical conditions included Heart disorder.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced SOMNOLENCE (kept sleeping), DECREASED APPETITE (no appetite), FATIGUE (real tired), PYREXIA (fever) and CHILLS (chills really bad). 17-Apr-2021, the patient experienced MYALGIA (body aches). At the time of the report, SOMNOLENCE (kept sleeping), DECREASED APPETITE (no appetite), FATIGUE (real tired), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills really bad) outcome was unknown.            Though patient had heart condition physician advised to take a shot. Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-392003 (Patient Link).
swollen lymph nodes near injection site (visible swelling in armpit), itching at injection site, swollen injection site (visible), pain at swollen lymph nodes
No Adverse event; they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose) and NO ADVERSE EVENT (No Adverse event) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 057A22A and 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Dec-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose).    No concomitant medication was provided by the reporter.  Nurse practitioner reports that they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose.   No treatment medication was provided by the reporter.