chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant via a company representative refers to a 12-year-old female patient. Her medical history, concomitant drugs, and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (reported as: Tdap) in her right arm (dose, frequency, route of administration, indication, lot# and expiry date were not provided) and meningococcal vaccine (unspecified) (dose, frequency, route of administration, indication, lot# and expiry date were not provided) in her left arm. Subsequently, at the same visit, according to the mother's decision, the patient was vaccinated with her first dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiry date were not provided) in the right arm (at the different location from diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid vaccine) for prophylaxis. A few minutes after receiving GARDASIL 9, the patient fainted and fell out of a chair. She was not hurt. She was observed with no intervention and no treatment, and went home because she seemed to be fine. The current status of the patient at the time of reporting was unknown. The reporter did not provide causality assessment between the event and GARDASIL 9 vaccine.
Exactly two weeks before the event, was given the first dose of a shingles vaccine.  On June 25th suffered a moderately severe stroke.
Headache, Myalgia, UrticariaPruritus, NauseaVomiting, Tachycardia,   Reports had R knee pain (prior injury there) and took tylenol, naproxen and  tramadol for symptoms which were intermittent for the next 10 days.   Narrative: Employee directed to go to ED and declined. Employee is a  physician. Employee took 2nd Pfizer Vaccine, EL1042 on 1/13/2021 and  experienced L shoulder injection site pain, headache, body aches. Fever up to  101F. Tx with tylenol, Reports in bed all day. Missed work on 1/14/2021 and  1/15/2021. 1/15/2021 got up and severe burning all over body. Smell decreased  and change in taste. Reports increased teeth sensitivity to cold, citrus tastes.  Feeling more weak and fatigue. Neurologist diagnosed with Small fiber  neuropathy R/ T Covid vaccine administration on 3/3/2021.
Pt had two days of fever <101 followed by two weeks of daily irritability.  Slept OK but during day time was irritable 90% of time.  No signs or symptoms of other illness.
Son received the flu vaccine.  6 days later our previously social butterfly of a child started withdrawing from all social interactions including speaking to anyone outside of his parents and his brothers. He became irratible, irrational, rage filled.  He slept for 16 hours straight after a huge rage meltdown and when he woke up he was a different child. His face was lopsided and his smile was crooked. His one eyelid was drooping and his smile was completely different. His facial muscles were not working correctly. He was extremely anxious, obsessed with everything regarding death and dying, he wouldn?t leave his moms side and if she tried to use the bathroom alone he would go into a full blown panic attack. He no longer had any interest in friends or playing. He curled up onto the couch in the fetal position and stared into space often. He became nonverbal to most people. Mom and dad tried behavior therapy, play therapy and had many visits to the pediatrician extremely concerned.  He was no longer carefree, and was no longer social. He was a different little boy, entirely.
Patient experienced sensation of throat closing and SOB. The next morning, he felt as if his throat was swollen. He has never experienced this sensation or reaction to vaccines in the past.
Patient had 1 dose of Modera Covid Vaccine on 1/25/23 and was due for dose number 2 in Moderna series. However, patient received Pfizer brand Covid vaccine instead for her second dose. Pt did not have any adverse events reported. Provider and staff became aware of the error on 4/19/23 when patient returned to clinic for routine visit. Provider informed parents of the error and reviewed CDC recommendations regarding this type of vaccine error.
Rash began on right elbow around 7 p.m. Slightly, itchy.  Then noticed new rash around 10 p.m. On my right shoulder then within minutes on my left shoulder and at the same time also on both of my cheeks and both cheek rash gradually enlarged. Then noticed more mild generalized rash across back and very slightly on abdomen. Slightly itchy.  Tmperature 97 Fahrenheit. Took Zyrtec 10mg. The next day when I woke up at 10 a.m. there was new rash on my ankles and tops of my feet and when I walked there some pain and almost swelling feeling at the bottom of both of my heels and some tightness in my fingers knees ankles and feet when I would bend them, otherwise felt fine. Currently about 3:15 p.m.  on 1/ 23 and I still have the rash on my feet and ankles, and slightly on cheeks. 97.7 F temp.
Within 8 minutes, post vax, pt had rash/hives over body. Was red all over body, eyes were swollen and was wheezing with difficulty breathing.
Drug specific antibody absent; Drug effect incomplete; Delirious; Vaccination related malaise; Fever; Difficulty sleeping; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4282514-00 (Abbvie).  A 34 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1156159) at citrate free for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Daily Dose: 1)first dose (1 in 1 Once), Route of Admin: 1)Intra-muscular, Lot number: Unknown), administration date: 02Feb2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: DELIRIUM (medically significant) with onset Mar2021, outcome "recovered" (Mar2021), described as "Delirious"; DRUG SPECIFIC ANTIBODY ABSENT (non-serious), outcome "unknown", described as "Drug specific antibody absent"; VACCINATION COMPLICATION (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Vaccination related malaise"; PYREXIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Fever"; INSOMNIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Difficulty sleeping"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious), outcome "unknown", described as "Drug effect incomplete". The patient underwent the following laboratory tests and procedures: investigation: no antibodies, notes: Unknown date DRUG TEST: no antibodies. The action taken for adalimumab was unknown.  Clinical Course: It was unknown if patient was enrolled in a covid-19 vaccine trial. Source o report is Study. Solicited report from the USA by a consumer of a 34 year old male with events of non-serious patient stated drug test revealed no antibodies, second Covid vaccine made patient delirius/high fever/could not sleep and very sick and patient thought humira drug had little affect with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced patient stated drug test revealed no antibodies and patient thought humira drug had little affect. In Mar2021, the patient experienced second Covid vaccine made patient delirius/high fever/could not sleep and very sick. In Mar2021, the second Covid vaccine made patient delirius/high fever/could not sleep and very sick resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
This case was reported by a physician and described the occurrence of a subject of unspecified age and gender not responding to therapy following vaccination with Twinrix for prophylaxis. On an unspecified date the subject completed the entire series of Twinrix. At an unspecified time following completion of the Twinrix series, the subjects titers were tested and the subject was found to have not responded to therapy. At the time of reporting the outcome of the event was unspecified.
Confirmed Breakthrough Case 1st Dose 5/15/2021 - Pfizer - en6202 2nd Dose -- Pfizer - EW2017
Information has been received from a physician concerning a 19 year old female with penicillin allergy and AUGMENTIN allergy who had two doses of MMR II in 1990 and 1992. There was no concomitant medication. It was reported the patient had a low titer for mumps. It was reported that the patient's present status has not improved. No product quality complaint. Additional information has been requested.
The pt came in on 4-1-22 for 11 year old vaccines and received MCV4 to left deltoid, TDAP to right deltoid. PT was not going to get recommended HPV shot, pt 13 year old sister was to receive HPV vaccine. After giving the HPV vaccine to left deltoid to, the nurse realized that she had given the HPV to the wrong sibling. The nurse explained to mother that HPV vaccine is recommended for 11 year old and apologized for the mistake. Mother verbalized understanding and she was provided with the VIS sheets for all 3 of the vaccines and an updated record of vaccines.   Mother is speaking another language and a translator was utilized for this encounter. Dr. and vaccine coordinator notified immediately of vaccine administration error.   Dr followed up with mom this AM, 4/4/22,  with the use of translator. Mom verbalized that pt was doing well and no adverse reactions reported.
No additional AE; T/E. Improperly stored VARIVAX administered to a patient on 28AUG2023, 0.5mL dose. HCP did not have information (lot number, expiration date) on DILUENT but confirmed it was Merck DILUENT; This spontaneous report was received from a Medical Assistant and refers to a 6-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 28-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter (once), lot #W039294, expiration date: 11-DEC-2024 or lot# U027947, expiration date: 08-SEP-2023, administered for prophylaxis (anatomical location, strength, and route of administration were not provided); and with sterile diluent (no details reported), and the vaccine was improperly stored: temperature 7.8F (6 F degrees up to 14 F degrees), time frame: 0 hour 30 minutes 0 seconds (no previous temperature excursion). No additional adverse event.
pt to hospital 1/11/22; positive for COVID; treated with dexamethasone and empiric ABX; O2 supplementation; AHRF; during hospitalization, CXR showed some improvement; pt dc'd to home on 2/2/22 with home O2; pt passed away in the home on 2/5/22
Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2012, at approximately 74 years of age, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Information has been received from a pharmacist concerning a healthy 35 year old black female with no history of drug reactions or allergies who on 23-JUN-2005 was vaccinated with a first dose of hepatitis A virus vaccine inactivated (lot # 648722/1125P). Suspect vaccination at the same time included a 0.5 mg second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 650044/0004R) which was given using two pediatric doses. It was noted that the patient received their first dose of hepatitis B virus vaccine rHBsAg (yeast) in September 2004. Other concomitant medication included ethinyl estradiol (+) norgestimate (ORTHO TRI CYCLEN). It was also noted that the patient also had no reactions to prior vaccine doses. Subsequently, 45 minutes later, the patient started vomiting and sweating. She was admitted to the emergency intensive care unit for an anaphylactic reaction and was given ephedrine and intravenous fluids. She was discharged the next day. Subsequently, the patient recovered from anaphylactic reaction. A product quality complaint was not involved. Follow-up information was received from the pharmacist who reported that the patient developed difficulty breathing and nausea and dizziness about ten minutes after being vaccinated with hepatitis A virus vaccine inactivated and hepatitis B virus vaccine rHBsAg (yeast). The patient had two episodes of emesis and went to the emergency room for evaluation. The patient was noted to have stridor and received methylprednisolone sodium succinate (SOLU-MEDROL) (125 mg IV), epinephrine (0.5 mg SC), diphenhydramine hydrochloride (BENADRYL) (50 mg IV), and cimetidine (300 mg IVBP). The patient was hospitalized for one day and recovered on 24-JUN-2005.   Anaphylactic reaction was considered to be immediately life threatening and an other important medical event (OMIC) by the reporter.   No further information is expected.  The records of testing prior to release of both lots in question (#1125P and #0004R) have been rechecked and found to be satisfactory. The lots met the requirements of the Center and were released by the regulatory agency.
Loss of taste; Stomach pains; Eexperienced body pain; Joint pains; Nausea; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), ABDOMINAL PAIN UPPER (Stomach pains), MYALGIA (Eexperienced body pain), ARTHRALGIA (Joint pains) and NAUSEA (Nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced AGEUSIA (Loss of taste), NAUSEA (Nausea) and FATIGUE (Fatigue). 16-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pains), MYALGIA (Eexperienced body pain) and ARTHRALGIA (Joint pains). At the time of the report, AGEUSIA (Loss of taste), ABDOMINAL PAIN UPPER (Stomach pains), MYALGIA (Eexperienced body pain), ARTHRALGIA (Joint pains), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.    This case was linked to MOD21-055337, MOD21-055429, MOD21-055432, US-MODERNATX, INC.-MOD-2021-046257 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-055337: MOD21-055429: MOD21-055432: US-MODERNATX, INC.-MOD-2021-046257:patient case (male)
This spontaneous report as received from a registered nurse refers to a 13 year old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 20-JAN-2016 at 16:33, the patient was vaccinated with the first dose of GARDASIL intramuscularly in the right deltoid, lot number L016428 (strength, dose and expiration date were not reported), which was improperly stored. The reporter stated that no adverse events were documented per medical doctor. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In May 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced papular rash. The patient was treated with calamine, zinc oxide (Calamine Lotion), valacyclovir hcl tablet and gabapentin. On an unknown date, the outcome of the vaccination failure, shingles and papular rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles and papular rash to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had shingles shot when shots first came out. Bumps did not come out until about 2 months ago of reporting date and they were not bad. Calamine lotion helps bumps. The patient stated he/she had internal shingles. The physician prescribed Valacyclovir HCL 1 GM Tablets twice a day and Gabapentin 300 MG Capsule thrice a day. The patient stated had not noticed any bad side effects from either one. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Approximately 35 minutes after the vaccination the patient developed flushing, redness on arms, neck, and face with itching.
GOT THE SHOT IN LEFT ARM NOW UNABLE TO LIFT ARM IN FULL MOTION RANGE OR LIFFT ARM ABOVE HEAD SINCE THE SHOT NOR CAN MOVE ARM BEHINDE BACK EITHER.
This spontaneous report as received from another health professional refers to a patient, who was over 60 years of age. On 27-AUG-2013 the patient was vaccinated with VARIVAX (Merck), 0.5 ml, instead of intended ZOSTAVAX. Route of administration of VARIVAX (Merck) was not provided. Lot number J00609, expiry date 21-MAY-2015. No adverse effects were reported. Additional information has been requested.
4-5 days following inject felt sick; devel hip pain, then backache which doesn't routinely exp; then noticed had been feeling warm & sweaty t102.6; began feeling better noticed a red rash under both breasts; notified MD 11SEP92;
Patient arrived to post-observation area at 16:50 after 15 minutes had been completed, complained of some nausea and numbness to right leg with some burping. Patient was asked to stay an extra 15 minutes. After monitoring him for an extra 15 minutes, patient stated that adverse effects resolved.
Pt. received vaccine, got very pale, c/o chest pain. BP 120/80, Sprite/ammonia offered. Placed in wheelchair and taken to ER.
Shot burned severely on injection in right arm.  In less than 5 minutes, a wave of numbness started at left ear and progressed in a wave across about 3/4 of face.  Both lips swelled; more in lower lip.  Burning sensation in arm continued for approximately 3 hours.  Minor arm pain for approximately 24 hours.  Periodic low fever (99.4-99.9) for 3 days.  Still no recovery of face.
twitching or jerking of both hands; observe next few days report number of times jerking occurs in a day;
Sinus infection; smelling saline; Chills; Fatigue; arm pain; Neck pain; ear pain; Jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain), EAR PAIN (ear pain), PAIN IN JAW (Jaw pain) and SINUSITIS (Sinus infection) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain), EAR PAIN (ear pain), PAIN IN JAW (Jaw pain), CHILLS (Chills) and FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced SINUSITIS (Sinus infection) and PAROSMIA (smelling saline). At the time of the report, PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain), EAR PAIN (ear pain), PAIN IN JAW (Jaw pain), SINUSITIS (Sinus infection), PAROSMIA (smelling saline), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Night tremors; upset agitated; not quite awake. 1-2x/night.
Site where shingles vaccine administered on the 21st of April at 10:00a.m., became very red, itchy and swollen to three inches in diameter, 1/2 inch high, rash covered the whole area, and arm was hurting so bad, patient took 2 ibuprophen every 4 hours along with 1 tsp.demerol (for likely alergy). Site is still red and itchy, but not as painful after 3rd day, but 50% better. Cold compresses help.  My husband had same vaccine at same time, and his arm was hurting, but did not have the rash.
light muscle and bone aches; light muscle and bone aches; felt like taking naps for a week; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced light muscle and bone aches and felt like taking naps for a week. It was unknown if patient was diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination. The outcome of the events was unknown.  No follow-up attempts were needed, information about lot/batch number could not be obtained.
Significant post-menopausal bleeding, beginning March 21, 2022 Second booster on April 5, 2022 Second episode of significant post-menopausal bleeding, beginning June 6, 2022