chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea, extreme heartburn and reflux increased frequency; Nausea, extreme heartburn and reflux increased frequency; Nausea, extreme heartburn and reflux increased frequency; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Nausea, extreme heartburn and reflux increased frequency), REFLUX GASTRITIS (Nausea, extreme heartburn and reflux increased frequency) and NAUSEA (Nausea, extreme heartburn and reflux increased frequency) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Aug-2021, the patient experienced DYSPEPSIA (Nausea, extreme heartburn and reflux increased frequency), REFLUX GASTRITIS (Nausea, extreme heartburn and reflux increased frequency) and NAUSEA (Nausea, extreme heartburn and reflux increased frequency). On 23-Aug-2021, DYSPEPSIA (Nausea, extreme heartburn and reflux increased frequency), REFLUX GASTRITIS (Nausea, extreme heartburn and reflux increased frequency) and NAUSEA (Nausea, extreme heartburn and reflux increased frequency) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.,
Seizure with fever, 30 seconds, witnessed in a public location, brought by ambulence to the ED.
Within 6 hours I had a fever, muscle/headaches, increased heart rate and chest tightness. Persisting symptoms are increased heart beat rate, chest tightness, increased resting heart rate, high blood pressure, irregular heart beat, fatigue, trouble sleeping and depression.
1 hour after vaccination, itchy eyes, swollen lip, tickle/scratchy throat. Went to ED. Took 25mg benadryl. Observed x 5 hours. Symptoms improved.
9/28/18 Redness/rash appeared on left rib cage. 9/29/18 Diagnosed as bite by MD. 10/2/18 Diagnosed as probable Shingles by dermatologist Prescribed Valacyclovir-1 gram dosage. No pain-widespread itching. After 8/6/18 immunization- fever, muscle aches, joint stiffness, site pain, nauseated, shivering, general malaise.
12-24 hrs after injection with 6 cm red, raised rash around injection site c/w urticaria/sensitivity rxn. Not infxn.
Experienced tingling at injection site that traveled down her arm, she felt that same sensation in her nose, left arm and stomach. Her nose began to run.  About 4 hours after the shit she vomited once. Has complained of moderate pain in arm, with some numbing sensation at injection site. Has experienced ongoing stomach pains and strange sensations through the following day.
1 minute after shot, severe dryness of throat and mouth. Did not report because didn?t realize the significance. 20 minutes (driving home), slight swollen tongue and throat began tightening . Took 2 Benadryl. Minimal effect. 45 minutes, continued throat tightness, very bad taste in mouth, dizziness, nausea. Used emergency asthma inhaler, no effect. 2 hours, itchiness that moved from place to place on my body. Itchiness in ears.  Continued mouth and throat symptoms. Chills, tremor. All other ongoing symptoms continued. 3 hours, left eye slightly swollen. Left cheek area around sinuses very tender, painful, lightly swollen. 3.5 hours, slightly swollen lips ( visible but not extreme). 4-10 hours: very uncomfortable, all symptoms ongoing, sleep very difficult, repeated Benadryl every 4 hours Went to see doctor first thing in the morning, approx.  11 hours after vaccination. Still had  allergy symptoms.
had chronic hives that seem to get worse with time; Scratching; This non-serious case was reported by a consumer and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hives (Verbatim: had chronic hives that seem to get worse with time) and scratch (Verbatim: Scratching). The patient was treated with benadryl (nos) (Benadryl). The outcome of the hives and scratch were not resolved.   It was unknown if the reporter considered the hives and scratch to be related to Shingles vaccine.     It was unknown if the company considered the hives and scratch to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20 Jul 2023 The patient stated that ever since he/she received shingles vaccine the patient had chronic hives that seems to be got worst with time. The patient had to take benadryl every night just to make it through the night without scratching himself/herself to death. The patient need help and would like to cure to this symptom.
Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N020010 and expiration date of 13-JAN-2019, (route of administration and anatomical location were not reported) for prophylaxis, which was stored in the range of -14 Celsius degrees to -10 Celsius degrees for 30 minutes. Previous temperature excursion was reported as -14 Celsius degrees to -10 Celsius degrees for 12 hours and 30 minutes. The vaccine was reconstituted with properly stored DILUENT MRK. No adverse effects were reported. No digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA003654: US-009507513-1808USA003653.
ELEVATED BLOOD PRESSURE; SINUS INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; JOINT PAIN; FEVER; FEELING BAD; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, non smoker and high blood pressure (currently on high blood pressure medication for 10 years), and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-MAR-2021 into right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the patient experienced an hour or two of slightly elevated fever (did not get temperature) and just felt bad. On 02-AUG-2021, the patient experienced bad headache, fever, coughing, general weakness, he was not eating, could not get out of bed (for 2 and half days), low level of oxygen (suspected covid-19 infection and suspected clinical vaccination failure) . On 02-AUG-2021, the patient experienced sinus infection and joint pain. On 04-AUG-2021, at 11:00, the patient went to the emergency room and tested positive for covid-19. As per the patient, he has received regeneron infusion and his blood pressure was elevated. Laboratory data included: Oxygen saturation (NR: not provided) low. The patient stated that he wants to talk to someone from JNJ and because the fact that he trusted JNJ and now here he was sick even after getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus infection, joint pain, elevated blood pressure, suspected covid-19 infection, fever and the outcome of feeling bad and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210807550 and 20210808196.; Sender's Comments: V0: 20210807871-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS. 20210807871--Suspected COVID-19 infection, elevated blood pressure. This event(s) is considered unassessable. The event(s) 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(s).
Entire night of sleeplessness, pain, severe headache, nausea, cold sweats, restlessness, shivering. Fatigue for 3 days.
12year old boy had gardasil at school and developed a wart on the 2nd toe of the right foot.
No additional adverse effects; some of the GARDASIL 9, spilled on the patient's skin; plastic syringe and needle came apart; patient did not receive a complete dose; This spontaneous report was received from a nurse and refers to a 13-year-old male patient. No information regarding his pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-NOV-2019, the patient was receiving the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 mg/once, intramuscularly, lot # R026716, expiration date 30-MAY-2021, for HPV prevention, but the plastic syringe and needle came apart and the patient did not receive a complete dose and some of the vaccine spilled on the patient's skin. The patient's skin was cleansed. No additional adverse effects were reported. The outcome of exposure via skin contact was reported as recovered on 13-NOV-2019. The causality assessment between the event and suspect vaccine was not provided.
This spontaneous report was received from a registered nurse refers to a patient of unknown age (gender unspecified). On 20-FEB-2013, the patient was inadvertently vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was reported) as opposed to VARIVAX (Merck). Concomitant medications were not reported. No adverse effect was reported. This is one of the three reports received from the same reporter. Additional information has been requested.
swelling in the right arm; rash in the right arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (swelling in the right arm) and VACCINATION SITE RASH (rash in the right arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-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 VACCINATION SITE SWELLING (swelling in the right arm) and VACCINATION SITE RASH (rash in the right arm). At the time of the report, VACCINATION SITE SWELLING (swelling in the right arm) and VACCINATION SITE RASH (rash in the right arm) 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.   Treatment: The patient was given antihistamine and cream as treatment.
Mother states patient has developed lower abdominal pain since her HPV.  Saw PCP who ran several tests all negative, but believed she has PID.  Mother was instructed to take patient to GYN for exam and treatment.  Mother denies that daughter is sexually active.
1. Sever Lymphadenopathy immediately after vaccine and still enlarged lymph glands 2.5 post vaccine.  2. Diarrhea, loose stools, undigested food beginning after vaccination and lasting for 1.5 years.    3.Abnormal liver function tests immediately after vaccine.                        4/10/01   2/13/02  5/15/03   Alkaline Phosphatease 366 U/L   291 U/L  282 U/L Absolute Monocytes   1514 c/mcl normal   na Absolute Eosinophils  757 c/mcl normal   na White Blood Count     17.6      normal   na
A day or so after the vaccination I experienced  a rash on my upper chest (Both sides)   It was splotchy , itched, felt gritty. Treated it with Aloe Vera for two days... Switched to Cortizoone 10 (Over the Counter)   Itching seems to be subsiding....
The pt was seen on 1/18/01 for gastroenteritis. The pt had follow-up visit on 2/1/01 and received Prevnar. The pt experienced a rash, allergic reaction to Prevnar versus purpura.
Patient received vaccine on 9/16/17. On 9/17/17 patient report a red spot at injection site. On 9/18/17 patient reported that the red spot was the size of a baseball and went to the doctor. Per patient doctor said that the spot was warm to the touch, swollen, and red. Doctor prescribed her a course of antibiotics (KEFLEX 14 day course). Outcome unknown at this time.
03/25/2000, one day post vax, total body rash began, no fever, itching, vomiting or diarrhea. 03/27 pt evaluated in office. Rash occurring for 2 days covering body,  no fever, itching, vomiting or diarrhea. Dx with urticaria. Prescribed Atarax 7.5 mg.
States has had pain at site since injection. Noted 1 cm brown colored are to left upper outer arm
Given Pneumoccus vaccine on 3/2/04 appt 1540. Had a reaction 0130 AM itchy, swelling lips tongue, systemic rash pain at injection site which was left deltoid. Referred to ER due to each and swelling in tongue.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 15-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 72 and 40. The lowest recorded temperature was 28. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Death; Covid-19 after vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and COVID-19 (Covid-19 after vaccine). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, COVID-19 (Covid-19 after vaccine) outcome was unknown.            Patient reported that  25-30 people who had the Moderna vaccination that either had COVID-19 or died.  Company Comment : This case concerns a patient(s) with no relevant medical history, who experienced the unexpected events of Covid-19 and Death  The events occurred at unspecified interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine); it's unclear from the source document whether this was first or second dose. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a patient(s) with no relevant medical history, who experienced the unexpected events of Covid-19 and Death  The events occurred at unspecified interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine); it's unclear from the source document whether this was first or second dose. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
The Pfizer COVID -19 vaccine was given to a 15 year old patient by National Guard.
Information has been received from a certified medical assistant concerning a 65 year old female who on 16-NOV-2007 was vaccinated IM into the right deltoid with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658673/0990U). On approximately 16-NOV-2007, the patient developed hot, painful, large swelling at the injection site. It was also reported that the patient was improving. The patient sought medical attention. The physician requested a lot check. A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). No concomitant medication information was provided. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines were reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022. The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication information was provided.
Within 15 minutes of vaccine: lightheaded, bad headache; itchy tongue & throat; tightness in throat and chest and nausea (I began Benadryl and tylenol). Lasted until about 1:30 pm and had lessened when I woke up at 3 pm. 7 hours after vaccine: chills, low fever, body aches, exhaustion, persistent headache (continued tylenol and benadryl). Lasted until 4 am.
Very bad side effects after the second vaccine; second shot was more than 28 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very bad side effects after the second vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot was more than 28 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION COMPLICATION (Very bad side effects after the second vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot was more than 28 days). On 10-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot was more than 28 days) had resolved. At the time of the report, VACCINATION COMPLICATION (Very bad side effects after the second vaccine) outcome was unknown.            The patient received 2 doses of COVID-19 vaccine but did not confirm the brand. She had very bad side effects after the second vaccine. The second shot was more than 28 days.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
on her right arm she experienced Bursitis or swelling on her elbow/Olecranon bursitis/Popeye's Bursitis; on her right arm she experienced Bursitis or swelling on her elbow.; hard of hearing; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9264; Expiration Date: 30May2021) via an unspecified route of administration, in right arm on 08Feb2021 (at the age of 80-year-old) as a single dose for covid-19 immunisation. The patient had no medical history and concomitant medications. Patient did not receive any other vaccines on the day of vaccination. On 08Feb2021, the patient got her first dose at her right arm and she experienced popeye's bursitis or olecranon bursitis/ Bursitis or swelling on her elbow. Patient stated that she was also hard of hearing on an unspecified date in 2021. Patient confirmed that the bursitis was located in her right arm. Patient was wondering if there was a connection, if the vaccine could have caused it as she had never had anything like that before. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Severe reaction within 8 hours of receiving vaccine was right arm severe pain, small temp of 99.9, chills, body aches. Had severe fatigue and arm pain x4 days after. The following symptoms began 10/01/2020: Right eye double vision Loss of clear vision right eye, only able to see vague shapes Right eye pressure Headache and head pressure. Right eye drooping (ptosis) During admission had 2 days of IV Methylprednisolone and 3 days outpatient IV. Many tests were performed (see item 19). I was seen 10/16/2020 at Eye Institute with a neuro-ophthalmologist. I had more testing along with visual field testing and the final diagnosis and determination was Tolosa-Hunt Syndrome (related to the pneumonia vaccine). I continue to have double vision out of right eye when open which inhibits driving, walking and all daily activities. Have follow up with the Neuro-ophthalmologist the month of November 2020.
Sore throat; cough; fever; Muscle soreness in right arm; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular in right arm on 20Dec2020 16:00 at a single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient has no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced sore throat, cough, fever, and muscle soreness in right arm on 21Dec2020 08:00 AM. The events were reported as non-serious. The patient did not have COVID prior vaccination and did not have COVID test post vaccination. No treatment was received for the events. The outcome of the events at the time of last observation was recovering.
Administered 40 mcg; Initial Report Received on 10-Jun-2021  A registered nurse reported that a patient (age, gender, race, and ethnicity not provided) received a 40 mcg dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On an unknown date, the patient received a 40 mcg dose of HEPLISAV-B (Lot #, expiration date, NDC #, serial number, route, and site were not reported). No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.