chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 07Apr2021 at 09:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, PTSD (post-traumatic stress disorder), sports induced asthma, chronic back pain (car accident), chronic neck pain (car accident) and allergy to milk chocolate. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) 10 mg for unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had been reporting ailments on the daily tracker. Beginning on 14Apr2021, the patient had a nagging sore throat and exhaustion. On15Apr2021 day of reporting the patient still had these ailments. Enough to be bothersome, but not to head to the doctors. The patient was just wanting to give a heads up. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event nagging sore throat and exhaustion was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
As per client a few hours after vaccination she developed (R) eye swelling and itchy throat. Went to ER. Treated for periorbital edema with BENADRYL 50mg PO and d/c'd.
Information has been received from a registered nurse concerning her 16 year old daughter, who, on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient fainted while she was walking down the hallway. The patient was in the physician's office during this event. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. Initial and follow-up information has been received from a registered nurse concerning her 16 year old white daughter with no medical history and no drug allergies, who, on 31-JUL-2007 at 11:15 was vaccinated intramuscularly in the right deltoid with a first dose of GARDASIL (lot# 657888/0523U). Concomitant vaccinations included a first dose of hepatitis A virus vaccine (unspecified) (Lot# "AHAVB1620B"), administered intramuscularly in the right deltoid and a first dose of meningococcal vaccine (unspecified) (Lot# "U2222AA"), administered intramuscularly in the left deltoid. There were no illnesses at the time of the vaccinations. The patient waited in the room for 15 minutes after the injection. On 31-JUL-2007 at 11:45 the patient was leaving the room and got lightheaded and passed out (previously reported as the patient fainted while she was walking down the hallway). The patient fell onto the floor and was passed out for approximately 15 seconds. The patient was in the physician's office during this event. No laboratory diagnostics were performed. The patient recovered on 31-JUL-2007 at noon. No product quality complaint was involved. Additional information is not expected.
AM after flu shot both my husband and I woke with a headache with stayed with me all day even with use of Ibuprofen. Within 24 hours tickle cough started with chest tightness. By weekend fever, chills, coughing increased. Chest cough very painful. Don't have asthma but started using and proventil inhaler. Called Center for Disease Control they recommended see doctor. Doctor said Bronchitis and watch/call if worse. Now 10 days later, still coughing, this remained all respiratory. Very thick mucous coughed up, very stubborn spells of coughing; still present and very hard to stop coughing spasm. Taking antibiotic drug to loosen tightness and this still persists.
notified by nurse on pediatric floor @ hosp pt was adm for dec platelet count poss due to MMR;
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old male patient who received Herpes Zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose of Shingrix received on 24th September 2019). On 7th May 2021, the patient received the 2nd dose of Shingrix. On 7th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The pharmacist reported that, the patient around 60 years old (no information about date of birth) had received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. No information about lot numbers and expirations dates from both Shingrix shots was reported. The reporter consented to follow up.
Patient had chickenpox after receiving varicella immunization. Had mild amount of involvement of legs, chrisind face.
Suspected vaccination failure; Shingles / have all had shingles; When your allergic to the shingles vaccine / had shingles; So miserable/worst; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, allergy and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles, allergy and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, allergy and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient felt worst on allergic to the shingles vaccine & had to endure the daily activities. The patient had shingles after vaccination. The patient had never heard that there was an age limit on vaccine. The patient stated that they were going through 3rd year and it was very miserable. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Pt. rec vaccine on 9-16-10 to (L) deltoid - she had a reaction - arm red - warm and indurated 4-5 inches around injection site.
6cm reddened area, swelling, and increased warmth to area.  No treatment needed, resident wasn't even aware of reaction.  No pain, discomfort or itch.
They have been seeing rashes more in patients; This spontaneous case was reported by a consumer and describes the occurrence of RASH (They have been seeing rashes more in patients) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza Vaccine. Past adverse reactions to the above products included No adverse event with Influenza Vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (They have been seeing rashes more in patients). At the time of the report, RASH (They have been seeing rashes more in patients) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication information was not provided by the reporter.
Vaccine give 15:15 - patient alert, tolerated well was wearing face mask. 15:16 fainted while walking/exiting exam room - fell on carpeted floor, Mom and RN picked him up and layed him on his side on exam table. Responded to verbal ques. Dr examined immediately after. Ice pack to superficial laceration on lower lip-slightly swollen. Water to patient initial BP 71/41 Pulse 47, oxygen saturation 99%.
GLANDS SWOLLEN; BODY ACHES; JOINT PAIN; FATIGUE / EXHAUSTION; MILD HEADACHE; BUG; THROAT HURTING; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21a, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 in Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bug. On 07-APR-2021, the subject experienced throat hurting. On 07-APR-2021, the subject experienced fatigue / exhaustion. On 07-APR-2021, the subject experienced mild headache. On 08-APR-2021, the subject experienced glands swollen. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from throat hurting, and glands swollen on 08-APR-2021, had not recovered from fatigue / exhaustion, bug, mild headache, and body aches, and the outcome of joint pain was not reported. This report was non-serious.
Information has been received from a physician concerning a 26 year old female who was vaccinated the first 0.5ml dose of GARDASIL vaccine (yeast) (MSD) on 17-JUL-2008. On 15-SEP-2008 the patient was vaccinated the second 0.5 ml dose of GARDASIL vaccine (yeast( (MSD) in the left arm. The patient took oral contraceptive (unspecified). A few hours later on 15-SEP-2008, the patient had a headache and blurry vision. The patient laid down and later woke up the tingling of right hand. The tingling resolved in 15 minutes. No treatment required. At time of report, the patient recovered on an unspecified date. The patient sought medical attention by phone. Additional information has been requested.
Gas pains at 10 am.  Diarrhea from 10 am to 4 pm off and on.  Black stools/some watery.  Then explosive diarrhea with blood twice.  Went to ER at 6 pm.     I have never had this before & I forgot to tell them I had the first Moderna vaccine.
Sensorineural Hearing Loss in Right Ear  No findings to suggest inner ear abnormality
Sore arm, entire muscle is very sore, very hard to lift arm. Painful to the touch and painful just went not using. Arm feels very heavy, hard to lift and use at all. Around 4 am, started being nauseas, having stomach cramps, diarrhea, and vomiting. This continued throughout the night and finally calmed down to just stomach pains around 11am.
Postural orthostatic tachycardia syndrome; This is a literature report.  A 19-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 18 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Alpha tumour necrosis factor (normal high range 7.2): 12.8 pg/mL, notes: elevated; Antinuclear antibody: 1:80, notes: elevated; Blood pressure diastolic: 10 mmHg; Blood pressure systolic: 16 mmHg; Blood thyroid stimulating hormone: Normal; Echocardiogram: normal; Electrocardiogram: normal; Electrocardiogram ambulatory: normal; Full blood count: Normal; Heart rate: 62, notes: BPM; 130, notes: BPM; Heart rate variability test: showed a significant, notes: increase in sympathetic tone after the head-up position. She responded fairly to salt tablets and propranolol; Interleukin level (normal high range 2.8): 6.2 pg/mL; Tilt table test: orthostatic tachycardia, notes: without OH, consistent with a diagnosis of POTS. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome. A 19-year-old female-developed dizziness, headache, nausea, bloating, excessive sweating, and fatigue after 18 days of receiving a second dose of BioNTech-Pfizer COVID vaccine. She has no significant PMH and takes no medication. Her echocardiogram, EKG, and Holter were within normal. Autoimmune panel showed elevated ANA 1:80, elevated tumor necrosis factor-a 12.8 pg/ml (normal < 7.2 pg/mL), and interleukin 10 6.2 pg/mL (normal < 2.8 pg/mL). HUTT showed orthostatic tachycardia without OH, consistent with a diagnosis of POTS. HRV spectral Fourier analysis showed a significant increase in sympathetic tone after the head-up position. She responded fairly to salt tablets and propranolol.; Sender's Comments: Based on available information, the causal association between the event postural orthostatic tachycardia syndrome and the suspect drug bnt162b2 cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200033614 Same article/ drug/event and different patient.;
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age. The patient was vaccinated with MMR II (lot # not reported) on an unknown date. It was reported the patient had an anaphylactic reaction to MMR II but no more details could be provided. Whether the patients sought for medical attention was not reported. The outcome of anaphylactic reaction was unknown. Upon internal review, anaphylactic reaction to MMR II was considered to be medically significant event. This is one of several reports received from the same source. Additional information is not expected.
Since the vaccination, the patient been tested for COVID-19 test on 28Sep2021 with positive result; Since the vaccination, the patient been tested for COVID-19 test on 28Sep2021 with positive result; This is a spontaneous report from a contactable health care professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 25Mar2021 16:30 (Batch/Lot Number: EP6955) (at the age of 41 years old) as dose 2, single and intramuscular, administered in left arm on 03Mar2021 14:20 (also reported as 14:30) (Lot Number: EN6204) (at the age of 41 years old) as dose 1, single, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was in Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included allergy (reaction to unspecified drug). Concomitant medications included Taynelo (as reported). The patient hadn't been sick. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 test on 28Sep2021 with positive result. On 28Sep2021, patient experienced vaccination failure and COVID-19. The patient underwent lab tests and procedures which included COVID-19 Test: positive on 28Sep2021. The outcome of the events was unknown.; Sender's Comments: Based on the available information, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
I had cracks in the sides of my mouth. I had a scaly, round mark on my back that I'm going to go to the dermatologist for. They are going to take a biopsy for that. It's still there - it's not worse but it gets scaly. It keeps regenerating a scaliness on it.
12 hours after receiving the vaccine, I developed body aches, chills and sweats. This continued for the next 24 hours, and I experienced periodic relief by taking 500-750mg of Tylenol every 5 hours. 24 hours after the vaccine, I noticed a swollen and painful lymph node under my left armpit. I haven't done anything about it yet, but will continue to take Tylenol and if it doesn't resolve in the next few days I will call my doctor.
Developed a rash on legs- ended up in the emergency room.  It was a petechial rash and upon further lab work and review, was diagnosed with Vasculitis.
Information has been received from a registered nurse concerning a 4 year old male with no pertinent medical history and no history of drug reactions or allergies who on 04-AUG-2008 was vaccinated with the second dose of VARIVAX (Merck) (lot#: 659606/1905U) 0.5ml SQ. There was no concomitant medication. Within 48 hours from getting the vaccine, on 06-AUG-2008, the patient complained of redness, swelling and soreness to a touch at the injection site. On 07-AUG-2008, the swelling and soreness resolved. The redness was getting less. The patient was treated with heat therapy. The patient was seen in the office. A lot check has been requested. This is one of several reports from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
pt was tensed and very anxious and was accompanied by grand parents to get flu and covid shot, right after shot pt had jerk and lay down on the floor. He was feeling dizzy and little cold. Rph checked and called 911 and monitored pulse and respiration which was normal through out. Pt was responsive and talking all the time. Was given gatorade to drink and EMS took over.
comes to ICU for dyspnea. Patient was beginning to have dyspnea 4 days ago and went to outpatient center for COVID testing. She was vaccinated x3 with pfizer. She came back positive and developed worsening dyspnea calling EMS. Upon arrival, per report, O2 saturations were in 50s and placed on NRB support with improvement in oxygenation. Patient was placed on HHFNC in the ED but still dyspneic and subsequently placed on BiPAP On arrival to ICU, patient was on BiPAP 10/5, 80% with MV around 7-8 and TV in 400s comfortable not in respiratory distress and speaking in full sentences without any drips.
Following 2nd dose of Hep B, the pt complained of runny nose, cough, sensation of heat in head, nausea and sometimes vomiting. No improvement with Motrin.
Swollen arm and rash  Fever  40+ 5 days  Tachycardia and still suffering with symptoms
Patient previously received 2 doses of covid Pfizer vaccin and got a Moderna vaccine by mistake.
Report discomfort to mid-chest with radiation to mid back. Treatment: Advil. Outcome: no improvement, continues to work, does not interfere with ADLS. Recommend to follow-up primary care doctor.
TIRED; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced tired, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and injection site pain. This report was non-serious.
shingles rash on my leg; This case was reported by a consumer via interactive digital media and described the occurrence of rash zosteriform in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 6 month prior to the reporting date).   On 28th April 2022, the patient received the 1st dose of Shingrix. On 1st May 2022, 3 days after receiving Shingrix, the patient experienced rash zosteriform. On an unknown date, the outcome of the rash zosteriform was unknown.   It was unknown if the reporter considered the rash zosteriform to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the Shingrix shot on Thursday and the day prior to reporting patient saw a small shingles rash on leg (where patient had it just 6 months prior to reporting). The patient asked should patient take the medications, or did that hurt the impact of the vaccine.
EXTREME SWELLING IN UPPER ARM BICEP MUSCLE AREA. THROBBING PAIN AND ITCHINESS. APPLIED ICE PACK ALL NIGHT. PAIN SUBSIDED BUT SWELLING REMAINS 24 HOURS LATER.
Whole body was covered with hives; She has red splotches all over her body.; pretty bad allergic reaction; This is a spontaneous report from a contactable consumer (patient's mother). A 21-year-old female patient first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EW0198; Expiration date: unknown) via an unspecified route of administration in right arm on 29Jun2021 at 17:00 (at the age of 21-year-old) as single dose for COVID-19 immunization. Medical history of the patient included COVID-19 and patient had no family history (none). Patient does take some concomitant medications (unspecified). Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No other vaccine was administered on same date with the COVID-19 vaccine. On 29Jun2021, at around 18:00 to 18:30 patient experienced hives after taking shower. It was an hour to an hour and a half after the vaccine. Patient had a pretty bad allergic reaction, her whole body was covered with hives, and she had to go to the ER. On an unspecified date in Jun2021, patient developed red splotches all over her body. Adverse events require patient to visit Emergency Room. On 29Jun2021, at ER patient underwent blood work (unspecified) examination, samples were sent to the CDC, results were not reported. Events were improving and patient was released from the ER this morning (date of report: 30Jun2021) at around 06:00. Reporter asked what her daughter should do about the second dose. Reporter stated that the E.R doctor recommended not to take the second dose. Outcome of the events whole body was covered with hives were and she has red splotches all over her body was recovering/Resolving. Outcome for the event pretty bad allergic reaction was unknown.  Follow-up actions are needed. Further actions are needed.