chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First Dose left arm pain at injection site; Given 05 Apr 2021 in the left arm in the muscle. That one was sore for a few days; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 05Apr2021 (at the age of 59 years) as DOSE 1,SINGLE for covid-19 immunization. Medical history included dizziness, thyroid disorder. Concomitant Products liothyronine sodium (CYTOMEL) taken for Underactive Thyroid since childhood. Vaccination facility was clinic type. list The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that nothing happened with first shot. On 06Ap2021, after First Dose the patient experienced left arm pain at injection site. First shot was in the muscle and hurt/sore for a few days after. But after a few days, that went away. On 19Feb2021, she did an MRI with contrast. She had some issues with dizziness, so her ENT wanted to do it as a precaution just to see if there were any issues. Everything was negative, but her question was that she took the contrast in the arm and wondered if there was an interaction with the vaccine. She did not have a name, Lot or expiration of IV contrast used. She had a Pap smear on 29Mar2021. She did not specify any results and stated it was not relevant. Blood analysis with a company and urine analysis and blood workup. Everything was negative. On an unspecified date in Apr2021, the events were resolved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vomiting, Diarrhea, Fever, Chills, Muscle Aches
Headache the next day following vaccination that started mile and ended up pounding by the evening.  No issues the next day.
no symptoms; improperly stored dose; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-FEB-2020, the patient was vaccinated with a dose of improperly stored  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly lot # 9029515 with expiration date 08-JUL-2021 (dose number, frequency, formulation and anatomical location were not reported) for prophylaxis. Lot number 9029515 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  The digital data logger was involved in recording the temperature excursion details. The vaccine was stored in temperature of 0.7 degrees Celsius for 3.048 hours. There was no previous temperature excursion. The patient did not experience any symptoms.
Pt had anxiety with SOB noted as well with patient observed in tent gave Benadryl  IM in the car. Pt refused to have someone come and get her. Pt observed 1 hour felt better walked back to car
Pt came in for a TD and I gave the TDAP on 8/18/200. He returned 8/20/08 to have his PPD read. Pt had no adverse reaction or symptoms noted from TDAP.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 04-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#, expiration date, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 24-SEP-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for the 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes and on 20-SEP-2013 for 40 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Pt recvd 1st Engerix-B vax 15JUL91 & immediately p/inject exp swelling @ inject site arm was rubbed & swelling went down immediately p/vax; Pt first noted on 29JUL91 p/ tan faded, a dark spot on inject site;big brown mark like sun blotch;
pt recv vax 12SEP96 & 3OCT96 pt devel a varicella rash consisting of vesicles w/clear fluid (less than 50 lesions);
Information has been received from a physician's assistant concerning a 12 year old female who on an unspecified date was vaccinated with her second dose of GARDASIL. Subsequently the patient experienced amenorrhea for a couple months after administration of her second dose of GARDASIL. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from amenorrhea. Follow-up information has been received which reported that a 13 year old (previously reported as 12 year old) female student with "1.5 months without period" at the time of vaccination on 27-OCT-2009 at 16:00 was vaccinated with the first dose of GARDASIL (lot # 663453/0249Y) in the right arm, and on 28-DEC-2009 at 16:00 p.m. was vaccinated with the second dose of GARDASIL (lot # 663453/0249Y) in the right arm. On 15-DEC-2009 the patient experienced amenorrhea. There were no laboratory studies performed. The patient's sister also experienced amenorrhea after vaccination with GARDASIL (MSD WAES # 1001USA01872). Additional information is not expected.
66 year old female admitted with a 3-4 day history of fever, cough, congestion, lack of appetite and feeling poorly.  Treated in ER with nebulizers and corticosteroids, admitted.
Rash down arm of injection at 5:30pm same day. Resolved with a dose of Benadryl. Next day site redness and heat. 2nd day bruising. Approximately a week later bruise returned and intermittent itchiness.
Clinic had issue with refrigerator, staff was initially told vaccines were okay to administer but later notified that small subset was not viable. No adverse symptoms in patient.
Patient received the vaccine without incident.  She experienced no pain at the time of the shot.  The next day her arm was very sore.  This has now continued for 20 days.  Her arm hurts to move it & sleeping is difficult if she is laying on it.  She does not have redness nor swelling.  Has not seen a physician.  Urged to do so.
That weekend of December 16th. 17th, and 18th of 2022. I was started my menstrual cycle and this cold /flu stuff started rearing its head. I was having extreme fatigue, headache and body ache. I never had a high fever; it was just shy of 100. I have coughing and a lot of sinus pain and drainage in the throat. I have facial pain as well. I was feeling bedridden and weak. I really wanted to sleep. That Sunday I felt a bit better. Then Monday I felt better but my child felt sick with fever took him to be COVID-19 tested and was negative but had Flu A. I was ill and sick that next day with same tiredness and fatigue, I slept again all day thinking it was flu. I went to the urgent care to see if I had COVID-19, I was negative but tested positive for Flu A. I have been taking at home COVID-19 tests due to my entire family except me having Flu and COVID-19. I assume I will be positive any day now. My symptoms have lessened but not as severe as the bulk of last week.
A healthcare professional reported that a 30 month old male with a history of upper respiratory infection received injections of Prevnar, Hib-Titer, and Infanrix on 12/18/2001. On 12/20/2001, he developed a 24cm by 12cm area of redness, swelling, warmth, and hardness at the site of the Prevnar injection. A 15-day follow up report received 4/22/2002 adds: Additional info received on 01/02/2002 frmo the Center for Biologics Evaluation and Research indicated that the child also developed 3 large bullae with numerous surrounding vesicles at the Prevnar injection site. Follow up info received from the physician on 04/17/2002 indicated that on 12/19/2001, the child developed pain and erythema on his legs bilaterally, significantly greater on his left than right. On 12/20/2001, he was seen by the pediatrician who prescribed Augmentin (amoxicillin/clavulanic acid), acetaminophen and warm compresses. Later that same day, he was taken to the ER after he developed increased erythema and bullae on the left leg. Laboratory results included: white blood cell count 5.98 with 2 bands, 40 segs, 49 lymphs, 4 monocytes and 3 eosinophils; hemoglobin 12.1; hematocrit 34.5; platelets 307; c-reactive protein 1.9. A blood culture is pending. He was admitted to the hospital with a diagnosis of cellulitis to bilateral thighs and treated with intravenous cefazolin and diphenhydramine. On 12/21/2001 he was seen by a pediatric infectious disease physician who diagnosed the infant with a possible hypersensitivity reaction. Fluid from the bullae was withdrawn and sent for Gram's stain and culture. The results are pending. A 15-day follow up report received 5/29/2002 adds: Follow-up info received from the physician on 05/21/2002 indicated that the child recovered.
Had a mild headache after receiving  the 1st and 2nd dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 12:00 (Lot number: EW0198) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I am currently breastfeeding", start date: 25Apr2021 (ongoing), notes: Other medical history: Had 2nd child and I am currently breastfeeding. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. The following information was reported: HEADACHE (non-serious) with onset 01Sep2021 07:30, outcome "not recovered", described as "Had a mild headache after receiving  the 1st and 2nd dose of the vaccine". Therapeutic measures were not taken as a result of headache.  Additional information: It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store Facility.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient pertinent medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # and expiry date were unknown) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Nasal congestion; sore throat; This is a spontaneous report from a contactable consumer (reported for himself). A 42-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 29Jan2021 08:30 at a single dose in the left arm for covid-19 immunization. Medical history included diabetic and traumatic brain injury, both from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021, the patient experienced nasal congestion and sore throat. No treatment received for the adverse events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The events were reported as not recovered.    Information on the lot/batch number has been requested.
-LT shoulder, deltoid muscle, upper arm pain - Treatment - ice, Ibuprofen and range of motion exercise
No additional AE reported; VARIVAX (also reported as PROQUAD) was administered to 1 patient following a temperature excursion; This spontaneous report was received from a customer and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-DEC-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039947, expiration date: 16-DEC-2023 (dose, strength, route of administration were not provided) as prophylaxis.  The vaccine underwent a temperature excursion of 27.9 degrees Fahrenheit (F) for a period of 1 hour and 35 minutes. The vaccine did not undergo any previous temperature excursion. The office manager reported that the patient did not experience any adverse event.
fever; chills; fatigue; weakness; pain in the arm (injection site)/sore arm; joint pain; Headache; This is a spontaneous report from a contactable other HCP. This 46-Year-old male Other HCP (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at 1 DF single dose at right upper arm for covid-19 immunisation on 11Jan2021 around 10 AM. Relevant history included ongoing asthma, environmental and food allergies (ongoing). The patient was also allergic to a few medications, both had his entire life. Relevant concomitant drugs were unknown.  The subject previously received the first dose BNT162B2 (Batch/lot number: EK4176, Lot number: EJ1685) at the right upper arm on 21Dec2020 for covid-19 immunisation. The patient was tested for COVID Virus before his vaccination either on 07Jan2021 or 08Jan2021. The patient experienced fever last night (11Jan2021), this symptom was gone but he described it as if fever went and came back but it seemed to be gone, he had also experiencing waking up with chills, fatigue, weakness, pain in the arm (injection site) and joint pain since the evening/night of 11Jan2021. He went and saw his primary care doctor. He had been using Tylenol and Antihistamines. He took Tylenol for joint pain. The patient stated it was not bad to start. Experienced fever, headache, fatigue, weakness, joint pain, waking up with chills, and a sore arm, which was to be expected. In general he was just really fatigued. Fever: Had come and gone. It was hopefully gone for good. He had a low grade fever last night, but he checked his temperature an hour ago and it was 98.6 Fahrenheit on 14Jan2021. The outcome of fever was recovered on 13Jan2021, the outcome of headache was recovering, the outcome of event pain in the arm (injection site)/sore arm was unknown. The outcome of other events was not recovered. on the 3rd day. He did a test for the virus and it came back negative.     Information about lot/batch number has been requested.
Patient had 2 seizures after receiving the Moderna vaccine for COVID-19. The patient did disclose that she stopped her seizure medication two months prior to the vaccine. Pt also reports that she did have one seizure an hour prior to the vaccination. Pt reports not informing the vaccination team of her seizure. Patient was treated at Hospital ER and was admitted for an observation stay at the hospital to control her seizures.
Prolonged crying night of vaccine from 8pm to 4am (night of 10/7/02).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Other medical history: Lupus. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive with Covid again; Positive, notes: tested positive with Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Patient received Paxlovid treatment from 04Jan2023  to 09Jan2023 for Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Site: Pain at Injection Site-Mild, Systemic: Bell's Palsy-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium
About 1 week after injection:  blotchy round rash with irregular borders at injection site, about 3" in diameter.  Light red, raised,  warm to the touch, tender, and itchy at outset.  After five days, rash is still present but slightly faded, less raised, less tender.
1:03PM- CODE 500 called for 19y/o female s/p COVID vaccine #1. Patient stated she was feeling funny, taken to exam room for evaluation. BP 155/93, HR 101, O2 99%, lungs CTA- patient thinks symptoms are anxiety related  1:08PM- BP 144/87, HR 96, O2 99%. Patient conversating, A&O x 3.   1:15PM- BP 153/87, HR 91, O2 99%  1:22PM- Patient sitting up, states she is feeling better, requesting to leave.  Mother at bedside throughout evaluation.
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 05-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in 31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiple temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815: US-009507513-1804USA003817: US-009507513-1804USA003818: US-009507513-1804USA003819: US-009507513-1804USA003820: US-009507513-1804USA003821: US-009507513-1804USA003822: US-009507513-1804USA003823: US-009507513-1804USA003824: US-009507513-1804USA003769.
m their arm was itchy, swelling a little, red and feverish at the injection site; their arm was itchy, swelling a little, red and feverish at the injection site; their arm was itchy, swelling a little, red and feverish at the injection site; their arm was itchy, swelling a little, red and feverish at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (m their arm was itchy, swelling a little, red and feverish at the injection site), VACCINATION SITE PRURITUS (their arm was itchy, swelling a little, red and feverish at the injection site), VACCINATION SITE SWELLING (their arm was itchy, swelling a little, red and feverish at the injection site) and VACCINATION SITE ERYTHEMA (their arm was itchy, swelling a little, red and feverish at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ZINC, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE WARMTH (m their arm was itchy, swelling a little, red and feverish at the injection site), VACCINATION SITE PRURITUS (their arm was itchy, swelling a little, red and feverish at the injection site), VACCINATION SITE SWELLING (their arm was itchy, swelling a little, red and feverish at the injection site) and VACCINATION SITE ERYTHEMA (their arm was itchy, swelling a little, red and feverish at the injection site). At the time of the report, VACCINATION SITE WARMTH (m their arm was itchy, swelling a little, red and feverish at the injection site), VACCINATION SITE PRURITUS (their arm was itchy, swelling a little, red and feverish at the injection site), VACCINATION SITE SWELLING (their arm was itchy, swelling a little, red and feverish at the injection site) and VACCINATION SITE ERYTHEMA (their arm was itchy, swelling a little, red and feverish at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       anti-itch cream used as a treatment medication.
2PM pt recv vax & 205PM pt was standing in front of mom as nurse was reviewing poss side effects;pt became pale & became limp against mom;pt assisted onto floor where quickly became aware of surroundings;lt bldg 215PM walked to car;