chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low grade fever of 99.4; sore joint pain on my knuckles and my wrist; felt kind of off and weak; felt kind of off and weak; Arm was a bit sore for 3 days; mild headache; This is a spontaneous report from a contactable healthcare professional (patient) reported that a 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 20Dec2020 16:15 at a single dose for covid-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Patient is not pregnant. Concomitant medication included fluoxetine taken from an unspecified date for an unspecified indication. On the second day of the vaccine (21Dec2020 10:00), the patient had a low grade fever of 99.4 (no unit reported), had sore joint pain on her knuckles and her wrist, felt kind of off and weak, her arm was a bit sore for 3 days and she also had a mild headache that would come and go. No treatment was received for the reported events. The outcome of the events was recovered.
Patient received Varicella booster at clinic.  He has subsequently been diagnosed with post infections myelitis. 10/15/08-records received-DOS 6/25-6/28/08 DC DX: Neurologic changes consistent with post-viral myelitis. Symptoms began after varicella booster. Vaccination records do not include booster information. Admitted with altered mental status and headache. C/O headache and fatigue for 1 month and difficulty walking for past 2 days. Low grade fevers. Bright lights hurt eyes. Back and neck pain. Gait abnormal.
Called patient 04/27/2023 and spoke to patient mother, notified her that upon documenting vaccine it was discovered that patient had previously received Pfizer Bivalent Pfizer vaccine on 12/21/2022 and was administered a second dose on 4/27/2023. Patient's mother denies patient having any signs and symptoms of adverse reactions. ER precautins given. Patient's mother verbalized understanding.
Pt received PNEUMOVAX at office visit. Within 6 hours injection site warm, red, swollen. Pt had chills. Seen by MD next day. 8cm x 4cm swelling, hot, tender, no rash. Pt treated with diclofenac and BENADRYL, cold compressed. Off work x 1 day.
Initial report received from a health care professional in the USA on 06 June 2007. A 29 year old, female patient (with a medical history of no allergies) developed a 102 degrees F-fever and a painful injection site, 1 day after she received Adacel (lot number C2610AA) intramuscularly in the right deltoid on 30 March 2007. On 01 April 2007, she "felt off balance" with blurred vision-she refused treatment and transport to the ER. She was seen in the physician's office on 02 April 2007 with a temperature of 98.8 F. The injection site was painful, warm to touch and had swelling. She has swollen axillary nodes. She had Keflex 500 mg TID for 7 days and warm compresses as treatment. The patient did not have any illness at the time of the vaccination. It was reported that she recovered.
Very high fever 102.4, that I never had before in my life. Lasted maybe 10 hrs. Then about 10 days after the second vaccine started loosing taste, so far only coffee. Started yesterday and tastes so foul I had to throw it out. My daughter, who had Covid experienced the same thing. Still lingers seven moths after she caught te infection
10/16/13 -Patient left our house suddenly and without permission. Later he said he did not remember leaving.  As his awareness returned and he saw he was on his way to school, he just walked to school and was taken in by staff. 10-21-13 - 6 PM - Patient once again left our house and later he again said, he didn't remember leaving. He was found by police over a mile from home going through people's mailboxes looking for 'his catalog'. He said he was heading to his daycare facility which was over 2 miles and a major highway away.  The week of 10-21-13 - patient had great difficulty processing, unable to remember known words while reading, respond appropriately to daily directions and was constantly argumentative in every setting. None of these behaviors were typical during the given time. All behaviors have stopped by 10-28-13. Dr. has referred patient to a pediatric neurologist to investigate potential seizure activity caused by either vaccine or medication and/or the onset of other neurological disorders, impairments.
Presented with SOB/ rapid HR; Afib + covid; CXR with LLL PNA; pt with bilat PE on admission; D-dimer >20; CRP 13.03; Ferritin 566.19; Tx: empiric antibiotics: Rocephin, maxipime; lovenox, singulair, zinc; remained on room air during stay
unable to care for self; Neurologic decline; Renal failure; This is a spontaneous report from a contactable physician. An 81-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  Medical history included hypothyroidism, neuropathy/drop foot from a knee surgery. No known allergies. Concomitant medications included thyroid meds and vitamins. The patient previously received first dose of bnt162b2 on unspecified date for COVID-19 immunisation.  Patient was not pregnant and not pregnant at time of vaccination. The patient experienced neurologic decline, unable to care for self, renal failure on 10Feb2021 with outcome of not recovered. No treatment received for events. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  neurologic decline and renal failure. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as 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
Severe headache with migraine symptoms - thumping pain, light sensitivity, nausea, diarrhea, loss of appetite, fatigue, sensation of swelling / tenderness around eyes.  Treatment - rest, darkness, Equate brand headache relief - acetaminophen, aspirin, and caffeine.  2 tablets , twice over 12 hour duration.
patient was vaccinated at 10:55 by 11:00 was anxious and pacing with tachycardia and sweating.  at 11:05 patient was given 50mg diphenhydramine in liquid form (20cc) and EMT personnel arrived at 11:15 to evaluate patient.  Patient chose to go hospital for evaluation
Episode of Bell's Palsy, possibly related to COVID-19 vaccine. Pt has h/o Bell's Palsy for the past 20 years. D/t reaction, Dr. advised against 2nd dose of COVID-19 vaccine.
Lymph Nodes swelling, fever, body aches, nausea, UTI, heavy menstruation, missing skipped menstrual cycle in month of May.
This spontaneous report as received from a registered nurse refers to a 9 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with VAQTA (dose, and route not reported) from lot # K005958, expiry date: 09-FEB-2017 for prophylaxis. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Severe menstrual bleeding/clotting 14 days before scheduled period. Painful uterine cramping.
pt was provided a pfizer covid 19 vaccination and become nauseous and light headed afterword, presented with syncope symptoms but didn't fully lose consciousness pt was given ice packs to back of neck, an emesis bag was provided pt never had vomitous,  pulse was strong throughout.  Pt was placed in a supine position with legs elevated, and we used alcohol pads as a smelling salt.  After aproximately 15 minutes pts color returned she was coherent and talking and stated she was feeling fine.  Pt has  history of fainting with all vaccines per her uncle (a registered nurse) who was present with the patient through out the entire process start to finish.  Will file an SCRT and Vaers report for this incidence.
After 5 day of taking the vaccine, a skin rash developed on most of my body with swelling in the face .  Went to the ER the next day and they gave me a steroid shot and pepsin . Two hours later and the rash still persists .
A report has been received from a Health Professional concerning an 8 year old, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced BURNING IN NOSTRIL. The outcome of the event of BURNING IN NOSTRIL is unknown. The report was considered to be non-serious by the reporter.
Nausea, dizziness started 2 days after treatment.  Vertigo started on 4th day, lasting 24 hour.
Tender axillary lymphadenopathy; crescent shaped rash at injection site; This case was reported by a physician via call center representative and described the occurrence of lymphadenopathy axillary in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced lymphadenopathy axillary and injection site rash. On an unknown date, the outcome of the lymphadenopathy axillary and injection site rash were unknown.   It was unknown if the reporter considered the lymphadenopathy axillary and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician wanted to advice on how to manage the side effect. The physician reported that the patient experienced tender axillary lymphadenopathy the morning after the shot was given, it was on the same side as the injection. Less than a day after vaccination the patient experienced crescent shaped rash developed last night in the area of the injection site.
Describe Event, Problem, or Product Use Error: {Johnson and Johnson vaccine] use for COVID-19 UNDER Emergency Use Authorization (EUA): Patient reported to MD that she felt increased exertional dyspnea and PAH related symptoms after receiving the vaccine, several months ago. She also reports morning cough and morning diarrhea, that may be related to Tadalafil use. The patient is also on Ambrisentan for PAH management.
Information has been received from a registered nurse concerning a 14 year old female with no medical history and no drug allergies, who on 09-JUL-2007 in the evening was vaccinated intramuscularly with a first dose of Gardasil (Lot# 655617/1447P). There were no illness at the time of the vaccination. On 10-JUL-2007 the patient developed a nose bleed. The patient recovered on 10-JUL-2007. There were no additional reports of the bleeding continuing. It was noted thathe patient went to vollyball practice right after receiving the vaccination. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Additional information is not expected.
6 months old Male was given the Fluzone High Dose Quad in error/No AE; 6 months old Male was given the Fluzone High Dose Quad in error/No AE; Initial information received on 09-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a six month old male patient who was given INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination in error (inappropriate age at vaccine administration and overdose).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
a booster shot was given 1 month earlier, which was 4 month after the 2nd shot.  The immunizer contacted the mom, and the patient does not have any abnormal symptoms developed.
RA symptoms returned and became worse than before taking Enbrel dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 05Jan2022 (Batch/Lot number: unknown) at the age of 55 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Enbrel for Rheumatoid arthritis, reaction(s): "heartburn", notes: Enbrel, Single Dose Prefilled Autoinjector. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 08Jan2022, outcome "not recovered", described as "RA symptoms returned and became worse than before taking Enbrel dose". The patient stated her knees felt swollen and had pain in hands and jaw.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fell back into bed; Achiness/sore; Headache; Nausea; Dizziness; Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack"; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack"), FALL (Fell back into bed), DIZZINESS (Dizziness), PAIN (Achiness/sore) and HEADACHE (Headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tinnitus (He was wearing a hearing aid in his right ear, on a scale of 1-10 he stated 3-4 as previous condition.).    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced TINNITUS (Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack") and DIZZINESS (Dizziness). On 31-Mar-2021, the patient experienced FALL (Fell back into bed), PAIN (Achiness/sore), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, TINNITUS (Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack"), FALL (Fell back into bed), DIZZINESS (Dizziness), PAIN (Achiness/sore), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-075143 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received on 05-Aug-2021 and included Non significant information.
Symptoms after 6 hrs., Severe Body Shaking (difficult walking unassisted), High Fever (102°F), Severe pain in lower back and joints, elevated heart rate (100 bbm, normal is 50 bbm) Symptoms after 10 hrs., High Fever (103.6°F), Severe pain in lower back and joints, elevated heart rate (100 bbm, normal is 50 bbm) Symptoms after 12 hrs., High Fever (101-102°F), Severe pain in lower back and joints, elevated heart rate (100 bbm, normal is 50 bbm) Symptoms after 30 hrs., Minor to no fever, General muscle soreness and fatigue. Symptoms after 48 hrs., No fever, General muscle soreness and fatigue.
This spontaneous report as received from a registered nurse refers to a 17 months old patient. The patient was vaccinated with first dose of M-M-R II (lot number 671686/1874AA, exp 30-NOV-2013) subsequently in thigh on 22-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The reporter said that during the injection, the patient moved the leg, and only half of the 0.5ml dose of vaccine was administered. No adverse effects reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
sore arm; fever; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 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 pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were unknown.  It was unknown if the reporter considered the pain in arm and fever to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the shingles shot and ended up with a fever and very sore arm. And what upset the patient was the price 190 dollar. And there was a need of another shot.
Moderna - 19 Vaccine EUA - tender, itching  and inflammation in an oval 3 - 4 inches around injection site.  Covid Arm ?
Started feeling unwell about 10 pm on day of injection.  Next morning (4/27) still not well.  so far, same reaction as first dose shot.  Got out of bed 2:00pm, feeling a bit better.  after about 2-3 minutes started feeling worse.  Took about 9-10 steps towards bedroom.   I fainted and broke my left wrist.  It has been set and casted, but may need surgery.    I have had hundreds, maybe thousands of shots in my almost 76 years and DO NOT have any anxiety around this issue.  I have NEVER before in my life fainted.   This was absolutely a reaction to the vaccine! If surgery is needed - unknown length of hospitalization or permanent damage or long term disability at this time.
client stated that 24 hours post initial vaccination client developed rash on inner thighs and genitals and swelling to lymph nodes under left arm and side of left breast. The rash got better with benadryl then resolved after 3 days. The swelling to lymph nodes have not yet resolved.
4 days post vaccine of nasal mist noticed decreased taste on L side of tongue. L sided facial droop. Belly Palsy diagnosis on 10/20/09. LACRI LUBE to L eye. Prednisone 60mg X 3, 40mg X d day, 20mg X 3 days, 10mg X 4 days. Acyclovir 400mg (g) DAILY X 7 days. Recovering as of 10/25/09.
Cervical insufficiency in pregnancy resulting in loss of pregnancy; Cervical insufficiency in pregnancy resulting in loss of pregnancy; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810) at the age of 31-years-old, via an unspecified route of administration in left arm on 23Feb2021 at 08:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. She has no COVID prior to vaccination, no other vaccines in four weeks, and no other medications in two weeks. The patient was pregnant. Her last menstrual date was on 11Oct2020. Her delivery date is on 18Jul2021. The patient received her COVID-19 vaccine in a hospital. She experienced cervical insufficiency in pregnancy resulting in loss of pregnancy on 03Mar2021 at 15:00. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization from 2021 to 2021 for 1 day. There was no treatment given in response to the events. She was not tested got COVID post vaccination. She received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) at the age of 31-years-old, via an unspecified route of administration in right arm on 16Mar2021 at single dose for COVID-19 immunization. The outcome of the events was unknown.; Sender's Comments: The information available is limited. The etiology for the reported events could be multifactorial in nature. However  until more information is available the contributory role of the suspect product BNT162B2 cannot be completely ruled out based on the potential temporal association noted. This case will be updated when more information is available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as 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 RAs, Ethics Committees, and Investigators, as appropriate.
This case was reported by a pharmacist and described the occurrence of headache in a 39 year old female patient who received an expired dosed of hepatitis B vaccine recombinant (Engerix-B). The reporter is the patient. On 12 January 2005, the patient received the third dose of Engerix-B (lot ENG537A4). The expiration date for this lot of Engerix-B is 13 May 2004. At an unspecified time following the administration of the third dose of Engerix-B, on 12 January 2005, the patient experienced a headache. The headache was ongoing at the time of initial reporting, 12 January 2005.
Breastfeeding her baby; 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 EXPOSURE VIA BREAST MILK (Breastfeeding her baby) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding her baby). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding her baby) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Concomitant medications not provided.  Treatment information not provided.  Reporter stated that she is breast feeding and her child eats her breast.
vaccine site itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (vaccine site itch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VACCINATION SITE PRURITUS (vaccine site itch). At the time of the report, VACCINATION SITE PRURITUS (vaccine site itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Reporter did not allow further contact