chrisvoncsefalvay/vaers-outcomes huggingface dataset:
within twenty four hours after receiving the vaccine i was barely able to walk; Very sore; Headache; not able to function mentally; muscle pain was in tenth/lots of muscle ache, muscle pain was intense especially in the lower region; muscle pain was intense especially in the lower region, my leg and hip area; severe leg pain; lower back pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0181) intramuscularly on 18Aug2021 at 10:00 as a single dose in the left arm for COVID-19 immunization. Medical history included blood clots in pelvis (needing 5 stent surgery; taking warfarin blood thinners) from 26Jan2015 and ongoing and I had COVID in Jan2021 and not ongoing (needed antibodies 1-hour long infusion of Bamlavinivimad (?)). Concomitant medications included warfarin taken for blood clot in pelvis from an unspecified date and ongoing. Concomitant products were also reported as no. Prior vaccinations were reported as no. On 19Aug2021, the patient experienced within twenty-four hours after receiving the vaccine I was barely able to walk, very sore, headache, not able to function mentally, muscle pain was in tenth/lots of muscle ache, muscle pain was intense especially in the lower region, muscle pain was intense especially in the lower region, my leg and hip area, severe leg pain and lower back pain. The events were serious for persistent/significant disability/incapacity. The patient reported that both shots of the vaccine resulted in total body inabilities to barely walk, very sore, headache, was not able to function mentally. She had the same with the second shot but also had severe chest pain (captured in AER: 202101309811). The patient stated that she almost went to hospital. She reported that she had COVID-19 in January 2021 and needed antibodies, 1-hour long infusion of Bamlavinivimad (?). The patient stated that having COVID was better than these 2 shots. She would not be doing any boosters. Treatment was not received for the events. Relevant tests were reported as none. The clinical outcomes of the events within twenty-four hours after receiving the vaccine I was barely able to walk, very sore, headache, not able to function mentally, muscle pain was in tenth/lots of muscle ache, muscle pain was intense especially in the lower region, muscle pain was intense especially in the lower region, my leg and hip area, severe leg pain and lower back pain were recovered/resolved on 20Aug2021.  No follow-up attempts are needed. No further information expected.
Given flu vaccine in office on Tuesday.  By Wednesday, developed swelling and redness of right leg from thigh to knee.  Had normal labs and sono of right knee. Treated with benadryl and motrin.  Resolved without further sequelae.
Fever for 4 days, swelling discoloration of left thigh. Gait favoring left leg.
pt recv vax 14APR95 sx severe h/a, vomiting 4-6 times, chills-dizzy;
Slight fever (+2F), chills, fatigue, muscle ache. From 2AM to time of filing.
In error pt was given a low dose pediatric flu vaccine, she was contacted and came back to the facility and received a regular dose of vaccine as recommended.
Rib fracture; Headache; Fall; This is a solicited report based on the information received by Pfizer from AbbVie (Mfr. Control Number: 21K-163-3907099-00). A contactable consumer (patient) reported that a 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 and dose 2 both intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date (Batch/Lot number was not reported, Citrate Free) to an unspecified date for colitis ulcerative and Crohn's disease. No known allergies. No relevant medical history. The patient concomitant medications were not reported. The patient experienced rib fracture, headache, fall on an unspecified date. The action taken in response to the event for adalimumab was permanently withdrawn on an unspecified date. The outcome of events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the available information, no evidence of a drug to event temporal association was provided. The Company considered there was not a reasonable possibility that the reported events rib fracture, headache   and fall were  related to the suspect  vaccine BNT162B2 (PFIZER-BIONTECH COVID-19).
Reviewed shot 3/18/21 at 5:00 pm. Next day fever, headache, sore arm. On March 21 woke with all over body red rash. Still running fever and sore throat.
After my son recieved his shots, he cried for only a few seconds then he just went limp- into a comatose state.  Noone could get him to respond and this lasted for approximately 10 minutes.  Finally the nurses went to undress him, and he oped his eyes a little.  After about 5 minutes of poking him, talking to him, etc.  He finally came back around. 20 minutes later he was smiling again and acting like himself.  No treatment was adminstered.
I am a RN and with my first Phizer vaccine 5/23/21 developed Tachycardia 120-130 bpm/ Fever lasting 48 hours, Lymphedema and joint pain lasting ~3 months. I did not seek care at that time due to short staff at work and taking advise from my clinic providers that the symptoms would go away.  I did not get 2nd booster until October because I was waiting for lingering symptoms to subside and then it became manditory at work. With my 2nd vaccine I  developed fever and tachycardia 12 hours after receiving vaccine  140-160 bpm and fever that lasted ~48 hours. I went to a local hospital ER for treatment.  I was given fluids, Toradol, and Metoprolol and discharged after monitoring in ER.  Since this second vaccine I have developed Chronic shortness of breath and chest pain with activity,  I was assessed by Cardiologist on 10/29/21 and was given diagnosis of Myocarditis. I have a pending CT angiogram and MRI of heart and was started on Cozaar as of 12/6/21.
Patient presented with puffy eyes approximately 4 minutes after vaccination. Was alert and oriented to time, person, and place upon questioning and was able to engage in conversation. Parent (mother) of patient was present who gave patient's medical history and reported allergy to grass with similar reaction.  Blood pressure was taken and found to be 150/80. Mother reported patient had not taken his blood pressure medicine yet that day but his normal is 115/70 with  medication. While nurse was assessing patient's pulse (patient's pulse was WNL at 85) and other nursing staff was obtaining medication to administer if needed after assessment, patient became unresponsive to verbal commands and his upper body became limp. At 1054, a one time, single dose of 50 mg of diphenhydramine IM was given in the left deltoid. On site EMT arrived on the scene at 1055, completed assessment, and confirmed giving diphenhydramine was the best course of action. At this time, 1055, patient became responsive to verbal commands and was oriented to time, place, and person. At 1056 O2 sat was at 97%, pulse 70, and at 1100, BP was 110/70. Patient stayed for observation 30 more minutes and remained stable. Patient and parent were educated on side effects of diphenhydramine, to watch for any returning symptoms of allergic reaction throughout the day, and if/when to head to the ER. Recommended patient not receive 2nd dose of COVID vaccination.
erythema @ inj site greater than 5" diameter, c/o itching;cool compresses x 24hrs;
The patient received his second dose of the Moderna COVID-19 vaccine around 2:30 p.m.  Roughly 10 minutes later he reported that he was feeling warm and had a headache.  He also said he felt nauseated.  Since he works outside as a cart pusher he felt that he should go home and rest.  I took his temperature which was normal.  He went home around 3 p.m.
approx 2 hrs p/receiving vax pt began crying loudly (not shrill) & cont to cry continuously for 4 hrs; p/4 hrs went to sleep & had no other problems;
in crease in the severity of my peripheral neuropathy. the increased pain levels caused significantly decreased physical ability and endurance due to increased pain levels.
Initial report received on 20 August 2007 from a consumer, who is the patient. A 49 year old female patient received ADACEL (lot # was unknown) into the left deltoid on 15 August 2007. The next day she developed left arm stiffness, stomach ache, and diarrhea. On 17 August 2007 she had fever of 99.3 (Fahrenheit), she was weak, tired and had headache. Her arm was red, sore and swollen. On 19 August 2007, the patient called a medical center that recommended heat to site and ZITHROMAX for cellulitis. The patient had not recovered. The patient had allergy to sulfa and amoxicillin. The patient's concomitant medications included FOSAMAX once a week. The patient was not ill at vaccination time and had no adverse reaction following prior vaccinations. Follow-up information received from a health care provider on 04 October 2007. The patient had received an intramuscular left deltoid injection of ADACEL as part of a routine medical examination. On 19 August 2007, the patient presented to the urgent care clinic complaining of flu like symptoms for several days, dizziness, tender axilla and occasional chills. Assessment notes indicate the patient had "left shoulder redness/swelling/tender injection site with tender left axilla/LN". The patient contacted the urgent care clinic on 20 August 2007 the following day and stated that her arm was still "swollen, warm to touch and stiff" and her symptoms of diarrhea and headache continued. The patient stated that her symptoms "aren't worse or better". The patient had not received any vaccinations during the four weeks prior to receipt of ADACEL. The patient's past medical history included hypertension NOS, mitral valve disorder, osteoporosis NEC, endometriosis NOS, anxiety state NOS, backache NOS, and irritable bowel syndrome. Concomitant medications on the day of vaccination included LIBRAX, Lotrisone, desonide, fluocinonide, tobramycin sulfate and FOSAMAX. No further information was provided and the patient had not recovered at the time of the report. Follow-up information was received from the health professional on 29 October 2007. The patient had not received any prior doses of ADACEL. It was unknown if or when the patient had received previous tetanus injections. Treatment for the event began on 19 August 2007, and in addition to ZITHROMAX included ibuprofen for body aches and pain, and heat to injection site. The patient was instructed to follow-up with the physician if symptoms worsened or did not improve; no further contact was noted. It was unknown when the symptoms resolved. No diagnostic tests were ordered.
Reported 4/27/2022 at 2031 that she awakened at 1100 on 4/26/2022 with swelling, warmth and redness 3-4 inches below the injection site on the left arm. Two circular areas marked. She  experienced pain in bicep area on 4/29/2022. By 5/2/2022, redness gone. Arm is still itchy but not as sore. She feels she has a sore lymph node under arm.
Patient reported feeling very weird and sweaty.  Hands were were wet and cold.  She appeared pale.  I retrieved a nurse in occupational health (the area I use for administration, as pharmacy has no room) and her BP was obtained as 54 (only number heard).  A walk-in physician was called in to assess.  He brought another physician and 2 nurses.  She denied any swelling in throat, itching, rash, or trouble breathing. Her BP was attained again with a DINAMAP and was 156/80 with a pulse of 60.  BP reattained as 161/70 and pulse ox 95%.  She was able to sit up in a few additional minutes and moved to walk-in via wheelchair.  She was observed for about 20 more minutes and given juice.  BP normalized to 120/80 and pulse 60.  She is on BP medication and had not had lunch prior to this episode.  She was released by MD with her husband and told to lay down if symptoms reoccur and seek further medical attention.  She was to eat a light lunch and drink plenty of fluids.  MD assessed this as a vasovagal reaction to the vaccine and not a true allergic reaction.  She had no history of vasovagal reactions in past, but this, of course, was first shingles vaccine.
Became "flushed felt unwell chills", blood pressure elevated, Lasted 30 minutes. Resolved on it's own.
Fever without source - labs obtained over course of week - increase WBC, increase ESR - admitted to hospital - Echo confirmed Kawasaki's with coronary artery dilatation. 8/15/07-records received for DOS 03/23-03/27/07-DC DX: Atypical Kawasaki Disease. Allergy/reaction. Presented to ED with reports of fever range 101-103 rectally times 7 days. Increased fussiness, decreased activity, slightly decreased po, decreased UOP. No rash, vomiting or diarrhea. 1 day HX of runny nose/nasal congestion. Per 60 day follow up: As of 6/07, his R conranary artery still ectasic, but no aneurysms. He is following up with cardiology evyr 6 mos. and continuing on daily aspirin.
patient received her first and second dose of IMOVAX RABIES but third dose (day 21 dose) will be received by the patient on day 24 / No AE; Initial information was received on 13-Aug-2021 regarding an unsolicited valid non-serious case received from a nurse via phone via Global Medical Information Inquiry Number: 00723480.    This case involves an unknown age female patient who received her first and second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] but third dose (day 21) will be received by the patient on day 24 (inappropriate schedule of product administration).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On an unknown date, the patient received first and second dose of suspect RABIES (HDC) VACCINE Solution lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination respectively(pre-exposure rabies).  It was case of an actual medication error due to inappropriate schedule of vaccine administered (latency: same day).  It was reported". The caller states that they were treating a patient for pre-exposure rabies. The patient had already received dose 1 and 2. Today was day 21 (13-AUG-2021) and the patient would miss the appointment. The caller would like to know if they may proceed on Monday, 16-AUG-2021 with giving the next dose. Nurse wants to know since the consumer cannot come today which is day 21 is it ok if she comes on day 24 instead of day 28 to get her dose. Nurse states the consumer missed her third prophylactic dose today but will come one Monday to take it. Product used: Used, First time product used: No, Still using product: No."  It was unknown if patient received the vaccine or not.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  There will be no information on the  lot number for this case.
08-22-2006 wake up in the am, complaining of headache, swelling at injection site, pain at injection site, low grade fever.  08-23-2006 in the afternoon complaining of low grade fever of 99.5 degrees, pain in the back of the neck, fatigue, pain at injection site and under arm area.
BODY ACHES; LETHARGY; FEVER; SORENESS AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 42 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced soreness at injection site. On 08-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.0 F. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, lethargy, fever, and headache on 09-APR-2021, and had not recovered from soreness at injection site. This report was non-serious.
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. Since 01-NOV-2016, an unknown number of patients were vaccinated with improperly stored dose of VAQTA, lot number not reported. Other vaccines improperly stored included RECOMBIVAX HB, GARDASIL 9, M-M-R II, PEDVAX HIB and ROTATEQ. No adverse effects reported. No further information provided. This is one of several reports from the same source. Additional information is not expected.
No further AE details; Improper storage of product in use; This spontaneous report has been received from a pharmacist concerning a 13-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug/allergy history, and concomitant therapies were not reported.  On 02-MAR-2023, a temperature excursion was registered for varicella virus vaccine live (oka/merck) (VARIVAX) (temperature of 70 Fahrenheit [F] for 9 minutes).   On 08-JUN-2023, the patient was vaccinated with the improper stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliter/once, Lot# W025273, expiration date was reported as 02-JUN-2023, but upon internal validation, it was established as 10-AUG-2024 (anatomical location and route of administration were not reported) administered for prophylaxis (product storage error).  No adverse events were reported.  This is one of several reports received from the same reporter.
Confirmed with caller the patient did not experience any other AE.; Caller reported an AE for ROTATEQ. The caller said the patient received a dose after a temperature excursion occurred.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 28-JUN-2022, the patient was vaccinated with improperly stored (product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (exact dose, strength, lot #, expiration date were not provided) for prophylaxis. Temperature excursion information: above 9 degree Celsius (8.98 degree Celsius; discrepant information) for 1 hour 40 minutes (also reported as 8 degree Celsius for 47 minutes). There was no additional adverse event reported.
shipment was delayed by 2 days, no averse event; shipment was delayed by 2 days, no averse event; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked to 2019SA320288 (same reporter).  This case involves a male patient of unknown age who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6719NA, Exp date: unknown), via unknown route in the left deltoid, on an unknown date.  Relevant medical history and concomitant medication were unknown.  It was an actual medication error due to the incorrect product storage. It was reported that shipment was delayed by 2 days (Product supply issue).  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 holder's 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.
Day 1 - 3: Severe nausea, body pain, muscle spasms (particularly bottom of feet), headache, stuffy nose, sore throat, bladder burning. Day 3 - 4: Different rashes on different portions of my body, including both arms, neck and front/back torso. Day 4 - current (which today is Day 17): The rash dissipated but the bladder burning remains, however now there is unbearable incapacitating severe bilateral pain and burning  in front/back of upper/mid torso, including painful sensitivity to clothing and sheets. Very painful at all times, including when sitting, lying down and walking. Went to Physician on Day 10 and later prescribed Gabapentin and Meloxicam. Minimal relief. Pain/burning comes back whenever medicine wears out. Doctor increasing dosage. Pain/burning is unbearable!
She tested positive PCR; She tested positive PCR; This is a spontaneous report from a contactable Nurse. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. Resident inoculated on 17Dec. She tested positive PCR on 29Dec2020. Currently in quarantine and asymptomatic. She was scheduled for dose 2 on 06Jan2021. This still fell in quarantine period. The nurse wanted to know if the patient could get the second dose on 06Jan, if not when should she get second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 vaccine cannot be completely excluded for reported event "test positive PCR".
arm pain; This case was reported by a consumer and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received the first dose of the Shingrix vaccine in unknown arm and had upper arm pain for 4 days and it resolved within a few days after he took Advil. For tolerance of 2nd dose refer case US2020255813.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020255813: