chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Course confirmed with MOC. Pt was not pre-medicated before injections on 8/10/15. Pt reported tenderness and soreness in the Left deltoid muscle with limited ROM first day 8/10/15. Pt was groggy next day but reported decreasing pain through the afternoon.  At bedtime, pt reported increased pain and awoke several times in the night crying 8/11/15.  MOC took oral temperature and reported that he was not febrile.  Pain was severe so MOC gave 7.5 mL of children's Motrin which helped.  MOC did not notice any redness until the next morning (8/12/15).  Pt complaining of increasing pain and redness.  Reported to urgent care for follow-up.  Pt presented with a large erythematous rash on the left lateral upper arm.  Irregular margins starting at the deltoid and spanning inferiorly to the middle of his upper arm and horizontally from the anterior margin of his deltoid to the posterior margin of his deltoid.  Pt was seen by a physician and diagnosed with cellulitis.  Margins were drawn with a sharpie and pt instructed to return for increasing margins, streaking or any changes and to follow-up in 24 hours.  Pt received Keflex 550 mg (11 mL) by mouth three times a day for 7 days and Tylenol or Motrin for pain or fever as needed.
Headaches and sleeplessness about 3 days after injection. Back began itching with bumps which turned to some dime size hives on nable, legs, back and private parts also buttocks. Never had this before. Left chest pain, for past 2 wks.
Cough, congestion, headaches, chills, fever, body aches, loss of taste x 2days. starting 11/3/21
This 15 year old received the following vaccines on 5/6/2009.  HPV Lot # 1129X, HAV Lot # 0932X, and Varivax Lot # 0050Y.  The primary medical doctor e-mailed me 7/15/09 concerned that the patient had "extreme dizziness and leg weakness a few hours after her 1st Gardasil which recurred the next day and again 6 days later. The leg weakness was significant enough that the patient could not bear weight on the leg.  Symptoms resolved.  PMH:  Pt has mild asthma and allergic rhinitis. Otherwise neg med hx.
Fatigue, extreme body aches, unable to move from upstairs, extreme tiredness, headache
My arm started swelling the day after the shot was given, then later the same day felt warm to the touch and turned red. I went to urgent care, on 12-8-17, they diagnosed my arm (left) with "cellulitis" and prescribed 2 antibiotics: cephalexin 500 mg (generic for KEFLEX 500 mg SMZ/TMP DS 800 - 160 tab AMN (generic for BACTRIM DS 800 - 160 tab.
Patient reports she held her Humira due to infection, Patient reports she has a cold after taking the flu shot. Patient reports her primary provider prescribed Ibuprofen, Prednisone and antibiotics. No additional information provided. patient does not consent to be contacted.
fever 102 degrees, body chills, cough, sore throat, nausea, fatigue, body aches
pt admitted to hospital via EMS with level 1 stroke; had tested positive for COVID 1 wk prior to admission; hx of ESRD on dialysis 3 x wk; per death certificate, pt died in the hosp due to the following:  COVID 19 Pneumonia, Undifferentiated Shock, ARF, ARDS
Guillain Barre syndrome (GBS); Patient was paralyzed; On a ventalator and had a trach put in he developed septic pneumonia; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a consumer or non-health care professional (patient's brother) via social media.  This case involves male patient (age unspecified) who experienced Guillain barre syndrome (GBS) (Guillain-barre syndrome) who was paralyzed (paralysis) and on a ventilator and had a trach put in he developed septic pneumonia (pneumonia bacterial), while he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain barre syndrome (GBS) (Guillain-barre syndrome), paralyzed (paralysis) and on a ventilator and had a trach put in he developed septic pneumonia (pneumonia bacterial), (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant and life-threatening. The patient was hospitalized for these events.  It was reported that which Guillain-barre syndrome attacks the nerves and patient was in intensive care unit (ICU) for 6 weeks.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Event outcome was unknown for all reported events.  There will be no information available on batch number for this case.; Sender's Comments: This case concern social media case which involves a male patient (age unspecified) who presented with Guillain-barre syndrome, paralysis and pneumonia bacterial after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations and other alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4513759-00 (Agency).  A 66-year-old female patient received bnt162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis in thumb", start date: 2016 (unspecified if ongoing); "Allergy", start date: 2016 (unspecified if ongoing); "Osteoarthritis in knees" (unspecified if ongoing); "Surgery to drain fluid in knee" (unspecified if ongoing); "right knee swollen" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfasalazine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Sep2022, outcome "recovered" (2022) and all described as "Covid-19".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
local injection site reaction, and itchy. told patient to apply cold compress and take Benadryl. will follow up with patient
S/Sx started on 10/17/2011, 3 days after vaccination with leg pains, inability to walk, progressed to back pain, locking knees and facial swelling. Feet: Mon; -> legs Tues; locked can't walk. 10/18 - Knees locking. 10/19 - Back pain; knees locking. 10/27 - Eyes O.U - hazy; keeps changing. 10/29 - (R) cheek swelling. 11/11 - still with symptoms. 11/01 - more blurry eyes. 11/5 - wrist hurt - stiff extremely sore knees. 11/21 - jaws tingling, ache and unable to move fully. Dec. 29 - cardiac issues - atrial fib; arrhythmia; no previous hx; diltiazem 1/2 tab x 6 times 6-8 wks; completely resolved. ECHO, cardiac test - (-). 5, 2012 - better days since flu vaccine.
All times in format HH:MM:SS after injection  T+00:05:00: Heaviness, weakness in left arm. Gradually cessated over four hours.  T+08:00:00: Interrupted sleep; insomnia lasting four hours; visual disturbances (flashing lights, geometric patterns). Ceased within 2 hours. T+18:00:00: Fever of ~1.5 degree F above normal; injection site reaction (soreness); weakness; fatigue; chills; all symptoms ?flu-like?. Slowly resolved over next 18 hours.
Severe wheezing and difficulty in breathing/shortness of breath lasting several days. Intense use of albuterol (2 inhalations every 4 hours) plus famotidine (20 mg/bid) was required before office visits to primary care physician, pulmonologist, and cardiologist. I was prescribed Symbicort (165/4.5 mg - 2 inhalations bid) and famotidine (40 mg bid). I am currently on that regimen.
Severe headache, tiredness, dizzy, short of breath at times, heart palpitations, weakness and nausea.
approx 3 days p/ vax pt exp raised, red swelling described as bumps @ inject site lesions spread to 12-5 days p/vax
Blisters on hands, legs and body. Use Benadryl to control it. Sometimes lips enlarged. I thought it was some strong allergy.
itching; swelling; tenderness at injection site; generalize malaise; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (generalize malaise), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swelling) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (generalize malaise). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (generalize malaise), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swelling) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported    This case was linked to MOD-2021-018567 (Patient Link).
Pt claimed that 3 hrs after receiving the flu vaccine, she had a hard time breathing.
Patient pulled her arm away - while the vaccine was being administered.  She didn't get the full dose- but- she did get some.
Vaccines administered 2/05/09 in morning. Parents report mom picked up child from crib for 9 p.m feeding. Child was unresponsive and limp. Father began CPR. Child responded. Ambulance arrived but did not transport child to hospital. I was notified of episode one week later. Child was electively admitted to hospital.  3/18/09 MR received for DOS 2/12-14/2009 with DX:  ALTE.  Pt presented 3 days s/p an episode of limpness.  Parent usure if child was breathing.  Parent began CPR and continued while pt was crying.  Upon EMS arrive pt behaving normally.  Episode reported to PCP  who recommended inpt eval which was (-). No apnea or brady. D/C on home apnea monitoring.
Patient experienced allergic Rx. Onsite EMS was called vitals BP 149/89  HR 60 99% O2 room
I woke up the following day after vaccine and looked like I had goiter. My neck was so swollen and under my tongue, it was hard to breathe through my mouth and my throat was like razor blades.. They did an ultrasound on my neck and said my lymph glands were swollen. I was given one injection of cortizone. It took about 5 days for me to be comfortable and about two weeks for all swelling to go down.
On the night of the 7th day following injection, the injection site began to get red, warm, and firm. By the following morning (8 days following injection) it was a red circle approximately 1.5? round with a smaller red dot underneath. It is warm and firm to the touch, but no pain or itchiness.
Information has been received from a 33 year old female consumer for the pregnancy registry for VARIVAX (Merck) concerning herself with no known drug allergies/drug reactions who on 06-MAY-2009 was vaccinated with the first 0.5 mL dose of VARIVAX (Merck). Secondary suspect vaccine included MMR II (MSD). Other concomitant vaccine included DTAP (manufacturer unknown). It was reported that the patient experienced pain at the injection site after getting VARIVAX (Merck), MMR II and DTAP. It was also reported that as of 04-JUN-2009 the patient was seven weeks pregnant. The patient sought unspecified medical attention. The last menstrual period was the "second or third week of April 2009" and the estimated delivery date was on 12-JAN-2010. No further information is available.
Pfizer-BioNTech COVID-19 Vaccine EUA  12/17/2020- 12/18/2020 First day into overnight: temperature that ranged between 99-100.5 F. severe body aches, chills, extreme skin sensitivity, slight rash on right arm near injection site and on right breast, right arm pain significantly increased, fatigue, cough, temporary confusion, joint pain, nausea.  12/18/2020 Second day: Fatigue, slept for most of the day but still did not feel rested, nausea, arm pain, joint pain, headache  12/19/2020 Third day: Felt better but still drained and slightly short of breath. Joint pain, slight headache and side of face pain.
Red, slightly swollen area around injection site. The area is very warm to the touch, sore with and without movement, and measures 3 inches x 4 inches. Fatigue started roughly 9 hours after vaccination and lasted for 24 hours. Cold sweats occured 48 hours after vaccination and lasted around 8 hours.
Within 30 minutes of shot, feeling of general comfort and a little tired.  Within 2 hours of shot swelling of left neck lymph node, which subsided in less than 4 hours.  Within 2 hours general itchiness felt on the skin with no visible skin reaction, subsided within 24 hours.  Within 2 hours feeling of drunkenness with no alcohol consumption.  According to my wife, I was even acting drunk.  General fatigue for up to 2-4 weeks; however, persistent fatigue measured over two shots is hard to determine.
About 11 hours after vaccine, woke up at around 4:45AM. Got up to go pee. Peed. Stood up and took a few steps. Felt like I was going to pass out so laid down on ground. Seconds later, passed out for about 10 seconds and eyes rolled back (according to my husband). Woke up and started to lift head and passed out again with seizure-like activity. About an hour later, did ECG and CT and was monitored at hospital. CT was normal. ECG said Nonspecific Intraventricular conduction delay 115. Emergency department thought it was vasovagal syncope possibly related to the Covid-19 vaccine.   (Note: this was my second dose of Pfizer vaccine. First dose was given to me in another country on June 19, 2021: Comirnaty - EU/1/20/1528,  1119349007 SARS-CoV-2 mRNA vaccine, Biontech Manufacturing GmbH.  Did not have any side effects after first dose).
A non-serious spontaneous report of administration to pregnant female was received from a nurse practitioner concerning a 27-year-old female. Neither past medical history nor obstetrical history was reported for this patient. On 04-Nov-2010, the patient received the nasal mist influenza vaccine at her family doctor. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Noticeable tingling in hands and feet and  crawly feeling in middle right of spine.
6/8/2023 - 6/12/2023 (4 days) weakness No indications for COVID-19 specific therapy. EJ1685 1/7/2021 EL3248 1/28/2021 FF2588 8/30/2021 FK9893 5/11/2022
This spontaneous report was received from a physician and refers to a 20 -year-old male patient. The patient had no known pertinent medical history, concomitant medications and drug reactions or allergies. On an unknown dates (reported as "6 years ago"), the patient was vaccinated with series of GARDASIL 9 (exact doses, routes of administration, anatomical locations, lot numbers and expiration dates were not provided) for prophylaxis. On 09-JAN-2019, the patient presented to the physician office as he developed wart on an unspecified cheek on his face. The patient as a treatment received a dose of GARDASIL 9 lot # R024264, expiration date 29-OCT-2019. There was no diagnostic tests performed. The outcome of skin papilloma was reported as not recovered. The causality assessment between the events and the suspect therapy was not provided.
Swelling, rash, redness, burning in arm receiving injection.  Apparently known as "Covid Arm".
She received her first Pfizer COVID-19 Vaccine on 19Jan2021/ tested positive for the COVID-19 Virus on 08Feb2021/ been sneezing and has lost taste and smell; She received her first Pfizer COVID-19 Vaccine on 19Jan2021/ tested positive for the COVID-19 Virus on 08Feb2021/ been sneezing and has lost taste and smell; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect and COVAX US Support from a contactable consumer (patient). A 44-year-old female patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at the left arm on 19Jan2021 15:40 at SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a hospital. Medical history was none and she has no prior health history. The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior vaccinations within 4 weeks. For concomitant medications the patient has been taking vitamins, supplements, and iron for quite sometime. The patient received her first Pfizer COVID-19 Vaccine on 19Jan2021 (reported as 3 weeks ago). The patient stated that she has been sneezing and has lost taste and smell. She took a Covid test on Friday (05Feb2021: COVID-19 PCR test) and received negative results on Saturday (06Feb2021: COVID-19 PCR test). She said she tested positive for the COVID-19 Virus on 08Feb2021 (COVID-19 PCR test). She said she was supposed to go for the second COVID-19 Vaccine on 09Feb2021. She said she went to the COVID-19 Vaccine site that administered her first vaccine dose, and was told she couldn't get her second COVID-19 Vaccine dose/ missed appointment because she tested positive for the COVID-19 Virus. She said she was asked to call back this week to rescheduled her second COVID-19 Vaccine dose, but she hadn't done so because her father just passed away. She stated she required no treatment, and quarantined after the positive COVID-19 Virus test result. The patient did not require a visit to Emergency Room or Physician Office. The outcome of the events was unknown. The patient added she is "not sick at this time" and has no pre-existing conditions and seeking guidance on the next dose and wanted to know if she is eligible to get the second COVID-19 Vaccine dose, asking about the timing of the second if it would still be valid even if it is beyond the recommended 3 week period?
A non-serious spontaneous report of administration of full dose of H1N1 2009 Monovalent Vaccine Live in one nostril was received from a certified medical assistant concerning an adult. The patient's medical history and concomitant medications were not provided. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
3-28-21 fatigue, bodyaches, night sweats,chills 4/14-no recommendations as symptoms are resolved at this time. informed him if he has pain with the next dose he can take his OTC analgesics, caller verbalized understanding.
Chest pains short of breath rapid heart rate day after vaccine. Continues today Oct 25/21 reduced frequency
immediate palpitations and shakes x 30 minutes,  2 days later severe body aches and fever, sunburn like rash x 24 hrs, , continued pain and swelling of the joints with numbness and tingling of the extremities
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (My arm was sore.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.  No Medical History information was reported.On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 15-Feb-2021 for Adverse event, at a dose of 2 tablet. At the time of the report, VACCINATION SITE PAIN (My arm was sore.) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications reported.This case was linked to MOD-2021-404784 (Patient Link).
Narrative: COVID infection following COVID vaccine series 02/20, Pfizer, dose #1 (NON-FACILITY) 03/13, Pfizer, dose #2 (NON-VA) 06/21 COVID swab, result: not detected 07/30 COVID swab, result: not detected 08/23 COVID swab, result: detected 08/23 pt cc: No symptoms exposure: unknown 08/23 SARS-COV-2 Variant Sequencing result: pending 10/01 COVID swab, result: NOT detected
Moderna Vaccine given to patient by nurse. Nurse unaware of fridge excursion from pharmacy on Saturday. Medication was out of range and after calling manufacturer, told not to give.   Patients call back for an immediate repeat dose per CDC guidelines.
pt felt nauseated & faint immed p/receiving shot; pt felt very weak, heart started racing, was SOB, gasping for air, unable to speak hands & legs tingling, became numb;
CHEST DISCOMFORT; LYMPH NODE IN RIGHT ARM PIT SWOLLEN; FELT LIKE FLU; HEAD FOGGINESS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included mild case of covid, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2020, Laboratory data included: Platelet count (NR: not provided) 417K/mcL. On 07-APR-2021, the subject experienced head fogginess. On 08-APR-2021, the subject experienced felt like flu. On 09-APR-2021, the subject experienced chest discomfort. On 09-APR-2021, the subject experienced lymph node in right arm pit swollen. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Platelet count (NR: not provided) 331K/mcL. On 16-APR-2021, Laboratory data included: CT scan (NR: not provided) unknown, and Chest X-ray (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest discomfort on 21-APR-2021, and lymph node in right arm pit swollen on 13-APR-2021, and had not recovered from felt like flu, and head fogginess. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.
pt exp vomiting & diarrhea x 12 hrs, fatigue-stomach & tenderness x 48 hrs;
When give the dose, the needle and the syringe separated at the hub.  Patient likely received only about 1/2 of the contents of the syringe.  Contacted Health department and was informed that we should not re-administer or give any additional dose.    Needle was removed from patient arm.  Patient noted that she would rather not get anymore dose and felt that she got most of the dose.  Pharmacy is following the patient closely.