chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myalgia, Arthralgia, fatigue, nausea;  Narrative:
Immediately after injection had slight "itching". 24 hrs later - area was "blotchy" and warm to touch. 48 hrs. later - erythematous area 4-6 " in diameter - warm to touch and mild pain at injection site.
COUGH; VERTIGO; DIZZINESS; LOSS OF APPETITE; SHOULDER PAIN; CHILLS; FEVER; NECK PAIN; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced neck pain. On 12-MAR-2021, the subject experienced muscle ache. On 12-MAR-2021, the subject experienced shoulder pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced cough. On 13-MAR-2021, the subject experienced vertigo. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced loss of appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-MAR-2021, had not recovered from cough, shoulder pain, and muscle ache, and the outcome of vertigo, dizziness, neck pain, loss of appetite and chills was not reported. This report was non-serious.
Initial report was received from a health care professional on 27 February 2012. A female patient (age and date of birth) had received an injection of FLUZONE HIGH-DOSE, sanofi pasteur Inc. (lot number, route, site and exact date not reported) in September of 2011 and broke out in psoriasis. At the time of the report, the condition persisted. No further information was available at the time of the report. The patient's outcome was reported as unknown. Documents held by sender: None.
Headache, sore throat, congestion, fatigue, runny nose, cough treated with over the counter medication for 2 days.  Requested and received Paxlovid on third day of symptoms.  Took Paxlovid for 5 days as directed.  Felt much better after second day of Paxlovid and completely back to normal by day 5.
UTI; This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received the first dose of Pfizer's COVID vaccine on 09Mar2021 and was scheduled for her second dose on 06Apr2021. Patient had a UTI (Urinary tract infection) and stated her doctor will most likely put her on antibiotics.  The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Breakthrough case admission after 2 vaccines Moderna 1/21/21 lot# 012L20A;  Moderna 2/18/21 lot# 016M20A
Information has been received from pharmacist concerning a 73 year old female who on 03-JAN-2009 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot # 663175/1553X) 0.65mL,  subcutaneously into her left arm. Concomitant therapy included ACTONEL. The patient developed an injection site reaction after receiving ZOSTAVAX vaccine (Oka/Merck). It was described as a 1 inch area that remained red and itchy at the injection site several days post vaccination. Patient was told to take BENADRYL. At the time of reporting, the patient had not recovered. The patient sought medical attention and called the pharmacy. Follow up information was received from the pharmacist who reported that the patient had a PERCODAN and a COMPAZINE allergy. It was reported that the patient experienced redness and itching on 04-JAN-2009. On an unspecified date the patient recovered. Additional information is not expected.
Chest pain that started the evening after he received his second dose of the COVID-19 vaccine (5/3) and persisted for 36 hours.  Went to the ER (5/4) where EKG demonstrated ST segment elevation, concerning for pericarditis.  He was transferred to our facility and admitted (5/5).  Symptoms and EKG consistent with pericarditis, unclear etiology however presumed to be related to COVID vaccine. He was started on treatment for pericarditis with ibuprofen 600mg by mouth three times per day.  Chest pain resolved on day of discharge.
Ongoing pain in my arm at the injection site since first dose up until the present time. I have limited range of motion and the pain is pinpointed where I received the injection. I was diligent in rubbing and moving my arm post-vaccination and even still - try to rotate and massage the area.   Ongoing headaches. I was never prone to headaches but since having the vaccine - I have been getting headaches several days a week. It hurts in the back of my head and wraps up to the front of my forehead. They always start in my sleep and last throughout the day, requiring the use of ibuprofen. I was warned that a headache was a side effect of the vaccine and I did have one for several days along with the fever and chills and general malaise and feeling of the flu (after both doses). While those side effects subsided about 4-5 days later, I am still getting a headache that feels the same as I did when dealing with side effects.
pt recv vax & devel an inj site rxn w/redness & soreness @ the site of pneumonia immune immune 23 administration;
HCP will investigate if expired doses were administered; HCP says what if hypothetically doses were given.HCP will investigate if expired doses were administered; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP will investigate if expired doses were administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP says what if hypothetically doses were given.HCP will investigate if expired doses were administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP will investigate if expired doses were administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP says what if hypothetically doses were given.HCP will investigate if expired doses were administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP will investigate if expired doses were administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP says what if hypothetically doses were given.HCP will investigate if expired doses were administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment  medications were reported.
Little local soreness at injection site at first.  About 2 days later - injection site became tender and numb.  This lasted for about 2 weeks, but is better now.
Fever, chills, weakness. 8/18/13- fever, weakness, confusion. Transport to hospital. given Tylenol in ER. Inpatient 8/19/13 through 8/20/13. At this time, treatment details for these 2 days are not available. Call from hospital 10am, moving to "special care". 10:20, daughter arrives,  intubated and unstable. family request transport to better hospital. Air transport to another hospital at 1:30 PM on 8/20/13.
Arm pain-radiating to neck and back rash at injection site and proximal arm.  Treated with Medrol/Atarax.
postnasal drip; not feeling well/feels like she is not getting any better; postponed her second dose of Moderna COVID-19 Vaccine; been coughing/ hacking cough; has horrible cold/ developed a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (has horrible cold/ developed a cold), UPPER-AIRWAY COUGH SYNDROME (postnasal drip), MALAISE (not feeling well/feels like she is not getting any better), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (postponed her second dose of Moderna COVID-19 Vaccine) and COUGH (been coughing/ hacking cough) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced NASOPHARYNGITIS (has horrible cold/ developed a cold) and COUGH (been coughing/ hacking cough). On an unknown date, the patient experienced UPPER-AIRWAY COUGH SYNDROME (postnasal drip), MALAISE (not feeling well/feels like she is not getting any better) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (postponed her second dose of Moderna COVID-19 Vaccine). The patient was treated with AMOXICILLIN on 07-May-2021 at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE DM) on 15-May-2021 at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (has horrible cold/ developed a cold), UPPER-AIRWAY COUGH SYNDROME (postnasal drip), MALAISE (not feeling well/feels like she is not getting any better) and COUGH (been coughing/ hacking cough) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (postponed her second dose of Moderna COVID-19 Vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.    Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received on 17-may-2021 new AE updated. On 24-May-2021: Non-Significant follow up received on 24-may-2021,  includes vaccination facility information and second dose postponed.
Patient seen at walk in care for redness/swelling/heat and pain to injection site/  Treated with Benadryl, Cephalexin and Prednisone for cellulitis
Red blotches on (L) arm, severe S.O.B., heart palpitations, increased pulse (up to 165), face flushing, could not eat, weight loss. Hospital in PT 2 times, Endoscopy, Colonoscopy, CT Scans, Echocardiogram, Blurred vision, severe diarrhea, etc, etc. 11/17/08-records received 11/17/08 presented to clinic on 11/29/08- for evaluation of C/O blotchiness distal to injection site for 3 days with soreness. On 11/21/08 felt tired and some lethargy. 1 day of congestion. Bit out of breath on 11/23 and 11/24/08. Assessment-viral syndrome. Next day C/O palpitations and feeling out of breath.Prescribed beta blocker but did not take medication. No hospitalization. 1/28/2010 I still have facial flushing, SOB and heart racing everyday. Also, diarrhea and feeling very tired at times. It has been 2 years now and I do not feel ike I did before the shot.
Menstrual spotting in the afternoon/evening on the day of vaccination after receiving vaccine. No strenuous activity was done to cause the spotting.  Heavy bleeding with ovulation less than a week after vaccination, which is abnormal for patient.
Patient was given a possibly undiluted dose of covid vaccine in addition to a dose of vaccine diluent (2 separate shots). The administering nurse reported that she did dilute the first dose, but it was unclear based on her description. Her PCP was called, left message on prescriber's personal phone number. Patient was told to wait for 30 minutes to observe for any adverse events.
So I did have side effects from the injection on the 10th, I had a sore arm, muscle ache, fever, headache, severe pain from my neck to mid back on the right side, I could not turn my head. This lasted for about three days and gradually decreased. I took TYLENOL on the 11th at 6:00PM, then I started to take the ibuprofen, I do have an inhaler as needed as well. On the 22nd, I started noticing facial swelling, the 22nd and the 23rd I felt like I needed my inhaler, I took antihistamine, and ibuprofen, I stopped the antihistamine on the 26th I did not take it on the 27th, on the 28th I woke up with facial swelling and the same severe pain on my neck and mid back on the right side like I had when I first had the vaccine. This is why connected the two, on the 28th I went to the Dr. and he described prednisone, My O2 stats were normal, all usual stats normal. Did not go to the ER just my normal Dr.'s visit. the facial swelling is down from taking the medicine, and I am starting to feel better.
Medication Beyond Use Date 10/30/21.  Medication Expire Date 12/21.  Medication administered on 11/1/21.  No adverse reactions noted.   Pt is 28 weeks gestation
Pneumovax 0.5cc 4/28/2006-4/29/2006 mid-day (+) fevers, diarrhea L deltoid red, painful. Unable to lift arm. ER-temperature 103-LP done-Keflex 500 po qid x 10 days, Motrin prn. Seen in clinic 5/1/06.
The Janssen Covid 19 vaccine was given to Clancey, who is 16 years old.  This vaccine is only approved for 18 and older.
Fever 101; Chills; lethargy; headache; arm soreness at vaccine site; This is a spontaneous report from a contactable consumer.  A 68-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EN6193), dose 1 via an unspecified route of administration, administered in right arm on 26Feb2021 at 17:30 (at the age 68-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included drug hypersensitivity (known allergies- Penicillin) from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), pseudoephedrine hydrochloride (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) and montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported received within 2 weeks. No other vaccine in four weeks. No COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Facility type vaccine at Pharmacy or Drug store. On 27Feb2021 at 11:15 the patient experienced fever 101, chills, lethargy, headache, arm soreness at vaccine site. The patient underwent lab tests and procedures which included body temperature: 101 on 27Feb2021. COVID tested post vaccination reported as no. The outcome of the events were recovered on 20221.   No follow-up attempts are possible. No further information is expected.
Sore arm; Headache; Fatigue; This is spontaneous report from non-contactable consumer, the patient. A 37-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8430) via an unspecified route of administration on left arm on 23Mar2021 at 08:15 as a single dose (at the age of 37-year-old) for COVID-19 immunisation. Medical history was not reported. The patient had allergy to penicillin and avocado. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 23Mar2021 at 20:30, the patient experienced sore arm, headache and fatigue. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events sore arm, headache and fatigue were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
A report was received from a health care professional on 2/5/04 concerning a 3 and a half year old vaccinee of unspecified gender who inadvertently received Fluvirin on 1/29/04. On 1/29/04 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Fever 101 per Mom's statement on 06/07/2005 evening.  06/08 am - rash at injection site, baby fussy.  Mom giving Tylenol infant drops and Motrin alternately.  06/08 pm - rash spread to body, eyes red and puffy.  06/08 - approximately 5:30-6pm - to hospital - treated with Benadryl suppository. Had right ear infection, treated with amoxicillin, also mosquito bites continues to give amoxicillin, cream on mosquito bites and over the counter antihistamine.  Mom states cultured insect bite, blister, on bottom of left foot.
I started noticing my irregular heartbeat, like a skipped beat. I noticed it all of a sudden and on and off all day long. It would be tachy sometimes. The reason why I sought out a cardiologist and PCP is because when trying to cough or bear down, it would not correct it. And it was becoming difficult to calm down normally. These events usually linger then leave. But this was off and on all day multiple days in a row. And this went on for 3 months. It went long enough to where I had to go see a doctor about it and then it would go away but then it could come back. For treatment, doctor put me on a heart monitor from 11/4 to 12/4 and was prescribed with Metoprolol.
Developed body aches, L shoulder pain morning after receiving vaccine. C/O some dizziness, nausea, point aches, head ache for next 2 days. Also had some redness, warmth, pain at area of injection for 3 days.
Patient is a 79 Y male with PMH of CAD c/b STEMI s/p RCA DES (2/2022), h/o stroke (2/2020), HTN, HLD, Afib on Pradaxa, T2DM, BPH, lumbar radiculopathy, chronic right hip pain, who presented on 3/20/23 for generalized weakness. Found to have fever to 101F and rapid Afib. Tested positive for COVID on 3/20/23, though did not have any respiratory or GI sx. Pt declined any COVID treatment. CT head negative for bleed, MRI L-spine noted only old L4 fracture. The next day on 3/21, pt was feeling much improved. Generalized weakness was felt to be likely in the setting of infection. He worked with PT who recommended no PT needs at discharge. At time of discharge, he was feeling well and stable to go home
following vax 11OCT93 mom noted hearing loss w/pt showing lack of response & misunderstanding words; tested by school; referred to audiologist 1NOV93 who stated there was deafness in lt ear; referred to NET; MD who tested for viral illness;
Patient received vaccine at roughly 2:40 pm on 7/28/21. Was advised to stay at location for 15 minutes prior to leaving . Patient was shopping in store and fainted . Found patient lying on floor with her mother by her side . Patient was alert but shaken . Patient said she had hit her head and scraped her leg. patient was put into a chair and given some juice and an ice pack for back of neck . After about 10 to 15 minutes patient said she felt well enough to walk and was taken home by her mother .
aortic aneurysms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8734) at the age of 56 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing). The following information was reported: AORTIC ANEURYSM (medically significant), outcome "not recovered", described as "aortic aneurysms". The patient underwent the following laboratory tests and procedures: Weight: About 130 pounds. Therapeutic measures were taken as a result of aortic aneurysm.  Clinical information: It was reported that patient had aortic aneurysms after getting the 3 Pfizer covid-19 vaccine. She is looking for more information and if there is a correlation between them. It was reported that patient Going to have to have open heart surgery, confirmed has not had open heart surgery yet. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). caller asked if a clinical trial going on to see if there is a correlation for the aortic aneurysm and vaccine.
After waking with only an hour sleep I could not get back to sleep and as night went on I became overwhelmed with extreme pain, not just body aches.  I fell asleep about 9:15 am on 2-13-2021 for about an hour and woke with fever but could hardly move.  I have had body ache from  being sick with flu before but never where I could hardly move.  I could drink but had no appetite that day.  The fever got to 103 at one point .  Eventually the fever broke about 4:00 am on  2-14 -2021.  The site where the shot was administered was swollen  with a rash that spread out about 5  inches long by 3 inches wide.  I had no side effects at all from first dose.
Father called at hospital on 9/7/02 to tell me that tigh had a 4inx3in red area at site of vaccination on left leg.
Fever 24 hours later then left arm pain in similar distribution to prior rash from shingles vs cervical radiculopathy- pain lasted several weeks - seen 04/11/2018 in the office for these symptoms.
local erythema, induration, swelling; recovered w/in 2 day period; vax given @ different office site; no details available Re: lot # & expiration date;
Fever to 103, extreme fatigue. Significant pain in posterior upper arm. Swelling, redness, induration of most of upper posterior arm.
No adverse reactions noted. Vaccine was given today, 02/20/2023 but the product expired on 02/16/2023.
8-10 hours after vaccine - swollen left eye, headache, stiff neck, shaky, nausea, soreness left thigh.  Most symptoms relieved with Benadryl p.o.  No reaction after 1st 2 doses of vaccine (8/10/07 & 9/4/07).
Information was received on 02-MAR-2017 from a registered nurse regarding "three to four" patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. The registered nurse reported he had given "thousands" of ZOSTAVAX (lot numbers and expirations unknown) subcutaneous for prophylaxis on unknown dates to unspecified patients. On unknown dates, three to four very mild cases of rash were reported to him after vaccination.  The outcome of rash is unknown. No further information was provided. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 12 year old male patient. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous (which had a lot # L000455 and an expiration date of 06-JAN-2017; however, dose, dosage number and anatomical location were not reported). No concomitant medications were reported. No adverse event was reported. No product quality complaint was involved. Additional information is not expected because the reporter refused additional contact.
Breakthrough case. Felt sore throat and major coughing. Took a home test and tested negative. The next day I took the home test again and it was positive. Went to the physicians office tested positive again. Was advised to take vitamin C and MUCINEX took for 3 days. Almost recovered, but hasn't been tested again.