chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body ache; mild chills; This is a spontaneous report from a contactable other healthcare professional (nurse, patient). A 62-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Left on 13Jan2021 at 16:15 (at the age of 62-years-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included docusate and naproxen sodium (NAPROSYN). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 22Dec2020 at 16:15 (at the age of 62-years-old) as single dose for covid-19 immunisation. On 14Jan2021 at 19:00, the patient experienced body ache, mild chills and no fever. The patient took acetominophen with relief. The outcome of the event was recovered on an unknown date. Therapeutic measures were taken as a result of body ache and mild chills.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
pt recvd vax & devel hives in diaper area 5sep am; hives spreading up back, abdo 6sep; meds given; 7sep all hives cleared;
Narrative: He relates having experienced nausea and myalgia that started about 2 hours after the initial vaccination. This lasted for about an hour and resolved  with rest. No therapies or tried or applied. He did not experience other common adverse effects including vomiting, abdominal cramping, and diarrhea. During the  episode, he was able to tolerate oral intake.
After the second booster in May I noticed that my arm had a a 6 inch in diameter around the injection area that was red, warm and itchy.  This lasted about a week.  I took a picture of this on May 5th.     I got a resting heart rate alert 3 times in a 24 hour period.  My heart rate was around 130.  This happened on May 22th and  23th.  Then there was nothing else until Wednesday May 27th I had another alert for the same resting heart rate.  To be clear, I was sitting, at rest each time.   I also have seen on my smartwatch report that on two nights, maybe 3/4 days apart, I had between 10 and 30 breathing difficulty episode between  3 and 4 in the morning.   It happened 3 or 4 nights later again and it stated I had between 30-50 breathing difficulty episodes between 3 and 5 in the morning.  Again, on August 1st I took a nap for about an hour long and my app reported another episode of breathing difficulty.    I have an upcoming cardiologist appointment August 24, 2022.
(*this was a booster shot) The menstrual period cycles in subsequent months after the booster shot was abnormal. I have very regular cycles in general (every 28-29 days) I had periods after just 21-22days. One in December, and anothe one in January.
Bells palsy.  7th CN palsy on ipsalateral side of injection approximately 2-3 weeks later.
This case was reported by a physician via sales rep and described the occurrence of swelling arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm, pain in arm and mobility decreased. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the swelling arm, pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the swelling arm, pain in arm and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patients arm swelled up significantly and the pain was substantial that she could not lift her arm, she called the physician office, she proceeded to go to the emergency room, they gave her antibiotics and cream. No other information was given to the physician office.
Patient reported a raised, red and warm to the touch area around the injection site.. a little itching and pain .. It started the morning after the vaccine and when I saw it was still the same 2 days after.  Ice pack was used on arm.
The patient complained of itching starting 2-3 days after the shot. First tried BENADRYL and then was put on a steroid for his doctor.
Pt seen in office 9/14/06 left upper arm swelling and red, low grade fever. Soreness some streaking toward left shoulder. Pt given Tavist 2 tabs twice daily x 8 days. Prednisone 5mg x 8 days. Domeboro packs to use x 3 days. Cimetidine 400 mg 1 tab twice daily x 8 days. Pt to take fever reducer. Pt to return to clinic 9/16/06. Pt to use cool compress ant rest.
By 9 pm I had fever 100, body aches, chills, soreness at injection site, headache, mild chest tightness, mild dry cough, nausea. The next morning fever was 101. Symptoms continued through next 24hours but were manageable with Tylenol and ibuprofen. The next morning mild headache remained. It should be noted that I did have covid19 on November 10.
Rapid heart rate, extreme fatigue, chills, chest pain, shortness of breath, chest tightness, nausea, dry heaves,  abnormal anxiety
This spontaneous report as received from medical assistant refers to several patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On unknown dates the unspecified number of patients were administered an unspecified number of doses of improperly stored VARIVAX (lot # M012990, expiry date-14-MAR-2018 and lot# M035687, expiry date 10-AUG-2018) as prophylaxis. It was reported that the vaccines underwent a temperature excursion of 4 degrees Fahrenheit to 14 degrees Fahrenheit for 50 minutes. The previous temperature excursion was for 6 degrees Fahrenheit to 14 degrees Fahrenheit for 7 hours and 40 minutes. It was reported that the sterile diluent {unknown lot, unknown expiration) used for reconstitution did not undergo a temperature excursion. A data logger was involved in recording of the temperature excursions. No adverse events were reported. No product quality complaint was filed. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA010501.
unconscious; unable to talk; unable to move her body; Optical injury; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization and experienced changes in her speech and cognition and legs, after the first shot. Medical history included multiple sclerosis for about 26 years, Covid-19 from Nov2020, and diabetic. It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medications were not reported. It was reported that the patient has been recently in a nursing home. She had Covid end of Nov2020. Once the patient recovered, the reporter (patient's daughter) was urged to get the patient vaccinated for Covid. She stated that she reluctantly agreed and wish she had not agreed. They noticed changes in the patient's speech and cognition and legs, after the first shot, but did not put two and two together, until after the second shot. In under 24 hours of receiving the second shot on 28Feb2021 at approximately 3pm, the patient could barely hold her head up and she could only move her lips, making a mumbling sound at best. She suffered optical injury, and as the hours passed unable to talk, unconscious, unable to move her body, etc. She had to receive a tracheostomy and food peg and is in a long-term acute hospital. She has since become more alert (awake versus sleeping and not responding), tracks people with her eyes, fairly consistently. As of 27Feb2021, she is tracking better but not following commands and the biggest thing is she can turn her head a little, left to right. Today, the reporter saw the patient swallow, twice (she still has a tracheostomy). They told her that the patent can only come out if she can follow commands, this do some therapy with the respiratory therapist. It was further reported that the patient received the Pfizer gene therapy shot. The patient is currently at an acute care facility. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Right hip pain causing difficulty walking which is new onset immediately following vaccination.  Woke with symptoms next morning.  Started with generalized weakness midnight after the vaccine.
"Pt w/ PMH Depression, Anxiety. No PSH.  Current Medications: Zoloft.  NKDA At approximately 1400, pt in observation, post-vaccination of Johnson and Johnson (received at 1353), was brought to triage area by TRN, d/t complaints of sweating and dizziness. Pt denied experiencing any other abnormal sxs. On-site NP and clinic lead ANM notified. On-site NP provided further eval with pt.   V/S taken at 1405: BP - 101/47, HR - 81, RR - 18, T - 97.8 V/S taken at 1408: BP - 111/66. HR - 74, RR - 20   Fluids encouraged and given. Pt placed on recliner chair. Per NP, after additional 15 min observation (and if pt is stable), pt is okay to be released from vaccination site.  Pt expressed improvement to sxs, stable gait, AxOx4. Pt stable to go home."
Tested positive to COVID-19/tested positive to COVID-19; Tested positive to COVID-19/tested positive to COVID-19; This is a spontaneous report received from a contactable consumer (Patient). This 42-year-old male consumer (patient) received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration at 11Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient developed symptoms of COVID-19 around 22/23 March 2021 and tested positive to COVID-19 on 25Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test positive on 25Mar2021. Patient was explained received different recommendation about the second dose, which was due on 1Apr2021.The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Chills, fever, drowsiness, headache, loss of time.  Body aches .
Data exchange not properly working in EHR. Office procedure did not include reconciliation of immunizations causing extra dose to be given.
Information has been received from a nurse concerning an 84 year old female patient who on 02-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot number unspecified). Subsequently in October 2009, the patient developed injection site reaction like pain, tenderness, swelling and warmth went down towards her elbow after getting PNEUMOVAX 23. At the time of the report the adverse event was improved. The patient sought unspecified medical attention. Follow up information has been received from a registered nurse concerning an 84 year old female patient who in 2003 was vaccinated with IM the first dose of PNEUMOVAX 23. Subsequently on 02-OCT-2009 the patient was vaccinated IM with the second dose of PNEUMOVAX 23 (Lot number unspecified). It was noted that the patient had no illnesses at the time of vaccination. Concomitant vaccinations included Flu vaccine (SKG) (Lot number AFLLA275AA). The registered nurse reported that on 03-OCT-2009 the patient experienced redness, swelling of arm extending from deltoid into just proximal to the elbow, warm to touch and no fever. On 04-OCT-2009 the following laboratory tests were performed: blood hemoglobin test (HGB): 11.3 g/dl; whole blood hematocrit (HCT): 35.2%; mean corpuscular volume (MCV): 99.9 fL and mean corpuscular hemoglobin (MCH): 32.1 pg. At the time of the report the patient had recovered. Redness, swelling of arm extending from deltoid into just proximal to the elbow and warm to touch were considered to be an other important medical event by the registered nurse. No further information is available.
Cellulitis. Treated with Keflex 500 mg T PO TID for 10 days.
The pt was sent from a nursing home because of abnormal labs on 2/4 and was hypotensive on arrival, 85/55, pt denied any complaints. Pt COVID positive 2/4. Pt admitted 2/6, is alert and oriented x2, on bedrest. No respiratory distress noted. Patient has PEG tube and IV in which they are patent. on 2/8 patient respiratory wise stable, on steroid, breathing treatment oxygen. 2/10 pt aox4, paraplegic, on RA not in distress, denies pain or discomfort, with ongoing tube feeding infusing well, on IV ABX given as charted. Moist nonproductive cough noted.  2/11 pt A&Ox3, VSS on RA with reports of 1/10 stomach pain. 2/12 pt discharged.
Received flu shot 10/17/02. Early Fri morning felt achy all over, but resolved. On 10/22/02 felt 'bad" in general. Wed 10/23 became achy again; flushed that evening. Thurs aft. 10/24/02 noticed L side of face drooping, mouth feeling "funny." Unable to blink L eye or drink well mouth not closing completely. Saw MD dx. with Bell's palsy. Given eye oint. on 10/31/02. Also c/o pain L ear.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 06-OCT-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K0105422, expiration date 25-FEB-2016, dose and route not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
At 10 pm I had the chills and went to bed earlier than I normally do. Around 2 am, I was experiencing an irregular and racing heartbeat. My resting heartbeat is normally around 68 to 70. When monitoring my heartbeat through my Watch, I experience a heart rate of 100 to 120 beats per minute and I could feel it was irregular too. I had a very restless night, elected not to go to the ER and the symptoms were gone by about noon, although I did have a terrible headache all morning long.
Started with an immediate headache after my second shot that lasted for 14 days and then at 14 days I got severe chills, fever that came and went, no appetite, and sleepy for 3 days.  Then on May 5th (10 days after my last day of chills and fever) I had chest pains bad enough to visit the emergency room.   The pain extended into my neck and jaw and was WORSE when I tried to lay down or lean backwards.   I was diagnosed with PERICARDITIS and given anti-inflammatories.   The pain subsided in about 24 hours from the onset.      I thought it was due to the vaccine but because the timeline was so strange I didn't immediately report.  After hearing about the young people that are experiencing the heart issues I felt I had to report.  It might be happening to more people in different age groups than is being reported..  I am a very healthy 61 year old female but I do have a history of issues with vaccines.   I get sick every time I have ever had a flu shot so I no longer get them.  I know this is a different technology so was hoping this wouldn't be the case but I got symptoms after both of my vaccines.  The second on was worse than actually getting COVID (which I had and survived easily last Feb...)
Around 7am, my daughter experienced a seizure for 5 sec, fell on my arm and her arms were compulsion with her eyes open.
rash on lower back within an hour after vaccine.  It disappeared soon.  At 2:00 am on March 4th - woke with severe headache, musle and joint pain, chills, nausea, genarlly feeling unwell.
Daughter, came to clinic and informed participant, passed away on 6/2/21 from COVID complications at Hospital.
Perspiring, blurred vision, felt "something there when I swallowed" (pointed to salivary glands across neck).  This lasted ~45 minutes, then she had chills.
Ten mintues after vaccination (Thursday 5/26) had a couple of hives that itched.  That pm through Friday (5/27) I appeared to have hives. I also had a UTI and assumed hives related.  Went to Urgent Care 5/28 for UTI. Also had doctor look at what I thought was a bug bite that I had scratched and was infected.  Treated me for both.  5/28 PM blisters began for form where all hives and potential bite were located.  6/30  due to significant exacerbation; blisters, redness and swelling doc's office encouraged me to go back to Urgent Care.  Urgent Care worried I had necrotizing fasciitis and referred me to ER.  ER r/o necrotizing fasciitis but could not rule out  chicken pox, MRSA,  but also discussed tick bites etc... Treated symptoms and referred to a dermatologist.  Dermatologist suspects bullous pemphigoid. Punch biopsy taken
1612 patient started having shortness of breath, throat swelling. Patient received 0.3mg of epinephrine at 1615 with minimal relief. Transported to ER at approximately 1616 and was given a 2nd dose of epinephrine, solumedrol, benadryl, famotidine and Lactated Ringers with immediate improvement.
both hands swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (both hands swelled up) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 28A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, PAROXETINE and CETIRIZINE HYDROCHLORIDE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PERIPHERAL SWELLING (both hands swelled up). At the time of the report, PERIPHERAL SWELLING (both hands swelled up) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Pharmacist suggested taking children's liquid Benadryl.
PATIENT LOST CONSCIOUSNESS WITHIN A FEW MINUTES OF RECEIVING  HER COVID-19 VACCINE (PFIZER- 1ST DOSE).  HEART RATE TAKEN BY NURSE REPORTED TO BE IN THE 40S.  PT WAS DIAPHORETIC. PT REGAINED CONSCIOUSNESS WITHIN 2-3 MINUTES.  UPON REGAINING CONSCIOUSNESS- PATIENT REPORTED BLURRED VISION.
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 month old female pt who experienced urticaria at the injection site. At 3 months of age, the pt received a dose on 22Aug05. No significant medical history. Indication for Prevnar was immunization. Product was administered on 22Aug05. Dose regimen was 1 dose (IM). Concomitant therapy  included Hib Titer vaccine (haemophilus b conjugate vaccine (diphtheria crm197 protein conjugate) injection) and Amoxicillin (suspension). Within 24 hrs, the infant developed urticaria at the site of Prevnar administration. The urticaria resolved within 24 to 48 hrs.
Terrible nerve pain throughout body.  1. Tingling in head and extreme pressure in head. 2. Tingling/Numbness throughout body (including hands) 3. Internal tremors  4. Burning Feet/Legs
Large red circle rash near injection site. Itchy and tender to the touch. Still present as of Feb 13th, 2021. Rash is moving away from injection site towards inner bicep. Rash is changing size by getting larger and redness disappearing from center of circle.
A report was received from a health care professional on 11/19/03 concerning a 29 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Feel weird; Face feels tingly; Face feels numb; Feeling hot; Out of body experience, like she got into an accident; Out of body experience, like she got into an accident; Fatigue; Vomiting; Headache; Delusions; Hair hurting; Dizziness; Shaking; Weakness; Heart racing; Scratchy throat; Sweating; Bone hurting; Elbow hurts; Ankle hurts; Jittery stomach; Chin hurts; A spontaneous report was received from a 51-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident, feeling weird, the left side of her face was tingly and numb.   The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 27 Dec 2020 at 9pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On the morning of 28 Dec 2020, the patient experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, and chin hurts. Treatment included paracetamol, which she stated did not work, but ibuprofen reduced some of the pain.  On 29 Dec 2020, she still experienced dizziness, shaking, feeling hot and weakness. She said the experience is an out of body experience, like she got into an accident, she felt worse than she felt when she had COVID 19. On 01 Jan 2021, the patient reported dizziness, feeling weird and stated that the left side of her face was tingly and numb. No additional treatment information was reported.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, delusions, hair hurting, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident and feeling weird, were unknown.  The outcome of the event, dizziness, was ongoing.  The outcome of events, the left side of her face was tingly and numb, were resolved on 01 Jan 2021.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Fatigue, vomiting and headache are consistent with the product safety profile.