chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he was in AFIB for about 3 hours after receiving his first dose of the COVID19 Vaccine; he noticed the rest of the day, right up to going to bed that he felt cold; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284) at arm, left upper, via an unspecified route of administration on 29Dec2020 06:15 at single dose for covid-19 immunisation. Medical history included atrial fibrillation (Afib) formally diagnosed around Jan2020. There were no concomitant medications. The patient reported he got the COVID-19 Vaccine at 06:15 on 29Dec2020 and had to sit for 15 minutes afterwards before he could leave. He said everything was fine, and he walked out to the hospital lobby, and was speaking with a work associate for 10 minutes before he headed to his car. When he got ready to leave, he got in his car, and started his car. He started driving home, and realized he was in AFIB. He did have an AFIB issue. His AFIB has been pretty well controlled for a year now, as long as, he didn't do something stupid. He had a moderately aggressive run of AFIB. He said his "smart" watch told him his heart rate was 117. His normal heart rate is around 60-70. He was in AFIB for about 3 hours. His typical runs of AFIB are considerably shorter. He only had a total of 2 episodes of AFIB in the last year. His prior AFIB episodes would have been about 4-5 minutes. The last time he had AFIB that lasted any length of time was when he was hospitalized for AFIB around Jan2020. He said at that time, he was hospitalized overnight for observation. He received medication during the hospitalization and his AFIB broke. He didn't remember what medications were given to him during the hospitalization. He said he had flutters before that hospitalization, but the flutters were always gone after a few minutes, so he never sought treatment because there would be nothing to treat. The patient reported he noticed the rest of the day on 29Dec2020, right up to going to bed that he felt cold. His house wasn't cold, and he didn't have a fever. He said the cold feeling went away during the night while he was sleeping. He said the cold feeling easily lasted for a 12 hours. He said the cold feeling could have been something else. The outcome of "he was in afib for about 3 hours after receiving his first dose of the covid19 vaccine" was recovered on 29Dec2020; of "he noticed the rest of the day, right up to going to bed that he felt cold" was recovered on 30Dec2020.
headache only at the left side of her head; pain on her left shoulder and arm after the first dose; pain on her left shoulder and arm after the first dose; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech-Covid 19 mRNA Vaccine, Solution for injection, Batch/Lot Number: Not Reported) via an unspecified route of administration on 30Apr2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache only at the left side of her head and pain on her left shoulder and arm after the first dose. Patient needed to go to work and asked if she can take Ibuprofen. Outcome of the events was unknown.  No follow-up attempts are needed, Information about lot/batch number cannot be obtained
intense pain at the injection site since he left the pharmacy; he felt his arm was very sore and he could not move it around; it triggered what felt like his rotator cuff needed surgery; it has the same since and he still is in pain
Difficulty breathing (wheezing); chest pain; chills; shortness of breath; vomiting; fever.
He had been weedeating a few days before and fell and broke humerus a few days before coming to ER for weakness and another fall.  He had appt with ortho apparently.   He lost balance and slid into the floor and was brought in due to this fall and weakness and had elevated cpk due to fall and laying in the floor.  He incidentally tested + for covid in ER.  Admitted 7-17-22.  He developed resp distress and had Upper GI bleed felt to be Mallory Weiss tear and  expired 7-26-22 and it was felt that he had complications from the covid.    Tx rem D and decadron
Patient reports lower limb pain, numbness, tingling. Reports forearm pain, weakness. Went on for approx. 3 to 4 wks.
Information has been received from a licensed visiting nurse through the pregnancy registry concerning a 18 year old female who became pregnant during the 3-dose of Gardasil (yeast). On 08-NOV-2006, the patient was vaccinated with the first dose of Gardasil (yeast). It was reported that the patient was not pregnant when she received her first dose of Gardasil (yeast). On 18-DEC-2006, the patient developed pelvic pain. The patient was seen in the emergency room. At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007.  Initial and follow-up information has been received from a licensed visiting nurse through the pregnancy registry concerning a 18 year old female who became pregnant during the 1-dose series of GARDASIL.  On 08-NOV-2006, the patient was vaccinated with the first dose of GARDASIL.  It was reported that the patient was not pregnant when received her first dose of GARDASIL.  On 11-DEC-2006, the patient developed pelvic pain.  The patient was scan in the emergency room.  At the time of this report, the outcome of the events were unknown.  Follow-up information indicated that the patient vaginally delivered a full-term, healthy, and normal baby on an unspecified date.  Additional information is not expected.
Left arm red, swollen and warm to touch. Erythematous area 3 cm diameter in location of vaccine
its been more than 42 days; they have not received the second dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (its been more than 42 days; they have not received the second dose.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (its been more than 42 days; they have not received the second dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (its been more than 42 days; they have not received the second dose.) had resolved.        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 drugs were reported.
Thrombophlebitis superficial lower limb right (blood clot in right foot). Warm compresses and time. Subsided.
Swollen and sore lymph node in right arm pit. Shot was given in left arm.
After 1 series of Hepatitis B vaccine(6/10/08, 7/15/08, and 11/25/08), the post-vaccine surface antibody on 3/10/2009 was negative.
MID NOVEMBER 2021 - MY HUSBAND BEGAN A SERIES OF STRANGE SIGNS AND SYMPTOMS. THESE SYMPTOMS INVOLVED SEVERAL TRIPS TO DIFFERENT SPECIALISTS WITH UNKNOWN DIAGNOSES, UNTIL THE CONDITION WAS FINALLY DIAGNOSED IN MAY OF 2022 BY  A RHEUMATOLOGIST AS POLYCHONDRITIS. POLYCHONDRISTIS IS AN AUTOIMMUNE DISEASE THAT CAN BE VERY SERIOUS AND LIFE THREATHENING. I CAN EMAIL YOU THE SPECIFIC MEDICAL PRACTIONER DATES AS I HAVE KEPT A CAREFUL RECORD.
pt started with uncontrollable arm and legs spams brought to surgery center in am but immediately sent to ER where an MRI was done  test results believed to be negative, then referred to Neurologist where findings were inconclusive. put on ativan, then klonapine. referred to physical therapy where they determined that she may never recover, the arm spasms subsided but continues to have leg spasm and would be unstable and therefore, would not be able to perform her nursing duties.
Headache, Sedation, Myalgia, Arthralgia, NauseaVomiting, Pain/Redness/Swelling/Rash @ injection site Narrative:
sinus issues; asthma; severe coughing; itchy red sore eyes; itchy red sore eyes; itchy red sore eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "sinus issues"; ASTHMA (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "severe coughing"; EYE PRURITUS (non-serious), OCULAR HYPERAEMIA (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "itchy red sore eyes".  Additional information: The reporter and her husband have received the Covid vaccines. Since receiving them they both had serious sinus issues. The husband had been diagnosed with asthma. They both suffered with severe coughing, itchy red sore eyes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
STARTING ON 12/03/22, PATIENT REPORTS HAVING RED RASH FROM ELBOW TO SHOULDER. ARM IS SWOLLEN AND WARM TO TOUCH.  THIS REACTION OCCURRED IN PATIENT'S PARALYZED ARM, FROM PREVIOUS INCIDENT.  PATIENT INSTRUCTED TO REACH OUT TO PRIMARY CARE PROVIDER.
This is a spontaneous report from a contactable nurse. This nurse reported similar events for three patients (male, 2 female). This is the first of three reports. A 70-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Feb 12, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Feb 12, 2021, nurse diluted vaccine with 0.8mL of diluent and administered to 3 individuals. Patients inadvertently received a higher dose. On an unknown date in 2021, patient had post vaccination  tenderness in arm and redness. 7-day post vaccination follow-up for these individuals. The outcome of the events: unknown. No follow-up attempts possible. information about lot/batch number cannot be obtained. Sender's comments: Linked report(s): US-PFIZER INC-2021224940 same drug/event, different patient: US-PFIZER INC-2021224939 same drug/event, different patient.
24 hours after vaccination patient developed fever body aches redness swelling, tenderness and site is warm to touch. Treated with Tylenol and compress
unilateral, vesicular rash on the front of her right leg that spread to the top of her back and did not cross the midline; unspecified physician thought it was shingles; This spontaneous report was received from a registered nurse (patient's mother) regarding a 3 years old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date in October 2016, the patient received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage schedule, lot# and expiry date were not reported) for prophylaxis. On 02-AUG-2019, the patient developed a unilateral, vesicular rash on the front of her right leg that spread to the top of her back and did not cross the midline (Rash vesicular). The mother reported that an unspecified physician had sent a sample of vesicular rash for analysis (results unknown). The mother reported that the unspecified physician thought it was shingles (Herpes zoster). The patient had sought medical attention and the physician had prescribed oral acyclovir and an unspecified topical steroid lotion. No product quality complaint (PQC) was present. Outcome of the events Rash vesicular and Herpes zoster was not recovered. Causality assessment for the events was not provided by the reporter.
Numbness; History of anxiety, depression, asthma presents today for symptoms onset within half an hour after receiving her second Madera COVID-19 vaccine dose at 10 AM today. She complains of numbness/"funny feeling" on left face, tongue, arm and leg. She denies headache, change in vision/speech/hearing/mentation/gait, focal weakness, lightheadedness or disequilibrium. She had a similar reaction following her first vaccination a month ago, but that cleared within 30 minutes.
Began with an excruciating headache, then chills, then a fever.  Soreness around injection site.  Muscle  & joint aches & pains.  A feeling of heaviness through out my body. No energy, extremely tired.  The headache, chills & fever occurred again Tuesday night (2nd nite after shot). The other symptoms  lasted  thru Thursday. Friday I was able to sleep thru the night and woke up feeling fine.
tingling sensation that starts behind his ear and goes down his neck to the top of his shoulder; he developed chills / shivers; fever; felt ill; This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included arm operation.   On 1st July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced chills, fever, feeling unwell and tingling sensation. On an unknown date, the outcome of the chills, fever and feeling unwell were recovered/resolved and the outcome of the tingling sensation was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, feeling unwell and tingling sensation to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine in right arm and developed chills, fever, and shivers after receiving the vaccine. The patient states that he also felt ill after receiving the 1st dose. Patient states that these symptoms lasted for approximately 24 hours. The patient states that some time between the 1st and 2nd dose, he developed a tingling sensation that starts behind his ear and goes down his neck to the top of his shoulder. The patient states that the sensation comes and goes.  Consented to follow up. For the tolerability of 2nd dose, refer case US2020AMR060590 reported for same patient.
Initial report was received from a health care professional on 21 March 2011. A 50 year-old female patient with a history of MVP, palpitations, tachycardia, hypothyroidism, hyperlipidemia and menopause had received an intramuscular left deltoid injection of ADACEL, lot number U3553CA (sanofi pasteur Ltd. lot number, C3677) and on 04 March 2011 at approximately 10:00 am, experienced "during cleaning" a racing heart and chest heaviness that lasted approximately 10 minutes. The patient also reported a low grade fever, generalized achiness that included her eyes and jaw stinging when she opened her mouth to eat. The low grade fever and generalized achiness that included her eyes that lasted approximately two days. According to the reporter, the patient was in a car accident "six days prior" (prior to what was not reported). Concomitant medications included SYNTHROID and Atenolol. Treatments were not reported. The patient received no other vaccines four weeks prior to or on 03 March 2011. The patient had no known illness at the time of vaccination and the reporter was not aware of any adverse events following prior vaccinations. No further information was available at the time of the report. The patient's outcome was reported as recovered on 18 March 2011. Documents held by sender: none.
Pt given Tdap 9/20/2019, Next day, developed (L) axilla swelling. No itching/redness. Resolved as of visit on 9/27/2019.
pt recvd vax 30DEC93 & was fine following vax; played outside for awhile; approx 5PM began to have red swollen face, lips & ears; mom stated difficulty breathing;
My mind just feels like it's in a state of constant anxiety.  I know where I am but it doesn't feel real. I am afraid to drive anywhere. My arm hurt really bad at the injection site on Wed. and improved on Thursday.  Today is Sat. 11/13 and my upper arm has a hard lump underneath the skin and gets itchy but not bad.  I still feel really unsettled though.
Severe shaking and chills at 9:30pm. Very quick onset, and transient episodes.  Fever related with chills.
I was notified that patient was experiencing severe muscle pain and tightness in muscle of injections starting early morning of June 25. Then later that night patient started to develop red bumps near injection site. Patient stated they took several doses of pain reliever, alternated hot and cold therapy on muscle and applied massage with only minimal relief. Patient also took an antihistamine for the red bumps.
Pt broke out with chickenpox after receiving chickenpox vaccine. Prescribed Benadryl.
One year old got a rash at the site of injection, bright red & raised (oval shaped)
Joints are very painful.  My shoulders hurt and rec cortisone shot and doing  pt.  My knees I was hoping it would go away but m y knees are very sore. They started hurting the night after the shot. I could barely walk. That night.  They started to get somewhat better with rest and Wishing it would go away but it is not. So I have an apt for my knees now   This is crazy. I use to walk everyday for 3-4 miles and I can?t barely make it to a car or down the steps.
This spontaneous case was reported by a physician and describes the occurrence of HAEMANGIOMA (40-50 hemangiomas (proven by biopsy) around her body on arms, legs and trunk) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMANGIOMA (40-50 hemangiomas (proven by biopsy) around her body on arms, legs and trunk). At the time of the report, HAEMANGIOMA (40-50 hemangiomas (proven by biopsy) around her body on arms, legs and trunk) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: haemangiomas (Positive) Developed Hemangiomas. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HAEMANGIOMA (40-50 hemangiomas (proven by biopsy) around her body on arms, legs and trunk) to be unlikely related. The reporter was a physician and informed that the He patient who received both doses of Moderna Vaccine developed 40- 50 hemangiomas (proven by biopsy) around their body on arms, legs, and trunk. No Concomitant product use was reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
The morning after the vaccine, I had fever and chills, vomited and diahrea at the same time so bad I had to lie on the bathroom floor for almost an hour exhausted. Got into bed and felt cold emanating from the inside despite the heat up high and loads of covers. Then had body pains hard to describe. Then everything stopped and I just was so exhausted I couldn't even roll over. The next day I was fine except for a very bad headache. The next 2 days I had coughing and slight shortness of breath. Now fine, a week later. I had these exact symptoms, end of  November 2019 that felt like pneumonia at the time. My niece was sick with this too. She was in contact with someone who was in contact with workers who came there for work. The Z-pack I took helped for a day maybe and then continued to be sick for several weeks.
By the time I got home, I knew I was extremely tired. That continued to increase as the evening went on so I ended up going to bed early for me. I took a Tylenol. I drank a lot of fluids and went to bed. I got up in the morning and I didn't even want to move. I was so exhausted. I experienced headache and body aches. I had a low grade fever off and on...very low grade. I experienced sweats off and on and a general sense of malaise. The exhausting was debilitating and lasted about 3 weeks.
Patient initially c/o itchiness of bilateral arms,legs,upper chest,scalp with fine raised reddened rash noted on upper chest only. Patient also felt increase warmth. 142/92 HR 100, alert and oriented x3, speaking clearly. Benadryl 25 elixier given, tolerted well. NKDA noted. Handed off to parametics, continued to observe patient. Patient feeling better and has refused transport to hospital. Discharged from facility at 1300, driving self in stable condition.
Rash on abdomen from navel down to thigh running to left all around to midback, not little bumps but large red splotches; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration on 08Feb2021 at 13:30 PM (at the age of 84-years-old) at a single dose for covid-19 immunisation. Medical history included healthy except sudden disabling spells of violent vomiting vertigo. Concomitant medications included topirimate, and tocopherol (Vitamin E). The patient did not receive other vaccines in four weeks. The patient did not have COVID-19 prior or post vaccination. It was reported that as per her experience she could only handle small doses of prescriptions. On 11Feb2021 at 09:00 AM, the patient had rash on abdomen from navel down to thigh running to left all around to mid back, not little bumps but large red splotches, close together, no itch and no pain. Patient reported that he did not had those symptoms until 11Feb2021. Event was treated however details were not reported. Outcome of event was not recovered.
Headache, Fever,  ARM SORENESS, LOWER BACK PAIN, BODY  ACHES, CHILLS, RASH AT INJECTION SITE Narrative:   Other Relevant History:
a pregnant patient received VARlVAX/ she is pregnant after administration of VARlVAX; The patient did not experience and adverse events.; This spontaneous prospective pregnancy report was received from a 32-year-old female patient who was referring to herself. The patient had no pertinent medical history, drug reactions or allergies or concomitant medications.  The patient became pregnant with last menstrual period (LMP) calculated as 10-NOV-2020 and estimated date of delivery (EDD) as 17-AUG-2021, based on pregnancy gestation reported as 8 weeks and 2 days at the time of the report.  On 07-JAN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T021821, expiration date not reported, but upon internal validation established as 25-JUN-2022, subcutaneously (exact dose not reported) for prophylaxis. The patient did not experience any adverse events. No lab diagnostics or studies were performed. The pregnancy outcome was pending.