chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 23 March 2021 I received the Janssen Covid-19 Vaccine LOT #1805025. I contacted Johnson & Johnson via phone to report that I was experiencing an intense, deep pain in my upper left thigh and a headache about two hours after receiving the Janssen vaccine. Case #ICSR Information : 20210346108 JANSSEN COVID-19 VACCINE SECURE! The pain in my thigh worsened whenever I stood or sat still. I inquired if thrombosis is a side effect or something that I need to be concerned about. The woman on the phone said she looked up thrombosis, but did not see it listed. I asked if I should start taking aspirin. The woman on the phone said that she could not give me medical advice. I was so concerned that I took a full aspirin about every four hours for twelve hours on that day and a full aspirin for about three days thereafter and two baby aspirin ever since. The pain in my thigh diminished by 26 March 2021, but ended a few days later. The headache occurred intermittently. I have had some chest discomfort since then, but it hasn't risen to the level of angina. I am still concerned about thrombosis because of the intensity of the pain.
Approximately 10 minutes after the shot pt felt weak, dizzy and slumped in chair and said his hands and arms felt on fire. We offered him cold compress and cold sugary drink and after a few minutes he felt better. We had him sit another 15 minutes and he felt good and left with other family members.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 10:00 as dose 5 (booster), single (Lot number: GJ6738) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 16Sep2023 to 20Sep2023. Clinical course: No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317526 same reporter/patient, different drug/event;
patient complains of tightness in lower back with accompanied by wrenching pain and intestinal distress approximatly 2 to 3 hours after administration
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided. Treatment information was not provided.
accidently administered a 4th dose of Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 10-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 25L32, expiry date 28-MAR-2025) for prophylaxis.   On 19-APR-2023, the patient received the 4th dose of Pediarix. On 19-APR-2023, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: accidently administered a 4th dose of Pediarix). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-APR-2023 The reporter was medical assistant. The reporter was consented to follow up via email or phone.  The patient was accidently administered a 4th dose of Pediarix, which led to extra dose administered.
On day 3 after the vaccine was given I had a local area of redness two inched wide develop. It gradually faded and went away, then after being completely gone for 3-4 days, on 1/11/21 another red blotch developed in the exact same spot, slightly bigger (2.5 ") and a darker color (dark pink vs light pink). It is indurated like a positive TB test but bigger. there is no pain, no itching, and I otherwise feel well. I just thought it was odd to have the pink area completely go away then come back a few days later more intensely. I wanted to report it in case this helps people at the CDC better understand the vaccine side effects. I stopped getting texts from the Vsafe app after having several days of no side effects.
Headache, Myalgia, Arthralgia, fatigue, chills Narrative:
Erythematous raised welt at all injection sites on both arms and multiple similar lesions on trunks, arms and legs.
hives on his legs; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.     Additional Information: GSK receipt date :21-OCT-2022 Reporters comment: This case was reported by wife for her husband via interactive digital media. The patient received shingle vaccine yesterday (day before reporting) and had hives on his legs
Rash all over body, itchiness, redness, dry skin, tingling scalp
On 05-22-2021, I tested positive for Covid. I received the J&J vaccine on 05-21-2021 and I must of picked up Covid from somewhere I went to and I didn?t even know it when I got the  J&J vaccine.  I experienced loss of taste and smell, coughing, had SOB, felt very fatigued, experienced headaches, nausea, body aches. At one point my temperature went up to 104F.  To this day I still feel very exhausted and I am still am coughing and experience SOB and my headaches come and go.
Left arm and left neck/face tingling, decreased sensation with subsequent Bell's palsy like facial asymmetry on the left side, brain fog, dizziness with position changes, pressure in head when bending over behind the left eye,  aching pain in left arm, fullness in the anterior lower right neck, episode of visual stars, food and drink dripping/falling out of left side of mouth, Pain in left rib cage/chest into the left back causing her to breath shallower. ER evaluation confirmed CT finding of right superficial vein thrombosis just above the sternoclavicular joint - see imaging report info.
No additional AE information provided.; HCP states that ROTATEQ was administered to a patient after temperature excursions.; This spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 17-OCT-2022, the patient was vaccinated orally with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot # W002561, expiration date 07-OCT-2023 (dose was not provided) administered as prophylaxis (Product storage error).   The improperly stored vaccine underwent a temperature excursion for 1 hour at 9.13 degree Celsius and for 37 hours at a minimum of -8.45 degree Celsius without previous excursions. No additional adverse events were reported (No adverse event).
Client became ill @ 4:30pm day of immunization (administered approximately @ 10am). C/O  N&V, chills, fever, headache, rapid heartbeat, light headed, tarry B.M. and sore throat.
This case was reported by a nurse via call center representative and described the occurrence of gastrointestinal disorder in a elderly male patient who received SHINGRIX. Concomitant products included LEVITRA, LIPITOR, Magnesium, Metformin, Aspirin, AMBIEN and PRILOSEC. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced gastrointestinal disorder, diarrhea and nausea. On an unknown date, the outcome of the gastrointestinal disorder, diarrhea and nausea were recovered/resolved. The reporter considered the gastrointestinal disorder, diarrhea and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 72 or 73 years old. The patient received the vaccination at a pharmacy. The nurse practitioner reported that the patient experienced gastrointestinal issues including nausea and diarrhea after the SHINGRIX vaccination.
Patient stated she started with soreness at the injection site and then the next day she had headache, joint pain, lethargy and muscle weakness/pain which lasted for 4 days. She would like to know if she should risk getting the second dose. She is worried the symptoms might be worse the next time.
Initial SAE report received on 04 April 2009. This subject is a female infant with no family history of seizures experienced febrile seizures while enrolled in a study of DAPTACEL which was administered along with ACTHIB, IPOL, PREVNAR (manufacturer Wyeth), ENGERIX (manufacturer GSK) on 28 August 2003 (lot numbers were not reported). The subject previously received INFANRIX (manufacturer GSK) on 27 March 2003 and PEDIARIX (manufacturer GSK) on 19 May 2003 (lot numbers not reported). The subject had suffered from seizures since birth (23 January 2003) which were controlled with phenobarbital and Dilantin. Her seizures were described as the subject turning red, giving a loud scream, jerking and stiffness which would last two to three minutes. On 09 July 2003 the subject had a neurology visit. During the visit it was noted that a recent EEG showed a relatively benign background, with photic driving on the left side and not on the right, suggested an asymmetry of the occipital lobe function on one side, possibly on the right. Developmentally at 6 months she had a high pitch cry as her mode of communication but had some babbling sounds emerging. She was not yet sitting up on her own, but would lie on her stomach and push herself into a V shape with her feet on the floor and then arch herself forward. Exam showed a weight of 7.35 kg, height of 25 inches, head circumference 16.5 inches. Neurological exam showed an alert, happy, interactive child. Facial movement was strong and symmetric. Motor examination showed relatively normal bulk, tone, and strength. MRI to be scheduled later that month and a referral was recommended due to the risk of developmental delays. In addition, hearing and ophthalmology screening tests will be performed due to risk in sensory areas. One day post vaccination, on 29 August 2003 the subject presented with a fever and change in mental status and was admitted to the hospital. The subject had a spinal tap which was negative and a CT scan of the brain which was normal. Her medication was adjusted and she did well, returning to baseline managed seizure disorder. The subject was discharged on 30 August 2003. On 29 October 2003 the subject had a neurology consultation. The subject continued to make excellent developmental progress and had been weaned off Dilantin. At the time the subject was taking on phenobarbital 4 ml twice a day. Upon assessment, her weight was 8.15 kg, height was 28 inches, head circumference 17 1/4 inches. Developmentally she was bearing weight, sitting independently, had a pincer grasp bilaterally, and reaching for objects. Impression included normal developmental and neurological examination. Follow up was recommended in three to six months. The fever was reported as "possibly due to receipt of vaccine". The seizure disorder was determined as congenital and unrelated. List of Documents held by Sender: progress notes and labs.
Rash on shoulders and privates, legs, chest itches like mad; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 21Jun2021 at 17:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Patient had no other medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cannabis sativa (MARIJUANA) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jun2021 at 03:00, the patient experienced "rash on shoulders and privates, legs, chest Itches like mad". The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported event which included treatment with cream for scabies. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of "rash on shoulders and privates ,legs, chest itches like mad" was unknown at the time of this report.
Approximately 3 days after receiving vaccines, patient experienced increased work of breathing and decreased po intake. Patient was intubated for respiratory distress.
Arm/shoulder pain since administration of shot. Patient complains of discomfort for a week now.
fever, myalgias, severe enough to require ambulance transport to ER, tachycardia
8 months later got shingles/ shingles 7 months later/ suspected vaccination failure; Lost most of hearing right ear; Shingles; Very painful right side of head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 7 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: 8 months later got shingles/ shingles 7 months later/ suspected vaccination failure) (serious criteria GSK medically significant), hearing loss unilateral (Verbatim: Lost most of hearing right ear) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and headache (Verbatim: Very painful right side of head). The outcome of the vaccination failure was unknown and the outcome of the hearing loss unilateral, shingles and headache were not reported.   It was unknown if the reporter considered the vaccination failure, hearing loss unilateral, shingles and headache to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, hearing loss unilateral, shingles and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and 8 months later experienced shingles. The patient stated that it was very painful at the right side of head and lost his or her most of hearing in the right hear. The patient stated that he or she received shingles vaccine and 7 months after experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient comes in for office visit on 2/9/21 for intermittent dull left upper arm pain since receiving flu shot November 18th.  Patient can feel the pain when she touches over the area and feels that there is a "knot" in her upper arm over the area.  The pain shoots downwards.  Patient has limited range of motion in her left arm because she can feel the area tightening and catching.  Patient states the pain is a 5/10.  Patient has not been taking anything for the pain.  Denies chest pain or shortness of breath.  Denies trauma or injury to her arm.  Patient has not been lifting any heavy objects.
Narrative: PT WAS IMMUNIZED IN A TIMELY MANNER WITH PFIZER MRNA VACCINE 4/21/21 AND 5/12 RESPECTIVELY. PT WAS INPATIENT ON 4J FOR STROKE REHAB WHEN HE CONTRACTED COVID. HE DECLINED MOST COVID TREATMENTS AND DID NOT QUALIFY FOR MONOCLONAL ABS. HE RECIEVED 02 SUPPORT UP TO 3L NC. WITH TIME, HE IMPROVED AND WAS TRANSFERRED BACK FOR FURTHER REHABLITATION
Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Mild, Systemic: Weakness-Mild, Additional Details: patient was sweating profusely, felt dizzy. We called 911 and they said patient's BP dropped  and may not have had a real seizure. patient said he had experience the 'excessive sweating' side effect before when he had allergic reaction (but did not tell the pharmacy staff at check in when we were asking if he had any allergic reaction to something)
very tired; sleeping a lot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired) and SOMNOLENCE (sleeping a lot) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced FATIGUE (very tired) and SOMNOLENCE (sleeping a lot). At the time of the report, FATIGUE (very tired) and SOMNOLENCE (sleeping a lot) outcome was unknown. Not Provided          No concomitant medications were provided. No treatment drugs were reported. Crosslinked with case MOD21-081439
pt had temp noc of 18JUL95 temp not taken;rash on face & legs on 19JUL95;20 hr p/vax red, blotchy rash-like blisters but not clear;pt is not bothered by rash-is energetic;20JUL seen by MD given DPH-rash resolving
Shingles on Tuesday. Two visits to ER to determine what it was. Pain right side and back.
PATIENT REPORTED FEVER, HEADACHE, JOINT & BODY ACHES THAT STARTED THE DAY AFTER VACCINATION AND WORSENED OVER THE COURSE OF THE DAY, RESULTING IN BEING SENT HOME FROM WORK. PATIENT MISSED THE DAY AFTER THAT AS WELL, ALTHOUGH PATIENT REPORTED SYMPTOMS HAD CLEARED BY THE SECOND DAY POST VACCINATION. NO FURTHER MEDICAL CARE OR AFTER CARE WAS NEEDED ONCE SYMPTOMS CLEARED.
Heart palpitations, chest pains, vertigo, nausea, trouble breathing with exertion, period stopped, brain fog, memory lost, fatigue.
Patient was given 1 full vial that was not reconstituted with diluent. Pt received all 3 doses that were in the vial. Family was notified. No adverse effects reported at this time/
suffered a massive heart attack the morning following his first dose of Moderna vaccine. He was hospitalized for 21 days, first at Hospital and then . He passed away on February 11, 2021, at .
3 hrs after receiving the second dose of Moderna vaccine, felt sudden heaviness/pain on my right eye, while talking on the phone. I was not straining or lifting any thing. When I checked my eye, I had subconjunctival bleeding on the outer side of the right eye. A few minutes later, I had a headache.  Placed ice pack on my eye. Felt pain when I move my eye. Rested the whole day and applied ice pack. Had headache until the following day. Took 1 dose of Tylenol in the morning of the following day. Bleeding on my right eye did not increase anymore.
Low grade fever, polyarthralgias, polymyalgias, central rash, chest and thorax.
I felt tired for a few days after receiving the 2nd dose. Around May 12th, I developed an itchy rash on my right shoulder near my armpit.  On May 24th, I went to the doctor. I was diagnosed with shingles.
Moderna Covid-19 Vaccine EuA Horrible body aches, headache, feels like bones were breaking, " was kicking my behind and feeling like poo".
Myocarditis necessitating admission to Pediatric ICU for monitoring. Elevated troponin and BNP with abnormal EKG.
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (arm was sore) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: ibuprofen (patient was on tablet ibuprofen is noted.).  On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 06-Mar-2021, the patient experienced AXILLARY PAIN (arm was sore). At the time of the report, AXILLARY PAIN (arm was sore) outcome was unknown. Not Provided   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-038042 (Patient Link).
Pt developed an area approximately 1" in diameter of tissue wasting in right thigh slightly above midline.
On 06/23/2000 the patient experienced a "full blown case of varicella. The lesions were too numerous to count, concentrated in the hair and groin, but also over the abdomen, chest, back, arms, and legs." It was reported that the patient recovered. Per F/U 6/17/02: On 10/13/99 was vaccinated SC, in the right arm, with a 1st dose of varicella virus vaccine (lot 631475/1003J). The NP reported that although the pt has an extensive cardiac history and is "fragile", he has been "growing beautifully" and has no known immunocompromise. It was reported that the pt  started wheezing on 10/25/99 and was dx'd with a right lower lobe pneumonia. The pt subsequently recovered from the pneumonia. From 11/19/98 until 5/99, the pt was enrolled in the Synagisis RSV vaccine cardiac safety trial, which was a multicenter placebo-controlled blinded study. It was unknown if the pt received Synagis or placebo, however on 12/18/99, the pt developed respiratory syncytial virus and recovered completely from his RSV. On 6/23/00, the pt experienced a "full blown case of varicella. The varicella lesions were too numerous to count, concentrated in the hair and groin, but also over the abdomen, chest, back, arms and legs". It was reported that the pt recovered. F/U info from the NP indicated that on 6/23/00, the pt had a full blown case of chicken pox. As of 6/28/00, it was reported that the lesions were clearing and subsequently, the pt recovered. No further info is expected.
Fever; headache for approx 1 week; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (headache for approx 1 week) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. No concomitant medication reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and HEADACHE (headache for approx 1 week). At the time of the report, PYREXIA (Fever) and HEADACHE (headache for approx 1 week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported.