chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever and chills developed within 12-15 hours of vaccine administration; fever registered at 102 degrees.  Within 36 hours, color of urine turned brown and eventually lightened to pink.  Patient went to the ER and was diagnosed with gross hematuria
Severe insomnia.; probably fever; covered in sweat; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm right on 08Apr2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ethinylestradiol; norgestimate (SPRINTEC), acetylsalicylic acid; caffeine; paracetamol (EXCEDRIN), trazodone (MANUFACTURER UNKNOWN), betacarotene; calcium carbonate; cyanocobalamin; folic acid; nicotinic acid; pyridoxine hydrochloride; riboflavin; sodium ascorbate; thiamine hydrochloride; tocopheryl acetate (ONE A DAY) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced severe insomnia, and probably fever. Usually goes to bed around 10pm, was unable to fall asleep until 4:30am. Woke up at 6am covered in sweat. 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 severe insomnia, and probably fever, sweat was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Information has been received from a health professional concerning an 3 year old white male who on 5/23/02 was vaccinated with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 7/28/04, the patient presented to the office with vesicles on his body that started on the ankle. The diagnosis was varicella. No labs or diagnostic tests were done and the child recovered in August 2004. Additional information is not expected.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date (couple of weeks ago), the patient was vaccianted with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not provided). On an unknown date, after receiving ZOSTAVAX, the patient broke out in what was referred to as 'chickenpox onn the arm and forearm'. It was not specified which arm. Patient sought medical attention, she called physician. Acyclovir and VALTREX were given for the treatment. The outcome of the event was reproted as not recovered/not resolved. Relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
No adverse event; administered 1 patient with the Moderna Covid 19 Bivalent vaccine more than 12 hours after first puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 1 patient with the Moderna Covid 19 Bivalent vaccine more than 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2022 at 8:40 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 1 patient with the Moderna Covid 19 Bivalent vaccine more than 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 1 patient with the Moderna Covid 19 Bivalent vaccine more than 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 1 patient with the Moderna Covid 19 Bivalent vaccine more than 12 hours after first puncture).    No concomitant medication information was provided.  Vial size was 2.5 mL and the vial was individual vial.  The vial was first punctured on 26-Sep-2022 at 09:00 A.M.  The vial was initially stored in the refrigerator on 26-Sep-2022.  The vial was stored at room temperature post puncture.  The vial did not undergo any temperature excursions.  The total amount of time during which the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius/46 degree Fahrenheit to 77 degree Fahrenheit) was less than 24 hours.  No treatment information was provided.
onset 4/13/99 w/lesions on lt chest;lesions painful to touch;mom consulted w/primary care MD;dx shingles;
This case was reported by a nurse to a sales representative and described the occurrence of arm pain at the injection site in a 49 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 25 October 2005, the subject received the first dose of Fluarix (lot AFLUA154AA). Information regarding previous immunization with influenza virus vaccine was not provided. One day later, on 26 October 2005, the subject experienced arm pain at the injection site. As of 10 November 2005, the event remained unresolved. In the reporting nurse's opinion, the event was probably related to vaccination with Fluarix. The nurse also reported the injection of Fluarix was "possibly administered too high."
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications and drug reactions or allergies were not reported. On 16-AUG-2018, the patient was vaccinated with improperly stored dose of PROQUAD, recombinant human albumin (rHA), subcutaneously (dose was not reported), lot # R006217, expiration date 28-AUG-2019, for prophylaxis. The vaccine was reconstituted with an unspecified dose of sterile diluent. The vaccine was stored in temperature range between -14 and -10 degrees Celsius for 1 hour 15 minutes (date unspecified). There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported.
2 blisters in scalp (clear vesicles), 3 blisters at injection site (L) leg both scabbed over. No tx needed.
Swollen, red, sore injection site of PNEUMOVAX injection. Rash that extended around arm. When asked if she had any trouble breathing, she said yes, but may be associated with COPD. Advised to take antihistamine.
headache; Exposure 07Apr2021 to someone who tested positive; This is a Spontaneous report from a contactable consumer (herself) to a Pfizer Sponsored Program COVAX US support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller, called to say 25Mar2021 was her first covid vaccine dose. She had exposure 07Apr2021 to someone who tested positive for covid 19. She was not experiencing any symptoms right now; she was still in quarantine and is wondering if she can get her second dose on 15Apr2021. She experienced a headache for half a day on 10Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test was she does not had any results on 12Mar2021. The outcome of the events was unknown.
A 53 year old female received FluMist vaccine on Oct 9 2005. On Oct 20 2005, while visiting her dentist to have her braces removed, she noticed that she had a left facial droop. Over the next three days after that, the patient reported that she experienced left sided facial paralysis, increased tearing of left eye, strange salty taste in her mouth, inability co close her left eye, pain above and below the left ear, some slurring of speech, left sided headache and hypersensitivity to sounds. On Oct 24 2005, she went to see her primary physician, who, after conducting a cranial nerve exam and based on her symptoms, diagnosed her with Bell's palsy. Lyme disease diagnosis was also considered initially but was leaning toward Bells palsy because she did not have any recent exposure to ticks. Currently, she is being treated with oral prednisone, acyclovir, and amoxicillin. Her symptoms have improved but continued except for ear pain, left sided headache and the slurred speech, which she has recovered from. No other procedures were performed. A call was made to her primary physician but have yet to hear back from him at the time of this report. The reporter assessed the events as possibly related to FluMist.
Pt. felt dizzy a few minutes after ADACEL (Tdap) given. Pt. then complained of stomach pain. Pt. given water and was sitting with head down for about 10 minutes. Pt. then reported feeling better but had pain & itching in right deltoid. Arm appeared red. Gave pt. ice pack, APAP 1000mg and Diphenhydramine 25mg. Pt did not report any problems with breathing or swallowing. Pt remained seated and in pharmacy for 30 minutes after shot given. Pt appeared better and mom took son home. The next day, the mom informed me that pt. got worse after leaving pharmacy and she took son to ER per MD recommendation. She reported son had high fevers and shaking. Per mom, pt. given IV fluids in hospital and was given Rx for Prednisone and BENADRYL at ER. Son is better per mom.
Rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2021, the patient received Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix and a month later she developed a rash (Adverse event was symptomatic). The patient enquired if patients typically experienced a rash sooner or later.  Patient also enquired how long after receiving the Shingrix vaccine the rash might last.  The patient was provided Shingrix FAQ's information in content regarding side effects.  The reporter did not want to provide additional details.  The reporter did not consent to follow-up.
Second dose delayed to 5 weeks from first due to strong inflammatory response. After experiencing vasovagal syncope following the first injection, received second injection while lying down and did not have recurrence of vasovagal syncope. However, had cardiac symptoms starting a day or two later. I could not stand and talk at the same time without losing my breath and needing to sit. Any exertion made my heart race and there was an immense pressure in my chest. This resolved in ~ a week. I did not seek treatment for it and I did not have a repeat CRP taken.
Gradually started with a headache that increased in intensity, nausea, vomiting, dizziness and chills.  At the time of this report, no improvement on symptoms.
sore arm; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Kinrix (Dtap & IPV) was given instead of Pediarix (Dtap, IPV, and Hep B).   Parents were informed.  CDC was called.   There is no harm to the patient.  Event was documented within our facility.
Rashes on (L) upper leg, (L) lower leg, (L) ankle, (R) ankle, (R) lower leg, (R) upper leg & torso. Positive for itching x 7 day. Treated with BENADRYL & Prednisone. No fever, no chills. Swelling on both arms.
Reported there were about 4 to 6 hives, mostly small and 1 larger, on her upper chest area; Itchy and started about an hour ago, but they are subsiding; Rash is less red; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Reported there were about 4 to 6 hives, mostly small and 1 larger, on her upper chest area), PRURITUS (Itchy and started about an hour ago, but they are subsiding) and RASH ERYTHEMATOUS (Rash is less red) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced URTICARIA (Reported there were about 4 to 6 hives, mostly small and 1 larger, on her upper chest area), PRURITUS (Itchy and started about an hour ago, but they are subsiding) and RASH ERYTHEMATOUS (Rash is less red). At the time of the report, URTICARIA (Reported there were about 4 to 6 hives, mostly small and 1 larger, on her upper chest area) and RASH ERYTHEMATOUS (Rash is less red) outcome was unknown and PRURITUS (Itchy and started about an hour ago, but they are subsiding) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  She was going to take diphenhydramine (BENADRYL) as treatment medication.
Diaphoresis; palpitations of 180-150 beats per minute, and SVT supraventricular tachycardia on the heart monitor.; palpitations of 180-150 beats per minute, and SVT supraventricular tachycardia on the heart monitor.; This is a spontaneous report from a contactable physician. A 56-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at 09:00 at single dose for covid-19 immunization. Medical history included hypertension, episode of SVT (supraventricular tachycardia) in the past. There were no concomitant medications. The patient experienced diaphoresis, and palpitations of 180-150 beats per minute, and SVT supraventricular tachycardia on the heart monitor on 18Dec2020. The events were reported as serious per medically significant. Event details: the patient received the vaccine 18Dec2020 at 09:00AM. About 40 minutes later the patient returned to hospital where he worked, where he received the vaccine, with diaphoresis, palpitations of 180-150 beats per minute, and SVT supraventricular tachycardia on the heart monitor. Reporter stated this was temporally related. Patient was given Adenosine 6mg IV with no response; then 12mg Adenosine with no response. Then the patient the spontaneously converted 10 minutes after the last dose of adenosine to 75 beats per minute and sinus rhythm, in one beat. The reporter was an emergency room (ER) physician and the patient was the ER right now. The patient was stable at time of reporting and expected to be discharged. The reporter did order a Troponin and cardiac workup. Troponin result was less than 6 which was normal. With regard to the Adenosine that didn't work reporter stated those vials usually went into a container and after consulting with another coworker stated the Adenosine vial had been discarded at this time and he was unable to provide NDC, lot or expiration date. The outcome of the events was resolved on 18Dec2020.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship and the description of the events,diaphoresis, palpitations and SVT, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Swollen under arm lymph node (same side of the arm as injection site)-Did not go away until 3-4 days after shot. Fatigue Injection site soreness Mild headache
I awoke at 3:30am in severe, excruiting pain in entire left arm! I took some ibuprofen and propped arm on pillow to relieve pain. Did not work at all!  Reported off of work at about 4am.  Waited until appropriate hour and called Nurse Access hot  line. I notified of symptoms of swelling of left side, face, neck, shoulder, arm to finger tips. itchy watery eyes , a little nausea and headache. Was advised to contact Doctor for appt. Doctor had no available appointments and advised to go to urgent care. Went to Urgent care and was treated with steroid shot and given Tylenol, benedryl, and Pepcid oral medications. Dr. prescribed prednisone 20mg twice daily along with Tylenol, Pepcid, Flonase, clariton and benedryl as nee
This spontaneous report as received from a 69 year old female patient concerning herself. Pertinent medical history was: none. Drug reactions/allergies: tetracycline. On 12-JUN-2015 the patient was vaccinated with ZOSTAVAX, subcutaneous, one single shot (dose and lot # was unspecified). Concomitant therapies included unspecified blood pressure medications, daily vitamins (unspecified), ALLEGRA and fluid pill. On 13-JUN-2015, the morning after receiving her dose of ZOSTAVAX, she indicated the area of the injection was red, raised, itchy, and saw one circle. There were no blisters or bumps. She called the pharmacy where the injection was given and was advised to apply ice and CORTIZONE 10 cream to the site each day. No lab tests were done. Her condition of injection site mass, injection site erythema and injection site pruritus was improving daily (resolving). Causality assessment was not reported. Additional information has been requested.
No additional AEs; HCP calling to report that GARDASIL 9 was administered via IM route to 9 month old patient.; This spontaneous report was received from a physician and refers to a 9-month-old female patient.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided  On 06-DEC-2022, the patient was vaccinated with with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at dose 0.5 milliliter once (lot #W011266 was verfied to be a valid number, expiration date reported and established as 05-SEP-2024), administered intramuscularly for prophylaxis (anatomical injection site and strength were not provided) (product administered to patient of inappropriate age). No additional adverse events were reported.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-AUG-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-MAY-2014, the patient was treated by physicians for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient describes feeling like she has a charlie horse, does not get worse, she said this and she probably held arm funny during vaccination.
Patient said she felt funny. Her stomach was upset & her head felt "funny". I talked to the patient & she became pale & I checked her blood pressure it was 71/33. Her breathing was labored & when I asked if she had tightness in her chest she shook her head yes. Epi Pen administered then after 5 minutes rechecked bp 95/73. EMS was alerted before the administration of the Epi Pen. The patient was then taken to the ER to be evaluated.
Tightness in chest, discharge from eyes, difficulty to breath, hoarseness. Lasted through 4:00 AM. Still having some symptoms of nasal congestion, tightness in chest, yellowish mucous discharge from eyes at 11:23 AM on 09/05/2013.
Cough, bodyaches, shortness of breath, ear pain, fever, chills, nausea and vomiting.
Skin rash starting 25 December 21 since then rash has spread to all over body. On 27 December In joint pain begins. 28 December 21 feet and hands started to swell also scratchy throat was noticed.29 December 21 scratchy throat goes away swelling continues . I'm in sure if this is vaccine related but it happened around the time I got the moderna booster
Rash; severe itching; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, batch/lot number were not reported) first dose via an unspecified route of administration, administered in left arm on 25Jan2021 14:00  and second dose on 15Feb2021 via an unspecified route of administration, administered in left arm as single dose for COVID-19 immunization. The patient's medical history included Addisons type II diabetes, had penicillin allergy. The patient concomitant medications were not reported. The patient had taken several prescription meds. He did not have Covid prior vaccination. The patient was not tested post vaccination. On 02Feb2021 13:00, patient experienced with Rash and severe itching. Therapeutic measures were taken as a result of rash and severe itching (Mefication). The outcome of the events were recovering.  Information on the lot/batch number has been requested.