chrisvoncsefalvay/vaers-outcomes huggingface dataset:
eyes were affected along with vision; Graves eye disease; left eyelid began swelling; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 06Feb2021 10:15 at the age of 42-years-old (Lot Number: EM9810) as single dose for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included hashimotos hypothyroidism, known allergies: Ceclore, sulfa drugs, COVID prior vaccination. Concomitant medications included levothyroxine. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in right arm on 16Jan2021 09:15 at the age of 42-years-old (Lot Number: EL3249) for COVID-19 immunisation. 2 days after second dose left eyelid began swelling. It was determined that was graves eye disease. Currently both eyes were affected along with vision, patient was waiting insurance prior authorization approval for treatment with Tepezza for the eye disease. The event onset was on 08Feb2021 06:00. AE resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment AE currently was no. The outcome of event was not recovered.
after receiving the shot within 10 minutes, patient became clammy, sweating. unable to feel his lower extremities, arms in contractors and fingers contorted. shaking but able to talk and breath, had trouble releasing his arms, could not grasp items or grip ion his hands
A physician reports child received vaccine & developed projectile vomitting & bloody stools & was hospitalized with intussusception on 11/4/99. Infant recovered and was released after 24 hours. A recurrent intussusception occurred on 11/18.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of VARIVAX (Merck) (lot#unknown). Pharmacist reported that the patient was administered with a dose of VARIVAX (Merck) instead that a dose of ZOSTAVAX (Merck). No adverse effect was reported. The patient sought unspecified medical attention. Additional information has been requested.
I experienced a little tingling in my right arm where I received both vaccination injections and starting in July I started experiencing tingling all over my body regularly.
Initial unsolicited report received from a pharmacist (director of pharmacy) on 12 Oct 2016. This case was linked to 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age, gender unknown) who was vaccinated with a dose of Fluzone Quadrivalent (batch number- UI669AA, expiry date: 30 Jun 2017, dose and site of administration was not reported) by intramuscular route on 04 Oct 2016. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On an unspecified date, following the vaccination the patient had swollen arm. The patient's lab tests and corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Patient is a 59 yrs old male with no significant PMH who initially presented to the ER with two days of progressive numbness and tingling which started in his hands and spread to his legs and then unable to get out of bed due to weakness of extremities. Patient was admitted to the hospital. His CT of head was negative. He was seen by neurology and LP studies showed evidence of Guillain-Barre Syndrome. He was started on IVIG. His EMG and nerve conduction was consistent with axonal varient GBS which has poor prognosis. During the hospitalization, he continued to have progressive weakness including his swallowing and respiratory status. He went into respiratory failure with COPD retention and was transferred to ICU. He was intubated. He was started for antibiotics for possible aspiration pneumonia vs hospital-acquired pneumonia. He had bronchoscopy with thick secretions. He had tracheostomy placement on 3/19/12. 3/24: Continues with vent and nebs. Completed all antibiotics. 3/25: Passed swallow evaluation and started on puree diet with nectar thick liquids. 3/26 failed repeat swallow evaluation, NPO. Resumed on tube feeds was placed on TC. 3/27 overnight, placed back on ventilator. States he couldn't breathe. Doing OK. No complaints. Placed on TC this morning.
Information has been received from a RN concerning a female pt who was vaccinated with a dose of hep b virus vaccine rHBsAg (yeast) (manf unk). Subsequently, the pt had a reaction to the vaccine. Additional information has been requested. The RN reported that the pt's mother had an adverse experience after therapy with hep B virus vaccine rHBsAg (yeast) (WAES0406USA01256).
10:53 client reported chest / pain  2/10   and was diaphoretic.    Was brought to lay down   Pso2   97%    pulse 78   right arm b/p 158/74. no improvement.  11:02 was taken to the ER for evaluation.  2pm follow up call made no answer.
Case number PHEH2012US022221 is an initial spontaneous report received from a nurse on 07 Nov 2012. This report refers to a 16-years-old male patient. He was vaccinated with only MenCYW-135 liquid conjugate of MENVEO (batch number: M11032) intramuscularly on 06 Nov 2012 and that he did not receive MenA lyophilized conjugate. No adverse event was reported following the maladministration.
Weakness; Chills; Redness at injection site; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Weakness), CHILLS (Chills) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included GERD and Short-bowel syndrome. Concurrent medical conditions included Hypertension. Concomitant products included FISH OIL for Cholesterol, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from an unknown date to 20-May-2021 for GERD, LISINOPRIL for Hypertension, TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for Non-alcoholic steatohepatitis, VITAMIN D3 for Vitamin D deficiency.   On 12-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ASTHENIA (Weakness), CHILLS (Chills) and INJECTION SITE ERYTHEMA (Redness at injection site). On 18-Feb-2021, ASTHENIA (Weakness), CHILLS (Chills) and INJECTION SITE ERYTHEMA (Redness at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-011287 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up received on 210521 and updated patient information,  added medical History, concomitant medications, new event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011287:First dose
24Jan91 @ 23 mos pt examined,found well,given DTP,15 hrs /p pt spiked a T & had a brief period of stiffness,eyes rolled to 1 side,did not change color, mom said lasted 1-2 mins,mom rubbed body,she loosened up &became usual self ...see  WORM
Patient reports routinely having spells of syncope with injections and still insisted on receiving COVID-19 vaccination. Gave injection into left deltoid. Had patient scoot up to table in immunization room with both legs fully under the table just in case there was an issue. I set the timer for 15 minutes and left him in the immunization room with his girlfriend, who also received a vaccine. A few moments later the girlfriend asked for our help stating he was feeling like he was going to pass out. I went into the IMZ room and checked with him. At the time, he was sweaty with a rapid hearbeat. I instructed him to take some deep breaths and went to get a cold paper towel to apply to his head. When I returned he had passed out, not responsive but still breathing, in his chair and his girlfriend was holding his head in her hand. We gently lowered his head to rest on the table while another associate called 911 per girlfriend's request. He began moaning a few moments later and was able to talk to us. He was very hot and sweaty, light headed and breathing rapidly. We applied a cooling pack to his forhead as he continued to lie his head on the table. He then said he might feel more comfortable lying on the floor. We assisted him to the floor, elevated his feet on a chair and placed his head on a roll of paper towels. At that time the paramedics showed up and said his blood pressure was fine and he was just having some hyperventilation. The paramedics got him back up in the chair and his girlfriend got him some apply juice. After about 30 minutes he was talking fine, shaking had stopped and his breathing a temp went back to normal
Pediatric patient was administered PROQUAD and was also administered Hep A and Hep B at 25 days of life.; Patient is having some sleepiness and sneezing.; Patient is having some sleepiness and sneezing.; This spontaneous report was received from a physician and refers to a 25-day-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-SEP-2022 (at the age of 25 days), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, lot number W020548, expiration date: 26-DEC-2023 (dose, strength, and route of administration were not provided) (product administered to patient of inappropriate age), and was also administered hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (reported as "Hep A") (product administered to patient of inappropriate age) and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (reported as "Hep B") (dose, strength, lot number, expiration date, and route of administration were not provided for both). All vaccines were administered for prophylaxis.   On an unknown date in 2022, the patient was having some sleepiness and sneezing. The outcome of the events was not provided.   The causality between the suspects and the events was not reported.
New lesions of venous malformation erupted approximately 1-2 weeks after first dose of Moderna COVI19 vaccine, consistent with his pre-existing lesions from congenital blue rubber bleb nevus syndrome. Patient had steady small sized lesions scattered in his body (less than 10 total) prior to new eruption after receiving the vaccine. Currently more than 10 new lesions are identified, ranging from 2mm to <1cm in diameter, through out his trunk and four limbs with no significant pattern. These lesions cause mild pain/tenderness. No bleeding episode. It is unknown if patient has mucosal surface lesion, but so far no symptom/sign of blood loss. Due to these findings after the vaccine, patient was advised not to receive the second dose of Moderna COVID19 vaccine.
I have never had a migraine before the Vaccine.  First migraine was the day after the first shot.  Second migraine was approximately 2 weeks later and had visual disturbances.  Third migraine was the day after the second shot.  Fourth migraine (worst of all of them) occurred approximately two weeks after the second shot and had significant visual disturbances that occurred while driving.
This spontaneous report as received from a physician refers to a 24 year old male patient without drug reactions or allergies. No pertinent medical history and concomitant medication were reported. The patient was administered doses of RECOMBIVAX HB (lot number not reported) on 25-OCT-2001, 03-DEC-2001 and 10-JUN-2002 (dose unknown). The result of a "hepatitis B titer" drawn on 31-JUL-2014 was "less than 5". As treatment for the "negative titer of less than 5" the patient was administered doses of RECOMBIVAX HB (Lot Number reported as 1572AA, Expiration Date 26-MAY-2014) on 19-AUG-2014 and 07-OCT-2014 which had expired (dose unknown). On an unspecified date in 2014 the patient was diagnosed with Bell's Palsy. No treatment for Bell's Palsy was reported. The outcome of the events was unknown. The relationship between RECOMBIVAX HB and the events was unknown. Additional information has been requested.
Headache / strong headache; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache / strong headache) and PYREXIA (Temperature) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011621A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 (Previously infected with SARS-CoV2 on Jun2020. Lasted 3 weeks to a month) in June 2020 and Breathing difficult. Concomitant products included TOCOPHEROL (VITAMIN E NAT) and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced HEADACHE (Headache / strong headache) and PYREXIA (Temperature). The patient was treated with ACETAMINOPHEN on 28-Apr-2021 for Headache, at a dose of 500 mg/8 hours. At the time of the report, HEADACHE (Headache / strong headache) and PYREXIA (Temperature) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-095085 (E2B Linked Report).; Sender's Comments:  MOD-2021-095085:
This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling at the injection site on an unspecified date. It was reported that the patient was ok at the time of report. Outcome of the event was therefore recovered on an unknown date. No follow-up attempts are possible, information about batch number cannot be obtained
large Lump at the base of neck by between clavicle and shoulder. Constant pain in shoulder still occuring as if todays date. Lump went away 2 weeks later. But pain in shoulder  and feeling of constant tightness has not left infact has gotten worst over time
Patient came into the pharmacy stating that her arm felt hot and feverish with a definitive red raised circle pattern on her upper left deltoid where the shot was administered.
Headache (m) for 12 hours severe, and 12 hours moderate. 11/22/2002 pt ok now.
The day following my second injection, I was extremely fatigued, and achy--particularly my face and shoulders.  I had a horrible headache, and every tooth ached, to the point I'd have gladly had them all removed.  I also had chills, off and on..  The following day, I awoke feeling 100%.   Just yesterday I collected a urine specimen for my doctor as I felt I had a UTI.  I haven't received the results yet, nor have I been given any antibiotics.  However, as well as urgent, frequent, painful urination, I experienced the exact same symptoms that I had from the Covid shot.  This morning I awoke feeling fine.  In fact, I'm not sure I still have a UTI.  I realize the vaccine is for the Covid virus, and shouldn't have any effect on bacteria, but I'm wondering if my immune system is somehow more reactive to any sort of infection in my body?
Pediatric patient received the third primary dose 13 days early. Patient was advised by provider to watch for any adverse effects, aside from the normal side effects. Given strict ER precautions. Told parents they have the option to bring their child in for another third dose after 8 weeks as is recommended by CDC.
Nausea, cold hands, vomited x 2. BPs 90/70 (pulse 68), 106/66 (pulse 92).
54 year old female received the Jannsen COVID-19 Vaccine Lot# 1802070 at College on 03/12/2021 @ 08:00. On 03/12/2021 @ 14:30 pt started experiencing headache, body ache, fever (103.1F), chills, and nausea. Pt took temp, was 99.1F @15:00 and 103.1F @ 17:00. Pt took vitals @17:30, BP-100/66, HR- 134 bpm. Pt took IBU for fever on 03/12/2021 @ 15:00 and Ondansetron (Zofran) for nausea on 03/12/2021 @ 16:30. Pt takes Diovan(Valsartan)/HCTZ 320/25 mg, Amlodipine (Norvasc) 10 mg, and Vitamin D. Pt is diagnosed with Hypertension and Fibromuscular Dysplasia. Pt has allergies to an injectable migraine medication, but could not name the medication. Since the pt took IBU @ 15:00, and the pt's temp increased from 99.1F to 103.1F, from 15:00 to 17:00; the pt was advised to immediately seek medical attention at an urgent care (pt did not want to go to the ED) and to not be/go alone. Pt was also advised to take Tylenol instead of IBU in the future. SPI was consulted and Dr. was notified.
Patient was admitted due to COVID pneumonia without hypoxia. She has a history of COPD, hypertension, hyperlipidemia, CAD, recent COVID-19 infection diagnosed on 04/16 presented to MMC ED for ongoing episodes of abdominal pain, nausea, diarrhea that has worsened for last couple of days.  Patient has had symptoms of generalized fatigue malaise weakness is his since 4/14 and has had been worsened and was seen in ED on 4/21 were symptoms of some COPD exacerbation were for home with COVID-19 and was prescribed antibiotics and steroids which he took at home.  Since then, patient has had symptoms of feeling more weakness, abdominal cramping pain radiating down his towards her groin with some burning in a.m. for urination and started noticing diarrhea, 3-4, loose, watery with yellowish output without any blood.  Has some nausea but no vomiting, poor appetite and is trying to keep herself hydrated but unable to complete full drinks.  Denies fever, and chills.  No active cough, slight wheezing at home, but she has used her nebulizer 4 times and had improvements Patient did not qualify for any treatment but her home medications were continued.  Patient did not have any shortness of breath, cough fever.  Patient also had mild renal failure which resolved.  Overall patient did well. Upon discharge examination, she denied any new complaints.  Her renal failure resolved.  She was recommended to stay 1 more day but she stated that she is feeling fine and want to be discharged.  So patient discharged and told to return to emergency center if she gets any fever, increased diarrhea, nausea, vomiting.
Patient complained of getting "knot" and red itchy area down left arm.  This started on Friday, 12-7-07.  Patient was given Benadryl 25mg  and PO OTCq 4 hours for itching and Dexamethasone 4mg IM to right UOQG was given.
This spontaneous report as received from a pharmacist refers to a 77 year old male patient. On 25-AUG-213 the patient was vaccinated with ZOSTAVAX 19400 PFU lot 3 J002692, 0.65 ml, subcutaneous in the upper left arm. The patient was seen at an unspecified physician's office at an unspecified date. The physician had advised the patient to be seen by the pharmacist. The pharmacist reported that on 28-AUG-2013 the patient had a really red area about 1 ½ inches in diameter on upper left arm, which looked like zoster itself in color but not raised, inside of a 5 inch in diameter lighter pink area, and the affected area looked like a bulls eye, was extremely sore and the patient could not lay on it. The outcome of the event is unknown. This case is linked by same reporter link to case # 1309USA006520 on a female patient who experienced redness and inflammation at the ZOSTAVAX administration site, on an unspecified date in 2013. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; Dose 03: Pfizer/ Dose 04: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 09:00 as dose 1, single (Lot number: EP7534), in left arm, on 08Apr2021 at 09:00 as dose 2, single (Lot number: EW0151), in left arm and on 20Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FE3509) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Apr2022 at 09:00 as dose 4 (booster), single (Lot number: 056A22A), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 17Sep2022 at 09:00 as dose 5 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "slightly elevated blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: XIGDUO XR, start date: 01Jul2023, stop date: 12Jul2023; ATORVASTATIN, start date: 01Jul2023, stop date: 12Jul2023; LISINOPRIL, start date: 01Jul2023, stop date: 12Jul2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Apr2022 at 09:00, outcome "unknown", described as "Dose 03: Pfizer/ Dose 04: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (20Jul2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2023) Negative, notes: Negative test 20Jul2023. Therapeutic measures, Paxlovid from 12Jul2023 to 17Jul2023 (Lot number: GF7308), were taken as a result of drug ineffective, covid-19. The patient has no known allergies.
within two weeks of the first dose of the vaccine the patient's menstrual period was late by two weeks and then her next period was 3 days early
I have had tinnitus for 7 years but it was inactive until 2-3 weeks after the initial Covid vaccine. My ENT set me up with hearing aids which I had to purchase. They sent me to a research doctor who advised me that there is no cure for tinnitus. They could only make it easier to bare with the use of the hearing aids.
This patient had fine red colored rash appear on both legs around his injection sites within 1-2 hours of immunization and lower legs. Feeling today, no induration, swelling. No treatment needed.
Patient presented to the clinic with red dots across her lower legs bilaterally that are in every hair follicle and there is extensive "nerve pain associated with it on the left leg.  (Patient's left leg had previously been numb from a work related injury 09/01/2020). Patient was given Prednisone 60mg PO for 5 days. Patient came back to the clinic 01/20/2021 and she continues to have the "red bumps" to her bilateral legs.  She states that these will fill with clear fluid and then "pop" and go away and then they will come back.  She describes continuing intense nerve pain in these spots.  She has also reported that her skin looks "mottled";  although, she reports today they are somewhat improved.