chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptoms included intermittent nerve pain throughout the body with both dose 1 & 2; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Apr2021 at 15:00 (at the age of 37-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 06May2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included cholecystectomy, premature at birth (birth premature), penicillin allergy, allergy to gluten and dairy intolerances. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), metagenics sinuplex (MANUFACTURER UNKNOWN) for unknown indications and birth control (unspecified); all from an unknown date and unknown if ongoing. The patient previously took cefaclor (CECLOR) for unknown indication on an unknown date and experienced drug allergy.  On an unknown date in 2021 (also reported as 06May2021 at 15:30), the patient experienced intermittent nerve pain throughout the body with both dose 1 and 2 as well as joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intermittent nerve pain throughout the body and joint pain were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a physician concerning a 25 year old female who on 12-JAN-2007 was vaccinated IM in the right deltoid, with a first 0.5 ml dose of HPV vaccine (lot#655619/1427F). There was no concomitant medication. On 14-JAN-2007 the patient developed raised erythematous papules with tenderness (previously described as skin eruptions, lesions), on the axilla of the right arm. It was reported that the patient was treated with Benadryl. The patient reported the patient's lesions continued for two weeks and were worsening.  At the time of the report, the patient had not recovered.  Additional information has been requested.  Follow up information indicated that labs (not specified) had been obtained and the results had not yet been received. The physician indicated the outcome of the erythematous and tender papules was unknown. Additional information has been requested.
From faxed correspondence received on 7/22/02, it was reported: This is in follow up to report(s) previously submitted on 7/12/02. Information has been received from a legal firm regarding a case in litigaiton concerning a male child who was vaccinated with a first, second, and third dose of hepatitis B vaccine recombinant in the left thigh on 1/17/94 (lot # 1069W reported, invalid for the product), in the right thigh 3/11/94 and 7/13/94 (route of administration not specified (lot #'s 610581/1692W and 610862/0594A respectively). Concomitant therapy included MMR (second generation) in the left thigh (route of administration not specified) on 4/12/95 (lot # 612418/1128A); HIB conjugate vaccine (ACT-HIB) in the right thigh on 4/12/95 (lot # M010M) (route administration not specified); a first, second, third and fourth dose of diphtheria toxoid (+) hemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid in the left thigh on 3/11/94 (route of administration not specified), 5/12/94 (IM), 7/13/94 and 7/7/95 (route of administration not specified); a first, second and third dose of oral poliovirus vaccine on 3/11/94, 5/12/94 and 7/13/94 (lot #'s 0684H, 0203C and 0700H); a dose of purified protein derivative on 11/3/94. The alleged result of these vaccinations is that the patient suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. This is an amended report. The fill numbers have been added for hepatitis B vaccine recombinant and MMR (second generation). Upon internal review, toxic neurological effects and mercury poisoning were considered to be other important medical events (OMIC). No further information is available. This report is corrected as amended. Follow up on 5/22/03: New version to update the medical assessment. Case is closed.
No additional AE reported; Caller stated the vaccine was administered after expiration; This spontaneous report was received from a register nurse and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 14-DEC-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (vaccination scheme frequency, route of administration and anatomical site of application were not reporter; lot number S004578 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 29-SEP-2021) (expired product administered) for prophylaxis.  No additional adverse event (AE) was reported (no adverse event).
Patient went into cardiac arrest on 05/04/2021 when she was getting into a vehicle. CPR was initiated from EMS in the ambulance to the hospital. CPR was done for approx. 30 minutes when family asked them to stop. Patient passed away on 05/04/2021.
No adverse event occurred for the patient. The patient received an initial dose of Moderna COVID vaccination at a local Pharmacy in July and came to Pharmacy for their 2nd dose. The patient stated he delayed receiving the vaccination because he was out of the country. After completing the vaccination the patient approached the vaccination area again to inform me that he had already received the Janssen vaccine back in April. He purposefully did not disclose this information to either pharmacy in order to receive the Moderna vaccination series.
I was feeling strange on 12/16/2022 and then tested positive on 12/17/2022. I was exposed to COVID-19 at a gathering. I had headache, my teeth hurt, 102 fever. I was really sick for 1 day and then didn't feel good for the next 4 days. I contacted my provider and we did a telehealth visit and was prescribed PAXLOVID then 4 days after PAXLOVID treatment. I got COVID-19 again on 12/29/2022. The second time I got COVID, I had more cold-like symptoms. I was cough, runny nose, etc. I also do not feel back to normal as of yet since having COVID-19.
HA, extreme body aches especially in joints, loss of appetite x 2 days followed by fatigue
Chills; fever; body aches; headache; fatigue; This is a spontaneous report from a non-contactable pharmacist, the patient. This 27-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), dose  2, single dose via an unspecified route of administration in the right arm on 04Jan2021 at 06:15 PM (at the age of 27 years-old) for COVID-19 vaccination. There was no relevant medical history. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), single dose, dose 1 in the left arm on 17Dec2020 at 12:00 PM and had injection site pain. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oral contraceptives.  The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 04:00 AM, the patient had chills, fever, body aches, headache, fatigue. The events were reported as non-serious. The onset was roughly 10 hours after dose. All symptoms apart from fatigue resolved between 36 and 48 hours after dose. The patient was treated for fever and muscle aches with over the counter (OTC) ibuprofen. The clinical outcome of chills, fever, body aches, headache was recovering and not recovered from fatigue.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
After the administration of the vaccine (Gardasil 9), patient gradually experienced left side pain near lymph nodes around subclavian over the next 5 days. Patient gradually progressed to lymphadenitis where patient sought to seek treatment.
Chills, headache, vomiting, nausea, body aches, stomach/kidney pain, fatigue
Patient  stated, " I have soreness under the left arm and noticed a one inch bump under my left arm on my lymph node."
Mild Bells Palsey -  Droopy left eye,   weak left side of mouth
Patient received GARDASIL 9 vaccine IM right deltoid. Usual complaints of discomfort at time of injection. Waited in office 15 minutes after injection and left office without further complaint or concern. Parent called next afternoon saying patient was complaining of right arm redness, pain and swelling. Swelling reported to have begun immediately after injection, 2/19/19. Redness started following morning, 2/20/19 with increasing redness throughout the day. Patient states he had hives night of 2/20/19 but they had resolved before his appointment here 2/21/19. Patient did not have this type of reaction to first GARDASIL received a year ago but had been taking Zyrtec routinely at that time. He has not been taking Zyrtec routinely recently. Mom gave Zyrtec 10mg evening of 2/20/19 and again morning of 2/21/19.
The patient's left arm is swollen and painful. There is raised irritation. The axial lymph nodes are swollen the size of an egg. There is numbness, tingling and a loss of movement and strength in the left arm and hand. There is ongoing pain in the lymph nodes and breast discomfort. There is some improvement, but not all symptoms are gone. The site of the injection is still visible on the upper left arm.
bruising around the shot site; nausea; aches,pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruising around the shot site), NAUSEA (nausea) and PAIN IN EXTREMITY (aches,pains) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 20-Apr-2021, the patient experienced NAUSEA (nausea) and PAIN IN EXTREMITY (aches,pains). On an unknown date, the patient experienced VACCINATION SITE BRUISING (bruising around the shot site). At the time of the report, VACCINATION SITE BRUISING (bruising around the shot site), NAUSEA (nausea) and PAIN IN EXTREMITY (aches,pains) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-082892, MOD21-079883, US-MODERNATX, INC.-MOD-2021-082955 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082892: MOD21-079883: US-MODERNATX, INC.-MOD-2021-082955:1st dose
0900 received second dose of Moderna vaccine around 1530 started feeling weak, body ache and nauseated around 1830 fever 99.9 then by 1930 extreme fatigue, chills, body  ache, soar arm, body sweat  and headache. Every hour it was getting worse by 2230 fever of 102. Heart rate 116 (didn?t check it any more because I was getting scared) 2300 vomited. Urine was dark amber. Shaking excessively so weak and tired but pain was so bad couldn?t fall asleep. Chest pain and throat starting hurting.  Around 4 am fever dropped to about 99 but very nauseated vomited 2 times at 0409. Still had the chills, headache, body ache, fatigue and only slight fever. At 0900 no more nauseated feeling or fever. Only headache soar arm and fatigue. Finally by Saturday around 1500 I was feeling better. Only symptom left is dark colored urine which is not my normal color.
Patient was given 0.2 ml of undiluted COVID vaccine.  Tolerated vaccine well.  Spoke with Stepfather on 10/25/22 who reported normal side effects and that child was feeling better by the next day.
This spontaneous report was received from a nurse refers to multiple unspecified patients of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (lot# K016966, expiry date 10-MAY-2017). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Diminished/loss of sense of smell; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: ER8732), via an unspecified route of administration on 27Mar2021 at 12:15 pm (Age at vaccination: 24 Years), as first dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not experienced COVID prior to vaccination. Caller state that after receiving the first dose of vaccine, on an unspecified date the patient experienced diminished/loss of sense of smell. Patient had not received the treatment for the event. Since the vaccination, patient was not tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who an on unspecified date was vaccinated intramuscularly in the deltoid with a 0.5 mL dose of Pneumovax 23.  Subsequently, on an unspecified date, the patient complained of injection site reactions.  The patient sought unspecified medical attention.  At the time of this report, the patient was recovering.  No product quality complaint involved.  Additional information has been requested.
Given 1/10/11 by evening felt like on fire, T (101.6) shivering uncontrollably. Called the squad, itchy eyes & at site body aches. Vitals per squad OK. Refused ER, on ADVIL and ice 1/11/11 better, sore, slight nausea.
@9PM 1 1/4 inch redness around inject site w/an interior knot the size of 2 large peas; @2AM, pt breast fed @ 50% intensity & was like a jellyfish, no resistance on all 4 extremities, didn't even want to grasp mom's fingers;
Patient stated that her left arm hurts, still has a radiating pain to chest area, she had an ER visit to check the cause of the pain,  pt was administered the vaccine at her left deltoid muscle, according to Pharmacy knowledge pt took Advil / Tylenol and cold compressions.
Headache, vision loss, stiff neck. Caused Aseptic Chemical Meningitis
Patient has had known reaction to previous medications so patient was a 30 minute wait. Patient began having tingling in her bilateral neck with itchiness. Itchiness and warmth were progressively getting worse.  Patient given 50 mg of liquid Benadryl, then tried to eat breakfast. Became nauseous and vomited three times. Tingling and itchiness did not worsen. Patient was in observation for one full hour and returned to work when itchiness and burning subsided. Did complain of tongue tingling but no swelling or breathing obstructionand returned to work.
diagnosed positive for COVID on 9/18/21; EMS brought pt to ED with altered mental state, increased SOB and hypotension; 70% O2 saturation on RA, glucose greater than 600; PMH:  DM, chronic kidney disease; treated with DKA protocol, dexamethasone, remdesivir, Olumiant, Budesonide; to ICU; BiPAP ; intubated on 10/3/21 requiring FiO2 of 100% and proned; septic shock; DNR; transitioned by family to comfort care with worsening condition of pt; pt died in the hosp
Approximately 35 minutes, post vax 1st Anthrax, pt got tingling feeling and extremely hot sensation in areas affected by rosacea. Pt has a five year history of rosacea.
Injection site pain; fever; chills; fatigue; myalgia; This is a spontaneous report from a non-contactable pharmacist (patient). A 43-year-old female patient (no pregnancy) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of left arm at 13:30 on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain, fever, chills, fatigue and myalgia in Jan2021. Facility type vaccine was in hospital. No other vaccine in four weeks. Adverse reactions did not result any serious consequences. The patient received paracetamol (TYLENOL) as treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovered in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No adverse event.  Realized I should have administered Fluzone instead of Flublok since patient was only 16
Patient has no symptoms.  Patient notified staff day after vaccines were administered that she was pregnanant.
feels itchy; burning; tingling and paresthesia all over her body; This is a spontaneous report from a contactable physician. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 12Jan2021, and she has had a serious reaction since; she felt itchy, burning, tingling and paresthesia all over her body. She has been on Benadryl for it. The outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events itchy, burning sensation, paresthesia. 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.
A hard, 3-inch circular spot showed up around the injection site.  I noticed it about a week after injection. Initially., just a small spot around  the needle stick was soar and hard. The  soar spot disappeared in about  3 days. Then, a couple days later, I get this big hard spot.
Covid-19 breakthrough. 1st vaccine received on 01/23/2021. 72 y/o with PMHx of Metastatic Breast Cancer on chemotherapy, Uterine Cancer and spinal metastasis presents to ED with c/o 2 week history of Cough, congestion, chest pressure, N/V, Fatigue, poor appetite, chills, and progressive SOB. Patient initially diagnosed with Covid-19 on 02/01/2022. CT Chest with multifocal viral PNA, room air sat 91%, placed on O2 2L NC. Oxygen demands increased until patient on 30L heated high flow. Afebrile. Patient treated with IV steroids, IV ABX and Tocilizumab.
Injection site began to swell and turn red. Pt began to feel pain and discomfort.
Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2015-08033) on 10-JUL-2015. Case received from Health Care Professional via health authorities on 08-JUL-2015 under the reference number DK-DKMA-ADR 23052207 and DK-DKMA-EF012592. The case is medically confirmed. The primary reporter was a physician. A 12-year old female patient had received the first and second dose of GARDASIL (batch number: D1: G004958 D2: G004958) via intramuscular route of administration in unspecified site on 27-OCT-2011 (D1) and 12-JAN -2012 (D2). On unspecified dates in 2012, she developed lower abdominal pain, nausea, concentration impairment, memory impairment and headache. On not reported dates, she developed chronic tiredness, dizziness, stinging skin (touch of the skin gives pain), itchy skin, blackout, energy loss, body pain that moves around, sensitive skin (a touch gives pain), chest pressure, the heart cramps and feels as if she has fever. The patient has  had absence from school due to the adverse reactions.  This case is serious due to the seriousness criteria disability and other medically important condition. No other vaccines or medications. The patient has been evaluated by the pediatric department and gynecologic department, where there were no remarks (not further specified). No information on medical history provided.  At the time of reporting, the patient had not recovered from lower abdominal pain, chronic fatigue, nausea, concentration impairment, memory impairment and headache. The outcome of the remaining reactions was unknown.
Body aches; Temperature for a couple of days after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and PYREXIA (Temperature for a couple of days after the vaccine) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches) and PYREXIA (Temperature for a couple of days after the vaccine). At the time of the report, MYALGIA (Body aches) and PYREXIA (Temperature for a couple of days after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Non Significant follow up added-Contact info and snapshot document added.
13MAY92 devel redness @ site rt arm today is 2" in diameter; sl hard; hot to touch; used APAP w/hot & cold packs; no improvement today; advised to cont tx; 12AUG92 erythema & swelling cleared p/2-3 days;
Large are of redness and blistering. States she now remember that she had a reaction like this when she little. She thinks that her brother had a reaction also.
swelling of upper lip Narrative:  Pt received COVID-19 vaccine (1st dose) on 1/27/21 and developed swelling on the left side of mouth hours later. Pt denied difficulty breathing, swelling of throat. Pt discharged from ED with famotidine 20 mg BID and diphenhydramine 25 mg TID.
Systemic: Dizziness / Lightheadness-Mild, Systemic: heart rate elevated seemed to be per apple watch-Mild, Systemic: Nausea-Mild.
Developed mild hives on arms, palms, legs and abdomen within a few hours after taking first dose of COVID-19 vaccine. At first I had thought they were bug bites and didn?t think anything about it until later around 4:00pm when I realized  they were hives so they had started a couple hours prior.   Called clinic that administered vaccine at 4:11pm and they returned my call at 4:27pm; they told me to take benedryl. I had Zyrtec on hand and took that. Hives began to be less itchy after about an hour.
More than severe dizziness, I had vertigo. Gradual onset for about 1.5 hrs, then extreme. Couldn't forces to deal a number, couldn't walk straight. Going to bed was the only safe thing to do. I lies bed until 2:30 AM. By 8:00 AM. all normal.