chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subsequently developed respiratory distress and pneumonia after testing positive for COVID. Pt died due to illness.
Fell asleep normal time and woke up 1.5 hours later feeling like I was going to have a heart attack, felt like I was jumping out of my skin as if I wanted to jump off a building and that has never happened before. 3 days later it happened again to the point that I was afraid to fall asleep. When I spoke to my niece, her husband was having the same experience. Strange part is that after the vaccine I had the normal feels, but I started feeling unsettled, couldn't sit still and edgy. They put me on Zanex which I've never been on and at first they put me on Valum for emergency situations and I ended up taking 5 of them. I was afraid to get the second dose because I have never experienced any phycological things like that before. It was just very odd and wouldn't have reported it if I didn't have others that shared the similar experience.
Case number PHEH2014US024359, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to an 89 years old female patient. Her medical history and concomitant medications were not reported. She had tolerated vaccines (no further details provided) well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 12 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. No adverse event was reported following this maladministration. Follow-up from a nurse received 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Patient received Covid Vaccine Dose #1 on 12/17/2020. Patient noted rash on neck and upper chest, arms, and abdominal area 1 hour after vaccine administered. Patient felt faint and developed strong chills. Patient was taken to emergency center and was given Benadryl 50mg PO. Patient was discharged at 12:30pm and instructed to take Benadryl 25mg every 4-6 hours PRN.
day she got the vax she felt like she was empty/doomed , said she felt like something wasnt right itching, red eyes, skin turned red  weakness, head aches, body aches, nausea, palpitations, weak legs, twitching in her right leg, said she felt like she was going to die blurry vision, PCP told her to rest and the issues would resolve themselves
TIA, on 9/25/2021 TIA, on 9/27/2021 Headache, slurred speech, memory loss  Whole body weakness  Confusion
I have medical checkups every six months and never had atrial fibrillation before. My doctor detected it at a routine checkup approdimately September 1, 2021
Dose 3 was given 1.5 after dose 2. No symptoms or adverse outcome. No treatment necessary.
Within 4 hours, pt. developed fever increased to 103 degrees F and dizziness. Went to ER that evening. Blood work, blood cultures, and U/A all negative. Antibiotics were prescribed as a precautionary measure. F/U at clinic on 8/16/16: Fever persists increased to 103 degrees F. Advised to continue with ABX and increase fluids. On 8/17/16 returned to ER with N/V, fever increased to 103 degrees F, dehydration and received IV fluids and ROCEPHIN, antiemetic, with PO antiemetic upon D/C. Used x 24 hours. Repeated labs and new CXR, all negative. Pt. feeling well by 8/18/16 evening/8/19/16 A.M.
A report was received from a health professional on 10/18/2001, concerning a 76 year old male patient who experienced an overdose, after inadvertently receiving the Fluvirin vaccine on 10/08/2001 and again on 10/18/2001. On 10/18/2001, the patient experienced an overdose after inadvertently receiving a second Fluvirin vaccination 10 days after the first vaccination. No adverse effects were reported at time of report. No other information was available. There was insufficient information to determine the causality assessment of the reporter.
Patient was given 3rd Hep B at 4 month appt. No adverse effects. CDC was contacted and stated that it is a valid dose.
This spontaneous report as received from a pharmacist refers to a 53 years old male immunocompromised patient with hypertension, diabetes, allergic to glipizide. The patient's medical history included kidney and pancreas transplant in 2003. The patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported) on 29-NOV-2012. No other co-suspects were reported. Concomitant medications included tacrolimus, CELLCEPT, amlodipine, omeprazole, fenofibrate, metoprolol, trazodone, pravastatin and KLONOPIN. On an unknown date in 2012 the patient developed a fever, nausea, vomiting and was confused. The patient was also experiencing a severe hypertensive crisis. The patient was hospitalized for medical attention. Treatment and intervention included injectable blood pressure medications, antibiotics, promethazine, IV immunosuppressive drugs. The patient was not recovered at the time of report. The adverse events were considered as medically significant, disability and life threatening by the reported. Additional information has been requested.
6/1/2021   Pt was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  " feeling faint".   Assessment : Time of assessment 355p. Complains of feeling faint, chest tightness, anxious.    Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN. VS at 3:55p- BP- 139/92, P- 83, O2- 100%, 4pm- BP- 131/89, P- 87, O2-- 100%, voices that she does have a history of anxiety, 4:05p BP- 132/80, P- 68, chest tightness resolved per patient, 4:10p BP- 133/80, P- 68, sitting up with no complaints, family here with patient       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 6/1/2021  3:35 PM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8736   NDC: 59267-1000-2
I have had a very bad headache ever since my first booster shot on 25Mar2022. That's a very long time to have a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 25Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "I have had a very bad headache ever since my first booster shot on 25Mar2022. That's a very long time to have a headache".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Within 15-minutes of vaccination, the patient reported chest tightness and was concerned she was having an asthma attack. EMS evaluated the patient on-site. The patient was hypertensive (150/85). The patient's EKG demonstrated NSR, rate 82bpm, no ST elevations. EMS administered 8L/min O2 and DuoNeb (2.5mgAlbuterol/0.5mgIpratoprium). EMS transported the patient to Emergency Department. In the ED, the patient reported general weakness and feeling mildly lightheaded in orthostatic position. The patient noted feeling better after taking their inhaler and receiving the DuoNeb treatment. Labs were non-actionable. The physician administered 1L normal saline and discharged the patient with diagnoses of Chest tightness, Adverse reaction to vaccine, Asthma, Orthostatic Lightheadedness. Patient was prescribed Albuterol Sulfate on discharge.
Chills, diaphoresis, fever, congestion, shortness of breath, chest pain, nausea, back pain, headaches, tachycardia
Initial information received on 28-Jan-2019 regarding an unsolicited valid non-serious case received from Other Health Professional. This case involves a 16 years old female patient who received 0.5 mL dose of vaccine FLUBLOK QIV lot QFAA1831, expiry date:30-Jun-2019 via unknown route in the right deltoid on 27-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. She did not receive any other immunizations at that time. It was a case of actual medication error due to Inappropriate age at vaccine administration. No adverse effects have been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
possible cellulitis right axillary skin and right breast skin; possible cellulitis right axillary skin and right breast skin; injection site on right deltoid with painful swelling lymph nodes; injection site on right deltoid with painful swelling lymph nodes; erythema/erythema over right axilla/progressive erythema over breast; This is a spontaneous report from a contactable other health care professional (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), intramuscularly in the deltoid right on 13Jan2021 at 07:00 (at the age of 62-year-old), dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included levocetirizine dihydrochloride (XYZAL); mometasone furoate (FLONASE); pregabalin (LYRICA); baclofen; ibuprofen; diazepam (VALIUM). The patient previously took Sulfa and had allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) intramuscularly in the right deltoid on 23Dec2020 at 13:00 (at the age of 62-year-old), dose 1, single for COVID-19 immunisation. On 09Mar2021, the patient had erythema. On 09May2021, the patient started Keflex for possible cellulitis right axillary skin and right breast skin. The patient had erythema over right axilla, the injection site on right deltoid with painful swelling lymph nodes and progressive erythema over breast. The patient seen at physician on 09May2021. The patient received Keflex for the events. The patient was not hospitalized for the events. The events did not result in multiorgan involvement but had dermatological/mucosal involvement. The patient did not receive any recent vaccines for any other conditions prior to the event and did not receive any other vaccines around the time of COVID-19 vaccine. The outcome of the events was unknown.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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.,Linked Report(s) : US-PFIZER INC-202101206514 Same reporter/patient/ product, different dose/events.
Sudden onset of right facial paralysis on 1/8/01. Seen in ER and Rx'd prednisone, Lacrilube and Natural tears. Symptoms and facial droop are improving but not resolved at this time. Dx'd with Bell's Palsy.
Right shoulder was sore within a couple of hours of shot given. This part was typical for me. But by evening I was unable to lift my right arm past my elbow. Slept fitfully that night, next morning could lift higher but with pain. Had to start taking advil at regular dose/intervals but was not getting any better after 1 week. Consulted doctor on 9/25 and she prescribed advil 600-800 mg/ 3X per day and tylenol overlapping.Did this until 9/28 without improvement at which point I went in for an office visit. Doctor prescribed naproxen for 2 weeks and put in an order for physical therapy.
Pt reported shortness of breath about 1 hour post vaccine and I instructed her to go immediately to ER. Upon follow-up, pt informed me she suffered anaphylaxis and has the flu.
Recv'd Short at 3:30pm at work; within 2 hrs, started feeling feverish and had cramping in the lower intestines.  While returning from the restroom, I passed out in the hallway, hit my head, refused medical treatment, was taken home by supervisor, who called every half hour to make sure I was OK.  Bad headache resulted from fainting due to hitting the back of my head on the concrete floor.  Headache lasted approximately 4 (four) days, accompanied by nausea.
Mild symptoms; Red on arm; Itchy on arm; Bump like a protrusion on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild symptoms), ERYTHEMA (Red on arm), PRURITUS (Itchy on arm) and VACCINATION SITE MASS (Bump like a protrusion on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Diabetic (Type 2).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION COMPLICATION (Mild symptoms), ERYTHEMA (Red on arm), PRURITUS (Itchy on arm) and VACCINATION SITE MASS (Bump like a protrusion on her arm). At the time of the report, VACCINATION COMPLICATION (Mild symptoms), ERYTHEMA (Red on arm), PRURITUS (Itchy on arm) and VACCINATION SITE MASS (Bump like a protrusion on her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that the patient's second dose was scheduled on 21-MAR-2021. Blood pressure and  type 2 diabetic medications are the concomitant medications reported. Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up TCR received on 22-Jul-2021 contains Updated outcome of the event.
On 2/21/2023, I developed head and nasal congestion, body aches, sore throat, cough, and fever. On 2/22/2023, I took a home antigen test and got a positive result at about 4 AM. I had a telehealth visit with my doctor later that day, and I was prescribed Paxlovid, which I began taking that day and completed taking on 2/26/2023. The Paxlovid seemed to help with the symptoms, though my fatigue persisted. On 2/27/2023, I tested negative. Aside from the persistent fatigue, I thought I was getting better. By 3/3/2023, I felt wonderful until later that evening, which is when the cough and fatigue returned. On 3/5/2023, I felt worse and had cough, nasal congestion, and fatigue. However, I had no fever. I took another test that day and got a positive result. I contacted another doctor on 3/6/2023, and the doctor told me that I had had a rebound. I was advised to isolate for five days from the onset of my symptoms and to mask for five days afterwards, which I did. I gradually got better, except the fatigue persisted for five or six weeks past the onset of the original symptoms. By the first week of April 2023, I think I was pretty much normal again.
After 2nd covid vaccine: 18-24 hours body aches; 36 hours swollen lymph  node under right arm pit which lasted 2-3 days (same arm as vaccine). Also, sporadic sharp pain in left groin/pubic area that started approximately same time lymph node under armpit was swollen. Still getting sporadic sharp pains today (4/7/21) but armpit no longer sore or swollen.
mom said pt had persistant high pitched crying x hrs, high fever p/vax 15JUN95 & was seen in ER w/rash on 16JUN95 dxd as virus was not reported to clinic as adverse rxn; mom did not report until rxn on 7SEP95;
Dr.  self disclosed that he administered  0.1 ml IM of Moderna vaccine .  Patient was notified via telephone and instructed to return to the site were she received a full dose (0.50 ml) of the Moderna vaccine as instructed by . No side effects reported by patient after administration or during resting period of 15 minutes. Supervisor notified and all vaccinators reminded that 0.5ml is the recommended dose for the Moderna vaccine.
My resting heart rate is in the 60 - 70 bpm range. In October 2020, I had the first Shingrix shot and more than 24 hours later my resting heart rate shot up to 130 bpm. I thought it might have been dehydration since it was so far removed from the actual time of the shot so before the second one I made sure I was well hydrated and kept drinking water for the days following. Again, I experienced an elevated resting heart rate that went up to 125 bpm approximately 17 hours after the injection.   My resting heart rate fluctuated between the 80s and up to 125 bpm but was elevated for a couple of days. As of  3 days after the injection my resting heart rate has returned to the 60 -70 bpm range.
At 10pm (12 hours after the injection), I began to experience chills, muscle aches and pains, joint pain, and a low-grade fever that rose to a high of 101.4 at 8:30 the following morning.
On 11/17/2022 I received my Covid 19 vaccine. On 01/27/2023 I woke up with a severe sore throat with coughing and sneezing throughout the day. The next morning, I began to have nosebleed severe headache body aches and fevers. The symptoms began to progress. I took a home Covid test and was tested positive for Covid-19. I contacted my doctor and was prescribed molnupiravir for 5 days. The following Wednesday I was still coughing with tightness and trouble breathing so I contacted my doctor again and was prescribed albuterol and TESSALON PEARLS. Symptoms are still on going.
Patient diagnosed with shingles on 07/19/19. Presented to Physician's Group on 07/17/19 with leg pain at left groin/thigh region x 24hrs prior to provider visit. Parents noticed a blister-like rash on the anterior ankle which spread upward. Patient complained of leg pain at site of rash on shin.  Parents deny fever, headache, changes in behavior, joint swelling or pain, and nausea/vomiting/diarrhea. Patient presented to ED and was admitted with leg pain.
Dizziness, NauseaVomiting, HYPERtension, lightheadedness, abdominal cramping Narrative:  Employee reported nausea and lightheadedness approximately 5 mins of vaccine administration. BP was 155/86. Within a few mins she developed a headache and dizziness. BP check at this time 165/93. Employee escorted to ED for eval. She was given 1 liter Lactated Ringers and 4mg IV zofran, which resulted in symptom resolution. She was discharged home from the ED around 1:40 pm.
sore arm; not mixed and the whole 0.2 mL of concentration was administered to the patients; not mixed and the whole 0.2 mL of concentration was administered to the patients; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 10 year-old male patient received bnt162b2 (BNT162B2), administration date 01Feb2022 12:58 (Lot number: FL0007, Expiration Date: 2022) at the age of 10 years as dose number unknown (tris), 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 01Feb2022 12:58, outcome "unknown" and all described as "not mixed and the whole 0.2 mL of concentration was administered to the patients"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The adverse event was non-serious. AE required visit was not applicable. Vial was not reconstituted. Communication error between pharmacist & tech. Only a sore arm. No other side effect.  No follow-up attempts are possible. No further information is expected.  Follow-up (23Feb2022): This is a follow-up spontaneous report from a contactable pharmacist. This pharmacist reported for the patient in response to HCP letter sent which included: Updated Information included: New event (sore arm) added. Event onset date updated for overdose and product preparation error.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200186001 Same reporter/drug/event, different patient.
chills, fever, body aches   Symptoms started aprox 24 hrs from 2nd dose, lasted approx  12 hrs
On 2-18-2021 I developed a red rash  on left arm around injection site. The rash was slightly raised, warm to the touch, itched, approximately 4 to 5 inches wide and almost circular in shape.  I  was not running a fever. As of today, 2-21-2021, the rash has gone down in size, redness is fading, no longer raised, itching has eased however still slightly warm to the touch. I did not take any oral medication to ease the itch only used a cold pack.
Patient got up from shot and went to purchase another item. Within 1 minute she was becoming red in the face and light headed. We sat her down and had her drink a bottle of water. She said she began to get chills within 10 minutes. On follow up, 7 hours later, she had become fevered to ~100 degrees F. She had a lower back ache as well.
30 minutes after vaccination in R deltoid had rash, fine red not raised on right forearm. Given benadryl 25 mg po. within 5 minutes developed subjective tachycardia/ and shortness of breath and felt light headed.  Rash on forearm improved some with benadryl. Given one epipen at the time 911 was called.  She felt short of breath, she was not audibly wheezing. EMT took her to the local hospital. She was always alert and conversant.
2 days p/vax pt exp pain in pectoral area @ rest-irritating dull & pain in lower teeth still persists
It was reported the occurrence of a blister around the injection site in a pt of unspecified age who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. The pt's relevant medical history, concurrent conditions, and concurrent medication were unknown. The pt had no adverse experiences following receipt of his  1 injection of Twinrix on an unspecified date. On 1/16/03, the pt rec'd his second injection of Twinrix. At an unspecified time post immunization, on 1/16/03, the pt developed a blister around the injection site. The reporter considered the blister to be possibly related to Twinrix administration. As of 1/17/03, the blister persisted.
This spontaneous report as received from a consumer refers to herself, a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 03-MAR-2018, the patient received VAQTA (lot # and expiry date were not reported) at pharmacy for prophylaxis. Other suspect therapies included sterile diluent. On 03-MAR-2018 the patient experienced facial swelling and rash. On an unknown date, the patient reported that the rash was still present and the patient will be receiving medical attention at an unspecified urgent care facility. The outcome of swelling face and rash was reported as not recovered. Causality assessment was not provided by reporter. No PQC involved. No further AE information provided.