chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after vaccine was administered, patient was told to wait in the store for 15 minutes.  Within 2 minutes, patient told their mom, he felt "woozy". Patient dropped to his knees.  Pharmacist was alerted by immunizing technician.  Pharmacist went to the lobby to assist.  Patient was alert but stated he did not feel good.  Pharmacist helped patient to a chair.  within another minute,  patient stiffened and would not answer to his name.  911 was called. ambulance arrived within 5 minutes.  Patient was alert, but pale, said felt sweaty, and dizzy.  paramedics took blood pressure and place the patient on the gurney.  blood pressure was normal.  paramedics stated they would run a few tests in the ambulance, and mom agreed to going to hospital after.  patient left the store with paramedics.
UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included: migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Information has been received from a consumer concerning  her 13 year old daughter with no previous medical history and no known drug allergies / reactions reported, who near the end of September 2007, was vaccinated with the first dose of GARDASIL (lot number not provided 0.5ml  . On 02-Nov-2007, the patient was vaccinated with the second dose of GARDASIL 0.5ml and on 01-Apr-2008 with the third dose of GARDASIL (lot number not provided) 0.5 ml. There was no concomitant medication. Two days after receiving her first dose of GARDASIL , on approximately 02-Oct-2007, the patient got her first menstrual period. After getting the second dose of GARDASIL, on approximately 02-Oct-2007, the the patient got her first menstrual period. After getting the second dose of GARDASIL , on approximately 02-Nov-2008, the patient experienced a headache and stomach issues. Also she experienced a rash on the back of her neck, numbness and tingling in her hands. since the third dose GARDASIL , she experienced joint and muscle pain that had yet to go away, Since she was vaccinated with the first dose of GARDASIL, she not had another menstrual period since until recently. The patient stated that some of her symptoms felt like she was "going through menopause". A blood work was performed (results not provided). The patient sought unspecified medical attention. As of 10-Nov-2008, the patient was not recovered. No further information is available.
The day of vaccine I had an extremely sore. An hour later I began to get very tired. Got home laid down. My legs and feet were very swollen. I could hardly walk so I went to emergency. The doctor told her there was no way that it could be Moderna. I asked how would he know that. He did not give an answer. Over a month or so the swelling went down.
Redness, swelling, pain, firmness, numbness in hand/arm, warmth.
Pt had x 3 immunizations. Tolerated well but nervous. About 5 ??? Pt. had near faint spell. Mom Reported (R) arm stiff then body weak. Pulse 92 Resp 20 B/P 110/60. Pt. knew her name. Placed on exam table with head slowly elevated with c/o dizziness. Pt able to walk out with aid in 10 minutes. Mom refused 911 or ambulance.
Woke up morning after Pneumovax was given. Patient could not move her left arm as that was the limb the vaccine was given in.  On 1/4/2014 the site became red and swollen. Patient also noted a fever. She then went to the ER and was admitted for injection site infection.
This spontaneous report was received from a nurse and refers to a 27 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-SEP-2017, the patient was vaccinated with a dose of PROQUAD lot # M044718, expiry date 07-MAY-2018 (exact dose and route of administration were not reported) for prophylaxis reconstituted with sterile diluent injection lot# L015432 and expiry date 24-JAN-2018 instead of VARIVAX (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild, Additional Details: Patient fainted after a few minutes of receiving 2nd covid vaccine in the waiting area.  Patient did regain consiousness within a minute and in few minutes patient started vomiting.  Patient refused call for emergency medical attention and states she has fainted before.  Patient was monitored for 30 minutes before leaving with younger brother and boyfriend.  She stated she felt okay before leaving.
Light headedness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced DIZZINESS (Light headedness) and HEADACHE (Headache). On 10-Feb-2021, DIZZINESS (Light headedness) and HEADACHE (Headache) had resolved.            No concomitant medication information was provided. No treatment medication information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Updated outcome of the event Headache and Dizziness from (Unknown to Recovered/Resolved).
Information has been received from a physician concerning a 12 month old male pt, with no past medical history and no concurrent conditions who was vaccinated SC into the right thigh on 01/06/2003 at 12:30 with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #643391/0506M) (lot #635740/0944M-diluent). Concomitant vaccinations on 01/06/2003 at 12:30 included an IM dose of Haemophilus B conjugate vaccine (ActHIB) (lot #4B345AA) into the right thigh, a SC dose of varicella virus vaccine live (lot #643083/0572M) (MSD) into the left thigh, and an IM dose of hepatitis B vaccine recombinant (ENGERIX-B) (lot #ENG5366A2) into the left thigh. It was reported that the pt developed diarrhea, fever and a maculopapular rash (previously reported as measles) confluent in the neck and face region. It was reported that there was no illness at the time of vaccination. It was also reported that the pt went to the ER. It was reported that the pt recovered. Additional info is not expected.
Facial shingles; Rash which itches and is red; Rash which itches; Feels hot; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, red rash, itchy rash, skin warm and incomplete course of vaccination. On an unknown date, the outcome of the shingles, red rash, itchy rash, skin warm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, red rash, itchy rash and skin warm to be related to Shingrix and Shingrix.  Additional details were as follows: The age at vaccination was not reported. Female patient herself reported that she received the 1st dose of shingrix vaccine year ago and have not received the 2nd dose yet,which led to incomplete course of vaccination but She stated that about one month back she was diagnosed as having shingles on the right side of her face which has resolved but on the day before reporting she started to experience again. According to her it was shingles with a rash which itches and is red in the middle of her back and she felt hot all over her body without a temperature. It was reported that patient did not receive the 2nd dose which led to incomplete course of vaccination. The reporter did not consent to follow up.
developed full on symptoms of COVID-19; developed full on symptoms of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "developed full on symptoms of COVID-19". Clinical course: . He received COVID-19 vaccine prior to the infection.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Extremely cold, migraines, nausea, tightness in chest, face rash, joint pains, extremely tired
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient stated after vaccination and allergic reaction onset that she was previously recovering from allergic/anaphylaxis reaction.  She has a history of idiopathic anaphylaxis with angioedema.  Patient predosed before appointment with benadryl 25 mg and self administered Amneal epinephrine as EMT arriving at pharmacy.  Patient complained of swollen lips and tongue with moderate difficulty breathing. Patient brought to Hospital for follow up.  Current epinephrine pen being refilled
Plan: This is a 51-year-old female who received her Covid vaccine about 4 hours ago. About an hour ago she developed a slightly sore throat with some fever blisters on the posterior left side. She has had a history of canker sores but was concerned that this might be a reaction to the Covid vaccine. On exam there are three 2 mm blisters on the left tonsillar region. The airway is completely clear, there is no stridor, no tachycardia or wheezing. Patient declined Benadryl here in the clinic, she has her own hypoallergenic children's version and will start that now. She does have strict ED precautions and lives only a few minutes from the hospital. Any worsening she is advised to go to the emergency department patient voices understanding of all instructions. Follow-up: No follow-up provider specified.
Generalized malaise and anorexia for about a day and a half. Took a Tylenol, doing better now
The same night I experienced malaise, headache, myalgia. The following morning I had a fever and chills. These symptoms continued for approx 5 days.    The myalgia continued for approx 1 month and is ongoing now.  The hands are mostly affected - unable to form a grip, swelling and joint pain - also trigger finger is noted in left baby finger.  I take meloxicam for the pain and swelling - with effect.
Started as a my arm being sore I could not fall asleep then my muscles started to get sore and a fever with chills happened right after and it wouldn?t let me sleep.
had 1st covid shot 4/9/21, had 2nd covid shot 4/30/21.  Then around 5/14/21 started to get cold sores on lip. Took acyclovir for 2 weeks. rash cleared for 2 weeks, then cold sores recurred.  Took acyclovir again. then recovered, then flared 2 weeks after stopping the acyclovir. took acyclovir again
Patient complained of Right hand jitteriness, pulsating throat without SOB. Malaise, generalized weakness, was also a complaint. BP 159/88, Pulse 82, R 18, and Oxygen 100%. Patient was released with he husband
Headache (lasted 2 days) Fever (100.5 began 12 hours after vaccination; lasted for 30 hours) (Normal for me is 97) Chills and shivering (began 14 hours after vaccination; lasted for 8 hours) Body aches (began 6 hours after vaccination; lasted 36 hours) Severe arm pain and swelling ( began 12 hours after vaccination and still hurts at time of this report)
Information has been received from a nurse concerning 4 female patients who on an unspecified date were vaccinated with GARDASIL.  It was reported that all 4 patients fainted within the 15 minute period following vaccination.  No specifics known about the patients.  At the time of reporting, the patients had recovered.  The patients sought medical attention in the office.  Attempts are being made to obtain additional identifying information to distinguish the individual patients.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/15/2008.  Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with GARDASIL. It was reported that the patient fainted within the 15 minute period following vaccination. No specifics known about the patient. At the time of reporting, the patient had recovered. The patient sought medical attention in office. This is one of several patients received from the same source. Additional information has been requested.
So for about several minutes after the vaccine, I had a weird feeling in my head. I can't describe it, it wasn't a headache, it was sort of like a buzz. The other thing was that on July 22, 2021, I felt hot and was feverish, my legs ached and my arms ached. I had a headache and felt like I had the flu. That persisted for about three and a half weeks. I contacted my DR on July 22 2021 because I thought I had Covid or the Flu. The DR suggested Tylenol and gave me Z-pak as well.
Left deltoid with erythema around vaccine site. No signs cellulitis; no lymphadenopathy.
Fever 101.9 F; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.9 F), HEADACHE (headache) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (Fever 101.9 F), HEADACHE (headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever 101.9 F), HEADACHE (headache) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient take Tylenol one yesterday and one today morning; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Headache; Nausea; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 24Feb2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included rosuvastatin calcium (CRESTOR), ascorbic acid (VITAMIN C) and vitamin d nos (VITAMIN D), all for an unknown indication from an unknown dates and unknown if ongoing. On 25Feb2021, the patient experienced headache, nausea and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea and fatigue was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Has seasonal allergies. Mom says she tends to have Fall allergies not Spring allergies. Mom also stated that patient had some pain on the side of her neck prior to taking any oral typhoid vaccine. Came in and received Tdap, Flu, and oral typhoid pills. Did not begin taking oral typhoid until 5/20/16. Timeline: 5/20/16-Took first oral typhoid pill at bedtime. 5/21/16-Woke at 8:30 am with allergy-like symptoms. Patient complained of scratchy throat, not feeling well. She took ALLER TEC in the morning and BENADRYL at night. 5/22/16-Woke up with same symptoms as on the 21st. Still taking ALLER TEC and BENADRYL. Took 2nd oral typhoid pill at bedtime. 5/23/16-Woke up with same symptoms as on the 21st but now has a sore throat and dizziness. Still taking ALLER TEC and BENADRYL. 5/24/16-Same symptoms and took 3rd oral typhoid pill at bedtime. 5/25/16-Woke up at 8:30 am patient stated that she couldn't breathe well, her face, eyes, and tongue were swollen. Her mother gave her 2 BENADRYLS and went to the urgent care. The physician there told her to stop taking the oral typhoid and continue with allergy treatments. 5/26/16-Woke up with similar symptoms but not as severe; achy neck. Travel. Dr. called in a prescription for 5-day course of prednisone. Over the weekend patient stated that her eyes were not so puffy but complained of neck and back ache. 5/28/16-Patient still has neck and back ache but states that stomach feels swollen. 5/29/16-Patient returned home and texted Dr. He told her if not feeling well in the morning to go to the doctor. 5/30/16-Patient awoke feeling bad again, face and eyes swollen and returned to urgent care. She was sent to the ER. The ER tested for strep which came back negative. They then tested for mononucleosis which came back positive. She was given a shot of prednisone and patient stated that symptoms subsided within 3 hrs. Still taking ALLER TEC and BENADRYL. 5/31/16-Woke up and throat is feeling better but by night throat was sore again. 6/1/16-Mom states that she is still not feeling good today. This is the last time I visited with the mother.
A vaccinator came to PHN to report a woman in the bathroom who was throwing up. PHN and vaccinator came to attend to the client. Client said she was feeling warm and her head was throbbing. Client said her name. Client was eventually able to sit up in a chair and said she was feeling hot and lightheaded. Client asked to lay on the floor and legs were placed on a chair. Client said she was feeling better after this. PHN came back to the bathroom with ice pack, fruit strip, water, and apple juice. Client seen throwing up again, vaccinator was standing by with client. Vital signs taken after episode of emesis. BP: 113/84 and HR: 75. Client asked to take deep breaths and slow breathing, which client was able to do. Client said she was still feeling hot so client was given another ice pack. Client felt cold after some time so both ice packs removed. PHN asked another PHN to come assess client and Dr. called in to assess client also. Client was throwing up for the third time, and Dr. suggested we call 911 to get her checked out. EMS called at 1808 by other PHN. Client said she is only allergic to an antidepressant but did not recall the name. Client continued to talk and be responsive throughout entirety of event. Client called someone she knew to pick up her truck as she knew she would be going to the hospital. PHN took down name of friend, his number, and client?s keys. PHN gave keys and information to client flow lead, who gave items to an employee to ensure keys were returned to trusted entity. EMS arrived. Client denied any swelling, throat closing sensation, sensation of a thick tongue, or itching. Client taken on stretcher to Hospital.
Face and eye swelled up. Also got very red. Next day low grade fever and extremely tired.
8 hours post vaccination, patient was shivering and very cold. She couldn't speak, had uncontrolled muscle spasms, severe headache and pain, and when she got to the ER she was vomiting.
3 mins after vaccines were administered, patient developed bright red rash of both cheeks and chin. Also reticular rash on on chest with a few hives. Normal vital signs, happy and alert, smiling. No angioedema or respiratory symptoms. No vomiting or diarrhea. Given PO benadryl 6.25 mg x 1. Observed for 30 min. Rash receded. No further symptoms developed
Complaints of right arm feeling swollen. No obvious changes noted.  Current medications: Prozac, Concerta, Ritalin, Risperidone, lamictal 12:10 BP109/66 pulse 80 resp 18 pulse ox 100% 12:25 BP 108/65 pulse 82 resp 18 pulse ox 100% 12:40 BP 115/60 pulse 82 resp 18 pulse ox 100% pt reported at this time that arm felt better.
patient received an expired dose of flubok today with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] today with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Oct-2022, the patient received a expired dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (dose, strength, formulation and lot number: unknown) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency: same cay)  No lab data was reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
Mild itching of left shoulder after vaccine. Redness and warmth of left shoulder starting 4/14/2021
3 months after second dose of Pfizer vaccine, I had a "flashback" to the symptoms I experienced following the injection: Very sore arm at the injection site (couldn't move arm), low back pain, general aches and pains, extreme fatigue. It lasted 3-4 days, then cleared up-- the same as the symptoms after the injection