chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up received on 26-MAY-2021.
received Boostrix instead of Flu vaccine; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and COVID-19 VACCINE for prophylaxis.   On 9th November 2021, the patient received Boostrix .5 ml, Boostrix Pre-Filled Syringe Device and COVID-19 VACCINE. On 9th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of Boostrix in the left deltoid. The patient received Boostrix vaccine instead of Flu vaccine, which led to wrong vaccine administered. The reporter consented to follow up. This case was 1 of 4 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021231230:SAME REPORTER US-GLAXOSMITHKLINE-US2021231229:SAME REPORTER US-GLAXOSMITHKLINE-US2021231232:SAME REPORTER
1/4/21 (one week after vaccination) redness, itching, swelling, painful, hot to touch, increasing in size
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 23-APR-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Information has been received from a pharmacist referred to a 85 years old female patient with hypertension and asthma. On 24-OCT-2012, the patient was vaccinated with PNEUMOVAX 23 (lot # 1947AA, exp date 20-OCT-2013) 0.5 ml once, intramuscular left deltoid. Other suspect therapies included Influenza Virus Vaccine (unspecified) on 24-OCT-2012. No concomitant medications were reported. It was reported that within "the next two or three days" on approximately 25-OCT-2012, the patient began to experience a loss of appetite. The reporter did not think the patient has been reported this adverse experience to her healthcare provider. According to the reporter, the patient reports that her appetite was still poor on 02-JAN-2013. No treatment was given. The patient did not sought medical attention. The outcome of loss of appetite was reported as not recovered. The relatedness for loss of appetite was unknown for PNEUMOVAX 23 and Influenza Virus Vaccine (unknown). Additional information has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 82 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
41 yo F w/ PMH significant for pulmonary sarcoidosis, Covid infection (2020), anxiety, depression, schizophrenia with bipolar disorder received a Covid19 (right deltoid) and flu vaccination on 3/23/21.  Patient had brief hospital admission (3/28-3/30) for worsening malaise and adenopathy which was attributed to the COVID19 vaccine and for GI distress possibly due to use of 1000mg ibuprofen q3h x 5 days.  Discharged 3/30.  Was seen in clinic on 4/12/21  for continued GI symptoms, weight loss, productive cough, dehydration and tachycardia.   Sent to ED.  Hydrated and given antiemetics before patient requested to leave.  Per ED MD, patient referred to GI clinic for possible ulcer and follow up of diffuse
4 inch area of erythema around the injection site; 4 inch area of erythema around the injection site/There was no induration or hives, nothing other than pain due to injection; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the first shot and over 4 days developed a 4-inch area of erythema around the injection site. There was no induration or hives, nothing other than pain due to injection. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Minor is 10yr 11 months old and received adult 12yo+ dose of pfizer bivalent instead of the authorized pediatric pfizer bivalent as instructed for 10 yo minor.
8 hours after the second shot I started feeling very aches, fever, chills, extreme headache and intense pain at injection site. This lasted 10 hours and then disappeared.  Had a mildly sore arm on day 3. After my booster, symptoms started similarly around 8 hours post shot. The fatigue was much worse, injection site pain was less, nausea was present. Lingered longer than with shot 2. Fatigue lasted several days finally waning at a week mark.  On day 4 my mouth started feeling weird and several hours later my lips swelled. I have never had lip filler. This lasted the evening and I took a benadryl.  Since then and continuing today my gums hurt and have ulcerated roof of mouth. Lips feel very dry. I seem to be very sensitive to eating.  No metallic taste. Just oral discomfort.  Recently had 6 month Deval checkup and everything was healthy.
Patient reported that she had thrown up and that she also felt hot. She did not know if she had a fever. She reported her symptoms at least a half hour after her vaccination. Recommended that if she develops a fever/ fever worses (once she took her temperature) or if she begins vomiting more frequently to seek medical attention.
Lethargic, t105 x 24 hrs, seizure x 1, nausea & vomiting; APAP & tepid water baths;
received two doses in 2017 and never received the third booster dose. They are a category risk 3 and require a booster dose due to travel with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA188357.  This case involves a 8 years old and unknown gender patient who, received two doses Of Rabies (Hdc) Vaccine [Imovax Rabies] in 2017 and never received the third booster dose. they are a category risk 3 and require a booster dose due to travel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient received two doses of suspect Rabies (Hdc) Vaccine (lot number: not reported, Expiry date: not reported) via unknown route in unknown administration site, indication: prophylactic vaccination) in 2017 and never received the third booster dose. they are a category risk 3 and require a booster dose due to travel with no reported adverse event (inappropriate schedule of product administration).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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.
My first Covid shot was 2/21 and my second Covid shot was 3/21. In April of 2021, I started having chills and sweats. I would go through 5 to 10 shirts a day. Starting in November of 2022 the chills got worse and I refer to them as freezing chills. I have to take 2 to 3 hot showers a day just to get my core temperature up. So I have been having a serious problem with chills and sweats for 2 years and 2 months.
Initial ringing of ears began night after vaccine.  It reduced in level 2 days later.  Then on evening of 4/12 began hearing heartbeat in right ear (Pulsatile Tinnitus).  Noticed it again last night.  Can hear it when everything is quiet and I am trying to sleep, but ear feels clogged during day (maybe not hearing in it as well) and I think if it were quiet, I would feel/hear the heartbeat.  I have never had this issue before.
Patient began feeling faint after a couple of minutes. She states she always has this reaction to needles (vaccines and bloodwork).  I had her lay down and put her feet up. She was given a cold cloth. She is used to this so knew that she just needed to lay down and be still for a few minutes. It was about 5 minutes and she felt like sitting up. She sat up for a few minutes and felt fine. She then went to the chair and was back to her normal self. After 15 more minutes of waiting she stated that she felt fine: back to normal. She is an employee so went back to work and will let us know if there are any more issues. She states there usually isn't after she starts feeling better.
On 3-25-21 approximately 8:00 pm started experiencing muscle aches and fever and chills.  Symptoms persisted through 3/26/21, taking Tylenol as needed.  3/27/21 muscle pain subsided to more of a sharp muscle pains and sporatic events of sweating with some mild fever through out the day with two major sweating  events during the early morning hours of 3/28/21.  Also experiencing headaches from time to time on 3/27/21 and the morning of 3/28/21.  Not sure what to do at this point.
Fever; Chills; Fatigue; Body aches; Tingling in face and arms; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Jan2021 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included leflunomide (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 07:00, the patient experienced fever, chills, fatigue, body aches and tingling in face and arms. 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 fever, chills, fatigue, body aches and tingling in face and arms was resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Middle Back region, Large Red Blotches horizontally, some exhibiting small peaks, from 8:30 AM on, Put Benadryl lotion on early AM, 2:30 PM administered Benadryl PO, and applied hydrocortisone cream.
This case was reported by a consumer (subject) and described the occurrence of itching in a 66 or 67-year-old female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to neomycin, codeine allergy, nickel allergy and shellfish allergy. On an unspecified date "4 to 5 years ago" in October, the subject received a dose of Influenza vaccine (unspecified) (unknown details, left arm). On an unknown date, less than one month after vaccination with Influenza vaccine (unspecified), the subject experienced itching. The subject stated that "this was the only time she had a reaction to a flu shot." The reporter did consult a healthcare professional regarding the event and that medical attention was not required. The reporter stated that she was "going into doctor's office for another reason and mentioned the reaction to the flu vaccine to her healthcare professional." At the time of reporting the event was resolved. The subject said it resolved in a "couple of weeks".
Whole body swell and itching; Whole body swell and itching; Burning sensations every where on body; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 04May2021 13:30 (Lot Number: EW013) as single dose for COVID-19 immunisation. Medical history included anaemia and recovered from Anemia, known allergies as bee stings, mango skin allergy, swelling of face response. severe itching / swelling. Concomitant medications included: thyroid medicine and multi vitamins. Two hours after shot on 04May2021, patient's whole body swell and itching, burning sensations every where on body, took antihistamine at home and went to the ER room where they gave patient steroids and EPI pen as well as more antihistamines. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.  Information on lot/batch was available. Additional information has been requested.
received her first dose Pfizer (LOT#: EW0150) on 4/02/21. Pt reported to EMT that she felt tired post vaccine and a little dizzy. Pt stated that the symptoms came in waves. EMT took pt vital signs BP: 118/82, HR: 87, O2: 98%. EMT offered pt medication or EMS. pt denied both medication and EMS. Pt asked to stay an extra 30 minutes. Pt's symptoms subsided. Pt walked out of vaccination site with a steady gait at 1635.
Narrative: COVID infection following COVID vaccine series 01/20, Pfizer, dose #1 02/10, Pfizer, dose #2 08/04 COVID swab, result: detected 08/05 pt cc: cough, diarrhea, fever, dyspnea exposure; daughter- unvaccinated 08/12 SARS-COV-2 LINEAGE result: B.1.617.2 08/12 SARS-COV-2 clade result: 21A DELTA
Patient felt dizzy and weak.  Lost color and lips were very pale.  Was awake, but confused and semi unresponsive via talking  Requested water and sucking candy. We called 911.  He started to improve. Color was coming back, but he was in a cold sweat. No signs of anaphylaxis.  Was much improved by the time paramedics arrived.  Checked out as precaution
arm hurt; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received 1st shot of Shingrix in afternoon. The patient asked, how long would his arm at shot spot hurt.
Leakage and the patient couldn't get the full dose/ there was a leakage and not all of the expected dose was administered; Leakage and the patient couldn't get the full dose/ there was a leakage and not all of the expected dose was administered; This is a spontaneous report received from a contactable reporter (Nurse) from medical information team.  A 17-month-old male patient received pneumococcal 13-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), UNDERDOSE (non-serious) and all described as "Leakage and the patient couldn't get the full dose/ there was a leakage and not all of the expected dose was administered".  Additional information: Caller stated that a patient (male, 17 months) was supposed to get a dose of the Prevnar 13 vaccine. However, there was a leakage, and the patient couldn't get the full dose. It exploded and the patient didn't get all the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (05Sep2022): This is a spontaneous follow-up report received in response to query. Updated information includes: updated reporter information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 4 hrs. after receiving vaccine HPV GARDASIL 2nd dose, he became pale and listless. Laid in bed for about 4 hrs., then was fine, I would call this a mild reaction, no headache, no fever, just weakness.
This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced seizure type activity. The patient received the first dose on 16-Apr-2010. On or about 18-Apr-2010, the patient experienced a seizure type activity. The child was taken to the emergency room but was not admitted although an unspecified computerized axial tomogram was performed and was reported as "normal". The child was afebrile. No treatment was reported. As of 23-Apr-2010, no further seizure activity had occurred. The patient was considered recovered. No additional information was available at the time of this report.
Patient  received bivalent -pfizer Lot: GJ6739 at 12:35pm  Patient went to car and started driving and felt her heart "racing" and she felt jittery. She stated that her tongue was tingling as well and turned her car around and came back to the COVID center.  The front desk notified nurses and she was put on a cart Patient denies allergies and no other illness at time of vaccination.  Denies and chronic or long standing conditions. Patient states she never had a reaction to any vaccine.  Summary: 12:55 143/82 Pulse 108 res 20 Pulse ox 100%- patient states she feels jittery, tongue tingling, no airway issues, heart racing: 1 pm 125/77 HR 104 Resp 20 Pulse Ox 100%  "feeling just a little better, face feels flushed, heart not racing as much but chest still feels tight, 1:05: 138/92  HR 188  Resp 22 Pulse ox 100%  1:10 Staff walked over and BP 140/90 HER 156- Patient very anxious.  1:11 Activated 911. 1:13 138/92  Pulse 110 Pulse ox 100% 1:16 143/86  HR 114  Pulse ox 100% 1:17  EMS arrived assessed patient. Patient remained anxious and wished to go to the ER. Husband- and son were with patient and went to the ER once patient left in ambulance.  Nurse: Rn Scribe : RN
I had J&J in November, so this was my first Pfizer as a booster.  Seven minutes after I received the injection, my entire left arm (shoulder to fingertips) went tingly, like I fell asleep on it.  I told the pharmacist and asked if it was normal because it was my first Pfizer shot.  He'd never heard of this happening.  He asked if I was sitting the whole time after the shot.  I said yes.  He advised me to sit for another eight minutes to see what happened.  The front desk worker who checked us in came over to see how I was.  My hand had feeling, but my shoulder was still icy.  The pharmacist said to drink water and take Tylenol.  It will ware away.  I was cleared to leave.  I started to drive home and three minutes later my scalp on the injection side (left side) started tingling and then so did my upper thigh on the left side.  I got home and by 4: 32, I had called the pharmacy that my lip and tongue were swelling and tingling.  While on the phone with the person who answered, my speech started to slur, but then corrected itself while we were still talking.  She said they don't handle that there and to call the hospital.  The hospital said I have to go in for evaluation because they can?t give medical advice over the phone, but they were honest and said they were very busy.  I don't feel "sick", so thought maybe I'd go later tonight if this continues.  My right hand started to cramp and tingle at 4:52 PM and now while I'm typing it is a bit cold and both shoulders are tingly.  The right one feels more tingly than the left at the moment.  I have had a few rushes of feeling feverish, but I'm in menopause, so that could be hot flashes.  I'm struggling focusing today, but it could be because I'm thinking about the loss of speech.  Not overly panicked, just a bit concerned.  Still in good spirits and can use my hands to type even though I can't properly feel my fingers.  They're kind of stiff, sweaty, tingly, cold, and my wrists are surprisingly sore all at the same time.
Small rash initially, raised, swollen and painful.  Ten days later and the rash has faded in color but EXTREMELY itchy and swollen.  Chronic insomnia following the injection and bouts of diarrhea.
Pain at injection site, joint pain, swelling, itching, hard lump at injection site, fever, redness.
Extreme fatigue      3/6 -03/7  fever (highest 100.4)      3/7/21 headache   3/6 - 3/7