chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/09/2022 I started coughing and had a tickle in my throat. I had been exposed to COVID. I started taking day time severe cold and flu. I tested and was negative. On 12/10/2022, I had a cough and headache and I tested positive that evening. I continued with a cough and headache. On 12/11/22 I also had night sweats. On 12/12/22, I began feeling better, had more energy, coughing less and a little congestion. I called my doctor on 12/12/22 and he said I sounded good, mild symptoms and gave me a prescription for PAXLOVID which I did not need to take. As long as I took my 1 tablet of severe cold and flu, I was good, my symptoms were gone. I had recovered by 12/13/22.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Looked over and saw patient slumped backwards in chair. He was unresponsive and mom had to catch him before his head hit the ground. I did not want to wait to determine if patient was breathing or not and gave him epinephrine in case he could have been allergic. I was concerned because he did not express any nervousness or history with fainting after vaccinations.
Severe joint pain; Headaches; Low Grade Fever; swelling; This is a Spontaneous report from a non-contactable consumer (patient). A 39-year-old male received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 26Feb2021 as dose 2, single (age at vaccination: 39 years) for COVID-19 immunisation. Medical history included none history. Concomitant medications were not reported. Historical vaccine includes received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 05Feb2021 as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks, no other medications in two weeks. No covid prior vaccination and did not tested covid post vaccination. No known allergies. On 26Feb2021, one full week after second dose and still experiencing moderate to severe joint pain. Still experiencing low grade fever. 24-72 hours after both first and second dose had severe joint pain and swelling, fever, headaches. The clinical outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Apr-2022.   The pharmacist reported that vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. The vial had not undergone any temperature excursions. The pharmacist does not have any other information on the patients at that time and would call Moderna when additional information was known. The health care professional further stated to provide missed information and mentioned that 155 patients were vaccinated with expired doses from 02-Apr-2022 to 19-Apr-2022.  No treatment medications were reported.
1) Pain around the location of the first shot.  The pain went away after a couple of days. 2) Chills, fatigue, and body ache after the second shot.  They all went away after 2 days.  However, 2 days ago (June 2, 2021) - that is 2 months after the second shot (April 2, 2021), I started to have chills, fatigue, body ache, and some low fever (99.5), the same exact feelings that I had right after the second shot!  I took one pill of ibuprofen and it helped with the body ache.  However, fatigue did not go away until 2 days later (June 4, 2021).  I was worried and thought I had caught covid, so I got tested, and the result was negative!  Today, June 4, 2021, I got up and felt like myself again!    What is the possibility that the side effect keeps coming back like this?  I asked the nurse, who informed me about my negative result, this question, and she said that I might have caught a bug!  I told her that it was unlikely I would have recovered quickly if that had happened!
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Large red swollen area on right arm.  Red area is hard and warm to the touch.  First seen by mother on Thursday 9/10/2009.  Went to urgent care evening of 9/10/2009 dx. with cellulitis right bicep tx with omnicef.  Red area increased in size by am of 9/11/2009 went to Pediatrician dx with allergical local reaction tx continue omnicef, benadryl (oral) q 6hrs.  Per mother after leaving peds office child complained of scratchey throat peds office notified advised mother to take to ER.  Sparrow ER dx as local reaction continue tx from above adding benadryl cream, pepcid and steroid.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022 at 12:19 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Feb-2022 at 12:19 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 12:19:38. . No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Patient of inappropriate age got Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   Concomitant products included PEDIARIX.   On 17-JAN-2023, the patient received Kinrix. On 17-JAN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient of inappropriate age got Kinrix). The outcome of the inappropriate age at vaccine administration 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 Information: GSK receipt date: 24-Mar-2023 The vaccine administration facility was the same as primary reporter. The reporter shared with 2nd line agent that a dose of Pediarix was administered. The reporter consented to follow-up. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Dizziness, Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative: Employee has fever of 100.8, myalgia, congestion, H.A., Nausea,dizziness. She feels like she was run over by a truck. She called in today and is calling in tomorrow due to fever. Tylenol is helping to decrease the fever, ibuprofen is helping with body aches.
Hives and rashes 48 hours after shot. Itching. One Benadryl taken, resolved within 10-15 minutes; Hives and rashes 48 hours after shot. Itching. One Benadryl taken, resolved within 10-15 minutes; Hives and rashes 48 hours after shot. Itching. One Benadryl taken, resolved within 10-15 minutes; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8730) via an unspecified route of administration in the right arm on 01Apr2021 at 15:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis. The patient had no known allergies to food, medicine or other products. The patient had not taken other medications within two weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 17:00, the patient experienced hives and rashes 48 hours after shot and itching. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of hives, rashes and itching which included treatment with one Benadryl and it resolved within 10-15 minutes. The clinical outcome of the events hives and rashes 48 hours after shot and itching was resolved within 10-15 minutes after taking one Benadryl on 03Apr2021.  No follow-up attempts are needed. No further information is expected.
Itchy since before 5/7/21.  No rash.  Terrible itching all over.  Hands, skin.  Some hives that come and go.  Benadryl some help.  Relatively normal reactions otherwise with both shots.  Chills, vomit, body aches.   This itchy thing is nuts.
I?m having trouble with GI, vomited bile. Upset stomach for 2 weeks, since 4/28/2021.  Also experiencing ache in right arm. Lastly, I?m in menopause but had a period in May that lasted 7 days. I haven?t menstruated  in over a year.
sore arm, redness around injection, itchy, and puffy.. these symptoms were there at least 2 days after injection, went away and yesterday, a week later showed up again.
This spontaneous report was received from a physician refers to a 33-year old male patient who was HIV positive. On 07-JUN-2013 the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and route not provided). The patient was outside the age range. Reported patient has had no adverse effects. Additional information has been requested.
Tinnitus bilaterally since 1st dose,; This is a spontaneous report from a non-contactable healthcare professional. A 59-year-old unknown gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 24Mar2021(at the age of 59-year-old) as a single dose for COVID-19immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, unknown if  the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 the patient experienced tinnitus bilaterally since 1st dose. No therapeutic measures were taken for the reported events. The clinical outcome of the event tinnitus bilaterally since 1st dose, was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning a 10 year old male son with no previous medical history reported, who on 19-AUG-2008 was vaccinated with 0.5 mL VARIVAX (Oka/Merck).  There was no concomitant medication.  On 20-AUG-2008, the patient experienced rash around the injection site.  As of 22-AUG-2008 the injection site rash persisted.  The patient did not seek medical attention.  There was no product quality complaint.  No further information is available.
Kinrix was given to a 7 mo old new patient for her Dtap/IPV immunization requirement.  The child was behind on his shots though the kinrix is only approved for kids at least 4 yo.  Mom notified 9/18/19.  No unusual local reaction.  No fever.  Doing well.  Have had contact with the CDC regarding this error - this dose of the Dtap & IPV do not need to be repeated.
Case number PHEH2015US019560, is an initial spontaneous report received from a health care professional (HCP) on 30 Sep 2015. This report refers to a 47 year old female patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. The HCP reported that the FLUCELVAX which was stored at room temperature for 24 hours was administered to employees. No adverse event was reported following the medication error (incorrect storage of drug).
On day following patient's second Rotateq vaccine he had an episode during the night where mom said he seemed inconsolable and had abdominal pain.  Then later that day he had one bloody stool.  The family was out of town when this occurred so I didn't see the patient at this time.
Patients arm was severely red, warm, and raised around injection site, symptoms occurred about 5 days after vaccine administration
Days 1&2: Flu-like symptoms: chills, body aches, fatigue Day3-present: heart palpitations, shortness of breath with minimal exertion, mild tachycardia at rest and intermittent bouts of extreme tachycardia (150-218 BPM heart rate) which lasts only a few seconds but causes nausea, weakness and lightheadedness requiring 15-20 minutes to recover.   Severe shooting thoracic level back pain occured within the first week but has subsided.  Intermittent chest pain which changes with position,  tachycardia exacerbated by sidelying position and muscle fatigue/cramping/twitching also occuring intermittently.  I am currently on a 10 mg propanolol PRN (taking 2x/day most days) and trialing 25 mg of Zoloft.  Propanolol has helped to control tachycardia but not fatigue and chest pain.  Zoloft has not had enough time to take effect (1 week in).
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in past) and Chicken pox vaccine (received in past). On 10th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, 12 hrs after receiving SHINGRIX, the patient experienced muscle pain, chills and headache. On an unknown date, the outcome of the muscle pain, chills and headache were unknown. It was unknown if the reporter considered the muscle pain, chills and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced muscle ache, chills and headache. The reporter did not consent for follow up. No further details were provided and the patient would follow up with their health care professional.
After second shot: Fever, chills, aches, weakness, brain fog, minor arm soreness. Symptoms started approximately 6 hours after the vaccine and lasted about 48 hours. Fever reached 102.6 before I took Advil. I took Advil twice to control fever in the 48 hours.
large red, swollen, warm and itchy patch on upper left arm at injection site. used cortisone cr for itchiness and oral Benadryl  .Day 3 rash is slowly failing and still very itchy.
I got what is described as "Moderna Arm" or "Covid Arm" several days after the vaccine, around the injection site I had a large hard red rink. Not a full rash, just hard and a little itchy and hot.
after the second dose she experienced body malaise, she was tired, and did not want to do anything; after the second dose she experienced body malaise, she was tired, and did not want to do anything; she did not feel like her self/ She just felt like something was not right; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 27Jan2021, for COVID-19 immunization. The following information was reported: MALAISE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "after the second dose she experienced body malaise, she was tired, and did not want to do anything"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she did not feel like her self/ She just felt like something was not right".  Additional information: She was calling to check to see if she waited too long for the booster. She wanted to know if it was okay to get the booster now. She was scheduled to get it 06Jan2022. She clarified and said she just said she did not feel like herself. She wants us to know it's not her fault she waited this long for the booster. She went to try and get the booster the same time she had the flu shot, but the doctor told her to wait.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy dry skin patches around arm, chest area, back and face.  Itchy ears, knot in back.
extra dose administered; Inappropriate schedule of vaccine administered; This spontaneous report has been received from other health care professional via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS# 2110USA001194) concerning 3-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-JUL-1999 and on 12-NOV-1999, the patient was vaccinated with first and second dose (Inappropriate schedule of vaccine administered) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB); the third dose on 28-JAN-2000 and a fourth dose on 17-JUL-2000 (Extra dose administered); all administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  This is one of 4 cases of the same patient.; Sender's Comments:  US-009507513-2110USA001194: US-009507513-2303USA008561: US-009507513-2303USA008560:
tenderness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (tenderness at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site). At the time of the report, VACCINATION SITE PAIN (tenderness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
27 Sep -1415 Injection L Arm  -2307 Noticeable feeling of being cold in 70° indoor office 28 Sep -0035 stomach pain and rapid onset of diarrhea, onset of chills/shivering -0130 chills/shivers, wearing jacket and wrapped in light blanket in 73° indoor office, shaking intermittently. -0300 Under heavy blanket, cold shivers and heartburn. 1 Dose Liquid Extra strength Gaviscon taken.  -0430 Fever and hot sweats -0600 Fever temperature taken, 103° forehead, 101° temple.  -0630 CPAP in use with Ice cubes in reservoir to chill breathable air easing breathing. 2 X 500mg Tylenol Extra Strength Pain Reliever and Fever Reducer Caplets -1530 Fever breaks and sweating stops, feeling of muscle fatigue and injection size pain.  -1700 Shower water temperature feels normal, body muscle fatigue in all extremities, low pressure migraine and occasional nerve tingling. Possible aggravation of nerve and muscle twitches from not taking medications in two days.  29 September  -0030 Muscle fatigue and low pressure migraines continue. Temperature Forehead 99.2°, Temple and Ear 98.6°. Knee and elbow joint pain making sitting uncomfortable. Forehead pressure. Appetite normal, intermittent feeling of abdominal discomfort and soft stool.
EPILEPSY, GENERALIZED IDIOPATHIC STATUS EPILEPTICUS EPILEPSY, UNSPECIFIED PULMONARY EMBOLISM, UNSPECIFIED.  PATIENT HAD SAME ADVERSE EVENT ON : 02/25/2022, 04/09/2022, 04/12/2022, 04/21/2022, 04/22/2022, AND 5/17/2022
This spontaneous report was received from a nurse referring to a 14 years old patient of unknown gender. Information about concurrent conditions, medical history and drug reactions was not provided. On 15-OCT-2018, the patient was vaccinated with a dose of PROQUAD (therapy type: recombinant Human albumin (rHA), lot # R008204, expiration date 16-SEP-2019) ) with sterile diluent (MERCK) (lot# reported as N029881 with expiration date May 2020 (reported as "34-MAY-2020")) subcutaneously for prophylaxis (drug administered to patient of inappropriate age). No Adverse effects were reported.
After receiving the second vaccine, patient reported feeling "tingly" approximately 10 minutes after dose was administered. EMT team monitored for effects, could not find any signs of anaphylaxis or swelling. However, patient still reported not feeling well. Patient was given 25mg of diphenhydramine at 2:32pm that did not help with the symptoms. Pulse was 91, pulse oxygen was 98%. Blood pressure was not taken. After attempting to have the patient stand, they became very dizzy and were asked to sit back down. After monitoring for approximately 40 minutes with no improvement in symptoms, emergency personnel were called.
SHINGLES  TX: 04/27/2021-RX ValACYclovir 1 gm QTY 21 Blisters, extreme nerve pain one month +
Dose 1 - starting 24 hours later fever, chills and fatigue. Resolved within 24 hours. Sore arm lasting 3-4 days.  Dose 2 - several hours after shot fatigue, fever below 100. On and off for about a week. Day 8 after shot developed hives/rash reaction on arms and legs.
stiff neck and back 2 days after vaccine, HA, body aches, throbbing in legs