chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWOO158) via an unspecified route of administration in the arm left on 21Apr2021 at 13:15(at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus. Concomitant medications included acetylsalicylic acid (ASPIRIN), insulin lispro (HUMALOG) and melatonin (MANUFACTURER UNKNOWN) from unknown dates for unknown indication. The patient previously took Sulfa and penicillin. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the 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. On 28Apr2021 the patient experienced Developed Shingles. Therapeutic measures included treatment with An antiviral drug prescription- Valtrex. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event Developed Shingles was resolving.   No follow-up attempts are needed. No further information is expected.
A rash appeared around the injection site  9 days after the shot. A swollen and slightly painful lymph node appeared 9 days after the shot. Rash went away within 3 days. Still experiencing swollen lymph node 6 days after appearance.
Initially I had a sore throat and raspy voice, the sore throat lasted about a half day and the raspy voice was gone after my second dose of Paxlovid. I was home testing since my husband had tested positive. I took three home COVID-19 test that came back negative even the day before my positive test. I called my doctor on Tuesday June 28, 2022 after my home COVID-19 test came back positive. She prescribed the Paxlovid that I started last night. As of this morning June 28, 2022 I am feeling much better.
Loss of taste and smell after Pfizer vaccine, symptom has continued to current date. I have never had Covid and I've had two negative Covid tests since symptoms occurred to confirm that I did not contract the actual virus.
Pt is an 87 yo M, hypothyroid and peripheral neuropathy who presented to the ED with weakness. Pt reports that he was outside loading a trailer when he suddenly felt lightheaded and like he was going to pass out. Pt also enorses nausea, denies vision changes. Pt lowered himself to the ground and called his son to help him and take him to the hospital to be assessed. Pt reports that he frequently has episodes of lightheadedness in the mornings for the past 5 years, but they have been increasing in frequency and this episode was the worst he has ever had. On arrival to the ED he continues to have generalized weakness and is unable to sit up and feels unsteady on his feet.
Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and SALBUTAMOL SULFATE (INHALERIN) for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (Arm was a little sore). At the time of the report, VACCINATION SITE PAIN (Arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Other concomitant medication included unspecified Ace Inhibitor, once a day.  No treatment information was reported.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-024834 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Chills, body aches, fever, headache, and sore arm for 32 hours.
This is a spontaneous report from a contactable consumer (patient). A 26-year-old (non-pregnant)  female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 26, via an unspecified route of administration, left arm, on Apr 15, 2021, at 16:45, single dose, for COVID-19 immunisation. Medical history not reported. The patient did not receive any concomitant medications. The patient is allergic to sulfa. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 15, 2021, at 17:00, 45 minutes after injection, patient felt her lips and face became numb and were still partially numb the next day. Therapeutic measures not taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of numbness in face and lips: recovered, with sequelae on an unknown date in Apr 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Patient was a 9 year old girl arriving to receive a age 5-11 Pfizer COVID vaccine under NDC 59267-1055-04 Lot number FK5127 Exp 1/15/22. Her mother was also receiving her Pfizer COVID booster. Both shots had been taken into the vaccination booth and the 9 year old received the adult dose of vaccine instead of the child. No adverse events to report at this time.
Red lump warm to touch day of shot 3 days later shot injection site itchy and itchy rash all over the body rash hurt to itch day 6 after shot having flu like symptoms headache body aches fever chills nauseated dizzy light headed and very fatigued day 10 contacted my Family doctor to see him but instead they called in a prednisone pack to pharmacy day 13 Husband called Doctors Office  asked for Doctor to see me , the Office called back and said go to urgent care went to Urgent Care Facility  they checked blood sugar and urine gave me a prescription for scabies wash hydrocortisone cream and told me to get over the counter Zyrtec only got Zyrtec and itchy rash stopped itching and started to gradually disappear on 8/20/2021 I was supposed to get Pfizer Covid 19 second dose and I refused I figured if I took it it could be life threatening with the reaction I have had from first dose I have developed new symptoms  on 8/20/2021 body tremors loosing bladder easily sore throat tightness in chest
Irritability started approximately 3 hours post flu shot during a phone call with my father-in-law. I am usually very patient and enjoy helping him with his computer issues but during this phone call, I completely lost it and had to apologize to him afterwards. When I woke the next day I wondered if the behavior, that was totally unlike me, might have been caused by the high-dose four strain flu shot. I looked to see if irritability was a side effect but found it listed only for children of regular strength four strain flu vaccine. Could my weight at about 110 pounds taking the high-dose be equivalent to a child taking an adult regular dose?  My Irritability was gone by afternoon of next day, so within 24 hours, but thought this event was worth reporting.
Sixty one yrs old female presented to foreign travel clinic at local health dept. Client requesting Hepatitis A and Typhoid vaccine. Client was given a 1.0 cc dose of Typhoid VI vaccine and a 1.0 cc dose of Hep A vaccine. Error noted immediately after administering the extra dose of typhoid. Client was given Typhoid VI lot number C1121-1 in rt deltoid muscle. Failed to re check dosage amount and re check name of vaccine being administered. Typhoid VI was provided in multi dose vial. Client is doing well. Steps to prevent future error slow down and follow re checking steps when administer any vaccines.
Chills/shivering; fever; body aches; cold sweats; headache; cramps/spasms in shoulders, stomach, sides, back, feet; stiff neck
10cm X 12cm red, swollen area at site of SC injection (Varicella) on left arm. Treated with Advil and Benadryl.
tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: el3246), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN9681), in left arm and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Jun2022 as dose 4 (booster), single (Lot number: 042121A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; ROSUVASTATIN; MAGNESIUM; VITAMIN D3; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN C [ASCORBIC ACID]; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive on day 10; Negative, notes: an almost-negative test on day 7. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed hives on right arm, right side of neck and face and swelling on right side of face on 8/2/14 after MENVEO vaccine on 8/1/14 still present on 8/4/14.
Within 24 hrs, pt began having chills, myalgias, nausea, extreme fatigue. Pt seen by PCP at 48hrs after injection with symptoms remaining.
Patient was administered vaccine at approximatley 4:30PM on right upper arm. I was talking with gaurdian about 5 min after administration patient stated that the site she received the injection on her right arm was itchy. When asked about the other side patient stated that side was fine. Went to find a provider to make so that they could evaluate patient and patient stated that she was itchy on both arms. Patient was assessed by provider and given 25 mg of benadryl, there was no reports of itching anywhere else on patients body. Proivider reassessed patient later and itching had improved and had not spread anywhere else.
Patient states previously had a non-severe allergic RXN to Covid vaccines (hives), but denies any severe allergic RXN (SOB, Wheezing, swelling, etc.). Approximately 10 mins after receiving Covid vaccine (at 14:20), patient did experience itchiness on hands, at injection site, and legs- gave Benadryl 25 mg PO, counseled patient that can cause drowsiness and instructed patient to go to ER if any worsening SXS. Patient was observed for 30 minutes.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 20-AUG-2015, the patient was vaccinated with expired dose of PROQUAD (Merck) (lot # K002483, exp. 18-AUG-2015, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several report from the same reporter. Additional information has been requested.
Per Staff - VARES 12:02 pm 11.06.2023 via phone  ** Warning: Knowingly filing a false VAERS report with the intent to mislead the Department of Health and Human Services is a violation of Federal law (18 Code § 1001) punishable by fine and imprisonment.  Practice Manager Although the employee did NOT have an adverse reaction (listed on the web site - PDF file for "adverse reaction(s)" the following form is to be completed.  The vaccine is intended to be administered to patients age 65 and above. The patient DID not experience any side effects, other than tenderness (next day) at the site location left deltoid.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA274230, 2018SA274229 and 2018SA274203 from same reporter. This case involves Adolescent male patient (age unknown) who received vaccines ADACEL and MENACTRA. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect MENACTRA lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient received injection of suspect ADACEL lot number, expiry date not reported via unknown route in unknown administration site. It was an actual medication error due to incorrect product. It was reported that from 30 Jul 2018 to 03 Aug 2018, patient received doses of vaccines stored outside the recommended range. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender- none.
Patient received the Monovalent Comirnaty vacccine and should have received the Pfizer Bivalent booster vaccine.  Patient contacted by clinic. No adverse outcomes noted.
Flu; Initial information received on 12-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves a adult patient (age and gender: unknown) who experienced flu while receiving  Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer (strength, dose, route and formulation: unknown) (lot and expiry date: not reported) in unknown administration site for prophylactic vaccination.   On 11-FEB-2022, the patient developed a non-serious event flu (influenza) (latency: unknown) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  At time of reporting, the outcome was unknown for the event flu.
innapropriate schedule of Hepatitis B vaccination; This spontaneous report was received from a medical assistant concerning a 9-weeks-old female patient. Information regarding the patient's current conditions, medical history and historical drug was not provided.   On 03-APR-2013, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) first dose. On 03-JUN-2013, the patient received the second dosis of the Hepatitis B Vaccine (Recombinant) (manufacturer unknown), and on 22-OCT-2013, the third dose was administered (dosages, routes of administration, lot numbers and expiration dates were not provided) all of them as prophylaxis.  There reporter did not provided the reason why the second dose was administered one month after the date it should be administered.  Vaccines administered concomitant with the second dose included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid; Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Manufacturer unknown) an Polio vaccine.; Sender's Comments:  US-009507513-1508USA008403: US-009507513-1508USA008403:
chills, fever stomach ache itching at site . bumps at site . spoke with pharmacist and was to that she now has chicken pox
Per nurse, he has ran fever of 101 x 2 days and he went home sick today. He started running fever around 730-800 pm on 3/16 the day of his vaccine, and he has had chills off/on. He reports that his Covid was severe back in November, but he wants his vaccine and cont. to want to his second vaccine when the time comes. Vaccine
We came to complete vaccines at the nursing home and was told Patient needed a 2nd dose. We did not have a pt's vaccine card available.  No immediate access to Database was available.  Shortly after giving vaccine, I came back with information that the pt was previously given Pfizer.  Pt was monitored and did not have any adverse effects at the time of this report.
Twinrix expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old male patient who received HAB (Twinrix) (batch number 57E3G, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th April 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 20th April 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 21-APR-2022 Reporter's Comments: Office manager stated that, the patient received expired vaccine. The consent to follow up are given. Additional supportive information: Twinrix expired dose was given to the patient, which leads to expired vaccine used.
After receiving the first dose of pfizer covid-19 vaccine, pt had stated she had itchy and burning sensation in right and left jaw, as well as same sensation on the upper lip.  Treatment for symptoms included oral intake of Cetirizine 10mg.  Pt was observed for 30 minutes without any developing reactions.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On 29-JAN-2018, the patient was vaccinated with a first dose of VAQTA (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecidies date in February 2018, (reported as "one month after the initial dose"), the patient was vaccinated with a second dose of VAQTA injection, 25U/0.5ML PED PF SYR CARTON OF 6, 00006409509, lot number N005605 with expiration date on 08-APR-2018 (dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported.
had vaccine, diagnosed with shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Pneumonia vaccine with an associated reaction of pneumonia (Pneumonia vaccine twice and was diagnosed with pneumonia 2 years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingles vaccine few years ago, even paid for it and still had been diagnosed with shingles. The patient was being treated for it now. The patient had the Pneumonia vaccine twice and was diagnosed with pneumonia 2 years ago. The patient also had Covid-19 vaccines. So far the patient had been healthy, but knew of others that were getting sick after having the vaccines. The patient stated that the vaccines did not work. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
left thumb pain, sore, warm, pain. about a week after the shot. My sister which got shot at a completely different location and day has  the same issue  but more severe .
PT AGE IS 15 YEARS OLD  AND  VACCINE IS RECOMMENDED FOR PTS OLDER THAN 18
Case number PHEH2014US024968, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 70 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 22 NOV 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion.
Few minutes after the vaccine, patient was sitting on the floor of exam room, slumped to the floor and lost consciousness. Had a brief jerking movement of limb, then stopped. Vital signs were checked. Heart rate was initially normal, dipped briefly to the 40s, then recovered to the normal range. LOC was brief < 1 minute. Immediately after, patient was alert and conversing normally. Patient had possible bladder incontinence during event.
Person received Modernal Vaccine when they had previously gotten Pfizer. No adverse reactions happened. They were monitored for 15 mins and then were released to go home.
Mild tingling of the right upper lip, no swelling no respiratory issues. Tingling resolved at 9:53am and the patient was discharged to home.
Patient stated that she had a metallic taste and headache after receiving the Moderna COVID-19 vaccine
Numbness on left side of face for 45min, began within 5min after injection.
Pure and absolute exhaustion, Almost fainted due to the exhaustion, Stayed in bed for three days, After the third day, I started feeling fine and went back to work.
Fever ranging 99.0 to 100.6, headache,  fatigue,  body aches, chills, shivering.