chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness in area where vaccine given and warm to the touch from shoulder to elbow. Advised BENADRYL / Ibuprofen for area to help with symptoms. Mom advised to call back for appt if sx did not improve. No further issues per mom.
Since receiving the second Covid 19 shot on June 4, it has changed my menstrual cycle. Starting in September I started menstruating every two weeks and the cycle last much longer than normal. I am 48 years old. I began my menstrual cycle at age 13 and I have always been regular. My cycle has always been about every 28 days. I do not have a history of any cycle changes or missed periods.
Patient had sl. reddened area at vaccination site after his first dose ,which lasted only a day. Now a week after his second dose, he has developed a red rash at the injection site, approximately 4 inches in diameter. There is also a hhardened area approximatedly 2 inches in diameter within the reddened area. He complained of itchiness at the site, but no pain. I gave him benedryl 25 mg last night. and the itchiness went away. This morning, he still has the rash, but denies any pain or itchiness. and he feels fine.i did call the doctor's office, but the nurse felt no other treatment was needed.
Rash; Redness; dizziness, headache, burning in her throat and chest, tingling in her chest, her arm felt light weight,; Hand was sore; Swelling; A report was received from a consumer concerning a 65-year-old, female patient of unknown race. Developed anaphylactic reaction and vaccine site reactions.  The patient's medical history included head injury and symptoms of passing out.  Concomitant medication included antibiotic (unknown name)  On 26 Feb 2021, the patient received their first of two planned doses of mRNA-1273 injection (Lot number- 030L20A) via unknown route in right arm for prophylaxis of COVID-19 infection.     On same day, immediately after receiving vaccination, the patient experienced dizziness, headache, burning in her throat and chest, tingling in her chest, her arm felt light weight, not responding to verbal stimuli, hard time breathing, low blood pressure. she also had her hand sore, swelling and redness. She  received Epi pen couple shots (number unknown) and was taken to Emergency room, where she stayed for 4 hours and was discharged with a diagnosis of sever allergy reaction. The treatment details in ER was reported.    Health care provider assessed the events  as related to the combination of vaccine plus antibiotic.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the anaphylactic events were resolved.  The causality assessment of the reported events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
I started feeling not well around the holiday. I had tested before traveling to (Privacy) and was negative for Covid. I could not get a test after coming home because the state of (Privacy) kept closing testing sites because of over demand. My wife and son did get tested, and they were negative. On 1/15/2022 I really started feeling poorly. The next week I was boiling hot and then frozen cold the next. I couldn't work. I took another Covid test and it was negative. I was still throwing up on 1/23/2022. On 1/25/2022 I stopped and started feeling better. My energy was up. Everybody that I'm around are all negative for Covid. My energy is still down and my hips are still inflamed.
This spontaneous report was received from a physician, refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with an unspecified hepatitis b vaccine (Manufacturer unknown), (route, dosage, lot# and expiration date were not reported). Concomitant therapies were not reported. On an unknown date the patient experienced dermatitis allergic, reported as an allergic reaction-rash. The outcome of dermatitis allergic was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Flu-like Symptoms; Dizziness; Fatigue; Injection Site Pain; Difficulty Eating; Shivers; Diarrhea; Weakness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, dizziness, fatigue, injection site pain, eating disorder, chills, diarrhea and weakness. On an unknown date, the outcome of the influenza-like symptoms, dizziness, eating disorder, chills, diarrhea and weakness were recovered/resolved and the outcome of the fatigue and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, dizziness, fatigue, injection site pain, eating disorder, chills, diarrhea and weakness to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of Shingrix in left arm muscle. The patient experienced diarrhea, weakness, shivers, difficulty eating, injection site pain, fatigue, dizziness, and flu-like symptoms.  The patient declines to provide health care provider information for follow-up due to not having a current doctor.  The reporter did not consent to follow up.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Swelling and redness and heat at injection site
Probable intraarticular injection with increased pain & immediate redness. 12/15/12 had cellulitis along AC & bicep groove. Resolved 12/17/12 with antibiotic & steroids.
Client reports she started to feel "off" just before bed on the day of the vaccination.  She felt tired and "not well" all day the day following the vaccination then at 1030pm on the 16th she passed out while sitting at the table. She was unconscious for 1-2 minutes and began vomiting when she came to. Her husband called the ambulance and she was transported to the County Hospital.  ER provider told Client that it was a reaction to the vaccination.
After getting the 2nd dose of Pfizer, two days later, my daughter developed chest pain. She gets the chest pain every day and it today's date is 4/27/2021. She went to urgent care on April 18, 2021. However, she kept having chest pain and Saturday, April 24th the chest pain was intense. Patient states she has daily chest pain. Chest pain tends to be intermittent but she has it several times throughout the day. Sometimes the chest pain can be intense. (patient has a history of Kawasaki Disease, she received IVIG as a toddler and was on aspirin for a few weeks after the treatment. We were concerned if the chest pain was related to her heart).  Currently, still monitoring her chest pains daily.
She had Hib (PedvaxHIB), PCV13 and Hepb (Engerix-B) at the same time. This was her second dose (first dose at 9 weeks) of all 3. She received the PCV13 on the right thigh, with no reaction. On her left thigh, she received the Hib and Hepb. I am not sure which of these two injections caused it, but she had a bump under the skin that was bigger than her nose in size and lasted one month. It was extremely painful when I touched it and if any time I accidentally barely touched her leg she would cry. It slowly decreased in size and was gone in a month.
patient was supposed to receive a dose of plain acthib (prp-t), but consumer got hib conjugated with dtap and a separate dtap as well with no reported adverse event; patient was supposed to receive a dose of plain acthib (prp-t), but consumer got hib conjugated with dtap and a separate dtap as well with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who was supposed to receive a dose of plain HIB (PRP/T) vaccine [ACT-HIB] but consumer got hib conjugated with dtap and a separate dtap as well with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination (immunization).  On 08-Jun-2023, the patient received a dose 4 dose 0.5mL but consumer got it twice making it 1 mL of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot UJ794AA expiry date: 08-Oct-2023 via intramuscular route in the thigh not specified for Immunization.  On 08-JUN-2023 the patient was supposed to receive a dose of plain acthib (prp-t), but consumer got hib conjugated with dtap and a separate dtap as well with no reported adverse event (wrong product administered) (extra dose administered) on the same day following the administration of HIB (PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.   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.
one of the patients wasn't feeling well; the patient took one Moderna shot and then 30 minutes later took a Pfizer shot; the patient took one Moderna shot and then 30 minutes later took a Pfizer shot; This is a spontaneous report from a contactable Other HCP. A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and, expiration date was not reported) as dose 1, 0.3 ml single and first dose of covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, lot number and expiration date was not reported) as 0.5, ml single via unspecified route of administration in the same day on 21Apr2021 (at the age of 38-year-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included gabapentin, pramipexole both taken for an unspecified indication. It was reported that the patient took one Moderna shot and then 30 minutes later took a Pfizer shot. It was reported that one of the patients wasn't feeling well on 22Apr2021(but not right afterwards it was the next day). Patient did not receive treatment for the events. Outcome of the event Malaise was recovered on unknown date in 2021 and other event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow up (23Apr2021/24Apr2021): This is a follow up#1 spontaneous report reported for a contactable reporter for a consumer. This consumer reported for a 38-years-old male patient which includes: new event, Concomitant medications, treatment information, Primary reporter's mailing address and patient DOB added, Vaccination facility information added.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
tightness, pressure and dull pain in left chest (small area over heart) - fluctuates over time - not constant, has not gone away after almost a year
Migraine Tylenol extra strength 500 mg (migraine became worse). Advil 200 mg (mild relief) (resting with hob slightly elevated:30 degrees) Sensitivity to light (darkened room, turned off all monitors and slept with heating pad x9 hours) Sore muscle at left arm injection site and area around it(cold pack for 40 minutes on 1 hour off for 3 days)
Pt received a flu vaccine on 9/7/23 and made another appointment on 10/23/23 for our immunization clinic schedule for flu on 11/8/23. when staff went over questionnaire and confirmed she wanted flu  pt agreed. it was after administration that staff realized pt had already received flu for this season. Consulted with OB provider and it was discussed that pt should be just fine and may even offer extra protection.
No AE; HBP called to report inadvertent administration of PROQUAD after a temperature excursion. Limited patient demographics provided. See AE case #02451227 and #02451228. No additional AE/PQC.   ?    Names of vaccines involved (including lot/exp): PROQU; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with an improperly storage measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live (PROQUAD) subcutaneous injection, therapy type: rHA, valid lot #W016359, expiration date: 16-NOV-2023 (dose, frequency, strength, route of administration, and indication were not provided) (Product storage error). Temperature excursion occurred at 7.3 Fahrenheit (F) for 30 minutes. A previous temperature excursion was reported at 7.9 F for 30 minutes. No additional adverse events were reported.
Hives all over body. BENADRYL here in office at f/u visit.
between 2-6 hrs /p vax /w MR, pt had nausea, vomiting, diarrhea, dizziness, rash all body
Experience a rash on the left torso . The rash look like insect bites.  The rash appear about 12 days after the vaccination. The only appeared on the left side of the body . The vaccine was given in the left arm.
Syncopal episode immediately following vaccinations: Tdap, MENVEO, varicella (L) deltoid. Initial BP 72/50 P 54 and regular. Clammy pale skin. Elevated legs, cool cloth, remained with pt. Recovered and assisted to vehicle.
Pt received FLUMIST, afterwards pt stood up and said he felt lightheaded. RN had pt sit with head between knees. Pt then fell forward and hit floor. Pt turned to his back and knees flexed. Pupils were dilated and agonal breathing, pulse absent to diminished. Episode lasted 20 - 30 seconds. Pt regained consciousness and pulse and respirations normalized. O2 with 2l via mask. Paramedics called to scene. Taken to ER.
I had no reactions to the vaccine. I had no fever, body aches, or nausea only some tenderness at the injection site that lasted a day. Around April 27, 2022 I had swelling in my saliva glands in my lower left jaw. There was pain. I went to the doctor and they examined my jaw. The doctor said I had a parotid obstruction duct. I was prescribed Augmentin, and I was given a Rocephin injection in my hip. The swelling and infection in my jaw is gone. I've been to the doctors four times for them to monitor my jaw. I'm fully recovered now, and there is no swelling or pain anymore.
Swollen lymph nodes under left arm , Arm of injection is L arm. In addition Rib pain across chest with pain while taking a deep breath
Tested positive for Corona virus; Headache; fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Corona virus), HEADACHE (Headache), PYREXIA (fever) and CHILLS (Chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (fever) and CHILLS (Chills). On 11-Mar-2021, the patient experienced COVID-19 (Tested positive for Corona virus). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Corona virus), HEADACHE (Headache), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 102f (Inconclusive) fever with 102 Fahrenheits. On 11-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Corona virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
SUSPECTED COVID-19 INFECTION; DIZZINESS; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a parent concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: epilepsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 01 total administered on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experience nausea (suspected covid-19 infection) and dizziness. On 02-FEB-2022, the patient underwent laboratory test which included: COVID-19 virus test (NR: not provided) Positive which resulted in suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and dizziness was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216410.; Sender's Comments: V0: 20220217623-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
NOT FEELING WELL; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (NOT FEELING WELL) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    No Medical History information was reported.   On 05-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On 28-Feb-2022, the patient experienced MALAISE (NOT FEELING WELL) and HEADACHE (Headache). In 2022, HEADACHE (Headache) had resolved. At the time of the report, MALAISE (NOT FEELING WELL) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624796 (Patient Link).
Extreme headache lasting for two days.  Worse than any migraine I?ve had.  I could stand the headache but the other symptoms need to be reported. SEVERE Chest pains.  Heart Palpitations lasting for two and 1/2 days.  I was definitely throwing PVC?s and at times I thought  I was having a heart attack.  I almost called 911.  This scared me so bad that I do not intend to get the second injection.
pt recv vax 1996 & 5min later pt devel a wheal the size of a quarter @ the inj site;a cold compress was applied to the inj site;same day pt recovered from exp;
Face feeling cold and nostril pain have become more sensitive to certain food consumption, such as, lime/lemon, honey and certain vegetables (Bok chow, green mustard and etc). Watchful of food type consumption and result is the same.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and treated with anti-viral (Paxlovid) from Jul2023 to Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Varicella Information has been received from a registered nurse concerning a seven year old female patient, who on an unspecified date, "years prior" was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In early September 2005, the patient developed chicken pox. The patient recovered on an unspecified date. The registered nurse mention that the patient's two siblings, a ten year old female (0601ISA0321) and a five year old male (0511USA01986) experienced similar events following vaccination with varicella vaccine live (Oka/Merck) No additional information has been requested.
11/01/2021  The patient presents with per husband: upper respiratory infection involving cough, congestion and SOB x 4 days. Pt has been taking antibiotics and husband believes she hasn't gotten better. Husband states she has had some episodes of uncontrolled bladder.  The onset was 4  days ago.  Associated symptoms: shortness of breath, denies chest pain, denies abdominal pain, denies nausea, denies vomiting, denies fever, denies chills, denies headache, denies dizziness and denies back pain.
Immediately when I got the shot it burned like really bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Immediately when I got the shot it burned like really bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Spasms (bad back spasms and for spinal). Concomitant products included DIAZEPAM, TIZANIDINE and TRAZODONE for Spasm muscle, MELATONIN for an unknown indication.    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Immediately when I got the shot it burned like really bad). The patient was treated with METRONIDAZOLE BENZOATE (METROZOLE [METRONIDAZOLE BENZOATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Immediately when I got the shot it burned like really bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included Ice, armband, shoulder rolls.
OBSTRUCTIVE SLEEP APNEA 11/4/2022 UNCONSCIOUSNESS, UNSPECIFIED