chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; has a mild allergy to egg; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 36 years old female patient who experienced hives and has a mild allergy to egg (contraindication for the vaccine administered) while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past vaccination(s) included FLUBLOK. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy.   On 26-Oct-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination, but since, the patient had mild allergy to egg, she was administered contraindicated vaccine (contraindicated product administered) (latency: same day).  On an unknown date, the patient developed a non-serious event of hives (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, she received the Fluzone QIV vaccine on 26Oct2022 and usually gets the Flublok because she has a mild allergy to egg. She states she developed hives and treated it with Benadryl and the hives went away.   Action taken was not applicable.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Urticaria.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event hives and was Unknown for the event has a mild allergy to egg.  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.
I got Shingles on the left side of face; Pain and more pain; Shingles on the left side of face and into my left eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (when patient was 19 years old).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (Verbatim: Shingles on the left side of face and into my left eye) (serious criteria GSK medically significant), shingles (Verbatim: I got Shingles on the left side of face) and pain (Verbatim: Pain and more pain). The outcome of the ophthalmic herpes zoster and pain were resolved (duration 2 years) and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient had chicken pox was awful, horrible, terrible and any other words you might conjure up. They were in patient's mouth, ears, behind her/his knees. no fat forward. The patient was about 70 years. The doctor told her/ him into the Shingles vaccine. The patient got shingles on the left side of face and into her/his left eye, pain and more pain. The patient would not ever get a shingles vaccine booster. At the time of reporting, her/his face was breaking out again with shingles. It happens about 18 months, to 2 years.  The follow-up could not be possible as no contact details were available.
No adverse event; patient was administered ROT ATEQ after a temperature excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were no reported.   On an 18-NOV-2021, the patient was vaccinated with an importer stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot # T033510, expiration date: 28-DEC-2021) 2 milliliters (strength, route of administration, frequency was not reported) for prophylaxis (product storage error). The vaccine underwent a temperature excursion of 47.29-degree Fahrenheit for a period of 3 hours 22 minutes. There was no previous temperature excursion. The patient did not experience any adverse event. At the time of the event, the outcome of the event was not reported.  The causal relationship between the event and the suspect vaccine were no reported.
On 10/13/21 she developed chills, skin hypersensitivity and redness "4" in diameter" at the injection site and a second area of redness below the injection site.
Information has been received from a physician concerning a female pt in her sixties who in approx Oct 2005, was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. On approx 05Oct05, the pt developed upper shoulder swelling, redness and tenderness. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
In October 2021 I started experiencing fatigue and occasional leg pain. The symptoms gradually became worse and in November of 2021 I had lab work done that showed severe anemia. By this time I had extreme leg pain and both knees hurt and I could hardly walk.
fluid in my inner ear; extreme aches, chills, and severe headaches; extreme aches, chills, and severe headaches; extreme aches, chills, and severe headaches; My ear still was feeling pressure; vertigo; vomitting; dizziness; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 15Apr2021 11:30 at the age of 56-years-old (Lot Number: EP6955) as single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Mar2021 09:15 AM (Lot Number: EN6205) as single dose for COVID-19 immunization. The patient previously took pencillin and experienced known_allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included estradiol, estriol (BI EST). It was reported: After first dose of the vaccine I felt fine but had the feeling that my right ear had a bit of pressure in it. After my 2nd shot on a Thurs. I experienced similar side effects as some do. I had extreme aches, chills, and severe headaches. I am a teacher and called in sick the next day. I still passed it on as no big deal until my headache didn't go away. By Monday my headache was severe but I tried going back to work. My ear still was feeling pressure. My Tues. morning I woke up with a headache and vertigo to the point I was vomitting. Went to doctor It was probably fluid in my inner ear. Woke up 2nd day with Vertigo again, went doctor and was given a migrain shot to control my headache. Vertigo subsided. Missed 2 more of work. One month later Vertigo returned with a severe headache. Went to the doctor and she prescribed vestibular therapy. They tested for crystals but ruled it out. They are now trying to treat nerve/tissue damage in my inner ear. Battling dizziness." All adverse events start date was 15Apr2021 07:30 PM. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Vestibular Therapy and Migraine Shot. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021671886 Same patient and vaccine, different dose and events
diarrhea; arm pain; chills; headaches; muscle aches; fatigues; received third dose instead of booster; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received third dose instead of booster), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm pain), CHILLS (chills) and HEADACHE (headaches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Emphysema and Kidney disorder.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (received third dose instead of booster). On an unknown date, the patient experienced DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and FATIGUE (fatigues). On 22-Oct-2021, EXTRA DOSE ADMINISTERED (received third dose instead of booster) had resolved. At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and FATIGUE (fatigues) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.  Patient was not immunocompromised.
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 15-May-2021 and 2nd dose on 29-Jun-2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and DA123A) for COVID-19 prophylaxis. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 15-May-2021 and 2nd dose on 29-Jun-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 15-May-2021 and 2nd dose on 29-Jun-2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if the patient had any side effects after administration of doses.  No treatment medications were reported.   This case was linked to MOD-2022-612876 (Patient Link).
Fever 102, shaking chills, throat clogged, cough 48 hour after vaccine (occurred after flu shot years ago).
intense body aches and fatigue for approximately 24 hours after shot. Onset of body aches - approx. 3:00 am 3/12/21.
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain 12/22/2020 05:30 to 12/23/2020 05:30 Tiredness/Headache/Muscle pain/Chills/Fever/Feeling unwell 12/22/2020 approximately  11:15am to 12/23/2020 06:30; Took Ibuprofen on 12/22/2020 at approximately 06:15pm Minor headache 12/23/2020 06:30am; took Tylenol
Febrile seizure - fever 102 3/8/17, brief less than 20 sec jerking, eyes rolled back. Eval in ER.
Pt had 0.05 ml of INFLUENZA vaccine at 2:00 pm. At 2:03 pm she had seizure. Has hx of uncontrolled seizures taking KEPPRA, ADVIL, amitriptyline, levetiracetam.
No additional AE details were provided and no additional AE's were reported; male patient came in to receive a dose of MMR-II and VARIVAX because he had low titers and received PROQUAD; This spontaneous report has been received from a licensed practical nurse, referring to a 40 years old male patient.  Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  The reporter stated that the patient came in to receive a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot number and expiration date were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route, lot number and expiration date were not reported) because he had low titers, but he received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (dose: 0.5ml, lot # U039260 with expiration date: 03-APR-2023) subcutaneously instead on 19-AUG-2022 (wrong product administered). The strength was unknown for all suspect vaccines. The indication for suspect vaccines was prophylaxis. No additional adverse event (AE) details were provided and no additional AE's were reported.
Information has been received from a nurse practitioner referring to unspecified multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (lot # L006381, expiration date 25-MAY-2016) (dose and route were not reported). The defrost cycles of vaccine temperature of -14 Celsius degrees occurred 6 days in October 2015, and -13 degrees Celsius for 5 days in September 2015. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 16Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 04Dec2019, stop date: 04Dec2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
At nurses station. Yelled-grabbed cold and feel down onto grass-not noted to lose consciousness able to respond verbally.  2 hrs remained patient c/o pain/nausea pointed at umbilicus area- T97 P88 chest CTA HR/RRR S1 S2 supine with feet up. Drank H2O. Called SAA. Home with parents - given 12/10/09.
This spontaneous report as received from a currently 62 year old female patient regarding herself. The patient's historical condition included shingles. The patient's concomitant medications were not reported. The patient had drug reactions/allergies to Penicillin. On 09-NOV-2010, the patient was vaccinated with a ZOSTAVAX, (anatomical location, dose, unit, frequency, expiration date and lot number not specified) injection for shingles prophylaxis. It was reported that the patient's doctor prescribed her ZOSTAVAX because of her age and in order to prevent future shingles outbreak due to a history of prior shingles. On 24-NOV-2010, 07-APR-2016, 29-APR-2016, and 25-APR-2017 the patient experienced shingles outbreaks and was still currently experiencing itching on the hip. On an unknown date the patient also experienced Myeloma (plasma cell myeloma) and Bronchitis. It was unclear if the Myeloma and Bronchitis were preexisting conditions or experienced after ZOSTAVAX was administered. The patient sought medical attention and visited the physician. On unknown date an unspecified blood test was done (details unspecified) (units and values unknown). It was reported that the patient was treated for the adverse events. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was reported as not recovered. The reporter did not assess the causality of the event with suspect therapy. A Product quality complaint was not involved. Upon internal review, the event myeloma were determined to be medically significant.
Ear started ringing; going to the doctor; This is a spontaneous report from a contactable consumer (patient). A 51-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL9265) via an unspecified route of administration on 01Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history included sleep disorder. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/Batch number: EL1284) via an unspecified route of administration on 11Jan2021 as a dose 1, single for COVID-19 immunization. The patient concomitant medications included zolpidem tartrate (AMBIEN) for sleep occasionally. The patient was wondering if anybody is reporting any severe tinnitus side effects of the vaccine. The caller stated that the day after she received her second vaccine on 03Feb2021, her ear started ringing to the point. The caller stated that she was going to the doctor tomorrow to try to figure out the reason. The outcome of the event was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
12 hours after injection, got low grade fever at 99 along with arthralmyalgia. 24 hours after, fever increased to 101 with worsening arthralgia and myalgia. 36 hours after, noticed some rash around waist line and fever keep recurring every 4 to 6 hours. 48 hours after injection, fever 103.1 with rash spreading  all over the torso and upper arm. The first 24 to 36 hours, took only ibuprofen but required to take every 6 hours as fever keep recurring. At 48 hours point when temperature went to 103.1 and rash starts spreading, took 400 mg ibuprofen along with 2 claritin and 20 mg prednisone. Fever stopped ever since then but rash still there.
The patient received a Pfizer Pediatric Bivalent dose that was 2 days expired.  The Pfizer had been in the refrigerator and the beyond use date was 12/26/22.  The patient received the Pfizer shot on 12/28/22.  The patient has not reported any adverse effects from the shot at this time.
Patient has had menstrual bleeding for two weeks after the vaccination and then on random days have heavy and light bleeding .
OP Visit 3/25/2021  Center  Source Organization Encounter Summary    72 y.o. Female; born Sep. 23, 1948September 23, 1948Encounter Summary, generated on Apr. 15, 2021April 15, 2021  Encounter Details Date Type Department Care Team Description 03/25/2021 Hospital Encounter         Cough;  Exposure to COVID-19 virus
Breakthrough COVID Case: Extreme debilitating fatigue, sore throat high in my throat almost on the roof of my mouth, nagging cough, slight fever. The worst of it was the fatigue.
Around 5-10 min after administration patient started to feel chest tightness, "lump in throat", SOB and headache. She was treated with 50mg of Benadrl. Initial vitals were : BP 152/103, O2 sat on RA 99%, HR 10# RR 16. Repeat Vitals were WNL.  Patient has hx of asthma and took 2 pumps of albuterol inhaler. She started to feel better and was sent home. Next day symptoms did not resolve and pt went to ER. She was not examined in ER due to wait time. She took abother 50mg of benadryl and 2 puffs of albuterol inhaler with significant relief. On today she is feeling much better.
Patient seen in office on 6/28/16 and mom reports that following vaccines on 3/22/16, patient had developed a rash that she believes was an allergic reaction.
This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On-19-AUG-2014 the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (dose/frequency not reported) (lot # H015133, expiry date: 09-AUG-2014). No adverse effects reported. No product quality complaint was reported for (Oka/Merck) VARIVAX. Additional information has been requested.
after about 3 days after vaccination; pt began to experience itchy hives around the vaccination area
3/12 vaccination 4/3 I noticed a small patch of rash on upper left of abdomen; itchy and on R outside thigh. It has spread across my belly, on my arms, elbows, back of thighs, back and on outside of my hips (worst section); some is dot like, some is scaly.  4/6 Saw OBGYN. She tested blood work; was normal. She told me I could use hydrocortisone and Benadryl if needed. I have a follow up appt on 4/20/2021. Still presently having rash and itching.  *3rd pregnancy, 6/3/2021 but having C-section on 5/27/2021.
Elevated heart rate (resting heart rate 145), chest pressure, difficulty breathing, arm heaviness
Headache, nausea, severe muscle pain, joint pain, chills fever, elevated BP, diarrhea, facial, hand feet and leg swelling. Back pain.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Mild
- Itchy red spots on chest - Itchy red, scabby spots on the upper back - Very dry, scabby patches around the eyebrows, outside corner of eyes, and one big dry scabby patch on the right cheek about 2 inches long and 1 inch wide
Soreness at injection site starting evening of injection. Next day starting midday, chills (shaking), fever of 100 degrees F.
She got the vaccine, got dizzy, laid down in the bathroom floor and laid there for a while and when she tried to get back up she was not able to move.  She does have life alert and the fire department broke into the house and she was taken to the ER.  In the ER they gave her IV fluids, checked her vital signs.  They did not do anything unusual to her.  She was then released after 4-5 hours.  She is feeling much better, still a little weak but otherwise fine.
5mo old pt recvd DTP/OPV/HIB TITER on 16SEP91; w/in 24 hrs babysitter noted a red rash on the pts abdomen; Later that night mom noted a rash on face; Brought to office on 17SEP w/generalized rash;
high fever 103 5 days p/vax;rx w/APAP & ibuprofen;fever lasted 5 days then devel a gen rash;
she only had a sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she only had a sore arm.) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A. and 003A21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (she only had a sore arm.). The patient was treated with ACETAMINOPHEN for COVID-19, at a dose of 1 dosage form and GUAIFENESIN (MUCINEX) for COVID-19, at a dose of 1 dosage form. At the time of the report, MYALGIA (she only had a sore arm.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) on 15Jul2021 she tested positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant product is given-Allergy meds OTC.   This case was linked to MOD-2021-258894 (Patient Link).