chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vials of Pfizer COVID vaccine were stored in the refrigerator with a use-date expiration on 10/19 at 1:30pm. On 10/25,  the patient was given their second dose of COVID vaccine with this vial. No harm detected.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis.  On 14th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the healthcare professional (HCP) for herself. The HCP experienced redness at the injection site following a dose of SHINGRIX. The HCP did not have access to the lot or expiration date.
RASH LOWER BACK AND ON RIGHT ANKLE AND LEG. ITCH AND SWELLING ON ANKLE -SWELLING IN MOUTH GUMS WAS GIVEN TRIAMCINOLONE ACCTONIDE-CREAM FOR RASH
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 02-JUN-2017 the patient was vaccinated with ROTATEQ lot # L048854 for prophylaxis. Concomitant therapies included PREVNAR 13 and hib conj vaccine (unspecified carrier)(HIB CONJ VACCINE (UNSPECIFIED CARRIER)). On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter.
Patient presented to hospital for fetal evaluation,. Patient came with  false labor at 38 weeks 6 days. Patient was discharged home and came back to hospital at 39 weeks 6 days for c section. Patient is asymptomatic.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Regulatory Authority, per guidance from the Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
Patient states two nosebleeds since receiving flu shot. States never had a nosebleed before.
No additional AE/No PQC.; HBP called to report a TE with PROQUAD from 8/19/2022.; This spontaneous report has been received from other reporter and refers to a 5-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 29-AUG-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant human albumin (rha) (PROQUAD) subcutaneous injection, 0.5 milliliter (ml) (valid lot number U039261 [expiration date 09-JUN-2023]) (dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion (product storage error).   No adverse effects reported.
Headache; The initial case was missing the following minimum criteria: no adverse  events. Upon receipt of follow-up information on 07May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient).   A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 11Feb2021 12:15 (Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive prior vaccination. The patient experienced headache on 11Feb2021 12:50; patient never experienced a routing headache like the one had after the vaccine. No treatment was given for the event. The patient recovered form the event on 11Feb2021 (stopped several hours after vaccine).  No follow-up attempts are needed. No further information is expected.
Bruise at injection site.  Bruise faded and then ended up as an indurated area which has become pruritic.  Small bumps at site that are palpable.  The area is oval in shape, measuring approximately 1.5 cm x 2 cm.  It is located on the tricep area of the right arm.  This is the site of the VZV vaccine.
(L) Armpit & Collar Bone Lymph Swelling and Pain  remains at time of form being written  (L) arm sit pain  Fever 102.7 for 14 hours  Joint pain
pt recv vax; immed p/ vax, pain down rt arm into elbow then forearm & wrist; also rt shoulder; achy each noc; spasms burning into hand x 10 days;
I am having a rash on both of my arms with a little itch- and now am getting rashes down my right thigh.
Fever, body aches, chills, fatigue, tachycardia and headache.
tested positive greater than 14 days after fully vaccinated  Narrative: tested positive great than 14 days after fully vaccinated
Patient had uneventful immunization at tiime of injection. Upon waiitng in 15 minute waiitng area, began to feel dizzy and "tingly"   Gave patient water, monitored pulse, applie cool rag. Pharmacist stayed with patient all the time. After 30 minutes, patient said dizziness subsided and was able to stand without assistance and able to leave with parents who were in the store at the time
After receiving FLUVIRIN on 10/5/11 - next day stood up from sitting and foot had no feeling - ER MD said was vaccine related neuropathy.
The evening after pt. received vaccine she developed puffy eyes; Blisters on face and both arms; heated at injection site. Temp of 99.1; itchy at blister sites pt treated at home with APAP and cold compress and BENADRYL sx lasted about 4 days.
Same day symptoms as vaccine administration: night sweats, fever-pt feels hot in 28 degree temperatures at work, fatigue, cough, rash on both hands that does not itch or hurt,  diarrhea, cough.
fainting sensation but she didn't pass out; fainting sensation/dizziness; flushing; numbing sensation on her jaw; tingling; weakness; jaw became heavy for a short time; experienced sore arms; This is a spontaneous report from a Contactable Nurse (patient).A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 14Aug2021 (Batch/Lot number was not reported) (at the age 46-years-old) as dose 1, single for covid-19 immunization. Medical history and concomitant were none. The patient was healthy person. On 14Aug2021, the patient experienced fainting, dizziness, flushing, numbness facial, tingling, weakness, tightness in jaw and pain in arm. The patient reported that she experienced side effects after getting the first dose last 14Aug2021. She specified she had it at the moment while on site. She experienced dizziness, had a fainting sensation but did not actually pass out, flushing, numbing sensation on her jaw, tingling all over the body but most especially on her jaw, jaw became heavy for a short time, and had sore arms. She mentioned that those that she mentioned did not last as she was able to walk out of the establishment. She added that she still experienced overall weakness after she left the vaccination site and a mild tingling sensation for 24 hours. The overall weakness and the mild tingling sensation only lasted for 24 hours that then they both went away, she does not have any side effects to now. The tingling sensation for the most part was kind of mild and she would say that the flushing was moderate because she felt like she had been standing under the sun for hours. The Causality reported as all related because they happened right after the vaccine. On 14Aug2021, the patient recovered from fainting, dizziness, flushing, numbness facial, tightness in jaw, pain in arm and on 15Aug2021, the patient recovered from tingling and weakness.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Syncope, Dizziness, Flushing, Hypoaesthesia, Paraesthesia, Asthenia, muscle tightness, Pain in extremity and suspect drug BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
As dose administered (very high on deltoid) could feel medication shooting through shoulder- not normal for a vaccine and was a little painful. That evening arm was very sore but never red or inflamed. Painful from shoulder to elbow with what felt like numbness and tingling down to wrist. This went on for 4-5 days. Could not sleep on that side and even when laying down in other positions, could not sleep because of pain. Could not raise arm high enough to put on deodorant for a couple weeks. Mild tingling and numbness in hand/wrist continues as of today. Shoulder pain continues to today but has lessened. Pain is minimal now throughout the day but for weeks was painful to rest on arm. I believe the shoulder pain was due to inappropriate administration site (way too high on deltoid, felt like it was given in shoulder joint) more than the drug itself.
1/12 day after administration site - swollen - red - hot - hard. Some improvement noted next day 1-13.
This is a spontaneous report from a contactable physician. This is a report received via a Pfizer sales representative. A 2-year-old male patient of an unspecified ethnicity received four doses of PREVNAR 13, intramuscular, all on unknown dates at 1 single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the physician reported that the patient's titers were undetectable. The physician was inquiring if the patient could receive a fifth dose of PREVNAR 13 in order to check his IGG responses. The clinical outcome of the event, the patient's titers were undetectable, was unknown.
11.5 X 145 inducted inflamed red area with some central echymosis, only mildly tender, not interfering with activity
This spontaneous report was received from a physician and refers to a 18 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-MAR-2018, the patient was vaccinated with GARDASIL 9 injection (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. (Drug administered to patient of inappropriate age), however, no adverse effect were reported.
Shingles diagnosed on 23May2021; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 42-year-old female patient received bnt162b2 (Pfizer covid 19, formulation: solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 13May2021 18:30 (at the age of 42-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included rubber sensitivity for allergies= Latex, HPV (Human papilloma virus infection). 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's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021, the patient experienced shingles and was diagnosed on 23May2021. Therapeutic measures were taken as a result of shingles was antiviral for 7 days. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; No adverse event; Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 29-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date).    No concomitant medications were reported.  The patient received full dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were reported.
Intermittent heart palpitations throughout the day. Lasts for a few seconds.  Patient declined office visit with primary care provider for now.  He  will continue to monitor and will call the office if persists
Increased "startle reflex" every few seconds X 30 min sticking tongue out and increased salivation. Fussy and pale. Refusing to eat. As reported by parent
Mom called regarding high fever of 105F (rectal).  Fever started at 1600 on 1/7/2020.  Patient without other symtoms besides fever.  Patient was evaluated in our office on 1/8/2020, flu testing performed and was negative.  Patient looking well without other symptoms.  High fever continued and peaked at 105.9F on 1/10/2020. Patient was rechecked in our office on 1/10/2020 and had mild upper left eyelid erythema and edema, however no other symtoms and was looking well, no other testing was performed.  Patients fever resolved and no fever noted since morning of 1/11/20.  Patient subsequently has been well since.
Very sore and swollen at the injection site, very tired, headache and muscle aches (entire body), I want to go back home and get into bed.
62 y/o female with past medical history of Environmental Allergies, who presents with itching post vaccination. Patient states that this is her 2nd vaccination in the two-dose series. Patient denies previous reaction to vaccinations in the past. Patient denies sore throat, difficulty breathing, shortness of breath. Patient received the vaccination to her R arm. NP at patient side. Patient is refusing vitals or evaluation by the paramedics. Provided patient with a bottle of water and Benadryl 25 mg PO x1. Patient observed for 20 mins with resolution of symptoms. Patient was cleared to go home.
crohns disease aggravated; flu-like illness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN'S DISEASE (crohns disease aggravated) and INFLUENZA LIKE ILLNESS (flu-like illness) in a 75-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) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced CROHN'S DISEASE (crohns disease aggravated) and INFLUENZA LIKE ILLNESS (flu-like illness). At the time of the report, CROHN'S DISEASE (crohns disease aggravated) had resolved and INFLUENZA LIKE ILLNESS (flu-like illness) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment details were provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Patient received her second dose of Heplisav-B on 02/06/2021 at 10:30AM. Patient notified Medical Staff Associate that she was feeling "lightheaded and woozy" at 11:41AM. Vitals were obtained at 11:50, and found to be 128/88 and HR of 116. Patient stated she felt this way during her first vaccination, and she assumed that it was a normal reaction to the vaccine. Other causes were questioned, and patient denied smoking and stated she had eaten prior to vaccination. Patient informed to notify MSA if symptoms persisted. At 12:45, a follow up was performed and vitals were found to be 139/81 and HR of 101 and symptoms still present. EMS was notified and refused upon arrival.
LAIV given on same day child was seen for a febrile illness. Discussed with parents who state child improving. No concerns re: FLUMIST per parents.
HEART RATE GETTING FASTER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported.  On 05-APR-2021, the subject experienced heart rate getting faster. Laboratory data included: Heart rate (NR: not provided) getting faster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart rate getting faster. This report was non-serious.
2 days T - up to 102.8. Pain could not lift arm. Local swelling with increasing margins. Rx TYLENOL, BENADRYL, day 3 - KEFLEX.
Mandatory Flu vaccine received on Monday 12/04/2017, at 1:04 PM. In the middle of the night on 12/05/2017, I started having excruciating headache, severe nausea and vomiting, and spasms in the left arm. I took a Fioricet first, then later in the morning I took Excedrin Tension. nothing was relieving the pain. I called the Dr and he saw me in the clinic around 10:00 am. He told me it was an adverse reaction to the flu vaccine. He prescribed Phenergan. I took it immediately and when I woke up around 2:00 the headache was better. Continued to feel weak and nauseous for the rest of the day. Slight headache relieved with Tylenol.
Received vaccine with no issues, then watched his mother get two vaccine and after that fainted/seized up for a few seconds and then came too. Sister was also in room crying hysterically prior to the fainting, which could have contributed. Patient was able to come to and 911 was called. An EMT did a patient assessment and determined vitals were normal and no hospitalization was required. Patient left pharmacy with mother.
CHILLS, LOSS OF BALANCE, LIGHT SENSITIVITY  PATIENT STATES FELT REALLY COLD DESPITE TEMP OF  103.1F, SHIVER AND SHAKES ALTERNATING HOT AND COLD AND  SWEATING. SYMPTOMS LASTED ABOUT A DAY AND A HALF.  SENSITIVITY TO LIGHT AND A HEADACHE UNRESPONSIVE TO PAIN MEDICATION. HEADACHE LASTED ABOUT 5 DAYS. ALSO NOTICED  FROM 2/12-2/13 LOSS OF BALANCE WHICH LASTED UNTIL 2/15/21
Information has been received from a licensed practical nurse concerning unspecified amount of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # reported as L0164228 with expiration date 30-JUL-2017, lot # L019287 with expiration date 14-SEP-2017 and lot # L019286 with expiration date 14-SEP-2017; dose and route unspecified). No adverse effects were reported. In addition, the reporter also stated that she was unsure if other improperly stored vaccines such as RECOMBIVAX HB, VAQTA, ROTATEQ, PEDVAXHIB or PNEUMOVAX 23 were also administered. Additional information is not expected as the reporter did not wish further contact.
A physician reported that a 40 year old male received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 11/8/00. The nest day, the pt developed pain at the injection site. Follow-up information received from the physician on 2/21/00, indicated that the pt was seen by the physician on 11/10/00. At that time, the pt complained of anxiety, myalgia and discomfort with left arm movement. The physician reported that the pt had "full motor function and no sensory deficits". He was treated with prednisone and Ativan (lorazepam).
Arm swelled into bump around injection site immediately after injection. Sent pt to walk in clinic. No other RXN (hives, anaphylaxis, pain, itching).
Burning, itchy, and Numbness of Left Thigh in a circle Appx 6 X 6
right side of face drooping, diagnosis Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: El8982), via an unspecified route of administration on 29Jan2021 09:00 at single dose on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot: El3246) received on 08Jan2021 at 03:00 pm on left arm for COVID-19 immunization. The patient experienced right side of face drooping, diagnosis as bell's palsy on 31Jan2021 06:00 with outcome of not recovered. Treatment received for the event included prescriptions. This event resulted in emergency room/department or urgent care. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination.