chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Light headedness, fever, muscle aches, headache. Began approximately 12 hours after dose was administered.  Prevented returning to work or any strenuous physical activity?have not waned noticeably now 34 hours after vaccination.
(R) arm became red and had welts - itchy. Took BENADRYL PO. & redness reduced.
Warm left arm at the injection site after 4 hours.  Both shoulder joints and hip joints were painful about 8 hours after injection. Took Tylenol.  Light headache and tingling under hairline on the back of the neck.  8 hours after injection.  2:30am chills until 3:00am.  Fell back to sleep.  8:00 am - 9:30 am. Sore muscles and bones from head to toe.  9:45am took Motrin and Tylenol seems to work.  I feel better.
Lots of pain in her arm, it is also swollen; Lots of pain in her arm, it is also swollen; Fever of 101; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller was calling on behalf of her mother who got the COVID vaccine yesterday on 21Jan2021 in the afternoon around 2 o'clock. She woke up this morning on 22Jan2021 with lots of pain in her arm. It was also swollen. She also has a fever of 101. The outcome of the events was unknown.   Information about lot and batch number was requested.
Information has been received from a female patient of unknown age referring herself. On an unknown date in 2015 (a few weeks ago before reporting time) the patient was vaccinated with VARIVAX (Merck) (lot# was not reported). The patient took a pregnancy test and found that she became pregnant. The LMP and EDD was not known. The pregnancy outcome was outcome pending. The patient experienced vaccine exposure during pregnancy. The outcome of the vaccine exposure during pregnancy was unknown. Additional information has been requested.
Opened IPOL was exposed to the temperature of 49.6F for 12 minutes with no reported adverse event; the patient received ipol post excursion with no reported adverse event; Initial information received on 23-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA146876.  This case involves a 4 months old female patient (24 cm and 5.7 kg) and reporter reported that the IPV (VERO) [IPOL] was exposed to an 49.6 Fahrenheit temperature for 12 minutes and the patient received ipol post excursion 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 PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and HIB VACCINE CONJ (TET TOX) (ACTHIB).  On 05-May-2023, the patient received suspect IPV (VERO) for Suspension for injection (with an unknown dosage, frequency, strength, lot: V1A022M, Expiry date: 17-Feb-2024) via Intramuscular in left arm for prophylactic vaccination (immunization) and the ipol was exposed to an 49.6 Fahrenheit temperature for 12 minutes with no reported adverse event. (product storage error) (unknown latency) and on the same day the patient received ipol post excursion with no reported adverse event (poor quality product administered).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  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 guidelines. 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.
Moderate pain in left arm around injection site; This is a spontaneous report from a contactable physician, the patient. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK9231), via an unspecified route of administration in the left arm on 07Jan2021 17:00 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisinopril. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 07Jan2021 23:00, the patient experienced moderate pain in left arm around injection site. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event, moderate pain in left arm around injection site, was recovering.
Mother refers she applied vicks to the injection site and pt started scratching the area. Next day the injection site became warm and slight edema.
Extremely sore arm - much more than flu shots and STILL very sore.  Ice and Ibuprophen 400 did not help.  Chills and shaking so much I put on flannel pj's.  Very tired next day.  Did almost nothing and took 2 naps.  Was still some tired today but better
After 3rd shot, pt had left elbow and wrist pain significant enough to impair work for 12 days after the shot.
following day very tired & arm sore;the second day p/vax had severe diarrhea & vomiting lasting 3 days;no treatment;
Extended length of soreness in injection site and swelling. Pain, numbness and swelling in arm and hand that the shot was given in. Unable to sleep due to pain that is both a dull ache and a shooting pain. A cortisone shot was given and anti-inflammatories.
Narrative:  Unexpected death with no adverse sequelae during observation period following second Pfizer COVID-19 immunization. Patient has a past medical history of atrial fibrillation, COPD, and hypothyroidism.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.
Circular red rash at injection site; Circular red rash at injection site; This is a spontaneous report from a contactable consumer, the parent. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), taken for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient experienced circular red rash at injection site approximately 2 inches in diameter, which was not painful or itchy. Therapeutic measures were not taken as a result of the event. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event circular red rash at injection site approximately 2 inches in diameter was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Began getting scratchy throat just after lunch time, then around 3:00 pm started minor sneezing, about 5:00 pm had stuffy nose and more "productive" sneezing, took Nyquil about 10:00 pm and went to bed.  Awakened about 4:00 am 9/30 with very sore throat (postnasal drip) and sinus headache.  Took Advil and Ricola cough drop about 4:45 am.  "Steam cleared" sinuses in hot shower about 7:00 am.  Took Advil Cold and Sinus at 9:00 am but still experiencing sinus headache.  Sneezing has ceased for now and sore throat eased but not gone.  Could possibly not be related to the flu shot, but uncertain.  Husband had been fighting a cold for past three weeks or so and I had no symptoms earlier, plus I was at community activities on 9/27 and 9/28 and could have been exposed to other viruses at those venues, though I am usually careful about washing my hands regularly and not putting my hands near my face.  I did though, at both weekend events eat something after touching "shared use" pens for filling out forms, without first washing my hands.
Itchy in all the body starting at 1 pm  Fiver starting at 6 pm  Severe Itchy and big rashes all the body
Anaphylactic response; A spontaneous report was received from a consumer who was a 50-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic response.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Jan 2021, a few minutes after receiving the vaccine, the patient experienced an anaphylactic response.  Her extremities went cold, her mouth was dry, and she couldn't swallow due to her throat being swollen. She was given intravenous fluids and oxygen due to her oxygen saturation being 82 percent. She was also given an epinephrine injection and was taken to the emergency room to be observed for a few hours.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, anaphylactic response, was unknown.; Reporter's Comments: This case concerns a 50-year-old female patient, who experienced a serious unexpected event of Anaphylactic reaction. The event occurred soon after first dose of the study medication administration. The patient was treated with an Epi-pen, Benadryl iv, and oxygen. 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
Patient experienced vasovagal syncope 5 minutes after receiving her vaccine. She woke up immediately after smelling alcohol and elevating her feet above chest level. 911 was called and was present within minutes and patient was taken to ER where she was monitored for 3 hours. She reported she had stable blood pressure, HR, and blood sugar. She was discharged after 3 hours of observation and is feeling well the next day.
Shaking chills, nausea/vomiting, headache, palpitations. No symptoms with initial vaccine.
Nerve damage; Still have severe pain in both legs; Extreme numbness and weakness in both legs; Extreme numbness and weakness in both legs; Could hardly walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 at 12:00 as dose 2, single (Lot number: Ep7533) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: En6205, Vaccine Administration Time: 01:15 AM), administration date: 19Mar2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "Numbness in left leg", "Numbness in left leg and foot". The following information was reported: GAIT DISTURBANCE (non-serious) with onset 19Apr2021 at 12:00, outcome "unknown", described as "Could hardly walk"; HYPOAESTHESIA (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 19Apr2021 at 12:00, outcome "not recovered" and all described as "Extreme numbness and weakness in both legs"; NERVE INJURY (non-serious), outcome "unknown", described as "Nerve damage"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Still have severe pain in both legs". The events "extreme numbness and weakness in both legs", "could hardly walk", "nerve damage" and "still have severe pain in both legs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoaesthesia, muscular weakness, gait disturbance, nerve injury, pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. Patient had no known allergies. About 3 Days after Dose 1 had numbness in left leg and foot About 10 Days after dose 2 had extreme numbness and weakness in both legs and could hardly walk Was about to go to ER but made appointment Dr. Patient had nerve damage from COVID 19 vaccination and reff. to Dr neurologist did tests. Treatment for condition nerve Damage will take about 1to1.5 years to recover from nerve damage 01Nov2022 Still have severe pain in both legs and for the past 3 weeks must use a Cane to walk 31Oct2022 Dr started treatment with for condition.
Information has been received from a physician concerning a 13 year old female patient who on 24-Mar-2008, was vaccinated with a dose of VARIVAX (Merck), 0.5ml, subcutaneously. On 24-Mar-2008, the patient experienced swelling and tenderness at the injection site. The physician reported that the symptoms were treated with Advil and Claritin and cold and warm compress. On approximately 26-Mar-2008, the patient recovered. The patient sought medical attention. This is one two reports received from the same source. No further information is available.
Severe swelling from elbow to upper arm redness and also 2" square at injection site had tiny blisters that were ruby red which later peeled. Similar to a sun burn. The swelling lasted approx about 3 weeks but the whole process was about 1 month. Currently now pt arm still has some discoloration.
Blank stares for a few days and febrile seizures that lasted a few months. I had discussed this with my doctor who didn't seem concerned that it was an issue. She eventually stoped and moved on to progress at her normal rate.
Pt recvd vax & 3 days later pt devel arm & wrist pain that kept getting worse; pt was dx w/acute neuritis & allergic neuropathies; sx have resolved;
presented 4 days p/inject w/ c/o inc t103 beginning 24-36 hrs p/inject; lt arm became red, hot & swollen; also c/o feeling lightheaded & had been bedridden x 3 days due to flu type sx;
This case was reported by a nurse via call center representative and described the occurrence of localized erythema in a 61-year-old female patient who received FLULAVAL Quadrivalent (batch number 5S349, expiry date 31st May 2017). On an unknown date, the patient received FLULAVAL Quadrivalent .5 ml. On an unknown date, an unknown time after receiving FLULAVAL Quadrivalent, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were unknown. It was unknown if the reporter considered the localized erythema and local swelling to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness and swelling in the deltoid area of her left arm after vaccination with FLULAVAL Quadrivalent.
CLIENT WAS NOT 18 AT TIME OF VACCINATION. MODERNA IS APPROVED FOR AGES 18 AND UP.
Large itchy 6"rash at injection site about 5 days after injection.    It is now subsiding  (3/2/21)  Left it alone...no treatment
Light bleeding; Cycle was completely off; More heavy bleeding with quarter sized clots; More heavy bleeding with quarter sized clots; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose.  A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in the left arm on 27Apr2021 at 14:00 (Batch/Lot Number: EW0171, at age 27-years-old at vaccination) as a single dose for COVID-19 immunisation at a Public Health Clinic facility. Medical history included hypersensitivity / allergies to nature and contraception (birth control had her periods very regular). There were no known allergies. The patient did not have COVID-19 prior to the vaccination. Concomitant medications included birth control, antihistamine and allergy injections. Historical vaccine information included the patient received the first dose of BNT162B2 vaccine, via an unspecified route of administration, administered in the left arm on 06Apr2021 at 14:00 (Batch/ Lot number=EP7533, at age 27-years-old at vaccination), as a single dose for COVID-19 immunisation and experienced cramping/spotting, large clots and heavy period on 22Apr2021. The patient did not received any other vaccines within four weeks of the BNT162B2 vaccine. On 27Apr2021, the patient received the second dose of the BNT162B2 vaccine. The patient was still spotting when she received the second dose of the vaccine. On 29Apr2021, 2 days after the second vaccine, the patient had light bleeding and then afterwards she experienced more heavy bleeding with quarter size clots. It was reported that prior to the vaccine her birth control had made her periods very regular and nowhere near as heavy as this bleeding. Now her cycle was completely off. No treatment was received. The patient has not had a COVID test post vaccination. The outcome of events light bleeding, more heavy bleeding with quarter sized clots and cycle was completely off was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021514929 same patient, different dose number and event
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 07:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 21-FEB-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route administration were not provided). No adverse experience was reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient started to get a red, itchy rash covering her entire upper arm the day after vaccination (2nd dose). Called her to check in today (8/10/18) 10 days after vaccination to see if it has resolved. She is still having the rash and itching but it has faded considerably. She is just using anti-itch cream for it. She had no reaction to the first dose.
Acute left shoulder pain, resulting in ER visit. X/ray, pain medication, orthopedic specialist, MRI, Bursitis/Tear, anti-inflammatory, Cortisone injection. Left with limited range of motion and weakness in left shoulder with possibility of further injections, therapy, surgery.  Restriction on multiple activities.
Fever 2 days  Fatigue 2 days  Shivering 2 days  Back pain 2 days Headache 2 days
The day after I was very weak, nauseous, and that evening my legs started hurting and cramping. On the 14th I had trouble walking and my legs went out when I was out and I had to go to urgent care. I had trouble walking that day and the following day. Also for six weeks after receiving the vaccine I would become extremely nauseous often and I was exhausted. The exhaustion and nausea were so extreme that I missed work.
Developed hives or something like them on top of my hand, only on left arm which is the same side the initial dose was received in.  There may be another name for they symptom as there were a couple larger patches that were raised and extremely itchy.
Bilateral medial forearms - transient, mild, NON- pruritic, macular (no raised lesions), pink, mottled /levido-like appearance between medial elbows and wrists.  First noted at home, 3.5 hours after vaccine.  No other new signs/ symptoms anywhere else in body following vaccine. (No respiratory symptoms, no swelling, itching or obvious other skin color changes.) Due to no associated itch or other discomfort associated with the BL medial forearm mottling, I would not have known the skin color changes had occurred if I had not removed my long-sleeved shirt upon arriving home 3.5 hours after vaccine. Therefore I do not know at what point during the 3 hours post-vaccine that the skin color changes occurred. The pink BL forearm mottling appeared to be more pronounced and visible after showering upon arrival home, but then it completely and rapidly faded within the next hour (and was completely resolved by 10:00 pm, 5 hours after vaccine). No treatment used for it that night or since (no topical or oral meds applied or taken).  It has not reappeared since. (It is now 5 days post vaccine.)  Just reported to PMD office next day and had followup call this week. No other action needed or taken.
Severe vomiUrinalysn and bleeding from rectum  diarrhoea, follwed by chest pai
This spontaneous report was received from office manager and refers to unspecified patients of unknown demographics. Information on concomitant medication, medical history, concurrent condition, drug allergies/reactions were not provided.  It was reported that, on an unknown dates, an unspecified amount of patients were administered improperly stored PROQUAD (rHA) (lot# N000677, expiration 05-JUL-2018 ; lot M044719, expiration 07-MAY-2018)( incorrect product storage) reconstituted with properly stored STERILE WATER DILUENT (unknown lot, unknown expiration). Concomitant medication included sterile diluent. Administered vaccine experienced the temperature excursion of 9°C to 8°C for 1 Hour; -14°C to-10°C for 1 Hour 30 Minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. The outcome of incorrect product storage and no adverse event were unknown. No product quality complaint(PQC) was involved. No further details provided. Lot number [N000677] (rHA) has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA004058:
day 2  rash started on opposite forearm day 3 spread to same forearm, shoulders, and trunk day 5 flu like symptoms:  joint pain, very tired, slight fever,  day 6 rash still there but no flu like symptoms as day before