chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pregnant, due date Sept 9, 2021 I developed hives about 24 hours after the 2nd dose. It started in left armpit and spread all over both arms and in the upper thighs near the underwear line. Nothing on torso, back, or lower legs.  I called my OB/GYN about 8pm to seek guidance on treatment and was instructed to take benedryl. The hives temporarily went away, and did not fully go away until Monday morning (3 days after the shot). I took benedryl: Saturday 8pm Sunday 8am, 7pm Monday 4am
Pt c/o burning in chest after administration of the vaccine. 143/82 BO 72P 16R denies any pain! s,s2 Heart sounds. Pt monitored for 40 more minutes in the clinic prior to departure.
A non-serious spontaneous report of two patients were administered expired FLUMIST was received from a health professional concerning an adult female. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 22-Dec-2010. On 03-Jan-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Provided patient with gatorade and oreos. Adverse effects subsided within 10-15 min.
Localized redness, swelling, heat and itching at vaccine site and generalized body aches without fever.
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022; Patient received an expired vaccine on 09-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 09-May-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (LOT- FE3592) on 20-Oct-2021 and Pfizer (LOT- FE3590) on 10-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 09-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 09-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 09-May-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The reporter stated that they initially called on 12-May-2022 and reported a total of 18 patients received expired doses after the 30 days Use by Date. On 17-May-2022, the reporter reported after doing further research, that the actual total number of patients that received expired doses after the 30 days use by date was 82 patients total and not 18 patients. The date the vial initially stored in the refrigerator was 11-Jan-2022 which meant that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. Reportedly, the vial didn't undergo any temperature excursions. On 09-MAY-2022, patient took first booster dose of Moderna Vaccine.   The patient had not reported adverse reaction to the reporter's knowledge.  No treatment information was provided.
itchy, urticarial rash on arms and legs. Treated with antihistamines and topical steroids
Information has been received from a pharmacist concerning a 73 year old female with penicillin allergy, sulfa allergy, allergy codeine, fish allergy and mercury sensitivity in December 2008, was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included PLAQUENIL, BENICAR, SYNTHROID, estrogens, PREMARIN, LASIX.  The pharmacist reported the patient developed a rash under both her armpits and elbows after administration of the vaccine.  Additional information was not provided.  Additional information is not expected.
On 6/11, developed local swelling and redness at injection site. (L deltoid) On 6/13, developed 2 vesicles in the center of swelling and redness at injection site. On 6/15, developed mild scattered erythematous papular lesions on face, trunk, extremities - Lesions not pruritic / itchy or painful On 6/15, ID team was consulted and patient was started on IV Acyclovir 10mg/kg q8hrs - As of 6/17, rash is stable, if not improving
9-28-08 8pm- while changing diaper experienced difficulty breathing with wheezing, eyes rolled back into head-mom picked her up and symptoms redin within 10 seconds. 10-05-08 same symptoms occurred as on 9-28-08 with same recovery.
c/o severe pain in arm, generalized body aches, fever chills started on day of Td vaccine 5/2/16, lasted 3-4 days and then resolved.
Developing a knot around vaccine site. Hard and Warm and Pain. 2.5 to 3 inches. It passed 7 days now. The knot is getting smaller to around one inch now, but still feel hard and pain.
Headache scratchy ears Narrative:  Employee reports headaches and "scratchy ears."  Reports took Tylenol (no dose/duration provided) for symptoms.
mom fed pt p/arriving home from clinic & put him to bed; (had APAP prior to nap);awoke @ 4:00 screaming;high pitched, lasting 1 1/2hr, inconsolable;temp nl them;fussy during noc;temp 98.8ax;
Approximately 30-45 minutes after receiving vaccination, hands started to itch.  The itchiness built to a level of extreme itchiness then eventually went away.  The total reaction lasted approximately 20 minutes.
The patient (who is right hand dominant) was in his normal state of good health when he received Adenovirus, TWINRIX, FLUMIST, Tdap, PREVNAR 13 and MENACTRA vaccinations on 12/13/11. The patient reported to medical for the first time on 12/30/11 with complaints of a 2 day history of right knee pain. The pt. was diagnosed with iliotibial band friction syndrome and treated with NSAIDS, ice and stretching exercises. His knee was injected with Corticosteroids on 1/3/12 for continued symptoms. On 1/11/12 the pt. was seen for a 5d history of left knee pain. An x-ray revealed mild tissue swelling. On 1/12/12 the pt. received TWINRIX #2 and IPV vaccinations. The pt. was seen in medical again on 1/13/12, 1/20/12 and 1/30/12 and 2/6/12 for either right or left knee pain. He was diagnosed with bursitis and treated with ice and NSAIDS. The pt. received a Yellow Fever vaccination on 2/14/12. He was seen in medical on 2/22/12 for continued right knee pain with prolonged activity. A slightly antalgic gait was noted on examination. The pt. states that he was the last person to complete the 3 mile run. He knew that "something was wrong"--it seemed like his legs were getting heavier and heavier and that his calves were not working properly. When he was finished with a physical task (running, walking, hiking) his legs "felt like noodles". The pt. denied experiencing lack of bowel or bladder control. When the pt. went to training he felt that the physical activity was always a constant struggle and that "his feet were on fire". He also felt like because his calves were not doing any of the work and that his quads were being "overworked". Although the pt. continued to pass the physical requirements he was always in last place and continually falling behind. When the pt. reported to school, April 2012 he began to experience left hip pain and eventually bilateral thigh pain. He was diagnosed with bilateral femur stress fractures (per Bone Scan 5/7/12) and had to walk with crutches. According to the patient, the Orthopedic provider considered recommending the patient for a medical board but the patient refused. When he reported at Aug 2012, he could not complete the fitness test due to weakness in his lower legs. The patient had issues with marching--he could not maintain the cadence due to "walking with a limp". When the patient explained that he had had issues he was referred to medical and placed TMPQ at Jan 2013. The patient has not attended drills for 12 months while undergoing evaluation per his medical providers. The patient was seen by his PCM and 3 Neurologists. The consensus is that the patient has Distal Spinal Muscular Atrophy.
Pt turned very pale and got very warm right away after her flu shot. Then she went into a blank stare then had seizure like activity were she was jerking back and  forth and not responding then after a minute she wondered what happened. Her BP got down to 50/34 but then came back up with some time. Pt still feels week from the flu shot a little over 24 hours.
felt feverish; This case was reported by a consumer via call center representative and described the occurrence of feverish in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on an unknown date and experienced experienced flu like symptoms and felt feverish, refer case US2019108612).   On 13th June 2019, the patient received the 2nd dose of Shingrix. On 14th June 2019, 1 days after receiving Shingrix, the patient experienced feverish. On an unknown date, the outcome of the feverish was not recovered/not resolved.   It was unknown if the reporter considered the feverish to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. Yesterday from the date of reporting, the patient stated that she received the Shingrix vaccine and felt feverish at the date of reporting. The call was disconnected and agent was not able to capture additional information.  The reporter was attempted to call back and left voicemail for patient to call back to provide additional details. This case has been linked to the US2019108612, reported for the dose 1 of the same patient.
Redness & firm nodule 1 x 1 1/2 in diam.
Moderna 2/1/21, 3/9/21, 10/28/21. Positive on 9/3/22
Patient complained of swollen tongue, dizzyness, nausea 5-10 min after vaccination.  Pt was noted to look pale and ? sl swollen tongue.  BP with wrist cuff not attainable, pulse 100+ and oxygen sat 98% iniitally.  Request for ambulance made. Pt was placed supine, feet raised.  Pt was recurrently assessed by MD on site as well as RN and Paramedics.  Pt felt nauseated.  Tongue not def swollen? lips not swollen, no respiratory distress.  IM benadry 50 mg given.  Pt felt better 5 minutes after benadryl.  BP when supine was elevated, HR in low 100s and sats remained good.  Pt was then transported to local emergency room.
Had a syncopal episode in the parking lot.  Received HPV, Hep A and TDAP.  Told mom that she had ringing in the ears and felt dizzy leaving the office.  When she reached the parking lot she was falling down and dizzy and started to pass out.  Called to the parking lot and she was awake,pale,talking and sitting on the ground. Assisted to a wheelchair and brought back to the office.
pain in the left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (pain in the left arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 024M20A and 013L20A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis and no other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: FLU SYRINGE (Allergies: Became severely ill in the 1970's after a flu shot) in 1970. Past adverse reactions to the above products included Illness with FLU SYRINGE. Concurrent medical conditions included Kidney stones (Start Date: 5 to 6 years ago, no  recent change in status reported) and Enlarged prostate (Start Date: years ago, Recent change in status was unknown.).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 14-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (pain in the left arm). At the time of the report, VACCINATION SITE PAIN (pain in the left arm) had resolved.            Concomitant medication reported included Unknown enlarged prostate medication.  The patient reported that after receiving their first Moderna booster dose on 14-Jan-2022, the patient experienced pain in the left arm that lasted several weeks and then resolved. The patient's height reported as 5 feet 10 inch and the patient mentioned that the patient was shrinking.  No treatment information was provided.   This case was linked to MOD-2022-569083 (Patient Link).
He started to have seizures on about 9/11/01. He is still testing. An EEG and MRI has to be taken. Dates of shots: 8/1/01, 8/4/01, 8/8/01, 8/15/01 and 8/29/01.
11x11" R deltoid, 7x7" distal, increase heat at injection site, central area large.  Tx: Benadryl spray, claritin 10 mg oral, ice to area
Spoke to patient on 07/20/2021 at 4:30pm. Patient received second dose on Day 20. Patient received first dose on 06/19/2021 and was told to make an appointment on 07/09 for her second dose, but wasn't told where to get it. Patient was consulted that she is fully vaccinated and does not need additional doses per email.  Patient doesn't present with any clinical issues.
From initial info received on 8/27/04 from an RN regarding an adverse event occurring in the USA, it was reported that a 45 year old female pt received a dose of TD ADS ADULT, lot U1020AA, administered ID in error, in the left arm on 7/29/04. That same day, the pt developed cellulitis of the left arm at the site of injection. She was treated with dicloxacillin 125mg every 6 hours for 2 days. The pt recovered from this event. From additional info received on 10/1/04 from an RN, the pt's full name, address and telephone number were provided. Per the reporter, the pt did not have any illnesses at the time of vaccination. The reporter had no additional info at this time. No further info is anticipated. This case is considered closed.
Unknown time pt recv'd 1st Hep B vac (unk mfg) with no ill effect. In 1994 recv'd 2nd dose of Hep B and sometime after exp. arthralgias & myalgias. Recv'd 3rd dose in 1994 and arth. & myalgias worsened. Diag. w/Crohn's dis immed. after.
3 days, post vax, the baby was very sleepy, unresponsive and unable to awake for 1 hour.
THE MOTHER OF THE GIRL STATED THAT AFTER THE GIRL WAS VACCINATED SHE DEVELOPED A HIGH FEVER AND WAS EXAMINED BY ANOTHER PHYSICIAN WHO TOLD THE MOTHER THAT THE CHILD HAD A THROAT INFECTION. HOWEVER OTHER PEDIATRICIAN GAVE THE MOTHER A DIAGNOSIS OF ROSEOLA INFARTUM.  THE MOTHER ALSO STATED THAT THE GIRL HAS CONTINUED WITH CONVULSIONS AND THAT HER GENETICIST TOLD HER THAT THE GIRL HAD A 4% AUTISM.
This spontaneous report was received from a physician via a company representative, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX 19400 plaque forming units (PFU) as prophylaxis (Dose, route, lot # and expiration date were not reported). On an unspecified date, 1 year later the patient inadvertently received a second dose of ZOSTAVAX 19400 plaque forming units (PFU) as prophylaxis (Dose, route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a currently 17 year old female patient. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose and route were not provided) by error. The patient had not experienced any adverse effects. It was also stated that the patient received a complete series of GARDASIL on 31-OCT-2006 with lot # reported as "0688F"; second dose on 17-JAN-2007 with lot # reported as "0961F" and the third dose on 20-SEP-2007 with unspecified lot #. Additional information has been requested.
Child received Tdap-Boostrix lot # C2770AA instead of DTaP Infanrix Lot # AC14B060AB. Mother was notified 09/04/08.
Severe muscular pain. Unable to move or use arm for 2 weeks, then most pain resided but soreness lingered until today. Today is over 8 weeks post-immunization and the more severe pain is returning. This is also happening with my mother and my sister, whom received vaccination at same place and time.
01/12/21 (First dose on 1/9): Exhaustion/confusion (lasted for about three days), recognized episodes of tachycardia that lasted for weeks; severe pain in right arm at vaccination site that lasted about 2 days. 02/9/21: Received second dose of vaccine on 2/6/21, recognized raised, oblong, red rash not at the location of the vaccination site on the deltoid, but on the top of the upper arm and down near the antecubital fossa that slowly crept down the arm over several days, was gone in about a week; severe arm pain for about 2 days; episodes of racing heart continues, was relieved with rest.  03/15/21-03/26/21: Exhaustion; recognized multiple episodes of tachycardia that was not relieved with rest (around 140 bmp, each episode lasted between 3-6 hours).  03/23/21-03/24/21: Pain in right arm 03/26/21-04/2/21: Recognized exhaustion/confusion, tachycardia that was not relieved with rest. 04/2/21: Right arm swelling and pain. Tachycardia (140 bmp), not relieved with rest. Chest pain/tightness. Arm turned purple and all the vasculature was present in the right arm and chest. Admitted to hospital, ultrasound revealed the subclavian vein was completely occluded down to the basilic vein near the elbow. CT scan showed pulmonary emboli in both lungs. Was placed on heparin drip and released from hospital on 04/4/21. Started on 10 mg Eliquis BID for one week on 4/4, now on 5 mg Eliquis BID for 6 months. 05/19/21: Received diagnosis of Factor V Leiden heterozygous mutation. Arm pain/swelling remains periodically.
Patient called to report reddened area on date of injection at injection site. Increased redness and lump at injection site noticed on second day following injection. Little itch, slight discomfort at injection site. No other symptoms. No treatment. Resolved in three days.
w/in min of getting vax pt devel sweatiness,clammy skin & paleness; appearance (glassy eyed) but could be made to respond;subsequently screamed uncontrollably for 30 mins then sleepy but rousable;given a soft drink-back to nl
This case was reported by a physician and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B. On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown). At  an unspecified time after completing the vaccination series with ENGERIX B, the subject experienced not responding to therapy and "failed to seroconvert". No other information was available at the time of this report.  At the time of reporting the outcome of the event was unspecified.
Arm grossly swollen and painful, body aches, chest pain, fatigue-developed within 48 hrs of receiving vaccine. Tx'd at another facility with antibiotic and steroid-sx's only reported back to me.
tiredness ,decreased appetite ,joint pain ,muscle pain ,headache ,feeling unwell ,blood pressure high diastolic, low systolic
Patients DOB, mistake to be 12 years of age instead of 11. Patient was administered 0.3ml of adult Pfizer instead of 0.2ml of Pediatric Pfizer, which was the appropriate dose. No ADE reported at the time of the completion of this form.
Patient presented to clinic Sept 29th and received an influenza injection at 4:50 pm. Mom reports the next morning Sept 30th, 2017, she noticed red blotches covering patients torso, arms, and legs. The next day Sunday Oct 1st, 17 mom took patient to immediate care (urgent care) was given 5 day RX for prednisone, BENADRYL and hydrocortisone.
Tremors with Second Vaccine; Fell and had to be helped up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 25Mar2021 (Lot number: ER8733) at the age of 71 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Covid-19", start date: Mar2020 (unspecified if ongoing), notes: States that the patient had Covid with severe symptoms in Mar 2020. There were no concomitant medications. Vaccination history included: Bnt162b2 (in the left arm), administration date: 04Mar2021, when the patient was 71 years old, for Covid-19 immunisation, reaction(s): "Tremors".  The following information was reported: TREMOR (non-serious) with onset 26Mar2021, outcome "unknown", described as "Tremors with Second Vaccine"; FALL (non-serious) with onset 26Mar2021, outcome "recovered" (26Mar2021), described as "Fell and had to be helped up".  No follow-up attempts are possible. No further information is expected.
Within 6-8 hours:  - Injection site reaction adverse event including pain, soreness, full stiffness down to the elbow.  - lethargy - heacache - fatigue In 24 hours:  - Severe muscle pain in right arm (unable to move arm due to pain) - Fever (lasting 12 hours with a max temperature of 102) - Nausea - Chills  - Red, itchy welts began to appear on right arm. Grew in size over a period of 12 hours (from 6pm on 12Sept2021 to 6am on 13Sep2021) until it encompassed about half my upper, right arm After 48 hours: - Fever broke - Still couldn't move my right arm due to the muscle pain - Rash/swelling wasn't going away
felt warm in head and down body then developed palpitations and lightheadedness which resolved within 5 mnutes
Pt vaccinated on 12/23. PCP notified that SOB and fatigue getting worse on 1/4. Unable to keep pre-op Dental work planned prior to mitral valve surgery on 1/14/2021. PCP referred her to our ED where she was diagnosed with COVID-19 and transferred to facility, which is where her surgery was planned.