chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 minutes after the shot at approximately 3:00 pm on 10/11/2021, I felt a warm tingly sensation in my arm around the injection site.  This went away after a couple hours, and I thought that  maybe it was a normal reaction.  I woke up around 7am the next day, the 12th, and noticed that the left upper arm near the injection site had 3 bumps/hives and it was red and appeared inflamed and was very warm to the touch.  Throughout the day, I  noticed more of these bumps appearing on my left forearm and becoming extremely itchy.  They continued to appear as of the 14th, and they were also becoming extremely itchy.  The first 3 bumps began to blister and remained warm to the touch as of the 14th, so I went to urgent care on 10/14/2021 at approximately 11:45am  The doctor said that it was probably an allergic reaction to one of the ingredients in the Moderna vaccine, and I was then given a steroid shot, along with 6 days of oral steroids.  As of Monday the 18th, many of the initial bumps/hives were almost healed, but more of these itchy bumps/hives appeared on my lower left wrist area.  As of today, the 19th, the remaining bumps are still extremely itchy.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX vaccine. The patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claimed damages as a result of: Injury to themselves; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the events was unknown. Causality assessments were related.
Dizziness, lightheaded since vaccine. Subsided some then late on 3/23/21 so dizzy could not stand. Refrained from driving till spell passed. I do not have a history of vertigo, symptoms started after vaccine. I did have active COVID-19 infection in September 2019 so understood 1st shot would be more robust.
Pt w/o medical hx/drug allergies presents with syncope in observation area s/p J&J injection. Patient stood up with dizziness and loss consciousness with head injury on counter. (Estimated 10 Seconds KO). Upon arousal pt presents tachypnea, pin-point pupils, hand contractions, one episode of vomiting, loss of memory. Orientated to name/dob although does not know location or recollection of receiving vaccine. EMS called responding to seen. Initial VS: BP: 86/55, O2: 96%, HR 81. Paramedics responding on scene EKG/BS checked patient taken to . Pt stabilized and transported with AMR paramedics to .
Started having strong chills that lasted an hour and was sweating although I felt cold. Felt dehydrated and heart was reaching. Woke up in the morning and felt sweaty, had temperature of 100.9F axillary. Took Tylenol. Still having body ache and headache through all this.
Suspected vaccination failure; still come back in a different spot; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced very mild case of shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the shingles vaccine and still experienced shingles in a different spot, every 4 months or 6 months. The physician gave him/her oral medication. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. The case had been linked with the case US2021AMR233775 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233775:multiple outbreak
The caller confirmed no adverse effects were noted; The HCP reported that a 6month old patient inadvertently received a dose of VARIVAX; This spontaneous report was received from a other health professional (nurse) referring to an 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapy were not reported.   On 16-NOV-2023, the 6-month-old patient was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection administered 0.5 mL once for prophylaxis (strength, route of administration, lot#, expiration date and anatomical location was not reported) (product administered to patient of inappropriate age). No adverse effects were noted after the adverse event occurred (no adverse event).
12OCT92 7PM c/o h/a & vomiting & sleepiness these sx cont off & on for 3 wks; went to hosp 3 wks ago had multiple test; pts mom states MD are not ruling out adverse reaction to vax;
can the moderna vaccine effect my heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (can the moderna vaccine effect my heart) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (can the moderna vaccine effect my heart). At the time of the report, CARDIAC DISORDER (can the moderna vaccine effect my heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information was provided.
Post vax, the pt developed a 5-6 cm erythematous lesion on right leg with slight increase in temperature.
after injection pt complained of dizziness and not feeling well. initial vital BP 66/52 HR 68 RR 15 spO2 97% RA. pt was in sitting position. became clammy, diaphoretic, blurred vision, and feeling worse and passed out. pt assisted to floor. MD called to bedside, 0.3 epi pen given to left thigh. no respirstory distress noted. fire and EMS on scene to transfer to ED. pt now a&ox4. VSS now.
This spontaneous report as received from a pharmacist refers to a 58 year old female patient with multiple cases of shingles per year. On an unknown date, when the patient was 57 years old, she was vaccinated with a dose of ZOSTAVAX (Lot number, expiration date, dose and route were not provided). Concomitant medications were not reported. The pharmacist reported that since the patient received ZOSTAVAX, she still had shingles outbreaks (three since receiving ZOSTAVAX). The amount of outbreaks per year had decreased and the outbreaks were much milder. The outcome of shingles outbreaks was unknown at the time of the report. The reporter did not assess the relatedness of ZOSTAVAX shingles outbreaks. Additional information has been requested.
Patient had anxiety on arrival to the Covid vaccine clinic.   Went into rapid atrial fibrillation on arrival due to anxiety.  This occurred prior to receiving the vaccine.   Patient recovered on her own and later received the vaccine.   She then went back into rapid Afib and was transferred to the Emergency Department.      Patient has a long history of A fib.  Does not appear to  be vaccine related.
Excessive Sneezing, Sore Throat, Headache, Stuffy/Runny Nose. Symptoms started around 6:30pm and have continued through Sunday to Monday and are still on going.
Heart rate 120 bpm, Blood pressure 170/110,  lightheaded, feeling faint, tingling, anxiety
Complaints of pain radiating down the arm.  Not just site reaction.  Pain continued for longer than 1 week.
only the DTAP-IPV portion was given and not the Hib portion with no adverse event; Initial information received on 13-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who experienced only the dtap-ipv portion was given and not the hib portion with no adverse event while receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR vaccine) for Immunization.  On 13-May-2022, the patient received Dose: 4, 0.5 ml once of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection strength: standard, lot U7197BA, expiry date: 18-Jan-2023 via unknown route and administration site for immunization.   On 13-May-2022 the patient developed a non-serious event as only the dtap-ipv portion was given and not the hib portion with no adverse event (single component of a two-component product administered). Caller mentioned that they discarded the Hib portion already to refrain from confusion.   Action taken was not applicable.  Outcome was Unknown.  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.
300 pm 3/7/14 - Inconsolable crying starts. Right lower thigh red, tender, and swollen. No fever. 3:35 pm - PCP instructed to give infant TYLENOL. 4:30 pm. Infant TYLENOL given. 4:50 - Crying stops. 3/10/14 - 9:30 am - Right leg normal. No further episodes of crying.
After shot 3 started having chest pains and racing heart and severe tiredness and aching body. Went to ER multiple times. Started having syncope and non epileptic seizures in January 2015.  3-5-2015 diagosed with Postural Orthostatic tachycardia syndrome.
Ten days after vaccination started having rash. Covered body, "flaming red", went away and came back that evening. Lasted a couple of days. The same day started having screaming fits. Screeching noise with arching of back and throwing head back, stiffening body. Called Dr and saw him next day (12-28-08).
Arm is still swollen; Arm painful to touch; arm itches; Allergy; This case was reported by a consumer and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced swelling arm, pain in arm, itchy upper limbs and allergy. On an unknown date, the outcome of the swelling arm, pain in arm, itchy upper limbs and allergy were unknown.   It was unknown if the reporter considered the swelling arm, pain in arm, itchy upper limbs and allergy to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm. The patient arm was still swollen and not directly near the injection site but a large portion of patient upper arm, and it was painful to touch and itches. The reporter enquired does that indicate allergy. The reporter did not give permission to follow up.
Shivering/Chills; Diarrhea; Not feeling well; This is a spontaneous report from a contactable physician (patient self). A patient of unspecified age and gender received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via an unspecified route of administration on 10Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and shivering and then diarrhea. Patient was not feeling well. Outcome of the events was unknown.
Dizziness and vertigo one hour and twenty minutes after injection. Headache, body ache, fever, chills/sweats, nausea, and foggy thinking beginning twelve hours after injection.
Pt received GARDASIL and Influenza, waited ten minutes after shots. Was feeling fine. Free to go. Ambulated to parking lot with Mom. Felt ill, fell in parking lot. Experienced LOC-not sure of time frame. Paramedic on hand, transported to ER via ambulance.
Received TDAP vaccine in left arm at work and shortly after felt pain in arm.  the next morning I was having severe arm and shoulder pain. It was difficult to raise arm and I have not had full range of motion since the TDAP vaccine was administered.  I went to employee health center at work that week and was examined and told to take ibuprofen to see if it helps. I continued to have pain and loss of range of motion in my left arm. for months. The employee health clinic had me see an orthopedic doctor who initially ordered an x-ray and gave me a steroid injection in my left arm. It was documented that I had rotator cuff tendonitis. I also went to physical therapy for several sessions.  I continued to have limited range of motion so at my six week follow up visit  my doctor ordered an MRI which was completed on July  10, 2019. The MRI results show a left shoulder labral tear and mild left acromioclavicular osteoarthritis. I follow up with Dr on July 23, 2019 for the plan of care.
Breakthrough case after Covid vaccination, Dose #1 2/24/2021 Dose #2 3/31/2021 C/O cough and chest pain/onset 9/12/2021
102°F fever, muscle aches, head ache, severe diarrhea for first 20 hours, severe nausea, upset stomach, tiredness.
atrial fibrillation; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 75-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248) via an unspecified route of administration on 21Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included palpitations years ago. The patient's concomitant medications were not reported. Patient received the vaccine at 15:00 on 21Jan2021 and around 20:00, patient started getting heart palpitations. Years ago patient did have palpitations at times but had not had them like this that did not go away. Patient went to ER and the heart monitor showed patient had atrial fibrillation. Patient was sent home to follow up with primary care physician. Patient would be seeing her this coming Thursday. This was the fourth day after patient shot and patient was still bothered by them. No treatment received. Patient asked if it was the vaccine that started these palpitations up. No covid prior vaccination. No covid tested post vaccination. The patient underwent lab tests and procedures which included heart monitor showed atrial fibrillation in Jan2021. The outcome of the events was not recovered.
She tested positive for covid 19; She tested positive for covid 19; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Right Arm on 06Apr2021 as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 25Apr2021 the patient tested positive for covid 19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Apr2021. Therapeutic measures were taken as a result of tested positive for covid 19. The outcome of event was unknown.   Follow-up (10May2021): New Information received from the contactable consumer includes updated events and dates, questions regarding events.  Information on the lot/batch number has been requested.
Did not feel normal; Cognitive impairment / lack of comprehension/could not understand what people were saying to her; She left work (started to cry); Felt / (like a panic attack) / She could not work; could not work; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included brain injury (due to car accident in 2016) and concussion (due to car accident in 2016). Previously administered products included antibiotic (recent unspecified antibiotic caused side effects including foggy type feeling). Concurrent medical conditions included weird feeling (weird reactions to medications since brain injury) and brain disorder nos (PPI- partial permanent impairment of the brain due to the car accident).   On 27th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, 3 days after receiving Shingrix, the patient experienced feeling abnormal, cognitive impairment, crying, panic reaction and impaired work ability. Shingrix was discontinued. On an unknown date, the outcome of the feeling abnormal, cognitive impairment, crying, panic reaction and impaired work ability were recovered/resolved.   It was unknown if the reporter considered the feeling abnormal, cognitive impairment, crying, panic reaction and impaired work ability to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received Shignrix shot in the upper arm. On 30th September 2019, the patient went to work as usual but did not feel normal. She stated that she could not understand what people were saying to her. She could not comprehend others.  The patient left work (started to cry) and called the pharmacy to ask if what she was feeling could be related to Shingrix patient states that other than the Shingrix shot nothing else had changed (example: she had not started any new medications).  The patient indicated that she remained in that state of cognitive impairment for a few days (2 to 4 days) and because she could not work; she indicated that she was felt very panicked (like a panic attack) during that time because of what was happening to her. All the symptoms were resolved after 2 to 4 days. The patient reported this experience to her physician and was advised not to get the second Shingrix shot. Therefore, she had not completed the series. The reporter consented to follow up.
Twenty-four hours post vax, arm ached, progressively worse, joints ached all over, arm swollen, hot and red. Knot in arm size of marble. Unable to lift arm.
BREATHING PROBLEMS; Chest pain; DIZZY SPELL/LIGHT HEADEDNESS; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (BREATHING PROBLEMS), CHEST PAIN (Chest pain), DIZZINESS (DIZZY SPELL/LIGHT HEADEDNESS) and HEADACHE (Headache) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced RESPIRATORY DISORDER (BREATHING PROBLEMS), CHEST PAIN (Chest pain), DIZZINESS (DIZZY SPELL/LIGHT HEADEDNESS) and HEADACHE (Headache). At the time of the report, RESPIRATORY DISORDER (BREATHING PROBLEMS), CHEST PAIN (Chest pain) and HEADACHE (Headache) had not resolved and DIZZINESS (DIZZY SPELL/LIGHT HEADEDNESS) outcome was unknown.            It was unknown if the patient was enrolled in COVID-19 vaccine trails.  No concomitant medication were reported.  It was reported that the reporters causality for the events BREATHING PROBLEMS, CHEST PAIN, HEADACHE AND DIZZY SPELL/LIGHT HEADEDNESS were not provided  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2022: Follow up received contains significant information updated LOT number of suspect drug humira and events added.