chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash (Erythematous rash and Pruritus after receiving 1st dose on 3rd May 2018, see case US2018139576). Concomitant products included amlodipine, biotin, folic acid, thyroxine sodium (Levothyroxine), metformin hydrochloride (Metformin), pravastatin sodium (Pravastatin), ramipril, cyanocobalamin (Vitamin B12), pyridoxine hydrochloride (Vitamin B6), colecalciferol (Vitamin D3), cetirizine hydrochloride (Zyrtec), glimepiride and ubidecarenone (Coq10). On 5th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 5th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the wife of patient.
Swelling of throat, given water, MD assessed. BP 118/74, HR 93, RR16. Patient stable and released from vaccination site, advised to follow up with PCP No N/A Resolved
Information has been received from a physician concerning a 6 year-old Asian male patient with a concurrent condition of eczema who on 02-Jun-1998 was vaccinated SC in the arm with a first dose of varicella virus vaccine live. The physician reported that recently the patient came to the office with 60-70 lesions, a fever of 101 degrees, and itching. The physician reported the patient had chicken pox disease with crops of vesicles intermittent became generalized. The onset of the chicken pox was reported as 24-Nov-2003. The physician noted the vesicles appeared in stages. There were no laboratory or diagnostic studies performed. The patient recovered on 01-Dec-2003. There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected.
bell's pausy; strange feeling in my lip; stiff neck; A spontaneous report was received from a consumer concerning a 73-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  developed Bell's Palsy (facial paralysis), stiff neck (musculoskeletal stiffness), and a strange feeling in her lip (oral discomfort).    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included vitamins, atorvastatin calcium and calcium   On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Feb 2021, the patient developed a very stiff neck and had a restless sleep. On 06 Feb 2021, the patient reported awaking with a strange feeling in her lip. She was advised by her primary care physician. On 07 Feb 2021, the symptoms had worsened, and her facial muscle had twisted. Treatment for the event included prednisone and valacyclovir.   Action taken with mRNA-1273 in response to the events was not provided/unknown.  The events, Bell's Palsy, stiff neck and strange feeling in lip, was considered not recovered/not resolved.; Reporter's Comments: Although a temporal relationship exists, there is not enough information to assess the causal relationship of the reported events with the administration of mRNA-1273 (Batch number: 038K20A).  Critical details such as patient's medical history and relevant diagnostic test are lacking. Additional information have been requested.
Pt presented to Pharmacy at 10:00 am on 11-4-14 with a rash across the back and down the leg. Pt had shingles 5 years ago and says it looks exactly the same.
Cellulitis at right thigh vaccine site. Started on Augmentin ES 600mg 15ml BID for 10 days.
Approximately 30 minutes after injection, client began to experience shortness of breath,  nausea, vomiting, hives on face and chest,  tightness in chest and severe anxiety attack.
Warm at injection site; Soreness under left armpit; Swelling under armpit; Rash on her neck and chest on left side; Injection site swelling; Redness around injection site; Little tender at injection site; This is a spontaneous report from a contactable consumer (herself). A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown) dose 1 via an unspecified route of administration, administered in Arm Left on 18Apr2021 15:45 as DOSE 1, SINGLE for covid-19 immunisation (at the age 45 years). Medical history included hypertension (Verbatim: High blood pressure), anxiety (Verbatim: Anxiety). The patient's concomitant medications were not reported. The patient previously took penicillin nos and experienced hypersensitivity, wellbutrin and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. The patient previously took flu shot at the age of 44. Caller stated the lot number is either EW0171 or EW0121, but it is probably more EW0171. Caller stated she also sees PS1285 which is on the same line as product name slash manufacturer. Caller stated she has high blood pressure, general allergies, and anxiety but she does not think they are relevant to her symptoms. The patient experienced injection site swelling, redness around injection, little tender at injection site, rash on her neck and chest on left side on 24Apr2021, soreness under left armpit, swelling under armpit on 27Apr2021 and warm at injection site on 28Apr2021. Caller stated just the normal symptoms of tenderness and pain in the arm. Caller stated she is calling about the COVID 19 vaccine. Caller stated she had the first dose on 18Apr2021 and she did not actually start getting any reactions until 24Apr2021 and she definitely has injection site swelling and redness around the injection site also at the site it is a little tender and hot. Caller stated she also has a rash on her neck and chest on the left side but it is a mild rash and then soreness under her left armpit which she thinks is just her lymph nodes and swelling too under her armpit. The patient did not received any treatment for all the events. The patient did not visit any emergency room or physician office. The clinical outcome of all the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Pt state 4 wk post inj arm still sore and lump where shot administered.
Information has been received from a physician concerning a female patient who was vaccinated on an unspecified date with the first dose of vaccine. There was no concomitant medication. The patient did not seroconvert after receiving a first vaccination. A second dose of vaccine was administered and again the patient did not seroconvert. The patient sought unspecified medical attention. Additional information has been requested.
pt recvd Cholera vax & devel a 3 inch wheal @ the inject site;
Pt felt hot, mom let splash in pool then started convulsing, eyes rolled back; To ER given IV & O2;
Pt received varicella vaccine and booster and today presents with chicken pox rash (no fever) with >50 lesions.
10 min after injection dizziness, lightheaded continued a few hours. Next day, extremely tired.
pediatric patients were inadvertently administered an adult Havrix; pediatric patients were inadvertently administered an adult Havrix; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 1-year-old female patient who received HAV (Havrix adult) (batch number J9587, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th May 2022, the patient received Havrix adult 1 ml and Havrix Pre-Filled Syringe Device. On 4th May 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JUN-2022  Reporter's comment: Medical Assistant called in to inquire as how to proceed and what to look for a pediatric patients who was inadvertently administered an adult Havrix (1 mL) dose. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered an adult Havrix dose, which led to overdose and inappropriate age at vaccine administration. This case is linked with US2022091775, reporter by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022091775:same reporter
This spontaneous report was received from an administrator (immunization coordinator0 and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unspecified date after 10-JUL-2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L013067 (dose, route of administration, anatomical location and expiration date were not provided). The vaccine was exposed to 9.1 degrees Fahrenheit for 1 hour. There was no previous excursion. The call was made because of a "data logger". The outcome of excursion was reported as "supported". No adverse effects were reported. Additional information has been requested.
SINGLE SUBSEGMENTAL PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONALE 5/2/2023 PREECLAMPSIA, THIRD TRIMESTER ACUTE PULMONARY EMBOLISM 5/2/2023 PREECLAMPSIA, THIRD TRIMESTER SINGLE SUBSEGMENTAL PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONALE 5/2/2023 MATERNAL DELIVERY OUTCOME, SINGLETON BIRTH, LIVEBORN ACUTE PULMONARY EMBOLISM 5/2/2023 MATERNAL DELIVERY OUTCOME, SINGLETON BIRTH, LIVEBORN
fever 104, 105 x 3 days;febrile sz on 2 consecutive nocs;MD attributed fever to vax rxn;
Pt recvd vax 2nd dose of vax 14AUG92 & w/in 24 hrs pt exp sl edema w/o redness, sl h/a, nausea, sl tenderness w/ a nodule @ the inject site; 1 wk later, exp nausea, h/a, aching joints, fever, chills, sweating, lower back pain, fatigue;
Patient received three Pfizer COVID vaccines, and the third dose was in September 2021. He developed chest pain worsening with deep breathing/cough and fever 101 on 12/21/21. He decided to come to ED on 12/23/21, and subsequently, he was admitted to the hospital due to extensive cardiac history. COVID PCR resulted positive at the ED, and a chest x-ray showed airspace opacities. He received Dexamethasone, Ceftriaxone, and Doxycycline for pneumonia. He was stable on room air. He was discharged home on 12/26/21.
I received the flu vaccine on Oct 18, 2018. The day after I received the flu vaccine, my left shoulder and upper left arm were sore. The soreness and dull pain has continued non-stop for 3 weeks now. Today is Nov 7, 2018. Last week on Oct 31, 2018, I contacted my Primary Care Physician to report my symptoms. They advised me to take ALEVE for 10 days which I am doing. Today I contacted the pharmacy where I received the flu vaccination to file a report with them. I am still experiencing dull pain in my upper left arm and shoulder.
Severe headache not long after the shot it lasted  for 2 days. Sore arm the next day.
3/9/2023 in the evening noticed chills, and body aches, muscle and teeth ache, runny nose, and profound cough. Cough was bad enough to keep me from sleeping. At home COVID-19 test, positive 3/10. Televisit with doctor, prescribed PAXLOVID, and to treat symptomatically. Symptom improvement noticed within 12 hours of taking PAXLOVID. Within 24 hours of staring PAXLOVID, symptoms had abated. After the course of PAXLOVID, there was a return of a slight runny nose and cough that resolved over the course of about 10 days.
Child left clinic after vaccinations-before he got into vehicle, complained of chest pains. Mother returned him to clinic, where he threw up. Left clinic- Mom called in a few minutes with report of severe hives. Referred to ER or pediatrician at Drs office, he was treated with epinephrine and given an Epipen. Dr. advised they make appointment with allergist.
Patient had reaction after Gardasil, a sensation where her left arm became numb.  She also was reported to be sleepy and had a decreased appetite.  Her symptoms disappeared after 4 days with no permanent sequelae.
Same day post vax, pt experienced erythema pruritic swollen maculo rash on the face.  Injected sclera and conjunctivae of both eyes.
extremely dizzy and lightheaded; had to take off work the next day due to the dizziness.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm left on 14Mar2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and high cholesterol. Patient had no known allergies. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and esomeprazole (NEXIUM); both taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 18:30 the patient experienced extremely dizzy and lightheaded within 30 hours of taking vaccine, the patient had to take off work the next day due to the dizziness, its been 4 days (when reported), still slightly lightheaded when turning the head, but able to work. The clinical outcome of the event extremely dizzy and lightheaded within 30 hours of taking vaccine, the patient had to take off work the next day due to the dizziness was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Left sided facial droop, Left eye droop with tearing, asymmetrical smile & mild headache no treatment
Severe right arm pain and muscular pain at injection site prompting patient to come into Emergency Department for care.  Patient took Tylenol and Ibuprofen with no relief in symptoms.  Patient also had low grade fever of 99.4
Friend of client, called on 4/2/01 and states that 2 days, post vax, pt started "getting slow" and "not himself". 1 week ago, he complained of right arm being "nervous" and saw MD on 3/27/01 because of arm and complaint of being dizzy and problem with thumb and was advised left thumb was probable carpal tunnel. Had surgical removal of a lesion on 3/29/01 that he received secondary to hitting his head on 2/12/01 )on tree limb). He was advised that he needs to see his regular MD for complete evaluation.
Cough, sob, fever, all over body aches, swelling at inj site.
Chills, body aches, fever, sweating, nausea, vomiting, headache. No treatment. Resolved in 8 hours except headache which resolved in 24 hrs.
My son has a severe stutter since the vaccine.  When he tries to speak he will get a head movement similar to a tick where he moves his head to the side and draws the word out with his head movement while his eyes are closed.  It is progressively getting worse and he is noticing it and getting extremely frustrated.  After seeing our pediatrician, she encourages us to report this.
Patient received a Pfizer Adult Covid vaccine 1 hour past expired time in right deltoid. Patients Provider PA-C was contacted in the clinic. Immunization Coordinator/LPN and Provider consulted. Immunization Coordinator/LPN contact Pfizer directly and Provider contacted Lead Immunization Coordinator. Provider Spoke with patient and he stayed in clinic for 30 minutes and did not have any adverse reaction prior to leaving.
Day after flu shot my left arm was painful. I assumed it was just sore from the injection. The following day it was still painful so I went to our Occupational Health Clinic and reported it as I was familiar with SIRVA and felt it should be reported "just in case".  I saw Dr. and told her my suspicions. She gave me steroids and had me follow up in one week. I followed up in one week with a PA with no improvement. He was not familiar with SIRVA and dismissed me just telling me to follow up with my PCP. After a few weeks of no improvement I went to my PCP and told him of my SIRVA suspicion. He just listened, but did not order anything. I also told my Neurologist, she did nothing. Months passed and the pain and my ROM got worse. I eventually complained enough my PCP ordered an EMG. The EMG confirmed slight damage from wrong injection placement, but at that point no surgical intervention needed (according to EMG). Pain has continually gotten worse and ROM poor. I contacted PCP again asking for MRI and physical therapy. I have gone to PT twice with no improvement. MRI on 1/13/2018. Shortened version of result findings: "Subtle signal variation at the articular and bursal surfaces suggest fraying/partial tearing of the tendon structures are contiguous and continuous with the full-thickness tears".  At this time I have stopped PT and am awaiting an Orthopedic Surgeon consult.
No adverse effects reported; expired MMR II (N024703 9/8/2019) was administered to a patient on 9/30/2019; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 30-SEP-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II), lot # N024703, expiration date 08-SEP-2019 (strength, dose, route of administration were not reported) for prophylaxis. It was reconstituted with not expired sterile diluent (lot # S025290, expiration date 20-MAR-2022). There was no temperature excursion for the vaccine and for the diluent. No adverse effect were reported.
Large erythematous right leg swelling 9cmx9cm. Admitted for questionable cellulitis (right leg). No fever, no positive cultures. Diagnosed: large, local reaction.
Within 15 minutes having the worst chest cold of my life.  I could feel my lungs filling.
vaccine in patient over the age of 45; This spontaneous report was received from a pharmacist concerning an unspecified patient over the age of 45 (unknown age and gender).    The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) (dose, route, lot# and expiration date were not provided) for prophylaxis.      This is a non-valid case due to lack of patient identifier.
He got sick on 07/13/2021 finally ended up going to the hospital 07/16/2021 for body aches headache  & weakness they sent him home and said it was a allergic reaction no bloodwork  they prescribed him Zoltan oft 4 mg oral tablet
About 7 days after injection I developed an itch at the vaccination site. Today (Day 8) the itch is still there. Redness, a little swollen. I understand this is a known side effect and will subside. I'm not treating it in any way at this point.
patient did get a 3rd vaccine, we did not check Impact prior to giving her the 3rd. vaccine, she had no adverse reaction, just one shot too many.  she got her first 2 shots.
Patient received 2 doses of Sinovac in4/11/2021 and 05/12/2021 - did not disclose during first 2 appointments.  Patient received Pfizer 09/04/2021 and 09/25/2021 as indicated in this report.
administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient administered dose under age; CDC guidelines followed to vaccinate for second dose; Consent was signed by parent.
Started getting tingling in right thigh followed by tingling in left lower leg & left foot. Severe muscle cramps in left calf. Intermittent tingling in both upper arms. This was followed by blurry vision in the left eye & intermittent dizziness.
thyrotoxicosis; Thyroiditis; Myalgia; Fatigue; Nausea; Chills; new progressive anterior neck pain and swelling; new progressive anterior neck pain and swelling; This is a literature report entitled Letter to the Editor: Thyroiditis and Thyrotoxicosis After the SARS-CoV-2 mRNA Vaccine. The full publication has been requested.   Rapid COVID-19 vaccine development and uptake are critical to mitigating the ongoing epidemic. Current vaccine candidates are at various stages of development and regulatory approval. These vaccines are broadly considered safe, though adverse effects have not yet been fully characterized. In this study we present the first description of thyroiditis linked to SARS-CoV-2 vaccination. A 57-year-old woman with no medical history received the first dose of the Pfizer-BioNTech SARS-CoV-2 vaccine 34 days before presentation, with associated fatigue, nausea, chills, and myalgias lasting 1.5 days. She received the second dose 13 days before presentation, and within 24 hours had recurrence of her symptoms associated with new progressive anterior neck pain and swelling. She was referred to the hospital by her outpatient provider for thyrotropin (TSH) 0.009 uU/mL, thyroxine (T4) free 2.6 ng/dL, and T4 total 17.4 mcg/dL (outpatient normal ranges [NRs] unavailable). On hospital arrival, she was febrile to 38.3 Centigrade with a pulse of 137 beats/min. Examination revealed right thyroid gland enlargement with diffuse tenderness, and no proptosis, lid lag, or periorbital edema. Laboratories showed TSH <0.008 uU/mL (NR: 0.4-4.2), free T4 1.92 ng/dL (NR: 0.8-1.5), triiodothyronine (T3) total 137 ng/dL (NR: 87-178) with thyrotropin receptor antibody <1.10 U/L (NR: 0-1.75), thyroid stimulating immunoglobulin <0.10 U/L (NR: 0-0.55), thyroid peroxidase antibody <0.5 U/mL (NR: 0-5.6), and thyroglobulin antibody 3.4 U/mL (NR: 0-4.1). Thyroid ultrasound showed an asymmetrically enlarged hypervascular heterogeneous right thyroid lobe suggestive of thyroiditis. She was treated with propranolol and ibuprofen and later started on prednisone as an outpatient.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported event, 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
day of vaccination felt fine.  following day- having a really bad allergy attack. non stop sneezing, frequently blowing nose. I took an otc allergy pill- Claritin.