chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Thyroiditis following COVID 19(mRNA) vaccine administration; This is a literature report for the following literature source(s):  While cases of Thyroiditis after COVID mRNA vaccination are reported, the recovery duration is not yet determined. Therefore, the authors present the time course of two healthy middle-aged South Asian patients who developed symptomatic, biochemical, and radiological evidence of Thyroiditis following COVID 19(mRNA) vaccine administration. Despite being more than six months post-vaccination, both arestill hypothyroid, requiring levothyroxine replacement. A 41-year-old female presented after the second dose of Pfizer BioNTech vaccine four weeks prior. Initial workup confirmed biochemical hyperthyroidism (TSH0.019uIU/mL, Free T4 -2.52ng/dl, TotalT3-233ng/dl). During five-month follow-up, laboratory workup showed hypothyroidism with TSH -8.570uIU/mL, Free T4 0.98ng/dl, Total T3-111ng/dl, and still requiring Thyroid hormone replacement for the past six months. She was started on levothyroxine 25mcg daily increased to levothyroxine 25mcg nine pills/week to target TSH 0.5 to 5.0uIU/mL. At the time of diagnosis, both had TPO (Thyroid Peroxidase)-negative, TSI (Thyroid Stimulating immunoglobulin)-negative, and no autonomic nodules on thyroid ultrasound. The patient also had a Technetium-99m pertechnetate uptake scan, which showed decreased radiotracer uptake in both the lobes of thyroid gland. Thyroiditis is an inflammatory disorder diagnosed based on clinical and laboratory findings. While there have been cases reports of Subacute Thyroiditis following immunizations, such as the influenza vaccine, the mechanism of thyroiditis after the COVID mRNA vaccine remains unclear. Subacute Thyroiditis typically manifests as a triphasic clinical course of thyrotoxicosis, followed by hypothyroidism and a return to the euthyroid state; however, mRNA vaccine-induced Thyroiditis seems to have a different disease course. In the authours' observation of these case series, both patients remained in the hypothyroid state requiring Levothyroxine replacement eight-and twelve-months post-vaccination, respectively. Whether they developed permanent thyroid damage or are able to recover with prolonged recovery time is still unclear, which needs further follow-up in the future.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Thyroiditis. 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.,Linked Report(s) : US-PFIZER INC-PV202200097378 Same article, drug and event different patient;US-PFIZER INC-202201282285 same article/patient, different drug/event;
Within 2 hours - severe arm pain lasting 48 hours Within 4 hours - redness below injection site that has lasted 5 days so far and has gotten larger and become itchy and painful. In the same timeframe the back of the tongue and throat developed 1/4 inch + tall white bumps that hurt and went down temporarily after taking Benadryl and resolved by day 4 Within 24 hours - High fever and pulse over 157 lasting 12 hours,
Booster Pfizer was to be given and Moderna vaccine was administrated by mistake, Patient was notified until 02.01.2022, No symptoms or reaction per patient went call to informed was vaccine was given.
The patient has not yet received her second dose of SHINGRIX; Felt tired; Sore arm; Severe pain on skin, like a sunburn with someone raking a wire brush against it; Pain may be due to a nerve; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not received the 2nd dose of Shingrix. In February 2022, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced nerve pain and skin pain. On 19th February 2022, the patient experienced tiredness and pain in arm. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the nerve pain and skin pain were not recovered/not resolved and the outcome of the tiredness and pain in arm were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the nerve pain, tiredness, pain in arm and skin pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's comment: This case was self-reported by the patient. The next day of the vaccination, the patient felt tired and a sore arm. A week later the patient experience severe pain on a small area on the skin of back.  The patient described the pain was like a sunburn with someone raking a wire brush against it. The patient went to a dermatologist who did not see anything.  About a week ago from reporting, the patient went to primary care physician who stated that the pain might be due to a nerve that runs under the wing of back.  The patient was prescribed with gabapentin for the pain but had not yet started.  The pain on her back had not resolved.  The patient had not yet received second dose of Shingrix. The details were reported for 1st dose. The reporter consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
This spontaneous report as received from a pharmacist refers to a female patient in her late 50's. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the dose of ZOSTAVAX (subcutaneously, lot # M001746, expiration date 07-APR-2017; dose was not provided). In September 2016 (reported as at the beginning of the week), the patient developed what her doctor later diagnosed as cellulitis. The patient sought medical attention and received an unspecified treatment of the adverse event. The pharmacist requested a lot check. The outcome of cellulitis was reported as not recovered at the time of this report. The relatedness between the adverse event and ZOSTAVAX was not provided. Upon internal review, the adverse event of cellulitis was considered to be medically significant. Additional information has been requested.
Woke up during the night with cramps in my legs (calf) and left arm. In the am, I was extremely tired, ~  sore throat  ~    bad headache  ~,  sleeping on and off  ~  muscles still cramping up  ~  odd taste in my mouth.   Just not feeling well  ~  daughter (nurse) suggested it was from the vaccine and should report this
Neurologic sx: impaired thinking, difficulty completing sentences, laughing inappropriately, speed of talking was slowed and pitch of voice different, acted like she was "under the influence" of a drug. When asked any question she could only answer "I don't know." She received vaccine on Monday, began acting strange on Tuesday, left work early on Wednesday and felt back to normal when she got up on Thursday. As a side note, she experienced the usual side effects of body aches sore throat and mild congestion.
pt recv vax 9OCT95 & devel redness @ the inj site;no tx necessary;pt recovered;
Im feeling unwell (tired, achy, etc) after yesterdays 2nd shot; Im feeling unwell (tired, achy, etc) after yesterdays 2nd shot/fatigue; Im feeling unwell (tired, achy, etc) after yesterdays 2nd shot/body aches; low fever; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 25Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 26Mar2021, the patient woke up with body aches, fatigue, a low fever and the patient was feeling unwell (tired, achy, etc) after the second shot. Patient was rested and drank fluids, took ibuprofen (ADVIL) for fever. Patient was rested for all day on 26Mar2021 and 27Mar2021. By 28Mar2021, the patient felt fine. The outcome of the events was recovered on 28Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient admitted for management of severe sepsis due to acute cystitis with AKI and hyperlactatemia. Sepsis bundle module was ordered and patient started on meropenem (PCN allergy) and vancomycin. Suprapubic catheter was changed in ED. AKI fully resolved after IV fluids. Urine originally pink-tinged and very purulent with sediment but now clear and amber. Patient completed 2 days of Vancomycin and 8 doses (3 days) of meropenem before being switched to cefdinir, which he has tolerated well in the past. Patient will be discharged with another 13 doses of cefdinir to complete 7 days total of cefdinir. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Severe Wheezing and High blood pressure. Called 911. Went to Emergency room but symptoms stopped after about an hour.
Itchy red bumps (about 8 or 9) that develop a head and break open. Breast and chest area.
Narrative: 7/15-COVID + complains of cough and SOB, nose bleeds 7/29-alos reports chills, fatigue, runny nose 8/3/-clinical resolution
Muscle cramps, locked joints, 103 degree temperature, chills, severe cough, blurry vision, difficulty breathing, fatigue, nosebleed.
PT RECEIVED SHOT IN RIGHT DELTOID MUSCLE; REPORTED A PINK BAND 3 INCHES UNDER THE INJECTION SITE A COUPLE OF DAYS LATER; NO ITCH OR DISCOMFORT
Hard, painful swelling above elbow on posterior, lateral, upper arm.  Applicatin of heat seemed to help.  Claims she was in bed for 5 days and could not move her arm.  Patient did not seek treatment.
Information has been received from a 52 year old female with menopause and no other pertinent medical history, who on 11/22/03 was vaccinated with a dose shot, 0.5mL of pneumococcal 23v polysaccharide vaccine (647635/0864N). The reporter indicated therapy with pneumococcal 23v polysaccharide vaccine was discontinued. Concomitant therapy included estrogens. On 11/22/03, two hrs after receiving a "shot" of pneumococcal 23v polysaccharide vaccine the pt experienced nausea, weakness, skin tingling, abdominal and lower chest pain, throat closing up, SOB, and elevated blood pressure. She went to the ERE and they gave her various cardiac tests, but her heart was fine. She began to feel better and went home. It was noted that no treatment was required for the adverse events and the adverse events abated. It was also noted that she felt fatigued for a few days, and then fully recovered. It was noted that she had a "flu shot" on 10/8/03. There was no product quality complaint reported. Additional info was received via telephone correspondence with a triage nurse in the physician's office, who reported that the female pt did not receive the pneumococcal 23v polysaccharide vaccine at their practice and the practice did not have any further info on the pt because she had not been seen at the practice since February 2002. Upon internal review nausea, weakness, skin tingling, abdominal and lower chest pain, throat closing up, SOB, and elevated blood pressure, and felt fatigued were considered to be important medical events (OMIC). Additional info has been requested. Nurse follow up on 02/13/04 states: "Follow up information was received via written correspondence from the consumer, concerning herself. She reported that "no physician prescribed the pneumococcal 23v polysaccharide vaccine". She reported the vaccine was offered to the general public by a regional medical center community outreach program and she had decided to get the vaccine. She reported that the adverse event was reported to the regional medical center ER, but indicated she is not a pt of any physician in that facility. Upon internal review, nausea, weakness, skin tingling, abdominal and lower chest pain, throat closing up, shortness of breath, and elevated blood pressure, and felt fatigued were considered to be important medical events (OMIC).  No additional information is expected."
Adverse side effects began approximately seven hours after receiving the Johnson & Johnson JANSSEN vaccine. Side effects included: Extreme chills, fever (approximately 99.5F), headache, muscle aches, and fatigue. Side effects lasted approximately 26 hours.
Information has been received from a medical assistant concerning a 16 year old female who in July 2008, was vaccinated with a 0.5 ml dose of GARDASIL intramuscularly into the deltoid (lot number not reported).  It was unspecified if this was the patient's first dose or a subsequent dose.  Subsequently, also reported as about a week ago, the patient experienced heart palpitations and chest pain.  The patient's mother called the office and the reporter instructed the patient to go to the emergency room.  It was reported that the office had checked with the hospital but it did not appear that the patient went to the emergency room.  Additional information has been requested.
This spontaneous report was received from a certified medical assistant (CMA) and refers to an unspecified number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients may have received doses of improperly stored doses of PNEUMOVAX 23 (M022086 expiry date: 09-OCT-2017 and L040053 expiry date: 10-MAY-2017) (route of administration not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Pt fainted after given the 1st doses of HPV at age 12 years while riding the train.
Per treating physician note: "MMR immunization...illicited a widespread allergic response in the patient including rash, fever and vomiting. This persisted for days and resolved with steroids."
pt recv vax 1OCT97 & home from babysitter @ 11Pm itching-mom noticed hives;hives large all over where shot was given very swollen-MD advised DPH;
I am having a very very heavy period compared to my usual with this vaccine. I had just started my period two days before the shot and usually I have one heavy day and then it?s over. It?s now been three heavy days of period since the shot. Thought I would report this as a potential reaction
Pt reported numbness down arm from site of flu injection. This occurred 3 weeks following administration of immunization.
Stiffness in shoulders that moves from one shoulder to other.; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in shoulders that moves from one shoulder to other.) and NAUSEA (Nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second 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) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in shoulders that moves from one shoulder to other.) and NAUSEA (Nausea). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in shoulders that moves from one shoulder to other.) and NAUSEA (Nausea) outcome was unknown.            No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of STIFFNESS IN SHOULDERS THAT MOVES FROM ONE SHOULDER TO OTHER with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of NAUSEA was not provided.  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.
This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had unspecified known allergies. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021 at 14:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. 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 26Mar2021 the patient experienced consistent headaches and tiredness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events consistent headaches and tiredness was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2013US018640, is an initial spontaneous report received from a medical assistant on 03 Sep 2013, with a follow up report from nurse received on 17 Oct 2013. This case refers to a 18-year-old female patient. She received only Men A lyophilized conjugate component of MENVEO, (batch number: not reported) reconstituted with sterile diluent intramuscularly on 27 Aug 2013. She did not received Men C, Y, W-135 liquid conjugate component of MENVEO vaccine. Patient had no adverse reaction however it was noted that she would not receive complete immunity to all her strains of the meningitis. It was recommended to re-boost in six months to provide the coverage. The nurse stated that the patient would re-boost in Feb 2014. Follow up report from nurse received on 17 Oct 2013: Updated information on re-boost of vaccine.
no additional AE; MMRII was given IM instead of subcutaneously; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 31-JAN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) 0.5 ml, lot #U031360, expiration date was reported as 17-OCT-2023, but upon internal review established as 07-OCT-2023, administered intramuscularly (formulation and administration site were not provided) for prophylaxis (incorrect route of product administration). No additional adverse events (AE) were reported (no adverse event).
This case was reported by a consumer and described the occurrence of abnormal laboratory test value in a 27-year-old female subject who was vaccinated with HAVRIX for prophylaxis. A physician or other health care professional has not verified this report. The reported was the subject's mother. At the end of January 2008 the subject received 2nd dose of HAVRIX (unknown). The pharmacy told the subject that she had received HAVRIX. At an unspecified time after vaccination with HAVRIX, the subject "recently" took a HIV test and it "came up inconclusive". At the time of reporting the outcome of the event was unspecified.
localized reddness, swelling & inj site;site warm & tender to touch;no fever;
Case previously recorded as MA2009-3763. Initial case report received from a consumer via MedCom on 06 NOV 2009. A 54 year-old female patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. unknown) i.m on 04 OCT 2009. The patient experienced hot flashes, nausea, heartburn, diarrhea and low grade fever one hour after receiving the vaccination. The patient did not recover at time of this report. MedCom reference no.: NA09-007700.
She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful; She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful; She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful; She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful/ got a knot her knot there; This is a spontaneous report received from a contactable consumer (Parent) or other non-non health care professional   A 16-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 08Jun2021 as 2nd dose, single for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD. Concomitant medications included methylphenidate hydrochloride (CONCERTA) taken for attention deficit hyperactivity disorder (ADHD), start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  Formulation: Solution for injection, Batch/Lot number was not reported) via a unspecified route of administration (at the age of 16-yesr-old) on 18May2020 as first dose single for COVID-19 immunisation and experienced no reaction on previous exposure to vaccine. it was reported that patient got second dose of vaccine last week on Tuesday, On Jun2021 she got a knot where she got her injection, it was red and burning yesterday on 16Jun2021 and now it has got a hard knot and it is painful on 17Jun2021.  reporter wanted to site where the vaccine was injected it has got a knot like a hard knot there and it was burning and red. No treatment was received for the events. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Received on 12/22/20 at about 130pm, symptoms noted around 12/23/20 at 7:00 am, stiffness in the right hand, with numbness and tingling of the right arm, weakness, decreased strength, 5-6 days later pain in the right axilla.  The pain in the axilla resolved, continues with the other symptoms
Started with oblong 1 1/2 x 3 in injection site reaction - warm, hard and red. Followed by headache and 1 1/2 days and soreness in elbows and knees. Then 9/25 blisters around lips up to this date 9/29/13.
vomiting, low bp, low blood sugar not resolved with fan, fluids, sent to er
to ED c/o diarrhea, poor appetite, weakness, low grade fever, all thought to be r/t COVID, CRP 8.52 TX: zinc, singulair, zithromax, zosyn for diarrhea (c.diff ruled out). No steroids or remdesivir, discharged home
lethargy difficulty breathing coughing headache increased heart rate blood shot eyes  milky white discharge from eyes tingling in mouth and lips increased temperature (100 degrees f)