chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient and describes the occurrence of BLISTER (allergy side effects/Bubbling on the skin/Blistering (Raw)) and DRUG INTERACTION (started having problem with her multiple sclerosis Medication/having a reaction to it after taking the booster) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 028A21A and 012A21A) for COVID-19 vaccination.  Co-suspect product included non-company product GLATIRAMER ACETATE (COPAXONE) injection for Multiple sclerosis. Concurrent medical conditions included Sulfonamide allergy, Multiple sclerosis, Breast cancer and Ulcerative colitis. Concomitant products included MESALAZINE (MESALAMINE) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. In 2004, the patient started GLATIRAMER ACETATE (COPAXONE) (unknown route) 20 milligram. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLISTER (allergy side effects/Bubbling on the skin/Blistering (Raw)) and DRUG INTERACTION (started having problem with her multiple sclerosis Medication/having a reaction to it after taking the booster). At the time of the report, BLISTER (allergy side effects/Bubbling on the skin/Blistering (Raw)) and DRUG INTERACTION (started having problem with her multiple sclerosis Medication/having a reaction to it after taking the booster) outcome was unknown. It was reported that, the patient did not get the vaccine because in Nov-2021 her healthcare professional advised she had COVID immunity to wait 90 days to get the shot. The patient visited her dentist. The patient started having problem with the multiple sclerosis medication that she had been taking for 18 years. The patient had allergy side effects like bubbling on the skin, and blistering (raw).  The patient was no longer taking Copaxone for multiple sclerosis. The patient was taking Copaxone for 18 years, currently she was having a reaction to it after taking the booster. The expiration dates were not provided. The patient was taking medications. The patient's healthcare professional was aware of side effects. No treatment details were reported.
itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation.  Medical history included known allergies: Sulfa.  The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity.  On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; No adverse event; Administered the vaccine to the patient after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date).    No concomitant medications were reported.  No treatment medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.
Patient developed erythema, mild swelling, itching, and warmth on left arm shortly after second COVID-19 vaccination.
This spontaneous report as received from a physician refers to a 68 years old female patient. The patient was vaccinated with a vial dose of PNEUMOVAX 23 (lot# reported as HOL3581) injected on 11-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-SEP-2012 the patient experienced swollen right arm and a "3/4 edema". The patient had sought medical attention by saw physician. BENADRYL was given for treatment. The physician requested a lot check. The outcome was unknown. Additional information has been requested.
INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; SHAKING; BODY ACHES; SERIOUS DIZZINESS; CHILLS; TIREDNESS; HEADACHE; .This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 110 kilograms, and height was 162.56 centimeters. The patient's concurrent conditions included non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergy. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: UNKNOWN) dose was not reported, administered on 07-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamins nos. On MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 07-MAR-2021, the subject experienced off label use. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced body aches. On 07-MAR-2021, the subject experienced serious dizziness. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body aches, serious dizziness, chills, and tiredness on 14-MAR-2021, and the outcome of headache, inappropriate route of vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V2: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
This non-serious spontaneous case, initially received on 15-Mar-2018 was reported by other health professional, concerning a non pregnant female patient of unspecified age. It was reported that, the patient had a weakened immune system. On an unspecified date first temperature excursion of the vaccine occurred. On 24-Jan-2018, after the first temperature excursion, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: XT59906, expiry date: 06-Jun-2018). On an unspecified the vaccine was stored out of range for 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines. Follow up report received on 04-Apr-2018: The vaccination date (24-Jan-2018) was added. The narrative was amended accordingly.
Fever; Body ache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Sep2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Sep2021, the patient experienced fever, body ache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, body ache and nausea was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(R) leg red and swollen at injection site Mom noticed morning after injections (10-26-11).
BODYACHE; CHILL; FEVER; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced bodyache, chill, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chill, headache and bodyache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210359266.
There were not adverse reactions. The patient feels fine and had no adverse reactions according to her mother. I discovered that I administered the pfizer booster to her and she is 14 years and 11 months old. This age has not been approved as yet for the booster. She made it through our system without us catching this fact. I discovered my error after examining the paperwork later. The parents are aware of this fact.
Moderna COVID?19 Vaccine EUA  -  Irregular Menstruation  - Out of Cycle by a week with heavier than normal flow following vaccine
Extreme pain in rib cage; pain in sternum; rapid heart rate; shallow breathing; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 10Apr2021 at 13:00 (at the age of 17-year-old), as a single dose for COVID-19 immunisation. Medical history included juvenile idiopathic arthritis, hypermobility and AMPS( amplified musculoskeletal pain syndrome). The patient did not have any known allergies to any food or medications or other products. Concomitant medication included birth control (unspecified) started from an unknown date for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 20Mar2021 at 13:00 (at the age of 16-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced extreme pain in rib cage and sternum, causing rapid heart rate and shallow breathing. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme pain in rib cage and sternum, rapid heart rate and shallow breathing was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt developed difficulty breathing, tingling in lips and face, elevated pulse and swelling of lips. 50mg diphenhydramine IM in R deltoid, symptoms slowly subsided over the course of 1 hour.
Dizziness, BPs 158/88 (pulse 51), 127/76 (pulse 89). O2 sats 100%. Ate crackers and drank water.
15 y/o male presents for evaluation of persistent nausea which began 3 days ago. Pt states that he got his COVID vaccine 10 days ago. He went for a short run 06/28/2021 and felt body aches when he came home. On 06/29/2021, pt started "feeling really badly." He vomited 3 times and had two episodes of diarrhea. He also started feeling lightheaded and weak at this time. He states that his sx somewhat resolved on 06/30/2021 but is worse again today, prompting his visit to the ER today. Pt states that movement exacerbates his weakness. Reports associated fever, myalgia, vomiting, diarrhea, weakness, dizziness, SOB, cough, and nausea. Denies associated hematemesis, CP, LOC, or dysuria.
Pt started w/fever of 101 on 9JAN92 in AM given APAP; temp cont to rise w/APAP t102 on 10JAN92; pt was limp & sleeping most of time & refused to eat; MD examined pt on 10JAN92; CBC & CXR were neg; MD felt rxn to vax;
administered Adacel to a patient today that expired on 09Dec2021 with no reported adverse event; Initial information received on 27-Jan-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 90 years old male patient who administered adacel which was expired on 09dec2021 with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5687AA via unknown route in unknown administration site.  On 27-JAN-2022 the patient had adacel that expired on 09dec2021 with no reported adverse event (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered Adacel to a patient today that expired on 09Dec2021 with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administered adacel to a patient today that expired on 09dec2021 with no reported adverse event.  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.
Patient tested positive on 28-Apr and started taking paxlovid on 29-Apr. The symptoms lessened within 48 hours of taking the medicine and patient tested negative on 06-May; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive on 28-Apr and started taking paxlovid on 29-Apr. The symptoms lessened within 48 hours of taking the medicine and patient tested negative on 06-May) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Patient had an allergic reaction to an unknown historical drug.     On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced COVID-19 (Patient tested positive on 28-Apr and started taking paxlovid on 29-Apr. The symptoms lessened within 48 hours of taking the medicine and patient tested negative on 06-May). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 04-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 06-May-2022, COVID-19 (Patient tested positive on 28-Apr and started taking paxlovid on 29-Apr. The symptoms lessened within 48 hours of taking the medicine and patient tested negative on 06-May) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 06-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 09-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information was provided.  Company comment- This spontaneous case concerns a 32-year-old male patient with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) that occurred 4 months and 6 days after vaccination with a third dose of mRNA-1273. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 32-year-old male patient with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) that occurred 4 months and 6 days after vaccination with a third dose of mRNA-1273. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt developed fever to 102F and body aches 11/29/17, after receiving the pneumococcal 23 and flu vaccinations 11/28/17 in clinic. He also had right shoulder soreness where he received both vaccinations. 11/30/17 patient reported in that morning the skin over his right deltoid became red and swollen. Reports sweats and chills and feels very fatigued, mild nasal congestion. He states he had had fatigue and body aches after a previous flu shot but never symptoms this severe. Has been taking TYLENOL, drinking a lot of fluids. He denies mouth swelling, hives, rash or trouble swallowing or breathing.   Pt appears fatigued,  Skin over right deltoid is diffusely erythematous, mildly edematous, and quite tender to palpation.   1. Suspected adverse effect of vaccine, initial encounter We discussed how fever and body aches can be a rare side effect from vaccinations, in particular pneumococcal 23. I was unable to find data on the CDC website regarding how long these symptoms typically last, although I anticipate not more than a few days.   2. Possible cellulitis of right upper extremity Given new erythema, edema and tenderness at vaccine site that appeared 2 days after vaccination along with his systemic symptoms, I have elected to treat for possible cellulitis. However, it is also possible the skin findings are simply a reaction to the vaccination rather than bacterial cellulitis. A skin pen was used to demarcate the border of the skin redness for pt tracking purposes. Pt's VS are WNL today during his visit. - cephaLEXin (KEFLEX) 500 mg Oral Capsule; Take 1 Cap by mouth four times a day for 5 days.  Dispense: 20 Cap; Refill: 0 3. Fever 4. Body aches
9 Days after the injected vaccine I developed a large, raised, red, and itchy rash on my left arm below the injection site.  I am using Hydrocortizone anti-itch ointment on the rash which a week later has lightened in color but remains itchy.
Headache x 6 days, knot in arm, nausea, fatigue missed 4 days of work. Following 2nd vaccine flu like symptoms felt terrible starting within 12 hours lasted next 3 days missed 2 more days of work 9/20 and 9/21. 2 weeks and 2 days following last vaccine I had a sudden severe onset at work in school of extreme Vertigo.  No history and no other symptoms.  By the time I got home I was nauseous threw up multiple times . My daughters drove me to Urgent Care next day 10/6/21 where I was given Zofran, prednisone, Meclizine and cefdinir.  Nothing helped except Zofran.  Nausea subsided.  Almost 2 weeks later on 10/17 I went to ER.  The vertigo was so bad I can?t drive walk straight, vision impaired.  I tested positive for Covid in ER with no symptoms and fully vaccinated.  Was released by health department on  10/16/2021 since vertigo began on 10/5/2021.  I was admitted 10/17,, 18 discharged 10/19.  Again missing more work.  Labs ran, CT scan, MRI head consult with neurologist no answers other than Covid or vaccine.  I?m 5 weeks in now and still dizzy all the time.
Patient developed a rash and knot with pain at injection site. She did not say what time she noticed it.
Information has been received from a registered nurse concerning a teenage female who on unspecified date was vaccinated with a dose of GARDASIL.  After receiving GARDASIL, the patient was lightheaded.  The outcome of the patient was not reported.  This is one of several reports from the same source.  Additional information has been requested.
Pt c/oitchy throat at 9:56am and denied any other discomfort. Vital sign stable. BP normal.  SaO2 99%. AAOx3. Patient felt better alert and calm leftat 10:17am. Denied any dicomfort or difficulty breathing.
Got the shot on 2/8/18 at about 5:00 about 7/8:00 I started shaking like I was chilled but I was not cold. Through the night it got worse. I shook so bad my teeth were clinched. I opened them with my fingers. The shivering slowed down in the morning. It shivered all the day and was worn out. (When I got up at night I could hardly walk). My arm hurt for two days.
dizzy; headache; This is a spontaneous report received from a contactable reporter(s) nurse (Other HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "dizzy"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "headache".  Additional information: Reported headache 48 hours "normal adverse events". Woke up last night same symptoms. Asked if she could have been exposed, immune response, or if this was an adverse reaction. She was to attend a baby shower, and the reasoning for her question.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.