chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken for moderna COVID-19 vaccine was Not  Applicable.  No concomitent medications were provided.  No treatment medications were provided.
Vaccine was incorrectly administered into the shoulder joint, not IM into muscle.  Felt the needle hit bone (?).  Immediately sore.  3 hours later could not raise arm above waist.  Could not sleep.  Pain 10/10
I was having a raspy and sore throat. The next day I woke up with a mild cough. I took an at home COVID-19 test before a shower and that was negative. After the shower I started having chills to the point of my teeth chattering. I had a fever of 102.6, so I took a second COVID-19 test which was positive. I called my doctor on Monday and my symptoms were worse. I had congestion and the cough was worse, I had a headache and I was just in pain. This lasted for about two more days or so and it wasn't until after the 21st that I was feeling better.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 3 October 2011 the subject received a dose of FLUARIX (.5 ml, unknown route, left deltoid) at her place of work. On 4 October 2011, 1 day after vaccination with FLUARIX, the subject experienced a 3 inch area of swelling at injection site. The subject also experienced erythema. The subject was treated with cool compress (cold compress) and BENADRYL. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX. The healthcare professional commented that a similar reaction was observed in a "couple of patients". No details regarding any additional subjects was provided.
TiA. Aphasia , saying words I didn't mean to say.  No treatment.  Testing. Started on daily 81 MG Asa. Referred to neurologist
Patient reported small area of redness and itching on left forearm. Patient also states she went horseback riding yesterday and had a similar rash on right forearm. Patient evaluated by EMT and MD. Blood pressure 128/87. O2 saturation 99%. Patient given Zyrtec X1 po.
The patient's medical history and concomitant medications were not reported. On 19Apr2021, patient got Covid-19 symptoms and he tested Covid-19 positive on 21Apr2021. He said that he missed the 2nd dose and the vaccination facility called him for a follow-up. Patient also mentioned that he got a clearance letter and he is not contagious anymore. The outcome of the event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headache) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had not resolved.        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.   Treatment medication was not provided.  Concomitant medication was not provided.   Reporter did not allow further contact
pt recv vax & the following day pt exp swelling @ the inj site & vasculitis;ER or MD visit was required;sx cont;
Red splotchy rash across arms, chest, and back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jun2021 (Lot number: EW0181) at the age of 23 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0191, Vaccine location: Left arm), for Covid-19 immunisation. The following information was reported: RASH MACULAR (non-serious) with onset 17Jul2021 11:00, outcome "not recovered", described as "Red splotchy rash across arms, chest, and back". Therapeutic measures were not taken as a result of rash macular.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested post the vaccination.  No follow-up attempts are possible. No further information is expected.
5/3/07 pt experienced uriticaria and hives over chest, back, arms, and legs the day after receiving vaccines (within 24 hrs) - seen in local ER and treated successfully with epinephrine, prednisone and Benadryl.
Abnormally severe chest pain around the general heart area. On-going ?chest? pains. Not related to diet or acid.
Narrative:  pt presents for triage, c/o allergic reaction to TDAP given 8/26/21 pt rt upper arm, red below deltoid and above elbow...warm to touch. pt states didn't noticed till yesterday. took 2 benedryl tabs last night. states sore and burning sensation . Right upper arm with 3in X 3in area warm, red. No swelling. Feels like a sunburn. No blisters. Area appears to be allergic reaction and he di dhave some imprvement with burning discomfort after benadryl 50mg last night. VSS w/ no SOB, facial or throat edema, or wheezing. Afebrile
Onset of hives approximately 12 hours post vaccine. (also had been eating chocolate and is allergic to chocolate, went to ER for evaluation - given Benadryl and Prednisone - Spoke with patient 24 hours post vaccine, Symptoms resolving.
Muscle soreness in left arm, fever at 99.6 degrees starting 6 hours after injection. Fever went to 100.5 degrees at 1am, 11 hours after injection, and stayed at over 100 degrees  until 6:30am, (100.4) when I took Tylenol as recommended by the nurse who administered the injection.
March 29,2021: Soreness and tightness in the left arm where the Vaccaine was placed. Soreness and tightness progresses throughout the night and into the next day. March 30, 2021: Soreness and tightness of the left arm still continues. Left arm is getting harder to raise and move and is slightly tender to the touch. Later on in the afternoon time around 3 PM symptoms started to pick up with sluggishness, slight fatigue, body aches and body temperature increase. At 5 o?clock temperature was at 101° and body was extremely hot but had the chills, body aches, very tired and fatigue. No headaches or dizziness. Still had an appetite and sense of taste and smell. By 6 o?clock temperature was at 102°. Body still extremely hot and started to sweat but still had the chills. Was able to take 30 mL of Tylenol extra strength p.m. Acetaminophen and rest for 2 hours. Temperature return back to normal after two hours of taking Tylenol and resting. The following day no symptoms of body aches fever or chills but left arm it?s still sore.
Received LAIV at 11:30 and at 16:05 chest/torso "felt itchy". Next morning, woke up and red blotches on chest/torso. Seen MD on 11/12/09 and rx of "ALLEGRA and steroid cream".
Mild headache; arm sore; This is a spontaneous report from a non-contactable consumer (patient herself). An adult female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; batch/lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced mild headache and arm sore. The outcome of these events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Monday, 08-25-08 at 6:15pm, patient received BOOSTRIX (Tdap), MENACTRA (MCV4) and HAVRIX (Hep A).  Tuesday, 8-26-08, patient had fever 99.5, mild body aches, headache, tiredness, slight nausea.  Given Tylenol at 0730, at 1200 - fever 101.3, by 1300 fever 103.1.  Went to doctor at 1345 fever 104.3.  Test for mono and strep were negative, blood test were ran.  Meds for fever every 3 hours.  Recheck at doctor's 08-27-08, fever normal range.
Pfizer Dose 1 3/19/21 (EN6208) Pfizer Dose 2 4/21/21 (ER8731) COVID Positive 12/27/21  12/27/21: The patient is an 88-year-old male past medical history significant for generalize osteoarthritis, essential hypertension, lumbar radiculopathy, obesity, spinal stenosis.   Patient Presented urinary frequency and incontinence of 1 week duration  Patient endorses that since 1 week back started to have urinary frequency with wetting himself.  He also felt generalized weakness and not feeling well.  Patient also has associated nonproductive cough with loss of taste and decreased appetite as well as generalized body aches.  Patient has had generalized osteoarthritis with lumbar radiculopathy taking medications.  In the emergency room patient was noted to be hypoxic on room air of 85% and required oxygen supplementation 4 LPM to have acceptable saturation.  Patient also noted to have atrial fibrillation hypokalemia of 2.5, elevated blood glucose of 160, lactic acidosis 2.6 with elevated proBNP of 27 31.  CBC showed lymphopenia and D-dimer was elevated 0.6 to; rapid COVID antigen test was positive.  CT angio of the chest did not show any pulmonary embolism but shows ground-glass infiltrate on both lung consistent with viral pneumonitis as well as cardiomegaly  1/17/22: Patient is an 88-year-old male with prolonged hospitalization for COVID requiring intubation.  He was extubated on 01/07/2022.  He is severely deconditioned and undergoing PT/OT.  On 3 L nasal cannula.  During his hospitalization patient also developed retroperitoneal hematoma with hemorrhagic shock.  All the anticoagulation has been stopped due to that.  Patient is saturating well on 2-3 L of nasal cannula oxygen and his breathing is much better.  During his hospitalization patient's Lantus was discontinued as he was developing episodes of hypoglycemia overnight.  It should be noted that the patient's insulin demand should be adjusted to the patient's needs once he arrives at skilled nursing facility.  Patient was discharged from the hospital on 01/17/2022 in a stable medical condition.
Newly diagnosed multiple sclerosis; This literature-non-study case was reported in a literature article and describes the occurrence of MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) in a 41-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) outcome was unknown. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) to be related.    No concomitant and treatment medications were reported.   This case was linked to MOD-2022-453474 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a literature-non-study case concerning a 41-year-old male patient with no reported medical history, who experienced the serious unexpected event of newly diagnosed multiple sclerosis. The event occurred on the unknown day after the unknown dose of mRNA-1273 vaccine administration. The event was conservatively assessed as related with the product administration since the temporal association cannot be assessed at this time. The rechallenge was not applicable since the dose number was not disclosed.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.
Given vaccine 10-12-11 at noon. Within 1 hr, 3-4 hrs. redness 6" diameter. And another welt at top of arm, pain. Saw Dr 10-16-11 & treated for infection "Dr. thinks vaccine." Per pt.
Client stated that she received Moderna Dose 1 and 24 hours later. She experienced: body aches, vomitting, headache, dizziness, fever and diarrhea for 3 days. She never sought treatment. Symptoms resolved on their own
Information has been received from a registered nurse concerning a female with an erythromycin and sulfa allergy and no other medical history who in 07/13/1995 was vaccinated with one dose of varicella vaccine. There was no concomitant medication or illness at the time of vaccination. On 05/22/2001, the pt developed varicella with a severe rash with over 100 lesions and was seen in a physician's office. It was also reported that the pt's sister was vaccinated at the same time with varicella vaccine and also developed varicella. Additional info has been requested.
minor sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphatic leukemia.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (minor sore arm). At the time of the report, PAIN IN EXTREMITY (minor sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-433338, MOD-2021-408990.
Initially patient felt warmth on top of head and around eyes and ears 20 minutes later experienced fuzzy vision, pain in back of right eye Warmth on top of head and around ears has gone away as well as fuzziness but patient is still feeling consistent pain behind right eye
Gassy; Had loose stools a couple of times a day; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (Gassy) and DIARRHOEA (Had loose stools a couple of times a day) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FLATULENCE (Gassy) and DIARRHOEA (Had loose stools a couple of times a day). At the time of the report, FLATULENCE (Gassy) and DIARRHOEA (Had loose stools a couple of times a day) had not resolved.            No relevant concomitant medications were reported.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-072662 (E2B Linked Report).; Sender's Comments:  MOD-2021-072662:First dose of vaccine case
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the second dose of GARDASIL. The patient was hospitalized with "muscle loss and weight loss" after the second vaccination. It was reported that the patient's "limb were turning inward". It was unknown if the patient was still hospitalized, and the outcome was unknown. The reporter felt that the events were not related to therapy with GARDASIL. No further information is available.
This case was reported by a healthcare professional via a sales representative and described the occurrence of nonspecific reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of BOOSTRIX (.5 ml. unknown). In 2009, at an unspecified time after vaccination with BOOSTRIX, the subject experienced nonspecific reaction. The medical assistant reported that two subjects reacted to BOOSTRIX. No specific complaints about the appearance or characteristics of the BOOSTRIX were provided. The sales representative had limited information. She could not provide details on the type of reaction the subjects experienced or whether the reaction was local or systemic. The reporter believed that a quality assurance problem may have caused the adverse event. No specific physical complaints with the product's appearance, etc. were provided. The medical assistant just thought that presentation of BOOSTRIX (vial or prefilled syringe) was used. Please see A0774667A for the second report of unspecified reaction to BOOSTRIX. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the unspecified reaction was possibly related to vaccination with BOOSTRIX. Follow-up received as quality statement performed on 15 May 2009: As per quality statement, the BOOSTRIX vaccine lot AC52B031AB met the requirements of the specifications and was confirmed as suitable for vaccination purpose.
This spontaneous report as received from a licensed vocational nurse refers to a 14 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 25-AUG-2015 at 12:20 p.m., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX injection, lot # L010145, subcutaneously (dose and expiration date were not reported) that was improperly stored. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
9-10 hrs after shot, joint aches, tiredness, fevers from 100-102 for 2.5 days
Emesis, swollen left injection site, altered mental status Unknown if related to vaccine per hospital record IV Rochephen and IV fluids
Rash vagina up to the neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash vagina up to the neck) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash vagina up to the neck). At the time of the report, RASH (Rash vagina up to the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.
Non-specific myocarditis.  This case was identified as part of the H-406-005 Enhanced Surveillance Study (5000005).
Lack of efficacy of COVID vaccine. Had COVID after vaccination.; Lack of efficacy of COVID vaccine. Had COVID after vaccination.; This is a spontaneous report  from a HCP received from Pfizer sponsored program.  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and  dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced lack of efficacy of covid vaccine: had covid after vaccination  on an unspecified date with outcome of unknown.  Had COVID after vaccination. 2 days of mild symptoms (sinus blocked)  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
After receiving second dose of Moderna patient stated she received J&J on 04/07/21.
Broke out with chickenpox.  10 on cheek, 30 on abdomen.
Had a serology and had a level of 3.9 but her other family members tested above 20.; pain in their arm; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was Reported that, Received call from consumer regarding the Pfizer COVID Vaccine. She got the double vaccine as well as the rest of her entire family.  While reporting for herself, she stated that the rest of her family got their vaccines at the same time as hers and had pain in their arm and she had no reactions whatsoever.Her husband just told her that her arm hurt a little after getting it.  It was like a tetanus shot but nothing bad. This report is to capture information on her husband's arm pain.She did not wish to complete a report on herself and did not wish to complete a report on her family.  She did not wish to provide a mailing address, email, date of birth or any further details.No further details provided. The outcome of the serology and had a level of 3.9 but her other family members tested above 20, pain in their arm on an unspecified date with outcome of unknown.The patient underwent lab tests and procedures which included serology test: 20 on serology test: 29 on.   Follow-up (22Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported information included.  Information about lot/batch number has been requested.
This spontaneous report was received from a healthcare worker via company representative refers to a patient of unknown age. On an unknown date in 2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date and route was unknown) and PROQUAD (Merck) (lot number, expiry date and route was unknown) on the same day. No adverse effect was reported. Additional information has been requested.