chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6206), in right arm, on 25Mar2021 as dose 2, single (Lot number: EP7533), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Double pneumonia from a respiratory virus" (unspecified if ongoing), notes: 7 years ago. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: after 5 days; (2023) Positive, notes: again on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: No known allergies. Patient received anti-viral treatment for Covid 19 with Paxlovod from 24Jul2023 to 29Jul2023.
Patient had received first dose of Moderna on 04/26/2021. Lump on clavicle noted one week later.  Sensitive upon touch.
I have had persistent elevated D-Dimer  since March 9.  Test dates? March 8, 2021 April 20, 2021 June  1, 2021 July 19, 2021
hot flash-sweating-extreme h/a-lining of brain; overall tremors-anxiety-running nose, intestinal cramping; shot in rt arm-inflamed-rash/weakness in rt arm; vision-eyes affected; sensitivity to light & loud noises;
At 10:OO PM the arm started hurting and started turning red and swelling. The next  day the arm was swollen and red from above the injection site to just below the elbow.
Shingles; Pain; Itch; Bright red / red area; Burning feeling; Scars; Pain latched on to the muscles on right side from kidney back down of hip; This case was reported by a consumer and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of herpes zoster (1st dose received on an unknown date and experienced lot of side effects that lasted a month, refer linked case US2019AMR117261). Concurrent medical conditions included blood pressure high and blood cholesterol increased (that was not that high).   On 7th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced muscle pain. On 21st September 2019, the patient experienced shingles, pain, pruritus, erythema, burning sensation and scar. On an unknown date, the outcome of the muscle pain, shingles, pain and pruritus were unknown and the outcome of the erythema, burning sensation and scar were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, shingles, pain, pruritus, erythema, burning sensation and scar to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on right arm. The patient experienced pain latched on to the muscles on right side from kidney down back of hip. 14 days after receiving Shingrix, the patient got shingles on same area which lasted for 5 days. The patient got shingles again same area back of leg and also buttocks. 14 days after receiving Shingrix, the patient experienced pain, itching and bright red burning feeling and scars.  On the reporting date, the red area, burning and scars were still there. The patent had no other medical conditions except medicine for high blodd pressure and high cholesterol (that was not that high). Prior to this shot the patient only had small area of shingles once a month.
redness around the shot sight.  Slight tingle in shot area.  NO fever or other reaction.
After approx 15 minutes, 1/2 dollar size welt at injection site, ice applied and decrease to quarter size within 10 minutes - no SOB, rash or other assoc symptoms.
This initial spontaneous case, was received from other health professional (nurse) on 08-Nov-2017, concerning a patient of unspecified age and gender. On 20-Oct-2017, the patient was administered with AFLURIA (TIV) (dose: (reported as one dose), expiry date: Jun-2018 (as reported) route of administration, anatomical location, and batch number: not reported). On the same day, the patient was administered with the vaccine that had been left out at room temperature from 9AM to 5PM. It was reported that, the patient did not experience any adverse event. The reporter assessed the case as non-serious.
Doses were stored in the fridge since 20Dec2022 and vaccines were administered on 24Jan2023; No adverse event; Pediatric patient was administered with Moderna COVID-19 Vaccine Bivalent doses after 30-day Use By Date (34 days); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patient was administered with Moderna COVID-19 Vaccine Bivalent doses after 30-day Use By Date (34 days)), PRODUCT STORAGE ERROR (Doses were stored in the fridge since 20Dec2022 and vaccines were administered on 24Jan2023) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 24-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient was administered with Moderna COVID-19 Vaccine Bivalent doses after 30-day Use By Date (34 days)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were stored in the fridge since 20Dec2022 and vaccines were administered on 24Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patient was administered with Moderna COVID-19 Vaccine Bivalent doses after 30-day Use By Date (34 days)), PRODUCT STORAGE ERROR (Doses were stored in the fridge since 20Dec2022 and vaccines were administered on 24Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric patient was administered with Moderna COVID-19 Vaccine Bivalent doses after 30-day Use By Date (34 days)) and PRODUCT STORAGE ERROR (Doses were stored in the fridge since 20Dec2022 and vaccines were administered on 24Jan2023).    Concomitant product use was not provided by the reporter. This case has information of 2 pediatric patient out of 2 pediatric patient case. Patient received initial booster dose.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-706646 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706646:Master case
onset of infantile spasms; sx appeared gradually according to mom; but mom approx time of onset APR94; pt followed by neruologist;
Fever; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received and does not contain any new information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of fever, a causal relationship cannot be excluded.
Subsequently, on February 19 I exhibited slight paralysis, by late evening on February 20th was convinced I was having a strok, went to ER and was admitted for apparent stroke due to presence of multiple fine bloodclots transiting area of brain controlling my right side (mostly arm/shoulder/hand paralysis), accompanied by irreguar heartbeat, leakage of heartvalves - these weer all new, never before reported symptoms.  Examination and blood tests showed sudden elevation of blood pressure, cholesterol, glucose, throid, liver and kidney values, all of which subsequently decline and returned to usual levels after treatment and release from hospital (02/24/2021).  Arrythmia has not been detected since and other measurement/blood indicators are back down/under control.  Only residual symptoms are  slight loss of speed of operation f/righ arm/hand and confirmed "moderate leakage in both heart valves".
Near miss of potentially administering a Moderna COVID-19 vaccine to an acutely ill patient; A spontaneous report  was received from a Healthcare Professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and for reported near miss of potentially administering a moderna covid-19 vaccine to an acutely ill patient.  The patient's medical history included fatigue, does not look well, nausea and a headache. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient did not receive their planned doses of mRNA-1273 (lot/batch: Detail Batch Number) via unknown route for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the healthcare professional wanted to know if a staff member who was experiencing fatigue, does not look well, nausea and a headache, should get vaccinated (medication error).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of event was recovered.; Sender's Comments: This case refers to a HCP who called to enquire if a ill staff member should get vaccinated. No record that they were vaccinated and there is no reported AEs.
Narrative: Patient has a history of seizures, not on any antiepileptic medications. Received lst dose of Pfizer COVID vaccine and reported feeling lightheaded after 5 minutes. Then synopsized (thought to be vasovagal reaction) and started to have witnessed seizure activity. Seizure activity lasted for approximately 1 minute and self-resolved.
Pain in left shoulder since date of injection. Injection was administered too high on the shoulder. I have experienced almost constant pain while trying to do most normal activities, such as driving, dressing & undressing , house work, exercising, sleeping, etc.  Nothing helps to relieve the pain, except for not moving at all, which is impossible.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No tTreatment medications were reported.
Left arm is red, swollen, warm to touch. Pt complains of pain radiating from injection site to elbow, painful to the touch.
This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown gender and age. It was reported that since 24-JUL-2014, improperly stored doses of (Merck) VARIVAX (dose, dose number, route, lot/batch number, expiration date were not reported) were administered to unknown number of patients in approximately 2014. No adverse effects were noted. No product quality complaint (PQC) involved. Follow up was received on 09-SEP-2014. The reporter stated that she does not have any additional information available at the time of reporting. Follow up information has been received from the nurse on 07-MAY-2015. The nurse reported doses of (Merck) VARIVAX (dose, dose number, route, lot/batch number, expiration date were not reported) which had been exposed to temperatures above the recommended range, had been administered to unspecified patients of unspecified dates. This is one of several reports from the same source. Additional information has been requested. Narrative was updated.
Case number PHEH2014US014479 is an initial spontaneous report received from a nurse on 17 Jul 2014. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications was not reported. The patient inadvertently received an intramuscular dose of MENVEO after the Men A and Men CYW-135 vials (batch number: not reported) reached 9.3 degrees Celsius for approximately 38 minutes and 20 seconds on an unknown date. No adverse reaction reported following this administration error.
Hospitalization: 1/29/2023 - 1/31/2023 (2 days) Presentation to the ED: intractable abdominal discomfort COVID + date: 1/22/2023 Treatment: NONE. PATIENT WAS PREVIOUSLY TREATED AND NOT ELLIGIBLE FOR ADDITIONAL TREATMENT.  Discharge to: home.  EN6200 2/19/2021 EN6206 3/13/2021
KINRIX RD and PROQUAD LD were administered to case. Developed body wide rash on arms and legs within 20 min. Complained of itching, general malaise and headache. Went to clinic to see doctor. Could not ascertain any specific vaccination site as worse than the other. Case developed fever of 102 degrees-103 degrees F that night but better the next morning. Mother stated that he is still taking some BENADRYL for itching a week later.
I received my vaccine on 12/22 around noon. I woke up at 4am this morning 12/25 with tingling in my lips and tongue, in addition to the left side of my face being swollen. Not entirely sure what these side effects are from exactly but thought it best to report my experiences I was hospitalized on 12/25 to 12/26 because my reaction did get worse. I was experiencing numbness on the left side of my body and swelling, numbness, and redness on the left side of my face as well. The hospital didn?t really give any explanations but I?m only now have mild swelling and numbness on the left side of my face. Everything else has resolved at this point in time.
Tdap vaccine administered approx 10 AM. Employee c/o (L) lower leg cramping around 5 pm. Employee c/o pain in (L) lower leg also.
Breakthrough case admission after 3 vaccines Pfizer 2/23/21 LOt# EN6200;  Pfizer 3/16/21 lot# EN6207;  Pfizer 11/8/21 lot# FH8028
Wrong vaccine administered; headache; loss of taste; body chills; fever; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Known allergies: shrimp" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Allergy: cephalosporins, reaction(s): "Drug Allergy". Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown.), for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown.), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 29Sep2022, outcome "recovered with sequelae", described as "body chills"; FATIGUE (non-serious) with onset 29Sep2022, outcome "recovered with sequelae"; PYREXIA (non-serious) with onset 29Sep2022, outcome "recovered with sequelae", described as "fever"; HEADACHE (non-serious) with onset 29Sep2022, outcome "recovered with sequelae"; AGEUSIA (non-serious) with onset 29Sep2022, outcome "recovered with sequelae", described as "loss of taste"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered". Therapeutic measures were taken as a result of headache, ageusia, chills, pyrexia, fatigue.  Additional information: Concomitant medication include prenatal vitamins. Patient did not have covid prior vaccination and not tested covid post vaccination. Patient received ibuprofen for the treatment of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm @ site of inj 2 1/2 x 3 " diam swollen, hard, red, hot section, painful;T102 tx w/APAP 100-102 controlled called MD not yet communicated told 24hr cont to go to ER;
2nd shot caused dizziness, loss of balance, nauseous, unable to eat, diahera, headache. Going on since evening of day of injection.
Patient received 0.25mL booster dose instead of 0.5mL third dose; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and ACCIDENTAL UNDERDOSE (Patient received 0.25mL booster dose instead of 0.5mL third dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 013A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In October 2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 25-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25mL booster dose instead of 0.5mL third dose). On 25-Oct-2021, ACCIDENTAL UNDERDOSE (Patient received 0.25mL booster dose instead of 0.5mL third dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.  It was reported that patient got a call from her doctor saying she should have gotten the whole vaccine (third dose) instead of the booster.
Four days after receiving a TDap in her Left arm, she received an MMR SQ in the outer aspect of her left arm.  The next morning her left arm was swollen, throbbing, reddened with blue around the periphery of the reddened area.  Stated that she felt feverish but she did not take her temperature. She applied oils to decrease her pain.  The client returned to the clinic to have her PPD test read and reported the reaction. At that time the reddened area was approximately six inches covering her outer arm.
I found out I was pregnant on March  3rd, 2021 from an at-home pregnancy test. The pregnancy was confirmed with blood work on March 6th, 2021. I received my first dose of the covid vaccine on March 8th, 2021. I noticed some light spotting afterwards.  The heartbeat was confirmed on March 22nd and I was told I was six weeks along. I received my second dose on March 29th.  The heartbeat was confirmed again during another ultrasound on April 20th, 2021. During an ultrasound on May 4th, 2021 I was told that there was no longer a heartbeat and the baby had stopped developing a week prior.  This missed miscarriage resulted in an D&C on May 11th, 2021.
she had "covid arm"; a lump; red; swollen; itchy; painful; she felt warm inside for some minutes; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (she felt warm inside for some minutes), TYPE IV HYPERSENSITIVITY REACTION (she had "covid arm"), MASS (a lump), ERYTHEMA (red) and PERIPHERAL SWELLING (swollen) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), HYDROXYCHLOROQUINE, ENALAPRIL and AMLODIPINE for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FEELING HOT (she felt warm inside for some minutes). On 27-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (she had "covid arm"), MASS (a lump), ERYTHEMA (red), PERIPHERAL SWELLING (swollen), PRURITUS (itchy) and PAIN IN EXTREMITY (painful). On 20-Feb-2021, FEELING HOT (she felt warm inside for some minutes) had resolved. On 05-Mar-2021, TYPE IV HYPERSENSITIVITY REACTION (she had "covid arm"), MASS (a lump), ERYTHEMA (red), PERIPHERAL SWELLING (swollen), PRURITUS (itchy) and PAIN IN EXTREMITY (painful) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol, hot and warm compresses were taken as treatment