chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to receive his third Anthrax vaccine dose, and after receiving vaccine reported to Immunization technician he is concerned his tremors started after he received his initial Anthrax dose. When questioned he reports he has had a tremor since at least September 2017. He received his first Anthrax dose in April 2017 and his second dose in August 2017. He denies cutaneous, constitutional, and systemic symptoms following his Anthrax doses. He denies prior adverse vaccine reactions. He complains of tremor affecting both hands which he feels is worse on the left side. He denies vision/hearing changes, speech/swallowing issues, and difficulty walking. He denies numbness, tingling, and weakness other than perhaps several occasions where he has dropped a can with his left hand due to "holding it too gently since I was afraid I would crush it."
Patient hospitalized for labor and delivery of healthy baby girl within 6 weeks of receiving COVID vaccination.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 64 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 22-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Experiencing fatigue, joint pain, muscle pain, redness and pain at the injection site, headaches, chills, bitter taste in mouth
paresthesia of face and arms; numbness and pain of face, arms, legs, and extremities; numbness and pain of face, arms, legs, and extremities; numbness and pain of face, arms, legs, and extremities; Back, Muscle, and Joint pain; Back, Muscle, and Joint pain; Back, Muscle, and Joint pain; This is a spontaneous report from a contactable consumer (patient). An unspecified gender 44-year-old patient received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on the left arm on 25Apr2021 at 15:30 (Batch/Lot Number: ER8735) at the age of 44-year-old as single dose for COVID-19 immunization. Known allergies included ragweed allergy, slight allergy to bananas, cat/dog allergy, alternaria allergy and birch allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 04Apr2021 at 03:30 PM (Batch/Lot Number: ER8737) at the age of 44-year-old as single dose of COVID-19 immunization. On 10Jun2021 at 17:00, the patient experienced initial paresthesia of face and arms, eventual numbness and pain of face, arms, legs, and extremities. Back, Muscle, and Joint pain. ANA positive, 1:1280. Negative for all rheumatoid and autoimmune diseases thus far. Still working with Neurology, no large muscle or nerve issues, small fiber skin biopsy scheduled this week. The patient performed PCR (Nasal Swab) on 07Jun2021 and result was negative. The events resulted in emergency room visit and physician office visit. No treatment was not received. The events were not resulted in hospitalization prolonged. The outcome of events was not recovered.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Mar2023 at 14:00 as dose 4 (booster), single (Lot number: GJ6743) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (ongoing), notes: Current: Sleep apnea; "skin rashes" (ongoing), notes: Current: skin rashes; "kidney stone" (unspecified if ongoing); "hepatitis A" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received the paxlovid treatment from 06Jun2023 to 11Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300223829 same patient, different drugs/events;
30 min observation r/t history of severe allergic reactions. Pt experienced hives on lower back and bilateral shoulders, c/o itching. Pt offered benadryl for reaction but refused. Site Manager made aware. Pt educated on sever allergic reaction symptoms. Vitals: 134/90, 90, 100%, 97.2. Reported being stable and with a friend to go back home with, to monitor as needed. Educated on notifying PCP with additional concerns. Notified to call 911 for respiratory distress. Pt verbalized understanding.
Burning/stinging rash; Burning/stinging rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Burning/stinging rash) and RASH (Burning/stinging rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Burning/stinging rash) and RASH (Burning/stinging rash). At the time of the report, SKIN BURNING SENSATION (Burning/stinging rash) and RASH (Burning/stinging rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  No treatment information was provided.
Information has been received from a physician referring to a currently 28 years old male patient. The patient had no medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (strength: 2.5 MCG/0.5ML; dose, frequency and lot# were not reported) as a child (vaccine underdose). There was no concomitant therapy. In 2015(reported as "now") the patient experienced low antibodies titer for Hepatitis B. The patient sought medical attention via seeing physician. On an unknown date, blood test was performed which showed low antibodies. The outcome of low antibodies titer for Hepatitis B was reported as not recovereInformation has been received from a physician referring to a currently 28 years old male patient. The patient had no medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (strength: 2.5 MCG/0.5ML; dose, frequency and lot# were not reported) as a child (vaccine underdose). There was no concomitant therapy. In 2015(reported as "now") the patient experienced low antibodies titer for Hepatitis B. The patient sought medical attention via seeing physician. On an unknown date, blood test was performed which showed low antibodies. The outcome of low antibodies titer for Hepatitis B was reported as not recovered/not resolved. Causality was not reported. Additional information has been requested.
Extremely limited range of motion, severe pain 8/10, shoulder, arm, elbow.
Patient had skin issues 3 days after the vaccine, extremely itchy spots on the body, Unbearably itchy. Not always the same area, different areas at different times. Hands, feet, legs, torso.; The area is also very red.; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Patient had skin issues 3 days after the vaccine, extremely itchy spots on the body, Unbearably itchy. Not always the same area, different areas at different times. Hands, feet, legs, torso.) and ERYTHEMA (The area is also very red.) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 3), PFIZER BIONTECH COVID-19 VACCINE (Dose 1) and PFIZER BIONTECH COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 17-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Jan-2023, the patient experienced PRURITUS (Patient had skin issues 3 days after the vaccine, extremely itchy spots on the body, Unbearably itchy. Not always the same area, different areas at different times. Hands, feet, legs, torso.) and ERYTHEMA (The area is also very red.). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Patient had skin issues 3 days after the vaccine, extremely itchy spots on the body, Unbearably itchy. Not always the same area, different areas at different times. Hands, feet, legs, torso.) and ERYTHEMA (The area is also very red.) had not resolved.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No medical history, concomitant disease, or risk factors were reported  It was reported that patient never had an issue with the first three doses of Pfizer vaccine. The patient did not experience any additional symptoms or events. The patient was using topical steroid on the areas and taking Zyrtec which seems to be help. But once stop taking the medication again the itchiness was appearing. No lab data or results were reported. No treatment medications were reported.
Case received vaccines 12/23/2020, and 01/13/2021. Public Health received notification that patient died 3/5/2021.  Not really sure if her death is related to vaccine administration but I was instructed to fill out this form.
11/19/03: left upper arm edematous/warm and erythematous from shoulder to elbow. Can't move arm in so much pain.
Patient reports she felt the administration of the vaccine was "very high" on her arm and felt as though it was injected into the burse.  She has been experiencing pain since the injection and taking over the counter medication for pain.
A patient received the Moderna COVID-19 vaccine on 27Jul2021 at 8:55 am from a vial punctured on 26Jul2021 at 10:33am.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 21st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was not recovered/not resolved. The reporter considered the injection site burning to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. The pharmacist reported that the patient called her today stating he continued to have burning in his arm above the bicep on his left arm where he had his vaccine. The pharmacist stated that she did instruct him to report the events to his physician.
Shingrix Vial Kit,  rx#6911326.  Within 2 hours, my upper left arm got very hot and hard and extremely painful.  My upper arm was very hot and hard for 7 full days with a huge red rash.  There was a large red mark about 5 x 6 inches.  I was nauseous, with severe headache and thickness in the head.  I vomited  and had muscle weakness.  The symptoms lasted for 7 days.
loss of taste and smell; sore throat, congestion, headache, bodyaches, starting on 8/20/21
Moderna vaccine dose administered after more than 12 hours past vial first puncture and the vial was stored in fridge post puncture; Moderna vaccine dose administered after more than 12 hours past vial first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine dose administered after more than 12 hours past vial first puncture) and PRODUCT STORAGE ERROR (Moderna vaccine dose administered after more than 12 hours past vial first puncture and the vial was stored in fridge post puncture) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine dose administered after more than 12 hours past vial first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine dose administered after more than 12 hours past vial first puncture and the vial was stored in fridge post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine dose administered after more than 12 hours past vial first puncture) and PRODUCT STORAGE ERROR (Moderna vaccine dose administered after more than 12 hours past vial first puncture and the vial was stored in fridge post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The facility received the vial on 22-Apr-2022 and it was thawed when the facility received it.  The vial was first punctured on 10-May-2022 at 2:20 P.M.  The patient received Moderna vaccine on 11-May-2022 at timing of either 8:30 A.M or 12:20 P.M.  The vial was not exposed to room temperature for more than 24 hours.  The vial did not undergo any temperature excursions. The patient did not report any adverse reactions to the expired dose.  The healthcare provider wanted to know if the vaccine was viable or should the patients be re-vaccinated or not.  Treatment information was not provided.   This case was linked to MOD-2022-567443.
Felt sick; like she is having the flu; could not do anything; was in bed the whole day; Headache; Achy; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick), INFLUENZA LIKE ILLNESS (like she is having the flu), IMPAIRED WORK ABILITY (could not do anything), HYPOKINESIA (was in bed the whole day) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ILLNESS (Felt sick), INFLUENZA LIKE ILLNESS (like she is having the flu), IMPAIRED WORK ABILITY (could not do anything), HYPOKINESIA (was in bed the whole day), HEADACHE (Headache), MYALGIA (Achy) and PYREXIA (Had fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in April 2021 for Adverse event, at an unspecified dose and frequency. In April 2021, ILLNESS (Felt sick), INFLUENZA LIKE ILLNESS (like she is having the flu), IMPAIRED WORK ABILITY (could not do anything), HYPOKINESIA (was in bed the whole day), HEADACHE (Headache), MYALGIA (Achy) and PYREXIA (Had fever) had resolved.            No concomitant medication reported.   This case was linked to MOD-2021-395584, MOD-2021-395713 (Patient Link).
Shooting pain started around 1:00 am on 08/06/21. Then the right arm went numb from the injection site down. Swelling of the arm started about 5 hours later. Arm continues to be numb and have a pins and needles sensation from injection site down through the fingers.
Steadily sharp increase in dercum's pain; Steadily sharp increase in dercum's pain; swelling; bruising; Dercums tumors from days 2-7; other vaccine same date product=Flu shot, other vaccine same date vaccine date=26Sep2021; other vaccine same date product=Flu shot, other vaccine same date vaccine date=26Sep2021; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2588) via an unspecified route of administration, administered in Arm Left on 26Sep2021 12:15 (at the age of 58-years-old) as dose 3, booster, single for COVID-19 immunization. The patient received influenza vaccine (FLU VACCINE VII), (Batch/Lot number was not reported) via an unspecified route of administration from 26Sep2021 to 26Sep2021, as dose 1, single for an unspecified indication. Medical history included known allergies: Beef, known allergies: pepper, Dercum's Disease (progressed; a rare progressive connective tissue disorder) by 2 researchers several years ago.), Lipedema, Diabetes 2 and Fibromyalgia. Concomitant medications included duloxetine hydrochloride (CYMBALTA); buspirone (BUSPIRONE). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:00 PM (at the age of 58-years-old) as dose 1, single for COVID-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm left on 23Mar2021 15:30 PM (at the age of 58-years-old) as dose 2, single for COVID-19 immunization. No COVID prior to the vaccination. COVID not tested post vaccination. On 26Sep2021, the patient received other vaccine same date product=flu shot, other vaccine same date vaccine date=26sep2021. On 27Sep2021 12:00, the patient experienced steadily sharp increase in dercum's pain, swelling, bruising and dercums tumors from days 2-7. There is no reliable treatments for Dercums. No treatment was given for adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
itching around injection site; felt like the needle didn't enter her muscle; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching around injection site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like the needle didn't enter her muscle) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary hypertension.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching around injection site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like the needle didn't enter her muscle). At the time of the report, INJECTION SITE PRURITUS (itching around injection site) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like the needle didn't enter her muscle) 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.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 antibody test: positive (Positive) Showed antibodies.. In March 2021, SARS-CoV-2 antibody test: negative (Negative) No Antibodies. On an unknown date, Heart rate: 55 (Low) dropped down to 55 and 30 (Low) further to 30.. On an unknown date, Lymphocyte count: low (Low) low lymphocytes. On an unknown date, nucleic antibody test negative.  No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-100843 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Lab data was updated.
The patient did not have any reaction to the vaccine in the office, the patient has loose stool and is fussy.
fatigue after receiving the second Moderna Covid-19 vaccine; Patient received her first vaccine on 1Apr2021 and Patient received her second vaccine on 20APR2021; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue after receiving the second Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 1Apr2021 and Patient received her second vaccine on 20APR2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 1Apr2021 and Patient received her second vaccine on 20APR2021). On an unknown date, the patient experienced FATIGUE (fatigue after receiving the second Moderna Covid-19 vaccine). On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 1Apr2021 and Patient received her second vaccine on 20APR2021) had resolved. At the time of the report, FATIGUE (fatigue after receiving the second Moderna Covid-19 vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
first shingrix dose in august of 2020 / never came back in for their second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient never came back for 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that the clinical data center advised that the person should get it as soon as possible but it had been almost a year now. No additional information available.