chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a61 year old female patient with no known allergies. On 20-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot# unspecified) 0.65 ml, subcutaneous. On 20-JUN-2013, the patient experienced tingling on the roof of her mouth and lips a 1/2 hour to 40 minutes after receiving the ZOSTAVAX. Pharmacist advised patient to take BENADRYL. The outcome of tingling on the roof of her mouth and lips was unknown. The patient had not sought medical attention. Additional information has been requested.
2 days after 2nd dose on 9/1/21diffuse rash, on 9/5/21 facial and throat swelling, 9/12/21rash continues, intermittent right hip pain, lethargy, daytime somnolence, fatigue.  Much better by 9/16/21 and declined an in person appointment in the office
Test: Nasal Swab/Result: Positive; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 at 11:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included sleep apnoea syndrome, food allergy (shellfish). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced test: nasal swab/result: positive on 12Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Jan2021. Outcome of the event was unknown.
Friday evening I had what I thought was normal reaction: chills, aches, headache, nausea. Saturday it was mostly aches. Sunday was dizziness, aches, nausea and cramping in left leg. Monday was nausea, aches, tingling in hands and feet, headache, brain fog. Tuesday I woke up with major imbalance and needed to use walls to walk without falling over. Dizziness subsided after some time to only rapid movements. I had a warm burning sensation in left leg with tingling hands and feet. Moderate headache. Reports came out of stopping the Janssen vaccine so I contacted my doctor with my symptoms and they ordered blood tests for clots.
She went to the waiting area after receiving the vaccine and came up a few minutes later and said that she had fainted.  She didn't hit the floor but dropped her phone and sweatshirt.  She said this is common for her and has had this happen several times before.
Left thigh edema mid thigh to knee joint firmness to lateral thigh, no erythema, no warmth no fluctuance.
My symptoms started on November 30, 2022 I experienced rapid heart beat during the, I would have a heart arrhythmia; hypertension; I went to see a cardiologist form my symptoms. I wasn't prescribed any medication for my symptoms.
4 x 5 inch red firm warm area on right outer thigh with centrally blanched area around injection site.  Temp 99.
Sores all over her body that burn, itch, hurt and spread (worse when it's humid); Sores all over her body that burn; Sores all over her body that itch; Sores all over her body that spread (worse when it's humid); Sores all over her body that hurt; Rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Sores all over her body that burn, itch, hurt and spread (worse when it's humid)), SKIN BURNING SENSATION (Sores all over her body that burn), PRURITUS (Sores all over her body that itch), SENSITIVITY TO WEATHER CHANGE (Sores all over her body that spread (worse when it's humid)) and PAIN (Sores all over her body that hurt) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 SKIN LESION (Sores all over her body that burn, itch, hurt and spread (worse when it's humid)), SKIN BURNING SENSATION (Sores all over her body that burn), PRURITUS (Sores all over her body that itch), SENSITIVITY TO WEATHER CHANGE (Sores all over her body that spread (worse when it's humid)), PAIN (Sores all over her body that hurt) and RASH (Rash). At the time of the report, SKIN LESION (Sores all over her body that burn, itch, hurt and spread (worse when it's humid)), SKIN BURNING SENSATION (Sores all over her body that burn), PRURITUS (Sores all over her body that itch), SENSITIVITY TO WEATHER CHANGE (Sores all over her body that spread (worse when it's humid)), PAIN (Sores all over her body that hurt) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include antidepressant. Symptoms started after the second dose. The patient went to Emergency Room and also consulted general practitioner and dermatologist. Patient had a biopsy and the results were unspecified. Treatment medications included steroid shot and cream.
CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced chills and headache for few hours (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. Patient experienced no symptoms after receiving the second shot of the Janssen COVID-19 vaccine (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache. This report was non-serious.
Redness, swelling, slight itchy, moderate to low pain, started after 4-5 hrs on same day of vaccination, Started on uperarm, spread toward for arm. Pt took trearment on staurday evening in ER , ( streoid injection, benadryl is given, advised to put ice pack on affected area
Felt sick on Saturday; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick on Saturday), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced MALAISE (Felt sick on Saturday), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE (Felt sick on Saturday), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Body temperature: 102 (High) high.         No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-Jun-2021 contains NNI; Reporter's Comments: N/A; Sender's Comments: N/A
Diagnosed with Covid-19; Dehydrated; unable to lift his left arm for 2 to 4 days; oxygen at 92; vomitting; fever at 102.9 degrees Fahrenheit; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19), DEHYDRATION (Dehydrated), MOBILITY DECREASED (unable to lift his left arm for 2 to 4 days), OXYGEN SATURATION DECREASED (oxygen at 92) and VOMITING (vomitting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), GLYBURIDE, METFORMIN and LISINOPRIL for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DEHYDRATION (Dehydrated), MOBILITY DECREASED (unable to lift his left arm for 2 to 4 days), OXYGEN SATURATION DECREASED (oxygen at 92), VOMITING (vomitting), PYREXIA (fever at 102.9 degrees Fahrenheit) and FATIGUE (Fatigue). On 05-Apr-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). At the time of the report, COVID-19 (Diagnosed with Covid-19), DEHYDRATION (Dehydrated), MOBILITY DECREASED (unable to lift his left arm for 2 to 4 days), OXYGEN SATURATION DECREASED (oxygen at 92), VOMITING (vomitting), PYREXIA (fever at 102.9 degrees Fahrenheit) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-073823 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073823:Crossed linked
Oth complications following immunization, NEC, init on 2016-10-17.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose and route were not reported) lot # L044917, expiration date 05-OCT-2018. It was reported that the vaccine was exposed to 29 Fahrenheit degrees for 96 hours. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt reported that starting 2 days after administration of Shingrix 1 of 2, redness appeared at injection site. Redness and bumps continued to occur spreading upwards to shoulder and even to his back. Reports no trouble breathing but bumps and red area are itchy and often waking him up at night. No soreness.
Tested positive on 06/20/2022. I received my 4th dose on 04/22/2022 and my COVID-19 symptoms started on 06/20/2022. I was sleeping a lot; sore throat; cough; body aches; pain; fever; and chills. We went to the local clinic to see my doctor who then prescribed me infusion because of my underlining conditions. I completely recovered after the infusion.
Itchy; Light headed; Heart started racing; Dizzy; Felt like I couldn't breathe; I couldn't speak; Felt like I wasn't getting enough oxygen to my brain; Mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild sore arm), PALPITATIONS (Heart started racing), DIZZINESS (Dizzy), DYSPNOEA (Felt like I couldn't breathe) and APHASIA (I couldn't speak) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy NOS. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy NOS.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Mild sore arm). On 27-Apr-2021, the patient experienced PALPITATIONS (Heart started racing), DIZZINESS (Dizzy), DYSPNOEA (Felt like I couldn't breathe), APHASIA (I couldn't speak), FEELING ABNORMAL (Felt like I wasn't getting enough oxygen to my brain) and HEADACHE (Light headed). On an unknown date, the patient experienced PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Mild sore arm), PALPITATIONS (Heart started racing), DIZZINESS (Dizzy), DYSPNOEA (Felt like I couldn't breathe), APHASIA (I couldn't speak), FEELING ABNORMAL (Felt like I wasn't getting enough oxygen to my brain) and HEADACHE (Light headed) outcome was unknown and PRURITUS (Itchy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Heart rate: 125 (High) Measured with pulsometer to125. On an unknown date, Chest X-ray: normal (normal) normal, patient went to ER one day later and have received same test result was found normal.. On an unknown date, Electrocardiogram: normal (normal) normal, patient went to ER one day later and have received same test result was found normal..         Patient had stated that he had go lie down, and felt like he was lying in the fetal position for 5 days because of his symptoms and patient reported  that his symptoms were likely vaccine related and he also stated that Tylenol seemed to improve his symptoms. Patient had stopped using stimulants, drinking coffee, allergic medication Xyzal , His  reactions were stopped after 1 to 2 days after stopping of Xyzal and returned after restarting allergic medication.   Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2021: Follow up document contains Missed information from initial document added that is lab data and changed outcome for itchy to recovered and added indication for concomitant drug Xyzal.
lymph nodes swelling; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes swelling) in a 46-year-old female 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 LYMPHADENOPATHY (lymph nodes swelling). At the time of the report, LYMPHADENOPATHY (lymph nodes swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-385641 (Patient Link).
1hour after shot, I felt chest pain and heart felt like it was skipping beats. Resolved within minutes.  On Day two, fatigue with any activity followed by increased heart rate, shortness of breath, mild chest pain.
a patient received their first dose of VARlVAX at the age of 5 years old; This spontaneous report was received from a pharmacist and refers to a 5-year-old patient (gender not reported). Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.      On 14-APR-2021, at the age of 5 years, the patient was vaccinated with the first 0.5 mL dose of varicella virus vaccine live (oka/merck)(VARIVAX) (route of administration, lot# and expiry date not reported) for prophylaxis (product administered to patient of inappropriate age). The reporter stated that the patient's parents did not want to vaccinate the patient at the age of 12 to 15 months when the first dose was recommended.
Accidental underdose; The liquid got in contact with the patient's arm; The liquid got in contact with the patient's arm; Needle leaked and less than the recommended dose was administered; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9335X, expiry date 29th January 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Boostrix (1st dose received on an unknown date).   On 27th April 2021, the patient received the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 27th April 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced accidental underdose, exposure via skin contact, inadvertent exposure to vaccine and needle leak. On an unknown date, the outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine and needle leak were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported but could be 32 or 33 years. The reporter stated that during the administration of vaccine the needle leaked and less than the recommended dose was administered which led to accidental underdose and needle leak. The reporter also reported that the vaccine leaked when the needle was removed from the patient's arm and the liquid got in contact with the patient's arm which led to exposure via skin contact and inadvertent exposure to vaccine. The reporter did not consent to follow up.
received COVID-19 vaccine on 12/19 at approx 1750. At 1804 pt c/o headache, racing heart, itching, and shakiness. Vaccine Commander called rapid response team (RRT). Upon arrival of RRT pt c/o increasing sx. Pt escorted via wheelchair to ED.
Bell's palsy; Pain/ Painful; Vaccine injured; Sick; Lack of energy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), PAIN (Pain/ Painful), VACCINATION SITE INJURY (Vaccine injured), ILLNESS (Sick) and ASTHENIA (Lack of energy). At the time of the report, BELL'S PALSY (Bell's palsy), VACCINATION SITE INJURY (Vaccine injured), ILLNESS (Sick) and ASTHENIA (Lack of energy) outcome was unknown and PAIN (Pain/ Painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that what vaccine did to her was painful, it had been 7 months and events are not recovered. Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2022: Patient gender and new serious event bell palsy was added. On 05-Feb-2022: Outcome updated for pain. On 05-Feb-2022: No new information added. On 05-Feb-2022: Vaccination site injury added as an event. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: Sick added as an event.
Information has been received from a physician concerning a 12 month old who was not vaccinated with a does of varicella virus vaccine live developed chickenpox after her 5 year old sister was vaccinated with a dose of varicella virus vaccine live (WAES0509USA04305). No date of onset was reported. It was unspecified if medical attention was sought. No further information was available at the time of this report. Additional information has been requested.
Vaccine given to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old). On 30-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old) had 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.   No concomitant medication were provided. No treatment medication were provided.
Initial misuse report received from a healthcare professional on 01 July 2013. It was reported that DAPTACEL was administered to a 13-year-old patient. No adverse event was reported. List of documents held by sender: none.
Patient complaining of prolonged right arm pain at the site where vaccine was administered. Pain has continued to occur since 11/8/18, so now has been occurring for over three weeks. Treatment includes: icing area 3-4 times per day, ibuprofen as needed.
BLISTERS ON BOTTOM/DIAPER RASH, LOW GRADE TEMPS, FUSSY AND VOMITING.
Pt recvd vax 18AUG92 & following inject fainted but regained conciousness w/in few seconds; pt was alert x 3, VS stable;
Pt vaccinated with DTP/OPV developed fever 103.8 & convulsions following immunizations. Hospitalized 5 days. Vomiting started day of discharge & diarrhea developed the next morning. Symptoms lasted 7 days - recovered.
she is always cold; Finger tips are very cold; she can´t get warm; Finger tips are whiteish; A spontaneous report was received from a consumer concerning a 64-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling cold, peripheral coldness, skin discoloration.  The patient's medical history was not provided. No relevant concomitant medications were reported..  On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced feeling cold, peripheral coldness, skin discoloration.  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 feeling cold, peripheral coldness, skin discoloration was unknown.