chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; chills; arm soreness and heat; arm soreness and heat; hip pain; abdominal pain; severe headache; partial face numbness ( right side); muscle pain; dizziness; tired all the time and Extremely fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 14:30 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "known allergies", notes: known allergies: Keflex. The following information was reported: PYREXIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 15Sep2021, outcome "not recovered", described as "chills"; PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious) all with onset 15Sep2021, outcome "not recovered" and all described as "arm soreness and heat"; ARTHRALGIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "hip pain"; ABDOMINAL PAIN (non-serious) with onset 15Sep2021, outcome "not recovered", described as "abdominal pain"; HEADACHE (non-serious) with onset 15Sep2021, outcome "not recovered", described as "severe headache"; HYPOAESTHESIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "partial face numbness ( right side)"; MYALGIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "muscle pain"; DIZZINESS (non-serious) with onset 15Sep2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 15Sep2021, outcome "not recovered", described as "tired all the time and Extremely fatigued". Therapeutic measures were not taken as a result of pyrexia, chills, pain in extremity, feeling hot, arthralgia, abdominal pain, headache, hypoaesthesia, myalgia, dizziness, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. Any other medications patient received within 2 weeks of vaccination reported as NA.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Joint pain; Low grade fever; Nausea; Redness at injection site; Pain at injection site; Warmth at injection site; Mild swelling in distal hand of injection; Moldy swollen axillary lymph nodes; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; This is a spontaneous report from a contactable Nurse(patient). A 35-year-old female patient received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021 16:00 at the 35 years old at single dose for COVID-19 immunization.  The medical history included PCOS, depression. The patient was not Allergies to medications, food, or other products. The concomitant medications were bupropion and venlafaxine. The patient previously took first dose BNT162B2 (lot number EK5730) on 21Dec2020 at 35 years old at Left arm for COVID-19 immunization. On 08Jan2021 08:00 the patient experienced Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes.  There was no treatment received for the adverse events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes was not recovered.  The information on the batch number has been requested.
Within minutes after vaccination patient became very lightheaded and nauseated.  Patient put their head between their legs and began dry heaving into garbage container.  Patient appeared unresponsive for a few seconds. Eyes were closed and was not answering voice or shaking of shoulder.  Called 911 and EMS responded and evaluated patient on site. Patient was already recovering, dry heaves had ceased, and patient was able to sit back up in chair on their own by  the time EMS arrived. Patient told paramedics she thought she did blackout and felt really warm while she was dry heaving.  Patient was stable and paramedics offered medical transport.  Paramedic questioning of patient revealed patient had not eaten or drank anything up to this point in the day.  Patient is also on multiple medications with hypotensive and dizziness effects. Including hydroxyzine for anxiety.Patient refused medical transport and left on her own with spouse and son.  Patient appeared fine at time they left the pharmacy area.
Information has been received from a physician concerning a patient who was vaccinated with ZOSTER (Oka/Merck) (lot # not provided).  Secondary suspect therapy included influenza virus vaccine (unspecified).  Subsequently the patient experienced unspecified adverse event.  At the time of the report, on 05-NOV-2008, the outcome of the patient was unknown.  Additional information has been requested.
pt recvd vax 24AUG95 fever 103 started 1115PM then vomited x 5 through the noc, t100 this AM 25AUG95, feeling better;
-Staring episode lasting 8 seconds. - irritability but not prolonged inconsoloable crying.
pt recvd vax AUG1982 & 7 days following vax devel fever 99.2 & had a sz; 3 months following vax exp another sx & exp 3rd dx sometime prior to the report, 7APR93; EEG was neg;
the vaccine did hurt; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Shingles vaccine for prophylaxis.   The patient's past medical history included shingles (had them and they were the worst). Previously administered products included Shingles vaccine with an associated reaction of injection site pain (1st dose received on an unknown date refer case US2021AMR259665).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said that the vaccine did hurt some, but he/she would take the 2 shots any day over having shingles again. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259665:same reporter
Pt recvd vax & exp severe pain @ the inject site & the entire arm; CNS involvement consisting of tingling, numbness & heaviness in the injected arm, lightheadedness, & dizziness; No further details were provided;
Had one dose of Shingrix but not 2nd.; This case was reported by a consumer via interactive digital media 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 on an unknown date).   On an unknown date, the patient did not 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 Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient did not receive second dose it's been over six months. The reporter asked what patient should do. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reaction or allergies were not reported. On an unknown date in 2011, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiry date were not reported). Then, on 07-NOV-2016, the patient was vaccinated a dose of GARDASIL 9 injection, lot # L048459 with expiry date 22-FEB-2018 (dose, route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Erythema developed to the right deltoid ( middle of right arm ) , warm to touch ( on the same day ). The erythema is resolving.
Approximately 10 days post vax, pt developed a measles like rash on the face and torso, fever, and diarrhea. Pt was treated with diphenhydramine and ibuprofen.
The patient had a bad reaction to MMR; This spontaneous report was received from a consumer concerning a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).         On an unknown date, the patient had a bad reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (ill-defined disorder).  The outcome of ill-defined disorder was unknown.        The causality assessment between the suspect vaccine and the event occurrence was related.
Suspected vaccination failure/Shingles, prior double dose shingles vaccine; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and VIRAL VACCINES (COVID VACCINE (NOS)) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and COVID VACCINE (NOS). On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's son/daughter. The age at vaccination was not reported. The patient was immunized with the double dose shingles vaccine 2 years prior from reporting date. The patient was diagnosed with shingles 3 days after the vaccination with covid vaccine. It was unknown if the reporter considered the shingles to be related to Covid vaccine. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the detail regarding laboratory test confirming shingles was unknown at the time of reporting. This case was 1 of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR242892:Same reporter US-GLAXOSMITHKLINE-US2021AMR242893:Same reporter
Weakness no energy on day one, day two extreme sore throat, day three aching day 4 nausea vomiting, sore throat, aching, temperature over 100, weakness, no appetite, headache, nasal congestion - symptoms are still continuing now.
8 days post vax, the pt developed a rash with low grade fever. Started in trunk and progressed to face and extremities and internally.
Mild muscle soreness; Urticaria; injection site warmness; RASH; Itchiness; injection site redness; injection site sore arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (Urticaria), VACCINATION SITE WARMTH (injection site warmness), RASH (RASH), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (injection site redness) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history.). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (injection site sore arm). On 04-Jan-2021, the patient experienced URTICARIA (Urticaria), VACCINATION SITE WARMTH (injection site warmness), RASH (RASH) and VACCINATION SITE PRURITUS (Itchiness). On 07-Jan-2021, the patient experienced MYALGIA (Mild muscle soreness). On 31-Dec-2020, VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (injection site sore arm) had resolved. On 05-Jan-2021, URTICARIA (Urticaria) and VACCINATION SITE WARMTH (injection site warmness) had resolved. At the time of the report, RASH (RASH), VACCINATION SITE PRURITUS (Itchiness) and MYALGIA (Mild muscle soreness) was resolving.        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.   He treated the reactions on 30dec2020 with ibuprofen. On 6jan2021 he treated the rash with topical diphenhydramine and the night of 6jan2021 he took diphenhydramine 25 mg.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sore arm; Fever 101; Chills; Shivering; A bit nauseous; Shaking; kid of jerking; Stomachache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomachache), DYSKINESIA (kid of jerking), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever 101) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache). On 29-Mar-2021, the patient experienced TREMOR (Shaking), DYSKINESIA (kid of jerking), PYREXIA (Fever 101), CHILLS (Chills), CHILLS (Shivering) and NAUSEA (A bit nauseous). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomachache), DYSKINESIA (kid of jerking), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever 101), CHILLS (Chills), CHILLS (Shivering) and NAUSEA (A bit nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter Treatment information was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow-up information received on 26-JUN-2021.Updated new AE sore arm.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Follow up report from the first VAERS reported, regarding patient reporting redness from deltoid to elbow. Called patient on 04/29/2021 patient indicated that she has taken Bendryl at night and there was imporvement. Todays follow up call 05/14/2021 patient indicated a few days after the bendaryl, all symptoms had resolved. Currently patient indicated that there is no longer a redness from deltoid to the elbow.
Case number PHEH2014US009493 is an initial spontaneous report received from a medical assistant on 08 May 2014: This report refers to an 11 years old female child. She was vaccinated with MENVEO (batch number: M13017) intramuscularly on 07 May 2014. This vaccine was stored at 33.8 degree Fahrenheit for 8.5 hours. No adverse event was reported following this administration error.
Painful lumpy knot at injection site; Muscle aches; Chills; Painful lumpy knot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Painful lumpy knot at injection site), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Painful lumpy knot at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE MASS (Painful lumpy knot at injection site), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Painful lumpy knot at injection site). At the time of the report, VACCINATION SITE MASS (Painful lumpy knot at injection site), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Painful lumpy knot at injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported. Treatment medication was not provided by the reporter.
6 patients received expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The Reporter explained that they thaw the vial on the same day that they had a vaccine clinic. Date the vial was initially stored in the refrigerator: 04-Nov-2021 and 01-Dec-2021. There were 6 total patients (but total 7 doses) who received the expired dose from lot number 047B21A. The vial did not undergo any temperature excursions. Treatment information include not provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 13 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies Penicillin" (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 Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: From 18Sep2023 to 22Sep2023 patient received Paxlovid as Covid-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
Rash starting on anterior trunk in chest region and spreading rapidly to entire trunk, anterior and posterior, then neck, then face and proximal arms and legs.  Nonpruritic.  No URI symptoms.  No fever.  Just a little irritable.
Local erythema and swelling spreading from injection site to involve arm (shoulder to hand) with temporary pain and limited range of motion.  Resolved in 48 hours with ibuprofen and Benadryl.
I have now tested positive again; I have now tested positive again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6200), in left arm and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunization. The patient's had no relevant medical history and no known allergies. Concomitant medication(s) included: TAMSULOSIN; FLONASE; TURMERIC and reported as patient taking other medications or products within 2 weeks of starting COVID-19 treatment. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "I have now tested positive again". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 12May2022 and stopped on 17May2022. Clinical course was reported as, After taking Paxlovid (which worked great) patient started having symptoms again 5 days after completing the series and after having tested negative for Covid. Patient have now tested positive again and in 3rd day of symptoms which are worse than originally had. Symptoms include congestion, coughing and feeling run down. Patient believe his wife was also experiencing the rebound but has not tested again yet. Rebound symptoms started on 22May2022. No treatment received for symptoms and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.