chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WOKE UP IN PAIN; FEVER WAS 102-103; DIDN'T SLEEP AT ALL NIGHT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 26-MAR-2021, the subject experienced didn't sleep at all night. On an unspecified date, the subject experienced woke up in pain, and fever was 102-103. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102-103 F, 100-99 F. Treatment medications (dates unspecified) included: tramadol hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever was 102-103, and the outcome of didn't sleep at all night and woke up in pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Fever after 12 hours after vaccine. Itchy Rush all over the body.  Lasting at least 18 hours
Information has been received from a consumer (an account manager) of unknown age and gender via a company representative referring to himself/herself. Information about patient's concurrent conditions and medical history was not reported. On unknown dates the patient received at least one dose of (Merck) VARIVAX (lot#, dose and route not reported) and later, on an unspecified date the patient's titers showed negativity to the varicella virus. Outcome of the event was unknown. The causality was not provided. This is one of two reports from the same source (other linked case # 1510USA010832). Additional information has been requested.
Two weeks after receiving vaccine,  experiencing severe pain in under left breast, radiating around to the back. Chest pain and some breathlessness.  I took her to the ER , on March 27, 2021,  thinking it might be her heart.  She was admitted for observation.  She broke out with a severe case of shingles the next day, 3/28/21.  She had been fully vaccinated for Shingles two years before (Shingrix).
I woke to a stye inside my left lower eye-lid; fever up to 102; fatigue; muscle aches; chills; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247, patient was 41-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 10:30 AM as DOSE 2, SINGLE, for covid-19 immunisation. Medical history included crohn's disease. Concomitant medication(s) included mesalamine (MESALAMINE); vedolizumab (ENTYVIO) taken for an unspecified indication from an unspecified start date to 15Feb2021 (last infusion), both were taken in two weeks of vaccination. No other vaccine received in four weeks, no covid prior vaccination, no tested covid post vaccination. No known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247), via an unspecified route of administration, administered in Arm Left on 02Feb2021 at 10:30 AM as DOSE 1, SINGLE, for covid-19 immunisation. On 23Feb2021 at 11:00 PM, the patient experienced chills, fever up to 102, fatigue, muscle aches, on 25Feb2021 at 11:00 PM, the patient experienced i woke to a stye inside my left lower eye-lid. The patient underwent lab tests and procedures which included body temperature resulted as 102 on an unspecified date in Feb2021. The patient received treatment for event (fever up to 102) with Tylenol and no treatment were received for other events. It was reported that no adverse reactions with 1st vaccine. Approx. 12 hours after 2nd dose experienced some of the typical adverse events. I am at times prone to styes but considered this an event worth reporting. As all other adverse events have cleared with the exception of the stye, I am continuing to monitor it and would seek medical attention if it doesn't clear as expected. The outcomes of event (I woke to a stye inside my left lower eye-lid) was not recovered and outcomes of events (chills, fever up to 102, fatigue, muscle aches) were recovering.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Information has been received from a Registered Nurse concerning a 14 year old male child with sore throat at the time of vaccination, who on 23-JAN-1997 was vaccinated with the first dose of VARIVAX (Merck) (lot# 619272/1339D) subcutaneously into his left arm. It was reported that the patient's mother and father were diagnosed with shingles. A few days later on 02-JAN-2011, the patient developed chickenpox - over thirty blisters, some were draining and some had crusted, and he also experienced eyes itchy and red but no blisters or requiring eye medications. On 18-JAN-2011, the patient recovered from the events. Follow-up information has been received from a physician concerning the 14 year old (also reported as "15 year old") male child with no medical history or illness at the time of vaccination, who on 23-JAN-1997 was vaccinated with the first dose of VARIVAX (Merck) (lot# 619272/1339D) subcutaneously into his left arm. Other suspect therapy included the first dose of MMR II (lot# 618617/0734D) subcutaneously into his right arm on the same day. The physician reported that on 08-JAN-2011 about 30 lesions (previously reported as "blisters") that went thru weepy and crusted stage itchy. The patient had enlarged lymph node (LN) with fever 101-102. It also reported that both parents were diagnosed shingles for few days before this patient's reaction (RXN). The patient had throat culture test for strep which was negative; "quick and plate". On 20-JAN-2011 (previously reported as "18-JAN-2011"), the patient recovered from the events. The patient sought medical attention via doctor visit. This is one of several reports received from the same source. No further information is available.
pregnant woman received  INFANRIX; received INFANRIX instead of BOOSTRIX; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 32-year-old female patient who received DTPa (Infanrix) (batch number 7H399, expiry date 13-SEP-2024) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 27-SEP-2023, the patient received Infanrix (right deltoid). On 27-SEP-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: received INFANRIX instead of BOOSTRIX). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant woman received  INFANRIX).  The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Infanrix): 28 Weeks Pregnancy Exposure (Infanrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2023 The medical assistant stated that she gave a pregnant woman Infanrix instead of Boostrix in her right deltoid which led to wrong vaccine administered and exposure during pregnancy. The medical assistant stated that she took the wrong vaccine out of the refrigerator by mistake.  The Pregnant woman is at 28 weeks gestation. The reporter consented to follow up.
1 week after Moderna vaccine, my left deltoid started itching. Skin colored raised bumps appeared, 1 at first, then quickly spread to a 2x3 inch area. I took Benadryl orally and applied Benadryl cream. The next day, a 2x3 inch red, slightly raised mark was there. Itchy, painful like a burn, and deep muscle soreness that was there immediately after the shot and had gone away, returned. The red spot was under the vaccine injection site, not around it. Almost like where gravity brought the vaccine fluid after the injection. It lasted 3 days and then went away.
fever (highest 102.8), chills, tremors, body aches, muscle aches, joint pain, vomiting (only once).  Lasted 2 days.
Diagnosed with Bells Palsy on 11/18/2020.  Received Zoster (Shingrix) dose #1 on 11/11/2020. Prescribed Prednisone 60 mg daily for 7 days; and Valacyclovir 1 Gram three times daily for 7 days.
91.2kg 79 yo nonsmoking/nonEtOH drinking M with PMH significant for Parkinson's disease, postural hypotension, recent hip surgery and eye problems was at the vaccine clinic for his 2nd Covid-19 vaccine with the product. Allergy history includes tree nut and MSG allergy (hives, swelling, pruritus) and Sinemet, midazolam and fentanyl causing nausea or vomiting.  After IM injection of the vaccine (lot # EM9810) into his left arm, the patient felt lightheaded.  Patient was diaphoretic and pale.  BP was 64/49 with HR 66 and O2 sats 92% on room air which is near baseline.  Patient was moved to a recliner chair with feet elevated and given something to drink and monitored
Hives on hands, neck, back & belly. Swelling on hands & outer ears. Swelling & itching went away with CLARITIN.
Tendonitis is flaring up/ ankles have had a tendonitis flare up; Excruciating pain in the right wrist; Pain was so excruciating that the patient couldn't even walk; Knees are flaring up and are swollen; Low grade fever; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Tendonitis is flaring up/ ankles have had a tendonitis flare up), ARTHRALGIA (Excruciating pain in the right wrist), GAIT DISTURBANCE (Pain was so excruciating that the patient couldn't even walk), JOINT SWELLING (Knees are flaring up and are swollen) and PYREXIA (Low grade fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tendonitis.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced TENDONITIS (Tendonitis is flaring up/ ankles have had a tendonitis flare up), ARTHRALGIA (Excruciating pain in the right wrist), GAIT DISTURBANCE (Pain was so excruciating that the patient couldn't even walk), JOINT SWELLING (Knees are flaring up and are swollen), PYREXIA (Low grade fever) and HYPERHIDROSIS (Sweating). At the time of the report, TENDONITIS (Tendonitis is flaring up/ ankles have had a tendonitis flare up), ARTHRALGIA (Excruciating pain in the right wrist), GAIT DISTURBANCE (Pain was so excruciating that the patient couldn't even walk), JOINT SWELLING (Knees are flaring up and are swollen), PYREXIA (Low grade fever) and HYPERHIDROSIS (Sweating) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medications were not provided by reporter.
Went to ER on 8/17/01 with facial swelling, hives, stridor and chest pain. Was given po steroids and had taken Benadryl at home. On 8/20/01, pt seen in office, fully resolved.
No adverse event; HCP advised that her office utilized vaccine vials that expired on 3-30-23. Vaccines were administered on 4-7-23 too 2 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP advised that her office utilized vaccine vials that expired on 3-30-23. Vaccines were administered on 4-7-23 too 2 patients.) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP advised that her office utilized vaccine vials that expired on 3-30-23. Vaccines were administered on 4-7-23 too 2 patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP advised that her office utilized vaccine vials that expired on 3-30-23. Vaccines were administered on 4-7-23 too 2 patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP advised that her office utilized vaccine vials that expired on 3-30-23. Vaccines were administered on 4-7-23 too 2 patients.).    No concomitant medications were reported. Total 2 patients were administered with the expired dose of vaccine on 07-Apr-2023. One patient received expired vaccine as first dose and other  patient received vaccine as a 2nd primary dose. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719336 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719336:Patient
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 3:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 66.44. Concomitant products were not provided. On 03-Mar-2021, Excursion time was 09 AM and 10 AM, and 1pm with temperature as 51, 34 and 35 respectively. Total doses given for the day was 200 for 9AM vials. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 24-Feb-2021 and. Vial was moved to clinic on 03-Mar-2021. 20 vials from 9 AM and 4 vials from 10 AM were sent to clinic. Vaccine BUD date was 26-Mar-2021 for 9AM,10 AM and 1PM respectively.  On 31-Mar-2021, Excursion time was 08 AM and 9 AM, and 1pm with temperature as 32, and 32 respectively. Total doses given for the day was 199 for 8AM vials. Condition of vaccine prior to administration was not frozen. 8 AM vaccine was moved to fridge on 30-Mar-2021. Vial was moved to clinic on 31-Mar-2021  Vaccine BUD date was 29-Apr-2022. On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 4 6, 3 PM: 46, 4 PM: 44 and 5 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there wa
received two doses on the same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a female patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   On 29th September 2022, the patient received the 2nd dose of Shingrix. On 29th September 2022, unknown after receiving Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   Additional Information: GSK receipt date: 30-September-2022 Reporter's comment: Reporter stated that on Sep 29th, 2022, a patient received two doses of Shingrix on the same day. Additional supportive information:  As patient received 2 dose Shingrix on same day which led to overdose. The reporter did not consent to follow up.
SKIN RASH, MUSCLE PAIN, HEADAID, ORTHOPENIA.  11/13/06 Received medical records from MC which reveal patient d/c 2004 s/p medical reasons & experienced left knee pain after a fall on 5/05 (xray neg).  Main problem appears to be PTSD for which he initially requested treatment in 7/05 due to marital problems, explosive temperament, insomnia, disinterest in others, hyperarousal/startle responsiveness.  Also suffered LBP, high cholesterol, intermittent abdominal pain s/p left herniorrhaphy 2003. 60 day Follow-up Information 24-OCT-2006: Abdominal pain, bone pain, muscle pain, skin rash, stomach problems, diarhrea, arthritis. Memory forgetfulness, weight gain.
HOT, RED AREA AT THE INJECTION SITE SPREADING TO THE BACK OF THE ARM DOWN TOWARD THE ELBOW AND ALMOST TO THE SHOULDER BLADE..ABOUT THE SIZE AND LENGTH OF HER HAND.
Pain across collarbone, neck and arm.  Shot was given in right arm up very high near the joint.  Pain began in arm and spread across chest ten minutes after shot.
Was vaccinated on 1/28/21 and around midnight started getting chills followed by feeling feverish. This continued on and off until the end of the day on the 1/29. I also felt very weak and nauseous.
5:41 patient mentioned feeling dizzy, weak and lightheaded. He sat down in a chair and began monitoring symptoms. He said he has a history of seizures. At 5:45 after making sure he could take deep breaths and his airway was cleared, he took a sip of water. At 5:47 he mentioned having an increased heart rate. At 5:49, he willingly laid on the floor. At 5:51 he said his chest hurt and had a headache. At 5:53 he then sat up and took a few more sips of water. He felt comfortable enough to stand back and go home. He and his fiancé left the building. He vocalized that his fiancé will be driving him home.
Pt called 5/12/2021 regarding of covid vaccine side effects. Pt stated pt got 2nd covid vaccine Pfizer 5/11/2021 and pt got itching/rash on back of ear, neck, head(fore head, all scalp) from last night and this morning. Pt said pt feels nausea, headache and very tired. On injection site(left arm) pt complained pain and swelling. Pt stated pt did not take any treatment/intervention for symptoms. Pt reported pt got rash, pimple from 1st covid vaccine and visited doctor rash and pimple after covid vaccine. Noted pt has DM, severe obesity (BMI 41.9) and pt is allergic to Ampicilin. Pt is educated covid vaccine side effect. The writer recommended pt to call 911 or go to ED for further evaluation.
Broke out in a rash and hives from head to toe; Broke out in a rash and hives from head to toe; This is a spontaneous report from a contactable other HCP (Patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 04Feb2021 (Batch/Lot number was not reported; 71-year at the time of vaccination) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ciprofloxacin. The patient previously received first single dose of bnt162b2 first dose on 21Jan2021 12:00 Right arm for Covid-19. Patient had Broke out in a rash and hives from head to toe on 10Feb2021 12:00; treatment received with Cortsone shot, benedryl, Claritin; Patient not had covid prior vaccination; not had covid tested post vaccination. The outcome of the events was recovered in Feb2021.  Information about lot/batch number was requested.
My are is sore, has a red circle about 3.5 inches around and is hard and hot to the touch.  I have a fever, chills, body aches, headache and nausea. It has been almost 48 hours since my vaccination and i am unable to work or perform my normal routine.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported by reporter. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Blood pressure increased: high (High) High.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Treatment information was not provided. This case was linked to MOD-2021-295405 (Patient Link).
my arm, the site is little swollen and sore; my arm, the site is little swollen and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2022 (Lot number: FL3198) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Verbatim:Diabetes; "COPD" (ongoing), notes: Verbatim:COPD; "defibrillator" (unspecified if ongoing), notes: Verbatim: I have a defibrillator; "asthmatic" (ongoing), notes: Verbatim: Iam asthmatic. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Mar2022, outcome "recovering" and all described as "my arm, the site is little swollen and sore". Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling.  Additional information: The patient stated that she got her first Pfizer shot on Friday and her arm, the site is little swollen and sore and she had been putting alcohol on it but it feels like going down. About the prior vaccination (within 4 weeks) the patient stated that she got injection for her blood sugar (Further clarifications unknown) on Thursday, when probed to clarify if it was a vaccine the patient stated no. The patient stated Just rubbed it with alcohol regarding the treatment received. The patient stated that she had diabetes, COPD, she had a defibrillator (further not clarified) and she was asthmatic. Regarding concomitant medication the patient stated it was a long list of names.  No follow-up attempts are possible. No further information is expected.