chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has rash on her arms, legs and previously on face. She uses lotion, which is not helping much. She also says her skin peels off when she showers. She first came and told me on 6/22.
Low grade fever (99.2-100.3.)  Body aches Weakness Fatigue Took one 500 mg Tylenol approximately 18 hrs after fever started. Symptoms lasted approximately 24-30 hrs.
Bell's Palsy; This spontaneous report was received from a nurse referring to a child of unknown age. The patient's concurrent condition, medical history and concomitant therapy were unknown.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, frequency, lot number and expiration date were unknown) for prophylaxis (reported as childhood vaccine).   On an unknown date, the patient experienced Bell's palsy. It was unknown if treatment was given. The patient sought medical attention. The outcome of the event was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not applicable. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.      Upon internal review, Bell's palsy was determined to be medically significant.
Pt fainted, 911 came to monitor Pt, after 15-20mins, parents came to pick up Pt.
I had some pain in my arm, not bad though; started itching 2 days after the dose; started itching 2 days after the dose ,"both arms and legs and chest sometimes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Patient received her 1st Pfizer vaccine dose and "had some pain in her arm, not bad though" and started itching 2 days after the dose, "both arms and legs and chest sometimes, it would go away and then it would come back." 2nd dose is scheduled on 06May2021. (3 weeks after 1st dose) She had a side effect after the first dose of the vaccine. She asked should she get the second dose. She got response you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. It was reported as PQC was not present. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt was given a Pfizer orange cap Bivalent Booster for ages 5-11 as a primary dose instead of the regular Pfizer orange cap for ages 5-11 for first dose.     The vaccine was diluted correctly.   The MD on for the day was notified. The patent waited for the 20 min required after vaccination.   No adverse reaction was noted. Provider cleared pt.
torn bicep 1 week after 2nd vaccination -previously reported torn hamstring 1 week after 1sts dose
Left arm pit became painful; injection site was swollen; Left arm pit is swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Left arm pit is swollen), AXILLARY PAIN (Left arm pit became painful) and VACCINATION SITE SWELLING (injection site was swollen) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced LYMPHADENOPATHY (Left arm pit is swollen) and VACCINATION SITE SWELLING (injection site was swollen). On an unknown date, the patient experienced AXILLARY PAIN (Left arm pit became painful). At the time of the report, LYMPHADENOPATHY (Left arm pit is swollen), AXILLARY PAIN (Left arm pit became painful) and VACCINATION SITE SWELLING (injection site was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Pt vaccinatd without DTP/OPV/HIB hx of DTP rxs, cried when given vaccination 5-7min later becamelimp, pale with eyes rolling. Afterwards was very sleepy.
Headache; blurred vision; unable to read at time; Difficulty focusing; right hand numbness; This is a spontaneous report from a contactable Nurse (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 04:15 PM, Intramuscularly at single dose (Vaccine location: Left arm) for COVID-19 immunization. Medical history was reported none. Concomitant medications were not reported. Patient did not have any allergies. Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced Headache, blurred vision and unable to read at time, Difficulty focusing and right hand numbness on 30Dec2020 12:00 AM. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.    Information on the lot/ batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events headache, vision blurred, cognitive disorder, disturbance in attention and hypoaesthesia cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Pt vax w/HIB/DTP/OPV hosp w/ T 106. Dx = meningococcemia w/o meningitis & DIC. Specimen grew Staph. epidermidis.  Se cultures 23Sep90 - no growth. Tx w/Amp & Rocephin.  Recovered at time of report.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: unresponsive for 1 minute
56 year old female presents with symptoms after getting 2nd dose of Moderna Covid Vaccine. Received first covid vaccine 1/26/21, and 2nd dose 2/26/21 at 11am. 30 minutes after getting vaccine, started feeling dizzy, like room is spinning, still has dizziness constanty. It is not as strong now. Denies nausea with the dizziness. 2/27 Saturday 2 am, started with vomiting and pain to the left arm where she had injection. Only had vomiting Saturday, pain to left arm stopped 8-9pm that night.   Started with fever, body aches, headaches, back pain, and feeling tired since yesterday, 2/28 around 6 am. Felt dizzy and fainted yesterday when she had fever. Temp max was 101.5F. Check today 99.5F 4 hours after taking Tylenol.  Today started with cough.  Has no appetite. Has increased water intake. Has been taking Tylenol/ Theraflu/ ginger with lemon tea.  Denies any residual swelling or redness to left arm. Denies diarrhea, loss of taste or smell, or SOB.
Fever of 100.6F; chills; fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100.6F), CHILLS, FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever of 100.6F), CHILLS, FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm). At the time of the report, PYREXIA (Fever of 100.6F), CHILLS, FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a 46 year old male. Initial information was received and processed with additional information received on 15-APR-2021.  The patient's weight and height were not reported. Patient's medical history included insomnia for which he took klonopin occasionally. Patient was non-smoker.  Patient's body fat was reported as 6% The patient received vaccination with Janssen COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin intramuscular, batch number: Unknown) dose was not reported, administered on 14-MAR-2021 13:00 in left arm for prophylactic vaccination. Batch number was not reported, will be requested. No concomitant medication was reported as patient reported not taking any medication at the time of the event. Patient' did not have any blood work done since taking the vaccine.  On 23-FEB-2021, platelet count was 206.  On 05-APR-2021, the patient was diagnosed with deep vein thrombosis. Patient reported that after 2 weeks of vaccination, he experienced pain in left calf muscle for 2-3 days. Physician sent the patient for doppler scan for his leg. Patient was diagnosed with deep vein thrombosis. Treatment medications included: Eliquis (apixaban). Patient was prescribed apixaban 20 mg a day for a week and continue with it 10 mg a day for 2.5 months.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A 46-year-old man was diagnosed with deep venous thrombosis (DVT) in his left leg 21 days after vaccine. There was no relevant medical history or concomitant medications, he is a nonsmoker, and there is no family history of thrombosis. Nineteen days before vaccine his platelet count was normal at 206,000 and no laboratory work has been performed since then. The patient was treated with Eliquis. Idiopathic DVTs often are followed by an extensive workup to identify the cause, and the patient is reaching out to his physician to discuss further. Based on information currently available, company causality is considered possibly related.
Local swelling in right upper extremity at site of vaccination.  Pt had associated nasal drainage/congestion, chills, fever and malaise.  Reported diarrhea also.  She missed work due to symptoms.  Did not feel otherwise like she had another illness prior to vaccination.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients whose on an unknown date, were vaccinated with an improperly stored doses of PNEUMOVAX 23  (lot # M022085, expiry date 09-OCT-2017). The vaccine was exposed to 51 degree F for 7 hours and 30 minutes. No adverse effects were reported. This is one of two reports from the same reporter source (linked to MARRS# WAES1609USA009020). Additional information is expected.
Patient received first dose of Pfizer vaccine on 9/24/21 at COVID vaccination clinic. Translation services was provided to patient instructing of Vaccine given, Vaccine information sheet provided, side effects to expect discussed, information regarding when to seem emergency medical services provided and information and written documentation of when second dose of vaccine due was also provided to patient. Patient' worksite offered another COVID Vaccine clinic the week after patient received first dose of Pfizer.  The Moderna Vaccine was being administered on that day for patients to complete their  second doses of  Moderna. However, patient mistakenly arrived to onsite COVID vaccination clinic requesting administration of COVID vaccine. It was not know at the time of patient's request that she received Pfizer vaccine the previous week and Moderna vaccine was administered to patient.  After Moderna vaccine dose was administered, it was later revealed that patient received Pfizer the previous week.  Patient was monitored for 1 hour and CDC was contacted for next steps . Patient had no reaction and no noted adverse effects . Patient contacted and monitored for several days later till date of 10-4-21 and no adverse event and no reactions. CDC indicates no additional doses needed.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Concomitant medications details was not reported.  Reportedly, the pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The patient received vaccine from a vial that underwent a temperature excursion in the freezer.  The patient received the booster dose.  All the vaccines were found to be viable.  Treatment details was not reported.
Information has been received from a physician concerning a male who on 13-SEP-2006 was vaccinated with a 0.65 ml dose of ZOSTAVAX. Subsequently "two to three weeks after vaccination," on approximately 27-SEP-2006, the patient developed shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
cold; Rash on back; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), RASH (Rash on back) and PYREXIA (Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), RASH (Rash on back) and PYREXIA (Fever). At the time of the report, NASOPHARYNGITIS (cold), RASH (Rash on back) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided by the reporter. No treatment information was provided   Reporter did not allow further contact
Pt. experienced pain on administration site, that she could not move arm. Area was red and warm. Dr. gave her an antibiotic and a pain medication. Pt. experienced side effects next day of vaccination.
States Sat she had her first COVID vaccine- Moderna. States on Saturday she was exhausted and slept most of the day Chills, too hot at times with nausea, exhaution Monday felt better, left arm with hot to touch , clavicle tenderness  and left armpit with swelling, painful putting on Deoderant today States no medications taken, able to keep down fluids Left arm at vaccine site is red and hot tender to touch today
6 month immunizations administered on 9/17/08; Mother reported local area of erythema on thighs bilaterally on evening of 9/17/08. Seen on 9/19/08. No fever rash, tenderness, or localized heat. Areas each dime-size. No treatment necessary.
soreness in/ arm/not the normal soreness; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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 are as follows: The case was reported by patient himself/ herself.  The age at vaccination was not reported. The patient received 2nd dose of Bexsero vaccine in unknown arm almost a week ago and experienced soreness in arm, had not gone away. The patient stated that it's not the normal soreness that he/she had with other vaccines, which he/she had.  The patient asked was this normal. The follow-up would not possible as no contact details were available.
Significant dizziness/ vertigo started on Saturday, worsened on Tuesday and continues to persist.
After vaccination, pt. returned home and later had nausea and vomiting.  The next evening he also had diarrhea.  Pt. reported to hospital today and is currently being treated for n/v and diarrhea.
Heart Racing, Fatigue, Insomnia, Nausea, Headaches, Severe GI issues, Shortness of breath
Post COVID vaccine patient complained of light-headedness and fatigue. She was hydrated and her Vitals were taken. She soon felt better
Patient reporting adverse reaction to Shingle shot series: Received first shot on 09/17/2019:  - reporting sore arm, redness and  bruising at injection site and felt tired after shot. Received second shot 11/19/2019 administered:  - reporting a pounding headache the day after receiving the shot -Body aches, muscle and tendons tightness and pain, had trouble moving due to the body aches and pain. -Pain then moved to just the right hip and leg, injection site still sore. -Patient consulted with Doctors, Chiropractors and Massage therapists to get relief from the pain and tightness in his right hip and leg. Walking with a limp due to tightness in his muscles and experiencing shooting pains in his nerves as of today 12/31/2019. -Patient states that he just started feeling a tingling sensation in his right leg today, 12/31/2019
shivering and chills; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.   This case involves a patient of an unknown demographics who experienced shivering and having chills (chills), after the patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number and expiry date not reported) via an unknown route and at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious shivering and having chills (chills), one hour following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the batch number for this case.
Pt had a four minute febrile seizure about 10 hours after vax. Pt also had a mild viral URI with fever at the time of the injection.
This spontaneous report was received from a physician via a company representative concerning an approximately 14 year old male patient. On 26-MAR-2013, the patient was vaccinated with the first dose of GARDASIL (lot number and expiry date reported as H014645 and 27-MAR-2015 respectively, dose unspecified), intramuscularly in the right arm. Concomitant therapy included MENACTRA (manufacturer, lot number, expiry date, dose and route unspecified) which was administered on 26-MAR-2013 (on the same day) in the left arm. On 26-MAR-2013, after receiving the vaccination, the patient experienced sleepiness and numbness in the right arm. It was unspecified if the patient sought any medical attention. No treatment was given and no lab tests were performed. Approximately on an unknown date in 2013, the patient recovered from the events. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.
Patient was sitting after the RN gave the shot playing his video game, the RN was in the room standing when she heard a noise and RN and father saw him fall hitting his shoulder and face on the ground. He was conscious and given water and juice and snack.  I examined him in few minutes and he was ok, vitals were stable, he was observed for 30 more minutes and discharged home in stable condition.
It was reported that a 43 year old female pt received a TD Adult vaccination on 01/26/2001 at 10:30am. Reportedly on that same day at 3pm, the pt developed 1cm induration, 10,, area of erythema to inner right forearm, slight blistering to area of induration. Itching all over, raspy voice, frequent cough. Treatment of Benadryl 50-75mg per oral was given. Reportedly the pt recovered from this experience. From follow up # 1 correspondence recieve on 03 APr 2001, no further information was provided. See reports U2001-00435, U2001-00438, U2001-00447 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Reconstituted with other sterile diluent; Reconstituted with other sterile diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA766A, expiry date 31st December 2023) for prophylaxis.   On 23rd February 2023, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comments: The reporter did not consent to follow-up. Additional Supportive Information: The nurse reported that Menveo was reconstituted with other sterile diluent instead of the one supplied, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
pt arrived home & APAP was given then took 1hr nap;awakened fussy & warm, t103(ear);arm & legs began jerking & those extremities became purple;pt did not lose consciousness;taken to MD lab work done;t104 APAP given;dismissed home t103-104;v
Local erythema and warmth to injection site 24 hrs after administration. No home treatment provided.
Patient went to ER on 7/11/10 c/o rash to (L) arm with no fever and few small lesions < armpit. Pt. stated rash started 7 days ago. Patient diagnosed with local vaccine reaction (not allergic reaction0. Possible early cellulitis.