chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Normal soreness in injection site.  My right knee which was replaced in September became very painful and woke me from my sleep the night of my vaccine.  Then the rest of my body began to hurt so badly I could barely get out of bed the next morning (4/28) it hurt to even touch my skin.  I developed a fever of 101 and tylenol did not help.  The fever finally broke in the middle of the night on  (4/29).  On 4/30/21 I still felt pain and again my joints and muscles kept me awake throughout the night minus the fever.   I found the other thing that remotley helped was to keep moving around .
neuropathy; tingling, pins and needles below waist and in right hand.;numbness in right foot. Appeared to re-activate long-dormant condition.
Normal pain in arm, but tinnitus (bilateral, nonpulsitile) developed within 24 hours of injection and is still present continuously at the date of this report.
Breakthrough case admission after three vaccines Moderna 2/18/21 Lot# 038K20A;  Moderna 3/23/21 Lot# 010A21A;   Moderna 11/16/21 Lot# 939903
Headache, body ache, fatigue - started morning after injection - treating with Ibuprofen and rest
received a third dose by accident; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA592A, expiry date 31st August 2022) for prophylaxis.   Previously administered products included Menveo (received 1st dose on an unknown date) and Menveo (received 2nd dose on an unkown date).   On 19th January 2022, the patient received the 3rd dose of Menveo. On 19th January 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of Menveo by accident, which led to extra dose administered. The reporter consented to follow up.
Heart murmur; Slip disc L2-L3; Problems with bone marrow; Slip disc L2-L3 which is affecting right leg; Hip is hurting; Nausea; Redness at injection site; Fever with higher temperature; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of CARDIAC MURMUR (Heart murmur), INTERVERTEBRAL DISC PROTRUSION (Slip disc L2-L3), BONE MARROW DISORDER (Problems with bone marrow), PAIN IN EXTREMITY (Slip disc L2-L3 which is affecting right leg) and ARTHRALGIA (Hip is hurting) in a 65-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 Hip replacement on 02-Sep-2020. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], LISINOPRIL and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC MURMUR (Heart murmur), INTERVERTEBRAL DISC PROTRUSION (Slip disc L2-L3), BONE MARROW DISORDER (Problems with bone marrow), PAIN IN EXTREMITY (Slip disc L2-L3 which is affecting right leg), ARTHRALGIA (Hip is hurting), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Redness at injection site), PYREXIA (Fever with higher temperature) and CHILLS (Chills). At the time of the report, CARDIAC MURMUR (Heart murmur), INTERVERTEBRAL DISC PROTRUSION (Slip disc L2-L3), BONE MARROW DISORDER (Problems with bone marrow), PAIN IN EXTREMITY (Slip disc L2-L3 which is affecting right leg), ARTHRALGIA (Hip is hurting), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Redness at injection site), PYREXIA (Fever with higher temperature) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications reported was small blood thinner.  No treatment drug details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up received on 18-JUN-2021 contains Updated reporters occupation. Added new events.
Client rec'd vaccine at 9:05. Around 9:15 she verbalized that her heart rate was going very fast, that her chest was tight, and that she was having trouble moving her hands. Client appeared very pale and was breathing rapidly.  Emergency response was called and 0.3 mL dose of epinephrine was administered around 9:20am. BP was 110/68, HR was 95, pulse ox was 96%, respiration elevated. Emergency response arrived and vitals remained stable. Client decided not to be transported to a hospital. Client was alert and oriented the entire duration of her reaction. Client was ambulatory when she left the clinic around 10:30am.
blood sugar over 300 all day; chills; body ache; fever; loss of appetite; tired; This is a spontaneous report from a contactable consumer (patient reported for herself). A 54-year-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Lot Number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Left (injection into the muscle of her arm) on 03Mar2021 14:56 (at the age of 54-year-old) as dose 2, single for covid-19 immunisation. Medical history included type 1 diabetes mellitus. Patient had no medical history (including any illness at time of vaccination). Concomitant medications included Insulin taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2, formulation: Solution for injection, Lot Number: unknown), dose 1 via an unspecified route of administration, on an unspecified date, as dose 1, single for covid-19 immunisation. The patient had no problems with all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) Covid 19 vaccine first injection. No other vaccines administered on same date with the Pfizer vaccine considered as suspect. No Prior Vaccinations (within 4 weeks) First Covid 19 injection. No AE(s) following prior vaccinations. The patient has not had the covid virus. On 04Mar2021, the patient experienced blood sugar over 300 all day, chills, body ache, fever, loss of appetite and tired. The patient underwent lab tests and procedures which included blood glucose: over 300 on 04Mar2021, body temperature: 98.9 fahrenheit on an unspecified date in 2021. The clinical course of the events as follows: She went to work on 04Mar2021 and came home with chills, body ache, fever, and her blood sugar was over 300. She stated that she checked her blood sugar 6 or 7 times, because it was over 300 all day. She also had a loss of appetite. Her husband came home and told her she was burning up. When querying information regarding her fever, she stated her normal temp runs 97.4F, and next day morning it was 98.9F with an oral thermometer. For fever, she took Ibuprofen 200mg, she took 2 tablets, a total of every 4 hours by mouth, and then she woke up and had a fever and then she took some on an unspecified day in the morning (expiration date: JUL2021). Her fever went away around noon time today 05Mar2021, everything else has pretty much gone away, now she just feels tired. No relevant tests performed. The events did not result a visit to emergency room and physician office. No Investigation Assessment was provided. She reported that everyone else she had spoken to have no problems with the vaccine. She reported that her husband also got the vaccine. The outcome of the event fever was resolved on 05Mar2021, the outcome of the events blood sugar over 300 all day, chills, body ache and loss of appetite was resolving and outcome for the event tired was not resolved at the time of this report.  No follow-up attempts are possible; no further information is expected.
I have been experiencing sexual arousal (think puberty) for a few hours; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 36-year) on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication includes Bunch of vitamins the patient received within 2 weeks of vaccination. Historical vaccine includes first dose of BNT162B2 in left arm administered on 20May2021 at 07:00 PM for COVID-19 immunization; the noticed light tingling in his head - super weird after the first dose. No allergies were reported. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. 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 received no other medications in four weeks. On an unspecified date in 2021 the patient experienced sexual arousal (think puberty) for a few hours. It was reported by the patient that "Nothing terrible, but within seconds to a few minutes after getting the first dose he noticed light tingling in his head - super weird. Also, the first 4-6 hours after the first and now second shot he has been experiencing sexual arousal (think puberty) for a few hours. Not a big deal, but interesting and he thought this info may be valuable." No treatment was received for the adverse event by the patient. The clinical outcome of the event was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Information has been received from a certified medical assistant concerning a 74 year old female patient with hypothyroidism, hypercholesterolaemia, an allergy to IV dye and drug hypersensitivity's to ACTIFED, PAXIL and LIPITOR (the reporter stated that the patient is currently on PAXIL and LIPITOR even though both are listed as allergies) who on 14-NOV-2007, was vaccinated subcutaneously with a second dose of pneumococcal 23v polysaccharide vaccine (Lot# 658673/0990U). Concomitant therapy included SYNTHROID, lorazepam, PAXIL, LIPITOR, ZANTAC, and DULCOLAX. On 15-NOV-2007, after her second dose with the vaccine, the patient developed redness and tenderness. The patient's arm was sore with a red area about the size of 4 by 8 inches. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. It was also reported that on 15-OCT-1997, the patient was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# reported as "435-954"). No product quality complaint was involved. Additional information is not expected.
headache; muscle aches; fatigue; nausea; face felt hot but no increase in body temperature; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ep7533) via an unspecified route of administration in the left arm on 07Apr2021 at 13:15 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's syndrome. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced headache, muscle aches, fatigue, nausea and face felt hot but no increase in body temperature. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache, muscle aches, fatigue, nausea and face felt hot was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
I never gt my period because I am on the depr-provera shot. However, two days after the shot I got my period and it lasted a week. No treatment was needed but this did seem to be a side-affect.
Patient states that symptoms of confusion and lack of normal hand-eye coordination began during his last shift at work.
Chills, stuffy nose, dry cough. Afebrile.  11/7/21-  ED NOTE:  She states that she fell asleep early, around 8 or 8:30 PM.  She states she woke up around 10, and her left arm felt numb and/or tingly, but this was brief, for 1 minute or less.  She states that she felt lightheaded, went to the bathroom, says she, "freaked out," and vomited.  She states she did call a friend.  No associated chest pain or palpitations with this, but she continues to feel lightheaded.  She states she did not pass out, feels she was awake the entire time.  She states that initially, at that point, she did have some flashing lights in her vision, almost like strobe lights.  She does have a history of migraines, states this was a little different than what she has experienced before with migraine aura.  She states she did not have a headache at that time, but is starting to develop a headache on the top of her head.  She states that this does not feel exactly typical for migraine for her.
11 days after injection three inches around the site has turned very warm and red. I did not have this reaction until this evening.  A day after the injection I did have a lot of muscle soreness and inability to raise arm io without a lot of discomfort. That mostly went away.
vomitting, feeling faint. We elevated patient legs and provided water, patient stayed in store about 30 minutes after vaccine
pt recv vax 945 on 5SEP95 & that afternoon devel fever, prolonged crying, local rxns @ site of inj & had trouble getting breath;
Low grade fever, around 100.4°F 24 hours post-injection. Felt lousy last night and this morning but did not measure temperature. Arm is sore at injection site, but better now than last night.
I got a low grade fever (100.9) last night (12 hours after injection) and that broke earlier this morning.
Low grade fever, headache, fatigue, balance issues, some dizziness. Started 2/28/21. Continuing as of 4/26/21
Pt developed left lower lip paresthesia that radiated to L side of face. 911 transfer recommended to which patient declined. Pt has history of TIA, Stroke, CKD, on gabapentin for facial nerve pain.
Within 24 hours patient began experiencing symptoms of recurrent ptosis which he has had in the past and previously diagnosed as myasthenia gravis . Symptoms continue and are associated with difficulty with vision and headaches
received Shingrix and Pneumococcal shot in left arm; pain in (Left) arm/pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On 4th January 2023, the patient received Shingrix and PNEUMOCOCCAL VACCINE (intramuscular). On 4th January 2023, unknown after receiving Shingrix, the patient experienced wrong technique in product usage process. In January 2023, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional Information: GSK receipt date: 05-JAN-2023 Reporters comment: The patient stated that she received Shingrix and Pneumococcal shot in left arm. She stated that she was having pain now and was concerned. Spoke per FAQ content. Referred to healthcare professional. Adverse event filed with limited information, patient did not want to provide and further information and disconnected the call. The adverse event was filed and did not consent to follow up. Additional Supportive Information: The patient Shingrix and Pneumococcal shot in left arm, which led to wrong technique in product usage process. It was unknown if the reporter considered the injection site pain to be related to Pneumococcal vaccine.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient experienced no adverse events.   This case was linked to MOD-2021-395985 (Patient Link).
site of inj rt thigh had local rxn;leg became red, swollen, & hot to touch;when child brought into clinic 5 days p/vax;site was still sl swollen & tight, hot in center;
Developed large urticaria about 12 hrs after injection - located over arms, abd, back, chest and scalp. Resolved with BENADRYL over 24-36 hrs.
Partial complex seizure (right side) assoc with fever. Thought to be a typical febrile seizure- work up pending (248 hours after immunization).
three patients received a dose of high dose fluzone which shipment was delayed for 48 hours, Three patients received the dose/No AE; Initial information received on 30-Aug-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (pharmacy other).  This case involves three patients of unknown demographics who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] which shipment was delayed for 48 hours lot number and expiry date not reported (route and site of administration not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Symptoms occurred 14hrs after second dose and lasted 12 hours: Myalgia  Fever Headache  Fatigue  *Tylenol taken 10hrs after onset of symptoms
Narrative:  COVID infection following COVID vaccine series 03/22, Pfizer,  dose #1 04/12, Pfizer, dose #2 10/27, Pfizer, dose #3 12/27 COVID swab, result:  detected 12/25 pt cc: diarrhea, sore throat, fatigue, fever, exposure: unknown  12/27 pt admit ED cc: myalgia, fatigue, sore throat, chills, headache dx: covid 19  LOS: 1 day 1/1 clinically resolved
NOT FEELING WELL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On JUN-2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling well was not reported. This report was non-serious. This case, from the same reporter is linked to 20210604721.
fever between 104 & 105; looses her balance; she ache's all over.; Chills; falling over; This is a spontaneous report from a Pfizer-sponsored program received from a contactable female consumer. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982, Pfizer COVID-19 vaccine NDC/EXP: Unknown,) in her right arm via an unspecified route of administration on 29Jan2021 10.30 (at the age of 69-years-old ) as single dose for covid-19 immunisation. Medical history included ongoing breast cancer since Feb2020. Caller said that she had breast cancer with radiation last June and July. She asks if this could be affecting her receiving her vaccine now. The patient concomitant medications were not reported. On 31Jan2021 patient experienced a fever between 104 & 105, looses her balance, she aches all over, having chills, and falling over and this has been going on for just under a week. She says she got the shot last Friday and the symptoms started Sunday (On 31Jan2021). The patient body temperature included fever between 104 & 105 fahrenheit , fever 100.4 for 4 days ,104.5 fahrenheit ,103 fahrenheit,101 fahrenheit. Caller said that her fever temperature has been 104.5 degrees Fahrenheit a couple times, and went down to 103 degrees Fahrenheit, was down to 101 degrees Fahrenheit and is back up today. Caller said she just took a couple of Tylenol 650mg UPC, Caller said she took 650mg today, that was the first she took, two 650mg.Therapeutic measures were taken as a result of fever between 104 & 105, chills and pain. The outcome of the events were unknown.
demyelinating peripheral neuropathy-both hands, both feet-misdiagnosed prev as arthritis;
Here as walk-in D/T had pneumonia vaccine Friday, 9-10-04 & IS concerned because the site was really sore until today. Now it's tender at the site. He took (2) ALEVES Friday night & Saturday nite & last night. The sheets couldn't even touch the site it was that sore. He also had a PPD skin test done in (L) FA. Area is bruised. Area on (L) arm is reddened from underneath axilla down to just above the wrist area. Not warm to touch & denies any fever. PPD- patient had a negative PPD skin test reading. No duration/raised area. Bruised only at site. Dr looked at site. Noted local reaction. Site checked by MD was that of PNEUMONIA vaccine & not PPD. Symptoms: 1. Rash
Two weeks of excruciating headaches and overwhelming fatigue. Slept most of the day. Decided to forego second shot, since it was my understanding that the reaction would be even worse.