chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt had sl fever night of 3MAR92; parent did not take temp; 4MAR92 @ 4PM rash devel to all extremities; red sore to touch w/blisters; no fever @ this time; 5MAR92 blisters scabbed over;
Shingles outbreak approx 2 week after first vaccine dose, otherwise healthy, no history of shingles since chickenpox as child. Diagnosed by PCP via telehealth visit who stated I was second shingles outbreak seen recently and she believed it may have been triggered by the vaccine. No other significant stressors or changes identified as possible contributing factors. Doctor was asked if it should be reported as possible adverse event to vaccine and told yes. Prescribed valacyclovir, outbreak relatively minor and largely resolved around 10 days after start.
This case was reported by a healthcare professional via a sales representative and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On unspecified dates the subject received 3 doses of Engerix B vaccine (unknown).  At an unspecified time after vaccination with Engerix B, the subject reported she did not seroconvert.  At the time of reporting the outcome of the event was unspecified.
Went to urgent care 4-5-2021. Doctor said I have shingles on my right side of my head. Doctor told me to report it sinice I have had 2 vaccine shots.
Vaccine administered with exp date 24 Oct 21; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered with exp date 24 Oct 21) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered with exp date 24 Oct 21). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Vaccine administered with exp date 24 Oct 21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter No treatment information provided by the reporter
Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-JAN-2013, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a healthcare provider. On an unspecified date, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Member had smallpox vaccine on 9/13/04 in left deltoid. On 9/21 (day 8) member developed fever, chills, myalgias and marked increase in redness at vaccine administration site. Denies cough, runny nose, N, V, D, or other symptoms. Member went to ER and was hospitalized and given IV fluids and IV Cipro and Rocephin overnight. Next morning, both antibiotics and IV fluids were stopped and member was sent home. Myalgias resolved by next morning with reduction in temperature and by 48 hours, temperature was normal and member felt fine. Now on day 11, member is well with good eschar for mention at site and resolution of most of redness and soreness at site. Most likely normal vaccine response.  Nurse follow up on 10/13/04 states: "headache, cramping/spasms of the L arm, inflamed throat, coryza-rhinitis, tenderness in ears, and rales."
NO ADVERSE REACTION- ERROR Patient was vaccinated with 0.27ml diluted vaccine and 0.03ml undiluted vaccine
Stiff injection arm; stiff neck; Chills; This is a spontaneous case from a contactable consumer.   A 66-years-old female patient received first dose of bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: EL9265), via an unspecified route of administration, administered in Left arm on 10Feb2021 08:30 at a single dose for covid-19 immunisation. Medical history included ulcerative colitis and known allergies: Seasonal hayfever. Concomitant medication included balsalazide, cyanocobalamin (B12-VITAMIIN) and calcium, ergocalciferol (calcium plus D). No covid tested post vaccination. No covid prior vaccination. The patient experienced stiff injection arm, stiff neck and chills on 11Feb2021 at 03:00 AM. No treatment was given for the events. No other vaccine in four weeks. The outcome of the events was recovered on an unspecified date 2021.  Follow-up attempts completed. No further information expected.
Patient was given a second covid bivalent booster when there is no literature at this time for a second bivalent booster
pt exp body aches,diarrhea,inflamed reddened area 3"-all around arm;itching-lump @ site;ice,ibuprofen,DPH
uncomfortable with site of injection; site of injection swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (uncomfortable with site of injection) and VACCINATION SITE SWELLING (site of injection swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (uncomfortable with site of injection) and VACCINATION SITE SWELLING (site of injection swollen). At the time of the report, VACCINATION SITE REACTION (uncomfortable with site of injection) and VACCINATION SITE SWELLING (site of injection swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Information has been received from a female patient of unknown age referring to herself. Pertinent medical history and drug reactions/allergies were not reported. Approximately in 2012 (reported as about 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) to treat shingles (product use issue). Concomitant drug was not reported. It was reported that the patient experienced burning and itching in her scalp and developed lumps under her arms while on ZOSTAVAX (in approximately 2012). On an unknown date, the patient had been seen by her physician. The outcome of the events "burning and itching in her scalp as well as lumps under her arms" was reported as recovering. The causality of the events "burning and itching in her scalp as well as lumps under her arms" with ZOSTAVAX was not reported. Additional information has been requested.
Fluzone HD was given to a 21 month old baby/No AE; Fluzone HD was given to a 21 month old baby/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21 months old male patient who received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines administered.   On 02-Oct-2019, the patient received 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Frequency = once) lot UJ249AA, expiry-30-04-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  Documents held by sender: none.
Throbbing ache in upper arm began within a few hours, and gradually went away over the next couple days.  By the morning after vaccination, ache in right shoulder and weakness in right arm. Weakness and increasing pain with motion at the right shoulder. Shoulder pain and weakness lasted for about a month. Aching returns intermittently in the 8 months since. Joint pain--particularly in the right hand but systemically as well--starting within a week of vaccination. Occurs at least once a day for the 8 month since. Hand cramps at joints. Pain is sometimes sharp, sometimes dull during occurrences. General fatigue and rapid onset of fatigue from exertion. Began about 2 weeks after vaccination. Not a constant state of fatigue, but a general decrease in ability to sustain exertion, increase in recovery time (both immediately following activity and time to total recovery). Fainting. Once on June 20th, 2022 (about 2 weeks after vaccination). Twice in rapid succession on January 3, 2023. May or may not be related to vaccine. These are the only fainting episodes I've ever had though, and the first time was not long after vaccination.
Fever, extreme fussiness, intensified gas, stuffy nose, increased sleepiness.
Started period about 1 week early. Started with spotting then was very heavy. Period is extremely regular so this was abnormal for me.
hives @ inj site-sore to touch;h/a Monday hs 3NOV97 stomach ache;pt in office 5NOV97;MD dx swelling pink hives x5 (1-2cm x 1/2cm @ inj site);
high bp; high bp and temp; Lungs/rib cage felt tight in certain position; felt more pain in joints; felt more pain in joints and flu like; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6206) via an unspecified route of administration in the left arm on 25Mar2021 at 13:00 (at the age of 80-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure (bp), allergy (es) and fibromyalgia (FM) which was ongoing. Concomitant medications included tramadol (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN), both for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021, started during night, lungs/rib cage felt tight in certain position, next morning on 03Apr2021, the patient experienced high bp (blood pressure) and temp (temperature). On an unknown date in 2021, previous during week, the patient felt more pain in joints and flu like, but having FM (fibromyalgia), the patient thought that was the cause. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events lungs/rib cage felt tight in certain position, high bp (blood pressure) and temp (temperature), felt more pain in joints and flu like were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Two days after getting shot, patient noticed a rash spreading from her bicep off from where the shot was administered. Patient noticed there was potential bleeding, but it came from an area different from where she received vaccination. Patient states it was not painful and there was no itching, that rash has stopped spreading.
Redness; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On 15th April 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient was experiencing redness and swelling at the injection site in size of 2 inches in diameter. No further details were provided.
After 2 weeks of getting my Pfizer shot I had extremely swollen gums; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported) via an unspecified route of administration, on an unspecified date, as UNKNOWN, SINGLE for covid-19 immunization . The patient medical history was not reported. The patient's concomitant medications were not reported.  On an unspecified date, after 2 weeks of getting Pfizer shot, the patient had extremely swollen gums. After almost more than 2 months they are better because patient using top quality toothpaste for gums as a therapeutic measure, but they are still there. The patient would like to know someone other also having this issue. Outcome of the event is was recovering at the time of the report.  Information on the lot/batch number has been requested
Extreme fatigue; Left arm swelling that was the size of a baseball and it hurt/itched; Left arm swelling that was the size of a baseball and it hurt/itched; Left arm swelling that was the size of a baseball and it hurt/itched; Whole body aches for three days after injection; Left upper rib pain that felt like was getting stabbed every time breathed in deep; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Sep2021 at 18:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) for an unknown indication and unspecified birth control medication, both from an unknown date and unknown if ongoing. On 11Sep2021 at 20:00, the patient experienced extreme fatigue, left arm swelling that was the size of a baseball and it hurt/itched, whole body aches for three days after injection and left upper rib pain that felt like patient was getting stabbed every time she breathed in deep. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event whole body aches was resolved on 13Sep2021, while that of events extreme fatigue, left arm swelling that was the size of a baseball and it hurt/itched and left upper rib pain that felt like patient was getting stabbed every time she breathed in deep were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Headache, body aches, congestion began at night on 06/01/2022 and continued.  Went to clinic on 06/03/2022
Days 2-5 fever, nausea, aches Days 8-11 fever, diarrhea, stomach pain Day 10 - vomiting. Day 14 - hives all over body
The patients presented to me 4 days after receiving the vaccine with a red strip along her pant line on her back that spanned the entire distance from left hip to right hip. It was not raised. It was about 1-2 inches from top to bottom and was not raised. It appeared just like a sun burn.
Lots of sleep; Mild fatigue/ exhaustion; Headache; Causing joint pain; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 08:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included ankylosing spondylitis. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sulfasalazine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 13:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 30Apr2021 at 12:00, 7 days after receiving second dose, the patient experienced mild fatigue, headache which continued through day 8, Symptoms increased on day 9 and 10 causing joint pain, exhaustion, and lots of sleep. The patient also reported that it seems odd to have side effects 1 week later. Since the vaccination, the patient had not been tested for COVID-19. 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 outcomes of events mild fatigue, headache, joint pain, exhaustion and lots of sleep were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt stated that it hurt a little when I inserted the needle then started to get sore later in the day and increased in soreness and now unable to use the arm it is to sore following the date shot is given.
Patient was with Medical Examiner.  She was reviewing his allergies (PCN, bee stings) and discussed with patient need to wait 30 minutes after vaccine for observation.  She then gave him pfizer vaccine.  Within 1 minute of giving vaccine, patient began to have seizure.  He was assisted to ground by MD and RNs at vaccination site.  He was assessed and assisted to remain safe throughout seizure, 911 called and arrived on scene.  Meanwhile, caregiver with patient stated seizures are "normal" for him and he has 4-5 a day.  She reported that in line he was not feeling well and had precursors to seizure.  Patient had reported to MD that he felt fine today and did not report seizure history to her previous to giving vaccine.  It was also later reported that he had a seizure the night before as well.   IVF were started by RN's.   When emergency services arrived, patient was recovering and refusing to go to ER - against medical advice.  He was assisted back into wheelchair by emergency services personnel.  Patient was alert, and oriented and able to make decision not to go to emergency room.  Patient left facility with caregiver in private vehicle.  Patient was instructed to contact his primary care physician and let them know what happened and ask if 2nd dose of pfizer is appropriate for him.  Patient was also instructed if MD wants him to get 2nd dose to go to a more controlled setting then Mass vaccination site.
Really severe reaction; High fever; Fatigue; Achy all over; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Really severe reaction), PYREXIA (High fever), FATIGUE (Fatigue) and MYALGIA (Achy all over) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020 and Clot blood (Patient was hospitalized for 7 days (discharged on 02Nov2020) because of a blood clot in the lung.). Concurrent medical conditions included Neurological disorder NOS (neurological ones, as she said COVID affected her spine and has problems with coordination).    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION COMPLICATION (Really severe reaction), PYREXIA (High fever), FATIGUE (Fatigue) and MYALGIA (Achy all over). On 17-May-2021, VACCINATION COMPLICATION (Really severe reaction), PYREXIA (High fever), FATIGUE (Fatigue) and MYALGIA (Achy all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.  Patient felt like having covid again.   This case was linked to MOD-2021-335178 (Patient Link).
Has loose stools; Feels like he has the flu; He woke up, he is fatigued; Been throwing up for about 3 hours; Has a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Has loose stools), INFLUENZA LIKE ILLNESS (Feels like he has the flu), FATIGUE (He woke up, he is fatigued), VOMITING (Been throwing up for about 3 hours) and HEADACHE (Has a bad headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced DIARRHOEA (Has loose stools), INFLUENZA LIKE ILLNESS (Feels like he has the flu), FATIGUE (He woke up, he is fatigued), VOMITING (Been throwing up for about 3 hours) and HEADACHE (Has a bad headache). On 09-Jan-2021, VOMITING (Been throwing up for about 3 hours) had resolved. At the time of the report, DIARRHOEA (Has loose stools), INFLUENZA LIKE ILLNESS (Feels like he has the flu), FATIGUE (He woke up, he is fatigued) and HEADACHE (Has a bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient has reported having an issue with fainting with vaccines in the past and patient requested to be given immunization while sitting on the floor. Patient was given a cold compress for his wrists before the vaccine was given.   Approximately 1 minute post vaccine, patient reported feeling dizziness and feeling warm.  Patient was given a cold compress for the back of the neck and the wrists.   Patient did not lose consciousness but did report dizziness.  Patient was able to hold conversation and reported feeling better after about 5 minutes.  Patient was monitored for an additional 15 minutes and reported feeling normal before he left.
No symptom repot. Vaccine expired on 5-1-17. Vaccine given 5-16-17; will repeat dose 6/30/17.
patient received influenza vaccine with a pediatric sized needle. patient was advised to seek an additional influenza vaccine IM
1 minute seizure - at home - when ambulance arrived - postictal - Temp 100.7 degrees at ER, CT Head=NL, observed in ER, TYLENOL and D/C home.
Patient found deceased at home on 2/15/2021. There was no known cause of death with no significant medical history.