chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 14-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 29-JUN-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA002267: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
Expired Menveo administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA690A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's Comment: The nurse reported that the patient received a dose of Menveo and it was already expired.  The reporter consented to follow up. Additional Supportive Information: The use of Menveo dose, which was already expired on 31st October 2022, which led to expired vaccine used.
It took until around 7pm that same day of the vaccination for me to start getting cold chills, body aches, and a horrible sore left arm. It continued until Sunday and then part of Monday as well.
20 minutes later started to feel very ill/feeling sick; stuffiness; Retching; very unusual; weakness; muscle pain; Headache; This is a spontaneous report received from contactable physician (patient father) via Pfizer sponsored program.  A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date in Aug2021 as Dose 1, single for COVID-19 immunization. The patient was strong, good healthy and non-smoker. The patient medical history and concomitant medications were not reported. After 20 minutes of vaccination, the patient started to feel very ill/feeling sick, muscle pain, weakness, stuffiness in nose, headache, retching and very unusual on Aug2021. The patient does not have a fever and no adenopathy. The outcome of the events was unknown.  No follow-up attempts were possible; information about batch/lot number cannot be obtained.
rapid heartbeat; developed anxiety; felt like it was going to beat out of my chest; slowed down a bit; beat again in the afternoon after lunch; four hours later, tension headache started in back of my neck; heart was pounding; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS, HEART RATE INCREASED, ANXIETY, CHEST DISCOMFORT, and CHEST DISCOMFORT in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PALPITATIONS and HEADACHE. On 18-Mar-2021, the patient experienced HEART RATE INCREASED, ANXIETY, CHEST DISCOMFORT, CHEST DISCOMFORT, and HEART RATE INCREASED. At the time of the report, PALPITATIONS, HEART RATE INCREASED, ANXIETY, CHEST DISCOMFORT, CHEST DISCOMFORT, HEART RATE INCREASED, and HEADACHE had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.
Shortness of breath; Fever; Body aches; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 15Dec2021 (Lot number: FE3594) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Clear cell renal cell carcinoma" (unspecified if ongoing), notes: Clear cell renal cell carcinoma surgery and "Carcinoma excision" (unspecified if ongoing), notes: Clear cell renal cell carcinoma surgery. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0161, Anatomical location: Left arm), administration date: 10Apr2021, when the patient was 31 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: ER2613, Anatomical location: Left arm), administration date: 20Mar2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Dose received: 3"; DYSPNOEA (non-serious) with onset 16Dec2021 at 01:00, outcome "recovering", described as "Shortness of breath"; PYREXIA (non-serious) with onset 16Dec2021 at 01:00, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 16Dec2021 at 01:00, outcome "recovering", described as "Body aches". Therapeutic measures were not taken as a result of dyspnoea, pyrexia and pain.  Additional information: It was unknown whether the patient had any known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. 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 and emergency room/department or urgent care.
12 hours after vaccine: sore stiff neck on right-side; persisted for 10 days. Then swollen lymph nodes on right-side on back of neck, side of neck, behind ear and on back right-side of skull appeared. 4 days later blisters appeared on right-side in hair line.  Diagnosed with shingles a few days later (20 days after vaccine). Mild case.
pain in the arm; redness in the arm; irritation at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (irritation at site of injection), PAIN IN EXTREMITY (pain in the arm) and ERYTHEMA (redness in the arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE IRRITATION (irritation at site of injection). On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm) and ERYTHEMA (redness in the arm). At the time of the report, VACCINATION SITE IRRITATION (irritation at site of injection), PAIN IN EXTREMITY (pain in the arm) and ERYTHEMA (redness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  She had irritation at the site of injection that went away. However, 8 days later it came back.  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.; 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.
Information has been received from a RN concerning a 7 y/o male with no medical history and no allergies who in approximately April 2003, 4 to 6 weeks ago at another practice, was vaccinated with a dose of varicella virus vaccine life. There was no concomitant medication . On 27May2003 the pt was seen for his first visit in the physician's office with lesions and a papular rash that had appeared that morning. The pt was diagnosed with varicella and treated with triamcinolone cream 0.025% bid to qid as needed for itching. On 27May2003 it was reported that the pt had not recovered. It was also reported that the pt's mother might be pregnant and was probably in her first trimester. The reporter noted that the mother wondered if her son was contagious. No product quality complaint was involved. It was also noted that the pt's 8 y/o sister was vaccinated with a dose of varicella virus vaccine live and developed varicella. Additional information has been requested.
I had chills with a low-grade fever along with fatigue and muscle aches. The symptoms dissolved within 18 hours. I did not use medication, I slept it off.
vaccine date was March 2, 2021. Developed herpes zoster starting March 6, 2021
Rash across chest and neck (about three minutes after the shot, went away an hour later), fever 103.5 by 3pm that day, nausea and vomiting by 8pm, panic attacks and night sweats throughout the night and the following day. Fever wouldn?t break with Tylenol for two days. Cramping in left calf to present day.
EPILEPSY, UNSPECIFIED 10/24/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
General malaise, then sudden swelling and pain of left supraclavicular lymph node (Virchow's node).  By 10/25/2013 condition worsened to include joint pain. As of today 10/28/2013 I'm feeling better, however Virchow's node is still swollen, though without pain.
dizziness upon waking up and getting out of bed in morning past 3 days after day 7 rabies vaccination.
large red, rectangular rash at injection site, slightly raise, warm to the touch, slightly itchy, 3 inches in diameter, another less homogeneous rash splotches half an inch distal to the primary rash, the more spotty blotch began to fill out  becoming maybe 2 inches in diameter throughout in the next 2 days while the primary rash became less red. Currently three days since noticing the rash, overall surface area of the rash has grown .
Ten days after vaccination I had an allergic shellfish reaction to a frozen lobster product.  Never happened before and I've had other Lobster on the east coast before.  I also ate shrimp a few days prior to vaccination with no reaction.  I have eaten other Lobster all my life with no reaction.    My sinuses and throat closed up making it very difficult to breathe.   I didn't know what was happening so I took decongestants and antihistamines then went to the doctor and got injected with a steroid immune suppressor.  I now have epinephrine just in case it happens again.
Patient states had reaction to vaccination: Chills, Aches, Neck pain, balance issues, headache; Patient took acetaminophen and went to bed. Felt better the next day.
Persistent headache and abd discomfort; also had temp of 102.6; went to ER initially on 12/4 and then Hospital on 12/5/2015.
Had flu like symptoms for 24 hours about 12 hours after I received my 2nd shot. I had a fever, the chills, muscle soreness through out my body. This lasted for about 24 hours as I feel fine now.
Hurts underneath her arm pit, that area underneath her arm where she got her injection; Kind of swollen and it hurts; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0186), via an unspecified route of administration, administered in Arm on 20May2021 as dose number unknown, single for covid-19 immunization. Medical history included lot of allergies. The patient concomitant medications were not reported. On 21May2021, the patient experienced hurts underneath her arm pit, that area underneath her arm where she got her injection and it's kind of swollen and it hurts. The patient did not receive any treatment for the events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Pt experienced varicella lesions subsequent to receiving one dose of varicella virus vaccine live. Follow up states patient recovered on an unspecified date. No further information is available.
This spontaneous report was received from Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored PNEUMOVAX 23 (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe loud continuous ringing (tinittus) in both ears. Unusually high blood pressure.
See attached notes dates 11/1/2011 pages 1 & 2 per doctor. Patient presents with flu like symptoms of achiness and tachycardia associated with right ear pressure and a sensation of decreased hearing on the right. She a a MMR and Tdap on 10/28/2011. She states that she had a dT in 2008 and an MMR also in 2008. She received immunizations for an immigration physical. She also has a tender left deltoid area where both immunizations were injected. She denies any fever, cough, abdominal pain, or diarrhea. She denies a headache.
Tingling from site of shot down arm.  Tightness around wrist.  Tingling and heaviness up left side of neck and face.  Abated some but heaviness remains around left eye (especially between brow area and eye) and left side of head.  Also feels warm in that area.  I am worried some but just keeping an eye on it at home.  Called my doctor?s office and nurse said go to pharmacy tomorrow and report it to them.  I am concerned about getting the follow up shot.
Her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Her arm was sore) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047T21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced MYALGIA (Her arm was sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Her arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported.   This case was linked to MOD-2021-261610 (Patient Link).
mensural bleeding; Bleeding with the clump; one side clump; soreness on the arm; This is a spontaneous report from a contactable nurse (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administrated in Deltoid Left on 19Aug2021 (age at the time of vaccination 58-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, via an unspecified route of administration on 07July2021 (age at the time of vaccination 58-years-old), as a single dose for COVID-19 immunization and patient experienced mensural bleeding; Bleeding with the clump; one side clump. On an unspecified date, the patient experienced mensural bleeding; Bleeding with the clump; one side clump; and soreness on the arm. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Pfizer covid 19 vaccine lot # FJ6369 administered beyond use date of 03/25/2022,  administered on 04/01/2022
patient stated that he had some arm pain which started to get better after Tylenol, nausea / vomiting , dizziness, and chills
Chief Complaint: Patient presents with Altered Mental Status per EMS, pt coming from nursing care facility for AMS, pt is A&Ox1-2 at this time, pt is not eating and lethargic. HPI. Patient is a 64-year-old female presenting to our ED via EMS from her ECF with chief complaint of altered mental status.  Patient has a past medical history significant for multiple myeloma in remission, CHF with preserved ejection fraction, CKD, seizure disorder on Keppra, hypertension, hyperlipidemia, CVA.  Patient has a mentation baseline of A&Ox2 per EMS report.  Patient was recently admitted to hospital for unknown etiology. Review of Systems. Review of systems is limited due to patient's dementia, developmental delay, altered mental status and/or inability to communicate.
Gastric issues; Headache; No energy; Pain in the eyes, eye lashes, eye brows; Sensation that the wall is moving away/previously able to watch TV for a long time, but now after 5 minutes it looked like it was rotating; Vomiting; Not being able to sleep; This is a spontaneous report from a contactable consumer (patient's son).  A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiration date: Unknown), via an unspecified route, administered in Right Arm on 27Jan2021 09:30 AM (at an age of 70-year-old during vaccination) as a 1st dose, single for COVID-19 immunization. The patient's medical history included hand pain, Diabetes, Sleep disorder, Iron deficiency, Blood pressure abnormal and blood thinner condition. The patient's family history was reported as none. The patient concomitant medication included metformin taken for diabetes from a long time and ongoing, paracetamol (ACETAMINOPHEN) taken orally for hand pain from two or three months and ongoing, lisinopril taken orally for blood pressure abnormal from a long time and ongoing, acetylsalicylic acid (ASPIRIN) taken for a long time and ongoing, atorvastatin taken for blood thinner from a long time and ongoing, cyanocobalamin (VITAMIN B 12) from a long time and ongoing, ropinirole taken for sleep disorder from a long time and ongoing, ferrous sulfate taken for iron deficiency from an unspecified start date and ongoing; insulin detemir (LEVEMIR) injected to his stomach at night daily for diabetes mellitus from a long time and ongoing. The patient was vaccinated at hospital not on other facility. The patient had not received any additional vaccines administered on same date of COVID-19 vaccine. The patient had not received any other vaccine with 4 weeks prior to COVID-19 vaccine. On 28Jan2021, the patient was not being able to sleep since the day of the vaccine. After one day (29Jan2021) he noticed gastric problems/gastric issues, headache on the top of his head, and no energy. His gastric problem gets better in the day and worse at night. He had been vomiting a lot after eating. Also complained of pain in the eyes, eye lashes, eyebrows, and the sensation that the wall was moving away. Added he was previously able to watch TV for a long time, but now after 5 minutes it looked like it was rotating. The patient was scheduled to get the next dose of the vaccine 18Feb2021. The reporter called on behalf of his father and mentioned that his father was diabetic, and he had some questions about his medicine. He wanted to know if the symptoms of his father had after getting the vaccine are related to the vaccine or to his usual medications and what was needed to be done. The patient was neither visited physician office nor emergency room. The patient had not undergone any relevant test and investigation assessments. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information was expected.
Severe Pain at injection site - right arm bicep area. Severe Pain in arm pit (lymph node) at 7:00 PM. Low grade fever at 8:00 PM. Aching joints and muscles at 8:00 PM. Light sensitivity at 8:00 PM. Muscle pain in tricep area on day two. Hot red rash in tricep area on day three.
On 4/6/2021, Vaccination administered in error to an individual under the age of 18 (age 17 years and 5 months at time of administration).  Upon identification of error, both patient and parent notified.  Patient experienced injection site pain within 12 hours of administration.  At 24hrs post-administration she experienced headache, fatigue, decreased appetite and mild nausea, and body aches.  At 30 hours post vaccination her symptoms were improved.  Symptoms resolved at 48hrs post-vaccination.
Dtap and Hepatitis A vaccine given at 2:20 p.m. on 03-01-07.  At 3:00 p.m. pt. Mom to clerical window stating child sweating and face red.  R.N. evaluated pt. and noted redness on face, back.  No SOB noted.  Instructed Mom to have child lie down for 10-15 mins. No improvement after lying down.  Pt. referred for evaluation.
Symptoms since vaccine: tachycardia; tremors, tics, headache, fever, chest pain, body aches; pain in left and right shoulders; icy back and back of arms; constant pain in left butt cheek; bulbous feeling in throat; severe fatigue; coughing; dry mouth; stomach pain  Symptoms seem to be moving through body, whereas, one symptom goes away and another one comes forward.
Approximately 3 weeks after 1st Moderna COVID-19 vaccine, patient began experiencing pain and swelling below right knee.  Patient was diagnosed 10 days later with DVT and prescribed anticoagulant therapy.  Patient received 2nd dose of Moderna vaccine after the onset of pain and swelling, but before being diagnosed with DVT.
COVID break through felt like a cold and last for about 5 days. Then the after effect, fatigue, in ability to think, no motivation and could complete a task. I couldn't keep a train of thought going. I made a lot of mistakes at work.
Extreme chills/shaking from 2:00 am till noon the next day Fever of 99.4 from noon 1/15 till 3:00 pm 1/15 Sore throat, headache, joint pain in elbows, knees and lower back from  2:00 am 1/14 till 11:00 pm 1/15 Nausea from 2:00 am till 9:00 am 1/16