chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE/; A vaccine coordinator called to report an AE where improperly stored dose of  were administered to a patient; This spontaneous report has been received from a vaccine coordinator regarding 18-month-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 21-OCT-2022, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) injection, lot # W023937 confirmed to be valid with expiration date 06-DEC-2023 (exact dose, route of administration, and anatomical location were not reported), for prophylaxis.  On an unknown date, before administration, the vaccine underwent a temperature excursion of 33.6 degrees Fahrenheit (F) for 3 hours and 46.9 degrees Fahrenheit (F) for 1 hour and 48 minutes (product storage error). On an unspecified dates, there were previous temperature excursions reported as follows: 34.3 degrees Fahrenheit for 48 minutes, 34.3 degrees Fahrenheit for 1 hour and 42 minutes, 34.9 degrees Fahrenheit for 1 hour 18 minutes, and 34.3 degrees Fahrenheit for 1 hour and 18 minutes. No adverse effects were reported. No additional information was provided to further clarify these details.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: Lisinopril; Hydrochlorothiazide. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 1 day after the suspect product(s) administration, outcome "unknown" and all described as "Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the available reported information, the causal association between the event drug ineffective and Covid-19 and the suspect drug BNT162B2 cannot be excluded.
Fever, body aches, vomiting, 8cmx7cm red rash at site; not indurated or painful.
Patient felt dizzy after getting the shot. As he walked to the  chair and fell down  as he was about the sit on the chair.  He got up and sat on the chair with help of his Dad. He also got sweaty and pale. After he sat for a while and got some water he said he felt better. He waited for  30 minutes and felt better and went home.
This case was reported by a lawyer and described the occurrence of swelling and pain in the joints in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced swelling and pain in her joints, muscle pain, headaches, flu-like symptoms, rashes, tingling in extremities. Raynaud's phenomenon, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. On 14 September 1999 and 15 October 1999, the subject received the first and second doses of LYMERIX. At the time of her first vaccination she reported that she had recently been bitten by a tick or other insect, and was placed on prophylactic doxycycline. The subject received the third dose of LYMERIX on 14 September 2000. On 03 October 2000, she reported her arm hurt at the injection site. On 06 September 2001, she was diagnosed with acute flexor tenosynovitis, right index finger. On 12 September 2001 she was evaluated for possible Lyme disease, with right hand lump and soreness. Impression included possible tendonitis versus arthritis of the second right metacarpal phalangeal joint. A Lyme titer was positive on an unspecified date. On unspecified dates, she developed memory loss, blurred vision, dry eyes, swelling of the feet and hands, and joint complaints. She was seen by an orthopaedist between 18 September 2001 and 03 June 2004, for wrist pain and swelling/polyarthralgia of the wrists, flexor tenosynovitis of the right finger, and flare-ups of dactylitis in both hands. Assessment included probable rheumatoid arthritis. Treatment included CELEBREX. According to a patient summary, subsequent to receiving LYMERIX she developed an "extremely sore shoulder after the shot", tendonitis of the right hand, body aches (knee, feet, elbow, and shoulder), left and right had swelling, suspected clinical rheumatoid arthritis, and general body aches. Medications included NAPROXEN and MOTRIN. The event of probable rheumatoid arthritis was assessed to be medically significant by GSK.
Having trouble going to the restroom; have been constipated for last 3-4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Mar2021 (Lot number: ER8733) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN HYDROCHLORIDE; AMLODIPINE. The following information was reported: CONSTIPATION (non-serious) with onset Mar2021, outcome "unknown", described as "Having trouble going to the restroom; have been constipated for last 3-4 days". Therapeutic measures were taken as a result of constipation.  Additional information: The patient took over the counter laxative magnesium citrate as treatment of the event.   No follow-up attempts are possible. No further information is expected.
Pregnant and due January 19, 2022, so far no effect on pregnancy. Adverse effect was bed ridden exhaustion for three days. Lethargy. Hard to walk or move.
I went to my doctor and had blood work and found an AA problem. During that visit, my blood pressure was very high. I was told to monitor my blood pressure and everyday my blood pressure was very high 194/97. Then I was prescribed blood pressure medication. I have never had high blood pressure before. The blood pressure medication is starting to improve my blood pressure readings.
Felt pricked by shoulder and has a scab there now; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age (Age: 65; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I felt pricked by shoulder and has a scab there now, could this happen due to the vaccine? The site which she received her vaccine is rescheduling people for after 21 days. The patient felt two pricks. She got a scab on her shoulder. She thinks he accidently poked her. The patient stated, "If the person that gave the vaccination pricked her shoulder before the shot could it have caused a little irritation on her shoulder? Whenever the man gave the shot, she wasn't looking at him, but he told her to hold her sleeve up. She was just trying to hold her sleeve up. He pushed his sleeve way up on her shoulder. She felt it way up on her shoulder, and thought it was strange. He squeezed her arm, and said he thought there would be good. She felt two pricks. She got a scab on her shoulder. She thinks he accidently poked her. He tried to say he thought he poked himself, but she is pretty sure he poked her. He gave the shot in her arm. He thought he had pricked himself but pricked her. Her question is, if that happens and the needle pricks the surface of the skin, can it make it blister the skin? Her main reason for calling is that she is signed up to get the second round. Now, the city she lives in is having trouble getting the vaccine. People that were supposed to get the first vaccine Monday and Tuesday had to be pushed to Wednesday because they didn't get their shipment. So now everyone will get them on Wednesday. The day she went it was very organized so she feels bad for these people. Since Pfizer is having trouble getting this shipped, then what is going to happen on 5 Feb 2021 which is the day she is supposed to get her second dose. What will happen if they don't have vaccines?". She would just like her questions answered. Her brother said he heard somewhere the vaccine doesn't have to be given at exactly 21 days like they originally said. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
RASH PRURITIC. Information has been received from a registered nurse concerning a 34-year old white female with no allergies or medical history who on 26-SEP-1988 (also reported as 27-SEP-1998) was vaccinated with a second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 2044N) (reported as a multidose vial). There was no illness at the time of vaccination. On 26-AUG-1998 (also reported as 26-AUG-1998) the patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (lot #2044N). On 27-SEP-1988, about seven hours following the second vaccination, the patient experienced a sunburn-like rash that was itchy. It was noted that a third dose of hepatitis B virus vaccine rHBsAg (yeast) was never administered. Unspecified medical attention was sought. The patient subsequently recovered on 27-SEP-1988. A product quality complaint was not involved. No further information is expected.
patient received first dose.  Left the consultation room and fainted within a few minutes.  Emergency personell were called and patient taken to the ER.  Patient given fluids and sent home follow up with family stated patient fine.
pt recvd vax & approx 530AM, awoke feeling nauseated & vomited once; exp immed onset of joint pain, burning of shoulders, hips, wrists, ankles & back, & bone pain in arms & legs; few days later also exp weakness in arms & legs;
2" circular of redness, swelling, itching, painful to (L) deltoid to injection site 24 hrs after influenza vaccine administration.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. On 19-AUG-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date reported as H021941 and 11-JUL-2014 respectively), intramuscularly. No concomitant therapy was reported. On 20-AUG-2013, the patient came back into the office to report the adverse event. Approximately on an unknown date in August 2013, the patient experienced a large raised rash near the bottom of the muscle, near the elbow which was very painful after receiving the PNEUMOVAX23. The patient sought an unspecified medical attention. It was unspecified if any treatment was provided or if any lab tests were performed. The patient was not recovered from the events. The medical assistant was requesting a lot check for the PNEUMOVAX23. The relatedness for the events was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
Sevrve Rash under right knee started approximately 5 hours after shot.  Applied deximethasone ointment  to affected area it helped
Unable to get out of bed.  Intense tiredness.  Slept for 36 hours.  When awoke could not walk.  Taken by ambulance to hospital.  Admitted to hospital for 5 days.  Then spent 4 weeks in Rehab learning to walk again.
01May96 Pt recv 1 dose vax. 16Jan98 Pt devel lesions all over body lasting 3 days.
Had Hep A vaccine--became dizzy and was lowered to the ground. BP 80/50, color pale.  Color returned quickly, BP 110/70 twenty minutes later
Pfizer 5/21 and 6/11. Positive on 12/13
started feeling dizzy/lightheaded ever since/have continued to feel dizzy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (started feeling dizzy/lightheaded ever since/have continued to feel dizzy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (started feeling dizzy/lightheaded ever since/have continued to feel dizzy). At the time of the report, DIZZINESS (started feeling dizzy/lightheaded ever since/have continued to feel dizzy) had not resolved.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported  No treatment medications were reported
swollen lymph nodes; headache; her face and lips are also swollen in the right side and her ear aches; her face and lips are also swollen in the right side and her ear aches; her face and lips are also swollen in the right side and her ear aches; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose of the Pfizer-BioNTech COVID-19 Vaccine on the 25th on her left arm and after 2 days on an unspecified date, the patient had swollen lymph nodes and terrible headache on the right side of her head, her face and lips were also swollen in the right side and her ear ached. She asked if these were caused by the vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
after recv vax pt 4 days later devel rash compatible to varicella, temp 102
10 minutes after immunizations, mom in patient room states "he's having problems." Visible hives and swelling, good air exchange on auscultation. Unable to get O2 saturation because of patient movement. 0930 given 15mg diphenhydramine (Benadryl) PO; 911 called. To ED about 1048 and discharged at 1245.
Client was vaccinated with MMR and Varicella vaccines at around 16 weeks pregnant. Estimated date is 03/02/2024. No complications currently in this pregnancy as reported by patient.
After 30 seconds of immunization, pt. complained from dizziness, stomach pain and nausea. Then, she had slurred speech, her heart rate was about 80 but blood pressure was 80/46. I called 911, and asked the patient to lie down raising her legs. Checking BP every minute and readings was 90/61, 92/66, 99/70 then EMS showed up. It took about 15 minutes until patient fully recovered and she was able to walk. She also was anxious from the shot, however she had to have it for school. Called patient after 4 hours at 10:23 PM and she was fine and has no issues or complaints.
Pneumonia of unknown origin after thorough testing within 2 week hospital stay. Patient never had history of past pneumonia.
Dizziness' upon returning  from shot , constipated, shingles like blisters itching left upper inside of thigh had brownish blotches, head itches a lot.
pt started crying the same noc w/fever;pt was better for 2 days & then started crying which went on & on;fever came 4 days from shot;pt was put on med;CBC abn;chem 7 nl;no VS;abd nl;ESR was high;CXR & abd x-ray negative;bone scan nl;
Case number PHEH2015US003393, is an initial spontaneous report from a pharmacist received on 16 Feb 2015 and with a follow up report received on 24 Mar 2015. This report refers to a 21-year-old male patient. Historical conditions were not reported. Concomitant medication included BOOSTRIX. He was administered only MenCYW-135 liquid component of MENVEO (batch number: X13064) without being reconstituted with Men A, intramuscularly on 14 Feb 2015. No adverse event was reported following the administration error (inappropriate preparation of medication). Follow up report received on 24 Mar 2015: Added concomitant medication BOOSTRIX and narrative was updated.
patient received expired vaccine MENACTRA with no reported adverse event; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (Reference number- 00735391).  This case involves a patient of (unknown demographics) who was administered expired vaccine MENINGOCOCCAL A-C-Y-W135 VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event 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 the Directive. 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.  There will be no information available on the batch number for this case.
Development of Severe eczema in left arm - near injection site, ears, face, neck, collar bone; significant degradation of life quality; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 at 13:00 as dose 2, single (Lot number: FG3527) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS(Polycystic ovarian syndrome)" (unspecified if ongoing), notes: PCOS; "Eczema" (unspecified if ongoing), notes: I had only had minor eczema when I was a kid. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single; Batch/Lot No: FF2589; Location of injection: Arm Left; Vaccine Administration Time: 07:00 PM), administration date: 01Oct2021, when the patient was 36-year-old, for COVID-19 Immunization. The following information was reported: ECZEMA (non-serious) with onset 15Nov2021 at 14:30, outcome "not recovered", described as "Development of Severe eczema in left arm - near injection site, ears, face, neck, collar bone"; QUALITY OF LIFE DECREASED (non-serious) with onset 15Nov2021 at 14:30, outcome "not recovered", described as "significant degradation of life quality". The events "development of severe eczema in left arm - near injection site, ears, face, neck, collar bone" and "significant degradation of life quality" required physician office visit. Therapeutic measures were taken as a result of eczema, quality of life decreased.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19, prior to vaccination and the patient has been tested for COVID-19, post the vaccination. Patient developed with severe eczema in left arm - near injection site, ears, face, neck, collar bone with significant degradation of life quality. Prior to the vaccine patient had only had minor eczema when she was a kid. She was 36 at vaccine application. Her dad and aunt had a similar reaction to the vaccine, also like me, 2 weeks after application. Averse Event resulted in doctor or other healthcare professional office/clinic visit. Patient was treated with steroid and anti-histaminic.
Fever/Seizure. Febrile seizure- evaluated at hospital 4/8/09.
Patient is a 81 y.o. female patient of MD with history of atrial fibrillation, hypertension, diabetes, hypothyroidism altered mentation presented to Hospital with  .   Hypoxemic respiratory failure.(Patient states she is on 2 L oxygen at home.) Covid-19 Virus Infection Date of onset of symptoms: Unknown Symptoms present on admission: Yes hypoxemia on 4 L oxygen. Date of covid positive test: 9/16/23 Vaccination status: Unknown- possibly Moderna x2 with last in 2021 Imaging: Chest x-ray 9/16 suspect very mild patchy infiltrate within the lower lungs. Oxygen requirements on admission: Yes 4 L Current oxygen requirements:2L NC Medical therapy: steroids- day 7, remdesivir- finished 5 day course 9/21 Consultants following: ID Anticipated special isolation end date: Unknown Patient with improvement in her respiratory status continue remdesivir and steroids Wean O2 as able-sounds like per nursing discussion with family patient was previously on 4 L nasal cannula for history of COPD but facility had been able to wean off oxygen. Finished Rocephin course    UTI Patient with dysuria  Urinalysis showing gram-negative bacilli?greater than 100,000 and E. coli which was pan susceptible Repeat UA ordered by ID. Nursing aware of need to collect Continue Rocephin per discussion with ID- completed course    Metabolic encephalopathy Patient awake, alert and oriented x3but with persistent hallucinations. Per nursing, during her discussion with family they mentioned that she gets hallucinations with UTIs.  Unknown baseline. CT head no acute abnormalities. Monitor. Atrial fibrillation Continue metoprolol, Eliquis as per home regimen. EKG per ED documentation sinus rhythm heart rate 62, abnormal ST-T segments and T waves. Troponin 35, 30. With negative delta    Diabetes On metformin at home Hold and initiate SSI.   Hypertension Continue metoprolol and losartan.   Hypothyroidism Resume levothyroxine.   Hypokalemia -resolved   GERD Pepcid   Patient seen and examined on day of discharge in full PPE.  Stable on 2 L nasal cannula.  States she has been having less pain with urination.  No fevers overnight.  Has finished off course of Rocephin.  Has patient off course of remdesivir.  Suspect white blood cell count likely in the setting of steroid use given no fevers, hypotension or tachycardia. Stable for discharge back to SNF on 2L NC
Arm pain started 1/26/10 opposite arm vaccine given in - Pain continued ER visit 1/28/10 - shingles but no lesions - started on NAPROSYN 1/28/10 Lesions started Sat ZOVIRAX and TYLENOL with Codeine called in 1/30/10