chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning a 37 year old female who on 20-DEC-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot # 667271/0680Z). On an unspecified date the patient experienced redness, swelling, warmth at the injection site (on the arm) and "rash" at the injection site. At the time of the report, the patient's status was unknown. The patient sought medical attention by office visit. The physician was not comfortable using the remaining doses of PNEUMOVAX 23. The reporter requested a lot check. A lot check has been initiated. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from a health worker concerning a 37 year old female patient with diabetes and of hepatitis C who on 20-DEC-2010 was vaccinated intramuscularly in the right deltoid with a 0.5 mL with PNEUMOVAX 23 (lot # 667271/0680Z). On 20-DEC-2010, on the evening of PNEUMOVAX 23 the patient experienced swelling at the injection site with associated redness, increased warmth and tenderness. No acute illness was reported at the time of vaccination. The patient sought medical attention by office visit. On December of 2010 the patient had recovered. No further information is available.
My daughter is now 22 months. I noticed a knot the day after her immunizations in her leg. It eventually went down some. It's approx. 4 months later and there is a marble sized knot on her upper thigh. She says it hurts when we apply pressure to it.
feels dizzy; bad soreness and pain at the injection site, specially at night; she cannot sleep; feels heavy; feels tight on top of where the injection site is; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (bad soreness and pain at the injection site, specially at night), INSOMNIA (she cannot sleep), HEADACHE (feels heavy), SKIN TIGHTNESS (feels tight on top of where the injection site is) and DIZZINESS (feels dizzy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Feb-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 26-Feb-2021, the patient experienced INJECTION SITE PAIN (bad soreness and pain at the injection site, specially at night), INSOMNIA (she cannot sleep), HEADACHE (feels heavy) and SKIN TIGHTNESS (feels tight on top of where the injection site is). On an unknown date, the patient experienced DIZZINESS (feels dizzy). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (bad soreness and pain at the injection site, specially at night), INSOMNIA (she cannot sleep), HEADACHE (feels heavy), SKIN TIGHTNESS (feels tight on top of where the injection site is) and DIZZINESS (feels dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
t104.5 due to DTP shot; cry steady for over 3 hrs; very upset for 2 days a/2 days p/crying spell; DT shot given @ 6 months & 18 months w/no problems;
Following receipt of primary patient 5/2006, patient endorsed recurrent episodes of brief mild dizziness, tinnitus, migraine headaches, and diplopia, non-medically attended.  In 3/2007 he had recurrent dizziness and tinnitus which occurred during a respiratory infection and became more pronounced and constant from that time on.  In Jun 2007 patient was diagnosed with dysautonomia.  Dizziness start: 05/30/2006.  Tinnitus start: 05/30/2006.  Headache, Migraine start: 05/30/2006.  Diplopia start: 05/30/2006.
5 Weeks Post-Vaccination Titer Did Not Reflect Adequate Immunity; Initial Report Received on 18-Oct-2021  A pharmacist reported that a female patient of unspecified age (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and her titer did not reflect adequate immunity.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient was reported to have completed the HEPLISAV-B series (Lot #, expiration date and NDC # not reported), route and site not specified.  Approximately 5 weeks after vaccination with HEPLISAV-B, the patient received a titer. Her titer did not reflect adequate immunity.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
pain in her larynx; numbness, like a "Novocain feeling" in her neck and jaw; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: EP7534, Expiration Date: Jul2021) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LARYNGEAL PAIN (non-serious) with onset 30Mar2021, outcome "recovering", described as "pain in her larynx"; HYPOAESTHESIA (non-serious) with onset 30Mar2021, outcome "recovering", described as "numbness, like a "Novocain feeling" in her neck and jaw". Therapeutic measures were taken as a result of laryngeal pain, hypoaesthesia.  Additional information: Patient was given Diphenhydramine (BENADRYL) and that BENADRYL helped. The patient said she was feeling better when she left. Event pain in her larynx was assessed as related to BNt162B2.  No follow-up attempts are possible. No further information is expected.
Had 1st complex partial seizure within 2 hours of vaccination.  5 days after vaccination had an EEG that was normal but continued to have seizures.  12 days past vaccination was admitted to hospital for 48 hour Video EEG.  Has now been prescribed anti-epileptic medication to control complex partial seizures.  Not yet under control as of todays date. Follow-up: Patient is still having daily seizures a year later. Up to 10/day.
This spontaneous report was received from a registered nurse concerning a female patient with an unspecified age, pertinent medical history or drug reaction / allergies. On 28-SEP-2009, the patient was vaccinated with the first dose of GARDASIL and on 10-APR-2012, the patient was vaccinated with the second dose of GARDASIL. On 01-NOV-2012, the patient was vaccinated with the third dose of GARDASIL lot # 666596/0766Z, exp date 15-OCT-2012, (dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. There was no adverse effect reported. The patient's outcome was unknown. The events were not related to GARDASIL. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to the multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported.     On an unknown dates, the unspecified multiple patients were vaccinated with a dose of RECOMBIVAX HB lot number: M037248, expiration date: 21-FEB-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 degrees Fahrenheit (35.2 degrees Fahrenheit) for 1 hour and 50 minutes. The previous temperature excursion was reported as 32 to 35 degrees Fahrenheit (35.4 degrees Fahrenheit) for 55 minutes and 47 to 77 degrees Fahrenheit (48.2 degrees Fahrenheit) for 40 minutes. Data logger was involved. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA015098: US-009507513-1704USA015099:
Patient had dermatological event/dermatitis to chest, left arm, shoulder and neck areas.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-AUG-2013, a pharmacist at a pharmacy administered ZOSTAVAX. The patient was inoculated with ZOSTAVAX to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # were not provided).  On or about 17-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events were unknown.  Causality assessment was related. Additional information has been requested.
Booster dose; High Heart rate; Fatigue; achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FG3527) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Caller states that she had all 3 doses on her Left arm., states that it might be R19265 or E19265), administration date: 04Feb2021, when the patient was 73 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "Booster dose"; HEART RATE INCREASED (non-serious) with onset 15Nov2021, outcome "recovered" (Nov2021), described as "High Heart rate"; FATIGUE (non-serious) with onset 15Nov2021, outcome "recovered" (Nov2021), described as "Fatigue"; PAIN (non-serious) with onset 15Nov2021, outcome "recovered" (Nov2021), described as "achy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states that she wanted to report side effects after the Pfizer Vaccine, she confirms it is the Pfizer covid vaccine. After the vaccine she had a high heart rate, she was achy and fatigued. This was after the booster and after the second dose.  After getting the booster she had a high heart rate and was achy and fatigued, it all happened on the same day but later in the day. The high heart rate, achy and fatigue subsided a couple days later. No allergies were reported.  Follow-up attempts are completed. No further information is expected.
Pt  developed chest pain , shortness of breath 2 days after initial COVID-19 vaccination he was admitted to Hospital with myopericarditis
pt recv vax 29JUL98 & 30JUL98 pt hand broke out in itchy welts which spread to neck & trunk;tx w/DPH;
Pt with swollen, warm to touch knot-benadryl q 6 hrs, Motrin or Tylenol-report in 24-48 hrs now pt is doing.
Incorrect route resulting in lower than authorized dose administered inadvertent subcutaneous administration of Jynneos 0.1ml when intradermal route was intended.   A second dose via intradermal route of 0.1ml was administered
5cm by 3cm tender erythema. No induration or blanches at injection site.
flu; Initial information received on 24-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who experienced flu (influenza), after receiving INFLUENZA VACCINE.  Past vaccinations included INFLUENZA VACCINE from which the patient got flu..  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  There will be no information available on the batch number for this case.
patient developed severe allergic reaction few minutes after receiving the vaccine, had severe redness and trouble breathing. patient was given one dose of Epi-pen 0.3mg  subcutaneously. patient started to feel better, redness was gone, started to breath well. 911 was called but patient declined the request to go to hospital , said there is no need as she started to feel well.
cough, fever, sinus issues, congestion, upset stomach, diarrhea.        Patient denies loss of smell, loss of taste. started 11/24/2021
Received shot around 12:30pm on 12/29/20, started feeling very fatigued and signs of body aches and chills around 8pm that night. Body aches and chills continued through the whole night. Tried taking Tylenol to help with the pain but did not work very well. Switched to ibuprofen and seems to be helping more with the body aches and chills for now.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 27-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Pt reports Aura in Left eye without Migraine pain  daily since vaccine. States the aura started peripherally and then moved medial
Pt had a well child check and was given immunizations on 9/28/20. He had no fever or other complaints post vaccination. The morning after Pt was given immunizations, he was found unresponsive, "shaking". Was admitted at Hosp where he continued to have Sz-like activity and abnormal EEG so he was  transferred to another hospital.  Despite aggressive anti-epileptic treatment, he  continued with seizures for a few days. MRI of brain on 10/1/20 showed progression of hypoperfusion state indicative of hypoxic ischemic event or status epilepticus. .  After a family meeting on 10/9, Pt's grandmother elected compassionate extubation and he expired on 10/12.
This spontaneous report as received from a physician via company representative refers to a 15 year old male patient. On 28-JUL-2014 the patient was vaccinated with PROQUAD (route, dosage, dose no. and lot no. unknown). It was reported that the patient received PROQUAD instead of VARIVAX. No adverse effect was reported. Additional information has been requested.
Child was seen in office 7/18/18 for rash, mother reports rash all over started 7/17/18. Immunizations were received same day in clinic. Questioning reaction to MMR per MD, BENADRYL prescribed
Case number PHEH2015US023692, is an initial spontaneous report received from a nurse on 11 Nov 2015. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient received FLUVIRIN (batch number: not reported) subcutaneously on 11 Nov 2015. No adverse event was reported.
Patient reported at 1210 with hx of allergy to PCN (reaction hives), cephalosporins. Patient reported flushed, L side of face warm, 0 dizziness, 0 lightheadedness, 0 CP, 0 SOB, PMH-0. Hx of feeling warm with injections. Water was provided to patient, snack was as well but declined. VS initially were 173/104, 102, 98% Sp02, R 16 unlabored. Repeated after water and assessment at 135/90. Patient left at 1226.
pt recv vax;some pain at inject site;2 hrs later devel pain lt arm,lt hand,lt shoulder & neck;pt exp periodic numbness;
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 15-JUN-2017, the patient was vaccinated with an expired dose of VAQTA, lot number M031695  with expiration date 28-MAY-2017 (dose, route, and anatomical location were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Prodrome of headache, fever, chills. Pleuritic chest pain. Hospitalized for 10 days after smallpox vaccination. ST elevation. Echo normal. CKMB elev 5.3. Troponin I elevated 0.97. CBC, BMP, sed rate all normal.
Dry cough; Sore throat; Stomach started to hurt; Kidney started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN UPPER (Stomach started to hurt), RENAL PAIN (Kidney started to hurt) and COUGH (Dry cough) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Bypass surgery (Triple bypass patient).    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN UPPER (Stomach started to hurt) and RENAL PAIN (Kidney started to hurt). On 10-May-2021, the patient experienced COUGH (Dry cough). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 09-May-2021, OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN UPPER (Stomach started to hurt) and RENAL PAIN (Kidney started to hurt) had resolved. At the time of the report, COUGH (Dry cough) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported  Treatment using tylenol( acetaminophen) to help relieve side effects was reported   This case was linked to MOD21-089343 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: The patient was not interested in providing additional details and disconnected the call.; Sender's Comments:  MOD21-089343:cross linked id - wife case
This is a spontaneous report from a contactable nurse. A 47-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date (received at 47-years-old) as single dose for COVID-19 immunization. The patient medical history included rheumatoid arthritis. It was unknown if patient was pregnant. Concomitant medications were not reported. The patient experienced increase in Rheumatoid arthritis pain due to being off medication for covid vaccine. She stated that MD (doctor) is aware and she was told to take aleve. Outcome of the event was not recovered.   Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information provided, the event "increase in Rheumatoid arthritis pain due to being off medication for covid vaccine" is likely to be an intercurrent event unrelated to the use of suspect product bnt162b2 (BNT162B2) in this 47-year-old female patient with underlying rheumatoid arthritis. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
No additional AE; Nurse calling to report adverse event for a dose of PROQUAD that was given in error.  Nurse reported that the patient received the PROQUAD dose in error when they were supposed to be administered the MenACWY meningococcal vaccine.  Nurse stated that; Nurse calling to report adverse event for a dose of PROQUAD that was given in error.  Nurse reported that the patient received the PROQUAD dose in error when they were supposed to be administered the MenACWY meningococcal vaccine.  Nurse stated that; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient received a third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). However, this third dose was administered in error as they were supposed to be administered meningococcal vaccine a/c/y/w conj (tet tox) (MENACWY TT).  The nurse stated that the patient involved did not report any adverse reaction or symptoms related to this vaccine administration error. The reporter reported that the patient involved had previously completed their series of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administration and this dose was the third the patient had received.
Headache, Myalgia & Fever Narrative:  Missed work following second dose due to symptoms  Other Relevant History:
Approximately 50 min. after receiving a varicella and Hepatitis B vaccine patient c/o throat tightening and increased Ht. rate. Instructed to go immediately to Emergency Dept.
Legs felt so heavy; Dizziness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Legs felt so heavy), DIZZINESS (Dizziness) and VOMITING (vomiting) 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 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced LIMB DISCOMFORT (Legs felt so heavy), DIZZINESS (Dizziness) and VOMITING (vomiting). At the time of the report, LIMB DISCOMFORT (Legs felt so heavy), DIZZINESS (Dizziness) and VOMITING (vomiting) 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.   Treatment information was not provided.