chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of DEATH (she passed away) and BRAIN NEOPLASM (Brain Tumor) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (she passed away) (seriousness criteria death and medically significant) and BRAIN NEOPLASM (Brain Tumor) (seriousness criterion medically significant). The patient died on 10-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, BRAIN NEOPLASM (Brain Tumor) outcome was unknown. Concomitant medications were not reported. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This is a spontaneous case reported by a consumer. A female patient of an unknown age, with no reported medical history, died after receiving second dose of mRNA-1273 vaccine. Within weeks of her second vaccine, she started not acting right, she got sick so fast and then passed away on 10-Sep-2021. It was also reported that within days of her getting the second vaccine, she was falling down. In addition, patient was diagnosed with a brain tumor on an unknown date. Vaccination date was not provided, latency cannot be assessed. The cause of death was not reported. It is unknown if an autopsy was performed. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case reported by a consumer. A female patient of an unknown age, with no reported medical history, died after receiving second dose of mRNA-1273 vaccine. Within weeks of her second vaccine, she started not acting right, she got sick so fast and then passed away on 10-Sep-2021. It was also reported that within days of her getting the second vaccine, she was falling down. In addition, patient was diagnosed with a brain tumor on an unknown date. Vaccination date was not provided, latency cannot be assessed. The cause of death was not reported. It is unknown if an autopsy was performed. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Unknown cause of death.
My entire back from the shoulder blades down broke out with pustules and a rash. My skin began cracking and flaking off later. It started to dissipate after a month or so then I had the second injection and it flared back up again. The second injection was in July 2018. I still have some of this on my back.  I reported it to the pharmacy where I had the vaccination and was told it could not possibly be from the vaccination. My dr looked at it and was not sure but "thought" it might it pityrias. My symptoms are lasting much longer than that disease calls for.
Information has been received from a registered nurse concerning a female with obesity and no drug reactions/allergies who was vaccinated with GARDASIL vaccine, 0.5 milliliter intramuscular, in May and in July of 2008.  In September 2008, the patient experienced bilateral numbness in her arms.  The patient sought medical attention in office.  Additional information has been requested. This is in follow-up to report (s) previously submittedon 11/14/2008. Medical records had been received indicated a female was vaccinated with the first (lot # 659964/1978U), the second (lot # 660553/0070X), left deltoid) and the third  (lot # 661766/0652X), right deltoid dose of GARDASIL on 05-May-2009, 30-Jun-2008 (13:10) and 03-Nov-2008 (09:08) respectively. The patient had eye problems/visual problems and wore glasses. The patient's health was good and had a past medical history of deafness. The patient had a history of unspecified surgery or had been a patient in a hospital. The patient had childhood immunization.The patient took precautions against sexually transmitted infections. The patient's first menstrual period was 12 year old and had heavy periods/cramps. The patient had one pregnancy when she was 22 year old also reported as the patient had one ectopic pregnancy and one miscarriage. The patient had used pill, condoms, sterlization, suppository/film, natural family planning (rythm) and withdrawl birth control methods in the past. Concomitant therapy included green tea and herbal for energy. The patient's blood pressure was 98/34 on 13-Sep-2008. On 10-Sep-2008 the patient complained of bilateral numbness in upper to mid-lower arms though she displayed good dexterity with testing ability of both hands. The patient denied tingling in both hands. The patient thought numbness was due to GARDASIL injection given on 05-May-2008 and 10-Jun-2008. The physician suggested the patient go to urgent care if numbness persisted or increased. The patient returned on 11-Jun-2008 for the third dose of GARDASIL and indicated that her arm was "sore" not numb. No further informatin is available. The VAERS # is 334035.
oozing at site, it was like an open wound; bump at injection site larger than usual; bruising at injection site; pregnant patient vaccinated with Adacel; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA260880 (same reported).  This case involves a 29 years old female patient who experienced oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported events occurred at unknown gestation period. The date of last menstrual period was not reported but reported as 27 weeks ago. The estimated due date is 04-Dec-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Sep-2019, the patient received a 0.5 mL first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5602AA, expiry date:19-Mar-2021 via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising)  (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of vaccine exposure during pregnancy.  Other relevant tests were not reported.  Final diagnosis was oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising).  It was not reported if the patient received a corrective treatment.  The outcome of the events was not reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  List of documents held by sender: none.
Initial report received on 11 January 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one case in series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 9 month old, female subject was identified by the investigator based on review of data from the Agency. The subject's vaccine history included 3 doses of PENTACEL: lot number C3496AA received on 25 January 2010, lot number C3555AA received on 01 April 2010, and lot number C3608A received on 07 June 2010 (route and site of administration not reported). Approximately 3 months after the last dose, on 03 September 2010, the subject developed a cough. Two days later, the subject developed a paroxysmal cough. The subject also experienced posttussive vomiting, cold-like symptoms and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 09 September 2010. Corrective treatment consisted of AZITHROMYCIN for 5 days starting on 10 September 2010. At the time of final contact on 04 November 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 35 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. Documents held by sender: None
infection in his liver; there was a spike in the blood work; This is a spontaneous report received from a contactable nurse and a consumer.  A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation; axitinib (INLYTA, Film-coated tablet, expiration date: 31Jul2023) orally from Feb2021 to an unspecified date at 5 mg cycle (two times a day on days 1-21 of every 21 day) for advanced renal cell carcinoma. Medical history included high blood pressure. No known drug allergies. Concomitant medications were not reported. The patient went to his chemo doctor and he's having an infection in his liver so right now they want him to stop it for now until he has an appointment. There was a spike in the blood work, but he did have his COVID shot. So, there's a possibility it's from that. Action taken in response to the events for axitinib was unknown. Outcome of the events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: The patient had underlying advanced renal cell carcinoma, and was recently on treatment with axitinib (INLYTA).  Based on information available, the reported liver infection with blood test abnormal were possibly due to co-suspect INLYTA, and unlikely causally related to the vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The 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 Regulatory Authorities, Ethics committees and Investigators, as appropriate.
the patient has been given second bivalent booster vaccine, one in October 2022 and one in January 2023 . patient didnt report side effects
Developed numbness and tingling in right upper extremity on 3/13/21. Was seen in the ER on 3/14/21, they thought it could have been an electrolyte imbalance so they checked bloodwork, but it was normal. Then over the course of several days, the numbness and tingling spread to left upper extremity and bilateral lower extremities. Developed difficulty with fine motor coordination in both hands as well as difficulty walking. Was seen by PCP who ordered more labs including inflammatory markers and vitamin D and B12 levels. Inflammatory markers were normal. Vitamin D and B 12 levels were mildly low, but not enough to cause symptoms. Was then referred to a neurologist. Had an MRI of brain and cervical spine to rule out stroke or MS, was normal except for a mild bulging disc at C5-C6. The symptoms of numbness, tingling, difficult fine motor coordination of hands/fingers, and trouble walking resolved on it's own after  2 weeks. Then for several weeks after that, there was noticeably more muscle twitches in all four extremities which have since resolved.
Anaphylactic shock 20 minutes after injection. Had EpiPen with her and went to ER for treatment.
Pharmacist reported that a 35 year old patient was administered a dose of PROQUAD at another facility.; No additional AEs/no PQCs.; This spontaneous report was received from a pharmacist referring to a 35-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection for prophylaxis (1 dosage form, strength, lot #, expiration date and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse events (AEs) were reported (no adverse event).
Headache and body aches relieved with Advil .  Histamine release at injection site.  Hard and red.  Hypopigmentation
Patient reported mild headache after ~10 minutes after vaccine administration, and lip numbness ~15   minutes after vaccine administration. Vitals 167/52, O298%, HR 67. Patient was evaluated by Dr. ~20   minutes after administration and monitored for 45 minutes. Headache and lip numbness resolved during   observation period. Patient remained well appearing throughout. Reviewed s/sx anaphylaxis, advised her to  call 911 if these occur at all today.
Returned to vaccine administrator approximately 15 minutes after receiving vaccine complaining of feeling flushed, rapid heartrate and chest congestion
burning in hands; painful hands; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: BURNING SENSATION (non-serious) with onset Feb2021, outcome "not recovered", described as "burning in hands"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "not recovered", described as "painful hands".  Additional information: Patient was received other medications Advil, muscle relaxer within 2 weeks of vaccination. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Administration time was reported 03:00 PM.COVID-19 vaccine was administered at other facility.Prior to vaccination, was not the patient diagnosed with COVID-19. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021563745 Same reporter/drug/event, different patient.
cold sore forming in nose; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold sores in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13-MAR-2023, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced cold sores (Verbatim: cold sore forming in nose). The outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingles vaccine.     It was unknown if the company considered the cold sores to be related to Shingles vaccine.   Additional Information: GSK receipt date:16-MAR-2023 The reporter enquired that did Lysine 1000 milligram effect the effectiveness of the Shingles vaccine. The patient had cold sore formed on his/her nose as a result of getting the vaccine on Monday.
Edema, warm to touch, redness, mild discomfort at injection site with swollen lymph node axilla  area of left  arm.  No treatment at this time.
Immunocompromised; tested positive for SARs-Cov-2; tested positive for SARs-Cov-2; This is a spontaneous report from a contactable pharmacist. A 6-decade-old (reported as 50s) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose, and then received the second dose in Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller on behalf of patient in ED.  Frontline medical worker received the second dose of vaccine twelve days before in Jan2021. Patient was tested positive for SARs-Cov-2. Immunocompromised.  Questioning the administration of Bamlanivimab. Potential AE. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  Immunocompromised is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient complains of fever, chills, aggravated asthma, nausea, diarrhea, and "pain in her bones". Reports feeling very sick. Reports this has happened 10 years ago after a flu shot, but this information was not given during vaccine questionnaire.
Information has been received from a physician concerning a 14 year old female who in June 2007, was vaccinated in the arm with GARDASIL (Lot # not available). It was reported that the patient also was vaccinated with varicella virus vaccine live at the same time in the same arm. In June 2007, the patient developed a red swollen area around the injection site. Subsequently, the patient recovered from the red swollen area around the injection site. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Patient stated his arm was swollen and warm and painful to the touch. He had fever of 102F for 2 weeks along with headaches that were sensitive to noise and light. He stated he also suffered severe hip and lower back pain for about 5 days after receiving the vaccine. Patient stated he did not seek medical treatment and used OTC pain relievers to treat. This was his second dose and he did not have any issues with the first dose.
3/31/2021 -  Nausea 4/01/2021 -   Fatigue, stood up after nap and fell with                                injuries 4/03/2021 -   Lymph Node Left Arm enlarged to size of                                 Golf Ball 4/04/2021 -   Left Arm very noticeably swollen with rash                                 on both fore-arms 4/05/2021 -   Loss of Appetite (not loss of taste or smell) 4/06/2021 -   Lymph Node swelling now size of lemon+ 4/09/2021 -   Dr visit:  Stat Ultrasound:  no blood clots.                                Started on Antibiotic CEFDINIR 300mg 4/10/2021 -   Still reduced appetite, arm swelling the same
vasovagal syncope s/p immunization and PPD skin test placement, pt regained consciousness 10-20 seconds after skin test placed.  Pt evaluated by physician and released 20 mins after syncope.
After about 3 hours of having taken the vaccine, my face started to swallow. I took allergy medicine (cetirizine hydrochloride tablets, 10mg/antihistamine) and got much better. After about 24 hours my face was back to normal. The reaction, treatment and recovery was very similar to what happens when I take aspirin, ibuprofen, or metamizole.
Raised, red, warm and itching at the injection site starting on 1-6-2021. No treatment 1-7-2021 same symptoms other than a little less itching
Approx 15 min after injection in R deltoid, patient noted "tightening", pain, swelling and hypersensitivity of the muscles and soft tissues of the L upper anterior chest wall. She described the swelling as approximately the size of her palm. No unusual rxn at injection site. No pulmonary, cardiac or systemic sx. Sx continued to increase for about 12 hours, but by the next morning had subsided by about 75%. At 4 days post-incident, sx resolved by about 95%. It is interesting to note that vaccine administrators at this facility who are very familiar with the anthrax vaccine, have noted a significant increase in adverse reactions to this particular lot of vaccine in other patients including 1 anaphylactic reaction.
Swelling at injection site within 12 hours. Weakness within 12 hours. Insomnia. No treatment.
Pt rec'd 2 mo. imms - approx 10 min after admin pt developed rash (mild) on thighs, bends of arms, trunk, nape of neck.
Pt was due for COVID #3 in the primary series, however received the bivalent booster for #3 instead of the monovalent primary series.
The pt's lab results revealed a negative varicella antibody titer. The pt sought unspecified medical attention. Additional information has been requested.
Severe Lower back pain; Electric shock kind of feeling in limbs worse in legs and calves; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 28Apr2021 at 12:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid (hypothyroidism), generalized anxiety disorder (GAD) and sulfonamide allergy. Concomitant medications included levothyroxine (LEVOTHYROXINE), sertraline (SERTRALINE), biotin (BIOTIN) and MG. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, the patient experienced severe Lower back pain and electric shock kind of feeling in limbs which was worse in the legs and calves. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event Severe Lower back pain was not recovered/not resolved/ongoing. The clinical outcome of the events severe back pain and electric shock kind of feeling in limbs which was worse in the legs and calves was not resolved at the time of this report   No follow-up attempts are needed; information about lot number cannot be obtained.
Redness, edema, warmth at injection site 1 day following injection.  Pt. called to report s/s but didn't want to come to clinic to be seen.  Being tx with Zithromax for another condition.
Found unconscious/ hospital MD/ hospital MA/ 7 months physical therapy/ from dioplast/ wheel chair/ never got balance back/ walk with walker/ lives in semi-care facility.