chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nauseous; headache; dizzy; vomited on and off/was throwing up bile by 6 am; could not lay down or close my eyes; felt horrible; could not lay down or close my eyes without it getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 18:00 (Lot number: ew0153) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy: avocados and apples" (unspecified if ongoing), notes: Known allergies= Avocados and Apples. Concomitant medication(s) included: ADDERALL. Vaccination history included: Bnt162b2 (Dose: 1, Lot no: En6206, Time: 04:00 PM, Anatomical location: Left arm), when the patient was 32 years old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 08Apr2021 04:00, outcome "not recovered", described as "nauseous"; HEADACHE (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "headache"; DIZZINESS (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "dizzy"; VOMITING (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "vomited on and off/was throwing up bile by 6 am"; SLEEP DISORDER (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "could not lay down or close my eyes"; FEELING ABNORMAL (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "felt horrible"; CONDITION AGGRAVATED (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "could not lay down or close my eyes without it getting worse". The event "nauseous" was evaluated at the physician office visit and emergency room visit. The events "headache", "dizzy", "vomited on and off/was throwing up bile by 6 am", "could not lay down or close my eyes", "felt horrible" and "could not lay down or close my eyes without it getting worse" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea, headache, dizziness, vomiting, sleep disorder, feeling abnormal, condition aggravated.  Additional Information: Patient did not taken other vaccine in four weeks. Patient taken other medication in two weeks. Patient taken treatment with Ondansetron. No COVID test was done on post vaccination.   No follow-up attempts are possible. No further information is expected.
GAVE SECOND BOOSTER THE DAY THAT IT WAS UNAPPROVED BY FDA/CDC 9/1/22, SINCE AWAITING DECISION ON BIVALENT.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71-year-old patient of unknown gender. No information was received regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced Herpes Zoster. The outcome of the event was not reported. The event of Herpes Zoster was resulting from zoster vaccine live (ZOSTAVAX).
fever 101 6FEB98 AM, lack of appetite, fatigue, fussy,loose bowel twice 6FEB98;7FEB98 loose bowels x 2 little harder-urine nl;vomited 6FEB98 AM 2 to 3 times about 15min p/feeding;eyes red, watery & crusty @ corner of eyes, discharge @ nose
Filing this report due to an administration error not associated with an adverse event.  Patient received second dose earlier than the recommended 21 day timeframe.  First dose administered 2/25/21, second dose administered 3/11/21.  Patient has not had an adverse reaction and no medical treatment has been sought to date.
24/7 tingling in hands and feet creating difficulty sleeping and requiring nightly sleep aids to sleep because the tingling sensation is so strong I can't sleep without a sleep aid.  Note - I've never before required sleep aids.   Started with tingling on the edge of 1 foot at night time only.  Over the next weeks, tingling spread to both feet (heel, arch, toes) and hands and the tingling has been 24/7 for the last few weeks.   At this time, it's been over 6 weeks and is not getting any better.
Information has been received from a registered nurse (R.N.) for the pregnancy registry for GARDASIL concerning a female patient who on an unspecified date was vaccinated with the second dose of GARDASIL (Lot #, date and route not reported). It was reported that the patient received the second dose of GARDASIL just before finding out she was pregnant. The patient sought medical attention at the office. Follow up information was received from a Registered Nurse (R.N.) concerning a 16 year old white primigravida female patient with history of chickenpox, no known drug allergies and with allergy to dogs and birds, who on 24-NOV-2008 was vaccinated with the first dose of GARDASIL. On 22-JAN-2009 the patient received the second 0.5 ml dose of GARDASIL intramuscularly into the upper right arm. It was reported that the patient received the second dose of GARDASIL when she was pregnancy. Concomitant therapy on 24-NOV-2008 included a 0.5 ml dose of DTP (+) Poliovirus vaccine inactivated (+) Tetanus toxoid intramuscularly into the upper left arm. It was reported that the patient was taking contraceptives pills (unspecified). It was reported that the interval of the menstrual period was 28 days, the duration was normal and the patient had experienced cramps in the past. It was reported that on unspecified date (present pregnancy) the patient experienced cramps, headache and urinary was high frequency. The blood pressure was measured and the result was 102/58. The last menstrual period was on 12-DEC-2008 and the estimated delivery date was on 18-SEP-2008. Family history was reported, hypertension and diabetes (grand mother and grand father), multiple pregnancy (mom). Additional information has been requested.
This spontaneous report as received from a pharmacist via field representative refers to a patient of unknown age and gender. On an unknown date, at least one patient was vaccinated with ZOSTAVAX (vial), 0.63 ml only (lot, expiry date was not reported). The reporter (representative) called about a pharmacy, which was getting a volume less than 0.65 ml when withdrawing reconstituted ZOSTAVAX when reconstituted, the total volume was 0.63ml only. The entire content of the diluents was withdrawn into a syringe and the entire content of reconstituted vaccine volume was 0.63 ml. Pharmacist informed at least one patient was vaccinated. No adverse effects reproted at this time. No other information provided. The information was  forwarded for review as product quality complaint (PQC) was involved. Additional information has been requested.
flu; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social Media.  This case involves patient (unknown demography) who got flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot 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 non-serious got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Developed a fever of 102.7 approximately a week after vaccination. She was irritable and obviously felt unwell for several days.
Shingles outbreak; This case was reported by a lawyer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intravenous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles. The action taken with Shingrix was unknown. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information:The patient had Shingrix and experienced shingles outbreak.
Still today (8 months later) it is still swollen.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2021 at 13:00 as dose 2, single (Lot number: FH8030) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Colloidal cyst removal from brain, thyroid" (unspecified if ongoing); "thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (prev dose product; COVID 19,, prev dose brand; Pfizer,, prev dose brand unknown; False, prev dose lot number; FF2593, prev dose lot unknown; False,, prev dose administration date=28Nov2021, prev dose administration time; 01:00 PM,, prev dose dose number; 1,, prev dose vaccine location=Left arm), administration date: 28Nov2021, when the patient was 42-year-old, for COVID-19 immunization, reaction(s): "Then a week later my left lymph node swelled", "the injection sight swelled". The following information was reported: LYMPHADENOPATHY, outcome "not recovered", described as "Still today (8 months later) it is still swollen.". The event "still today (8 months later) it is still swollen." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy.  Report about covid treatment: Yes, Reporter type: Patient, Is pregnant: No. Most recent dose details: product: COVID 19, Brand: Pfizer, lot number: FH8030, administration date: 19Dec2021, administration time: 01:00 PM, dose number:2, vaccine location: Right arm. Previous dose details: product: COVID 19, Previous dose Brand: Pfizer, Previous dose lot number: FF2593. Previous dose administration date: 28Nov2021, Previous dose administration time: 01:00 pm, Previous dose dose number:1, if other vaccine in four weeks: No, Other medication in 2weeks: Synthroid. Adverse event: After my first injection in my left arm, the injection sight swelled. Then a week later my left lymph node swelled. Still today (8 months later) it is still swollen. Adverse event start date: 05Dec2021, Adverse event start time: 06:00 AM. Ae resulted in: [Doctor or other healthcare professional office/clinic visit]. If patient recovered: Not recovered, If treatment ae: Yes, ae treatment: Sonographic evaluation of left breast and axilla. if covid prior vaccination: Yes, if covid tested post vaccination: Yes. covid test post vaccination: covid test type post vaccination: Nasal Swab, covid test name post vaccination: (Company name), covid test date: 28Jun2022, Known allergies: No. Other medical history: Colloidal cyst removal from brain, thyroid.  No follow-up attempts are possible. No further information expected.
This spontaneous report has been received from a Medical Assistant referring to a 53 year old male patient with asthma, hypertension and rhinitis allergic. The patient's medical history was not reported and he had not any other allergies or reactions. Concomitant therapies included albuterol sulfate(VENTOLIN), lisinopril (manufacturer unknown), famotidine(PEPCID), amlodipine besylate (NORVASC) and beclomethasone dipropionate (QVAR). On 24-APR-2017, the patient was vaccinated with PNEUMOVAX23 (strength and dose were not reported) intramuscular in an unspecified arm, lot #N003997 and expiration date on 20-OCT-2018, for prevention of pneumonia. Later, on that day, the patient began to experience injection site soreness and decreased range of motion in the arm where injection was received (unspecified arm). The patient called the physician and was given treatment (details not reported) for the events. No laboratories diagnostics were performed. Subsequently, on an unknown date in April 2017, the patient recovered from the events. No further information was provided. The causal relationship between the events and the suspect therapy was not provided. Additional information has been requested.
The patient was seen at an unspecified urgent care center and treated for cellulitis; This spontaneous report was received from a physician assistant, referring to a female patient in her fifties to sixties. The patient's concurrent conditions included breast cancer in remission; her previous drug reactions or allergies, and concomitant medications were unknown by reporter.  On an unspecified date in 2019 reported as "prior to December 2019", the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (dose number was not reported; route of administration, lot number and expiration date were unknown by the reporter) as prophylaxis.  On an unspecified date in 2019 (reported as "late November or early December 2019"), the patient sought medical attention and was seen at an unspecified Urgent Care Center and was treated for cellulitis with antibiotics (unspecified). It was unknown by the reporter if laboratory diagnostics or studies were performed.  The outcome of cellulitis was unknown by the reporter.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the cellulitis was not reported.  Upon internal review, cellulitis was determined to be medically significant.
After receiving the pneumonia vaccination on 06/22/2012, I began to see swelling and discoloration in my left arm at the point of entry for the vaccination. I began to develop a head ache and slight fever. By the next morning, 06/23/2012, I had a temperature of over 100, my arm was severely swollen and discolored. I had a head ache and body ache. That afternoon I went to the Emergency Room where they stated I was having an allergic reaction to the vaccination I had received the day before, by the time I reached the hospital my temperature was 103 and my arm had gotten much bigger. I was given Bactrim as an antibiotic and also some medicine for pain. After taking the Bactrim, I had another allergic reaction to that medicine which sent me back to the ER on 06/25.
I woke up at 3 am with extreme vertigo, the room spinning, very nauseous, for the next 24 hours I could not keep anything down, I went to the ENT that afternoon and they gave me some medications. For the next 2 days I continued with extreme vertigo. I kept throwing up. For the last 12 days I still have dizziness and ear pressure, my balance is bad, I have trouble seeing, I have terrible head ache. Its almost been 3 weeks since I started having symptoms. I have never been this sick in my whole life. They did a brain MRI but it came back normal. I also saw my PCP and they gave me a 5 day prednisone pack but it did not really helped.
Severe right shoulder, neck and arm pain; Severe right shoulder, neck and arm pain; Severe right shoulder, neck and arm pain; Muscle tightness; Aches; Finger tingling; Dose 1: 07Apr2021, Dose 2: 30Sep2021; This is a spontaneous report from a contactable reporter (consumer). The reporter is the patient.   A 30 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 30Sep2021 at 12:00 (Batch/Lot number: 506780) at the age of 30 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19". Concomitant medications were not reported. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: EW0153, Anatomical site: Left Arm, Route of administration: Unspecified, Administration time: 12:00), administration date: 07Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: ARTHRALGIA (non-serious), NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), MUSCLE TIGHTNESS (non-serious), PAIN (non-serious), PARAESTHESIA (non-serious) all with onset 01Oct2021 at 06:00, outcome "not recovered", and all described as "severe right shoulder, neck and arm pain, muscle tightness, aches and finger tingling.'' The events severe right shoulder, neck and arm pain, muscle tightness, aches and finger tingling were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, neck pain, pain in extremity, muscle tightness, pain and paraesthesia.   Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were taken as a result of arthralgia, neck pain, pain in extremity, muscle tightness, pain and paraesthesia and included treatment with chiropractor, cupping and acupuncture.
Joint pain; Sore at the injection site; Low grade fever; Body aches; I was tired; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Sore at the injection site), PYREXIA (Low grade fever), MYALGIA (Body aches) and FATIGUE (I was tired) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Sore at the injection site), PYREXIA (Low grade fever), MYALGIA (Body aches) and FATIGUE (I was tired). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 200 mg. At the time of the report, ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Sore at the injection site), PYREXIA (Low grade fever), MYALGIA (Body aches) and FATIGUE (I was tired) outcome was unknown.        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 relevant concomitant medications were reported.   This case was linked to MOD-2021-303286 (Patient Link).
pt began exp shaky feeling, nausea, abd pain, lower back pain;pt seen by MD the next day & had upper resp sx: e.g. runny nose, sneezing, cough, congestion;back pain dx as pulled muscle;17DEC96 pt has lingering cold sx;
Patient should have received Tdap but received DTap.  Patient had no signs or symptoms after vaccine was given.
Vaccine recipient reported that after receiving the vaccine they developed headache and discomfort going down the right side of their neck. Vaccine recipient declined treatment. The day after the vaccine recipient experienced body aches, shortness of breath, and a low grade fever. They took Advil. They did mention that they do have lymph node swelling. During a follow-up phone call on 1/6/2021, vaccine recipient reported that symptoms have resolved. Moderna COVID- 19 Vaccine EUA.
adult patient received a pediatric dose; adult patient received a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 62-year-old female patient who received HBV (Engerix B) (batch number lp724, expiry date 18th May 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2022, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 8th July 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date :GSK receipt date: 18-Jul-2022 Reporters comment:  The medical assistant reported that the adult patient received a pediatric dose of Engerix-B as second dose. The reporter consent to follow-up. Additional Supportive information: The adult patient received a pediatric dose of Engerix-B which led to underdose and adult use of child product.
pt recv vax 10AM & 1 1/2hrs p/vax devel fever of 104,pt became cold,chills,oral cyanosis;prev recv vax w/o problems;
History of shingles in groin area in 2009. Primary MD ordered ZOSTAVAX 2011 6/6/2011 Received ZOSTAVAX injection. Experienced redness, swelling and some pain at the site the next day. 6/14/2011 Developed double vision/horizontal diplopia - worse to the right. An ophthalmologist ordered an MRI of the brain and orbits. Referred to neuro-opthalmologist for eval. Results: Negative/normal Dx: 6th cranial nerve palsy. CDC site information listed shingles as a cause of 6th nerve palsy. Wondered if the ZOSTAVAX -live virus- could have caused the double vision. Doubt that many older patients would "link" the two events or take the time of report it, but the timing of onset makes sense to me. Double vision was been extremely debilitating, since I work with computers daily. Also difficult to walk unassisted. Fear of falling. Neuro-ophthalmologist and retinologist both agree that the problem should resolve in 3-4 months. I also have ARMD - wet - both eyes - stabilized with LUCENTIS/AVASTAIN inj q 4-6 weeks.
VACCINE WAS EXPIRED ON 09 SEP 2023. ADMINISTERED TODAY 09-22-23. NO ADVERSE EVENTS REPORTED AT THIS TIME.
This spontaneous report was received from a medical assistant and refers to an unspecified number patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. No adverse reactions were reported. On an unknown dates, the unspecified patients were vaccinated with improperly stored doses of ROTATEQ lot # M007125 with an expiration date of 06-OCT-2017 and lot number reported as M0295421 with an expiration date of 14-MAR-2018 for prophylaxis (strength, dose, route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA004019: US-009507513-1701USA005953: US-009507513-1701USA005954: US-009507513-1701USA005955: