chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 6 month old patient who was vaccinated on 30-NOV-2022 with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023, orally (PO). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
Patient was given a dose of vaccine and had symptoms while waiting. About 5 minutes after vaccination, he experienced weakness, nausea, sweatting, and vomiting. His blood pressure was 105/65 with pulse 60. He was evaluated by paramedics and released.
This spontaneous report was received from a nurse practitioner via company representative, refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL, (dosage, route, lot # and expiration date were not reported). Concomitant therapy was not reported. The nurse practitioner reported that the patient was vaccinated in other facility, however during an office visit reported that on an unknown date she experienced alopecia. The outcome of alopecia was unknown. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning a 66 year old female patient with blood cholesterol abnormal, diabetes mellitus and hypertension. The patient had no known allergies (NKA). On 28-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # N022704, expiration date: 27-FEB-2019, for prophylaxis (dose # and route of administration were unknown). Concomitant medications were not reported. On an unspecified date in 2017, the patient experienced "pain in the arm all the way to her neck" along with "swelling and redness in the arm". The patient was taking acetaminophen (TYLENOL) for the pain, and was also recommended by the pharmacisto to take ibuprofen (MOTRIN). At the time of reporting, the patient had not recovered from the adverse events. The causality assessment between the adverse events and PNEUMOVAX 23 was not provided.
No adverse advent to report.  Patient was unaware that he was not to receive another vaccine 14 days post receiving Moderna Covid vaccine.
pt recv vax SEP95 & 14JUN97 pt exp chickenpox w/30 lesions;
I?m hurting  from head to toe. I also have developed sore throat (sometimes) w/ a runny nose & fatigue as well. I?m very tired from fatigue. The head to toe body pain hurts & the headache is awful. It hurts bad. My head & body (all my muscles & joints) hurt the worst. I started having side effects about 36 hours after receiving the vaccine. It?s about 2 weeks later & they seem to just keep getting worse.
Child presented to our office on 07/11/2003 with erythemous area over medial aspect of left arm.  No other symptoms expressed by mother.
Pt was supposed to receive 2nd dose of pfizer covid-19 vaccine. However, pt received moderna covid-19.
Approximately 24 hours after injection developed a 3X3 in area of redness about an inch away from injection site.  It was warm to the touch and painful.  I also had tenderness in my left breast and left ribcage.  Was seen at an urgent care center on 11/23 and was put on bactrim and prednisone for cellulitis.  The doc first called it hives until I explained it did not itch.  The area is less red now and only mildly tender.
Patient recived Covid bivalent vaccine by error  as a second dose instead of monovalent vaccine.No adverse reaction noted.
Within 24 hours after vaccine patient observed that right arm near YF-Vax injection site became red and swollen and that the area became itchy, especially in the sun. She also reported nickel- or quarter-sized bruise near YF-Vax injection site. Seven days after vaccine, injection site was still red and slightly swollen and bruise was starting to fade. Patient also noted some nausea during the past week which she states may or may not be due to the vaccine.
Syncope and tonic clonic seizure within 1 to 2 minutes after vaccination, self resolved within 40 to 60 seconds.  Transferred to ER.  10/29/09 Medical records recieved for DOS 10/26-10/27. DX: Syncope, possible seizure.  Child had syncope with pissible seizure s/p vaccine in PMD office. Apparent Tonic-clonic of 40 seconds. Stiff leg movements. Post-ictal appearing after. Had not eaten in prep for lab work.  PE  in ED WNL.  Cheerful and talkative.  Discharged to home.
Patient administered Herpes Zoster Vaccine.  After administration it was discovered that a previous dose had been administered 3 years prior. No adverse events currently noted.
Caller has a patient that received a covid-19 vaccine and then 3-4 days later was diagnosed with Covid; Caller has a patient that received a covid-19 vaccine and then 3-4 days later was diagnosed with Covid; This is a spontaneous report from a contactable physician. A 5-decade-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Caller has a patient that received a covid-19 vaccine and then 3-4 days later was diagnosed with Covid. Patient has made a full recovery and the caller would like to know what the guidance was for receiving the 2nd vaccine in series. The patient underwent lab tests and procedures which included COVID-19 virus test: diagnosed with Covid on an unspecified date. The outcome of events was recovered on an unspecified date.  Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and drug ineffective due to temporal relationship.  This case will be reassessed once additional information is available.
Patient received Janssen vaccine on 3/31/2021.  Patient had complaints of sharp pain on right side of head starting 1 week after receiving the vaccine.  Patient went to doctor 3 weeks after receiving the vaccine with complaints of frequent sharp pain on right side of head.  He was then prescribed blood pressure medication.  MRI was performed and the patient was told everything was fine.  He visited the pharmacy today on 6/2/2021 and explained to employees that he is still having sharp pains on the right side of his head but they are less frequent.
fever; Headache; muscle pain; joint pain; injection site pain; swollen lymph nodes in my left arm pit; tiredness; Indigestion; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: ER2613) via an unspecified route of administration on the left arm on 20Mar2021 at 07:30 AM (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. The patient was allergic to dye in cat scan. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) 100 mg, lansoprazole (MANUFACTURER UNKNOWN) 30mg since unknown date and unknown if ongoing. The patient had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: 6198) via an unspecified route of administration on the left arm on 27Feb2021  as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 3:00, the patient experienced fever, headache, muscle pain, joint pain, injection site pain, swollen lymph nodes, indigestion and tiredness. The patient had not received treatment for the reported events. The clinical outcome of fever, headache, muscle pain, joint pain, injection site pain, swollen lymph nodes, indigestion and tiredness were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever; Soreness in the muscles of the left upper arm; Covid arm; Tenderness in the left upper arm; Lethargic; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash), PYREXIA (Fever) and MYALGIA (Soreness in the muscles of the left upper arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash), PYREXIA (Fever) and MYALGIA (Soreness in the muscles of the left upper arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication included topical spray of all natural mint and eucalyptus and anti-allergic medications to alleviate the symptoms.  It was reported that patient was supposed to take second dose on 26-SEP-2021.
Migraine- worse I ever had, with shooting pain on the left side of my neck up to base of skull on the same sideI received the shot in my shoulder
The pt experienced pain, erythema, chills, fever with axillary pain and tenderness at the lymph nodes and swelling at the site.
She had scaly rash all over her neck for 4 or 5 months; Severe allergies; They were not sure if her throat would close; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TALWIN [PENTAZOCINE]. The following information was reported: EXFOLIATIVE RASH (non-serious), outcome "unknown", described as "She had scaly rash all over her neck for 4 or 5 months"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Severe allergies"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "They were not sure if her throat would close".  Additional information: This patient called for asking if any ingredient of the Pfizer COVID-19 Vaccine was left in the body that might interact with Talwin. Reporter stated that she had severe allergies with the first dose of the Pfizer COVID-19 Vaccine. Patient had 2 shots and 2 boosters. On her 1st shot, patient had to go to the allergy department for 4 hours because they were not sure if her throat would close up and also stated that she had scaly rash all over her neck for 4 or 5 months. Patient reported that the vaccine was new to her since her last vaccine was from when she was 8 years old. She threw her back out and in pain and wanted to know if she can take Talwin. She had seen 3 pharmacists who told her to call Pfizer. Patient wanted to speak to an allergy department to help her what to do and wanted to know how the Pfizer COVID-19 Vaccine works and if it can affect Talwin or related medications. Patient stated that she feels like everyone's in the dark about it and it happened so fast. Other Conditions and investigations reported as not Provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
headache; weakness; dizziness; sleepy; This is a spontaneous report from a contactable consumer. This consumer reported that, an 89-Year-old male patient that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated her father who received the first dose of the Pfizer covid vaccine and on an unspecified date (yesterday) he was experiencing headache, weakness, dizziness, sleepy. He was given Tylenol. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.  Follow-up (03Apr2021): Follow-up activities closed no further information expected
Pt presented to ED 1/16/22 for flu-like symptoms, worsening weakness and dizziness.  - ED workup significant for fever T-max 101°, HR 148, RR 22, elevated BUN 35, elevated troponin 70 (baseline 29-31) and BNP elevated 12,916, elevated liver enzymes with alk-phos 119, AST 56 and ALT 45.  Normal lactic acid 1.7 - EKG reveals atrial fibrillation with rapid ventricular response and diltiazem 20 IV x1 given in the ED.- Chest x-ray with bilateral opacities concerning for pulmonary edema versus bilateral infiltrates.   - COVID-19 positive (son and DIL both positive) - COVID + 1/16/22. Received Pfizer vaccine 2/15/21 & 03/09/21.  Discharged 1/21/22.
It was urgent diarrhea that - two or three times, I didn't make it to the bathroom. I had this for weeks and it was three or four times a day. I had no control over it. I just felt the urge and I had to go. There was no cramping; I didn't feel bad or feel sick. There was no warning. It has lessened in that it hasn't been so frequent but the last week and 1/2 but my bowels have been loose - still real no control, but not coming as frequently.  I called the doctor and he put me on Imodium for two days. It lessened the symptoms for a short while (maybe 2-3 days). And then I sent the doctor a text message and he said to do further tests to find out what could still be causing it would be a wait. He said I could maybe get back to him around this time frame presently. I had a normal bowel movement this morning. I haven't had a normal bowel movement for several week so this is a change.
17 year old male had syncope episode with fall from seated position to floor with spontaneous regain of consciousness. 911 was called. Normal vital signs. Legs were elevated. Patient assessed by paramedics, PA and NP.  Patient declined transport to hospital for further medical evaluation and was encouraged to seek medical care if symptoms worsened. Yes
chills; like a had a fever; loss of taste; sneezing; diarrhea; slight cough; migraine; complete body aches and pains; headache; arm soreness; slight finger tingles; This is a spontaneous report from a contactable other hcp (Patient). A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0172) via an unspecified route of administration on 03May2021 at 13:00 (at the age of 43-years-old) in right arm as dose 2, single for COVID-19 immunization. Medical history included allergy to plants. Concomitant medications were not reported. The patient previously took Ceclor and experienced drug hypersensitivity. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration on 12Apr2021 at 13:00 (at the age of 43-years-old) in left arm as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. Since the vaccination, the patient has been tested for COVID-19. Patient received 2nd injection dose, 1 PM on Monday. On 03May2021 around 8 PM, (Monday evening), started to experience typical arm soreness and slight finger tingles (which she also experienced after the first dose) around 10 PM is when a headache started to come. Tuesday (04May2021), head pain continued and turned into a migraine along with complete body aches and pains. Wednesday (05May2021) arm no longer was sore but all of the other above symptoms continued-adding in a slight cough. Thursday (06May2021) all of above continued in addition to getting the chills and feeling like a had a fever however, temp was 98.4-98.6 throughout the day. Thursday (5/6) at lunch is when she started to notice loss of taste. That was confirmed that evening when she was eating dinner and could not taste anything at all. Today she still continued to have loss of taste, headache, bodyaches, chills, cough, and now sneezing and diarrhea. She did a rapid test which came back negative and she was still awaiting the PCR results. It was the lost of taste that concerned her. The Patient did not received treatment for the events. The patient underwent lab tests and procedures which included body temperature: 98.4 - 98.6 on 06May2021, sars-cov-2 test: pending (PCR) and sars-cov-2 test: Negative (Rapid test) on 07May2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Chills described as ?internally cold,? uncontrollable shaking, fever,  body aches, light headache onset 14 hours after second vaccine dose administered. Woke up from sleeping with these symptoms. Shaking discontinued after taking vitamin C, zinc, and Tylenol.
Irregular (late) menstruation; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via unspecified route of administration on an unknown date (at the age of 27-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via unspecified route of administration on an unknown date (at the age of 27-year-old); both as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced irregular (late) menstruation. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event irregular (late) menstruation was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient reported feeling dizzy and lightheaded accompanied by a feeling of numbness in the mouth and thickened saliva.
Rash all over body similar to shingles. Swollen lymph nodes. Was in ER two different times due to the rash, and face swelling. Lip was swollen on right side similar to a very large cold sore that has lasted for 8 weeks. Very painful.  Doctors also have tested me for an autoimmune disease, that has come back positive. ANA Titer 1:1280. Possibly this has brought to surface an underlying autoimmune disease due to the fact that I had Covid-19 so bad. Was hospitalized with it, and had neurological issues along with GI problems. No respiratory problems.
nightly fevers up to 102F; This is a spontaneous report from a contactable pharmacist. A 28-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Jul2021 (age at vaccination: 28 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Medical history included HIV infection from an unknown date and unknown if ongoing He has a new diagnosis of HIV 25 days ago, and 7 days ago is when he got the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced nightly fevers up to 102f on 08Jul2021. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on  degrees Fahrenheit, HIV test: HIV diagnosis on 25 days ago, weight: 220 lbs on 2020 lbs Last year, on 2020, patient was 220 lbs. Therapeutic measures were taken as a result of nightly fevers up to 102f was Tylenol. The outcome of the event pyrexia was not recovered.  Information about lot/batch has been requested.  No follow-up attempts are needed. No further information is expected.
PATIENT WAS ADMINISTERED A COVID BOOSTER IN A LONG TERM CARE FACILITY BY A PHARMACIST.  PHARMACY OBTAINED CONSENT TO VACCINATE AND DATABASE DID NOT SHOW A PRIOR BOOSTER. PHARMACY LATER LEARNED PATIENT HAD ALREADY RECEIVED A BOOSTER. WHAT PHARMACY THOUGHT WAS A BOOSTER WAS ACTUALLY A 4TH DOSE ADMINISTERED.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with RECOMBIVAX HB (lot # K007263 with expiration date of 09-JUN-2015, lot# J012520 with expiration date of 30-JAN-2016, therapy type, dose, strength and route unknown), which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient passed out as she was walking out of the exam room, Mom caught her and leaned her against the wall and eventually into a chair. Nursing staff as well as ARNP entered the room quickly after mom called out for help. Patient was awake but disoriented and very pale. BP was 76/33 and HR was 50. Child was instructed to remain seated and offered sips of water. Patient was rechecked after 8 minutes; Patient's lips appeared pink and slowly color was coming back to patient's face. HR went up to 76 and repeat BP was 93/55.Patient walked out to waiting room to sit for a few more minutes before being escorted home by mom. A handout from the CDC was given to mother on syncope with TDaP and MCV vaccines.
The evening folllowing vax w/DTP/ORIMUNE pt woke up crying for 10-30 mins (not a high-pitched cry); pt was also shaking head during this crying episode; event subsided w/o intervention; MD feels episode was not a sz;