chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hemorrhagic stroke; Apparent neurological deficits; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization. The following information was reported: HAEMORRHAGIC STROKE (medically significant), outcome "unknown", described as "Hemorrhagic stroke"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "Apparent neurological deficits". Clinical course: Patient received 2nd monovalent vaccine dose. Within 1-2 hours post dose, patient was not feeling well and layed on floor. Patient was diagnosed with a hemorrhagic stoke and has apparent neurological deficits from the event. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the event Hemorrhagic stroke. 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.
Ischemic stroke, - pneumonia - intubated, --- some residual post cva  weakness
4 months old  patient who received a dose of Pentacel which had a temperature excursion below zero/No AE; Initial information received and additional information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA255196, 2019SA255155 and 2019SA255195 (same reporter).  This case involves a 4 months old male patient who received a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ135AA, expiry date- 26-02-2021 via unknown route in unknown administration site on 12-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Patient entered clinic for HPV gardisil 9 vaccine and MCV4 menactra vaccine.  Verified name, DOB, insurance, and ID.   Verified no allergies, or previous reactions to vaccines before. She has no record of these vaccines before.  Patient stated she was not sick at time of vaccine encounter.   Administered MCV4 and Gardisil-9 vaccine in the left arm.   Approximately 1-2 minutes after vaccination, patient  was seated on the tablet in an upright position and when I turned aroung to hand her paperwork she started to faint and I got up, went to help her steady, alerted family outside, and called 911 immediately after patient was safe on exam table. She was very pale and then came to awareness awaiting EMS arrival. Upon arrival of EMS they confirmed the following vitals: temp 98.4, BP 74/41, 85 blood glucose, and initated a bag of IV fluids before escorting her to ER via ambulance. Patient stated verbally she was feeling back to normal before leaving, and also her mother and sister said she had nothing to eat today, was not drinking fluids throughout the day. They also stated she had one previous incident of fainting, 3-4 years ago, unrelated to vaccine.
Received smallpox on 03/21/2005. Had itchy rash appear on 04/01/05 along with flu like symptoms x 24 hours. Took Benadryl.
From 07-16-2021 to 07-17-2021, Patient experienced chills, fatigue, and nausea few hours after Shingrix vaccination. Patient reported her experience on 07-19-21, and said she is feeling normal again today.
accidentally administered an expired dose to 50 patients; A spontaneous report was received from a nurse concerning 50 patients of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and were accidentally administered an expired dose.  The patients' medical histories were not provided.  Concomitant product use was not provided.  On 22 Feb 2021, 50 patients accidentally received an expired dose of mRNA-1273 (batch number 012M20A; expiration date 21 Feb 2021) intramuscularly for prophylaxis of COVID-19 infection.   Treatment information was not provided.  Action taken with mRNA-1273 in the response to the event was not applicable.  The event was considered resolved on 22 Feb 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 012M20A) with no associated AEs reported in a group of 50 patients with unknown age and gender.
Three teenagers / received an adult dose / instead of a Pediatric dose; Three teenagers / received an adult dose / instead of a Pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-year-old female patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd June 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 details were provided as follows: The patient received an adult dose of Havrix instead of a Pediatric dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This is 1 of the 3 cases reported by the same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021130436:Same reporter. Patient #1 of 3. US-GLAXOSMITHKLINE-US2021130439:Same reporter. Patient #3 of 3.
I woke up with a running nose, fatigue, cough, and a slight sore throat. The second day I saw a nurse at an urgent care, and she tested me for COVID-19 which was positive. I got a prescription for Paxlovid. I started feeling better day 4-5 of taking Paxlovid but my cough lasted for a couple weeks. I didn't test negative for COVID-19 until the 16th day. I still occasionally have a cough.
No adverse event to a patient.  Vaccine administration error:  Additional diluent was added to the Pfizer vaccine vial allowing administrator to withdraw an additional dose from 3 different vials.
headaches; big tongue; thrush on the tongue; stomach pain; body aches; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), SWOLLEN TONGUE (big tongue), ORAL CANDIDIASIS (thrush on the tongue), ABDOMINAL PAIN UPPER (stomach pain) and PAIN (body aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches), SWOLLEN TONGUE (big tongue), ORAL CANDIDIASIS (thrush on the tongue), ABDOMINAL PAIN UPPER (stomach pain), PAIN (body aches) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (headaches), SWOLLEN TONGUE (big tongue), ORAL CANDIDIASIS (thrush on the tongue), ABDOMINAL PAIN UPPER (stomach pain), PAIN (body aches) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
roughly 2 weeks after the vaccine a rash appeared on my face. it looks like small, red, pinprick dots that begin below my cheekbones and down to my jawline. the rash gains and loses intensity throughout the day. it is sometimes hot, but does not itch. this has happened roughly 2 weeks after each vaccine in the series so far.
Site: Pain at Injection Site-Mild, Systemic: radial nerve pain, swollen/raised veins on left arm-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient reports mild to moderate pain on left arm along the crease inside elbow, as well as swollen/raised veins in that same area, and sometimes some numbness to the hand/fingers. Patient noticed symptoms about 1 to 1.5 weeks after second dose of Moderna and continues to have those symptoms now. Patient advised to see doctor or go to urgent care.
Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; This is a spontaneous report from a contactable other hcp reporting for herself.   This 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) the first dose on 15Dec2020 14:00  (Lot # EK5730) in the left arm and the second dose on 04Jan2021 12:45 (Lot # EL1284) in the right arm, both via an unspecified route of administration at single dose for Covid-19 immunisation. Medical history included asthma and allergies to Penicillin and Oxycodone. Concomitant medication included omalizumab (XOLAIR), salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA).  On 04Jan2021 23:00, the patient experienced injection site soreness, fatigue/chills (day). Bad diarrhea at night. No treatment was performed. The outcome of the events was recovered. The patient underwent lab tests and procedures which included Nasal Swab, Covid test on 28Dec2020 was negative. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.
Right arm deltoid region red, swollen and hot to touch. Advised to keep cool cloth on affected area and tylenol. 3/22/04 talked with mother. Says arm much better today.
No adverse reactions occurred, vaccine dose was not supposed to be administered as she received a previous bivalent dose before.
Light headache & injection area soreness at 2pm  10pm started to notice some aches.  Midnight (14 hours post injection) awakened by intense headache, severe body aches, sweating, hot and cold. Extreme fatigue. In bed & slept all day.  8:30pm still have headache, fatigue & light body aches.
Bruising above the injection site; swelling all the way down the arm, into the lymph nodes, and breast; soreness, shakes, aches, low grade fever, headache
Insomnia at 3am  on  Headache moderate,  Fatigue , mild malaise Mild ache at injection site
Fatigue, lymph node swelling, night sweats and fever, chest tightness, muscle ache and pains (full body). All symptoms persistent and ongoing, beginning after second dose.
Approximately 2 months after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms: cough, fever, runny nose and headache. I did not take any treatment on my own and decided to speak to my doctor about it and was prescribed with PAXLOVID for 5 days and it did help with my symptoms and I felt a major improvement. As of today 07/07/2022 I feel completely fine and back to normal.
Patient received 2 doses of bivalent Moderna COVID-19. No adverse events were reported. Administered outside of protocol.
little headache; pain in the arm for 1 day; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for herself that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got her first dose on 04Apr2021 and second dose on 22Apr2021. She did not experience any reaction after getting the first dose, only a little headache and pain in the arm for 1 day in Apr2021. She was asking if it's possible that she will get reactions after the second dose. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient needed a different vaccine for school qualification, needed conjugate vaccine instead. Patient qualified for both since over age of 10 based off guidelines, however school requirement only conjugate will qualify.
In error, dose of bivalent Pfizer given to an 11 year old male without dilution
Red rash, swelling, hardness, and tenderness below injection site. Size approximately 4 inches X 2 inches. 2 days ago far.
I have been very dizzy since and tired. This started about 24 hours after the first dose and has continued. I have continued taking my OTC allergy meds but nothing is working
Pt complained of throat tightness and being lightheaded beginning at 1127 hours (5 minutes after vaccine).  She arrived at emergency/symptoms reporting station at 1129 hours.  She denied tongue swelling, denied rash, denied difficulty speaking.  No rash was seen by medics either.  Pt did not have wheezing or stridor.  Medics on scene and student medics under the direction of Medics, placed the patient on the monitor.  Her HR was stable in the 70s and her sats were 99-100% on room air, with a strong pulse and RR of 16.  The pt became more anxious and demanded that someone assist her with her Epi pen administration. RN explained sxs of anxiety and sxs of anaphylaxis.  Pt became agitated and again remained adamant that medics give her Epi.  At 1132 hours a student medic under the direction of Medics administered the pts own epi pen to her.  Vitals signs after epi were HR of 88, BP of 170/97, RR 22, sats 100% .  A transport unit was called as precaution and to potentially transport.  Pt appeared to have an increase in agitation as indicated by her speech with medics being short and her stating that she was "irritated" with "everyone talking", that she "can't hear everyone all at the same time", that this is just "too much" and waving her hands in the air.  Pt was transported to the ER via Medics for continued care and follow up.
Pt reported feeling dizzy 5 mins s/p vaccine administration. Pt was escorted to exam room for monitoring, VS taken,  BP 112/70, HR 95, O2 sat 97% on RA. Pt given apple juice and monitored; no LOC. S/s resolved within 20-25 mins. Repeat vitals as follows: BP 112/73, HR 93, O2 sat 98% on RA. Pt ambulated out of clinic.
Myalgia, Fever, FATIGUE/SWELLING AT INJECTION SITE Narrative:
Initial report received from a consumer or other health care professional on 22 October 2013. A female patient whose illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported, but received an Flu vaccine (lt number not reported, site and route of administration were not reported) on an unspecified date. The next night after receiving the flu vaccine, she developed headache, sore throat, congestion but got better in a couple of days. Laboratory investigations were not reported. Corrective treatment was not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: None  Follow-up received on 13 November 2013: No new information can be obtained.
Information has been received from a physician concerning a 2 year old female who was vaccinated PO with her third dose of ROTATEQ.  On 16-APR-2008 the patient experienced rotavirus and lost 10% of her body weight and was subsequently hospitalized.  Subsequently, the patient recovered.  No further information available.  There was no product quality complaint.  Additional information has been requested.
This spontaneous report as received from a pharmacist via a company representative refers to three unknown patients of unknown gender and age. The patients' pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On an unspecified date, the patients were vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot#, and expiration date were not reported). On the same day, the patients were administered additionally a dose of unspecified influenza virus vaccine (reported as flu vaccine). Both vaccines were administered in the same arm in all three patients. On an unknown date, the patients experienced severe flu like symptoms, consisting of high fever and chills. The patients sought medical attention but it was unknown if treatment was given for the event. Outcome of adverse event was not reported. The relatedness between the event was not reported. Additional information is not expected as there was no consent to contact the reporter.
bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (bad headache). At the time of the report, HEADACHE (bad headache) outcome was unknown.            No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Had Hepatitis B vaccine left deltoid. Shortly after child got home developed rash around waist, chest and thighs areas. Had scratching in throat and headache. No respiratory difficulty.
sinus like symptoms/ bad runny nose; sinus like symptoms/ congestion/ sinus congestion; Itchiness; chills; body ache; head ache; This is a spontaneous report from a contactable other health professional (patient). A 28-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), intramuscularly on 23Dec2020 at single dose for COVID-19 immunization because he work in a hospital. Medical history was reported as none. There were no concomitant medications. The patient reported to have been vaccinated last Wednesday and developed symptoms on Thursday (24Dec2020) with a pretty bad chills, body ache, headache, itchiness, then got sort of better and that was on Thursday. He felt better on Friday (25Dec2020) but reported a really bad runny nose and congestion, he started to develop sinus like symptoms like runny nose, like sinus congestion and that's so something that he was experiencing like 26Dec2020 to Saturday. The patient was asking if these were the typical symptoms/ normal reaction to the vaccine and if he had that reaction were normal and how long would they usually last. The outcome of chills, headache, itchiness was recovering, of the other events was unknown.
99.7 Fever; Serve migraine; Dizziness; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease and allergy to gluten. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 12:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On Friday the 16Apr2021, the patient experienced 99.7 fever (unspecified units), severe migraine, dizziness and exhaustion. The fever came on and off both Saturday 17Apr2021 and Sunday 18Apr2021, migraine and dizziness would come and go as frequently as the fever. Exhaustion lasted all three days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, severe migraine, dizziness were recovered on an unknown date in Apr2021; while that of the event exhaustion recovered on 18Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 10:28, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505.
Symptoms:  Swolen, Red, Hot - shoulder area about 6 inches. Treatment:  Motrin 800.
"Bursitis" like pain described by patient, still ongoing since day of immunization (2 months later)
Patient was given the injection (right deltoid) on 13 January 2001 and noticed pain under that arm  on  16 Jan 2001.  On January 19th, she noticed itching to the deltoid area and then on the 20th, a red rash appeared. It was warm to the touch and 21 Jan she stated the area of redness was warm and hard to touch. I examined the patient and did not find any induration but agree with warm to touch and an irregular shaped area with noticeable erythematous area measuring  5cm X 7 cm.  Gave her an injection of Clindamycin 300mg and a prescription of Cephalexin 500mg four times a day for ten days.  Will re- evaluate in 24 hours.  No other symptoms to report.