chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke; Hypertension; This is a spontaneous report received from a contactable physician from medical information team, Program ID: (RA).  A 72-year-old patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Feb2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPERTENSION (non-serious) with onset 2023, outcome "recovered" (2023); CEREBROVASCULAR ACCIDENT (medically significant) with onset 2023, outcome "recovered" (2023), described as "Stroke". The physician was calling about the Pfizer COVID-19 vaccine new variant or booster. The patient who had a stroke, hypertension, is high-risk he said but it is healthy now and had the last bivalent 6 months ago. The physician is further asking when it will be available so that his patients, specifically older people will be able to get it. doctor was asking for the availability status of the XBB variant for his older patients. They're about 10 to 20 patients. These patients will be traveling in Sep2023, and the physician would like to know if they should wait for the release of the XBB vaccine or get another Bivalent booster or just leave it like that.  The information on the batch/lot number for BNT162b2, BNT162b2 OMI BA.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, the event stroke is more likely related to the elderly patient's underlying medical conditions so that is not considered related to the suspect vaccine BNT162b2, BNT162b2 OMI BA.4-5. 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. This case will be reassessed once additional information is available.
blindness; vision problems/vision changes; This spontaneous report was received from a patient's mother via a consumer and refers to a 10 or 11-year-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, site of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced vision problems and blindness. It was unclear if the patient was diagnosed with optic neuritis, but at the reporting time, the patient was experiencing vision changes and blindness. The outcome of the event was not recovered/not resolved.   The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event of blindness was considered to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA003867:
client received Moderna at check in when checking ID card. Staff reported to Lead RN PHN via walkie talkie. At 13:40 Lead RN consulted with Client and his mother in the upstairs lobby of building where Client was returning for second dose of Moderna today.  Lead RN educated both Client and his mother regarding Moderna's suggested application to 18 years and older only. Lead RN assessed Client for tolerance after first dose, and Client denied any adverse reactions or side effects and stated only "I had a slightly sore arm".  Client and his mother denied any significant Medical history, current medications, supplements, or allergies.  Client along with mother were also educated by Lead RN about the CDC's interim clinical considerations for COVID Moderna unauthorized age group. Client and his mother verbalized understanding and expressed a desire to proceed with vaccination.  Lead RN reinforced Client and his mother to please stay for the full 15 minutes in the observation area, and explained the VAERS and VERP reports would both be submitted for the incident. Client received Moderna vaccination #2 lot# 046A21A from RN at 13:57pm.  Lead RN checked on Client in the observation room at 14:13pm where Client denied all side effects and left the observation room with his mother.
Noticed some tension - 24h after injection. Developed significant Sx of H/A within 48 h. H/A became severe and AGOSC with vomiting within 72h after injection. H/A persistent but variable since. Still having H/A and N at time of this form completion.
the next day devel an inj site rxn characterized by a large area of  redness & induration;tx w/applications of ice & DPH;pt recovered;
Information has been received from a registered nurse (RN) concerning a patient who on 03-JAN-2008 was vaccinated with the first dose of Rotateq 25 days later than 12 weeks of age. It was unknown if medical attention was sought. NO adverse symptoms were noted. Additional information has been requested. 02/11/2010 Information has been received from a registered nurse concerning a 16-week-old patient with no known drug alliergies who on 03-JAN-2008 was vaccinatied PO with the first does of GARDASIL (Lot #656379/0505U). Concomitant therapy administered on that same day included the first IM dose in the right leg of (OMPC) (Lot #657174/0497U),  the first IM dose in the left leg of PEDIARIX (Lot #AC21B130AA) and the first dose in the right leg of PREVENAR (Lot #6540150). Medical attention was not sought. No adverse symptoms/events were reported.  No further information is available.
Patient was administered the 720 units (0.5ml) indicated for patients 18 years of age instead of the 1440 units (1ml) for patients 19+ years of age.
Contacted patient's mother to inform her wrong vaccine was given. Advised her to take patient to ER if any reactions would occur. NA
Child developed a sparse rash on abdomen, back and chest.  No rash was noted on any other part of the childs body. Child showed no signs of respiratory distress, child was down playing at a play table and going around a room opening drawers.  He also had a pacifier in his month the entire time.  Clinic was called and child will be seen by the on call Dr.  Child was sent to the Clinic in care of his Mother at 2:50 PM.
Moderna was given to a 17 year old patient. Moderna is only approved for 18 years of age and older. Patient contacted and no issues reported. Patient's Doctor was also notified of the incident. Based on CDC recommendation patient to receive Pfizer 28 days post Moderna administration
metallic taste; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Lot number: ER8737) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE; VITAMIN D3.  The following information was reported: DYSGEUSIA (non-serious), outcome "recovering", described as "metallic taste". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: I developed a strong metallic taste in my mouth and strong odor in my nose approximately twenty minutes after. Patient not taken any other vaccine in four weeks. No COVID prior vaccination. Patient not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Swollen and sore lymph node, left collarbone area.  It started to be sore and noticeable about 28 hours after the vaccine.
developed a case of shingles that affected my right , scalp and forehead. later developed post herpetic neuralgia. Symtoms started on 7 31-2021 and neuralgia persists to this day.
ALL muscles hurt, (like the day after lifting weights) . Mild headache, fatigue. Went to bed at 8:45pm. Next morning woke up cold and stood up got nauseous broke out in a sweat. Slept the entire day. Woke up to drink water no appetite severe headache all day. 82 degrees in my house and I am wrapped in a blanket  until 8:30pm. Friday morning 4-9 (third day after shot) mild headache. Felt normal at 11:30 am.
She received the vaccine the morning of 10/19/2018. That evening she started jerking occasionally as if she were startled. The activity was not recognized as seizure activity, but was quite odd. The next day in the afternoon, she started the startling movements again. They occurred every every few minutes, but she went back to normal as if nothing had occurred in between. Again, it was not known what was going on. Then, that same afternoon after a series of startling movements, she blanked out with a stare out of the corner of her eye and moving her lips in a rhythmic fashion. She was not responsive and was very hot. She was rushed to the local emergency room. They sent her home stating that febrile seizures were common with vaccines and to come back if it occurred again. She was given fever reducing medicines. Then early the next morning she had another seizure and was rushed again to the emergency room and then transferred to a hospital out of town were testing including EEG was performed. She was put on anti-seizure medication. Although she is on the medication, she has continued to have seizures anytime her fever spikes suddenly.
Fatigue; Inflammation; pain; headache; Oral Surgery; This is a solicited report received from contactable reporter Consumer for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4185276-00.  A 44 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; HUMIRA, citrate free, subcutaneous (Batch/Lot number: unknown) for uveitis, psoriasis. The patient had no relevant medical history and no Known Allergies. There were no concomitant medications. Vaccination history included: Covid-19 vaccine manufactured by johnson & johnson (Route of Administration: Intramuscular), for Covid-19 Immunization. The following information was reported: ORAL SURGERY (medically significant) with onset 2021, outcome "recovering", described as "Oral Surgery"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; INFLAMMATION (non-serious), outcome "recovering", described as "Inflammation"; PAIN (non-serious), outcome "recovering", described as "pain"; HEADACHE (non-serious), outcome "unknown", described as "headache". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of oral surgery.  The reporter's causality for the events of oral surgery, inflammation and pain with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the events of fatigue and headaches was not provided. The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Opinion is that there is no reasonable possibility that the events of oral surgery, fatigue, inflammation, pain and headaches are related to Humira (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events (except oral surgery)  and suspect drug BNT162B2 cannot be excluded. Based on the  information in the case report oral surgery may not be related to suspect drug BNT162B2 .
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 2 month old male pt who experienced fever as high as 103 degrees F and became irritable. At 2 months of age, the pt received the first dose on 01Nov04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 01Nov04. Dose regimen was 1 dose (IM). Concomitant medications were not reported. A mother reported that her son developed fever as high as 103 degrees F (pyrexia) and became irritable on 01Nov04 after his Prevnar injection. The child recovered within a couple days. See related case(s): HQWYE997313OCT05 (adverse event, non expedited) and HQWYE997413OCT05. No additional information was available at the time of this report.
pt recv vax;devel chickenpox w/ a rash w/ less than 20 vesicles and a mild fever;pt's brother also vaccinated w/ varivax and devel similar sx;
Swelling of lips; Face swelling; received the Johnson and Johnson vaccine for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of lips), SWELLING FACE (Face swelling) and WRONG PRODUCT ADMINISTERED (received the Johnson and Johnson vaccine for the second dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (received the Johnson and Johnson vaccine for the second dose). On an unknown date, the patient experienced LIP SWELLING (Swelling of lips) and SWELLING FACE (Face swelling). At the time of the report, LIP SWELLING (Swelling of lips), SWELLING FACE (Face swelling) and WRONG PRODUCT ADMINISTERED (received the Johnson and Johnson vaccine for the second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient took Benadryl as treatment medication.
Body aches, fever (>100 degrees), chills-onset 8 hrs. After administration of FLUZONE. Lasted over night, until next A.M. Took Tylenol po.
Extreme pain in arm, getting worse and today has become unbearable. Thumb is numb. Tingling started in forearm, now felt in bicep. Feeling of tightening in arm, pain radiating up through the shoulder and down through elbow.  Entire arm feels numb to the touch. Episodes of increasing pain with tightening and numbness. Nausea and dizziness.
Received flu shot at clinic on 10/26/05  Developed periorbital swelling about 6 hrs later  Went to personal MD, treated with Benadryl. No history of allergies, no known previous reaction to vaccines (has had several Flu shots in past).
Faint; Dizzy; A spontaneous report was received from a consumer regarding a female patient (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizzy and faint (medically significant).  The patient's medical history and concomitant product use were not provided.  On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, post vaccination, the patient felt very dizzy/faint. Treatment details for the events were not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events dizzy and faint were considered not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Child was brought in for their second dose of Pfizer  vaccine early.  The first dose was given on 1/13/22 and the second was given on 1/28/22.  There have been no reported adverse events.
Woke up this am 10/14/05 with right thigh swelling and redness and warmth. Temp started evening of 10/13/05. Continues to have temp 100.5
Left deltoid skin reaction. Erythema and Edema. Benadryl 1 tsp q 4 hours. Motrin 2 tsp q 3 pm T hours or pain.
I received the first dose of the Moderna vaccine  at 2:55pm on 4/7.  An hour or two later, I started to get a sore throat.  The sore throat was very painful by the early morning of 4/8.  On 4/8 I went into a doctor to see if I had strep throat because of the level of pain and since I didn't think I could get a sore throat from the vaccine, but he said it was not strep and that it was likely just a side effect of the vaccine.  On 4/8 I also had a fever topping 101.4, fatigue (I slept a lot that day), mental fog, pain at injection site, and all-around body pain.  The sore throat lessened greatly by 4/9, so it clearly wasn't a strep infection and seems it was indeed a side effect of the vaccine.  From 4/9 through 4/11 I had general "cold" symptoms: runny nose, phlegmy, watery eyes, redness and pain at injection site, muscle aches, elevated temperature (not fever), and general fatigue. By 4/12, these symptoms are nearly completely gone.  Some of these symptoms seemed quite strange as side effects from the vaccine, but they started and perfectly paralleled the expected vaccine side-effects, which makes me think they were caused by the vaccine.  I have no reason to think I had another illness at the same time as when I was experiencing these side-effects.  I had had Covid-19 previously (in December 2020; I tested positive and had mild symptoms).  Perhaps having had Covid-19 already provoked these strange side-effects.
1530-C/0 of "pounding H/A, itchy throat & fast heart " VS:146/93 HR:118,RR 14, SAT 100%, T. 97.7 Doctor phoned order for Benadryl 25 mg PO , given at 1545. 1615- BP 133/95, HR91, SAT99% RR15 T 98.1 1620- Patient states- itchy throat is gone & headache is off & on 1625-Patient leaves with daughter to husband in waiting car.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE COAGULOPATHY, UNSPECIFIED TYPE ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY CARDIOGENIC SHOCK 10/27/2022 --  RECURRENCE OF SAME SYMPTOMS
This case was received from a consumer on 22 January 2008.  An 88-year-old female patient, with a history of hypertension, received a left deltoid injection of Fluzone (lot number U2506AA) in November 2007; route and exact date of administration were not provided.  Approximately two days after vaccination, the patient began complaining of pain in her left arm.  The pain subsequently spread to the right arm, shoulders, and lower extremities.  The patient was seen by a physician, and was being treated with Celebrex and "Ulhamer".  Bloodwork and x-rays had been performed, but results were not provided.  At the time of the report, the pain was ongoing, and the patient was scheduled to see a neurologist.  Follow-up information was received 04 March 2008 from a consumer.  According to the reporter, the patient had been seen and evaluated by the neurologist.  Results of the neurologist's consultation were not provided.  The reporter indicated that the patient's condition had worsened and described the patient as having "Flu like symptoms" and clarified flu like symptoms as "constant aches and pains".  For about a month now, the patient had episodes that come and go, which consisted of hoarseness where she can barely speak.  No further information was provided at the time of the report.  Follow-up information was received from a health professional on 17 March 2008.  Based on the new information received, the case was determined to be serious.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  According to the reporter, the patient had severe diffuse myalgias with proximal muscle weakness and an increased CRP.  An electromyelogram and nerve conduction studies showed polyneuropathy.  The patient still had ongoing pain, and treatment included Ultram (previously reported as "Ulhamer"), Lyrica, Cymbalta, and Motrin.  Based on the available information, the patient had been diagnosed with "cervical spine pathology, stenosis as alternative diagnosis".  The patient had been seen by a neurologist, and contact information was provided.  The event had not yet resolved.
The pneumovax 23 vaccine was administered at  11:00 A.M 6/30/2020 - Around 1:00-1:30 left arm began to ache. the pain increased and was constant quickly. movement of arm was unbearable. fever, chills - started as well as body aches/joints 4:00 PM - vomiting started around 4:30 PM. Fever 101.9 Pain continued to increase + went to emergency room -
Patient reported to ER on 20 Jul 08 with "Red" rash all over her body to include arms and legs.  PT received Smallpox vaccination on 9 July 08.  PT fwas given Benadrayl and released.
low grade fever (99.2); weakness; severe nausea; tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), NAUSEA (severe nausea), FATIGUE (tired) and PYREXIA (low grade fever (99.2)) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (weakness), NAUSEA (severe nausea) and FATIGUE (tired). On 10-Mar-2021, the patient experienced PYREXIA (low grade fever (99.2)). The patient was treated with AMMONIUM CHLORIDE, CAMPHOR, SALICYLATE SODIUM, STRYCHNINE SULFATE (PEPTOL) at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, PYREXIA (low grade fever (99.2)) outcome was unknown. At the time of the report, ASTHENIA (weakness), NAUSEA (severe nausea) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99.2 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment for the events also included anti-nausea medication
A BIT OF SORENESS IN ARM; A STRANGE HEADACHE THE DAY AFTER VACCINATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a bit of soreness in arm, and a strange headache the day after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a bit of soreness in arm and a strange headache the day after vaccination was not reported. This report was non-serious.
This am right deltoid, injection site firm and warm to touch.  This is 10 days after injection.  Area is approximately 3 cm in diameter.  Fine non raised rash is present to both forearms.  Headache present.  Right neck lymph node with slight swelling and is tender to the touch.  Very tired today.  Had no concerns up until today.
Pt had shots 11/08/2001. On 11/15/2001 at 4 PM pt had slight temp. Mom gave Tylenol. About 7:40 pt went unconscious, then began to shake uncontrollably. 911 called during seizure. Ambulance checked temp 104. Mom states when seizure started child did not have fever. ER MD diagnosed as febrile seizure.