chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt felt hot on 7/1/05. Gave Tylenol at bedtime. On Saturday fever went up and down. Got tired before nap on 7/2/05, laid down and had seizure of 4 minutes. Temp at this time was 103.7F.
Information has been received from a physician concerning a 15 year old female who was vaccinated (route, site and dosage not reported) with Gardasil (lot # not reported).  Concomitant therapy included Menactra, Flumist and Adacel given on the same day.  Post vaccination, the patient stood up and started talking and subsequently fainted.  The patient fully recovered.  Additional information has been requested. Information has been received from a physician and follow-up information from a nurse concerning a 15 year old female with no relevant  medical hisotry, known drug allergies or illnesses at time of vaccination who in 17-NOV-2007, at 11:00 am was vaccinated intramuscularly in the deltoid muscle of the upper left arm with the first 0.5ml dose of HPV vaccine (lot # 658283/0929U). The patient was concomintantly vaccinated with MENACTRA (Lot #62403AA) given intramuscularly in the deltoid muscle of the lower left arm, FLUMIST (Lot #500489P) given intranansally and ALACEL (lot #C2771AA) given intramuscularly in the deltoid muscle of the right arm. The patient fainted post vaccinations. At 11:10 am the patient stood up walked over to the other side of the room and was talking with her family and fell over, hitting her head on top of a chair. The patient was faced down on the ground for approx 30 seconds. The patient came to and started talking. The CNNP came in to the room immediately and gave the patient some water and ice pack for the red area on her forehead. The patient's mother was instructed to watch patient carefully for 48-72 hours. The reporter stated that if the patient started to vomit, get a severe headache, sleeping too much the patient should go to the emergency rooml. No lab diagnostic test were performed. The patient left the office and was fine. The patient fully recovered. No additional information is expected.
I got the shot on Tuesday morning, and then by Wednesday morning I had a bad afib event, and still have afib and am at  Hospital.  I haven't had an event like this in 2 years.  The cardiologist here thinks it's related to the vaccine.
Inflamatory illness; Inflamatory illness; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflamatory illness) and ILLNESS (Inflamatory illness) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflamatory illness) and ILLNESS (Inflamatory illness). At the time of the report, INFLAMMATION (Inflamatory illness) and ILLNESS (Inflamatory illness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       12 to 20 year old patient developed killing inflammatory illness related to Pfizer Moderna .  Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
diabetes; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 58-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2015 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes". Additional information: Pharmacist calling about Prevnar 20 who has a patient that got Prevnar 13 back in 2015. Patient is 58 years old and diabetic and reporter is looking to see would Prevnar 20 be better for him to get than the 23 would be, since usually they do Prevnar 13 and then a year later do Pneumovax 23.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: The association between the event diabetes mellitus with PREVNAR 13 can not be fully excluded based on the limited information and unclear timeline.  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.
Day 1 post vaccine arm hurt and a 2" x 2.5" raised red area around vaccine site. Felt this way for a few days. Redness and pain started fading after 4-5 days. Day 8, I still have a little pain but the site is itching and there is now a deeper red area with some discoloration. I am on Day 9 post vaccine now.
On November 23, 2022, I woke up with a lot of congestion, fever and headache.  On December 7th, I started coughing up blood when I went to the urgent care.  I was diagnosed with pneumonia and given Doxycycline.  All of my symptoms have gone away but I still have the cough.  Not a productive cough from the chest.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. Patient's concurrent conditions or historical information were not reported. On an unspecified dates in February 2015, unspecified number of patients were administered with six doses of GARDASIL (lot# K009202, expiration date: 17-DEC-2016), 0.5 ml, intramuscular, (frequencies and routes not reported) that were exposed to temperatures outside of the recommended range. No adverse effects reported. Follow up has been received. The nurse stated that 5 patients received doses of improperly stored GARDASIL (lot# K009202, expiration date: 17-DEC-2016). Additional information was received from the registered nurse, concerning one out of five patients, namely a 11 year old male patient. He was vaccinated with improperly stored (temperature excursion) GARDASIL (lot# K009202, expiration date: 17-DEC-2016), intramuscularly on 17-FEB-2015. This is one of several reports from the same reporter. Additional information has been requested.
Severe pain in left arm where injected, fever of 104. .1, then 101.1 then 100.9., body aches severe headaches, bilateral burning on legs and feet, chills nausea, severe sweating , fatigue.
One & a half inch red area around injection site noticed the next day. Red area still present after 4th day. Headache, fatigue and sore arm.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX. Concomitant products included amlodipine, DIOVAN, flecainide, glucosamine, hydralazine, Levothyroxine, Montelukast, omeprazole, Pneumococcal vaccine, TYLENOL and XARELTO. On 20th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache. On an unknown date, the outcome of the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache were not recovered/not resolved. It was unknown if the reporter considered the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 14th May 2018 the patient received 1st dose of pneumococcal vaccine on right arm intramuscularly. The patient reported that he experienced muscle aches on his legs, back and shoulders. The patient planned to follow up with his physician on an unknown date.
Itchy eyes, mild fever and redness to injection site right deltoid. Tx: Benadryl 50mg x 2 doses.
My throat got thick feeling and I started to throw up mucus and blood x3  that night. I got sick with flu like symptoms and unable to do anything for 5 days following the injection. My body ached so bad you could barley touch me. I feel like my energy has never returned and my body aches more then ever following the injection .
MD states pt was seen by ER MD c/o febrile sz 2 wk p/vax given; MD told PHN didn't think it was related but fits in to adverse rxn time frame;
itching was everywhere; Rash/she has a patient that developed a rash/rash is red everywhere; Discomfort; Bumpy rash; This non-serious case was reported by a physician via call center representative and described the occurrence of generalized pruritus in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced generalized pruritus (Verbatim: itching was everywhere), red rash (Verbatim: Rash/she has a patient that developed a rash/rash is red everywhere), discomfort (Verbatim: Discomfort) and papular rash (Verbatim: Bumpy rash). The patient was treated with cetirizine hydrochloride (Zyrtec), famotidine (Pepcid) and fexofenadine hydrochloride (Allegra). The outcome of the generalized pruritus, red rash, discomfort and papular rash were not resolved.   The reporter considered the generalized pruritus, red rash, discomfort and papular rash to be related to Shingrix.     The company considered the generalized pruritus, red rash, discomfort and papular rash to be related to Shingrix.   Additional Information: GSK receipt date: 11-SEP-2023 and 13-SEP-2023 The reporter was a physician.  The physician stated she had a patient that developed a rash and itching after first Shingrix dose, that was initially on her back and back of legs, but now a week later, the rash and itching was everywhere.  The rash was red, raised and bumpy.  Reaction included skin itching, rash and discomfort. The patient was already on Zyrtec, Pepcid and steroid burst, the physician now was adding Allegra. No further details were collected because call had to be transferred from GlaxoSmithKline (GSK) response Center to GSK Medical Information. The reporter consented to follow up.
Information has been received from a physician concerning a 9 year old female patient who on 01/07/00 was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. On 12/07/99, the patient subsequently experienced mild arthralgia of the hips. She sought unspecified medical attention. No further information is available.
First noticed Redness and egg shape bump on left thigh on 04/20/18 at 7:00 am while getting dressed for school sent him to school. After school around 1 pm on 4/20/18 the redness had spread now the left thigh felt hot to the touch and the redness was spreading more than I had originally noticed he was also running a low grade fever 99.9 at this point I notified Pediatrician of what was happening to my son after getting both vaccines on the same leg in such close vicinity to each other. It was late Friday evening I treated my son with some Zyrtec to help with the Itching he was experiencing I also gave him Children's Motrin to lower the fever. Next morning I scheduled a visit at my Urgent care were he was diagnosed with Cellulitis of the Left lower leg and Allergic reaction.
Hospitalization for COVID, hypoxic respiratory failure 1/5/22-1/13/22. Treated with Remdesivir for 5 days. Treated with barcicitinib, dexamethasone, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily.
On 12/07/2022 I was shoveling snow when my Heart Rate started increasing and I started experiencing a 7-8 level of pain from my clavicle to the back of my tongue as soon as I stopped shoveling my heart rate decreased and was normal. I waited a few days and went to my Cardiologist. I was to wear a heart monitor for 2 weeks and was diagnosed with Paroxysmal Supraventricular Tachycardia and a Sinus Rhythm was identified.
Pt. with whelps, itching, and all over body rash.Seen by local MD and treated with steroids and antihistamine.Rash progressively got worse over the next day, but no fever.
Within 12 hour I experienced typical symptoms: local arm pain, fatigue, body aches and headaches. I was also dizzy. Those symptoms resolved quickly. In the following 8 days I experienced an increase in the frequency and severity of migraine. My usual frequency Is 1-2 a month and I had 4.that week. After the fourth migraine on Saturday, nov. 6, I experienced acute onset atrial fibrillation which lasted 48 hours and required an ER visit. I was highly symptomatic of atrial fib with lightheadedness and dyspnea. I was started on Eli quiz/a blood thinner.
Oxygen Saturations dropped to 80%; This is a spontaneous report from a contactable nurse.  An adult female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included COVID-19 (covid prior to vaccination: yes) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced oxygen saturations dropped to 80% (The patient underwent lab tests and procedures which included oxygen saturation: 80% (dropped to 80%) on 08Jan2021. Therapeutic measures were taken as a result of the event which included treatment with the use of oxygen. The patient recovered from the event on an unspecified date.; Sender's Comments: The reported event of oxygen saturation 80% was most likely due to COVID-19 prior to vaccination, and unrelated to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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.
had joint pain; This is a spontaneous report from a Pfizer sponsored Program from a contactable other hcp. A 70-years-old female patient received bnt162b2 (BNT162B2 , Formulation: Solution for injection, Batch/Lot number : Not reported), via an unspecified route of administration on an unspecified date (at the age of 70-year-old) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had joint pain on an unspecified date. The Patient reported last blood work showed kidney filtration levels dropped. MD changed dose of methotrexate from 6 tablets weekly to 3 tablets weekly started 2 weeks ago. No change in joint pain reported. Patient held xeljanz (XELJANZ) 5mg, orally once daily dose from 21Sep2021 for 2 weeks after covid shot. MD aware patient to receive vaccine. had joint pain but it wasn't bad per patient report. patient concerned about blood work and increased water intake with some energy drink per md recommendation. The patient underwent lab tests and procedures which included blood test: kidney filtration levels dropped. Outcome of the event was unknown.  Follow-up (16Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient reports immediate L arm pain after procedure and weakness that has lasted over the last few months. He could not recall other injury, and states that injection itself had no pain associated. Came to my clinic and on examination found to have L biceps tendon rupture. It is unclear if this was related to vaccination.
Admission for cardiology procedure performed: Redo sternotomy for mitral valve replacement using a 31 mm mechanical valve via transseptal approach. Placement of temporary ventricular pacing wire. Hospital admission within 6 weeks of receiving the COVID-19 vaccine.
The next day, Oct. 27, patient woke up with a red, raised, uniform, rash. The rash was not itchy and there was a raised bump at injection site. Patient states on 10/31 the rash had decreased to about halfway.
Muscle soreness in left arm for the first two days then marked fatigue on days 3-4, major urticaria developed on day 8 after vaccination with large patches of red, raised, very itchy rash on both sides of the anterior abdomen, with smaller patches on both of the lower legs and some on the posterior upper arms.  The itching made sleep very difficult for the next two nights.  The itching was decreased somewhat by the use of 1% hydrocortisone cream and moreso by 10 mg of Loratidine. The severity of the urticaria has decreased somewhat over the last 3 days since onset but is definitely still present.
Administration error. First dose of vaccine administered more than 6 hours after first vial puncture. Vial punctured at 1040AM on 5/24/21 first punctured. Shot administered 5:40PM on 5/24/21. Expired for an hour.
2 inches raised red and itchy rash on left upper arm at site of injection.; 2 inches raised red and itchy rash on left upper arm at site of injection.; 2 inches raised red and itchy rash on left upper arm at site of injection.; covid test; This is a spontaneous report from a contactable consumer (patient, reported for self).  A 72-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for Injection; Batch/Lot number: 6/2021; Expiration date: UNKNOWN), via an unspecified route of administration, administered in Left arm on 25Feb2021 11:15 (at the age of 72-year-old) as single dose for COVID-19 immunization. The patient known allergies: Penicillin; other medical history included CLL (Chronic lymphocytic leukaemia), HBP (Blood pressure high), anxiety. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medications included losartan, cefalexin monohydrate (LEXIPRON), rosuvastatin calcium (CRESTOR), etodolac (LODINE) all taken at an unspecified dose for unspecified indications from unspecified date and unknown if ongoing. The patient did not receive other vaccines prior to the COVID vaccine within 4 weeks.   The patient experienced 2 inches raised red and itchy rash on left upper arm at site of injection on 06Mar2021 20:00 (reported as 08:00 PM). The patient underwent lab tests and procedures (COVID tested post vaccination) which included nasal swab test on 04Mar2021, result: Unknown. The patient had tested for COVID-19 post vaccination. The patient did not receive any treatment for the events. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Benzonate" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "overweight" (unspecified if ongoing); "sensitive stomach" (unspecified if ongoing), notes: sensitive stomach. Concomitant medication(s) included: FAMOTIDINE; ROSUVASTATIN; SYMBICORT; MONTELUKAST; VITAMIN D [VITAMIN D NOS]; ZINC. Past drug history included: Known allergies: clarithromycin, reaction(s): "Known allergies: Clarithromycin". Paxlovid gives patient very unpleasant adverse events. It starts with a lasting metallic taste 30 min after patient took it, and it progresses to stomach ache (epigastric pain), abdominal discomfort, nausea, overall sensation of feeling unwell, occasional headache, tingling sensations, weird hallucinatory smells (urine), and a feeling of being somewhat slightly sedated. These effects last for more than 3 hours after each those with the metallic taste, which is very strong, lasting even longer. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever, Chills, Generalized body-aches. Frequent burning micturation with hematuria.  Treated with antipyretics (max. strength Tylenol), IV antibiotic, and a regime of antibiotic (ciprofloxacin) treatment for 2 weeks. Fever and body-aches have subsided. Some residual discomfort in urinating, but other symptoms have subsided.
Red swollen about 10" long down to elbow pt put ice on it to left arm. Lasted about a week!
arthritis; This is a spontaneous report from a Pfizer-sponsored Program, regulatory authority from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 22Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop dates were not reported. The patient experienced arthritis on an unspecified date. The clinical course was as follows: She called to say how long she needed to wait to take ibuprofen for her arthritis from the date she got the vaccine. She received the 1st dose on 22Mar2021. She mentioned that she took acetaminophen (TYLENOL) after the 1st dose. Therapeutic measures were taken as a result of arthritis. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
skin around her ankles and feet are getting discolored; itchy, it is strange; tiredness; muscle pain; chills; fever; injection site hurt a bit; nausea; feeling unwell; dreamy; bad dream; This is a spontaneous report from a contactable consumer (patient) via Medical Information team and Pfizer sponsored program. A 92-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 at single dose for COVID-19 immunization. Patient noticed the skin around her ankles and feet are getting discolored, wanted to know if the vaccine can alter the skin. They are also itchy, it is strange. Her skin around her feet is different than it was. She asked if anyone had reported this or any other skin discoloration or skin symptoms and what she should do about it. Patient stated she certainly experienced tiredness, had muscle pain somewhat, had chills, a small fever, the injection site hurt a bit but it didn't swell, nausea and feeling unwell. She stated she felt like she was being dreamy, not really hallucinations, but like she was having a bad dream. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
redness under the arm and a very sore arm. patient said that she could barely move her arm. Patient states her arm is still sore and has limited range of motion but redness is gone now.