chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient state they had severe reaction to flu shot - lost consciousness and was unable to function for about 30 minutes.
Sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS SHOT for prophylaxis.   Concomitant products included allopurinol, vitamin d, telmisartan, amlodipine, icosapent (Vascepa) and vitamins nos (Multivitamin).   On an unknown date, the patient received Shingrix and TETANUS SHOT. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix and tetanus shot, the patient experienced sore arm. It was unknown if the reporter considered the pain in arm to be related to TETANUS SHOT.
Pt recvd vax on 18AUG92 & approx 3 days p/vax exp flu-like synd sx gradually resolved over several days;
Day 1-Fatigue; Day 2-Mild symptoms including fatigue, diarrhea, itching at injection site, headache, joint pain, muscle aches
SEVERE SHARP PAIN IN SHOULDER AND ARM. LASTED 3 WEEKS. UNABLE TO USE ARM OR TO DRESS ALONE. SAT UP IN A CHAIR TO SLEEP. STLL HAVE WEAKNESS IN ARM.
Pt c/o pinprick with tingling and dizziness briefly after receiving vaccine. No SOB. Denies LOC. VS at 1523: BP 149/81, HR 86, RR 17, O2 sat 100% on RA. VS at 1540: BP 128/90, HR 90, RR 16, O2 sat 98% on RA. VSS at time of discharge. No s/s of distress noted. Pt refused w/c to exit.
TWO HEART ATTACKS; This spontaneous report received from a patient via social media through 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, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced two heart attacks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two heart attacks was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210805250- COVID-19 VACCINE AD26.COV2.S-two heart attacks. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Shingle shot-No ad mentioned patients would get shingles. I wrote Merck president. He did not reply-got form letter unsigned!-saying their tests showed no one got shingles. My doctor said all who got shot got shingles-live cultures-I was not told. I did own tests and discovered (from friends) that all got shingles!!! Please have them (Merck) publish this fact!!. At @240.00 a shot (I had to pay). I have Medicare A + B + D and an AARP supplement. So far, all refuse to reimburse me even a fraction. Dr is my primary care. The unsigned forms from Merck hide the person responsible!!!. I am now breaking out for 2nd time since shot.8/5/08-records received-office visit 2/18/08 vaccine administered. 5/13/08-Blood surgars elevated. Left sciatica. Rash on wrist and finger resolving. Left neck pain.
The patient incorrectly given a full dose of Moderna (0.5 milliliters), instead of the half dose (0.25 milliliters) as a booster dose. The patient was told to monitor but had no adverse events thus far.
Patient's arm began to swell a few hours after getting the vaccine. He called his Dr. when the swelling did not subside. He developed a "knot" in his bicep. He is still experiencing pain at this time in his arm and shoulder.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # K026533, expiration date: 07-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 48.6 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. Concomitant medications were not reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever of 102.8, nausea and vomitting lasting 3 days.
(L) deltoid, erythema, warmth, well demarcated edges radiating down to elbow. Tx BACTRIM DS, prednisone 40 mg PO QD x 5 days.
gave an expired Adacel to a patient today, no AE; patient was administered with 0.05 ml dose of vaccine, No AE; Initial information received on 30-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 year old female patient who was vaccinated with an expired 0.05 mL once dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5980DA, expiry date: 22-Jun-2020) via an unknown route in the right deltoid for prophylactic vaccination on 30-Jun-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation and Meuzieo .  It was an actual medication error case due to expired vaccine used and vaccine under dose. It was reported that the nurse gave 0.05 ml expired Adacel vaccine to a patient today.  At the time of this 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 holder's 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.
Some very light spotting occurred after first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 19Apr2021 at 11:30 AM as dose 1, single for COVID-19 immunization. The patient medical history included breast cancer, high blood pressure, both from an unknown date and unknown if ongoing. The patient concomitant medications included tamoxifen 20 mg, lisinopril 2.5 mg, trazodone 50 mg, all drugs taken for an unspecified indication, start and stop date were not reported. The patient previously took quinoa for drug allergy. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On an unspecified date in 2021, the patient experienced some very light spotting occurred after first dose. AE resulted in doctor or other healthcare professional office/clinic visit. Adverse event: Post-menopausal bleeding started occurring 2 days after 2nd dose. Some very light spotting occurred after first dose. I have not had a period in over a year. Due to taking Tamoxifen for breast cancer dx 4 years ago, I have scheduled an appointment with my OBGyn on 17May to be checked out. Treatment for the adverse event was unknown. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
face hurts; Tooth hurts; This is a spontaneous report from a contactable consumer (patient).   A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (Lot Number: ER8737; Expiration Date: 31Jul2021) at SINGLE DOSE in Left shoulder for covid-19 immunisation.  The patient medical history was not reported.   No Prior Vaccinations (within 4 weeks).  The patient's concomitant medications were not reported. The only medication she takes is cholesterol pills. She received her first dose of the Pfizer Covid 19 Vaccine this morning and ever since she came home, her tooth hurts and her face hurts on 1Apr2021.  She would like to know if teeth and face hurting are side effects from the vaccine. She reported her teeth at the top are hurting, teeth on the bottom are okay. Said its the both sides of mouth on the top that are hurting. The patient reported this is happening off and on.  The outcome of Tooth hurts was unknown, of face hurts was recovering.  No follow-up attempts possible. No further information expected.
I developed Mononucleosis six weeks after my second dose of the Pfizer vaccine. Fever, severe night sweats, severe fatigue, loss of appetite, head aches, and blisters on my skin. I have not been exposed to Mononucleosis that I know of and have been isolated from the public because my husband had not been vaccinated yet. Mononucleosis has a 4-6 week incubation period which is when I took my second vaccine shot
1. Paresthesias in both legs from knees down 2. Formication 3. Tinnitus  4. Many new neurofibroma on my scalp
pt recvd vax then came home took a nap & awoke screaming-loud & shrill; pt was very pale & blue around mouth, nose & hands; pt was fretful; remained pale;
Information has been received from a registered nurse concerning a 4 year old female with no medical history who on 10-NOV-2008 was vaccinated with the first dose of MMR II (lot #660209/1119X), 0.5ml, SQ. Concomitant therapy included HEP B (lot # 660462/0599X, duration and dose not reported). There was no concomitant medication. A week later the patient began stuttering. The patient has been referred to a speech therapist, but the patient's mother has declined to take her at this time. At time of the report the patient was not recovered. The patient did not have any lab diagnostics. The patient sought medical attention by phone call. Additional information has been requested.
Beginning the evening of the shot, my arm /shoulder began to hurt and I became fatigued. By the following day it worsened and that night required sleeping with hot compresses on shoulder. Hot compresses were need the third day. By this time severe fatigue and low blood pressure set in, to the point of getting lightheaded and nauseous with normal activities, and had occasional loose stools. Range of motion on the shoulder became extremely limited (slightest lifting of arm caused pain) and this continued for about 10 days, curtailing normal activities. During this time, the fatigue, lightheadedness and low BP persisted. Avg. BP was 90/61 and at times was 87/50 (note my normal BP is about 101/68). After that the pain started subsiding and by about day 16, the arm pain was resolved and I could resume normal activities. The extreme fatigue also improved. BP is still low for unknown reason.
Got the vaccine, shortly after that had a feeling of having a novocaine shot numbing feeling from her right side of her arm, her shoulders, head/neck, and then to the left arm.  This then passed.  That evening she was tired, sleepy and then the next day she had a bad headache. (possibly related to menstrual cycle beginning).  She took Excedrin for that and when she woke up the 2nd day she was fine.    Then on 4/12/21 she had her hair pulled up and reached the back of her neck and felt a pimple like feeling on the back of her neck.  She then had her daughter look at her neck who informed her that she had a red rash, squeezed it and it popped and then noticed she had several on her neck.  She then had the numbness return that she had on the right hand side of her face, her arm and a little down her leg.  She went and got some Vitamin E ointment and rubbed it on the back of her neck, which seemed to resolve the rash eventually.  Then that numbness feeling went away within an hour or two.   The following night she also had recurrence of the same events from the previous day.  Last night 4/14/21, she had the rash again on the back of her neck, and had actually  moved down into her back area, down to her shoulder blade the same pimply type rash, and numbness down her side.  She now has the same feeling around her ear area.  She tried again the vitamin E ointment which did not help anything.  She then took a Vitamin D pill which did not seem to do anything either.  She woke up multiple times during the night as she still had the feeling and did not go away.  When she woke up she felt sort of okay, has the rash, had the feeling of having had a headache/achy feeling, and can feel the rash on the back of her neck again.    She has a call into her doctor to see if she can be seen.    She has also noticed that her right arm had some swelling around the elbow area, but last night's episode she could definitely tell that it was swollen and the skin tight in the upper inside of the elbow and up to about the armpit.
Aside from sore arm; Fatigue; I had a severe migraine.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 12Feb2021 at 13:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included drospirenone, ethinylestradiol (GIANVI) and esomeprazole magnesium (MANUFACTURER UNKNOWN) both for unknown indication from unknown dates. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 at 13:00, the patient experienced aside from sore arm and fatigue. Aside from sore arm and fatigue the patient had severe migraine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with migraine specific medicines (unspecified) and ibuprofen (ADVIL). The clinical outcome of events sore arm, fatigue and severe migraine was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
On April 10 strong headache. On April 17 and until today, April 21, I present a lump / ball at the level of the Left clavicle and I feel an inflamed lump and it hurts when I move my neck or exert any force. I have not seen improvement despite taking anti-inflammatory.
After 2nd Pfizer Covid-19 shot, my arm began to soften around and under the injection site; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included scleroderma, diabetes, and breast cancer. Patient is not pregnant at time of vaccination. Concomitant medications included triamterene; amlodipine; pravastatin; potassium chloride (POTCHLOR); and omeprazole. The patient previously took eucalyptus 14% and experienced allergy. Patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: F13247), on 02Feb2021 11:00 AM, in right arm for covid-19 immunisation. Patient had scleroderma in both right and left arm, wrist, and fingers. After 2nd Pfizer Covid-19 shot, her arm began to soften around and under the injection site. Over the next couple of months the tissue started to soften down the right arm, and now patient had more movement in that wrist but the left side remains the same. No treatment was received. No covid prior vaccination. The patient underwent lab tests and procedures which included Rapid Test (Nasal Swab): negative on Apr2021. The outcome of event was recovering. Information on the lot/batch number has been requested.
Information has been received from a physician concerning a 20 year old female with a history of lightheadedness and low blood pressure (February 2007) who on 10-JAN-2008 was vaccinated with the first dose of Gardasil.  Concomitant therapy included methacycline.  On 10-JAN-2008 the patient experienced lightheadedness, tunnel vision, cold sweats, nausea, lowered blood pressure, a swollen tongue and her throat started to close roughly 2 minutes after receiving Gardasil.  Subsequently, the patient recovered from lightheadedness, tunnel vision, cold sweats, nausea, low blood pressure, swollen tongue and closing throat.  The patient sought unspecified medical attention in the physician's office.  No further information was provided.  Additional information has been requested.
No adverse event; 1 dose 1 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose 1 day BUD) and NO ADVERSE EVENT (No adverse event) in a 49-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose 1 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose 1 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose 1 day BUD).    No concomitant medications were reported. It was reported that one of the nurses in clinic gave 1 dose 1 day BUD. No treatment information was reported.
Redness after 24 hrs that progressed in size to span most of her lateral left upper arm. Hard lump at injection site. Weeping, blisters, increased pain. 2 ER visits 1st gave antibiotics KEFLEX and BACTRIM, 2nd visit gave 5 day prednisone treatment.
Shingle developed in hair approximately 2 weeks after 1 dose of vaccine.  Unknown if patient was treated for shingle.
I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 11/12/2021 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 11/12/2021 FAILURE TO THRIVE SYNDROME, ADULT
Pt experienced significant swelling, erythema with a 3cm by 4cm knot in the left deltoid and extreme tenderness. No fever.
he had been getting headaches for 5 days after the shot but now they have still not gone away; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1 single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date the caller stated he previously called because he had been getting headaches for 5 days after the shot and not gone away. He is scheduled for the second dose that day within an hour and a half from now. Nothing he took care of it, not Aspirin or Tylenol. It was reported that he had headache continuously since the 23rd and said hay he had no history of getting headaches often. He asked if it is safe to get the second dose. He stated he saw his doctor on the 6th and informed that would probably a side effect and should go away and suggested to get the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.  Follow-up (16Apr2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for himself that: Patient stated that the headache goes up and down and moves around his head. Somedays it is bad and somedays it is not as bad. He said that he normally does not get headaches. His second dose is scheduled for today 16Apr2021. He wants to make sure that it is not contraindicated for him to get his second dose while he still has a headache. Patient was waiting for the confirmation from Pfizer that it is safer to take second shot No follow-up attempts are possible; information about lot/batch number cannot be obtained.
administered PENTACEL to a patient without reconstituting/ only liquid portion was administered with no reported adverse event; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case from a other healthcare professional  via Media Information (under reference 00768848).  This case involves a 2-month-old female patient who was administered with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without reconstituting/ given only liquid portion (product preparation issue).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) (other dosing details were not reported).  On 09-Sep-2021, the patient received 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (1x, total, lot UJ542AA, expiry date 10-Jul-20222) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (same day).  It was reported "caller states that they administered PENTACEL to a patient without reconstituting. Caller clarifies, only liquid portion was administered to patient. Caller asks what they should do for the patient in this situation.   At the time of reporting no adverse event was reported and the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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. Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case from a other health professional.