chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; Redness; Muscle pain; Shivering; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2022, the patient received the 1st dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced pain, erythema, muscle pain, shivering and tiredness. On an unknown date, the outcome of the pain, erythema, muscle pain, shivering and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the pain, erythema, muscle pain, shivering and tiredness to be related to Shingrix.     Additional Information: GSK receipt date: 20-Apr-2022 Reporter's comment: The patient received a dose of Shingrix two days ago and had pain, redness, muscle pain, shivering and tiredness. The patient just wanted to know how many days he/she could expect the side affects to last. The patient did not provide full name, mailing address, email address, phone number and date of birth. The patient did not consented to follow-up.
Muscle pain and aches from 11 am on day of vaccine until midday the following day, headache for same amount of time, fever developed overnight, 100.3 fever at 5 am, all symptoms improved with Tylenol
Severe injection site pain (aching) approximately 3 hours after injection on 2/2. Took 400 mg ibuprofen at 2200 to take the edge off of the pain in order to fall asleep. Beginning at 0600 on 2/3: Temp of 100 F, chills, body aches, headache. Took 400 mg ibuprofen at 1000 which lowered temp and reduced other symptoms for approximately two hours. Symptoms returned at 1200 with temp reaching 100.2 F along with chills, headache, and body aches that were more intense in the shoulder/neck area. Used a heating pad along my back, shoulders, and neck which helped with the body aches. Slept from 1500 to 1800 and woke up with an intense frontal headache with pain shooting through my eyes as well. Temp was 100.7 F. Took 400 mg ibuprofen which made the symptoms more bearable. Tried to stay hydrated by drinking water throughout the day. Also had two servings of soup. Symptoms seemed to lessen by 2200. The only symptoms lingering today, 2/4, are a slight headache, fatigue, and mental fog. Otherwise, condition has improved tremendously.
I got these reaction every time, every time I have gotten COVID Vaccine I have gotten sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM; LOSARTAN; NEBIVOLOL. Vaccination history included: moderna coviD-19 vaccine (Moderna (1st Dose) (Moderna COVID-19 Vaccine), Date of administration: 14Jan2021, LOT#: 028L20A (Captured in tab)), administration date: 14Jan2021, when the patient was 62-year-old, for Covid-19 immunization; moderna coviD-19 vaccine (Moderna (2nd Dose) , Date of administration: 12Feb2021, LOT#: 013M20A), administration date: 12Feb2021, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (Pfizer (3rd Dose) , Date of administration: 17Nov2021, LOT#: FH8027), administration date: 17Nov2021, when the patient was 63-year-old, for Covid-19 immunization, reaction(s): "I got these reaction every time, every time I have gotten COVID Vaccine I have gotten sick", "I had Moderna, moderna, Pfizer, Pfizer, Pfizer", "I got these reaction every time, every time I have gotten COVID Vaccine I have gotten sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got these reaction every time, every time I have gotten COVID Vaccine I have gotten sick".  Additional information: It was reported that patient got these reaction every time; had gotten COVID Vaccine; gotten sick.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300177316 same patient/vaccine, diff dose/event;US-PFIZER INC-202300177412 same patient/vaccine, diff dose/event;
throat pain at night; swallowing pain at night; a swollen red hard patch in the arm; dry throat; whole body itchiness (mostly back and arm); This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat), PRURITUS (whole body itchiness (mostly back and arm)), OROPHARYNGEAL PAIN (throat pain at night), ODYNOPHAGIA (swallowing pain at night) and VACCINATION SITE INDURATION (a swollen red hard patch in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DRY THROAT (dry throat), PRURITUS (whole body itchiness (mostly back and arm)) and VACCINATION SITE INDURATION (a swollen red hard patch in the arm). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat pain at night) and ODYNOPHAGIA (swallowing pain at night). On 11-Apr-2021, DRY THROAT (dry throat), PRURITUS (whole body itchiness (mostly back and arm)) and VACCINATION SITE INDURATION (a swollen red hard patch in the arm) had resolved. At the time of the report, OROPHARYNGEAL PAIN (throat pain at night) and ODYNOPHAGIA (swallowing pain at night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was reported.   This case was linked to MOD-2021-079688   See case MOD-2021-079688
A few months back my pulse rate started going up. My pulse rate has never been that high ever as I am a very healthy man. I now have to monitor my heart rate daily, and I am 73 yrs old and now I am experiencing things I have never.
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2008 the patient was inoculated with ZOSTAVAX vaccine at a health center for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015 the patient was treated at a health center for onset of a severe vesicular rash, which was diagnosed as severe herpes zoster As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Debilitating and extreme fatigue & malaise, chills, fever,  body aches, nausea, inability to eat/keep food down set in on Thursday 4/15, 2 days after the shot.  Friday evening he felt better and was oddly animated and somewhat manic.  Early Saturday morning the symptoms returned and lasted through Monday afternoon, then the manic behavior set in again along with a sense that he was better.  He wasn't; by bed time Monday he was down again.  Same for Tuesday.  Saw the doctor Tuesday at noon, was prescribed an anti-nausea medication and submitted to blood work that found nothing abnormal.  This is Tuesday evening and he is still not feeling right, day 6 of symptoms.   I have never seen him so sick and miserable and weak.
expired Adacel was administered to patients; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to 2019SA178356 and 2019SA178358 (same reporter).  This case involves male patient (normal age) who was administered expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5654AA and Exp. Date 27-Apr-2019, via unknown route in unknown administration site (vaccine was reportedly given on 17-May-2019 and 24-May-2019).  The patient past medical history and family history were not provided.  The patient did not receive any concomitant medication.  It was an actual medication error case due to expired vaccine used.  It was reported that the Adacel expired on 4/27/19. Caller stated that the vaccine was given on 5/24 and 5/17.   No symptoms 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.
deep vein thrombosis on Sunday; Extreme fatigue on Friday; This is a spontaneous report received from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via unspecified route on left arm single dose for COVID-19 immunization on 17Mar2021, 10:45 AM, at 72-year-old. Medical history was not reported. The patient had not had COVID prior vaccination. Concomitant medications in two weeks included: fluoxetine 20 mg; atorvastatin 10 mg. The patient had not had other vaccine in four weeks. The patient previously took morniflumate (FLOMAX) and had allergy to it. The patient was extreme fatigue on Friday 19Mar2021 and deep vein thrombosis on Sunday 21Mar2021 06:00 PM. I was hospitalized for two days including a veinogram to remove the blood clots from my left leg. I'm now taking rivaroxaban (XARELTO) 15 mg twice a day and were wearing a compression sock for my left leg. Treatment also received as IV heparin. Emergency room/department or urgent care involved and reported as serious due to hospitalization for 2 days. The patient had not had COVID tested post vaccination. Outcome of the events was resolving.
irritable for 1 day, no fever; 3 x 3 1/2 cm induration @ inject site; rx ASA, DPH, Duricef;
Bright red rash on stomach between waist and breast. A couple of splotches on back.  No itching or pain
Got shot waited 15 minutes, walked to elevator, felt dizzy returned to vaccine admin area.  Headache, vitals checked and were okay.  Continued to feel weird rubbing chest and short of breath but no chest pain.  Decided to take her to the ED.  On the way she passed out and was not responsive still had a pulse.  In ED became responsive, reports numbness in both arms and short of breath.   Received Benadryl complete assessment, doesn't appear to be an acute allergic reaction.  ECG & vitals were okay. Patient observed for 4 hours and seemed to improve so discharged.
Starting 10/1/2021 I noticed my arm twitching very hard. The twitching moved to legs, abdomen, face. It comes on strong sometimes and others not as hard. I feel like my head has a Tik. Today is 10/15/21 and it continues. No treatment has been sought.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jul2023 at 13:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (23Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 16Oct2023 to 21Oct2023. Clinical course: It was unknown if patient got other medication in 2 weeks.  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: Linked Report(s) : US-PFIZER INC-202300349457 Same reporter/patient, different drug/event;
Platelet transfusion; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4445836-00.  An 81-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; venetoclax (VENCLEXTA), (Batch/Lot number: unknown), oral. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLATELET TRANSFUSION (hospitalization), outcome "unknown". The action taken for venetoclax was unknown.  The reporter considered "platelet transfusion" related to BNT162b2.  Additional information:  Patient was hospitalized and needed platelet blood transfusion. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of platelet blood transfusion with VENCLEXTA (VENETOCLAX) was no reasonable possibility.  Company's opinion is that there is no reasonable possibility that the event of platelet blood transfusion is related to VENCLEXTA (VENETOCLAX).  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 reported event: "Platelet transfusion" and the suspect drug BNT162B2 cannot be completely excluded.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
vomiting,  diarrhea, headache, pain, fever, body aches, flu-like symptoms, Heaviness in legs, could not raise the left arm, tiredness, slept for 2 days,
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
At the off site flu clinic, pt. was given Fluzone HD and Comirnaty.  After given the both shots, patient then said she only needs Covid 19 only because she already received Flu shot already.
That same day I got vaccinated I started getting warm, getting chills and was not feeling good. The next day I had a fever of 102 and felt really tired I took Tylenol and Advil to help with the symptoms. On the third day, I felt much better but for 5 days I still felt tired with no energy.
The day after my Pfizer booster for COVID I lost my taste. I got tested for Covid at the airport community testing location and it came back negative along with a bimax rapid test that I took as soon as I noticed. I had a headache and didn't feel great but those were side effects from the shot as that is how I felt with the other two vaccinations. I had Covid last year at then end of September and I lost my taste then. And then a month later I experienced distorted taste which affected what I was able to eat. I still have distorted taste and smell from that. But now I have lost my taste partially again after receiving the booster.
3 days after I received the first shot of the Moderna vaccine I developed terrible tinnitus. I already had mild tinnitus but this was 10 times worse. It hasn't gone away. when I researched it online I realized many other people had also gotten tinnitus from the vaccine. I went to an ENT today April 2nd to get my hearing checked. My hearing is not registering as damaged but the audiologist told me several other people had been coming in because they got tinnitus from the covid-19 vaccine. I'm very worried about getting the next vaccine especially because I have been reading reports of people going deaf from it and people whose tinnitus has not resolved in several weeks.  My tinnitus has not resolved either and I'm worried the damage to my ears could come later. I can't sleep because of the ringing and I'm really scared.
Developed Shingles on lt side of back and lt breast; Off label use; Booster dose; This is a spontaneous report from a contactable consumer (patient) reporting for self. A 71-year-old non-pregnant female patient received third dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: FC3184) via an unspecified route of administration, administered in Arm Left on 28Sep2021 17:00(at the age of 71 years) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included high blood pressure, Shingles (in early 20's; received Zostavax in 1999 at age 50) both from an unknown date and unknown if ongoing. Concomitant medications included amlodipine besilate (DEXCEL), losartan potassium both taken for an unspecified indication, start and stop date were not reported. The Historical vaccines included BNT162B2 (BNT162B2, Solution for injection) via an unspecified route of administration, administered in Arm Left on 30Jan2021 09:30AM as DOSE 1, SINGLE and dose 2 BNT162B2 (BNT162B2, Solution for injection) via an unspecified route of administration, administered in Arm Left on 20Feb2021 09:30AM as DOSE 2, SINGLE (at the age of) for Covid-19 immunization. Zostavax from 1999 for shingles (at the age of 50). Patient previously took Ampicillin and experienced allergy. Prior to vaccination the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced developed shingles on lt side of back and lt breast on 30Sep2021 17:00. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Event Descrition: Red, irregularly shaped, slightly raised, itchy rash on left upper arm at area of injection site measuring 6inches by 8 inches. Appeared about 9 or 10 days after injection and remians to date. Size has decrease and to 4inches by 6inches but remains itchy and red but no longer raised.   Treatmnet: None Time Course: Above S/S have lessened but not reolved at day 25 post injection with day of injection neing Day 1 Outcome: Ongoing
slightly light-headed Friday, 01/15 pretty severe headache Saturday, 01/16 2 waves of nausea, upset stomach, diarrhea Sunday, 01/17
Shortness of breath; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (Shortness of breath) 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 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.   Reporter did not allow further contact
I received the flu vaccine on Tues. 11-25-2003. The following day, Wed. 11-26-2003, I was very sick. I had the symptoms of the flu(whole body aches, feverish, congestion in head) except I was also vomiting. I am still very achy and feverish. I have had the flu vaccine before but I have never any symptoms from it. I don't know if this was a coincidence or if I got sick from the vaccine. I called the physicians office and was told that they had had several reports of this after the vaccine was administered and there was nothing they could do, they advised to get bed rest, take something like acetominiphen for pain and drink lots of fluids. So now I wonder if something is wrong with the vaccine. I don't know how many people have gotten sick from it.
Constant strong panic attacks for no reason. I've had panic in the past but never as frequently and seemingly out of the blue. I get headaches as well. When they started I would go for a week when I would recover and feel like "normal" and after a week I would get a rapid heart rate out of nowhere, a burning headache and panic. This has been happening for over a year. I also had 3 months of insomnia in the beginning which I've never experienced either. I've been trying different medications, outpatient hospital therapy and counseling, but the recurring panic is not subsiding. Also, I am not in menopause according to bloodwork, but have constant light periods.
Redness, warmth and swelling, treatment antibiotics, physician possible diagnosis of abcess.
Pain for 5 days at injection site; Headache; Body aches and pain; Febrile 101 temp.
not feeling well; really tired and fatigued; didn't eat anything the day after body just was not up to it; stayed in bed all day/ couldn't get her strength back; This is a spontaneous report received from a contactable consumer.  A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 24Feb2021 (Lot number: EN6202) at the age of 91 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "blood disease" (unspecified if ongoing), notes: on blood thinners. The patient took concomitant medications. The following information was reported: MALAISE (non-serious) with onset 25Feb2021, outcome "unknown", described as "not feeling well"; FATIGUE (non-serious) with onset 25Feb2021, outcome "unknown", described as "really tired and fatigued"; DECREASED APPETITE (non-serious) with onset 25Feb2021, outcome "unknown", described as "didn't eat anything the day after body just was not up to it"; ASTHENIA (non-serious) with onset 25Feb2021, outcome "unknown", described as "stayed in bed all day/ couldn't get her strength back".  Additional information: The reporter mentioned that the patient also has had a blood disease and was on blood thinners. She had underlying conditions, it may have been anemia or a version of that but the reporter knew the patient has had a blood disease and was on a blood thinner and something else. The reporter stated that the lot said ENG202, he thought but the G could be a 6. The reporter didn't know what to do for the patient other than take her to a doctor and it was a headache going down there so he might try to get her to the nearest immediate care place.  No follow up attempts are needed. No further information is expected.