chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/03/2022, I woke up with head cold like symptoms. The next day, it was worse, so I tested myself for COVID-19 that evening and was positive. I had a loss of taste and smell, body aches, headache, and some cough. When I would cough, there was a dark phlegm. I called my doctor on Saturday and did a telehealth visit. He prescribed PAXLOVID. I began taking the PAXLOVID that evening, and I have almost completed the 5-day prescription. My symptoms remained the same for a few days after beginning the medication, but then began to improve and I feel better today than I have since this all began.
About 1 minute, post vax, the pt experienced hives on lower chest, lower back and legs. No hives noted on neck, face or head. Pt was given Benadryl and hives disappeared within 30 minutes. Pt remained at office for 90 minutes.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (lot # L000610 with expiration date 31-JAN-2017; lot # L013429 with expiration date 21-JUL-2017; lot# L026602 with expiration date 19-OCT-2017, strength, dose, frequency route were not reported). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Eye pain in right eye; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administration date 08Dec2021 12:00 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: EYE PAIN (non-serious) with onset 11Dec2021 12:00, outcome "not recovered", described as "Eye pain in right eye". The event "eye pain in right eye" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of eye pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient had not been diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I had the standard symptoms for the first few days after I received the first dose (pain at injection site, fatigue, headache, etc.). 7 days after the first dose, I began to feel a sharp chest pain which led me to the emergency room. They completed an EKG, blood work, and chest x-rays to rule out a heart attack and collapsed lung, and then sent me home.  3 weeks after the first dose I started to have pain and a feeling of stiffness and numbness in my hands, arms, legs, and feet. Its been over 7 weeks since I received the vaccines and I am still experiencing all of the above mentioned symptoms. Doctors have been unable to determine or solve the issues.
Persistent cough. We tried Prednisone and a course of Augmentin along with some cough suppressant - Benzonatate 100 mg as needed to help with the cough. That course didn't work. We tried Albuterol  - just doing some of that with the cough suppressant. It's still there (the cough). I was told it was a viral or bronchitis since it didn't respond to the previous treatment. Was told to give it some time. The facility that I went to initially gave me the antibiotic and the prednisone did lung x-rays and COVID test.  After the course of the prednisone and antibiotics and I was referred to my doctor's telehealth NP and she put me on Albuterol  - 24th of September.
2.5 hours after 2 month shots given (DTaP, HIB, Hep B, IPV) child reported back to office with red, raised rash to entire face with the erythema and swelling greatest around perioral area. Right thigh at site of DTaP and HIB was swollen, erythematous and warm.
Patient states felt hot flashes following injection in waiting room went home became lethargic that evening having difficulty answering questions at night patient states she became apneic and husband had to watch her breathe.  Did not go to the ER.  Patient states fully recover the next day and fully recovered 5 days later.  No rashes fever generalized weakness that resolved.
Expired TENIVAC was administered with no reported AE; Initial information received on 26-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 66 years old male patient who experienced expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [Tenivac] was administered with no reported AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jan-2023, the patient received a 0.5 ml (frequency: once), dose of expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT with no reported AE (strength and formulation: unknown, expiry date: 22-Jan-2023, lot U6922AA) via intramuscular route in the left deltoid as immunization (expired product administered).  No lab data was reported.  Action taken:  not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome Unknown   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.
Menactra and  Adacel were not given in deltoid; Initial information received regarding an unsolicited valid non-serious case received from a consumer (patient grandmother) via call center and transmitted to Sanofi on 03-Nov-2020.  This case involves a 12 years old male patient for whom it was reported DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] were not given in deltoid (Product administered at inappropriate site) Lot number unknown via unknown route in the left arm for prophylactic vaccination.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and both these vaccines were not given in deltoid, reporter was saying that the vaccine was given to low from deltoid muscles and The patient was thin. Reporter said giving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lower for a thin child only means lesser muscle mass. Reporter said that she also called Merck and Glaxo and they told her the same thing. Reporter did not mention any other vaccine names. Reporter said it was given in left arm. Reporter did not had any other information for the template.   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.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB, lot# L002866, expiry date 10-NOV-2017 00:00 and lot# L030865, expiry date 07-JUN-2018. No adverse effects reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of four report received from the same reporter. Additional information has been requested.
Face became flaming hot and neon red within minutes of injection. Head started hurting, hands shaking, alittle light headed. Put my face in front of air conditioner in car. Redness went away after about 25 minutes. Headache in  2hrs.
03/24/2021 Patient had open wound that was draining and it was not diagnosed at the time of the vaccination. Six days later it was diagnosed as staff infection 03/30/2021 09:00 AM prescribed antibiotics for days and she was not able to eat and drink, became dehydrated and had violent shakes. Was sent to the hospital, tests performed by Doctors. Had a GBS 03/09/2021 prior to vaccination then after the vaccination on 03/29/2021 infusion. Nursing home facility for 1 month after the hospital.
Immediate sharp pain at the vaccine site radiating to the forearm and hand associated with tingling dysesthesias into the forearm. Pain and tingling lasted three days then lessened with rest and ibuprofen only to recur at 7-10 days with increasing pain with arm movement and then at two weeks after injection to near constant throbbing pain in the shoulder, sharp deltoid region pain with abuduction and elevation . Pain wakes her from sleep at hight.
Sore throat; Little bit of headache; A spontaneous report was received from a consumer concerning an unknown age, female patient, who received Moderna's COVID-19 Vaccine and experienced little bit of headache and sore throat.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of events, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced had a little bit of a headache and sore throat.  No treatment information was provided  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events headache and sore throat was not reported.; Reporter's Comments: Very limited information regarding these events have been provided at this time. at therapy date and onset of the events is lacking.  No further information is expected as reported denied additional information. Headache is consistent with the known safety profile of mRNA-1273.
Had some swelling and 2 or 3 blisters on my lower lip the next day. It felt like my lip had been burned. The feeling lasted about 10 days.
no adverse effects pt forgot they got their 2nd dose with pharmacy and they got an extra dose of shingrix. they discovered after going back home from their immunization records
Since having a shot after about three weeks, my left and right arms where the deltoid muscles are stay on fire and in pain daily. The nighttime I can barely move my arms. I suffer from extreme hot flashes throughout the day. And my glutinous maximus muscles are continually sore day and night. Making it very difficult to move about throughout the day
fainting hit head and face unconscious for less than ten seconds contusion crown of head contusion nose and cheek (left) three superficial lacerations cheek (left)
Headache, Myalgia, Fever, Fatigue Narrative: Fever 101
This spontaneous report as received from an office manager refers to a patient of unknown age. On 24-JUN-2013 the patient was vaccinated with the second dose of GARDASIL (lot #0552AA, expiry date on 23-JUN-2013, route and dose were unknown) had expired. The first dose of GARDASIL (lot # 0552AA, expiry date on 23-JUN-2013) was administered on 23-MAY-2013. No adverse effect reported. Additional information has been requested.
8/23/14-> Swelling, itching and hives on th e(L) arm that lasted for 2-3 days. 8/26/14-> lip and eye swelling -> improvement with BENADRYL.
20 second generalized grand mal sz then fell asleep; t101.7R APAP given normal neuro exam; referral to neurologist t99.4 R 1 hr p/APAP;
lost sense of taste and sense; cold; fever; chills; aches and pain during the night; lose of smell; This is a spontaneous report from a contactable consumer (patient herself). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient had got 1st dose on Sunday, after couple of hours on an unspecified date patient had lost sense of taste and sense. Also had a cold, fever and chills. Then aches and pain during the night. Everything was gone except still no sense and no taste. Patient enquired was lose of smell/taste side effect from the vaccine or not. The outcome of event lost sense of taste and sense, lose of smell was not recovered while it was resolved for all other events on an unspecified date.  Information about Lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Temp 101.8 for about 30 hours.  Vomiting multiple times in 24 hour period.
Felt feverish; horrible stomach cramps; Initial information received on 29-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer/non-health care professional.  This case involves adult male patient of an unknown age who experienced felt feverish (pyrexia) and horrible stomach cramps (abdominal pain upper), after receiving INFLUENZA VACCINE.  The patient's vaccination included INFLUENZA VACCINE (Had three in 20 years) after patient experienced each time felt feverish afterwards, then horrible stomach cramps like was beaten with a 2x4.  The patient's medical history, medical treatment, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious felt feverish (pyrexia) and horrible stomach cramps (abdominal pain upper), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "had three in 20 years. Each time felt feverish afterwards, then horrible stomach cramps like i was beaten with a 2x4".  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.
11 year old female inadvertently administered a 12 year and older 1st dose of Pfizer Covid 19 Vaccine instead of 5-11 year old1st dose  of Pfizer Covid 19 Vaccine.
Fever 101 temp and malaise since vaccination on 1/4/21 @0930, symptoms began 24 hrs later (body aches and induration at injection site). Febrile on 1/5@1430 to 101. Fever at 100.5 this morning. No recurrence but still very fatigued.
Accidentally administered 1.0 mL of the Moderna Covid-19 vaccine; A spontaneous report was received from a nurse concerning a patient who was accidentally administered 1.0 mLof the Moderna Covid-19 vaccine.    The patient's medical history was not provided by reporter. Concomitant product use was not provided by the reporter.    On 24-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 24-FEB-2021, vaccine was  accidentally administered 1.0 mLof the Moderna Covid-19 vaccine. Treatment information was not provided.    The outcome of the event, accidentally administered 1.0 mLof the Moderna Covid-19 vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273 (lot # unknown) with no associated AEs reported.
Fever, chills, malaise. Arm pain and swelling (left). Red demarcated rash below the injection site.
Fever, chills, headache, nausea, dizziness x 1 week.
My wife got the shot, and got really sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: My wife got the shot, and got really sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-JUN-2023 This case was reported by a patient's husband via interactive digital media.
Employee evaluated at Occupational Medicine regarding ongoing right shoulder pain. RPA note states employee received flu shot 4 weeks ago and after 2 hours developed right shoulder pain which has continued. Employee states pain increases with activity, has been taking ibuprofen with some relief but not getting better. Reports dull ache in right shoulder at rest that becomes increased pain with certain movements. No redness, ecchymosis or swelling. ROM of right shoulder is full in all planes with pain to movement. Plan methylPREDNisone 4 mg oral tablet, referral to Physical therapy with follow up appointment in 1-2 weeks.
High fever 8 hours; low fever 22 hours; aches 30 hours; headache 30 hours; fatigue 36 hours.
Within 2 hours of receiving vaccine, broke out into a hive like rash nickel size hives. Rash initially started around injection site left thigh, then spread to other leg and randomly over body. Child was given oral BENADRYL and rash improved. Rash returned when BENADRYL wore off. Is redosing with BENADRYL every 6-8 hours for 48 hours. No respiratory issues noted.
"Covid Arm" - large raised rash expanding outward in large circumference about a week after being vaccinated. Site is hot to touch, itches and is tender. Exhaustion and body aches, tender lymph nodes. This is a second wave of symptoms from the vaccine. Thought the initial immune system flare up had ended. It just took a break. Its come back for more.
Information has been received from a physician concerning a 14 year old female who was vaccinated with a 0.5ml dose of HPV vaccine. Subsequently the patient developed a rash 10 minutes after vaccination. The patient was treated with antihistamine. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
3 hr after vax pt was screaming & crying loudly. mother given tylenol,  wouldn't eat
Patient presented to ED on 4/9/21 with weakness, fatigue, and SOB. Found to be covid positive after fully vaccinated. Patient was treated for covid 19 pneumonia during admission
received his second dose of the vaccine and then died; got very ill; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had unspecified underlying health issues. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization and experienced COVID-19. The reporter's mom's cousin who was in his late 70s/ early 80s, had some underlying health issues. He received his second dose of the vaccine, got very ill, and died. Reporter was unsure if he received Pfizer vaccine or different brand. The outcome of got very ill was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: received his second dose of the vaccine and then died
on the evening of the second day after receiving vaccination Pt noticed his right shoulder feeling tight and swelling in the shoulder area.  On 3rd day in the morning Pt noticed redness and swelling in the Right Shoulder worsening.  Pt reported to clinic and was diagnosed with suspected Cellulitis.  Pt will receive treatment with Primary Care.
Swollen lymph node; Injection site pain; Joint pain; Muscle pain; Dizziness; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0171), via an unspecified route of administration on 11May2021 (at the age of 36-year-old) as single dose for COVID-19 immunisation. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number unknown) an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history included diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetic, cerebrovascular accident from 2019 to an unknown date. The patient's concomitant medication(s) included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient probed for the side effects, consumer stated, Joint pain, muscle pain, the injection site pain. I did had some dizziness but that the patient do not really mind because the patient had dizziness from stroke already (later stroke clarified as history, hence not captured as event) but then the patient have a swollen lymph node. It was stated that the patient had started Aspirin, children aspirin (not clarified) and Motrin (not clarified). The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
pt started to feel faint before shot and pt in and out of frozen catatonic state.  head started to fall back.  called for pharmacist. out for 3 to 5 minutes and felt better and wanted the shot...nothing happened after the shot.  this all occurred before the shot due to anxiety and this has happened to the pt before
This spontaneous report as received from a other health professional refers to a patient (in source document referred as patient 2) of unknown age and gender with no reported medical history. On unknown date the patient was vaccinated PNEUMOVAX23 (route and dose unknown), lot number H04196 with expiration date 19-MAR-2014. No other suspect therapy or concomitant medication was reported. On an unknown date the patient experienced cellulitis at the injection site following administration. No treatment information was reported. The outcome of cellulitis at the injection site is unknown. The reporters relatedness of cellulitis at the injection site to PNEUMOVAX23 is unknown. This case is linked with MARRS number 1304USA005056 (same reporter link). Additional information is not expected.