chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My blood pressure spiked to 190/121 and my heart rate began to race drastically while grocery shopping with my daughter; that's when I decided to walk over to the pharmacy to check my blood pressure. They urged me to go to the emergency room. They saw my heart rate was 150BPM and my speech was slurred. I passed out upon arrival at the emergency room, but they determined I wasn't having a heart attack or stroke, just extremely high blood pressure. I had blurred vision and a pretty severe migraine at the time; they drew blood cultures to confirm diagnosis and recommended me to follow-up with my cardiologist since my blood pressure began to regulate on its own. This past Monday, 04/18/2022, my doctor performed a stress EKG and currently awaiting results from that.
An accidental 3rd dose; A late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number 2BR9G, expiry date 09-JUL-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received the 1st dose of Shingrix on 17-Aug-2020.).   On 21-APR-2023, the patient received the 3rd dose of Shingrix. On 01-SEP-2022, the patient received the 2nd dose of Shingrix. On 01-SEP-2022, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: A late 2nd dose). On 21-APR-2023, the patient experienced extra dose administered (Verbatim: An accidental 3rd dose). The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The pharmacist reported that the patient received the 1st dose of Shingrix on 17-Aug-2020, a late 2nd dose on 01-Sep-2022, and an accidental 3rd dose on 21-Apr-2023, which led to drug dose administration interval too long and extra dose administered. Patient received 3rd dose at the pharmacy. Details provided for 3rd dose of shingrix. The reporter consented to follow up.
Mother noticed patient to have a fever on 2/21/16 at 10:00 AM axillary temp of 101 and then highest temp was 103.5 until this morning temp of 106.0 core temp.
Heart Palpitations with any strenuous activities, such as walking, climbing stairs,  Racing heart, chest pain, shortness of breath
Pt recv vax on 12/3/98; on 12/9/98 pt exp fever (103); 12/10/98 pt exp rash & respiratory distress
Acute Pericarditis, heart surgery - pericardial liquid drain and permanent pericardial window. 6 month on colchicine.
Event occurred after 2nd dose.  Patient could only eat small amounts of liquid type nutrition and was having small amount of loose stool. Abdominal pain varied between a 5 and 10/10
Tired; Headache; Feverish; Eyes felt allergy like; Lips felt chapped; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) at single dose for COVID-19 immunisation. On 08Jan2021, the patient was tired, had headache, was feverish (but not elevated temp), eyes felt allergy like, and lips felt chapped. All were mild. Clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was reported. On 29-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided) and a dose of (Oka/Merck) VARIVAX injection (dose, route of administration, lot# and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
This is an spontaneous report from a contactable pharmacist from Non Clinical Study Program (IBCC (Inbound Call Center for Health Care Professionals). A male patient of an unspecified age and ethnicity started to receive PREVNAR, via an unspecified route of administration from an unspecified date to an unspecified date at single for. The patient experienced tingliness of lips, numbness of lips, restless and feeling upside down on 27Apr2015 with outcome of unknown. The action taken in response to the events for PREVNAR. Follow-up (19JUN2015): Follow-up attempts completed. No further information expected.
Information has been received from a healthcare worker and a licensed practical nurse, concerning a 51 year old female who on 3/23/06 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650644/0004F). The healthcare worker reported that within a few hours, on 3/23/06, the pt developed swelling and bumps at the injections site. The nurse also reported that the pt developed a swollen deltoid to the elbow, redness, heat to touch. It was also reported that the pt experienced sore and had malaise. Unspecified medical attention was sought. No treatment prescribed. It was noted that the pt was not hospitalized and the experienced were not life threatening. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 3 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-AUG-2016. On 12-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD, lot # M019233 with expiration date of 17-OCT-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 15 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA013888:
Not adverse as result of vaccine (as I told caller!) Contracted Covid in July 2 months after vaccine. Had usual symptoms and took Paxlavid as prescribed by Urgent Care. Tested negative 10 days later.
This spontaneous report has been received from a nurse practitioner via company representative referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 20-SEP-2017, the patient was vaccinated with ROTATEQ dose 2, orally (strength, lot# and expiration date were not reported) for prophylaxis. It was reported that the patient's mother called to stated that on 20-SEP-2017, the patient vomited throughout the night (vomiting ) and was not doing well throughout the night (malaise). The patient's outcome for vomiting and malaise were unknown. At the time of this report, the causality between the events and ROTATEQ was not reported.
36 hours after vaccine administered, patient reported 4 hours of "explosive diarrhea", which then resolved.
On 04/12/2021, I received my second COVID-19 vaccine. I had a few bumps on the top of my head which I thought were mosquito bites from working outside at dusk. Two days after I received second vaccine shot, I got a cluster of bumps and a headache. I contacted my primary care physician at medical facility on the following Tuesday. The Doctor said it looks like Shingles and started me on medication.
Sever lower back pain, chills, WBC elevated, sedimentation rate elevated, C-reactive protein elevated, generalized weakness, muscle ache all over the body. tachycardia.
Had a pretty extreme response to booster.  Ran a fever for three days after shot and was very fatigued until Friday after getting the shot on Monday.  Started to have altered taste around Thursday of the same week.   On September 2nd, started feeling an irritation in my right eye.  By Thursday night, face was asymmetric and right eye clearly not blinking, could not smile.  Was diagnosed on Friday, September 3rd with Bell's palsy.
Patient's mother reports substantial disruption of the ability to conduct normal life functions about 4-6 months after receiving Pfizer vaccine including: heart palpitations, tachycardia, brain fog, fainting, migraine, nervous system damage, among others. He was a previous runner and can no longer enjoy running.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Child received Tdap Boostrix, Lot #C2770AA instead of Dtap Infanrix Lot #AC14B060AB.  Mother was notified on 09/03/08.
low grade fever; Sore throat; slight congestion; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old patient of unspecified gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: en6205), via an unspecified route of administration in the right arm on 16Mar2021 at 15:45 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to sulfa antibiotics (MANUFACTURER UNKNOWN), chlorthalidone (MANUFACTURER UNKNOWN), amoxicillin-pot clavulanate (MANUFACTURER UNKNOWN) and nitrofurantoin (MANUFACTURER UNKNOWN). Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) 10 mg, omeprazole (MANUFACTURER UNKNOWN) 40 mg and loratadine (MANUFACTURER UNKNOWN) 10 mg; all for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, 2 days after the injection, the patient began to get a sore throat and slight congestion. The sore throat lasted for 5 days and worsened overnight into the mornings. The patient had a low-grade fever 100 (unit unspecified) 3 days after the sore throat which started 5 days after injection on 21Mar2021. It was reported that the symptoms were gone by day 8. On 21Mar2021, the patient had a body temperature of 100 (units unspecified). The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore throat, nose congestion and fever were resolved on 24Mar2021.  No follow-up attempts are needed. No further information is expected.
Rapid onset of swelling and pain within 12 hours followed by fever. About 3x4 in area of swelling; Left Deltoid
pt recv vax 28MAR97 & 5APR97 pt devel a rash on face, tummy & back;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 5:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 5:28 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.88.  Concomitant products were not provided.  On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Received 0.5 ml dose for their booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster). At the time of the report, ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-363330 (Patient Link).
The pt experienced a fever on the night of administration. Over the next several days, the left arm swelled to twice the size of the right arm. Mild cellulitis was noted at the next visit. Treated with Keflex.
Supraventricular Tachycardia Elevated heart rate 250-260 BPM for up to 1 hour Hospitalization
Chills, body aches, joint pain, fatigue, dizziness. I took ibuprofen 400mg q6 with minimal effect. I felt much better by my second day after the vaccine but still with fatigue, dizziness and joint pain. By the third day after I felt back to normal.
(L) deltoid area - warm, tender to touch, red with a blanched ring around injection site, itchy.
Dizziness, NauseaVomiting, Palpitations, Tachycardia, None Narrative:  Employee experienced listed symptoms appox. 1800 on 12/30. Has made it difficult to perform daily routine. All non listed vitals within normal limits.
Moderna COVID-19 Vaccine EUA Fever, joint pain, headache, nausea. Treated at home with OTC meds Severe rash on torso, arms, neck, thighs. TakingSteroid dose pack, Benedryl, Ibuprofen. Not yet resolved.
Patient went to the pharmacy to state that the area where the vaccine was administered was inflamed and painful. We encouraged him to go to the doctor to be evaluated. Patient went to the doctor. The doctor prescribed the antibiotic Ciprofloxacin 500 mg tablet to take twice a day. The patient was called days later for follow-up and patient stated that he feels better and he no longer has pain in the affected area.
Got shot at 1:00 pm on thursday sept 10th 2009 at pharmacy by pharmacist. 30 minutes after shot started profuse sweating and feeling like my stomach and skin were on fire then had some trouble swallowing. 3 pm became red rashy and hived on face neck and upper chest and at 4pm begin urinating every 5 to 10 minutes and until 10 pm that evening. Started taking Benadryl at 4 pm called family physician. No response til next day from them. Called pharmacy also next day which recommended Benadryl and call doctor. Doctor advised Benadryl.  Doctor gave prescription of Atarax Sat Sept 12th due to still having flushing/hiving but has become less harsh and coming and going away. I am somewhat better today Sept 13th but still have mild symtoms but a little lightheaded feeling. Family doctor said to avoid any future flu vaccines despite being in the risk category of needing one and for your information I also regularly get flu vaccines yearly though last year (2008) it hurt from my shot location to my hand and up through my neck but cleared up within two days and I did not report that did not know it was a potential problem. This 2008 shot was also at the same pharmacy.
Dizziness, Headache, Myalgia,   dizziness later in the day after vaccine; all other symptoms started next day including fatigue and chills.
injection site Areas was hurting; injection site Areas was red / pink; spot at the injection site; area was bruising; Area was Blotchy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number T7S73, expiry date 17th September 2022) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 18th September 2020, less than an hour after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site rash, injection site bruising and skin blotches. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site rash, injection site bruising and skin blotches were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site rash, injection site bruising and skin blotches to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in right arm. Within an hour after vaccination, the patient had a spot between the size of a quarter and a half dollar at the injection site on her right arm that was pink and bruised.  The patient claimed that the areas was hurting, red, blotchy and bruising.  The symptoms had not resolved till the time of reporting. The reported called back with batch number and expiry date for the Shingrix administered. No further follow up information reported.
Patient developed dizziness, nausea, lightheadedness, and felt like he was going to pass out. Resolved after about 5 minutes of sitting down and sipping water.
I got Covid from family gathering, was exposed 11/10 and 11/11, I departed on the 12th to return home, PCR Covid test results were positive on the 11/14.
I was injected with my 2nd dose of SHINGRIX 5mcg. The pain in my arm was unusually high, and remained so to the point I had a hard time sleeping that night. The next day I felt I had a serious case of the flu - body aches and muscle pain, and headache to the point I left work a few hours early. When I got home, I got in bed and slept for 5 hours. Woke for a light dinner, and then slept for the next 8 hours. I went to work a few hours late and by mid day, was feeling significantly better. My arm is better but still sore to touch the area administered. My husband had his 2nd dose of SHINGRIX at the same time, and other than commenting on the immediate pain and through the night, his pain was almost disappeared although still sore to the touch. I also had more side affects with the first dose than my husband. I was nauseous with that one, but not the 2nd. Sincerely, patient.
I had soreness swelling and pain in my left armpit swelling went down after two days pain persisted until now. Saw my GP who recommended a breast ultrasound which came back negative for any cancer/benign However, swollen nymph nodes were detected. The doctor prescribed massage to alleviate pain.
Son called health dept. stated arm red and sore, took dad to doctor and was told infected given pills.
I was given the first dose of the  Moderna vaccine on 1/15/21. Eight days later on 1/23/21, the site of the injection became red, hot, itchy, painful, slightly swollen and my entire left arm hurt. I used over the counter hydrocortisone for 3 days.  I called my allergist and she told me to take Zyrtec (I am taking 5mL liquid because the 10 is too strong and I fall asleep at work) and to use Mometasone Furoate Ointment USP, 0.1%  twice daily. I have taken the Zyrtec and used the ointment daily since. My arm continues to be very red, but not swollen, or itchy two weeks later. I have the next vaccine scheduled for 2/12/21 and am concerned about whether I should take it, if this reaction  continues?  Is it normal for a reaction to last this long? I would appreciate a response as I am very worried about the second dose and the reaction I might have if this one continues.
Red/ redness keeps spreading/redness/is 11 ½ cm x 20 ½ cm; Swollen/swelling is 8 ½ cm x 5 cm; Itching; Hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red/ redness keeps spreading/redness/is 11 ½ cm x 20 ½ cm), PERIPHERAL SWELLING (Swollen/swelling is 8 ½ cm x 5 cm), PRURITUS (Itching) and FEELING HOT (Hot to the touch) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On 17-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (Red/ redness keeps spreading/redness/is 11 ½ cm x 20 ½ cm), PERIPHERAL SWELLING (Swollen/swelling is 8 ½ cm x 5 cm), PRURITUS (Itching) and FEELING HOT (Hot to the touch). At the time of the report, ERYTHEMA (Red/ redness keeps spreading/redness/is 11 ½ cm x 20 ½ cm) and PERIPHERAL SWELLING (Swollen/swelling is 8 ½ cm x 5 cm) had not resolved and PRURITUS (Itching) and FEELING HOT (Hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The relevant concomitant medications were also not provided. No treatment information was provided.