chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider at a healthcare facility recommended and or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-JAN-2010, a health care provider (unspecified healthcare professional) administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 18-SEP-2015, the patient was treated by a health care provider (unspecified healthcare professional) for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
From approximately a half hour after the vaccine was administered I began experiencing light-headedness/dizziness. I was told by the pharmacist that this was normal and to drink plenty of water. I was so dizzy that I had to cancel my plans for the rest of the day. At 3 am on the morning of the 28th, I was woken up because I was experiencing a severe episode of epistaxis. It took a while to stop bleeding. For several days I experienced extreme fatigue and dizziness, which eventually improved for me to be able to go back to work. On February 5th, I was putting away dishes when my knuckle brushed up against a kitchen utensil and my knuckle was dripping blood. I'm usually not much of a bleeder so I was surprised at how much I was bleeding and how long it took it to stop. Tuesday, the 8th I was taking a shower and noticed significant patchy bruising on my inner and outer thighs--bilaterally. They were tender to the touch. I had also begun to notice that the dizzy/lightheadness had returned. I scheduled a doctor appointment to be seen by my doctor. I explained the situation  and my concern with these bruising/bleeding episodes that I didn't put together until the bruising was noted on my thighs and became concerned since they started the evening of my vaccine. He was also concerned and ordered blood work. On Friday the 11th, I had a dizzy spell so bad that I needed to be picked up from work and leave early. I have now also been experiencing headaches and an achy feeling in my chest. I have been referred to a cardiologist and a hematologist.
Received injection on May 4, 2011. She started itching 1-2 weeks later. Today, May 23, 2011, pt noticed 3 bumps on her upper (R) arm where she received the injection. She denies pain, but says the site itches. The area is about 1 inch wide with 3 boil-appearing reddened bumps. Pt to RTC in 2 days.
Red... face; warm ...face; itchy face; warm ...ears neck and chedt; itchy ears; itchy...neck and chedt; Red... neck; Red... chedt; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 4 (booster), single (Lot number: P59267-0304-02) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA taken for immunisation, on 13Oct2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE), for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "Red... chedt"; ERYTHEMA (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "Red... face"; ERYTHEMA (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "Red... neck"; EAR PRURITUS (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "itchy ears"; PRURITUS (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "itchy face"; PRURITUS (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "itchy...neck and chedt"; FEELING HOT (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "warm ...ears neck and chedt"; FEELING HOT (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "warm ...face". Therapeutic measures were not taken as a result of erythema, feeling hot, pruritus, feeling hot, ear pruritus, pruritus, erythema, erythema.
Rash over face/abdomen/back papular vesicular in different stages started one day after he received varicella vaccination.
Redness at injection site - lasting 48 hours Pain at injection site/sore arm - lasting 48 hours Low grade fever (99.5F) - started 2nd day lasted for 24 hours Generalized body aches - started 2nd day lasted for 24 hours Headache - started 2nd day lasted 24 hours
I did not have an adverse event after receiving the vaccine. I developed symptoms like I was getting a sinus infection with sinus pressure. I tested positive for COVID-19 on 11/22/2022. I contacted my doctor and received the prescription PAXLOVID and azithromycin. I tolerated the medication. As of today, I still have a runny nose and sinus will cause me trouble.
Pain in arm, then got really tired and headache felt hot yet cold, woke up around 3 AM needing to use restroom. Couldn't fall back asleep then checked temperature, 100.7 Took Tylenol but didn't really help. Fever went away around 10 A.M. that morning, but I was super tired and fatigue
Hives on legs, some difficulty breathing (is an asthmatic), hoarseness, dizziness, weakness, headaches. Advised to call physician or go to ER if condition worsened. Seen in ER, given Motrin and sent home.
extreme fatigue; severe headache; some minor aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 09:00 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "history of seasonal allergies" (unspecified if ongoing), notes: history of seasonal allergies; "Covid-19", start date: Nov2020 (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. The following information was reported: FATIGUE (non-serious) with onset 06Mar2021 07:00, outcome "recovered" (2021), described as "extreme fatigue"; HEADACHE (non-serious) with onset 06Mar2021 07:00, outcome "recovered" (2021), described as "severe headache"; PAIN (non-serious) with onset 06Mar2021 07:00, outcome "recovered" (2021), described as "some minor aches". Therapeutic measures were not taken as a result of fatigue, headache, pain. Additional information: 24 hours after first series vaccination, patient experienced extreme fatigue, severe headache and some minor aches. It is worth noting that she was diagnosed with COVID-19 in Nov2020 and while mostly resolved, experienced continuing effects through mid-Feb2021. The patient had covid prior vaccination. The patient was not tested for covid post vaccination. The Pfizer US Drug safety unit recently received the attached report submitted by you. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. The patient learned of the event on 10Mar2021. I am not the patientthis was reported to me by a patient who is not a Pfizer colleague.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning unspecified patients.  The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided.        On unspecified dates, improperly stored doses of with VAQTA (dose, frequency, lot# and expiration date were unknown) were administered to the unspecified patients for prophylaxis. No adverse experience has been reported. The VAQTA was exposed to 35F for a time frame of 60 hours. No data logger and previous temperature excursion were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1611USA010129: US-009507513-1611USA010288:
experiencing episodes of palpitations and chest discomfort; experiencing episodes of palpitations and chest discomfort; palpitations; lightheadedness; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7933) via an unspecified route of administration in the arm left on 14Apr2021 at 10:00(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (EUTHYROX) from an unknown date for an unknown indication. The patient had no known allergies. 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 14Apr2021 at 13:30, about 3.5 hours after the vaccination, the patient experienced heart racing and lightheadedness at rest which was resolved after a few minutes. On 16Apr2021, two days after the vaccine, the patient started experiencing episodes of palpitations and chest discomfort for 5-10 minutes at a time. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events and included the treatment with aspirin (MANUFACTURER UNKNOWN). The clinical outcomes of the events heart racing and lightheadedness was recovered on 14Apr2021 and of the episodes of palpitations and chest discomfort were recovering.   No follow-up attempts are needed. No further information is expected.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.    This case was linked to MOD-2021-395985 (Patient Link).
third dose in a female patient  today /  patient recieved another dose; had a temperature; nausea; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 444M2, expiry date 10th April 2022) for prophylaxis and INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HD) for prophylaxis.   Previously administered products included Shingrix (receivd 1st dose in 2020).   In August 2020, the patient received the 2nd dose of Shingrix. On 27th August 2020, the patient received the 3rd dose of Shingrix. In August 2020, the patient received FLUZONE HD. In August 2020, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever and nausea. On 27th August 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the fever, nausea and extra dose administered were unknown.   It was unknown if the reporter considered the fever and nausea to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of vaccine in unknown arm. The pharmacist wanted information regarding a Shingrix third dose in a patient. The patient received 3rd dose of Shingrix which led to extra dose administered. The reporter stated that in last week the patient received 2nd dose. The first dose was started in year 2020 before coronavirus. The pharmacist reported that patient over the past week following dose 2 felt like she had a temperature and experienced nausea. The patient also got a Fluzone HD shot the day of 2nd dose of shingrix but in different arms. The reporter consented to follow up. It was unknown if the reporter considered the fever and nausea to be related to Fluzone HD.
The 2 toes next to the baby toe on his left foot swelled up; The finger next to the pinkie on his left hand swelled too and is painful,he can't bend it; He has throbbing in the joints of that finger, and it sometimes wakes him up; Chest discomfort from the center of the chest over to the left side of the chest; This thing with the shot is really irritating; Sharp pain in his left shoulder; Left arm hurt & was sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (The 2 toes next to the baby toe on his left foot swelled up), PERIPHERAL SWELLING (The finger next to the pinkie on his left hand swelled too and is painful,he can't bend it), PAIN IN EXTREMITY (He has throbbing in the joints of that finger, and it sometimes wakes him up), CHEST DISCOMFORT (Chest discomfort from the center of the chest over to the left side of the chest) and VACCINATION COMPLICATION (This thing with the shot is really irritating) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (The 2 toes next to the baby toe on his left foot swelled up), PERIPHERAL SWELLING (The finger next to the pinkie on his left hand swelled too and is painful,he can't bend it), PAIN IN EXTREMITY (He has throbbing in the joints of that finger, and it sometimes wakes him up), CHEST DISCOMFORT (Chest discomfort from the center of the chest over to the left side of the chest), VACCINATION COMPLICATION (This thing with the shot is really irritating), ARTHRALGIA (Sharp pain in his left shoulder) and VACCINATION SITE PAIN (Left arm hurt & was sore). At the time of the report, PERIPHERAL SWELLING (The 2 toes next to the baby toe on his left foot swelled up), PERIPHERAL SWELLING (The finger next to the pinkie on his left hand swelled too and is painful,he can't bend it), PAIN IN EXTREMITY (He has throbbing in the joints of that finger, and it sometimes wakes him up), CHEST DISCOMFORT (Chest discomfort from the center of the chest over to the left side of the chest), VACCINATION COMPLICATION (This thing with the shot is really irritating) and ARTHRALGIA (Sharp pain in his left shoulder) outcome was unknown and VACCINATION SITE PAIN (Left arm hurt & was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-347048 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Event -Vaccination complication was added and also Vaccination Facility details were added.
Swelling of lymph nodes behind ears, soreness both armpits, chills, Rash, fever, headache, nausea, malaise, myalgia, mild conjunctivitis, mild rhinorrhea, decreased appetite, photophobia, pharyngitis, one ulcer in mouth
pt recvd vax & w/in 24 hrs of vax pt had either an onset of or an inc in apnea;
extreme exhaustion for 36 hours, nauseated - wanted to throw up until about 6pm the next day....appx 24 hours total but didn't start until I woke up the day after the shot
Initial report received from healthcare professional on 04 November 2013. A 13-year-old male patient and his mother, whose medical history and concomitant medications were not reported and had the vaccine every year since 2003, were both received a dose of Flu vaccine (manufacturer, batch number, route and anatomical site of administration were not reported) on an unspecified date of Saturday.  It was reported that, after vaccination in the same day at 2:30 PM patient told to his mother his arm hurt and was swollen. There was a black and blue mark around the injection site, about 1 cm in diameter. His shoulder was noticeably swollen compared with the arm, and it was hard to the touch. He didn't have a fever. Patient's mother gave him 200 mg Ibuprofen. later that night (around 9 pm) the swelling was reduced but still there. His arm was still sore. On Sunday (the next day), his arm was still sore but not to the point. Documents held by sender: none. Follow up information received on 28 April 2014. It was reported that patient had received FLUZONE vaccine on 02 November 2013. The patient had illness at the time of vaccination was reported as none and patient had allergic to sulfa antibiotics. The patient other medications were reported as none. On 02 November 2013 i.e. on same day of vaccination patient had experienced his arm hurt and was swollen. There was a black and blue mark around the injection site, about 1 cm in diameter. The outcome of the event was recovered on an unspecified date.
Patient reported blurred vision, slurred speech, ligthheadedness and headache lasting for 2-3 hrs except headache which persists.  Additionally, noted throat feeling tight and panicky while brushing teeth this morning (9/25/2013) and she administered 2 puffs of her albuterol inhaler.
430PM 27OCT94 got tingling feeling all over & lips sl numb, severe h/a started @ 11PM & got worse this AM 10AM 28OCT93 achy shoulders-no temp;
there is a red patch extending about 2 inches out from around the site of the shot; the red skin is warm, hard, and very painful. I?m also feeling a bit under the weather/like a very mild flu.
Information has been received from a certified medical assistant concerning a 73 year old female with a history of colonic polyp, hyperlipidaemia, and hypertension who on 26-MAR-2007 was vaccinated with Pneumovax 23 (lot # 655501/1035F) 0.5 ml IM in the left upper arm.  Concomitant therapy included BENICAR, hydrochlorothiazide (MSD), CLIMARA, furosemide, and trazodone HCl.  On approximately 27-MAR-2007, one to one and a half days after the vaccination, the patient experienced cellulitis that was not at the injection site but a couple of inches below the injection site.  The area was warm to touch and very slightly raised.  The affected area was round (baseball size) that extended around the left arm.  The patient sought medical attention and was told to take TYLENOL and BENADRYL.  On 31-MAR-2007, the patient recovered.  Additional information has been requested.
Dad said patient went home from school 4-17-15 with a migraine in the morning. Received immunizations 4-17-15 at 1600. Mom said he started hot feeling well 4-17-15 around 1900, while they were out to eat. 4-18-15 woke up around 1000 with fever 104. Patient was seen in urgent care around 1200 with fever, headache, stomach ache. He was seen again 4-19-15 in the ER for fever at 2130. On 4-22-15 he was seen in the clinic for continues fevers. Continues to run fever off and on.
Private MD provider called Hlth Dept stating child had abscess @ inject site, child started on Augmentin;
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient came in today (4/28/21) complained about the injection site being swollen and painful after her second Pfizer injection on 4/25/21. She reported no such pain occurred during the first dose of the series on 4/3/21. The pain got worsen on 4/26/21 and was keeping her awake at night. Injection site observed to be swollen and patient reported it is warm to the touch.
I had a really bad nose bleed the morning after (about 19 hours) my bivalent booster shot. It was lots of bright red blood, then a large clot, then more bright red blood. I got it to stop after about 5-10 minutes. I never had this with any of the other doses. I do not have a history of nose bleeds.
Muscle pain, fatigue flu like symptoms, peaked 18 hrs, better 24 hrs. Pt had to take day off from work. Rested felt much better 2nd day.
Patient became lightheaded after receiving this vaccine. He was revived with ammonia capsule, after it was placed under the nose. He was given water to drink. Vitals were taken BP 120/70, P 68, R 16. Patient stated that he felt fine, no longer dizzy or lightheaded. He was made to sit for about 20 minutes. He refused to lay down and stated he was fine.