chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a consumer (who is a nurse) on 07 Oct 2010: This patient with an unknown medical history was vaccinated with FLUVIRIN (batch number unknown), 0.5 ml intramuscularly on 27 Sep 2010. After the vaccination the patient experienced severe reactions such as increased blood pressure, uncontrollable shakiness, redness and swelling at injection site, numbness of the left side of face and upper body on 27 Sep 2010. The patient was admitted to emergency (ER) for a day. The patient also experienced severe headache 04 to 05 days after the vaccination. The patient received treatment with ZOFRAN and SOLUMEDROL. The outcome of the events was reported as condition resolved on 02 Oct 2010.
4:45 AM 8/21/21 - Diarrhea and vomiting, chest tightness; 5:05 AM 8/21/21- syncope. Another period of vomiting, diarrhea, and syncope between 5:45am and 7:30AM. Patient's husband said he wanted to take her to local ED but she had refused. At that point she seemed stable and was resting comfortably at home. I offered monitoring parameters for HR and breathing. I also told him to give her diphenhydramine 25mg and famotidine 20mg to mitigate any early allergic reaction. At 9:00am she reported feeling slightly better with no other side effects.
low grade, continuous ear ringing (tinnitus)/tinnitus became severe and is constant; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 11Mar2021 (lot number and expiry date were not reported) as a single dose (given at the age of 44 years old), and then dose 2 via an unspecified route of administration, administered in the left arm on 01Apr2021 12:30 (lot number and expiry date were not reported) as a single dose, for covid-19 immunisation. Medical history included blood pressure (abnormal), and patient had COVID over a year ago (date unspecified), and had lingering inflammatory issues since that time, but not tinnitus. The patient had no known allergies. Concomitant medications included unspecified blood pressure medications in two weeks prior to vaccination. The patient had no other vaccine in four weeks. It was reported that within a few days after the first shot, patient had low grade, continuous ear ringing (tinnitus) started (Mar2021). Patient went to the doctor, who thought it would resolve on its own and advised to get the second shot. The tinnitus did not resolve prior to the second shot (3 weeks later). Within 2 days of the second shot, the tinnitus became severe and was constant. Doctor prescribed a high dose cycle of steroids (6 days) starting that day; steroids have not improved symptoms. It's been over a week since the second shot-no relief. The patient was not tested for COVID post vaccination. The event was reported to have resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the event tinnitus was not recovered.   Information on the lot/batch number has been requested.
Fever, chills, fatigue, muscle aches, nausea, death 48 hours after injection
Information has been received from a consumer, for VARIVAX (Merck), a Pregnancy Registry product, concerning his 14 year old sister with no known medical history and no known drug reactions/allergies, who on 25-AUG-2010 was vaccinated with VARIVAX (Merck) (Dose/Frequency: unspecified) (Lot#/ Exp. Date: unspecified). There was no concomitant therapy. The patient was pregnant before she got the vaccine shot. She had bruising, swelling and pain at the injection site. The patient was at the hospital for 4 to 5 hours. They did blood work on her, results not provided. The patient's bruising, swelling and pain at the injection site persisted. The patient sought medical attention by going to the hospital. Additional information is not expected.
Swelling, itching, burning, redness, blocked ears (I needed to hold my nose and blow) itching - mostly hands, face, torso. Redness - hands, arms, torso, crotch. Called primary MD,  called  Healthcare facility clinic, went to pharmacy and spoke to pharmacist. Took Benadryl.
Booster shot 11/6/2021 11/08/2021, started feeling vulvar irritation. Pt has vulvodynia so did not think much of it, examined site and noticed ulceration, bleeding. Sought medical care on 11/9/2021, HSV culture swab of ulcers collected. Valacyclovir prescribed to take until results return. Pt has no prior history of herpes outbreaks, no recent sexual contact. Had covid July 2021, experienced severe mouth ulceration during infection. 11/18, hsv culture resulted negative, ulcers never crusted over or took typical herpes appearance, pt?s clinician assessed as likely related to immune response from vaccine, not herpes virus.
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. The patient also experienced skin striae. In August 2018, the outcome of the pain in arm and skin striae were recovered/resolved. It was unknown if the reporter considered the pain in arm and skin striae to be related to SHINGRIX. Additional details were provided as follows: The physician called to report an adverse event for himself. The patient was administered SHINGRIX in the left arm 2 weeks before the reporting date. The patient stated that he experienced pain in the left arm. One day after receiving vaccination, the patient experienced striae in the left arm. Both the events lasted for approximately 1 week before going away.
PNEUMOVAX 23 and FLUZONE given in same arm (2 inches apart) on same day. Pt was getting a TDAP at MD's office later same day in left arm on 12-8-10. Pt reported on 12-11-10 Rt arm is swollen, red & hurts.
immediately following the vaccination (within seconds) patients head dropped down. I said his name bc I thought he was looking down at first but he would not respond for about 20-30 seconds before he came to.  He blacked out for that short amount of time he said everything suddenly went black. He was able to get to the floor with assistance once he came to and he laid down, he was sweating and pale. his BP was 138-78 pulse 88 about 10 minutes after the event.  he had reported being nervous when he first arrived for his appointment. he also has severe food allergies but never had a reaction to a vaccine.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). Case identifier: NUS2022US023693_NC. A 71-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 71, Dec 2021, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medication: Ramipril. Vaccination history included the COVID-19 vaccine (primary immunization series complete, manufacturer unknown), for COVID-19 immunization. The patient developed a rash (non-serious), with outcome of recovering; pruritus/itching to his lower extremities below the knee to the ankles, with outcome of recovered and skin discoloration/skin still discolored at the rash site (non-serious), with outcome of not recovered. Therapeutic measures were taken as a result of rash, pruritus and skin discoloration. Additional information: The patient currently using a steroid cream on the rash and improving. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
One hour after administration of vaccine patient developed red, raised welts on forearm lasting for one hour. (Two patients reported the same reaction on the same day at our facility).
Elevated heart rate, chills, nausea, perspiration, body aches, neck and lower back stiffness
Two weeks after vaccine woke up with tingling running up and down left leg and being based in the left foot. Throughout the day tingling turned to numbness as if leg were asleep, and feeling in foot turned to strong pain. Had ultrasound in the leg to check for clots (although they did not check foot) and nothing was discovered. After this pain escalated and a week after I was unable to keep my foot still for more than a minute without the intense pain rushing back - the feeling was as if my foot were cramping to an extreme. Elevating helped somewhat but for the most part if I wasn?t moving I was crying in pain. The numb feeling is still there as of over a month later but I?m able to hold still without feeling as if my foot is rapidly atrophying.
1.4hr p/vax pt started screaming episode that lasted over 4hr;pt was inconsolable;had no other unk illness;
stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke".  Clinical course: The patient had a stroke within a couple months after getting the Pfizer vaccine at a pretty young age when they had no health issues earlier.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (05Apr2023): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation of below mentioned query: Removed patient's details (age group, gender and non-Study Pt ID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (18Apr2023): This is a follow-up report to notify that the case 202300145036 and case 202300161896  are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202300161896.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300145035 Same reporter/ drug/ AE, different patients;US-PFIZER INC-PV202300062721 Same reporter/ drug/ AE, different patients;
Fever to touch 3/14 in the evening left thigh with redness, slight edema and warm to touch when awoke this AM. Fever also.
I21.4 ACUTE NON ST ELEVATION MI 2/14/2023 ASPIRATION PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 2/8/2023 ASPIRATION PNEUMONIA R57.0 CARDIOGENIC SHOCK 2/14/2023 ASPIRATION PNEUMONIA I21.4 ACUTE NON ST ELEVATION MI 2/14/2023 CHF, STAGE D J96.00 ACUTE RESPIRATORY FAILURE 2/8/2023 CHF, STAGE D R57.0 CARDIOGENIC SHOCK 2/14/2023 CHF, STAGE D I21.4 ACUTE NON ST ELEVATION MI 2/14/2023 ACIDOSIS, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 2/8/2023 ACIDOSIS, UNSPECIFIED R57.0 CARDIOGENIC SHOCK 2/14/2023 ACIDOSIS, UNSPECIFIED
Muscle soreness,  swelling,  and redness at site area. Second day of the issue.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received FLUARIX Quadrivalent. In 2015, the patient received FLUARIX Quadrivalent. On an unknown date, less than a month after receiving FLUARIX Quadrivalent, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. The reporter considered the pain in arm to be related to FLUARIX Quadrivalent. Additional details were received as follows: This case was previously reported to manufacturer. The reporter was Director of Pharmacy and was asked to contact GlaxoSmithKline by employee health department to saw if there were any reports of extreme arm pain. The reporter stated that, their hospital changed FLUARIX Trivalent to FLUARIX Quadrivalent this year. The reporter stated that, last 2 weeks ago from reporting date, the patient had received FLUARIX Quadrivalent and experienced severe arm pain. The patient was nurse and after severe arm pain she had to miss time from her work. The reporter did not have the further information about patient and vaccine. The reporter did not know when the arm pain began or resolved. This case was linked to case US2015149595 reported by the same reporter.
I have experienced "occasion sinus tachardia" several times since my 2nd dose of Pfizer Covid vaccine. On 5/20/2021 - one week after my 2nd dose - I had to call EMT's because of a sudden accelerated heart rate. This happened again on 6/26/2021 and I had to go to the Emergency Room - by the time I got there, it had subsided and they couldn't determine what the problem was. I saw a Cardiologist in July 2021 and they were unable to find any major abnormalities. The same thing happened again in August of 2021, then I have not had any events until Yesterday, 6/21/2022. The EMT's EKG said: Sinus Tachardia w/occasional premature complexes" This is the first time the event was caught in progress. I find it compelling that since I had the 2nd dose of the Pfizer Covid-19 vaccination, I have had  3 events only weeks apart, and then a year later, another event, so I feel I need to report this as it adversely affecting my health, both physically and mentally and also affecting me financially.
blood clot coming out of the mouth when coughing; Nose bleed; pain in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. K1OC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in her left arm). On an unknown date, the patient experienced RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) (seriousness criterion medically significant) and EPISTAXIS (Nose bleed). At the time of the report, RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) and EPISTAXIS (Nose bleed) outcome was unknown and VACCINATION SITE PAIN (pain in her left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: patient's address was updated (changed), adverse events updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Weakness Confusion Falling down Vision impairment  Legs really weak All of the  above symptoms started on March 14, 2021 On March 18,2021 she was not out of bed except for just a few minutes.  On March 19, 2021 she was on the floor laying beside of the bed and my father noticed blood looking stuff on her shirt and bed covers. She was really confused and lethargic. She was really weak and could not stand. She was extremely fatigued. At around 10:30 she fell again on the floor and my father and sister in law was able to get her back up and put her in a chair and she went to sleep. At 12:55 my father noticed she was not breathing and called 911. When they did CPR blood was coming from her mouth and nose. When the ambulance arrived they immediately took her to the hospital where she was pronounced dead at around 3:30 pm.
Her arm was red and hot at first 2 days after the reaction and  she was  happy that it was going away until she woke up the next day (3rd day) and she was not able to lift her arm.
swelling; redness; pain; fever; This case was reported by a nurse via sales rep and described the occurrence of swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received Shingrix. On 11th July 2019, 3 days after receiving Shingrix, the patient experienced swelling, erythema, pain and fever. On an unknown date, the outcome of the swelling, erythema, pain and fever were unknown.   It was unknown if the reporter considered the swelling, erythema, pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine and experienced pain, redness, swelling and fever. The reporter was agree to follow up.
One day on late July she entered the room and could not talk coherently, she was vomiting. Taken to the doctor and doctor thought it could be viral meningitis, no test were done. She had no energy for a week. could not lift head off pillow, 1 more week passed until she recovered. Late Sept pts knee caps began to pop. Taken to orthopedic surgeon and currently on physical therapy once a week at office and twice a week at home. MRI found that certain muscles were underdeveloped and physical therapy is trying to correct it. Pt was a swimmer but due to problems with knee caps and hips quit swimming for season. Currently taking anti inflammations has a cyst behind left knee cap. Pt is wearing corrective shoes because arch fell. Ligaments not supporting the arch.
Palms, skin around nails, back of hands are hot and at same time, palms and skin around finger nails are very red. Accompanying feeling feels like how face feels when running fever. Fingernails feel very warm to touch. Face feels hot and same burning feeling also to eyes, neck, chest, back of upper arms. Rash. Filled out vsafe form this morning but forgot to add these.
Fatigue; Body aches / Muscle Pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Body aches / Muscle Pain), CHILLS (Chills) and PYREXIA (Fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 039C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Body aches / Muscle Pain), CHILLS (Chills) and PYREXIA (Fever). On 31-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, FATIGUE (Fatigue), MYALGIA (Body aches / Muscle Pain) and CHILLS (Chills) outcome was unknown.            patient stated fever occurred only last night and does not have fever that day. Concomitant medications were not provided. Treatment includes intake of lot of fluids.
Information has been received from an 87 year old female with allergy to sulfa drugs and a history of gall bladder removal, who on 19-OCT-2006 was vaccinated by injection with a single dose of Pneumovax 23.  The patient concomitantly was vaccinated with influenza virus vaccine (unspecified), (name and manufacturer unknown) and other concomitant therapy included LASIX, DIOVAN and PROTONIX.  On the same day, 19-OCT-2006, the patient began to experience "severe burning feelings inside her entire body."  The patient reported that this only occurred at night and it had occurred every single night since this began.  She said that the outside of her body is cool even though she was "burning up inside."  She said that she was convinced that this was due to the Pneumovax 23, because in the past years she had received the same flu vaccine and had never had any adverse reactions from it.  The patient sought unspecified medical attention.  She added that she had gone for many different types of tests, but her physicians could not find anything to explain what she was experiencing.  Additional information has been requested.
Administered a pediatric dose of 0.5 ml split from a adult Engerix formulation syringe; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th May 2021, the patient received Engerix B adult .5 ml and Engerix B Pre-Filled Syringe Device. On 10th May 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced inappropriate reconstitution technique. On an unknown date, the outcome of the inappropriate reconstitution technique was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. 2 pediatric patients were administered with a pediatric dose of 0.5 ml split from an adult Engerix formulation syringe. One patient was administered the dose on 10th May 2021 and for the other patient details unknown. This led to inappropriate reconstitution technique . Pharmacist unable to provide details on vaccine and patient. Did not consent to follow-up. This case was linked with US2021AMR123242, for same reporter; Sender's Comments:  IT-GLAXOSMITHKLINE-IT2021112529:Deleted US-GLAXOSMITHKLINE-US2021AMR123242:Same reporter
Patient indicates that since 3/26/15 she has a rash on the vaccination area.
Had a sore arm(where the injection site was); Had a sore arm(where the injection site was); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Guillain-Barre Syndrome", start date: 2006 (unspecified if ongoing), notes: The caller states she Guillain-Barre Syndrome(GBS) 16 years ago following a case of shingles; "shingles" (unspecified if ongoing), notes: The caller states she Guillain-Barre Syndrome(GBS) 16 years ago following a case of shingles; "Peripheral neuropathy" (unspecified if ongoing), notes: She developed Peripheral neuropathy in her feet after having Guillain-Barre Syndrome(GBS).; "Exposure to COVID-19" (unspecified if ongoing), notes: Caller has been Exposed 2 time to COVID19 and never got it. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as Had a sore arm(where the injection site was).  Additional information: Patient states she has had the Pfizer COVID vaccine primary series 1 and 2 and 2 previous booster doses from Pfizer. She had No side effects from the 1st dose and with the 2nd dose she Had a sore arm (where the injection site was) and the 2nd booster dose she experienced fatigue. I don't get the shingles shots, flu shots or pneumonia shots. Because they have the virus in them.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201357266 same patient, different dose/event;US-PFIZER INC-202201357265 same patient, different dose/event;