chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness and tingling in fingers on the right hand; Numbness and tingling in fingers on the right hand; Soreness on wrist and in right hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Jul2021 13:00 (Lot number: EW0179) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hbp" (unspecified if ongoing), notes: Other medical history: Hbp. Concomitant medication(s) included: DILTIAZEM. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 30Jul2021 06:30, outcome "not recovered" and all described as "Numbness and tingling in fingers on the right hand"; PAIN IN EXTREMITY (non-serious) with onset 30Jul2021 06:30, outcome "not recovered", described as "Soreness on wrist and in right hand". The events "numbness and tingling in fingers on the right hand", "numbness and tingling in fingers on the right hand" and "soreness on wrist and in right hand" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, pain in extremity.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Approximately 1 hr and 45 minutes after vaccinations pt phoned the clinic with complaint of abdominal pain,scratchy throat, and SOB. client was advised to call 911 for transport to ER. At 14:50  P/C to client . RE: status she advised she was driving to Er. At 15:00 client phoned from ER where she is receiving treatment.
This spontaneous report was received from a registered nurse concerning a patient of unknown gender and possibly with 12 month old or 21 month old. On 26-MAR-2013 the patient received inadvertently a dose of PROQUAD and a dose of VARIVAX (Merck) (lot number and expiration date of both vaccines were not reported) (route of administration of both vaccines was not reported). Concomitant therapies were not reported. The reporter stated she was still in the process of identifying the patient involved, that was seen in the clinic on 26-MAR-2013. No adverse effects reported. Additional information has been requested.
Saw doctor 5 times - took Keflex - Mupirocin ointment, still drains - has 3rd scab as 79/17/07 - still red around scab.
patient received 4 doses of COVID vaccine. dose 1-2 back in December and January. received a moderna doe in March and we administered the 3rd Pfizer (4th total) dose 9/30/21 unaware of the moderna dose.
Swelling, redness at site on left arm.  Treated with BENADRYL & clindamycin.
First felt light headed, then my tongue, throat, and neck felt sore within approximately one hour of injection. Then my eyes started itching and it was more difficult to breathe through my nose. Things looked funny/off and I felt off; heavy/like lead and fuzzy and spacey at the same time. My vision was blurry when I tried to look at objects up close - like my phone. I had to blink several times and hold the object further away to see it. By dinner time, around 5:30, I noticed raised bumps on the sides and back of my tongue. To my knowledge, they were not there prior to the injection, but I don?t usually inspect my tongue. I did so around dinner because of how sore, puffy, swollen, and big my tongue felt. It looked splotchy in shades of white and yellow. My throat also felt puffy and swollen. At 3:50 am I woke up and my left eye was puffy and difficult to see out of. I was cold, clammy, and sweating. I had a really bad headache and felt nauseous. I took 2 ibuprofen and went back to bed. Around 7:30 or 8:00 am I got up and moved around. My left eye was no longer puffy and I could open it, but my eyes, nose, and throat were itching so badly that I wanted to scratch at them. My tongue, throat, and respiratory system felt puffy and swollen. I noticed it took much more effort to breathe. I got some water and took a Benadryl. I layed down and put  my feet up. I covered up because I was cold. I fell asleep. A few hours later I woke up and could breathe easier. The itching was less intense and my tongue, throat, and respiratory system felt less swollen and more normal.
Erythema, pain and warmth at site of injection - exaggerated, measured at 9 x 7.5 cm.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JUL-2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a health care facility/office (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-JUL-2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Day after flu vaccine, at 7:20PM, my child had what seemed to resemble a seizure. While my child was sitting in my lap, she threw her head back and her whole body became rigid.  Her eyes rolled back.  She was unable to control her body or respond to me for aprox 60 secs.  When she came out of it, she was tired and upset.  911 called.  I transported child to ER.  ER Dr ordered blood work and CT Scan. Both normal. Released at 4AM on Jan 12th. No meds given.  Instructed to monitor child and follow up with pediatrician on Monday, Jan 14, 2013.
4/28/21 @ 630p headache,muscle pain,nausea,left arm pain. 4/29/21 715am slight headache, mild left arm soreness, over whelming nausea, dizziness followed by passing out. 4/30/21 715a slight left arm pain. Feeling fine.
Patient had left the health department but returned in 30-45 minutes stating her lips were numb and under her tongue it felt funny. Consulted with Dr. in patient's presence. Dr. asked about difficulty breathing, itching which patient denied. We suggested she go to her doctor's office and tell him about her symptoms and see how she was feeling then and what he wanted her to do. Patient called back about 2:15 PM. Stated she had had a reaction. She went to her doctor's office but he was not there so she went on to the ER. They gave her Benadryl and a Rx for a steroid. I told her to call again if anything more happened.
Migraine type headache since receiving the 2nd dose; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 04Mar2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included prostate cancer. The patient had no allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included montelukast (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and alprazolam (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Mar2021, at 18:00, the patient experienced migraine type headache. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse events was reported as no. The clinical outcome of the event migraine type headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
2-3 days of swelling  of throat/neck  with a sensation of a foreign body in throat then  lost voice or raspy voice for weeks.
13yo patient had already received dose one on 5/14/21 and dose two on 6/25/21 at clinic.  Father called to make an appointment for patient to receive second dose of the vaccine. Patient was scheduled to receive second dose on 12/30/21. Mother came in with patient and vaccine was given. Patient did not have vaccine card. Upon checking  vaccine record to print for parent, I realized that patient had already been given two vaccines and finished series.  Patient and parent were notified of error at the clinic. Mother thought that patient was at clinic to receive a booster while father thought patient needed a second dose.    Patient was monitored for 30 mins. No complaints of side effects or adverse reaction noted. Covering PCP Dr. made aware and spoke with parent over the phone.
experiencing tinnitus / residual ringing; This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number C5JL7 ?, expiry date 30th November 2021) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix. On 26th February 2020, 2 days after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were reported as follows: The patient received Boostrix and after 2 days experienced tinnitus and till the time of reporting experiencing residual ringing.  Reporter consented to follow up. This case has been linked with case US2020098380, reported by same reporter. Note:lot corresponds to Boostrix lot however it was reconfirmed that the reporter mentioned it as Shingrix; Sender's Comments:  US-GLAXOSMITHKLINE-US2020098380:same reporter
administered Rotarix via intramuscular route; This case was reported by a other health professional via call center representative and described the occurrence of wrong route of administration in a 1-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 3594G, expiry date 2nd May 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 9th March 2022, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 9th March 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration 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 provided as follows: The reporter was practice manager. The reporter reported that patient was administered Rotarix vaccine via intramuscular route, which led to wrong route of administration. The vaccine was given into the thigh, but reporter did not have information regarding if it was right or left. The reporter stated that the parents had been notified. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
HEPLISAV-B given subcutaneously; Initial Report Received on 24-Jun-2019, 27-Jun-2019, and 25-Jul-2019  A pharmacist reported that a 34-year-old female patient was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. "HEPLISAV-B (was) given subcutaneously."   Relevant medical history was not provided. The patient previously received 2 doses of the 3 series hepatitis B vaccine. The patient had no known allergies.   Concomitant medications were reported as none.   On 24-Jun-2019, the patient received the first dose of HEPLISAV-B subcutaneously in the left interior arm from a pre-filled syringe (lot # 933094, expiration date 17-Apr-2021, and NDC # 43528-003-05). On this date, the adverse event report was received via voicemail.   On 27-Jun-2019, the pharmacist reported that she was "confused" when giving the injection because she had been giving a lot of subcutaneous vaccines lately. The patient had no adverse reactions at that time and when the pharmacist spoke with the patient on this date, the patient continued to have no adverse reactions to report. No further information was provided.   On 25-Jul-2019, the pharmacist reported that she did not administer a second dose of Heplisav-B yet.   At the time of this report, no adverse events were reported.   The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of incorrect route of product administration as non-serious. The event of incorrect route of product administration is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of incorrect route of product administration as non-serious. The event of incorrect route of product administration is unlisted per HEPLISAV-B USPI.
No additional AE; Customer reports an expired dose of V AQTA was given to a patient; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 30-OCT-2020, the patient was vaccinated with an expired, pediatric dose of hepatitis a vaccine, inactivated (VAQTA) 25 U/0.5 mL injection, 1 dose, lot # S026003, expiration date 17-OCT-2020 (dose number and anatomical location were not specified) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026003; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient had grand mal seizure like activity this morning, is being evaluated in the local ER for possible reaction. Unknown dx at this time of report. She is responsive and reporting her symptoms. She has not had seizure in the past she reports. Was feeling symptoms of fever and chills and fatigue on 10/31 and 11/1 after her Moderna booster stayed home from work on 11/1 felt improved on 11/2 and 11/3 reported feeling well then around 11 am she collapsed and had seizure. Unknown of details as Pt is in ER currently.
Information has been received from a physician concerning an 8 month old patient who was vaccinated with a complete series of Rotateq. Subsequently, a complete series of the patient experienced intussusception, sought unspecified medical attention and recovered. No product quality complaint was reported. No further information was available. Upon internal review intussuception was considered an other important medical event. Additional information has been requested.
COVID-19 virus test positive; COVID-19 virus test positive; Headache; Sinus congestion; This is a spontaneous report from a contactable consumer reported for himself. A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9899 and expiration date unknown), via intramuscular on left arm on 22Dec2020 at single dose for COVID-19 prophylaxis. The patient medical history reported as none. Concomitant medications reported as none. The patient is a radiology technician that reported that he got the Pfizer vaccine on the 22Dec2020. He said that he got a positive Covid test on 04Jan2021. The patient had the Covid symptoms as of last Monday night on 04Jan2021. He stated that he developed a headaches and sinus congestion on the 04Jan2021. Stated that he has not had a fever. He said that there was no adverse reaction from the vaccine itself. He said that he was due for the second dose on the 11Jan2021 and he is currently quarantined so he will not be getting the second dose. The outcome of the events was unknown.
Injection site pain within 24 hours, lasting 48 additional hours.  Nausea onset 30 hours after first dose injection.  SEVERE vomiting 33 hours after first dose injection which came in frequent waves over the following 3 hours, but then subsided.
This spontaneous report as received from a consumer refers to a 11 year old male patient. The patient's medical history was not reported. On 25-FEB-2015, the patient was in the physicians's office to receive M-M-R II (albumin status not provided), GARDASIL and unspecified tetanus toxoid vaccine (lot #, dose, route and site of administration were not provided for all the vaccines). The patient received 2 out of the 3 vaccines during the visit. The nurse administering the vaccines informed that the patient received M-M-R II and tetanus toxoid vaccine. On 25-FEB-2015, after administration of the 2 vaccines, the patient's face became pale white and he passed out. When the patient regained consciousness, he vomited. No medical treatment was given for the adverse events. The outcome of loss of consciousness, vomiting and pallor was unknown. The relatedness between the events and M-M-R II and GARDASIL was not reported. Additional information has been requested.
Information has been received from a 25 year old female certified medical assistant concerning herself that she was vaccinated IM with the third 0.5 ml dose of GARDASIL.  Subsequently she experienced extreme arm pain, including shooting pain in her arm, and difficulty lifting her arm for 2 days and she recovered.  This is one of several reports from the same source.  Additional information has been requested.
Patient had a vasovagal syncope episode immediately after vaccination and again in observation area 20 minutes after vaccination. Patient hit head on asphalt after second vasovagal syncope episode. Patient had small abrasion to front left side of head. Patient has a fear of bodily harm and was thinking about vaccination causing his second vasovagal syncope episode. 9-1-1 was called and Medical Doctor provided aid to patient until EMS was onsite. Patient was transported to Hospital by EMS.
The patient received both the seasonal and pneumonia vaccines on 1/20/10, both in the left arm, one 5 cm below the tip of the shoulder, the other 3 cm below the first (she is unsure which was which). Within a few hours, she noticed swelling, redness and pain in her left arm extending 3-5cm below the lowest vaccine site to about 5 cm above her wrist. She did not have any tingling, numbness or itching. She immediately took BENADRYL. She called her physician who told her to take ibuprofen, apply heat and elevate her arm. Her swelling and pain gradually subsided and completely resolved on 1/31/10.
On Friday, 11/3/00, left upper arm developed itching (felt like that around leg insect bite) by that evening, arm was aching, slightly swollen and warm to touch. Arm continues to be swollen, red and sore.
No adverse event; received doses after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030g22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date).    No concomitant medication information was provided.  It was reported that Individual vials or unbroken cartons was in the box, Vial size was 2.5ml Date the vial was initially stored in the refrigerator was 03-Oct-2022. Vial did not undergo any temperature excursions. No treatment medications were provided.     Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2022: Live follow up received included patient information.
Approximately 48 hours after the vaccination was received I developed moderate headache, body aches,chills, dizziness and nausea and was completely bed ridden.I was unable to complete any activities or work.  On day two, the dizziness and nausea worsened and I began vomiting.  On day 3 of symptoms, I was able eat, sit up and walk around, but still have moderate headache.  I also developed diarrhea on day 3.
MMR II was given on 05-JUL-2022 after expiration date of 30-JUN-2022.; no adverse event; This spontaneous report was received from a certified medical assistant referring to a 13-month-old female patient. The patient's pertinent medical history, concurrent conditions previous drug reactions or allergies, and concomitant therapies were not reported.   On 05-JUL-2022, the patient was vaccinated with a fist dose of an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter (ml), with and expiration date: 30-JUN-2022, administered subcutaneously for prophylaxis (strength, anatomical site and lot number were not provided) (expired product administered).  No additional adverse event (AE) information was provided.