chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 05-FEB-2019, the patient was vaccinated with a dose of improperly stored VARIVAX, lot # N034551, expiration date: 05-DEC-2019 for prophylaxis (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of 21.7 degrees Fahrenheit for 3 hours 45 minutes and previous temperature excursion of 12.9 degrees Fahrenheit for 30 minutes. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA004129; US-009507513-1902USA004130; US-009507513-1902USA004131.
FAIRLY SIGNIFICANT LETHARGY; BODY ACHES; HAVE NOT FELT WELL; DAILY HEADACHES; TINGLING IN VARIOUS REGIONS WHICH  STARTED ON THE RIGHT SIDE OF BODY AND MOVED TO BOTH FEET/LEGS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient reported that the patent was previously very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced fairly significant lethargy, body aches, have not felt well, daily headaches, and tingling in various regions which started on the right side of body and moved to both feet/legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, and the outcome of have not felt well, daily headaches, tingling in various regions which started on the right side of body and moved to both feet/legs and fairly significant lethargy was not reported. This report was non-serious.
ELEVATED HEART RATE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced elevated heart rate. Laboratory data included: Heart rate (NR: not provided) under 100 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate on 09-MAR-2021. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (vision problems/blurred vision - it occurs temporarily lasts for a few seconds and then goes back to normal) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (vision problems/blurred vision - it occurs temporarily lasts for a few seconds and then goes back to normal). At the time of the report, VISION BLURRED (vision problems/blurred vision - it occurs temporarily lasts for a few seconds and then goes back to normal) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment medications were not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Upon internal review on 17-May-2022, significant correction was performed. The reporter country was updated.
Patient called clinic to report cold symptoms and L arm pain and joint pain after receiving vaccination and PPD test yesterday. pt denies cp, sob, swelling, numbness or tingling. pt was instructed to call tomorrow morning if not improving for an urgent care appt. pt verbalized understanding.
slight fever; injection site arm pain; felt 'woozy' (Dizziness); This is a spontaneous report from a non-contactable pharmacist. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 06Apr2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as unknown. It was unknown whether the patient had any allergies to any medications, food, or other products. It was unknown if the patient received any other medications within two weeks of vaccination and also unknown, if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. 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 06Apr2021, after the vaccination, the patient felt woozy (Dizziness). A couple of hours later, at 15:00 on 06Apr2021, the patient had a slight fever and injection site arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events felt woozy (Dizziness), slight fever, and injection site arm pain were recovered a few hours later on 06Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Client started to stumble down hallway, grabbed her arm, she started to fall to onside, I laid her on floor, clients eyes rolled back into head, arms pulled upward toward face, then relaxed, I put cool paper towel on forehead and back of neck, client opened eyes, focused on me, then wanted to sit up, gradually sat up against wall, provided 1 juice box, client stated she had felt dizzy and hot then everything went black, no longer feels dizzy, hot or having any nausea.  Client back to normal within 7-8 minutes. Father reports this happened when she was treated for a dog bite a few years before.  Family is from a foreign country and returning home in the next month.
Cellulitis Left upper arm 11/3/06. Augmentin 875mg by mouth twice a day for 7 days.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion).    Concomitant product use was not provided.  It was reported there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case was for patient 24 out of 104.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:
Upper and mid back spasms, no pain per se.  SOB especially on exertion and sinus drainage which produced a cough.   No fever.
Pt had vomiting, diarrhea, chills, fever 102 & was acidotic w/in 1 hrs p/ DTP/OPV/HBOC; following day pt stopped vomiting & was given 1/2 strength Isomil; next morning pt had fever, rigors, & secretory diarrhea; hospitalized; Pt recovered;
MISCARRIAGE AT 7 WEEKS 5 DAYS GESTASTIONAL AGE, 1 PREVIOUS HEALTY PREGNACY IN 7/17/2019, NO PREVIOUS HISTORY OF MISCARRIAGE
I had side effects with the first dose too but this time was worse. Shortly after receiving the vaccine I got muscle and joint aches. Next I felt hot and got really sweaty. Then I got a bad headache. Then the joint pain got worse.  Then I got real sweaty. The worse thing was in the middle of the night I felt like my heart stopped twice. I had the headache for 3 days. I also felt really tired and slept a lot.  I had the joint and muscle pain for two days. The heart episode happened once. I won't get a booster bc of all the problems I had.
Low grade fever; Head congestion; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jan2022 11:00 (Batch/Lot number: unknown) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 03Jan2022 18:00, outcome "not recovered", described as "Low grade fever"; HEAD DISCOMFORT (non-serious) with onset 03Jan2022 18:00, outcome "not recovered", described as "Head congestion"; OROPHARYNGEAL PAIN (non-serious) with onset 03Jan2022 18:00, outcome "not recovered", described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, head discomfort, oropharyngeal pain.  Additional information: Facility type vaccine: Hospital. covid prior vaccination. no covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm soreness for a couple days Diagnosed with Extensive DVT 2/27/2021 and PE in Left lower lung; May Thurner Syndrome Thrombectomy & stent with IVC filter 3/11/2021 Thrombectomy & stent  3/25/2021 Thrombectomy 4/11/2021
Extreme vomiting after onset of naseau for almost 12 hours.  Elevated heart rate for about 24 hours
erythema @ site of MMR (ldt), no swelling; ice pack applied x 15-20mins-slowly resolving;
sneezing and just continues to sneeze; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing and just continues to sneeze) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced SNEEZING (sneezing and just continues to sneeze). At the time of the report, SNEEZING (sneezing and just continues to sneeze) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
The day after my booster Covid-19 vaccine, I started having pain/pressure in my left chest. It hurt more to take a deep breath in. After a few days it started getting better, then on 11-16-2021 the chest pain got a little worse and I started getting short of breath by walking around the house. I continued to have a hard time taking deep breaths and continued to feel chest pain and shortness of breath, so I called my doctor who was not able to see me on 11-17-21 but recommended I schedule to be seen that day or go to urgent care. I went to urgent care later in the day and they did a chest xray, labs, and an EKG, all came back normal. Today on 11-22-2021, I continue to have mild chest pain/pressure.
Numbness ,tingly sensation, weakness, pain on left hand palm that started at 130am and traveled to the forearm by mid morning and shoulder.  Went to ER on 6/15/21 , several tests were done, all was normal.  The pain continued the next day 6/16/21, we went to Hospital  ER , more tests done, all was normal once again and we were told to follow up with primary care doctor for Neurology referral
This spontaneous report as received from a nurse refers to an 8 months 15 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
got light headed; Had stomach discomfort; This is a spontaneous report from a non-contactable other hcp (patient) received via a representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, Expiration date were not reported), via an unspecified route of administration on an unspecified date, as dose number unknown , single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced got light headed and had stomach discomfort on an unspecified date and only lasted for 12 hours. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information on lot /batch number could not be obtained. No further Information expected.
Five days after Vaccine devoloped numbness in the left 4th finger that radiated into thumb and other fingers lasted about a minute, Also had vision disturbances.
No adverse reactions.  Patient was given the 5 year old Pfizer dose for COVID 19 instead of the 4 year old dose.
On 3/5, pt had minimal redness to surrounding area and denies other complaints. On 3/7, complained of joint pains, redness, erythema and induration traveling away from site to axillary. On 3/8, stopped Benadryl and started on Zyrtec and continue Motrin 800 q8h. On 3/10, complained of neck pains, generalized malaise, elevated BP, extending redness with less erythema and induration. Labs ordered and returned negative. On 3/11, improved resolving redness, less joint pain and normal BP. Dx: Dermatitis secondary to vaccinia.
Pt is a 47 year old female who presented to the vaccination site organization. PT received vaccine in her left arm and 5 minutes post injection she had numbness and tingling in her left hand. Pt reported very mild symptoms with no other associated complications. Pt had normal strength and sensation was intact. PTs vitals were taken with showed BP 135/96, HR 85, SPo2 98%. PT was observed for the next 25 minutes with her symptoms resolving  upon observation of 30 minutes.
Right arm erythema/induration 4x4 cm: warm to touch/ raised and malaise and watery eyes and rhinitis.
Dizziness; Lose of balance night of 3/21into 3/22; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route in the right arm on 20Mar2021 at 15:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol and anxiety. The patient was allergic to latex gloves. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included rosuvastatin (CRESTOR), valsartan (MANUFACTURER UNKNOWN), sertraline (ZOLOFT), bupropion (WELLBUTRIN) and varenicline (CHANTIX) received on unspecified dates for unknown indications. The patient previously took oxycodone (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 02:00, the patient experienced dizziness and lose of balance night of 21Mar2021 into 22Mar2021. Therapeutic measures and treatments were not taken for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of dizziness and lose of balance night of 21Mar2021 into 22Mar2021 were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Patient fainted in waiting room while checking out after receiving first guardasil vaccination.  Treated with observation and remaining supine with monitoring of vital signs - was alert/oriented and vital signs stable - observed about 45 min to one hour as she was dizzy also up until about 45 minutes after the event.  Mildly hypotensive.
Pt broke out into chickenpox like rash all over body within a hour of leaving office with LGF. Rash lasted few days with the fever.
red / injection site; swollen / injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient asked to use ice on a red and swollen Shingrix injection site.
Influenza shot. Left arm red and itchy at shot sight just below shoulder socket in muscle.
SLIGHT FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 12-APR-2021, the subject experienced slight fever. On 12-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever and fatigue was not reported. This report was non-serious.
Patient received H1N1 flumist at approx. 1:15pm on 10/30/09. Family noted pt. began sneezing and had some swelling around eyes was taken to PCP was diagnosed as local reaction and given prescription for pediapred 6.7mg/5mL 2 tsp BID x5 days, and OTC BENADRYL.
On the 8th day after receiving my first dose of the Moderna vaccine I woke up and my upper left arm (near site of vaccine) was red, warm to the touch, swollen, bumpy and itchy.
Felt really bad; this case would be deleted. Reason for case deletion: The case needs to be deleted as it was not clear after which dose patient had experienced the adverse event.; Sender's Comments:  US-GSK-US2023AMR036582:Same patient - (Split case)
The patient is afraid of getting the booster in her arm because she feels like she had more swelling after the initial 2 shots; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "The patient is afraid of getting the booster in her arm because she feels like she had more swelling after the initial 2 shots". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A report has been received from a Health Professional concerning a patient. Female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. Reporter indicated that the patent received expired FLUMIST and did not report ant adverse events. The patient experienced EXPIRED FLUMIST ADMINISTERED. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was considered to be non-serious by the company physician.
Case number PHEH2014US002860 is an initial spontaneous report received from the nurse on 07 FEB 2014. This report refers to a 19-year-old female patient. Her medical history and concomitant medications were not reported. She was accidentally vaccinated with MENVEO (batch number: 13011) subcutaneously on 07 FEB 2014. No adverse event was reported following this medication error (inappropriate route of vaccination).
11/10 Same day had symptoms, body aches, all injection sites sore - by Thurs 11/11 ROQ fevers, inflammation. Pt. did c/o at time injection given, pain & felt like a sledge hammer hit her when vaccine went into the muscle. PCP treated her that following Saturday at her home with antibiotics. She was not feeling well for 1 week. Treated with BACTRIM. Pt is a nurse & requested that she get all vaccinations same day. And she requested where she preferred they be administered. The Influenza site was the ROQ IM. This was the site of reaction to vaccine.