chrisvoncsefalvay/vaers-outcomes huggingface dataset:
.This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX. Concurrent medical conditions included eczema and cold sores. On 27th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles, pain localized, localized erythema, local swelling and pimples. The patient was treated with VALTREX and antibiotics nos (Antibiotic (drug Name Unknown)). On an unknown date, the outcome of the shingles, pain localized, localized erythema, local swelling and pimples were unknown. It was unknown if the reporter considered the shingles, pain localized, localized erythema, local swelling and pimples to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in 2018, she developed all the side effects that representative mentioned, she also developed shingles on her middle and ring finger where she had eczema it was very painful, red, swollen, she had what looked like 2 white pimples on each finger that grew, and eventually burst and oozed, she ended up in the followed up with her doctor who confirmed it was shingle, she was put on VALTREX and antibiotic. It was still red to this day but much better. Not sure if anyone else had commented on this, or any other type of reactions such as that.
This spontaneous report as received from a registered nurse refers to an adult patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 12-MAR-2019, the adult patient was vaccinated with a pediatric/adolescent dose of RECOMBIVAX HB injection 5mcg/0.5 ml, intramuscularly, lot # reported as 97Y27, expiry date 05-FEB-2021, (dose not reported) for prophylaxis. The patient experienced no adverse effects. Lot number 97Y27 is an invalid lot number for RECOMBIVAX HB.
ABOUT 7 DAYS AFTER HER FIRST MODERNA DOSE, PATIENT NOTICED RINGING IN HER EARS. EARS WERE STILL RINGING 13 DAYS AFTER HER DOSE. SHE IS CONSIDERING NOT GETTING HER 2ND DOSE AS SHE IS CONCERNED ABOUT THIS.
Rash, ErythemaMultiform, NauseaVomiting, injection site pain/arm pain
8/21/21  presents for hypoxia and lightheadedness that was brought on by standing.  He has history of diabetes, obesity, CAD, HTN,  And BPH
Per patient she had pre-medicated with an anti-histamine and as soon as the anithistamine wore off she experience itching all over her body. Upon taking another anti-histamine itching subsided. Then, while asleep the night of the vaccination, patient experienced profound chest pain while having a dream someone was stepping on her chest - after getting up and eating patient felt fine and has not had any other chest pain. Patient also complains of mild headache every evening after receiving vaccine.
When patient came in today (4/26/21) for his 2nd shot he said that his first shot had been administered to close to his shoulder and had caused him to have pain that lasted for weeks after his first dose. He did not seek any type of medical treatment or express continuing issues but wanted to ensure the second dose was administered properly into the deltoid muscle.
No AE/ PQC reported at this time; HCP called in to report a temperature excursion; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 26-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T030944, expiration date 09-MAR-2022 (dose number, dose and route of administration were not reported) for prophylaxis.  The vaccine was stored improperly in the temperature between 14 degrees Fahrenheit (F) and 46 degrees Fahrenheit (26.6 F) for the time frame of 3 hours and 20 minutes. There was no previous temperature excursion. Digital Data Logger was not involved. No adverse event was reported.; Sender's Comments:  US-009507513-2107USA008190: US-009507513-2107USA008378:
developed symptoms and tested positive for COVID 19; developed symptoms and tested positive for COVID 19; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "developed symptoms and tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Reporter stated that he had been vaccinated and boosted with "the Pfizer Vaccine" for COVID 19 and about eight weeks ago developed symptoms and tested positive for COVID 19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
C/O itching redness and mild swellig app. 5 in. below injection site.  Lasted app. 72 hrs.
This case was reported by pharmacist via call center representative and described the occurrence of injection site numbness in a 22-year-old female patient who received FLUARIX Quadrivalent. On 16th August 2017, the patient received the 1st dose of FLUARIX Quadrivalent (intramuscular) .5 ml. On 25th August 2017, 9 days after receiving FLUARIX Quadrivalent, the patient experienced injection site numbness, injection site tingling and injection site swelling. On an unknown date, the outcome of the injection site numbness, injection site tingling and injection site swelling were recovering/resolving. The reporter considered the injection site numbness, injection site tingling and injection site swelling to be related to FLUARIX Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. The patient received FLUARIX Quadrivalent in left arm and experienced events in her left arm. The patient came back on 29th August 2017. The pharmacist observe little bit of swelling on the left arm in the area of the injection. The pharmacist reporter declined the patient information, pharmacist was transferred to medical Information for further discussion.
Soreness upper thighs, upper arms all over achiness and weakness in these areas. Severe discomfort.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment medication details were not reported by the reporter.
Pain and swelling at injection site. High fever (over 102 degF) for 2 days after vaccine. Low grade fever (100 degF) starting day 3, and still continuing as of date of report. Neck pain and migraine headache started day 2 after vaccine, and still continuing as of date of report.
Client reported itching in head 10 minutes after receiving second dose of Moderna.  RN provided with Benadryl 25mg PO to take. Informed client to follow up with PCP.  Client left clinic 15 minutes after taking Benadryl with no c/o respiratory issues.  RN contacted client @ 3:30pm and client reports that she didn't follow up with PCP.  Returned to work and vomited 1x.  State's, "I'm feeling ok."  Encouraged to follow up with PCP for evaluation.  Verbalized understanding.
A non-serious spontaneous report of eye exposure to FLUMIST was received from a registered nurse concerning a four-year-old male. The patient's medical history and concomitant medications were not reported. During the administration of the second half of FLUMIST, the patient turned his head and some of the FLUMIST got in his eye. Also, some of the FLUMIST leaked out of his nose. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponser causally assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune;s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. 10/14/2009 A non-serious spontaneous report of eye exposure to FLUMIST was received from a registered nurse concerning a four-year-old female. The patient's medical history and concomitant medications were not reported. On 27-Aug-2009, during the administration of the second half of the first dose of FLUMIST, the patient turned her head and some of the FLUMIST got in her eye. Also, some of the FLUMIST leaked out of her nose. On 14-Oct-2009, the reporter confirmed there was no adverse event associated with this medication error therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was received on 14-Oct-2009 and incorporated into the narrative included: confirmation the patient did not experience any adverse events, the patient's date of birth, correction to patient's sex, and number of FLUMIST doses administered.
Patient is fully vaccinated as of 3/31/21, patient is symptomatic and has tested positive as of 8/9/21
Swelling of face on left side, mouth, lips, cheek. Teeth and mouth going numb. Itching on scalp and foot of left side. Palms itching.
"Bad" Headache, nausea, dizziness, diarrhea, weak/wobbly legs, generalized fatigue.   Treatment included increasing fluid intake, Motrin for Headhace/discomfort and close monitoring.   Mom reports the Advil did not help with the headache at all.  By day #2 after vaccines pt was still extremely fatigued and severe headache. Headache continued through day #3 post vaccination, but other symptoms have improved.
Swollen (R) arm, fever of 102 deg, nausea, pain in arm x 2 days (could not lift arm) red area, hot to touch, hard
Patient reported swollen supraclavicular lymph node on left side. Has been swollen since first dose, remained swollen since then. RN was able to palpate it, pt reported no pain/tenderness. No other sx.
cold sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 31Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cold sore on 01Feb2021. She was wondering if she is okay to use an anti-viral product. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Received Varicella and Hepatitis A vaccines on 5/13/09 at 1500 hr. Around 1830 hr., developed urticaria, swelling on eyes and mouth. He began coughing and scratching at neck. Was given 3.75 ml of Benadryl and taken to Urgent Care. Was given more Benadryl and a steriod shot. Was discharged at 2030. Slept well and is fine today.
Patient experienced swelling at the injection site 24 hours after the Zostavax vaccination. There was a hard nodule at the injection site that has alrady gone away. There was no fever. His arm was significantly swollen and red. He applied hydrocortisone to the rash for relief. He is going to see is PCP on Tuesday for evaluation.
This spontaneous report was received from a Registered nurse refers to a 70 year old female patient. The patient had no pertinent medical history and drug reactions/allergies. There were no concomitant medications. On an unspecified date, the patient was vaccinated with ZOSTAVAX (strength, dose, lot/batch# and expiration date were not reported) subcutaneously for prevention of shingles. On 16-AUG-2017, the patient experienced blisters around the injection site. On an unknown date, lab diagnostics/studies were performed, which showed "abnormal liver enzymes". No treatment was given for the adverse events. The patient did not seek medical attention. Nurse declined Varicella-Zoster Virus (VZV) packet. There was no product quality complaint (PQC) involved. The outcome of the event blisters around the injection site was reported as recovering. The outcome of the event abnormal liver enzymes was unknown. The causality assessment was not provided by the reporter. No further information was provided.
Fainted for 10 seconds after the shot, then got chills and started shaking and teeth chattering. That is normal to me when getting shots. But I shook for 30 min straight and on and off the rest of the day. That part isn?t normal. I had flu like symptoms which the pharmacist said could happen. I slept all day the next day. Today, my arm still hurts but I can move it. I?m feeling really tired weak still but not like yesterday. My appetite is coming back too.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 3:39 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 41.49.  Concomitant products were not provided.  On 03-Nov-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 10-May-2021, vial was moved to clinic on 11-Mar-2021. 06 vials were sent to clinic. Vaccine BUD date was 11-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
I waited 15 mins like the pharmacist asked, was not exhibiting symptoms at the time, took my child to eat, started feeling extremely nauseated, a bit dizzy and then feeling tightness in my chest.
She had a rapid test performed that was positive and went a received a PCR test for confirmation; She had a rapid test performed that was positive and went a received a PCR test for confirmation; This is a spontaneous report from a contactable consumer (patient self, a Physician Assistant). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, the first dose on 18Dec2020 at single dose and the second dose on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had a weekly PCR test. Her last test on Tuesday April 20th was negative. On evening (Friday 23Apr2021) patient felt exhausted and slightly congested and realized she was the only member of the household that had not received a screening test that day. She had a rapid test performed that was positive and went to receive a PCR test for confirmation. Her symptoms had progressed since then including severe fatigue, dry cough, significant congestion, and become easily winded with minimal exertion. She had been monitoring her temperatures and O2 sats. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
With in 15 minutes I started burning up, my face turned purple. My eye lids felt like I had 10 pounds weights on them, I couldn't  keep them open. I short episode of shortness of breathe and that went away. I got nausea, felling all of a sudden like crap. I felt like I was hypotensive for the rest of the day. I drove home I ate two eggs on rye bread. I took two Tylenols and took a nap.  I woke up at noon with serve abdominal pain for about an hour. I got out of bed and just couldn't stay out of bed, I could stand up right, I felt hypotensive. I had to be laying down.  The next morning I woke up with a slamming headache, I took two Tylenol and it went away.  I was ok after that until about day 6 after the vaccine. I had chills and thought i maybe had Covid but tested negative. My arm started swelling up, my whole upper arm was swollen. It was hot to touch and itchy, they thought it was cellulites and put me on medication, after 5 days It wasn't doing anything and it was getting worse. I went back to the Urgent Care, he had me finish the medication and took Benadryl over the next two days and it started to get better.  I was advised not to get the second shot.
Chills; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and INJECTION SITE PAIN (Pain at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced CHILLS (Chills) and INJECTION SITE PAIN (Pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (Chills) and INJECTION SITE PAIN (Pain at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-may-2021 contain no new information
pt devel hives approx 2-3hr p/vax;c/o nausea & nervousness before vax;seen by MD p/school & recv DPH;MD recommends no third dose;
Pt became severely sick with flu-like symptoms and could not work on April 20-22.  He worked on April 23.   He told people he was sick again on April 24.    He was very anxious and committed suicide some time between April 27-28.
patient reports numbness, tingling or left upper arm and perioral numbness/tingling about 5 mins after vaccination.  Benadryl given  and symptoms resolved by 2:08pm
April 2 I woke up with a headache, fever, chills, and body aches. April 4, vomiting and diarrhea, stomach cramps in the evening.
Since the shot, I have experienced sever joint pain (primarily in knees and shoulders) for the past 4 weeks and it has not subsided.  I have arthritis in my joints, but have never experienced this level of pain in all joints at the same time.
Information has been received from a lawyer regarding a case in litigation concerning a male 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 recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 05-JAN-2013, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 27-OCT-2016, the patient was treated by a healthcare provider 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 his 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 including 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered.
Child had DPT and Hib and Polio on 7/8/04. Child was seen again on 4/10/04 with marked swelling of the thigh and redness and itchiness. Child was not with any discomfort, he was walking without any pain.
May 30th, 2022 I started to get symptoms. Pressure in my ears, headache and postnasal drip. On May 31, 2022 I took an at home COVID-19 test and tested positive. I contacted my doctor via my health portal and requested a PCR test. My doctor's office wouldn't provide me with a PCR test because I had already tested positive. I had a doctor's visit on June 1, 2022. At the doctor visit the doctor asked me a bunch of questions and we spoke about Paxlovid but I did not met the requirements and my symptoms were pretty mild.