chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ipol was exposed at 27.7F for 15 minutes in October 2019/no AE; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 year old male patient who received  0.5 ml IPV (VERO) [IPOL] which was exposed at 27.7F for 15 minutes (product storage error) on 23-Aug-2019 for prophylactic vaccination via intramuscular route at the left deltoid (batch number P1E701M and expiry date 09-Nov-2020) (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for prophylactic vaccination; HPV VACCINE (HPV VACCINE) for prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  It was of actual medication error case product storage error temperature too low.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
flu like sx for first 4 days p/vax;arm red, sore & minor swelling in bed all 4 days;these sx cont for 3wk duration, although not as sever-some days not as bad as others;arm red from elbow to shoulder for 3wk;low grade fever;
Severe sore throat x24 hours- 1-1-10. flushing 12/30/09, diarrhea-12-31-09, heavy cold symptoms-12-31-09, some shortness of breath 12/31, chest conjection-12-23-09.
Patient came to Clinic today and received his first Covid vaccine (Pfizer) and an influenza vaccine.  During the observation period after the vaccines he began to c/o itchy throat and it feeling a bit tight and dizziness.  Has hx of chronic idiopathic urticaria, has not been taking any anti-histamine recently as not getting symptoms.  Only medication is prn Clonazepam.  Denies any lip or tongue swelling.  No wheezing.  Felt better when he sat up. Hives present on RUE. Benadryl 25mg 1 tab administered at 1157. Vitals taken every 15 mins. HR 108-126bpm.
Administered vaccine at 10:15AM. Patient states she started feeling hot and tingly at 10:30AM. Took a BENADRYL at 11:30 and came to check in with me. Had her sit and take the second BENADRYL at 11:45AM. She stated she was feeling better. Went to the bathroom. Reported she threw up at 11:55AM. At 12:10 used her VENTOLIN inhaler. Stated no problems breathing just chest tightness. Awaited call back from MD-But pt stated she was feeling better. Husband picked her up and was going to MD.
Runny nose two days ago/sniffles; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose two days ago/sniffles) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose two days ago/sniffles). At the time of the report, RHINORRHOEA (Runny nose two days ago/sniffles) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
I got out of bed the morning after the vaccine after having slept/laid down for 12 hours. During that time I was extremely hot but could not break a sweat. My face felt like lava and all my joints were inflamed. There were moments through the night where I'd feel an intense pain in a specific area, it felt like my bone being struck with a hammer. Other times I'd shiver as if my nerves were vibrating. I could feel a throbbing/pulse in my head and ibuprofen seemed to do nothing. My entire body was wrenched in pain, even my eyeballs felt injured. Upon getting out of bed after such a miserable night of supposed rest, I walked up a flight of stairs and had to sit down towards the top because I suddenly felt nauseous. I quickly went back down the stairs hoping I would make it to the bathroom in time. As I lifted up the toilet seat I took a seat on the edge of the bathtub. All I wanted was to wipe off the rim of the bowl with a Clorox towel but even that small task seemed too daunting as I knew my body was starting to turn on me. Throughout my whole being I could feel a wave travel through me as if an electric current had zapped me. Nausea was no longer my concern but rather a dread like something was about to happen but I didn't know what. A pulse hit me which felt similar to when a limb falls asleep and slowly regains circulation however this was all over. The pulse happened twice then my sight started to blur, tunnel vision, as I began to fall backwards into the tub. I never lost consciousness but as I began to feel normal again I instantly felt cold all over. My head felt like I had stuck it in the freezer and chilled me to the bone. As I got out of the tub and snuck a glance in the mirror I was pure white, there was absolutely no color in my face. I went to the living room to rest on the couch and focus on my breathing so as not to have the nausea return. As I did this my whole body felt like it had been asleep, similar to my limb reference earlier, and caused me pain as it regained blood flow. Within 5 minutes I felt normal again but proceeded to have joint pain and fatigue for the rest of the day. On Wednesday I resumed work and my body felt like it had been through an ordeal much like a day of snowboarding and the soreness that comes with it.
My left arm has a bit of pain. It feels like someone punched me there hard. 4 hours after the shot, I did not feel it. About 7 hours after the shot, I started to feel the pain in my left arm.
Pt reported he received Flu vaccine at 12:00 PM. At 4 PM developed left shoulder pain (bursitis) lasting 3 days then developed severe right UE pain (opposite of injection site). Pain moves joint to joint.
Information has been received from a pharmacist via a company representative concerning 2 or 3 patients of unknown age and gender. The patients' concurrent and historical conditions were not reported. On unknown dates the patients were vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were unknown). Concomitant medication was not reported. On unknown dates within 30 days following vaccination, the patients developed a mile case of shingles. Outcome of the event was unknown. Additional information is not expected as we have no consent to contact the pharmacist.
On day of vaccination, soreness and slight swelling at injection site. The next morning I awoke about 7:10am  lightheaded, took dog out, hooked up leash, opened the door.  The next thing I knew I was on the floor.  I had passed out and did consider damage to my body.  I called 911. They took all tests (EKG, oxygen, BP, blood sugar, etc.) and all was normal. They bandaged me up, gave me 2 Tylenol, and put me to bed.  Later that day, I went to the guest bathroom, slightly lightheaded.  Then passed out sitting on the toilet and hit the floor.  Afraid to stand, I scooted on the floor back to the bedroom.  Along the way, I must have passed out again because I did remember where I was.  I spent the rest of the day and night in bed, except with assistance from an aide hired to stay with me. I am OK today, weak but no lightheaded.
During night sx "must have started"-L arm 3-4" around in upper arm-swollen and red, achy to touch.
Adacel reached negative 2.1c from 07mar2022 until 31mar2022 due to temperature excursion due to a refrigerator malfunction with no reported adverse event; medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2022SA143416, 2022SA143406, 2022SA140729, 2022SA140912, 2022SA141394, 2022SA142501, 2022SA142502, 2022SA142504, 2022SA140733, 2022SA141172, 2022SA143721, 2022SA140726, and 2022SA140723.  This case involves a 41 years old female patient who received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] that reached negative 2.1c from 07-Mar-2022 until 31-Mar-2022 due to temperature excursion due to a refrigerator malfunction with no reported adverse event and medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard with no reported adverse event.  The patient had no other vaccines The patient's past medical history, medical treatment(s), concomitant medication and family history were not provided. Pregnancy: No   On 24-Mar-2022, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (strength: standard, frequency: once, lot C5963AA; expiry date: 18-Jan-2024 and formulation: unknown) via unknown route in the left deltoid for immunization.  Caller reported a temperature excursion due to a refrigerator malfunction for the Product adacel. Due to a malfunction low temperature of  negative 2.1C from 07-Mar-2022 until 31-Mar-2022 was reached (product storage error) (latency: same day, Onset date: 24-Mar-2022). No human error involved. The product was used by/ administered to the patient. This situation was reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard (poor quality product administered) (latency same day; Onset date: 24-Mar-2022).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events  At time of reporting, the outcome was Unknown for the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Based on information previously received, the following information [Event, "No adverse event" was updated and replaced by events "incorrect product storage and Poor quality vaccine administered" and Case Classification was updated from non case to Valid with no AE.] has/have been amended
Headache, dizzy, nausea, elevated BP, seen in Ed 11/12, (negative head and neck CT & MRI) persistent & continuing but lessening in severity, referred to PCP 11/17.
Stroke; More than 36 days have passed since first dose, still didn't get second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included AMLODIPINE, ENALAPRIL and METOPROLOL TARTRATE for Blood pressure abnormal, ATORVASTATIN and EZETIMIBE for Cholesterol total abnormal NOS, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have passed since first dose, still didn't get second dose). The patient was hospitalized from 29-Mar-2021 to 15-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have passed since first dose, still didn't get second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of Hypertension, cholesterol. may remain risk factor for this event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of Hypertension, cholesterol. may remain risk factor for this event.
It felt like I had cockle burrs inside my veins and my blood was on fire. Very painful and miserable for about 48 hours.  Arm swelling and soreness for nearly a full weeks.  Headache and nausea.
unusually large black and blue circle; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (unusually large black and blue circle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroid goitre, Parathyroid tumor (parathyroid) and Cataract. Concurrent medical conditions included Cancer (immunocompromised), Environmental allergy (Environmental allergy to harsh chemicals) and Perfume sensitivity.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (unusually large black and blue circle). At the time of the report, SKIN DISCOLOURATION (unusually large black and blue circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller did not provide demographics or consent; do not know if the caller is from . Caller wants to know if she can take tamoxifen and then 5 days later receive her second dose of vaccine.   Reporter did not allow further contact
Patient developed fever and flu-like symptoms, including vomiting for two days, cough, rhinorrhea, muscle aches, and possible sore throat. Symptoms not yet resolved as of this report. Parents unsure if he received flu shot last year, and records not yet available from prior office.
headache; nausea; vomiting; chills; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced CHILLS (chills). On 18-May-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
intermittent cold chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:01), for covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset Feb2021, outcome "unknown", described as "intermittent cold chills". The event "intermittent cold chills" was evaluated at the physician office visit. Therapeutic measures were taken as a result of chills.  Additional information: Clinical course:The patient has reported these symptoms to her doctor and received medical advice from him to take Tylenol.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
paresthesias and hyperesthesia from hips up to scalp. slowly improved over next week, no treatment provided
EXTREME insomnia/COULD NOT SLEEP. I was waking up every 30 minutes. All night.; was absolutely exhausted; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 15:45 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was reported as several. The patient received several unspecified concomitant medications for unspecified indications on unknown dates. The patient had many unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Apr2021 at 22:30, the worst side effect the patient experienced was extreme insomnia. The patient was absolutely exhausted, took all of her medicines, including muscle relaxers and high dose gabapentin and could not sleep. The patient was waking up every 30 minutes, all night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the reported events and included all the patient's medicines, including muscle relaxers and high dose gabapentin. The clinical outcome of the events extreme insomnia and absolutely exhausted was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
8JUN seen in ER c/o entire upper lt arm was itchy & tender; Upper lt arm observed to be swollen; dx poss cellulitis; tx ATB, DPH, ice, APAP; 9JUN seen by MD improvement noted; 10JUN sl swelling @ inject site noted by RN;
First booster shot after receiving J and  J.  Shoulder started hurting and continually got worse until I needed to see an orthopedic doc.  Diagnosed with SIRVA-----frozen shoulder.  Got two steriod shots and referred to PT
Patient's wife called 3/22/21 and stated patient had a cough, fatigue, and low grade fever running around 99 starting 3/20/21.  Patient went to airport testing center on 3/23/21 to have a rapid COVID test performed.  Patient tested positive.  Patient called PCP office on 3/29/21 to notify PCP that he had been admitted to Hospital.   Patient was admitted for COVID pneumonia and acute respiratory failure with hypoxia.  Patient was treated with Remdesivir and dexamethasone while in the hospital.  Patient was discharged from Hospital 4/10/21.  Patient was discharged home with home O2 of 1lpm.
Pt received vaccine without incident and left facility. Her angina/chest pain began enroute to her house.  She returned  and reported to Med Observation 1 at 1205. Vitals HR 62 BP 137/77 O2 sat 97% on RA L sided chest pain 6/10 Pt states L sided chest pain radiates to L posterior back " it feels like someone is sitting on my chest" Her pain is very similar to her "angina pain". 1210 HR 63 BP 127/75 O2 Sat 97% one sublingual nitro given of patient's own medication. 1215 BP 157/69 HR 62 96% on RA Pt states pain is 4/10 second sublingual nitro given. 1220 BP 156/77 HR58 100 % on RA Pain rates 2/10 pt does not want to go to ER 1230 convinced pt she should go to ER, 911 called.  chest pain remains 2/10 1240EMS arrives for transfer BP 161/73 HR 61 97% on RA chest pain 2/10 Left facility via EMS at 1250.
REDNESS TO L UPPER ARM  THE DAY AFTER VACCINE GIVEN.  OVER WEEKEND INCRESED PAIN AND INCREASE REDNESS.  AREA RED ROUND INDURATED MACULAE AT INJECTION SITE.
"knocked out" by the second dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient was "knocked out" by the second dose of the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ (lot# L035276, expiration date 09-JUN-2017, dose, anatomical location were not reported) oral route of administration. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT POSTED ON FACEBOOK THAT SHE FELT LIKE CRUD. CALLED TO CHECK ON HER YESTERDAY AFTER HEARING THAT. SHE SAID ARM WAS SORE. TODAY SHE CALLED AND STATED THAT HER ARM WAS NUMB, AND COULDN'T LIFT ANYTHING WITH IT AND THAT SHE COULD NOT RAISE HER ARM ABOVE HER SHOULDER WITH OUT PAIN.
Patient tripped over red cord cover post-vaccination, hit nose and face and landed on left arm.  Transported to ER by EMS.
Instantly felt nauseous after administration of Flu Vaccine during Work Flu Clinic. About an hour later felt dizzy and pain. By 11am felt numbness in the left arm where vaccine was administered followed by tingle/pins and needles. From noon into the evening felt as if had "FLU"so went to bed at 8:30pm w/out taking any NSAIds. Woke up fine 09/19 8am.
Initial and follow-up information has been received from a 21 year old female office worker concerning herself who in March 2009, was vaccinated with the first 0.5 mL dose of GARDASIL (LOT# not reported). On 01-APR-2009 the patient woke up and had loss of vision in her right eye. At this time of reporting, the patient's loss of vision had not recovered. Upon internal review, loss of vision was determined to be an other important medical event. Additional information has been requested.