chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got the Tdap shot while sitting down, was able to get up and walk over to the cashier at the front of the store. About 5 minutes after injection, she lost some level of consciousness/control over her body and couldn't see. She wasn't able to stand up, so her dad carried her to the back of the store, where the pharmacy that administered the vaccine is located. Site of the injection was initially red. Patient's throat started shutting down and she was crying in pain, couldn't swallow without feeling pain, her face was extremely pale, looking green/grey/yellow. Her mouth was dry, top. Her oxygen levels were taken, and were at 100%. Her sugar levels and blood pressure were taken and were low. 911 was called and paramedics took her vitals and report. The paramedics suggested taking patient to the hospital, but we (parents) declined.
Body and joint pain; Temperature: 100.4; Chills; swollen lymph nodes; swollen injection site; Headache; Nausea; Fatigue; Body and joint pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown)), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Body and joint pain"; PYREXIA (non-serious), outcome "unknown", described as "Temperature: 100.4"; CHILLS (non-serious), outcome "unknown", described as "Chills"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swollen injection site"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received Covid-19 booster shot. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm was sore after the vaccine; while administering vaccine to the patient plunger was pushed hard as it did not push down; Initial information regarding an unsolicited valid serious case was received from a pharmacist. This case involves female patient (unknown demographics) who experienced arm was sore (pain in extremity) ) while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm was sore (pain in extremity) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It is also medication error case due to while administering vaccine to the patient plunger was pushed hard as it did not push down (wrong technique in product usage process) (latency: one day).  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.  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.  There will be no information available on the batch number for this case.
This spontaneous report as received from a physician refers to a 65 year old male patient without drug reactions/allergies with hypertension and hyperlipidemia. On 25-AUG-2014, the patient was vaccinated with ZOSTAVAX single dose (lot # J013135, exp date: 17-JAN-2015) subcutaneously. Concomitant therapies included CRESTOR. On an unspecified date in 2014, the patient experienced shingles-like rash. The distribution of the rash was not provided. The patient sought medical attention, he called to the office. No treatment was given for the adverse event. No labs diagnostic tests were performed. The outcome of he has a shingles-like rash was reported as not recovered/not resolved. Additional information has been requested.
In the past few months, I have started having significant nerve pain around my torso/rib cage and on my arms. It feels like an intense sensitivity to cold and like "pins and needles". The feeling is intermittent. On a scale of 1 to 10, the worst it has been would be about a 7. Sometimes just my clothes rubbing against my ribs and back is painful.
Information has been received from a pharmacist concerning an immunocompetent 65 years of age or older (exact age not specified) female patient. Information about concomitant medication, pertinent medical history and drug reactions was not provided. On 02-DEC-2018, the patient was administered a dose of PREVNAR 13 (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 14-FEB-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 (intramuscular, lot # R031961, expiration date 09-JUN-2020; strength and dose were not reported) for prophylaxis. The patient did not tell the pharmacist that she had received PREVNAR 13 less than a year ago until after the dose of PNEUMOVAX 23 was administered. No adverse effect was reported. Sender's Comments: US-009507513-1902USA006096.
Around 3/25/2021 after the 2nd vaccine, my head got very itchy and bumpy. I went to my dermatologist 4/1/2021 and was diagnosed with dandruff. I was instructed to get OTC dandruff shampoo. On 4/7/2021, I started to notice pressure in my head. It felt like a headache and painful. I took ibuprofen and Tylenol to relieve the pressure. Around the same time, I also started developing bumps on the tops of both hands to my knuckles and feeling very lethargic. I went back to my dermatologist 5/27/2021. I was prescribed triamcinolone cream. The cream is working but it's taking a long time and it hasn't fully resolved.  I finally went to see my doctor about my headaches who ordered a CT scan. The CT scan came back normal. The pressure in my head resolved on its own after about a month. I also notice I am more sensitive to the sun, and it hurts to be outside in the sun on the places where I have developed a rash after the vaccine.
A week after the vaccine [ March 2, 2021] experienced itching and redness at the left upper arm ; redness disappeared after a few days however itching and tiny rashes still persist. Consulted my primary care physician a week later and prescribed ZYrtec and Sarna cream over the counter. Prior to that I already applied Hydrocortisone cream. Itching persists  so I called her again and prescribed Triamcinolone cream 0.1 % and continue takind Zyrtec this time twice a day [10 mg. each]. Itching persisits up to this point {March 19] not getting worse and my arm itches too.
few minutes after vaccination store manager came to pharmacy said need assistance aisle 3 patient fainted. When I arrived patient was sitting on floor alert. Stated doesn't remember fainting. Forehead sweating. has headache no other symptoms
Woke up day after vaccination with chills, dizziness, exhaustion and a temperature of 99. As the day progressed, temperature went up to 101.8, then steadily declined into the evening.
Pain at injection site. Very large area of redness. Weak and tired on awakening next day. More than usual joint pain. Terrible pain in right buttock ( related?). Slept all day. Normally very active for my age.
Flu like symptoms, elevated heart rate, slight dizziness, weird vision, slight fever one day, anxiety, weakness.
I have been diagnosed with pre-diabetes, microscopic, hematuria, I've had frozen shoulder, and patellafemoral syndrome all discovered in my blood work in June. I've never had health problems before receiving the vaccine. I am going through physical therapy at the moment.
ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/2/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
pt recvd vax & became "fainty" for approx"; BP 130/82; P88 8:40; BP 122/80 P84 8:41; BP 110/72 P82; let pt lie down, elevated feet; sips coke; recovered;
Patient was a perfectly healthy and bright 15 MO. After these shots he immediately withdrew, stopped making eye contact, stopped feeding himself, stopped pointing, lost all his language, started spinning or lining up everything. He was diagnosed with autism and speech impairment at age 5. I am 100% certain that my son was injured by the MMR and/or the chicken pox vaccine at 15 mo. He is now 21 and receives benefits as he has a disability caused by these vaccines. He will have to live with us forever. There is no autism on either side of our family and our other 3 children are neurotypical. My husband's IQ is 134 and mine is 137. I had a perfectly healthy pregnancy and patient was almost 10 pounds at birth.
MOC (mother of child) called to clinic on 3/4/09. Info vax received today. Spoke to MOC, states child had reaction of 3" redness, muscle hard and itching. 12 hours to 24 hours after vaccine to rt arm. States she tx w/ BENADRYL BID X 48 hours, redness, itching gone now.
First 24 hours I was fine no symptoms, woke at 2:45 AM and was dizzy and spinning. Low grade feaver of 99.7 on 4/10 and dizzy.  Dizziness still on 4/12/21.
after the vaccine, she experience a swollen arm and says it was kind of hot; Swollen arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (after the vaccine, she experience a swollen arm and says it was kind of hot), the first episode of PERIPHERAL SWELLING (Swollen arm) and the second episode of PERIPHERAL SWELLING (Swollen arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concurrent medical conditions included Seizure. Concomitant products included LISINOPRIL, SERTRALINE and LEVETIRACETAM (KEPPRA) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (after the vaccine, she experience a swollen arm and says it was kind of hot), the first episode of PERIPHERAL SWELLING (Swollen arm) and the second episode of PERIPHERAL SWELLING (Swollen arm). At the time of the report, VACCINATION SITE WARMTH (after the vaccine, she experience a swollen arm and says it was kind of hot) had resolved and last episode of PERIPHERAL SWELLING (Swollen arm) 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.   Treatment information was not provided.
Extreme chest pain for 3 days moderate chest pain 3 weeks and continued chest pain that wont go away Extreme abdominal pain for 7 days
Vaccines given approximately at 2:10 PM, pt. sent to lobby to await discharge when mother noticed rash started. Brought back to room, evaluated by provider. Dx with red rash to torso and face. Pt. was calm but warm to touch, no fever, no wheezing, lungs clear.
Drowsy; Rash Spot; Distorted Vision; Had a bad reaction; Reactions to the vaccine as they were pretty strange; Sore Arm; Red Spots; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction) and VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), OMEPRAZOLE and ROPINIROLE HYDROCHLORIDE (ROPIDOPIN) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction), VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange), VACCINATION SITE PAIN (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Spots). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction), VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange), VACCINATION SITE PAIN (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned  that she had a bad reaction because she had covid before the pandemic, and it  was the antibodies that attacked the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: New events feeling abnormal, vaccination site reaction were added.
After inserting  the needle of  the flu shot into the patient's arm, I tried to depress the plunger of the prefilled syringe but  the plunger would not move, so I  aborted the attempt  and repeated the process with a  new prefilled syringe and new needle , but  again the plunger would not move. The patient at that point did  not want to continue and said she would get  her flu shot at a later time.  I  reversed the claim and she went on her way.
Nerve damage in right arm. I have peripheral neuropathy, blood clots, bone infection and blood veins infected in right arm.
Urticaria, "unexplained chronic hives" lasting for 6 months, the hives were on his entire body: stomach, arms, legs, neck, back, and around penis.
fever between 99.6-100.1, body aches, chills, nausea, dizziness, extreme fatigue, all lasting 24 hrs
This case was reported by a pharmacist and described a 39 year old male pt who did not respond to the Engerix-B immunization series. The pt reported "occasional" alcohol use. On an unspecified date, the pt received the 3rd dose of Engerix-B (lot ENG35466A4). Approx. 2 months after the 3rd dose of Engerix-B on an unspecified, a hepatitis B surface antibody titer indicated that the pt was "non-immune". The reporting pharmacist reported that the pt had begun the "second series" of immunization with Engerix-B.
unspecified patient received a dose of improperly stored VARlVAX; This spontaneous report as received from a vaccine coordinator and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 09-JUN-2020, the patient was vaccinated with one dose of improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S032351, expiration date of 14-OCT-2021, for prophylaxis. STERILE DILUENT used for reconstitution of vaccine was properly stored.
Strong pain in the arm during the middle of the night. While getting up to get an ice pack, I felt nauseous and fainted, apparently from the pain. I stayed on the floor for some minutes in quite a bit of pain and then it subsided all at once.
Mom phoned today 01/21/2009 @9:24am with c/o pt. was very tired last evening. She did well through the night. Mom states that today patient would stiffen her legs, blink her eyes hard and make a fist with both hands. We assesed the patient today in the office. The patient was scheduled with Neurology (appt. pending) and we are to obtain an EEG.
2 inch red, raised area on right thigh, hot/pain to touch. Denies fever. Given Tylenol/ibuprofen for pain.  Dtap given in the right thigh and MMR/Varicella in the left thigh.
12h post vaccination: headache, chills, flush/pruritus, malaise, fatigue, arm soreness (acetaminophen, antihistamine, hot shower, sleep) 24h post vaccination: symptoms resolved except malaise and headache (acetaminophen) 48h post vaccination: symptoms resolved ~10 days post vaccination: maculopapular rash on R flank ~14 days post vaccination: maculopapular rash spread to entire torso and bilateral upper extremities
PT CAME IN REPORTING THAT SHE WAS GETTING HER 2ND VACCINE BUT WHEN ENTERING DATA INTO REGISTRY, IT SHOWS THAT PT HAS RECIEVED 2 DOSES PRIOR. PT RECIEVED 3 DOSES OF MODERNA. THE FIRST DOSE WAS IN JANUARY, THEN 4/2, THEN 5/4. ATTEMPTED TO CONTACT PT TO CONFIRM BUT HAVE NOT HEARD BACK.
Vaccines were kept frozen until they are ready for administration; Vaccine administered beyond use date or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated.  No treatment medication was provided by reporter.
Patient asked for vaccine. Technician asked him if he wanted the covid vaccine, he responded yes. Pharmacist counseled patient on Covid vaccine, expected side effects, asked if it was his first Covid vaccine. Patient responded yes. Pharmacist advised patient that she was administering the Moderna Covid vaccine, and that he would need to return for his second dose in 4 weeks, then administered the vaccine. Ten minutes later the patient returned and stated that he had previously received both Pfizer Covid vaccine doses earlier this year, and he did not want the Covid vaccine today, he wanted tetanus. Not eligible for booster at this time.
Dizziness (vertigo) and tinnitus (ringing in ears) have been substantial and noticeable since about a week to 10 days after the vaccine
Friday night my arm was so sore that I was unable to move it. Muscle aches also began Friday night. Night sweats throughout the night. Saturday joint and muscle pain as well as 100.7 fever throughout the day. I slept all day Saturday and through Saturday night as well.
This case was reported by a nurse via sales rep and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed a rash on the arm a few days after vaccination. A field representative called into medical information to initiate an adverse event report on behalf of the health care professional. She was given minimal information. The health care professional was going to follow up with once they contact, where it was administered to gather batch information.
4 days after vaccination woke up with severe foot Pain. 7 days later found out this was a superficial thrombophlebitis with a gastroc DVT and 4 right subsegmental pulmonary embolisms
1 hour later grandmother had to call 911, because patient's heart rate has increased. (She is 8 years old).
Fever up to 102.6 on 5/24/12. On 5/26/12 she developed small red bumps/rash on the trunk of her body, extremities and a few on the face.
Patient experienced left sided facial paresthesias immediately after getting the flu shot in her left arm (no motor involvement). Advised ibuprofen
Itching, red blemishes two months at this time. Under care of dermatologist.
Burning pain around back started within a few days followed by numbness in legs about a week after that. Prescribed prednisone and IV steroids. Referred to Neurology and diagnosed with Transverse Myelitis. Symptoms improved over several months, but pain and numbness persist. Adverse event onset date is date numbness started.
Initial report received from a healthcare professional on 23 May 2012. This case is linked to AER# 2012-05599. Cluster of 8 patients whose age and gender were not specified, received a dose of ADACEL (lot number: C4051BA route and site of administration were not reported) on 02 May 2012. It was reported that 2 patients developed pain, heat, swallowing and redness at the site with swelling of axillary node. One of these patients was administered antibiotics. Both were better in 2-3 days. 1 patient complained of flu like symptoms with fever and sweat along with large local reaction, and was better symptomatically in couple of days and by 2 weeks he had a small knot left at the site. The remaining 5 complained of more pain as compared to the what they usually got with TD. Outcome of the events was unknown. List of documents held by sender: none.
INADVERTANTLY GAVE AGE 5-11  PEDIATRIC DOSE OF PFIZER COVID RATHER THAT VACC FOR AGE 12 AND UP
Patient stated that she had a headache and felt like she was having an out of body experience. She later complained that she was experiencing pain in her temples, occipital lobe and sinus cavity, with a pounding sensation. At 2:30 PM she stated she was feeling better and left the clinic.
6 to 8" cm red circular welt- allergic reaction. Given Benadryl.
SSCP, worse with lying down and DOE 3wks after 1st Pfizer COVID vaccine.  Pericarditis.
Temp 104. Developed tonic-clonic convulsions with post ictal. Treated with Tylenol, Oxygen.
states wakes up 75% of time screaming, crying for no reason becomes rigid when cries; has not seen MD since recvd shots; sx started 2 days p/shots;