chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chronic rash/ Break out; first, my skin has evaluated into a blisters; the blisters are so severe and they are unbearable; skin is hurting; Allergic reactions; This is a spontaneous report from a contactable consumer (patient). This 33-year-old female patient received  the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172), via an unspecified route of administration in the left arm on 25Apr2021 (at the age of 33-year-old) as single dose for COVID-19 immunization. Medical history included migraine, seasonal allergy, and ongoing asthma. Concomitant medications included sumatriptan succinate (IMITREX) taken for severe migraine, diphenhydramine hydrochloride (BENADRYL) taken for seasonal allergy, salbutamol (ALBUTEROL) taken for asthma, and acetylsalicylic acid/ caffeine/ paracetamol (EXCEDRIN MIGRANA) taken for mild migraine. The patient previously received the first dose of BNT162b2 (Lot number: ER8733) via an unspecified route of administration in the right arm on 05Apr2021 (at the age of 33-year-old) for COVID-19 immunization and experienced breakout onset on 08Apr2021, she went to emergency room, received antibiotics & recovered on 13Apr2021. The patient reported, "This breakout I experienced is way worsened. First, my skin has evaluated (erupted) into blisters (on 11May2021). I was fine until 2 days ago and I couldn't take the itching and scratches. The blisters are so severe, and they are unbearable. So, I went to the emergency room yesterday (13May2021), they had to do biopsy of my skin to test the skin; they cut two holes to do Pin test to make sure there was not a chronic rash. I have been prescribed medications for allergic reactions (May2021) and they gave me some ointment to put on my skin because my skin is hurting (May2021)" also reported as "an ointment to rub on the blisters that are the worse". Then she came home yesterday (13May2021). The patient also stated, "They gave me some prescriptions when I went to the emergency room to help with the allergic reactions: One of them is called cetirizine and that one is 10 mg tablet that they told me to take one tablet everyday by now and the other one is prednisone this one is 20 mg tablet to be taken three times daily by now." Referring to the result of the lab test (skin biopsy), she stated, "There was a nothing, there was chronic rash. The dermatologist she is the one who gave me these prescriptions that I just read up to you and I have to follow up with her on Monday (17May2021). The clinical outcome of the allergic reactions, skin blisters, chronic rash/ break out and skin is hurting was not resolved.  Additional information has been requested and will be provided as it becomes available.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550697 same patient, different vaccine dose/event
After first dose I developed a rash on day 3 on my right arm, which continued to worsen and then appeared on left arm and then on both legs from the knees to ankles.  Took 3 weeks to completely disappear.
Developed tinnitus in both ears day after bivalent booster, has persisted continuously for 5 months.
Patient presented to clinic 9 days after vaccination with chest pain and sob. Worse when recombant.  Diagnosed with vaccine related pericarditis, responded to tordol and treated with indocin.
-Inj. shot in L arm. L arm fine but R arm felt as if the  shot was from there but not.  Dizziness, weakness, chest pain, slight fever, headache,  minor swelling back of neck, slight spinal tingling (briefly), joint pain in hands (usual).
persistent (i.e., daily) diarrhea that started a day after the first dose and lasted for approximately 10 days after the second dose.
Pt's eyes were red and her throat felt like they were closing up. Took a BENADRYL. (Itching)
3/12/21 5 AM strong pain in arm when moved  7:30 AM lower abdominal let side aching on and off for several hours  8:00 AM Dull Pain behind eyes for 10 minutes  Mid abdominal slight aching -comes and goes for the day  8:15 AM general aches-with pins and needles like fleeting prickling in left finger,  mid abdomen 8:51 AM lower back pain fleeting Cramping in right hand fleeting 9:08 AM lungs feel tender  breathing in-for rest of day  10:45 AM flu like achy 6 on scale 1-10  Feeling feverish 98.7 temp  After doing some housework and having one client session 11:18 AM more light housework, getting dressed and feeling exhausted 7 rating on scale 1-10 And achy 6 rating , over more parts Of body?hips deep aching  12:50 PM  Ate 1:30 PM amys squash soup, 1/4 c low fat cottage cheese and about 10 red grapes  Its 1:40..PM caved in and took one Tylenol 50mg  As all over aching  is so strong- rated 8   I am in bed  feel feverish  Temp is 100.1 2:28 PM achy 4 rating..fleeting prickly sensations on back of calves Very tired -hard to stay awake Dull pains 4 rating running from inner right side of head, starting deep Inside near  center of head and radiating out on right side of head  just in front of right ear and up closer towards temple too Fell asleep 2:55 PM achy still rate 4 no headache  now  4:41 PM searing fleeting pains in hands and feet ..achy bones increasing to 5 rating  Lower ab left side faint aching comes and goes in and out  3 Rating  In bed resting 3:51 PM sharp pains lower abdomen 5 rating  5:02  PM Joints hurting in feet -dull, continuing 4 rating 6:10 PM overall  aching 7 rating Wirh  headache.. Tylenol seems to be wearing off.. going to try not to take another .. feet aching rating 4 but not hands anymore  6:25 PM Chills  7:25 PM chills, stabbing pain lower left abdomen  All over very achy rate 8 & Headache  Hard to focus  Slept  5:15 AM 3/13/21 Rough night Jabbing ear pain, rated 5 on and off thru  night  Loud Ringing in ears that is now a barely audible humming  Lower L abdomen-nearly constant ache rates 4 -7 aaa night progressed  Awoke to find both arms swollen and shot arm completely numb-couldn?t move fingers.  Got up, walked around...feeling came back-but no pins and needles sensation as the feeling returned to my arm and fingers...as i expected  7:00  AM just very tired  No more symptoms except exhaustion -maybe from bad night sleep  Sunday-tired but nothing else  Now its Monday and I feel slight chills today and still very tired .
No adverse events took place. It was discovered that patient had received 2 dose of the vaccine early this year and presented to the pharmacy for an additional dose. The additional dose was administered to the patient unknowingly. The patient reported to the pharmacist that she was there for her first dose. Upon documentation, it was discovered that a 3rd dose had been administered. The patient did  not report experiencing any adverse effects to us.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-JUN-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336 (dose, route and the expiration date were not reported). The total cumulative hours out of range were 64 hours with 48 degrees C as the highest recorded temperature. On the other hand, the total cumulative hours out of range were 328 hours with 29 degrees C, 304 hours with 33 degrees C, 88 hours with 30 degrees C, 40 hours with 34 degrees C as the lowest recorded temperature. The storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
1st vaccine:  Injection site tingling.  Felt lightheaded, dizziness, nauseated, vomiting.  Developed headache.  HR: 84, BP 106/68.  Rash all along arm, back and neck.  Applied hydrocortisone.  Went away within 1 day.  Throughout the week body chills, headaches, sinus pains, low grade fever.  Recovered in about 1 week.  Took Benadryl and Dayquil.  Extended observation and sent home.  Advised to notify PCP.
A few hours after vaccination, severe pain/numbness/tingling started in left arm.  Severe pain lasted several days.  Pain is now intermittent, sharp shooting, describes as needles.  Pain is often more severe at night, and interrupts sleep for hours.  About 10 days after vaccination, pain began in right arm as well.  Same pain/numbness/tingling.  Currently has symptoms in both arms.  Treatments: tylenol, ice, warm compresses, wrist braces, cortizone injection in left wrist, Meloxicam taken for 14 days in mid April.  All treatments with little to no effect on symptoms.
Case number PHEH2013US016586 is an initial spontaneous report received from a physician on 18 Jul 2013. This report refers to an adult female patient (age was reported as thirties). Her medical history and concomitant medications were not reported. It was reported that one MenCYW-135 vial in the box of MENVEO (batch number: M12129, expiry date: Aug 2014) was broken. On 17 Jul 2013, the nurse opened the box, went to draw up the vaccine and as she was grabbing the base of the vial, she cut her finger. The outcome of the event injury was not reported. The seriousness and causality was not reported. No other information was provided.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included pantoprazole, CELEXA and PREMPRO. On 2nd February 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd February, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On 3rd February 2018, the patient experienced cold sores. In February 2018, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the cold sores was recovering/resolving. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. The reporter considered the cold sores to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The pharmacist reported that a patient experienced extreme the arm where she received the SHINGRIX vaccine starting the day of the dose. The severe pain lasted 2 days and during that time it was enough to make her cry and she could not lift her arm. The pain had resolved. The patient also developed a cold sore the day after the vaccine. The patient had no history of cold sores and over the counter treatment did not improve it. The patient had to visit the physician to get a prescription for VALTREX and it was now resolving.
Information has been received from a pharmacist concerning a 42 year old male patient. The patient had no pertinent medical history. The patient had no drug allergies and reaction. On 07-APR-2015 the patient was vaccinated with a dose of M-M-R II (0.5 ml, lot # reported as K007743, expiration date: 28-MAY-2015, subcutaneous). The patient had no concomitant therapies. It was reported that the patient developed pain, stiffness, and discomfort in his ear and neck (side unspecified) within 3 hours on 28-MAY-2015 after receiving the M-M-R II. Naproxen was given as treatment for the events. The patient had visited the pharmacy for medical attention. There was no lab diagnostics performed. The outcome of the events were reported as recovering. Lot # K007743 was not valid for M-M-R II. Additional information has been requested.
Booster dose Pfizer administered to a 17-year-old. Vaccine administration error. Patient not 18 and not eligible for a booster dose of Pfizer.
Swollen lips with blisters; Swollen lips with blisters; Sore swollen gums; Sore swollen gums; flared ms symptoms, (i.e. hand trembling and band around chest),; flared ms symptoms, (i.e. hand trembling and band around chest),; Aching body; Fever; chills; Coughing; This is a spontaneous report received from a contactable consumer (patient) reported herself that. A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: Ep7533) via an unspecified route of administration at right arm on 19Apr2021 13:00 (at the age of 53-year-old) as dose 2, single for COVID-19 immunisation. Medical history included CVID (Common variable immunodeficiency), MS (Multiple sclerosis), PE(s) (Pulmonary embolism), Allergies, Bone disease, Pacemaker, Wheelchair bound. Patient did not have covid prior to vaccination and post vaccination patient did not test COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Patient do have allergies to medications, food and other products. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: Er8727) via an unspecified route of administration at right arm on 28Mar2021 13:00 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation. The patient experienced swollen lips with blisters, sore swollen gums, flared ms symptoms, (i.e. hand trembling and band around chest), aching body, fever, chills and coughing on 19Apr2021. Patient visit the physician office visit for the events. Outcome of all events was not recovered.  No follow-up attempts are needed. No further information is expected
Within 3 minutes of receiving vaccine I had Instant fever, nausea, arm pain, face and lips numb, dizziness, blood pressure low, chills. The pharmacy had to call 911 for a paramedic. I'm still feeling symptoms almost 24hrs later. I chose not to go to hospital in ambulance.
I came down with a sore throat and a cough May 21. It got worse, and on May 23, I tested just barely positive with a saliva home test kit. I retested May 24 with a saliva kit, and it was a strong positive. I confirmed with a nasal swab test kit. May 25 I felt much better. May 26, felt better. May 27 (today), still feel better, but I tested again and I'm still positive.
I was in hospital with covid pneumonia. I had already had one shot; I got shingles / I had already had one shot; This case was reported by a consumer and described the occurrence of covid-19 pneumonia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced covid-19 pneumonia (serious criteria hospitalization and GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the covid-19 pneumonia and shingles were unknown.   It was unknown if the reporter considered the covid-19 pneumonia and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and experienced shingles on butte when was in hospital with covid pneumonia. The patient had already had one shot but it was not quite time to get second one so now have to wait 6 months to get second one.
Abdominal cramps and vaginal bleeding diagnosed as threatened abortion in ER. 1/20, 11/24 and 11/30 Medical records received for DOS 11/15/09 Final DX: threatened abortion Presented w/pelvic cramping and dark red vaginal bleeding w/some clots.
I felt a tapping on my leg, and I thought it was my kid, but it was my arm. I couldn't stop it from moving. I was unable to use my hand and could only bend my arm at the elbow. I finally started to get control of it again. I never lost consciousness, but my mind felt a little distant. I went to the Emergency Room because I was worried I was having a stroke. They gave me an Anticoagulant and kept me overnight. All my scans came back clear, and they diagnosed me with a seizure.
This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ, orally (unknown strength and dose). Concomitant medications were not reported. There was no known adverse effect. The outcome of the events was unknown. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a 20 year old female student with sulfonamide allergy, house dust allergy and mycotic allergy and a history of mitral value prolapse, mitral value regurgitation, "other episodes" of syncope, cardiac disorder and migraines who on 29-MAR-2007 was vaccinated with Gardasil IM in the left deltoid. Concomitant therapy included Ortho-Tri-Cyclen. On 29-MAR-2007, immediately following vaccination, the patient felt faint and nauseous. The patient's blood pressure was 117/86. The patient was treated with smelling salts, cool compress, food and cranberry juice. The patient went home after feeling better. On 30-Mar-2007 the patient visited the physician in the student health center at school where the patient complained of nauseousness and dizziness. The physician's diagnosis was hypotension and GI upset. On 03-Apr-2007 the nurse contacted the patient who was fully recovered from the events. The patient will continue the series of vaccinations. Additional information has been requested.
SEVERE DIZZINESS; 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, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced severe dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe dizziness was not reported. This report was non-serious.
expired Moderna vaccine administered to patients; Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Reporter reported that the administration of vaccine occurred from  6-Apr-2022 to 9-Apr-2022. Patient had not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 1-Dec-2021. Vial was initially placed in refrigerator on 5-Apr-2022. The product did not undergo any temperature excursion issue. Reporter wanted to know if patient need to be re-vaccinated.   This case was linked to MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672, MOD-2022-538676, MOD-2022-538696, MOD-2022-537580, MOD-2022-538673, MOD-2022-538675, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538691, MOD-2022-538697, MOD-2022-538702 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Patient details were added. Updated reporter information. Added suspect drug dose details.
Overall body ache, chills, stiff neck, lower back pain, lethargic feeling for the entire day.
Symptoms: 9pm-1am weakness and muscle aches 10pm-12am fever ranging from 100 degrees to 101.7 degrees, shivering, chills
States that he awoke this morning with his left eye swollen shut with bruising around his eye.  His right eye swollen, his sinus feeling painful and full and his face appearing full.  Also complains of equisite muscle and joint pain and local site injection redness, swelling and pain.  Denies breathing difficulties / wheezing.  Seeking care in ED this am.
I woke up in the middle of the night after the vaccine with feverish chills. I took Tylenol and went back to bed.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received BOOSTRIX (batch number TF422, expiry date 15th December 2019) for prophylaxis. On 31st May 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to BOOSTRIX. Additional details were provided as follows: The reporter had a consumer that received the BOOSTRIX vaccination on left arm. The patient experienced redness and swelling at the injection site the size of a baseball. These symptoms had been present for approximately one week.
After 3 minutes of the application, the patient  got paleness, weakness, shakeness, generalized stiffness. She asked then "What happened? The BP went down to 80/60, and heart rate around 50's. The situation resolved in 15 minutes. No aditional treatment was given.
Deep pain in right leg, could not walk for a week. Slight pain still present. Fatigue, dizziness, nausea, blurred vision