chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 66 year old male patient regarding himself. The patient's medical history included bladder cancer. Patient had no allergies or drug reactions. On 02-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot# reported as J000927, expiry: 10-APR-2009) in the left arm. Concomitant therapies included ZOLOFT, NEXIUM and LIPITOR. On 04-APR-2013 (reported as 2 days after the shot), the patient experienced constant ache in his left shoulder. Whenever he lifts his shoulder 90 degrees or more or when he lifts something heavy, he has a constant pain in his left shoulder. No treatment was received. No laboratory tests were performed. Patient sought medical attention (called pharmacist). The outcome of constant ache in shoulder was reported as not recovered. This is 1 of 2 reports
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II (dosing details were not reported (incorrect product storage). There were several previous temperature excursions. Time frame and temperature excursion were not reported, but reporter stated that the temperatures the vaccine were exposed were above the range and the range was back. There were prior excursions reported. It was unknown if the call was due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Pain in the upper arm where vaccine was given, not necessarily on the injection site, whole upper arm up to shoulder area. Patient experienced pain one week after receiving the vaccine.
By 14:00 on 4/30/2021 my body started aching all over.  by 20:00 the pain was severe, even the arches of my feet hurt.  I had taken acetaminophen by 18:00 and again at 24:00.  Much to no avail.  At 06:00  the pain was pretty severe yet and acetaminophen was not cutting it.  I had some hydrocodone from a previous injury still in my medicine cabinet, so I took one of them.  It made a big difference.  By 08:00 most of the symptoms had diminished.  I didn't take anything else until 17:00.  By then my left arm was really hurting.  By 21:00 the pain was all the way down my arm and up into my neck and  jaw.  I took another hydrocodone.  The pain was still pretty severe at 22:30 so I took 2 Ibuprofen.  my pain had diminished enough to get to sleep by 23:30.  When I work up this morning my pain was localized to just around the injection site .
Patient reported pain the next day and swelling at the site of injection. She felt overtired and achy as well. She reported no fever. When she came into the pharmacy a week after the injection on 3/26/19, she had a 4 inch diameter red spot over the injection site. She said the pain was still there but not as bad. She denied fever at that time as well.
NO ADVERSE REACTIONS REPORTED - HOWEVER DOSE WAS GIVEN TO PT (16 YO) EVEN THOUGH INDICATION IS 18 AND OLDER  REPORTED THE VACCINATION ERROR ONLY - NO ADVERSE REACTUOI
He got the vaccine, felt like it went to the bone and has had a continuous ache and soreness.  He started to return to weight lifting and was not able to list the barbells to do so.  It has affected his ability to exercise his right arm.  He is limited by his breathing due to his COPD but his activity level has declined and his right arm is still not working strength was.  He is able to cook and use it but not where it was before he got the vaccine.  His joint itself cracks and pops.  He is normally a physical person even with his condition, but is limited in exercising now.   He has not seen his doctor for this, due to COVID his last appointment was over the phone.  He did call the pharmacy and mentioned it perhaps to his doctor but not been seen for it yet.
FLUVIRIN vaccine administered on 09/07/11 - patient's caregiver called on 09/09/11 stating the area was red, inflamed and warm to the touch. Suggested to the caregiver to begin BENADRYL.
April 17th started having headaches and nausea that quickly morphed into all over body aches and high grade fever. Feeling of pressure on chest was present. Started around 6 pm lasted until I went to sleep at 6 am by the time I woke up at 1:45 pm Sunday April 18th I felt significantly better. Still have aches in torso, and occasional pangs in chest. No medicine has been taken.
High Fever of 104 Degrees F.  Didn't want to eat very much and felt pretty sick when fever would spike towards the end of the Tylenol. Called family doctor, administered Tylenol every 4 hours, luke-warm bath, and given Children's Motrin at bedtime.  Woke up next morning fever-free.  No other symptoms and did not get sick with anything else.  Felt fine after fever broke.
Started to feel warm and light headed.  VS @ 15:15 HR 72, RR 16, BP 112/68, S02 98%
After each of the shots, my cholesterol has taken sudden jumps despite no changes in anything else, despite better eating habits, In this last one, it took the biggest jump high, enough now that I have to be on medication for it, which is not something I had to do prior.
Red Welt; Red Circle diameter is 4inches does not hurt/Outer ring of Red circle is a darker red ring; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Red Welt) and ERYTHEMA (Red Circle diameter is 4inches does not hurt/Outer ring of Red circle is a darker red ring) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced URTICARIA (Red Welt) and ERYTHEMA (Red Circle diameter is 4inches does not hurt/Outer ring of Red circle is a darker red ring). At the time of the report, URTICARIA (Red Welt) and ERYTHEMA (Red Circle diameter is 4inches does not hurt/Outer ring of Red circle is a darker red ring) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
At 1448 on 11/26/2013 this pt. received Tdap, HPV, Hep A and Hep B at this clinic. He has been receiving immunization since 1992 without any adverse reaction. At 1508 on 11/26/2013 seen by a medical provider at this clinic for genital warts, penis. While at the clinic the pt. did not show any signs/symptoms of an adverse reaction to the vaccines. At 1959 on 11/26/2013 the pt. was seen at the Medical Center. The ER physician noted that the pt. had received vaccines 11/26/2013. Several tests were completed which are attached. The pt. was discharged from the ER 11/27/2013 at 00:27. "Impression: Seizure, leukocytosis - unspecified" pt was prescribed KEPPRA at that time. This pt. has been under neuro. care since his TBI 6/10/2012. On 1/13/2014 the pt. returned to this clinic for a refill on the KEPPRA. On that day he was seen by one of our providers. On that date Dr. dx the seizure of 11/26/2013 as "related to adverse effect of immunization". I am not aware that the ER physician or Dr. had attributed the seizure of 11/26/2013 to the vaccines. Since Dr. has related the seizure to the vaccines we are notifying VAERS today 1/16/2014. Please let me know if you need any additional information.
booster vaccination; crohn's disease symptoms flare with booster vaccination; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4202674-00.  A 15 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as cf for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN (number unknown)), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster vaccination"; CROHN'S DISEASE (medically significant), outcome "recovered" (2021), described as "crohn's disease symptoms flare with booster vaccination". The action taken for adalimumab was unknown.  The reporter considered "crohn's disease symptoms flare with booster vaccination" related to bnt162b2. The reporter considered "crohn's disease symptoms flare with Humira" as no reasonable possibility. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case provided, the causal association between the event Crohn's disease flare up and the booster dose of the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
01/31/22 presents to ED for "generalized weakness". PMHx of "alcoholic liver disease hepatocellular carcinoma"
NO ADVERSE EFFECT; inadvertantly received Varivax after receiving proquad; This spontaneous report was received from a certified medical assistant referred to a patient of unknown age and gender. Information regarding medical history and concurrent conditions were not reported. On 22-OCT-2019 the patient was vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live (Wistar RA 27/3), varicella virus vaccine live (Oka/Merck) PROQUAD (concomitant medication). On 22-OCT-2019 the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, with lot # R030606 and expiry date 23-OCT-2020 for prophylaxis (dose and route were not reported) after receiving measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live (Wistar RA 27/3), varicella virus vaccine live (Oka/Merck) (PROQUAD) (Inappropriate schedule of product administration). The patient did not experience any adverse effects.
Moderna arm rash - a red area  (horizontal oval shape 4-5in diameter) on the location of the vaccine injection.  It feels warmer than the rest of the arm. It hurts a little when touched. Started noticing it 2 days after the injection. No other symptoms or side effects. It has been only a few hours since I noticed it.
Redness, swelling around the injection site that has spread down out and around the upper deltoid and into the left side axilla bicep.
December 16, 2018: Excessive Vomiting, 102.5 fever, Malaise, Excessive sleeping. December 17, 2018: Dehydration/I.V., Vomiting, Loss of appetite, Decreased Fluids, Decreased wet diapers, Weakness, excessive sleeping, 103.5 fever. December 18-Present 2018: Malaise, weakness, excessive sleeping, poor appetite, not responding to name and not acting as normal.
Patient has a fever, chills, and emesis. Patient also has a red spot on left thigh where vaccine was administered. Patient was given Amoxil 400/5 1 tsp BID x 10 10 days.
This spontaneous report as received from a registered nurse refers to the patients of unknown age and gender. The reporter stated that there was a supported excursion affecting ROTATEQ (lot # K006458, expiry date: 24-FEB-2016) which was also affected by prior supported excursions, starting 19-NOV-2014. Subsequently incorrectly stored ROTATEQ was administered to the patients (the onset date if therapy: 19-NOV-2014; dose and route of administration were not reported). There were no adverse events observed in patients post-vaccination and the patients did not seek a medical attention. Additional information has been requested.
pt recv vax 12MAR96 & temp @ 5PM 104.7,persistent high pitch whining,crying for a couple of hrs;pt was also noted to arch back;APAP was used to dec temp but pt vomited-APAP suppository  used which made temp dec;13MAR still fussy
no adverse event; daughter was administered GARDASIL 9 on 27-MAR-2019 after was administered GRADASIL 9 on 09-JUN-2017; This spontaneous report was received from a registered nurse, referring to her 14 year old daughter. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 09-JUN-2017, when the patient was 12 years old, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 27-MAR-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No adverse events were reported.
The day of the vaccination I was unaware I was pregnant at the time, I was 4 weeks pregnant. The day I had normal side effects swelling and redness at the injection site that lasted three days. On September 11, 2018 I took a pregnancy test. I was found pregnant. I saw my OB doctor on September 14th, who confirmed my pregnancy, however she was concerned since my line was faint and sent me for HCG testing. My HCG results proved to be low and I miscarried 9/20/2018. I do not know if the flu shot caused this, however I feel it is important to report since It was close to vaccination date. This would be my fourth pregnancy, two pregnancies to term. My last child was born 9 months prior to this last pregnancy. If this pregnancy would have continued the baby would have been born May 2019.
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  Additional Information: The reporter has issues on tinnitus and it was reported that the patient had the same issue after both Pfizer shots.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101097446 same reporter, patient, product, drug/AE, different patients
Fever, mild headache, shortness breathing. ZITHROMAX 150 mg, Levofloxacin 500 mg, Cefdinir 300 mg, Amox-Clav 500 mg.
7/25/18 PM: Burning feeling during shot. NP said it was probably the alcohol she cleaned my arm with. It was internal burning, not the alcohol. By bedtime I was running a fever, arm was tender.  7/26/18: Redness and swelling began, injection site warm to touch, fever increased, felt fatigued.  7/27/18 AM: Called my primary physician left message for nurse. PM Nurse returned my call, advised to go to minor care, make sure it's not cellulitis. I went to Immediate Care, and was given prescription for BACTRIM Sulphur antibiotic for 7 days. Began feeling better after 3 to 4 days, was doing paperwork, reached into my trash can and felt a pop and burn in my shoulder few inches above injection site. Subsequently felt like a catch in my shoulder, tried exercises and chiropractic care over approx. 5 weeks with ibuprofen. Mobility continued to decrease. Went to my family doctor on 9/14, took x-rays and checked range of motion, possible rotator cuff tear due to infection from vaccine weakening the muscle. Have appt with orthopedist for Oct 3rd, 2018.
She experienced a sudden deafness in her right ear in between receiving both her shots.; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date not reported), via an unspecified route of administration on 16Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a sudden deafness in her right ear in between receiving both her shots. Her second dose was on 06Feb2021. The outcome of event was unknown.  Information about batch/lot number has been requested.
Pt came home from school with a sore throat, runny nose and mild fever of 99.7 (no illness or symptoms that morning). Fever dissipated that evening and by the following day (24 hours) both sore throat and sniffles had abated. He took a vitamin C orange drink supplement and zinc (as recommended by attending doctor at urgent care facility).
if you get the Covid shot you wouldn't get Covid or spread it; if you get the Covid shot you wouldn't get Covid or spread it; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 62-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "if you get the Covid shot you wouldn't get Covid or spread it". Clinical Course: Reporter considered event was as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Seven days after first dose I noticed two red swollen bumps about 2-3 inches below vaccine injection site. In the course of 24 hrs the red bumps spread to cover 2?x4? area that was itchy, red, swollen and warm. The patch of swollen skin remain for 2 days and started to dissipate and mostly gone by day 4 after appearing.
enlarged lymph node; moveable mass that was 8 mm in size right below the supraclavicular area; This case was reported by a nurse via call center representative and described the occurrence of enlargement of lymph nodes in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 17th September 2020, the patient received the 2nd dose of Bexsero (intramuscular). On 21st September 2020, 4 days after receiving Bexsero, the patient experienced enlargement of lymph nodes and mass. On an unknown date, the outcome of the enlargement of lymph nodes and mass were not recovered/not resolved.   It was unknown if the reporter considered the enlargement of lymph nodes and mass to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient was seen at office and had a moveable mass that was 8 mm in size right below the supraclavicular area and is still there currently. On 24th September 2020, the patient had an ultrasound done and was found to have an enlarged lymph node that was still there currently. The patient was referred to an oncologist. The reporter did not consent to follow up.
Pt received GARDASIL, no c/o at time of vaccine. Pt found on floor moments later in lobby mom stated pt fell face first, pt brought to room, put on 2L O2, VSS, MD aware, 911 was called pt taken to ER.
PT EXP HIVES FOLLOWING 1ST DOSE OF ENGERIX-B.
Every other day my period would come one day & be gone the next. This lasted for about a week which is a long time for my period because my periods usually last for 3 days.
PATIENT'S RIGHT ARM WAS SWOLLEN, RASH DEVELOPED AND WAS SORE. PATIENT ALSO REPORTED NAUSEATED AND FEVER AND A HEADACHE.
Less than 24 hrs had severe leg cramping, swollen glads in throat with throat very sore, tired, sore arm.  Next several days itchy skin, tired, generally not feeling well, one week after had swelling in hand, achey joints, still tired.  10 days out covid tounge; swelling and blistering near throat, still tired.
39 y/o patient had Moderna covid vaccine 4/1/21 has chronic ITP platelet counts around 35,000 dropped to 16,000 and  he had minor hemorrhoidal bleeding.
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 18-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Dizziness; Abdominal Pain; No Appetite; Fatigue; Extreme Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal Pain), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue) and HEADACHE (Extreme Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 38K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) and METHOTREXATE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal Pain), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue), HEADACHE (Extreme Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal Pain), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue), HEADACHE (Extreme Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Received covid vaccine number one on December 23. By December 25 she developed tingling in the tips of her toes and  in her fingers. She found this concerning. She spoke to her rheumatologist as well. The rheumatologist recommended she go to the ED.  She was recommended to  see a neurologist. Neurologist is planning to test her for GBS.
Elevated temperature 102-103.0 about 5 hours after receiving MENACTRA and TDaP  vaccination at the clinic during pts KBH. Injection site at right deltoid has golf-ball size edema with discoloration that mother states looks bruised. Pt came into clinic on 8/2/18 and was evaluated from physician and swelling had decreased, but still had redness and warmth. Will continue to monitor.