chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joint pain; fatigue; fever; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration on 16Mar2021 at 11:45 AM (at the age of 72-year-old) as a single dose for COVID-19 immunisation. The patient medical history included prostate cancer and seasonal allergies. Concomitant medications included gabapentin (MANUFACTURE UNKNOWN), celebrex (MANUFACTURE UNKNOWN), acetaminophen (MANUFACTURE UNKNOWN), allegra (MANUFACTURE UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, the patient experienced joint pain, fatigue, fever and nausea. The clinical outcome of the events joint pain, fatigue, fever and nausea were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient was vaccinated with her second dose on Wednesday, February 24th. A family member contacted us to let us know she was sitting in a casino exactly one week later and passed out, going into cardiac arrest. The patient did pass away.
Pt received vaccine high in left shoulder, reported pain at injection site immediately after. has had ongoing pain and numbness in ring and little finger.
Three days after I became very tired and had chills. Also I felt very achy and did not have a fever. The next morning I felt a little better. I had sinus infectious .
harsh pain in several joints, mostly in two knuckles on right hand and knuckle of my right foot. Other than those body aches.
Noticed blood in urine about 2 pm on day of injection (Sunday Feb 21, 2021). Also blood in urine at about 5 pm and 9 pm that day. Also the next morning at 7:30 am and 10:15 am but gone by 4 pm when I am writing this up. No pain on urination. Some discomfort  inside. Had  general and ob/gyn check up already scheduled for tomorrow at 8 am.
Urticaria with erythematous streaks, swelling of entire thigh, right circumference 3 cm > left.
Took 4th shot in morning, by early evening had numbing of fingers on left hand (shot on left arm). Contacted doctor's office, saw different doctor. Still having same problem along with hand being ice cold, saw regular doctor 2 weeks later. (Doctor told me to wait for 2 weeks). Kept going back to Dr. about hand every 2 weeks and hand kept getting worse. In November, had an Electric shock thing done to arm. Visited with Hand specialist and Neurologist in the months following. Hand become worse, no longer able to make fist or thumbs up.
This spontaneous report as received from the Department of Public Health newsletter refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the unspecified patients were vaccinated with doses of M-M-R II injection (strength, dose, route of administration, lot# and expiry date were not reported). It was reported that the patients received two doses of M-M-R II. There were no concomitant therapies reported. On an unknown date, the patients experienced mumps. The outcome of the event was unknown. The relatedness between M-M-R II and the event was not provided. Additional information has been requested.
Information has been received from a physician concerning a friend of his son who was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on 06/01/2004, the patient developed chickenpox breakthrough.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The physician mentioned his son also developed chickenpox post vaccination with varicella virus vaccine live.  The reporting physician also mentioned that he, himself, had negative titers post vaccination with varicella virus vaccine live.  Additional information has been requested.
Patient received the flu vaccine first and the MMR approximately 3 minutes later.  The patient stated that she was fine after each vaccine but then about 3 to 4 minutes after the MMR she stated that she felt very nauseous and then very hot.  I immediately began to fan her and at first she said she was ok and able to breathe deeply when asked to do so.  Within another minute or so the patient appeared to be losing alertness and I called for assistance. The patient never lost consciousness although seemed unable to respond briefly and at that point I directed my assistant to call 911. At hearing that,  the patient almost immediately became alert and responsive and stated that she was fine and "coming back"  The patient was observed for approximately 15 minutes more, offered further assistance but declined and stated she was OK
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Anemia" (unspecified if ongoing), notes: occasional anemia. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures (Treatment with Paxlovid started on 09Jul2022 and stop date on 14Jul2022) were taken as a result of covid-19, drug ineffective.  Clinical course: I am testing positive again for Covid via two different rapid tests. Mild symptoms include fatigue and general feelings of being run down. Some mild congestion and coughing. Other medication in 2weeks product Generic for Lexapro taken daily. Known allergies No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse effects; improperly stored dose administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported.  On 30-MAY-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (lot # R026362, expiration date 15-MAT-2020) (exact dose, frequency, route, site of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -9 degrees Celsius (C) to 8C (5.8C) for 17 days. Digital data logger was involved. There were no previous excursions reported. No adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000729:
result back w positive covid; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse reporting for herself.  A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Dec2020 11:00 (at age 39 years old) as a single dose (Dose 1) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient was not administered any other vaccine in the 4 weeks prior to COVID-19 vaccination.  Medical history was none. There were no allergies to medication, food, or other products. The patient's concomitant medications were not reported; however the patient had not received any other medications in the last 2 weeks. The patient experienced a sore throat, voice loss on day 4, loss of smell on day 5, went to test, and the result came back with positive COVID. The events resulted in a Doctor's office visit. The patient was tested post vaccination on 22Dec2020 via NAAT-PCR (nasal swab), with a positive result. The patient had not been diagnosed with COVID-19 prior to vaccination. There was no treatment received for the event(s). The clinical outcome of the event positive COVID was unknown The event was reported as non-serious.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The association between the event drug ineffective (COVID-19 infection) with BNT162b2 can not be fully excluded.
states that the hub on the end of the syringe is loose (like its stripped) with no AE; Product splashed on the nurse and the patient with no AE; When they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere /As the product was being injected into the patientwith noAE; When they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere with noAE; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 48-year-old female patient for whom it was reported "when they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere (Device leakage) states that the hub on the end of the syringe is loose (like its stripped) (syringe issue), product splashed on the nurse and the patient (Occupational exposure to product) and when they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere /As the product was being injected into the patient  Underdose)" while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient past medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.  On 15-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ765AC and expiry date:30-Jun-2022] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to device leakage, syringe issue, underdose and occupational exposure to product [Latency: on the same day].  It was reported "product leaking from the tip of the syringe".   At time of reporting, the outcome was unknown for the events.   At the time of report, no adverse event was reported.
Moderna COVID-19 Vaccine EUA Itchy rash at injection site - mild.  No f/u treatment necessary.  Became noticeable about 10 days after injection.
Fatigue, followed by low grade fever, followed by facial rash that developed into upper body rash.
I woke up with vaginal bleeding, as heavy as a period, but not time for my period with pelvic pain. I went to my doctor on the day the symptoms started March 6, 2023. The bleeding continued until the 6th of March; I am awaiting an ultrasound that is schedule for April 5, 2023. We ruled out pregnancy, STD's, any other possible causes with history. My vitals did not present for an ovarian torsion.
Feeling light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling light headed) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Feeling light headed). At the time of the report, DIZZINESS (Feeling light headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Patient has rash, right upper deltoid area with papular rash oval in shape 3x1.5 cm. Slightly tender to touch. Patient had fever to 102 after PROQUAD on 1/29/18-2/6/18. History of shaking and arm flapping after DTAP/HIB/IPV shots at 6 months of age along with fevers to 104. Also, "spaced out" look. Questionable absence seizures.
Information has been received from a 78 year old female consumer, who was also the patient, with a history of platelet and red blood cell disorder. The consumer mentioned that she had been taking Prednisone daily since April 2008. Her dose of Prednisone started at 40 mg daily and had been decreased over the past several months. At the end of June 2008, the patient was vaccinated with a dose of ZOSTAVAX. Route was reported as oral. At that time her Prednisone dose was 20-40 mg. Beginning in July 2008, the patient developed sleep disturbance, panic attacks, heartburn and anxiety. Electrocardiogram was performed that was negative. The consumer reported that the symptoms had continued and had increased in intensity. The patient sought unspecified medical attention at office. No further information is available.
Administration error - 0.1mL administered. Patient returned to POD and was administered additional 0.4mL on the same day.
Donor C/O lightheaded and dizzy, nausea & vomiting mild stomach lightening & stated felt like he had a fever. First reported at 6pm and was spoken to at 7P & 830P. Stated felt sick but did not fed need to seek med F/U at thee time - Advised to seek med attention if worsens or resolves & call center.
Gave me shot did not feel anything. Probably 2-3 minutes later, it started to feel  flush and chest tightening, and heart started racing. I did sit down, because they were monitoring us. Had my Apple watch on and heart was going up and down. They kept me monitored for about 30-45 minutes before I was hooked up to BP pressure machine. First reading was 180/110. At that point, they asked if I wanted to go to ER. I went to ER and they did an EKG which was normal. Heart rate came down with Benadryl. I was still feeling little tight in chest. Blood pressure 167/97 upon discharge. Sent home instructed to take Benadryl. At home was relaxing, few hours later, heart rated spiked again and stayed for 15-20 minutes. Took Benadryl and heart rate came down. Did not take BP at home. Next day one other time where heart rate spiked again.
Beginning 5 days after my first dose, I began to experience panic attacks that do  not appear to be triggered by anything. The only change in my routine was the vaccine, and between dose 1 and 2 I had a total of 7 panic attacks; since dose 2 I have had 3 panic attacks, for a total of 10 panic attacks. All attacks last for approximately 1 minute and occur at varying times of the day and night.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 28-JAN-2016, the patient was vaccinated with an improperly stored ROTATEQ 2 ml oral injection (lot# L008997, expiry date 04-DEC-2020; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to a temperature excursion (data unspecified), lasting for 352 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling, pain, rash. Rash is about 12cmx10cm in diameter. Around injection site, there is a blanching, erythematous circle. There is then a clear ring, which is surrounded by another blanching, erythematous ring. Patient also reports arm heaviness, some pain.
4 days after vaccination, developed blisters swelling and severe redness on entire face, neck, swelling and blistering on hands.
Pain; arm is red/redness has spread down to the elbow/color is mild; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Pain) and VACCINATION SITE ERYTHEMA (arm is red/redness has spread down to the elbow/color is mild) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN (Pain) and VACCINATION SITE ERYTHEMA (arm is red/redness has spread down to the elbow/color is mild). At the time of the report, PAIN (Pain) and VACCINATION SITE ERYTHEMA (arm is red/redness has spread down to the elbow/color is mild) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included "Mepitor". Treatment medication included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received monovalent vaccine on Friday, 4/21/23 after the FDA deauthorized use of monovalent vaccines.
Mother 89 years of age went to get flu shot at pharmacy at 5:00-5:30, was given the Phizer booster instead, they called her daughter a half hour later to inform her, asked if she was ok and that she would need a booster anyway. Mother had received two Moderna shots earlier in the year.On Monday someone from pharmacy called to see if she was ok. I called on Monday Oct. 11thto get report of incidence from pharmacy , the pharmacist I spoke to , I didn't get his name stated they are not allowed to give it out and the already reported it to her doctor and filled out a report. Now my mother is afraid to get the flu shot!
Patient developed ulcerative colitis 1 month following his vaccine, had no previous issues with bowel health. Developed rectal bleeding and abdominal pain.
Nausea, mood swings, weight gain, pain in teeth, dizziness, headache, joint pain.
This 6-7 wk old child was given his 2 mo vaccines on 11-5-15. He was found without resp or pulse the morning of 11-6-15 in Mother's home not sure if he was in a crib or mother's bed.
2nd dose administered on Thursday morning the 29th of April. Flu like symptoms felt Friday and Saturday. Recovering slightly on Sunday. Noted a very swollen lymph node on my left collar bone. Lost voice on Monday the 5th and remained hoarse through the week. I monitored the swollen lymph node. Made a clinic appointment when a 2nd node in the same area appeared. Area tender and uncomfortable. Severe fatigue and general "feeling icky." Headaches, body aches, sleeping all night, but not waking up rested.  Appointment was on the 17th of May. Doctor agreed to monitor the issue as it was concerning and I was to come back in 3-4 weeks if symptoms did not subside. Was prescribe antibiotic for 10 days. Antibiotic appeared to have no effect. I scheduled another appointment for June 21st as symptoms were getting worse. Provided the following list of symptoms to doctor.  Sinus pain/pressure, Ear Pain - sharp, Jaw/joint Pain, puffy swollen face, redness on face increasing, exhaustion - weakness/no strength to walk, headaches, throat stiff, occasional voice loss, full night sleep but waking up tired, swollen lymphnodes/ducts on collarbone AND now showing on jawline, crusty nose, week long cold sores in mouth, constant for 3 weeks, eye pain/twitching, shortness of breath and chest pain, sudden urge to sleep (mid sentence), random join/muscle pain in arms and feet/legs.  Bloodwork showed no elevated white bloodcell count, but it did exhibit an elevated fatty liver. Concerned enough, doctor scheduled and Ultrasound. That did not occur until July 7th.  Results were negative for anything concerning.  As to how I'm still feeling, almost all of the symptoms listed above are all still around and its life changing. I have SHARP nerve pain showing up now. Sleep is tough, inner ears are very painful.  Walking is difficult and its a challenge to do anything with family or work. If feels like a constant sinus/ear infection with body pain, but no infection can be found except the swollen nodes.   I'm in pain, and all this started a couple days after my 2nd dose.
Extremely sore arm, even more for the second shot than the first; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Extremely sore arm, even more for the second shot than the first". Additional Information: Lot number for BNT162b2 was misplaced or discarded. Patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392780 same drug/reporter/patient, different dose and events
tingling sensation along his spine; This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had Shingles in the past).   On 13th January 2022, the patient received the 2nd dose of Shingrix. On 13th January 2022, less than a day after receiving Shingrix, the patient experienced tingling sensation. On an unknown date, the outcome of the tingling sensation was not recovered/not resolved.   It was unknown if the reporter considered the tingling sensation to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's daughter.  The reporter called in to report that the patient received Shingrix day before reporting and later that same evening he reported feeling a tingling sensation along his spine which had not resolved.  The reporter asked if that was a common adverse reaction, spoke on common side effects.  The reporter also noted that the patient had Shingles in the past, advised the clinical trials did not include patients who had a history of shingles.  The reporter refused to provide mailing address and Health care professional information. The reporter did not consent to follow-up.
Burning when injected.  Arm Ache more than usual for several weeks.  Lost normal function of left thumb & two fingers.  Could not pinch within days of vaccine.  Continued to worsen next couple months.  Some functions started to resume in August.
Pt. developed chills, fever, SOB after ADACEL administration on 8/24/09 - Evaluated on 8/26/09 - Tx OTC TYLENOL.
Pt presented 10-12-10 w/ a large red rash around injection site & a significant rash down (L) arm. Small rash on (R) arm & states rash on chest as well. She said it's very itchy. Pt also states her (L) wrist is swollen.