chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 7 hours had mild headache low grade fever, mild myalgias; Next day fever to 102.4, severe headache, severe myalgias; Following day felt better but has maintained low grade fever to 100.4 for for 7 days since vaccination. 12th day still have headache, started to feel numbness in Left arm below elbow.
pt recvd flu vax & the following day devel soreness, redness, itching, & warmth @ the inject site;
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Joint Pain-Medium
Pt began having joint pain, sometimes severe (especially in AM). This hadn't been noted before the vaccine was given. Some swelling occurred. Advised to try anti-inflammatory medications to take the edge off of the discomfort. Still on anti-inflammatory meds.
Complained of complete loss of muscle tone in lower extremities evening of vaccination (is MS patient). States "hot and cold spells and muscle aching. Loss of muscle tone lasted 45 min. Symptoms eased. Slight dizziness also reported.
On the 29th after a walk, my hamstrings felt tight and I  had burning in my calves and I took it easy for a few days and Saturday Jan 2, I started having bilateral upper gluteal pain, and kept progressing On the night of the 6th I had increasing bilateral joint pain, on 8th I had a med clinic visit, pain constant increasing of bilateral gluteal pain and it kept progressing and I started feeling bilateral sciatica pain tingling in my feet, I was advised not to receive the 2nd dose. As it constantly progressed and pain focused on SI Joint and bilaterally , I saw  a NP on the 12th they ordered an MRI of lumbar spine with and without contrast. They did see irregularities in sacral joints. NP prescribed methyl prednisone, I started taking that Feb 3-Feb 8. I also was having fasciculations and both of my legs.
Around 5:00 PM 48 hours after vaccine, I developed a full body rash with hives that I tried to treat at home with Benadryl and when I went to bed it was very uncomfortable. The next morning, I went to urgent care because I had it for over 72 hours with no reprieve and they gave me a steroid to treat it and it helped with the rash.
I had rapid heartbeat, nausea, muscle pain, weakness, chills, dizziness.  I was just "out of it", nearly incomprehensible
Her surgery in the morning went very well according to her doctor.  Later in the afternoon, pt. had a massive stroke. Next day pt. died at  Hospital .
Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date; No adverse event; Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported. On 24-Oct-2022 at 9:33 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture. Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were administered >12 hours post puncture. Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture. Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture. Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Doses were administered >12 hours post puncture. Dose administered after 30-day Use By Date).    No concomitant medications were reported. The doses were administered post 12 hours of puncture. Visuals were first thawed on 20-Sep-2022. The vial size was 2.5 mL The vial was initially stored in the refrigerator on 20-Sep-2022. The vial was first punctured on 17-Oct-2022 at 9AM. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature for less than a minute. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-665349 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665349:Patient 1
After my second dose, I  experienced fatigue and fever but my symptoms only lasted 4 days. I now have a white mark on my skin that is inflamed, located on my left forearm radiating to my left hand.  I do not know how I got it and my PCP sent me medication to my home address, where I am to take this pill orally to help decrease my inflammation. I did not have this mark before receiving my Pfizer vaccine and this is very concerning to me.
Patient's arm became really sore later in the day after receiving vaccine then overnight became very swollen according to the patient's wife.
Developed hives 1 1/2 hours after administration. Hives continued to next day @ legs, @ chest, @ arms advised CLARITIN qd.
Patient had flu like symptoms, which was expected. The symptoms of concern was that she felt a "heaviness" in her chest for 2 days and that she was SOB while going up stairs. I took her to her pediatrician's office for EKG. EKG was a sinus arrhythmia and did not show  endocarditis. Patient felt better 4 days after her injection.
PRESENTING PROBLEM: Acute alcohol intoxication, with unspecified complication (HCC) [F10.929] Alcoholic intoxication without complication (HCC) [F10.920] Community acquired pneumonia of right lower lobe of lung [J18.9] COVID-19 virus detected [U07.1]   HOSPITAL COURSE: The patient is a 67-year-old female with history of dementia and alcohol abuse who presented to the emergency department acutely intoxicated from her independent living facility.  Labs were stable in the emergency department.  Lactic acid was elevated to 3.1.  The patient was positive for COVID.  Ethanol level was 426. Chest x-ray showed a right basilar lung opacity.  IV antibiotics were started.  The patient was admitted for further continuation of care.  Antibiotics were stopped on admission.  The patient's procalcitonin level was unremarkable.  CT head was negative for an acute process.  Her mentation improved.  She was alert and oriented x4 the day of discharge.  Her lactic acidosis resolved with IV fluid hydration. She was asymptomatic from a COVID-19 perspective.  Social work evaluated the patient.  She was discharged back to independent living in stable condition.
Per mom, adminstration of the first dose of vaccine may have unmasked or otherwise been associated with the development of Behcets Syndrome. Upon receipt of second dose, symptoms returned more strongly and a questionable, causal association was made between the development of Behcets and the Gardasil vaccine. Mom is against further vaccination with gardasil for patient.
Diarrhea issues; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIARRHOEA (Diarrhea issues) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea issues). At the time of the report, DIARRHOEA (Diarrhea issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2021-435439, MOD-2021-435236 (Patient Link).
Around March 2020, I noticed new onset palpitations for a few seconds that were self limiting. No other associated cardiac symptoms, no shortness of breath or chest pain Never had palpitations before. Palpitations were self limiting and have not recurred for 5-6 months I am concerned that they may have been ASSOCIATED with my vaccination and am concerned to have a 3rd/booster injection.  I'd greatly appreciate some guidance based on knowledge regarding this situation of palpitations
This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4, 7 or 8 November 2011 the subject received a dose of FLULAVAL (.5 unknown, unknown route). On an unknown date in November 2011, several hours after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pruritus. According to the pharmacist, the hospital had a flu clinic between 04 November through 08 November 2011. Approximately 40 subjects were administered FLULAVAL from the same lot. Of the 40 subjects, five subjects experienced injection site redness, swelling and pruritus. This case was associated with a pharmaceutical product complaint. The pharmacist was suspected a questionable batch of vaccine. She noted that a sister site had administered FLULAVAL with a different lot number and had no adverse events reported. At the time of reporting the outcome of the events was unspecified. This is five of five cases. See cases A0952517A, A0952520A, A0952521A and A0952522A for information regarding the other cases.
dry cough, chills, stomach ache, headache, weakness, fatigue, tingling skin, pain in chest, with continued worsen symptoms
pt. reports feeling like her throat is swollen on the R. Side.  hx of  asthma.  pt denies any difficulty swallowin &/or other s/s medics present.  pt. took benadryl 25mg - 1215 today, and again around 1400 today.   1415: 117/82; 69   16
increased frequency in urination; A spontaneous report was received from a consumer concerning a (patient age and gender: unknown) patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced increased frequency in urination/micturition urgency.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided. On an unknown date, prior to the onset of the event, the patient received their first of their two planned doses of mRNA-1273 (Lot number: unknown) through unknown route at unspecified site for prophylaxis of COVID-19 infection.  On an unknown date, reported about several people over age of 70 years experienced increased frequency in urination after receiving the first dose from Moderna's' COVID-19 vaccine.  Treatment activities for event was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, increased frequency in urination was unknown.
hives-inside arms, stomach, lower back-size of quarter (arms), stomach very tiny, all raised, itched; gone by next AM;
TD vaccine administered to pregnant woman (EDD 02/19/2018) instead of Tdap vaccine. No adverse reaction to report.
Patient got ZOSTAVAX on 5/22 and came back to the pharmacy on 5/25. She had a large, red spot on her arm that was warm to the touch. Told her to watch it.
Systemic: shaky, weak, tachycardic, gave O2, pt has heart issues already
IMMEDIATE ELECTRICAL SHOOTING PAIN DOWN ANTEROLATERAL ARM. INTERMITTENT SHOOTING PAINS WITH ROM SINCE THE EVENT.
I went on December 30  2021 to get my Covid Booster Shot and when I received the shot the RN that gave me the shot advise me it would be 15 mins and she did not check my arm after she gave me the shot. I began becoming sick on  December 31 2021 at 12:35 PM  and I was throwing up and I had a high grade fever and then I went to the Emergency room and I was seen by DR who checked me out and advise me that my arm was swollen and hot and that I had an infection due to the Booster shot when the RN that gave me the shot broke my skin and shot the booster in me I had an infection. The Medication he Prescribed for me is Acetaminophen 500 MG take when needed for pain Bactrim 400-80 MG   two times Daily  and Keflex 500 MG  every 8 Hours  I am still taking the Antibiotics and I went to my primary doctor and he drew blood to make sure it was only an infection and nothing else related to covid on 01/03/2022 I saw Dr. and he drew blood to make sure it was only the booster vaccine that gave me the infection. The Hospital Refuses to report to the CDC and advise me to Report the event that happen.
Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age. There was no information about the patients' medical history and concurrent condition. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K020216, expiration date: 17-SEP-2016; lot # L007558, expiration date: 10-NOV-2016)(strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of the reports received from the same reporter. Additional information has been requested.
Rash, consistent with acute urticaria. Started on antihistamine. Plan for prednisone if no improvement after 24-48 hours.
Rash is on his neck and belly concentrated on the right side and both of his legs; lowgrade temperature of 100 degrees F; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash is on his neck and belly concentrated on the right side and both of his legs), PYREXIA (lowgrade temperature of 100 degrees F) and CHILLS (Chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), LISINOPRIL, MELATONIN, COLECALCIFEROL (VITAMIN D3 1000), HCTZ and FERROUS SULFATE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (lowgrade temperature of 100 degrees F) and CHILLS (Chills). On 16-Jan-2021, the patient experienced RASH (Rash is on his neck and belly concentrated on the right side and both of his legs). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and TRIAMCINOLONE for Rash, at an unspecified dose and frequency. On 14-Jan-2021, PYREXIA (lowgrade temperature of 100 degrees F) and CHILLS (Chills) had resolved. At the time of the report, RASH (Rash is on his neck and belly concentrated on the right side and both of his legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt was sitting in observation area, became very pale, cool, & nauseated, became diaphoretic.  Pt laid supine with legs propped up,  within 5 minutes, patient skin was pink warm & dry, patient allowed to rest for 30 minutes, sat up slowly, states he felt much better.  Offered EMS, patient declined, patient called father to transport home.  patient left clinic ambulating independently, smiling, thankful for treatment with father to drive home.
This spontaneous report as received from a healthcare professional refers to 2 unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (lot # L009445, expiration date 01-JUN-2017, doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-2415) was received from a consumer on 23-Sep-2019. It described a female consumer who "took one dose of unrefrigerated Vivotif" (PT: Product storage error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 22-Sep-2019, which was left unrefrigerated for 3 weeks.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
I became a little light-headed about 30 minutes after the shot it lasted about 30 minutes. And about 9:00 p.m. my arm got a little sore and then increased about twice as bad as a flu shot does cleared up in about 24 hours.
permanent scarring; a severe and painful shingles outbreak; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On or around 07-AUG-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a severe and painful shingles outbreak. As a result of zoster vaccine live (ZOSTAVAX), she suffered additional, recurring shingles outbreaks, consisting of blistering, redness, and burning pain. These continuous shingles outbreaks have resulted in permanent scarring on her back and were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experience mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Patient and his mother were sitting down in the waiting area post-vaccination. Patient reports feeling pain in his head and blurry vision. Mother reports patient stopped talking and fell over in chair. She caught patient before he hit the floor and called for help. I (pharmacist and Immunizer) helped support the patient for several minutes. He was dizzy and not talking. He was visibly sweating and shaky. After about 3-5 minutes the patient felt better. In a few more minutes his vision returned to normal.
Hives, nausea, headache.  Given benadryl.  Hives resolved.  Residual dull headache.  Patient sent home with scheduled Benadryl x 24 hours, has Epipen. Encouraged to use prn and to seek medical attention prn.
Patient came to the pharmacy at 1:05pm to notify us of sharp pain in the left hip bone area starting 10 minutes after the vaccination. She was unable to get assistance at the vaccination clinic and came to pharmacy for documentation. still getting pain at the pharmacy counter.
About two months after taking pfizer Covid booster, I was diagnosed with Hypothyroidism. I had no symptoms prior.
This spontaneous case reported by a consumer, describes the occurrence of "broke-out with a rash" in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced "broke-out with a rash." At the time of the report, "broke-out with a rash" outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine):  unknown. No concomitant medication or treatment information provided.
On 11/19/21 Patient came in for her first Pfizer vaccine appointment.  Consent form was completed without questionable concerns for administration.  Patient was administered the Pfizer vaccine while seated in the pharmacy waiting area.  After the shot was given, I asked discussed reminder date for second shot, common side effects of vaccine, and asked her to remain seated in the pharmacy area for a little bit to make sure she was feeling alright.  While administering the next patient's vaccine in the pharmacy waiting area just a few minutes (2-3 mins) later, my back was facing Patient across the room and as I was speaking to the other patient, I heard a loud clunk hit the floor. I immediately turned around to see Patient collapsed on the floor in front of her chair. We immediately call 911 and the floor manager and I rush over to her and place her on her side and call her name to elicit a response.  She is responsive within about 15 seconds of calling her name.  She begins to talk normally while remaining on the floor with me on the floor beside her. I asked if she had ever had a reaction like this to a vaccine to which she said no but she has had fainting episodes in the past. A few minutes go by and she has called her father to come pick her up and shes seated in a chair.  The paramedics arrived and discussed with Patient her medical history, took vitals, and asked if she would like to go to the hospital.  Patient said no and I confirmed that her father would come to pick her up from the pharmacy.  As the paramedics are walking to the exit of the building, Patient fainted again and was quickly responsive again.  The paramedics came back over and got her buckled into the stretcher for transport to the ED.