chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. states that after receiving the 1st dose of Shingrix 01/03/2021, started to experience symptoms 15mins later of extreme pain at the injection site. 2hrs later pain radiating throughout the inside of the arm to the shoulder and Left side of the chest, fever presenting close to 100.0 continuing. Primary communications 01/05/2021 (still waiting for recommendations, Communications with Pharmacist recommendations of reporting. Swelling 01/05/2022 under the Left armpit with visual development, pain is presistant and continuing to travel throughout the left side of the body.
This case was reported by a nurse via call center representative and described the occurrence of rash in a 50-year-old female patient who received SHINGRIX. Concomitant products included ADDERALL and spironolactone. On 15th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th January 2018, 1 days after receiving SHINGRIX, the patient experienced rash and pustule. On an unknown date, the outcome of the rash and pustule were not recovered/not resolved. It was unknown if the reporter considered the rash and pustule to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in right arm and noticed a rash containing pustules on both legs, with the right leg being worse. Issue worsened last night on 16th January 2018 but had improved today on 17th January 2018. The patient thought the rash appeared to resemble a shingles type of rash.
no adverse effects were reported; received doses of VARIVAX and MMR II following a temperature excursion; This spontaneous report was received from a medical assistant and refers to a currently 4-year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, lot # N026073 with expiration date on 20-SEP-2019 (dose and site of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ( recombinant Human albumin) (M-M-R II) subcutaneously, lot # N023150 with expiration date on 24-AUG-2019, and lot # N011005 with expiration date on 05-APR-2019 (dose and site of administration were not reported) for prophylaxis. Administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion of 8.3 degrees Celsius for 1 hour 23 minutes. Administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) experienced the temperature excursion of 9.5 degrees Celsius for 1 hour 36 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA004564: US-009507513-1808USA004565: US-009507513-1808USA004566:
This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (GI Symptoms which presented as diarrhea), ARTHRALGIA (Pain in joints) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1805031) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ARTHRALGIA (Pain in joints) and PYREXIA (Fever). On 19-Mar-2021, the patient experienced DIARRHOEA (GI Symptoms which presented as diarrhea). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. On 12-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (GI Symptoms which presented as diarrhea) and ARTHRALGIA (Pain in joints) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 110.6 (High) fever of 110.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided
Beginning Jan 07 fell and couldn't get up. Neighbors had to bodily pick me up. Could not control any part of my body, had walker and had to get a wheel chair couldn't walk or do anything. Seen doctor on Jan 10. Then seen him on Feb 7 and he threw me out of his office and said your got a walker and wheelchair use it, see your own physician. Hospital said I had neuropathy. My physician sent me to a neuro doctor. He did blood test and an EMG and told me I had a virus from my flu shot. April 2 2007 he sent me for intravenous some monoglobulin for one week every day. Had therapy for 3 months finally I am able to walk and I do have control of my body. He also said I had Guillain Barre a slight bit for a while. Thank God I am ok now.  1/8/07 Clinic medical records reviewed which reveal patient experienced difficulty climbing stairs, falls, weakness, tiredness, difficulty walking, numbness in lfingers & toes starting in 1/2007.  Her pain woke her at night.  Seen in Neuro clinic 3/6/07 & dx w/polyneuropathy.  Was already received home PT & had aide to assist w/ADLs.  Returned to clinic 3/28/07 for EMG/NCS & started tx w/IVIG for total of 4 doses.  Returned to clinic 5/14/07 able to ambulate w/cane but still had numbess of hands & feet. Returned to clinic 7/10/07 & continued to improve, using cane only when outside, paresthesias had resolved, no pain & had normal use of her hands.  Clinic records indicate flu shot given 11/2006, not 4/2007 as patient reported.  Shot record not available. FINAL DX: Guillain Barre syndrome, resolving.
Light headed, dizzy, skin turning pale within first 5 minutes of second dose.  Heart palpitations (heart rate 118) from 11:30 pm that night to midnight the following day.  Did not sleep for 13 hours as I felt ?jacked? up.  Went to ER due to the elevated heart rate.
half of her face was numb; half of her face was tingling; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (half of her face was numb) and PARAESTHESIA (half of her face was tingling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (half of her face was numb) and PARAESTHESIA (half of her face was tingling). At the time of the report, HYPOAESTHESIA (half of her face was numb) and PARAESTHESIA (half of her face was tingling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I have had a low-grade fever initially, chills, sweats, and very severe body-wide muscle and joint pain. The severe pain has ceased today and is now mild/manageable. But I'm still feeling pretty sick--chills, sweats, mild aches. I was just alarmed at the sudden appearance of it at 1am and the severity. It felt like years ago when I had H1N1, but worse. It was sudden and severe. I was moaning and crying all night. It seemed like a bit much from just a vaccine. I got the vaccine on Friday, spent the whole day in bed on Saturday and still in bed today on Sunday.
Recurrence of erythema, edema, warmth, pain and itching at injection site at 10 days post innoculation.  About 4cm diameter.  No associated fever or other systemic symptoms.
12 hours post vax for flu had substantial muscle soreness, pain in arm at injection site and most of all in whole body side, shoulder, back neck back, Got massage therapy which helped reduce pain. 3 weeks post still having residual effects.
This is a spontaneous report from a contactable pharmacist obtained via a Pfizer sales Representative. A 70 years old patient of unspecified race/ethnicity and gender received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. On the vaccination day the patient experienced redness and swelling at the injection site. Next day the patient noticed that the redness had darkened closer to a blackish color. At that point the patient went to see the physician. The reporting pharmacist was unaware if any medication was administered, but none was filled at that pharmacy. Events outcome was unknown. Information on the batch number has been requested.
hospitalized for Multiple Pulmonary Embolism; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (hospitalized for Multiple Pulmonary Embolism) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (hospitalized for Multiple Pulmonary Embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 24-Oct-2021 due to PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at a dose of Blood thinner. At the time of the report, PULMONARY EMBOLISM (hospitalized for Multiple Pulmonary Embolism) outcome was unknown.            Concomitant drugs were not reported.  It was reported that when patient was first admitted to ER they thought it was a heart attack and was given blood thinner Eliquis as treatment.  Company comment: This case concerns a 63-year-old female patient with no medical history reported, who experienced the serious unexpected ADR of pulmonary embolism after second dose of mRNA-1273. The event occurred 6 months after second dose of mRNA-1273. The re-challenge is not applicable since event occurred after second dose and event outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-403992 (Patient Link).; Sender's Comments: This case concerns a 63-year-old female patient with no medical history reported, who experienced the serious unexpected ADR of pulmonary embolism after second dose of mRNA-1273. The event occurred 6 months after second dose of mRNA-1273. The re-challenge is not applicable since event occurred after second dose and event outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Employee complained of blackening of lips and tongue 1 day after receiving the vaccines. It has since resolved
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 71 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 21-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 21-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. Flu vaccine was delivered on 20-Sep-2016 at 13:30 to 14:00 and the refrigerator was reading 10 degrees Celsius that afternoon. On 21-Sep-2016, it was 6 degrees Celsius, on the 22nd it was 10 degrees Celsius and on the 23rd (morning), it was 7 degrees Celsius. One dose was given between 21 and 22-Sep-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
84 yr old immunocompromised by MTX and a biologic agent, is vaccinated against COVID but developed symptoms and tested positive 2 days prior to admission.  Came to ED for progressive dyspnea and generalized weakness, unable to manage at home.  Records only indicate 1 dose of Pfizer series.
Increased blood pressure, light headed, nausea.  Symptoms resolved in the ER and employee was able to return to full duty.
Initial misuse case was received from a healthcare professional on 28 OCT 2013. Cases were received on 21 March 2014. A 1 year old patient whose demographic details, medical history and concomitant medication were not reported received a 0.25 ml dose of FLUZONE on 25 SEP 2013 and 01 OCT 2013. (Route, site, dose and Batch number not reported). It was reported that on an unspecified date patient received a vaccine of invalid scheduled. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 21-APR-2008 the patient was vaccinated with first dose of improperly stored VARIVAX lot # 658023/0824U. On 19-MAY-2008, the patient was vaccinated with second dose of improperly stored VARIVAX lot # 658023/0824U. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Got vaccinated still tested positive for covid19 afterwards; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got vaccinated still tested positive for covid19 afterwards) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EK730) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2022, the patient experienced COVID-19 (Got vaccinated still tested positive for covid19 afterwards). At the time of the report, COVID-19 (Got vaccinated still tested positive for covid19 afterwards) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The ethnicity was reported. No concomitant medications were reported. It was reported that patient had no prior vaccinations(within 4 weeks). No treatment medications were reported.  Company comment: This spontaneous case concerns 44 years old male patient, with no medical history, who experienced the unexpected non serious AESI event of Covid -19 (reported as Got vaccinated still tested positive for covid19 afterwards), which occurred unspecified days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. At the time of report outcome of the event is unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 44 years old male patient, with no medical history, who experienced the unexpected non serious AESI event of Covid -19 (reported as Got vaccinated still tested positive for covid19 afterwards), which occurred unspecified days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. At the time of report outcome of the event is unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Right arm swollen and red in color 3" wide, 3.5" in length. Hot to the touch and painful to move, per pt. Expressed to use cool compress and childrens Advil for discomfort and swelling. Parents were to call if needed.
Patient has a history of atrial fibrillation, Grave's disease, anxiety.  She was very anxious about receiving the vaccine.  She complained of tingling in her feet, tongue, and mild chest tightness.
pain from my elbow to the top of my arm and down to my wrist; pain in his right arm; pain that radiated down his arm; can't sleep on his right side because it hurts to bad; This is a spontaneous report received from a contactable consumer (reporting on himself). A 73-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN5318 and Expiry date was not reported), via an unspecified route of administration in Arm Right on 30Jan2021 13:00 as single dose for COVID-19 immunization. Medical history included hypertension, diabetes mellitus both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had a covid 19 shot the first dose on 30Jan2021. He have pain from my elbow to the top of his arm and down to his wrist. It has been persistent since he got the first vaccine. patient have been to the clinic several times and they did x-rays and mentioned something about physical therapy. It's been four months. The first vaccine created pain that radiated down his arm. He doesn't know what the vaccine did or caused. This pain has been present since he received his first Covid 19 vaccine. He reports the  clinic suggested physical therapy. He's a side sleeper and he can't sleep on his right side because it hurts to bad. He reports he called Pfizer about a month ago and left his phone number and did not receive a call back. He had an x-ray at the clinic and nothing was wrong with his arm. For medical history and concomitant medications he reports he has diabetes and high blood pressure. He takes medicines for those but he does not feel they are relevant to this report. He reports his bones are sound, he has no arthritis. His right arm was still sore and hurting. He received his second vaccine on 20Feb2021 (Lot# EN6200, Expiry 30Jun2021) and I didn't have any side effects from that one. He had no swelling or redness. He need some kind of recommendation of what to do. When he went for his second Covid 19 vaccine, he was close to the emergency room so he went. The emergency room gave him Diclofenac Sodium, an ointment. He uses it on his right arm and it diminishes the pain for about 45 minutes or so. It was Diclofenac Sodium Gel 1%, 16 gram tube, Expiry 14Sep2022. He reports the pain in his right arm is not diminishing, he's having pain ever day. If this was muscle pain it would have repaired itself by now. The outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
ROTARIX was administered through intramuscular and not orally as it should be administered. Patient's site of injection is red and warm the patient is also inconsolable and has been crying.
This spontaneous report was received from a nurse practitioner refers to a 46 years old patient who on 22-AUG-2012, was vaccinated with a dose of M-M-R II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1033AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
VACCINE received on Friday 1/15/2021 afternoon; Monday evening 1/18/2021 felt slight chills; early to bed. Tuesday AM awoke with severe 'bed-rocking' chills, nausea and fever 100-101 degrees. recommended I go to Hospital ER.  At ER, temperature increased to 102 degrees.  Covid test was negative, but cost X-ray showed reasons to suspect pneumonia. No one suggested I was just suffering acute reaction to vaccine.  Returned home w/ prescription for doxycycline hyclate and request that I return to the ER the next day if I continued to feel ill.  The next morning, 1/19/21, I again awoke with intense, somewhat frightening chills, vomiting and a mild fever.  As instructed I returned to the ER.  Assuming the COVID Test may have been a false negative, a second one was given; it too turned out to be negative, but I remained at the ER and then admitted to Hospital to remain under observation.  Im the hospital the chills, nausea and fever came to an end, but acute headache and utter fatigue lasted until I was released on Jan 22.  My discharge papers indicated no further signs of pneumonia or any other infection; my attending doctor, concluded that my experience was an unusually strong (and delayed) reaction to the 1st dose of the Moderna Vaccine.
Lightheadedness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 2 via an unspecified route of administration on 09Feb2021 as dose 2, single (at the age of 77-year) for covid-19 immunisation. The patient's medical history and concomitant medication was not reported. She took vaccine on 09Feb2021 and experienced lightheadedness in the afternoon. The patient asked that if she can take Tylenol. The clinical outcome of the event was unknown.  Information on the lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.