chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ARM AND SHOULDER ACHED WHEN RAISED. RED BLOTCH ABOUT A QUARTER INCH BELOW INJECTION SITE. SWELLING WITH FEVER IN BLOTCH AREA.  BLOTCH SPREAD LARGER OVER THE FOLLOWING TWO DAYS AND IS STILL TENDER.  TODAY IS THE THIRD DAY POST VACINE AND THE BLOTCH IS LARGER.
Along with mild flu-like symptoms--esp achy bones, and pain at needle entry site returning next day and lingering, the ball of my right foot became so painful I could hardly walk on it. Feels swollen and hot but not to eye or touch. Any bending or stretching of toes or pressure on the ball is excruciating.  Some improvement to almost gone with treatment and over the course of day, by 2nd day, but returns overnight and moving foot in bed causes pain.
Patient received the shot, 10 minutes later her mother came to the pharmacy window saying her daughter couldn't breathe. I went to speak to patient and patient said she "couldn't breathe" then lost consciousness shortly thereafter. I injected her with an epipen in her left hip. She regained consciousness about 90 seconds later. Her lips were blue, she was pale, her pulse was strong, and heartbeat rapid. She expressed a phobia of shots before the shot and her mother said she has high anxiety about shots. Was taken away via ambulance.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This refers to a 3 month old infant patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
ITCHING TO THROAT, HANDS, AND "ALL OVER", REDNESS AND SWELLING TO PALMS OF HANDS, STATES THROAT "FEELS LIKE IT MAY CLOSE". GIVEN IM SOLU-MEDROL AND IM DIPHENHYDROMINE PER CRNP ORDERS.  PT REQUESTED & GIVEN ICE. PT OBSERVED AND NO SYMPTOMS NOTED. ADVISED TO GO TO HOSPITAL IF SYMPTOMS RETURN.
Approximately 2 weeks post vax the pt developed a rash with 15-20 lesions and a fever.
Patient received original monovalent Pfizer COVID-19 vaccine vs. new updated bivalent Pfizer COVID-19 booster.
PT presented to medical w/ dizzyness.  PT states approx. 20 mins after vaccination.  PT denies med or med HX.  PT vitals obtained - WNL.  PT B/G - WNL.  After approx. 10 min PT felt better & released from care.
For 4 nights, she was unable to sleep; She had body aches; chills like she had a fever; a little fever; fever sores in her mouth; tender under her arm; pain underneath the arm; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EN6202 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 04Mar2021 (at the age of 73-year-old) as DOSE 1, SINGLE for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving the first dose of vaccine, the patient was unable to sleep For 4 nights, had body aches, a little fever, and pain underneath the arm but went away in 24 hours. chills like she had a fever, tender under her arm, fever sores in her mouth. The patient stated that at first she thought about maybe it was because her arm was a little sore, most of the pain was under her arm but in 24 hours it went away. So patient thought that maybe she did not sleep that first night because her arm was sore, but patient still has not slept even through last night. The patient stated that she also got the chill where she had to put on multiple coats and blankets and just was watching television. The Caller stated that she still is not sleeping, she did not sleep last night either.  The outcome of the event Insomnia was not recovered, while that of the events  body aches, Chills, fever, Fever sore and Tenderness was unknown and that of the event pain underneath the arm was recovered on an unspecified date in 2021 (24 hours it went away).  No follow-up attempts are possible. No further information is expected.
Vaccination + 9.5 hours:  sharp  headache Vaccination + 15.5 hours: fever (98.5 - 100.0 °F), sharp headache, extreme fatigue Vaccination + 20 hours: fever (98.5 - 100.0 °F), sharp headache, extreme fatigue, near syncoptic episodes when standing Vaccination + 40  hours: resolved
5 minutes aafter receiving vaccines, patient complained of loss of vision, became diaphoretic, weak and had dry heaves. Systolic BP was < 100. Recovery (complete) occurred within 15-20 min.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's inoculation, patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the outcome of shingles was considered as not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patients medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N019822, expiration date 13-JUL-2019 for prophylaxis. Concomitant therapies included MRK STERILE DILUENT. The doses of Oka/Merck VARIVAX were exposed to a temperature excursion of 6°Fahrenheit to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA002453: US-009507513-1804USA003075: US-009507513-1804USA003062.
Fever, muscle aches, fatigue , soreness in the arm and swollen lymph node under armpit about the size of a golf ball.  Insomnia the next of the injection.  Still experience symptoms 3 days after vaccine.
Fever 102  to highest 103.6, with cough on 10/25/09. On Monday 10/26/09 to daughter to MD at 10 am, had fever of 101. At 3 pm, began vomiting and fever to 102.
Pt states she woke up this morning (8/23/13) with left neck pain. Took Ibuprofen 600 mg Lymph node swelling noted (left side). (Left AC lymph node).
Waited 15 min in office after vac. administered -> no reaction. Went home, was very tired & went to sleep. When she awoke her face was red & swollen. Trunk & extremities covered in hives. No diff. breathing. Given BENADRYL by mom.
Patient stated she began to have heart plalpitations a couple mins after sitting down then followed by vision and hearing by the time nurse arrived. Patient stated feeling like she going to pass out then asked nurse to hold her hand. EMT arrived checked vital signs all within normal limit per patient. Patient then states that everytime she is in a medical setting she pass out or has vision and hearing loss due to panick and anxiety attack. Stated everytime to gives blood she has this is sure. Patient also refused homecare.
Patient received his first Moderna COVID vaccine. While he was waiting the 15 minutes he started to feel pressure behind his eyes, started sweating profusely, felt dizzy, and nauseous.  I had the patient go into the IMZ room where I had him sit down.  I took his blood pressure. His heart rate was 55 bpm and his blood pressure was around 110/70.  He was not having any trouble breathing or had any signs of anaphylaxis (swelling of throat, tongue, lipps, etc). I had him remain seated and talked to him for 5 minutes. He felt like he was starting to come out of it and we took his blood pressure again.  His heart rate and gone back up to 65 and his blood pressure was around 135/75.  I had the patient remain seated for another 5-10 minutes.  Took his bp again and the numbers were similar to the second one that was previously mentioned.  He wanted to stand up and see how he was feeling.  He stood up right outside the pharmacy for another 15 minutes and said that he felt back to normal.  I explained that in the previous case where this happened to a woman they recommended she have someone drive her home and I recommended he do the same.  He seemed to think he was fine and I believe he was planning to drive himself home.
pain and discomfort is greater with the post-vaccination side effects; pain and discomfort is greater with the post-vaccination side effects; she has not being able to sleep in two nights.; throat inflammation; nasal congestion; coughing; she developed headache / forehead pain; throat pain; pain in the internal ear; some mild allergies; she developed pain on her arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route on 28Feb2021 (reported as Sunday) as first dose, single dose for COVID-19 immunisation. Medical history included COVID-19 with the following symptoms: mild flu, sneezing, headache and body aches from an unknown date (reported as near February 5th) and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced pain on her arm on 28Feb2021; some mild allergies (reported as suffers from "common allergies") on 01Mar2021 (reported as Monday); headache, throat pain and pain in the internal ear on 04Mar2021 (reported as Thursday); forehead pain, throat inflammation, nasal congestion and coughing on 05Mar2021 (reported as today); and pain and discomfort (reported as greater with the post-vaccination side effects than with the COVID-19 infection) and not being able to sleep in two nights on an unspecified date. Therapeutic measure, paracetamol (TYLENOL), was taken as a result of the events. The patient underwent lab tests and procedures which included COVID-19: Positive on an unspecified date (reported as near February 5th). The outcome of the events pain on her arm, pain and discomfort is greater with the post-vaccination side effects and not being able to sleep in two nights was unknown; while the outcome of events some mild allergies, headache, throat pain, pain in the internal ear, forehead pain, throat inflammation, nasal congestion and coughing was not recovered. The patient has not presented fever, stopped working on Wednesday and wanted to know if these were reported side effects of the vaccine and how long could these side effects last. The patient has an appointment with her physician on March 17th.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable consumer calling on behalf of husband. A male patient of an unspecified age and ethnicity started to receive PREVENAR 13, via an unspecified route of administration on an unknown date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on the "30th" (not further specified) and during the night he was achy all over, he hurt some, he tells, it hurt down in his legs. He had some problems with his chest and abdomen hurting so I ended up calling the paramedics and they said that they thought it could have been a reaction to the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). He was achy all over and he hurt. He had a red spot, probably where the vaccine was in that area, it was kind of a dark reddish, it was probably between an eight and a quarter of an inch across. The clinical outcome of the events was unknown.
Severe pain in the arm muscle, followed by 3 days of headache, fever and intense pain in the arm, shoulder and right hand with pain and swollen knuckles and fingers, up to the right lung. Immobility from pain, I took TYLENOL, the discomfort was passing but the pain in my arm remained. I put hot water every day and applied the arnica cream after bathing to reduce the pain that intensified at the end of June along with the shoulder. I went to the doctor, she prescribed ibuprofen 800. To withstand the pain and regain mobility. She order Physical Therapy I had 10 sessions with physical Therapy. It has improved but I still have pain in my arm although I still have not finished with the sessions.
Patient received the Covishield vaccine series overseas. She came to the booster clinic and received Moderna vaccine as a booster. Pfizer is the only vaccine approved for booster use following a WHO-approved (but not FDA approved) vaccine series.
Feb 2021 lost taste & smell, dx with covid by PCR test. Taste & smell returned.  Recieved 1st dose Pfizer covid vaccine 4/9/21, lost taste & smell again 4/10/21. Negative PCR covid test 4/16/21.
Pt vac /w DTP @ 12:30 pm, on the same day pt was described as pale & limp lasted about 2-4 min. Pt brought to clinic & admitted for poss. hypotonic/hypotensive episode.
About 5-6 hours later entire swelling locally with pain and numbness of all fingers and then unable to move left arm. Severe pain vs vaccine causing immobility unclear.  About  12 hours later next day my swelling,  weakness and numbness, and ability to use my left arm resolved. But pain even after 2nd dose has not completely resolved completely. Plus headache daily that awakes me more pronounced after 2nd dose on 01/26/2021. I am now over 2 weeks since the 2nd dose but the daily headache that awakes me some nights not responsive to aspirin or Naprosyn.
Fever, chills, almost passing out twice (followed by sweating), nausea, pain in joints, skin hurt, injection site sore, depression, heart racing (flip flop feeling); sharp pains in different parts of body miserable for 24 hours.
Breakthrough case admission after 3 vaccines Pfizer 1/4/21 Lot# EK9231;  Pfizer 1/21/21 Lot# EL3249;  Pfizer 10/20/21 Lot# FF2590
a rash a bunch of bumps all over my body mostly like check my breast my stomach my back my size; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (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: URTICARIA (non-serious) with onset 29Aug2021, outcome "unknown", described as "a rash a bunch of bumps all over my body mostly like check my breast my stomach my back my size". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 25oct94; next day inject site was red at 1 1/2" around site; at point of inject has raised 1/2"x1/2" white spot; spot still fading 2 wks later; had aches, fever of 103 x 2 days;
PULMONARY EMBOLISM, UNSPECIFIED. 6/25/2021 ADULT OBSTRUCTIVE SLEEP APNEA, MILD  PULMONARY EMBOLISM, UNSPECIFIED. 6/25/2021 ADULT OBSTRUCTIVE SLEEP APNEA, MILD    GAS GANGRENE  PULMONARY EMBOLISM, UNSPECIFIED. 6/25/2021 GAS GANGRENE
Patient received 0.25ml as a dose instead of the 0.5ml. Patient was informed of the situation and will receive the 0.5ml dose 8 weeks after the 0.25 ml (non-qualifying) dose,  as were the instructions per the CDC for such an event.
14 year old received a Moderna booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received a Moderna booster dose) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (3 dose, for ages 12 and up) on 14-May-2021, Pfizer (second dose and for ages 12 and up) on 07-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 25-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received a Moderna booster dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received a Moderna booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  Patient received Moderna booster to a 14 year and up.  No treatment medications were provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 1, single (Lot number: GH9697) at the age of 37 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2023) Positive; (12Oct2023) Negative; (14Oct2023) Negative; (15Oct2023) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: No known allergies. Patient tested positive on Wednesday evening 04Oct2023, visited telemedicine doctor immediately and was prescribed Paxlovid. Began 5 day course evening 04Oct2023, ending Monday morning 09Oct2023. Treatment helped, symptoms improved steadily, eventually testing negative on Thursday 12Oct2023 and again on Saturday 14Oct2023. Symptoms began returning morning Sunday 15Oct2023 and test came back positive. Currently, symptoms are not severe and include runny nose and cough. Patient received COVID 19 Antiviral treatment orally with Paxlovid from 04Oct2023 to 09Oct2023.
This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication history not provided. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information received on 18-MAY-2021 contain non significant information.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008132A and 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced COVID-19 (Covid-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Covid-19) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2022, SARS-CoV-1 test: positive (Positive) positive. On an unknown date, SARS-CoV-1 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient had tested positive on 10Jan2022, and yesterday he tested negative. No Concomitant medication were reported. No Treatment medication were reported. Company Comment: This is a spontaneous case concerning a 57-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 8 months 21 days after the second dose of mRNA-1273 vaccine administered on 20-Apr-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 10-Jan-22 was positive and that done on an unknown date was negative. At the time of report outcome of the events was Resolved. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 57-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 8 months 21 days after the second dose of mRNA-1273 vaccine administered on 20-Apr-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 10-Jan-22 was positive and that done on an unknown date was negative. At the time of report outcome of the events was Resolved. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
It was reported that a 46 year old female received Fluzone UNSP '99-'00 on 10/18/99. On the same day, she experienced "numbness around mouth and lisp". No further information is available at this time.