chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient caled me Friday afternoon around 3:30/4.  She said her arm started hurting badly within about 2 hours.  Now, she said the site was very swollen and she could not lift/move her left arm.  She was in pain and I could hear the anxiety in her voice.  I recommended she get seen ASAP to make sure everything was ok.  She agreed.  I called to follow up 4/30 around 8pm, 5/1 at least 4 times, 5/2 about 4 times, and every shift since, several times.  The other pharmacists here also tried to call her to find out how she was and get additional information.  She has never answered nor responded to our voicemails.
This spontaneous report as received from a nurse via a company representative refers to 30-40 patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, lot # K007973, expiration date 03-JUN-2016). No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not grant permission to contact them or physician.
Generalized Tonic-Clonic Seizure for 30 seconds.  No treatment needed.  Afebrile.  No trauma. 10/28/2009 ED records from 10/26/2009. Patient with tonic-clonic seizure activity, eyes rolled back, incontinence, itching, runny nose and cough. Neuro exam WNL, no repeat seizure activity, no tx noted. DC DX New Onset Seizure ? related to H1N1 vaccine.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The patient's medical history was not provided. Concomitant medications were not provided.
Patient presented with mother to receive the Pfizer Covid 23-24 vaccine.  Writer verified patient's first and last name, DOB.  Pre-vaccination checklist was reviewed with mother.  Mother denied any significant health history, any reactions to prior Covid vaccines, or  other types of vaccines received.  Mother denied known allergy to Benadryl or Epinephrine.  Writer administered the vaccine in patient's left vastus lateralis but then realized she had administered the 12 year + vaccine, not the 6mo - 4yr vaccine. Writer informed Charge RN who contacted Dr., attending provider for the Peds Immunization Clinics.  Writer advised parents that patient had been given the wrong dose vaccine for his age and answered their questions.  Parents spoke to Dr. over the phone to have their questions answered and concerns addressed.  Parents reported to writer and charge RN Dr. advised that patient may experience more acute and/or hyper side effects from the vaccine such as fever.  Patient and parents remained in the observation area for approximately 20 minutes.  No acute side effects noted during this time.
Vaccinated 11/23/03 at SRP military clinic. 2 days ago (12/2/03) first noted few lesions on shoulder. Then 1 day ago noted crossed shoulders. Today on back and chest. Denies fever, muscle aches.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021 at 9:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided. 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. Age of patient was reported as 66.59 for dose administered on 2-Mar-2021 and 177 doses were administered on 2-Mar-2021. No concomitant medications were reported. Batch number 019B21A underwent temperature excursion on 2-Mar-2021 with temperature 27-36 degrees Fahrenheit from 09:00 AM to 03:00 PM. This vial was moved to fridge on 24-Feb-2021 and moved to clinic on 2-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported.
Urticaria, tachycardia, tachypnea greater than 24 hours.
Received J&J 8/6/2021. Fever, fatigue, ears ringing, foggy brain, within 12 hours. This continued until Wednesday 8/11/2021 at which time I felt a tightness in my chest, pinching and continued ringing ears. I also continued feeling foggy brain. I called my primary care doctor and reported that by blood pressure was 160s over 90s and she prescribed blood pressure medication as I had previously had a medication induced uncontrolled hypertension in 2019/2020. Saturday 8/14/2021, I went to a walk in clinic with continued pressure in my chest and had an EKG which was normal. She referred me to the ER for a cardiac workup. I went to the ER and had an EKG, bloodwork and CT with contrast. All test results came back normal. One month post vaccine, continued chest pressure, ringing in the ears, and foggy brain. Additionally, within three weeks of the vaccine, I have come down with a UTI, infected hair follicle in my armpit and an eczema episode has occurred on both my eyelids causing them to be red, swollen, itchy, oozing, and painful.
I had 1st dose on Feb. 19, 2021.  My right arm started to have a rash under the injection.  later the red area became a circle shape,  feel warm and itchy, and raise a little(very little) above the skin.  The rash went away after maybe 2 days.  but the rash came back around  Feb. 28, this time a little bigger red circle, still feel warm and itchy in the red area.  The itchy are endurable.   I feel tired.  No cold or fever.  I video called TelaDoc.  The tele doctor prescribed antibiotics.   I then google online, find "Covid Arm".  and decide to report my side-affect.
pt c/o nausea & stomach cramps p/leaving clinic; pt became sleepy in car & woke c/o itching all over; w/in 1 hr devel hives, rash & eye lids became swollen according to mom; parents took pt to hosp;
Leaving the exam room and entering the lobby patient stated he felt like he was going to pass out. He began to sweat and become clammy. MA's got ice packs to put on patients neck and gave him water to drink. Pt asked for wet paper towels to wipe his face off.  A Nurse Stat was called and they came and evaluated pt and checked his vitals before he was able to leave.
headache; Joint pain in fingers; numbness in hand; This is a spontaneous report from a sponsored program. A contactable consumer reported for self. A female patient of an unknown age received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 05Feb2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient got the vaccine on 05Feb2021 and on 06Feb2021 she was experiencing a headache, numbness in hand and joint pain in fingers. Outcome of the events was  unknown.  Information on the lot/batch number has been requested.
This is a pleasant 34-year-old female with past medical history of neuromyelitis (on chemotherapy), and 25 weeks gestational with twins, who was transferred for further medical evaluation and treatment of COVID.  Patient has been having shortness of breath for the past 2 weeks.  She tested positive for COVID. She was  exposed by her toddler in day-care.  She is vaccinated Pfizer x2.  She endorses shortness of breath, nausea, vomiting, non- productive cough, right ear ache. She denies chest pain, palpitation, dizziness, abdominal pain, fevers, and chills.
Pfizer 4/5/21, 5/3/21, 11/4/22. Positive on 12/29/22
Face swelling and redness; Rash on arms, face and chest; Face swelling and redness; Numbness and tingling in face; Numbness and tingling in face; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in left arm on an unknown date in Mar2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Past medical history included COVID-19 infection on an unknown date. The patient was allergic to sulfa. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On an unknown date in Mar2021 at 12:15, the patient experienced face swelling and redness, numbness and tingling in face and rash on arms, face and chest. No therapeutic measures were taken for the events. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events face swelling and redness, numbness and tingling in face and rash was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
sz @ 1PM, jerking, staring into space, nonresponsive 3-4 mins; took to ER; tests done: EEG showed enlarged brain; appointment w/neuro in November; no further complications;
My father felt like he had a cold, gave him the test; Somewhere between 13th to 15th they go the covid virus; Somewhere between 13th to 15th they go the covid virus; This is a spontaneous report from a contactable consumer received via medical information team. A 71-year-old male patient received first dose of bnt162b2 (Formulation: Solution for injection), via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced somewhere between 13th to 15th they go the covid virus. On an unspecified date the patient experienced my father felt like he had a cold, gave him the test. Calling on behalf of his parents who received the first dose of the Pfizer covid vaccine on 01Feb2021. Somewhere between 13th to 15th they go the covid virus. My father felt like he had a cold, gave him the test. The patient did not receive any treatment for the events. The outcomes of events the events was unknown.  Information on the lot/batch number has been requested.
The patient is a 13 year old girl who was inadvertently enrolled to receive Moderna vaccine after her mother, gave permission for her daughter to be vaccinated. She looked older than 18 years and so her age was not double checked at the time of administration. Patient was observed for 30 min after the immunization and looked well at the time of discharge.
SEVERE RASH; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced severe rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe rash was not reported. This report was non-serious. This case, from the same reporter is linked.
TD Left deltoid 13:35, Hep B Right 13;35, Approx 5 min post shot, c/o itchiness left deltoid above shot site, Returned 14;20 itchy  + 2 hives right arm
pt reported immediate intense pain /burning on injection site and followed by tingling of tongue. she refused calling for aid or waiting around ; she said she has EpiPen on her person and husband in care that will drive her to er/urgent care.
8/30 large (5 x 2.5 inch), sore, risen, hot, red patch at injection site, fatigue 8/31 fatigue, red patch worse, headache, diarrhea 9/1 symptoms still present but improved some 9/2 still a red patch, more fatigue, fever of 99.5, bad body aches 9/3 smaller red patch, fever up to 100.4, very bad body aches, chills, sweets 9/4 fever up to 101.6, sweets, red patch more off color, darker but still visible (like when a shingles blister has healed but the skin is discolored), body aches improved some 9/5 fever broke, fatigue, patch faded but still present
My first symptoms were on June 14th which was a cough. We were going to be traveling, and I took a test and it was positive. We canceled those plans. I had symptoms on the 14th and I had test results on the 15th. I had a telehealth visit with my doctor on the 17th and prescribed Paxlovid. I began taking that the same day for 5 days. I completed that on June 21st. On June 24th I tested negative. The course of my symptoms the whole way through, I was using a digital thermometer and pulse oximeter. The digital thermometer never went above 99.4. My temperature never reached 100 degrees. My oxygen never read below 93. That was good during the whole course. The symptoms I had the worst of was a sore throat and coughing that wouldn?t stop. I also had congestion, headaches, and felt feverish. I had a productive cough from drainage and a tiny bit of wheezing. I also had a tiny bit of gastric discomfort and a tickle in the chest. Basically, my symptoms ended by June 22. They were never really that intense except for a very sore throat for 24 hours at the same time I couldn?t stop coughing. That was uncomfortable. Pretty sure this came from traveling on the plane between 2 flight, 3 cities.
pain in her armpit; swelling in left arm pit; sore; This spontaneous case was reported by a pharmacist and describes the occurrence of AXILLARY PAIN (pain in her armpit), PERIPHERAL SWELLING (swelling in left arm pit) and PAIN IN EXTREMITY (sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced AXILLARY PAIN (pain in her armpit), PERIPHERAL SWELLING (swelling in left arm pit) and PAIN IN EXTREMITY (sore). At the time of the report, AXILLARY PAIN (pain in her armpit), PERIPHERAL SWELLING (swelling in left arm pit) and PAIN IN EXTREMITY (sore) outcome was unknown. Not Provided      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.
fever & body aches devel 24hr p/vax;fever lasted 12hr;
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 14-SEP-2018, the patient was vaccinated with a improperly stored dose of PNEUMOVAX 23 lot number R005345, expiration date 01-MAR-2020 (strength, dose, dose number and administration route were not reported), for prophylaxis. The data logger registered a temperature excursion below 0 Celsius (C) for 41 hours and 0 C to 1 C for 49 hours. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA009938.
Mild fever 99.7 within 24 hours of dose, lasted less than 24 hours
After my 2nd dose I immediately became tachycardia and dizzy for 20 minutes followed by typical covid vaccine symptoms. It took my 3 days to recover. Then on April 25th I woke up feeling jittery in my stomach, which proceeded to jitteryness all over my body. It caused weakness, severe fatigue, tachycardia, tingling and numbness in arms legs and gradually led to tremors in my neck and head. I reached out to my pcp and my pots specialist. My pcp was unsure of what was going on. My specialist ordered a holtor monitor and echocardiogram which resulted in being put in propranolol for tachycardia. It reduced some symptoms. I engaged in acupuncture  as well. I saw my specialist for a follow up and I?m being referred to neurologist in September
A call was placed to the office on 02/12/17 via Agency, she stated that patient was baker acted and sent to behavioral unit after he received the flu shot, he was seeing things and hearing voices tell him to kill and he tried to hang himself.
Information has been received from a physician referring to 6 patients of unknown age and gender. Information about patients' concomitant medication, concurrent condition and medical history was not reported. The physician reported that on unspecified dates ranging from 17-FEB-2016 through 22-FEB-2016, the patients received doses of improperly stored GARDASIL 9 (dose and route not reported, lot # L020015 with expiration date 16-AUG-2017 or lot # reported as L043213 with expiration date 28-AUG-2017), according to a "vaccine for Children (VFC) report of data of 30F for 15 minutes on 17-FEB-2016". The physician also stated that her refrigerator was in correct range and the VFC data was wrong due to the "incorrect placement of a [robe". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 27-JUL-2018, the patient was inadvertently vaccinated with an expired VAQTA intramuscularly for prophylaxis, lot #N005796 and expiration date 26-MAY-2018 (strength, dose and frequency were not reported). No adverse effects were reported.
Swelling from top of thigh to below the knee, redness, rash, hot, hard
Irregular menstrual cycle: Missed period following second dose (expected 10/7). Daily use of ovulation test strips also showed no ovulation during this time. Next cycle resumed the following month as expected (11/12). No other history of irregular or missed periods, or lack of ovulation.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of hpv GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minutes and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA000781: US-009507513-1705USA007705: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712.
Medication error, medical assistant did not double check vaccine vial before administering vaccine intended to give PENTACEL but gave GARDASIL.
hives, itching 3 hours after receiving the vaccine.  no egg allergy.  had in the past without issue.  red, itchy rash, swelling of hands.  no SOB, throat tightness.  no denies any other new contacts with any foods, products, etc.  no new meds.  tried benadryl with little relief.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) on 04-OCT-2016 from a pharmacy, for its intended purpose: the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately 2016 [reported as shortly after receiving ZOSTAVAX], the patient developed an intermittent, sharp, throbbing pain and blisters on her back. The patient was diagnosed with shingles lesions and postherpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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. The patient has incurred and will continue to incur medical expenses as a direct result of the use of ZOSTAVAX. ZOSTAVAX did not prevent shingles, persistent strain of herpes zoster/shingles lesions, and postherpetic neuralgia were considered to be disabling. Additional information has been requested.