chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiration date 02-MAR-2017; lot # L040459, expiration date 06-APR-2017. The administered doses experienced the temperature excursion of 32 degrees Fahrenheit for 63 days. The temperature excursion was detected by a data logger. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
02/12/2021 8:00 AM INJECTION OCCURED. 9:00 AM DEVELOPED HIVES ON TORSO THEN PROGRESSED WITHIN THE HOUR TO ENTIRE BODY. AT THE SAME TIME LEFT DELTOID BECAME INFLAMED AND SWOLLEN TO THE SIZE OF A SMALL ORANGE. 9:15 AM SELF  ADMINISTERED TWO Diphenhydramine 25 MG CAPSULES  AND TWO Hydroxyzine Hydrochloride 25 MG TABLETS. REPEATED EVERY 4 HOURS FOR THE NEXT 3 DAYS.  02/15/2021 SELF ADMINISTERED ONE Diphenhydramine 25 MG CAPSULE  AND ONE Hydroxyzine Hydrochloride 25 MG TABLET EVERY 6 HOURS.
Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched and burned on my head; Rash to my face; Body aches; weakness; fatigue and woozy feeling xs 4 days; fatigue and woozy feeling xs 4 days; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 20Jan2021 23:15 at a single dose for COVID-19 immunization. Medical history included Raynaud's, hypotension, known allergies: barley, oatmeal, pork, tomatoes. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took doxycycline and experienced allergies. Benadryl prior to administration. On 20Jan2021 03:00 PM, the patient experienced hives that itched and burned on her head - still remain after 6 days but improved. Rash to her face, body aches, weakness, fatigue and woozy feeling for 4 days. Events treatment included diphenhydramine (BENADRYL). The facility where the vaccine was administered was in a nursing home/senior living facility. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID test post vaccination included Nasal Swab (Rapid and PCR) on 21Jan2021: negative. Outcome of the events was recovering.
Patient reported swelling in both hands, knee and throat that occurred several hours after getting the vaccine. Patient reported associated symptoms of itching of the entire body,  body aches, ear ache, and swelling at the injection site. Patient reports improvement of symptoms with the use of Benadryl.
The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 27Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer or other non HCP (a manager) and from a contactable Physician. This Physician reported similar events for 2 patients. This is 1st of 2 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13 intramuscular at single dose at right deltoid on 13Jan2017 11:00 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced erythematous rash, which progressed to a tender, edematous plaque with fever, all treated for a cellulitis episode. The outcome of the events was apparently recovering. The AEs required an emergency room or physician visit. The patient was apparently recovering. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017135693 same reporter/drug/AE, different pt; US-PFIZER INC-2017070703 same reporter/vaccine/ event, different patient.
10 minutes after receiving the first dose of Pfizer, the patient began feeling dizzy and had a syncope event. BP 105/59. HR 59. 100% saturation on room air. Repeat vitals 10 minutes later: BP 95/39, HR 66, 100% sat on room air. Blood glucose 109.   Patient noted she came from the gym and had not eaten a full meal. Patient reports passing out after donating blood, and felt similar to that experience. No history of syncope events related to vaccines.
Patient received vaccine at workplace.    Symptoms started at night: area started getting knotted, turned red, turning like a bruise and stiffness on arm and neck.  Next morning, symptoms worsen; a 4 inch bruise started to spread from injection site--on back of arm and bottom of arm. Area was hot--like fever.    At work doctor thought it could be an infection.  Patient called PCP and also went to employee health.  They gave patient an steroid cream and use of ice packs.  The cream was helpful and inflammation decreased.   Today, there is a little bit of redness on vaccine injection; it doesn't hurt to touch anymore.   Stiffness in arm is almost gone. In terms of recovery, at 95%, symptoms almost resoved
This spontaneous case, initially received from other health professional on 25-Oct-2018, concerns a 45-year-old, adult female patient. The patient underwent chemotherapy in past (reported as less than 8 weeks of completing chemotherapy). The patient did not receive any concomitant medication. On 19-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252234 and expiry date: 30-Jun-2019). On an unspecified date in Oct-2018, within 24 hours of vaccination, the patient developed pneumonia. On 20-Oct-2018, the patient was admitted to the hospital and was discharged on 23-Oct-2018. The patient was also febrile. At the time of this report, the patient had not recovered from the events (still febrile). The reporter assessed this case as serious due to hospitalization.
Per patient's mother, patient endorsed minor pain later that night on the day of vaccine administration 9/20/2020, however, no noticeable signs. Today after school, 9/21/2020, patient endorsed consistent pain and patient's mother noticed erthymea around site of administration and slight tenderness. Per patient's mother, no fever, difficulty breathing, or known drug allergy.  Patient's mother was recommended to try children's APAP or Ibuprofen and apply a cold compress if swelling and warmth as well as contact pediatrician as soon as possible.
Information has been received from a registered nurse concerning a 9 year old white male student with asthma and no known allergies who on 9/30/96 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 616866/1508B). There was no illness at the time of vaccination. On 10/2/04, when in the office for vaccination, the patient presented with a rash with papules on his trunk in various stages. Unspecified over the counter treatment was used for comfort. Subsequently, the patient recovered from the rash. There was no product quality complaint involved. It was reported that the patient had no adverse events following prior vaccination. Additional information has been requested.
Seizure; She kept having seizures and progressively got worse; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SEIZURE (Seizure) and CONDITION AGGRAVATED (She kept having seizures and progressively got worse) in a 47-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and CONDITION AGGRAVATED (She kept having seizures and progressively got worse) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) outcome was unknown and CONDITION AGGRAVATED (She kept having seizures and progressively got worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medication reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected serious events of seizure and condition worsened, seizure progressively got worse. The event seizure occurred the same day after the first dose of mRNA-1273 vaccine administration while the event condition worsened, seizure progressively got worse exact occurrence unknown but stated that the event occurred after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected serious events of seizure and condition worsened, seizure progressively got worse. The event seizure occurred the same day after the first dose of mRNA-1273 vaccine administration while the event condition worsened, seizure progressively got worse exact occurrence unknown but stated that the event occurred after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Given DTP developed, according to his mom, swelling on the thigh; This did burst @ home & produced, according to her mom also, yellow pus; Seen by MD 11FEB91-sinus apprx 3cm in depth-cultured &grew a sparse growth of streptococcus, Group A;
Diffuse Urticaria type lesions of abdomen lower extremities, swelling of knees, 48 hours post vaccination.
Leg turned blue 2 hours after injection. 911 called. Positive redness -> Pt seen positive pulses + 2 femoral/popliteal/DP. Positive redness severe local reaction -> responded to BENADRYL and prescribed Prednisone.
Fatigue and headache, then also fever/chills, muscle aches and stomach cramps all night long; very painful.
Sudden hearing loss left ear after two days. Muffled, pressure, hyperacusis
Patient received the FLUZONE High Dose and had a severe local reaction on her right arm, including redness, swelling, localized warmth and itching. She had received the FLUZONE High Dose vaccine many times in the past and had no reaction.
Within a few days had an inflamed rotator cuff that took ~1.5 months to resolve.
This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In May 2016, the patients were vaccinated with the improperly stored dose of ROTATEQ orally, lot # L037574, expiration date on 30-JUL-2017, lot # L035511, expiration date on 21-MAY-2017 and lot number reported as: L033694, expiration date on 16-JUN-2017 (dose was not reported). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
My symptoms included: sore arm (mild to moderate to severe pain), redness and swelling where the shot was given, very tired and weak, muscle pain, headache, fever, nausea, shivering. It just flattened me! But the symptoms only lasted a little over a day. I got the vaccine on Friday April 13, 2018 and by Sunday April 15, I was feeling much better and by that Monday April 16, I was back to normal.
Information has been received from a physician concerning an unspecified age female who in "JUN-2007", in "AUG-2007" and in "SEP-2008" was vaccinated with a first, second and third dose of GARDASIL respectively (routes and lot numbers not reported).  The physician reported that the patient received her third dose of the vaccine in "September 2008" which was over a year from the time that she received the second dose of the vaccine.  The physician then continued that in "December 2008", the patient was diagnosed with "Horner's syndrome" and her one eye started drooping.  Physician noted that the mother of the patient wanted to know if her daughter's experience is associated with GARDASIL.  At the time of the report the outcome of the patient was unknown.  The patient sought medical attention by physician's office.  On an unspecified date a magnetic resonance imaging was performed results not reported.  Upon internal review, Horner's syndrome was determined to be another important medical event.  Additional information has been requested.
This was her first injection. She received the vaccine at 1100 and within 15 minutes was ?just not feeling great.? Felt a little faint and light headed. We gave her juice and watched her until 1130 and she felt better. Vitals were stable throughout. She was sent home at that time and denied any symptoms. Pt returned to the floor within 10 minutes and states by the time she walked down to her car, she began having tremors and upon her return, her face was all flushed. She has a Sulfa allergy and described the same feeling she felt when she had the Sulfa reaction. Brought pt to a room and obtained vitals-stable VS. Dr saw pt and due to possible allergic reaction, asked that we call 911 to transport her to ER for further evaluation.
3 days fever 2 weeks jittery, fine tremors not himself (can't explain it)
Patient got redness, itchiness and slight swelling at site of injection. Area of redness was approx. 2 in leng and 1 inch wide. Patient noticed s/sx about a day after vaccine administration. Used ice and spoke to her doctor. No pain experienced.
Woke up with generalized hive-like rash on trunk. During the day, hives spread to arms and neck with petechiae. Was treated with oral antihistamines and prednisone.
This spontaneous retrospective report was received from a female patient of an unknown age, who was reporting on herself. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #, dose, route and site of administration and expiration date were not reported) with sterile diluent (STERILE DILUENT). On an unknown date, after receiving VARIVAX, the patient had low titers. On an unknown date, the patient got pregnant. At the time of the report, she stated that she was no longer pregnant. The last menstrual period (LMP) date and estimated date of delivery (EDD) were not known and could not be calculated. The pregnancy outcome was unknown and the fetal outcome was unknown. The outcome of the event was not provided. Causality assessment was not provided. Additional information has been requested.
Sore arm Headache Fatigue Dizziness  Nausea Lasted 2 days
vaccine started to spill; Patient did not receive full dose of the second Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (vaccine started to spill) and UNDERDOSE (Patient did not receive full dose of the second Covid-19 vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 19-May-2021, the patient experienced DEVICE CONNECTION ISSUE (vaccine started to spill) and UNDERDOSE (Patient did not receive full dose of the second Covid-19 vaccine). At the time of the report, DEVICE CONNECTION ISSUE (vaccine started to spill) and UNDERDOSE (Patient did not receive full dose of the second Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown. Treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.
Right Bell's Palsy (facial droop) on prednisone. Seen hospital ER 12-13-09.
Very extremely tired; Very sore arm can not sleep on that side; Lots of congestion; Headaches; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 30Apr2021 at 16:30 (at the age of 37-year-old) at single dose for COVID-19 immunisation. Medical history included anxiety with panic and hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021, the patient experienced very extremely tired, very sore arm could not sleep on that side, lots of congestion and headaches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The clinical outcome of the events was recovered with sequelae (reported as recovered with lasting effects) in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: events details added (no treatment was received).
Both arms (back) started itching. Right leg from calf to glute tighten up and would not loosen up. Three fingers on right hand tighened up. Still having problem with hand. Leg stayed tight for three or 4 days. Developed rash and redness in both arms. Rash has cleared up, but skin is still tender.
pt recvd vax & exp heat related injuries during physical therapy run; became lightheaded & dizzy; pt devel a rectal t of 102.9; admitted to hosp;
Headache, Myalgia, site pain, swelling, chills, fever, fatigue and headache x days 1-2 after 2nd dose.  Narrative:
A few days after the first dose, I started wheezing, shortness of breath, severe fatigue, sore throat, and a slight cough. I had to go to urgent care. Please note this did coincide with my period which may have made things worse. My second dose also coincided with my period, and I experienced fever, chills, sore throat, body aches. The second shot also coincided with my period. The vaccine has also changed the schedule of my period cycle. It came a week to two weeks earlier. While I am not worried about my fertility anymore, I worry about younger women. Call if you have questions.
31st December 2020: mild tingling down left arm within 10 minutes of injection. Sore arm at vaccine site. 1st January 2021: increasingly sore left arm at site.  2nd - 3rd January 2021: moderately sore arm, mild dry cough and mild neck and head ache. Tiredness. 4th January 2021: moderate headache not completely relieved by pain medication, muscle aches, nerve type pain both sides of neck, fatigue. Took day off work. 5th January 2021: as with 4th January plus some loss of smell and taste, some nausea, occasional sneezing and mild sore throat. Had appointment  with doctor; doctor recommended covid test also to double check. Day off work. 6th January 2021: had covid test morning. Ongoing symptoms same. Easing headache now though, more stomach irritability with eating, cannot taste or smell completely now. Needed another day off work. 7th January 2021: Awaiting covid test results, cannot work due to this and also still unwell. Ongoing symptoms including muscle aches, neck ache and feeling of nerve pain left more than right side of neck. Improved stomach, not as irritable. Another day required off work.
Difficulty walking; Fever; chills; Headaches; Muscle pains/body ached all over; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficulty walking), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headaches) and MYALGIA (Muscle pains/body ached all over) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Difficulty walking), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headaches) and MYALGIA (Muscle pains/body ached all over). At the time of the report, GAIT DISTURBANCE (Difficulty walking), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headaches) and MYALGIA (Muscle pains/body ached all over) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-138450 (Patient Link).
do not remember whether they got the 1 and/or 2 doses of the vaccine/they got vaccinated was 3-4 years ago; do not remember whether they got the 1 and/or 2 doses of the vaccine/they got vaccinated was 3-4 years ago; This case was reported by a other health professional via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received doses 3 to 4 years ago of reporting date, did not remember dose number 1 or 2).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and extra dose administered were unknown.  Additional details were reported as follows: The case was reported by the patient's for himself. The age at vaccination was not applicable for this report. Health care professional (also patient) reported that he wanted to have, it might be a 3rd dose of Shingrix. The patient did not remember whether he got the 1st and/or 2 doses of the vaccine, which was the circumstance or information capable of leading to medication error and if had already received 2 doses, this dose would result in extra dose administered. The reporter asked when was he vaccinated and the patient told that they got vaccinated was 3 to 4 years ago. The reporter called to have more data regarding getting re-vaccinated. The reporter consented to follow up. The case had been linked with  US2021149599 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021149599:Same reporter
A healthcare professional reported that a female pt received an injection of flu shield on 11/27/2001. Immediately following immunization, the pt developed pain at the injection site. She was seen by a physician and treated with applications of ice to the affected area. No further info was available at the date of this report.
The nurse providing the vaccine,  failed to diluent the medication and gave the entire contents of the vial  which was  100 mcg  verses the 30mcg that was ordered.