chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 4 month old  patient (gender unknown). On 13-SEP-2013 the patient was vaccinated with an expired dose of ROTATEQ lot # 0050AE, expiry date 30-AUG-2013, oral. Dose was reported as 0.5 ml (considered underdose). No adverse effects reported. Additional information has been requested.
Patient had a vagal episode. Patient has an extensive medication history, comorbidities, and health conditions. Patient did not eat breakfast and presented hypoglycemic. Patient was given water, glucose, and 911 was called. No transient sequelae.
Fever (100.0-100.2); headache/foggy head; muscle aches; pain at injection site. Symptoms lasted 36-48 hours.
Non febrile seizure - was in high chair started to twitch then stiffened head back eyes rolled back last < 1min then kick x 5-10min then back to baseline.
Lymph nodes inarmpit of arm that was injected became tender about 2 days postinjection and stayed tender for another 5 days.; Local pain, and swelling at injectionsite starting day after injection andlasting about 4 days.; Local pain, and swelling at injectionsite starting day after injection andlasting about 4 days.; Headache that lasted for about 3 days, starting about 30 min post injection.; Feeling unwell (flu-like symtpoms) for about 36 hours.; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 04Apr2021 at 09:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN) indicated for kidney stones from unspecified date. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 14Mar2021 at 09:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 10:15, 30 minutes post injection, the patient experienced headache and felt unwell (flu-like symptoms). On 05Apr2021, the patient experienced local pain and swelling at injection site. On 06Apr2021, the patient felt that lymph nodes in armpit of arm that was injected became tender about 2 days post injection. No therapeutic measures were taken as a result of these events. These events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event headache was recovered on 07Apr2021, after the duration of about 3 days. The clinical outcome of the event flu-like symptoms was recovered, after the duration of 36 hours. The clinical outcome of the events local pain and swelling at injection site was recovered on 09Apr2021, after the duration of about 4 days. The clinical outcome of the event tender lymph nodes was recovered on 11Apr2021, after the duration of 5 days.  No follow-up attempts are possible. No further information is expected
04/26/2021 @ 08:30- Swelling (size of a golf ball), red, itchy, and pain at site of injection
headache, increased heart rate, Swelling to. ips, diaphoresis, limbs shaking
'COVID arm' - swollen; red; hot; itchy; painful; red ring from shoulder to elbow. After that subsided, itchy nodules and rash persisted now for 9 weeks. Swells at night after 5:30 pm. Gets red and itchy. Injection site weeps and scabs. Tried: Zyrtec, ice pack, Benadryl stick and steroid cream.
after waiting 15 minutes, patient walked over to pharmacy counsel window and let the pharmacist know that he was feeling nauseous and slightly dizzy. pharmacist asked him to wait around to make sure symptoms cleared up without worsening of symptoms and pt refused. he said that he was going home with his family member and didn't want to wait.
Patient had fever/chills/sore muscles. Patient reports going to take shower to help with flu-like symptoms and fainting in the shower. Patient's parents helped patient and had him hydrate. He has recovered now, with a lingering Head Ache.
Fever 101.2; Body aches; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 14:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included carvedilol (MANUFACTURER UNKNOWN) taken from an unknown date for an unknown indication and lisinopril (MANUFACTURER UNKNOWN) taken from an unknown date for an unknown indication. The patient previously received codeine and opiates and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13Mar2021 at 14:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 04Apr2021 at 05:30, the patient experienced a fever 101.2 (unspecified units), body aches, chills and headache. The events did not result in a doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events fever 101.2 (unspecified units), body aches, chills and headache were resolving at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
about 10 hours after second vaccine shot - mild fever,  chills, headache and inflammation of lymph nodes in armpit, along collarbone and in neck on shot side.  Fever broke about the 20 hr. mark. nausea and diarrhea on second day. followed by additional fever and chills at  48 hours post shot. second fever subsided next morning with headache continuing for third day.  lymph node inflammation is continuing at this time (day 5 post shot)
nausea, dizziness, fever (101°), weakness, muscle ached, tachycardia, shortness of breath, headache, coughing
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a male patient who received Bexsero for prophylaxis. On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, less than a year after receiving Bexsero, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Bexsero. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Bexsero about a month an half ago from the date of reporting. The patient experienced pain at injection and unable to move arm. The reporter did not agree to contact on follow up.
activity of daily leaving impaired; fever; shivering; diarrhea; flu like symptoms; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2019AMR078143).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, shivering, diarrhea, influenza-like symptoms, nausea and activities of daily living impaired. The patient was treated with ibuprofen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, shivering, diarrhea, influenza-like symptoms and nausea were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the fever, shivering, diarrhea, influenza-like symptoms, nausea and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever shivering nausea and diarrhea, just like the flu.  The event lasted for 24 hours, incapacitating. The patient gave consent to contact the safety physician.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient develop Covid-19 diagnosed by PCR about may be six or seven days after received the vaccine. The patient recovered from the event.   Information on the lot/batch number has been requested.
Right arm is painful with a rash and redness in the area.  There is also pain from the elbow to the shoulder.  Pain especially with lifting my right arm or lifting something with right arm.
Didn't menstruate for 5 months; This is a spontaneous report from a contactable healthcare professional. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 04Jan2021 at 18:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included unspecified birth control medications from an unknown date and unknown if ongoing. On 10Feb2021, after the vaccination, patient did not menstruate for 5 months. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 30Jun2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event did not menstruate for 5 months was recovering at the time of this report.
Pain at injection site (More severe than previous vaccines taken years ago). Weakness and muscle/joint pain appearing next morning. Shortness of breath(trying to inhale deeply results in dry cough). Slight headache. All symptoms are still present over 24 hrs since injection but seem to be lessening.
Henoch - Schonlein Purpura (HSP) Rash 24-48 hours after Hep A #2, Fluzone. No Treatment. No complications. Self resolved in < 1 wk.
Received a third dose of the Moderna vaccine on September, patient not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received a third dose of the Moderna vaccine on September, patient not immunocompromised) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 013L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced OFF LABEL USE (Received a third dose of the Moderna vaccine on September, patient not immunocompromised). On 01-Sep-2021, OFF LABEL USE (Received a third dose of the Moderna vaccine on September, patient not immunocompromised) had resolved.            Concomitant medications were not provided Treatment medications were not provided
started screaming, punching, throwing objects, eyes glazed over, flushed, very out of character for pt;pt has no memory of this incident taking place;
Dtap, HIB, ROTATEQ were administered at approximately 10:10 am on 1/24/12. Received call from mom at 2:30pm reporting facial rash was developing. Patient arrived at office and complete body rash noted. Patient was given 0.15 ml epinephrine IM, 1/2 tsp BENADRYL PO, and 15 mg ORAPRED po at 2:55 pm. Patient was monitored for 45 minutes and rash decreased. Patient was stable and sent home.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 01-DEC-2015 at time- 01:07, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.6 and 1.7 (units unspecified) for 4 hours and 32 minutes respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Pt states she experienced itchiness at injection site and noticed a red circle at site. She thinks it developed the day after the injection but she is not sure.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. An unspecified number of doses of ZOSTAVAX (lot#, expiration date, dose, route not reported) for vaccination that were improperly stored might have been administered between 03-SEP-2013 and 29-OCT-2013. No adverse event reported. Additional information is not expected.
Patient had previously had two doses of Pfizer Covid vaccine. I inadvertently gave her a booster dose of Moderna Covid vaccine.
The pt experienced hives to the bilateral inner forearms and palms of both hands. This occurred approximately 3 hours post vax. Treated with Benadryl, Zyrtec.
Patient had a syncopal episode post vaccine administration and was assessed by local Fire Department.  Refused all treatment and transport.
7 days after injection I've experience a new redness around the side.  It is also firm/hard and itchy.
Patient received Moderna booster from an opened vial that was exposed to room temperature for over 24 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster from an opened vial that was exposed to room temperature for over 24 hours) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster from an opened vial that was exposed to room temperature for over 24 hours). On 13-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster from an opened vial that was exposed to room temperature for over 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator:- 10-JAN-2022, The vial was opened on 11-JAN-2022, Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):- 48 hours. No concomitant products were reported. No treatment information was reported.
Red hand swelling, induration, "fist sized at VZV injection site. Soreness, stiffness, (-) F/ (-) red streaks.
Arm is still sore; Swollen a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is still sore) and PERIPHERAL SWELLING (Swollen a little bit) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is still sore) and PERIPHERAL SWELLING (Swollen a little bit). At the time of the report, PAIN IN EXTREMITY (Arm is still sore) and PERIPHERAL SWELLING (Swollen a little bit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by Reporter.
Pt has increased confusion from baseline and acute metabolic encephalopathy.  No respiratory symptoms.
burning, painful blotchy hands, sweating. Rash escalated to face, sweating, 10/10 pain all over body, shallow breathing. itchy tongue. fevers
Vaccine was given on 01-29-2021 at 3 pm.On 02-05-21 patient stated she noticed her vision was blurry at night when she was reading in bed--this happened 3 nights in a row and on 02-08-2021 she said her vision was blurry driving home during daylight. Had Heart palpitations on 02-08-2021 and again on 02-09-2021. On 02-08-2021 she was in shower and noticed her left arm was itching where it had been sore from getting injection and when she looked in the mirror she noticed how swollen and red it was. Stated it was very warm to touch, red and very itchy. PC today on 02-09-2021 to Health Dept requesting advice on what she could do to help it.Had taken some Benadryl the night before.Had attempted ER visit on 02-08-2021 but was there x 3- 4 hrs and was never seen so she left.
Complain of nausea and feeling hot post vaccine. Appeared diaphoretic with flush face and hands. Removed from general area and sat in medical bay for observation. Symptoms self resolved. No complaint of shortness of breath or throat closure. Respiration easy and non labored. Lungs clear and heart rate regular.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 12:30 (Lot number: FA6780) at the age of 36 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Currently breastfeeding" (unspecified if ongoing), notes: Currently breastfeeding. Concomitant medication(s) included: Tylenol; Motrin; Afrin [Oxymetazoline Hydrochloride]. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EW0191, lot unknown=False, administration date=05Aug2021, administration time=08:30, dose number=1, vaccine location=Left arm), administration date: 05Aug2021, for Covid-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 26Aug2021 23:00, outcome "recovering", described as "Rigors"; PYREXIA (non-serious) with onset 26Aug2021 23:00, outcome "recovering", described as "fever temperature max 100.4"; FATIGUE (non-serious) with onset 26Aug2021 23:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 26Aug2021 23:00, outcome "recovering", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, fatigue, pain. Additional information: Facility type vaccine was Hospital. The patient did not have other vaccine in four weeks.  Patient did not have Covid-19 prior vaccination. Patient did not Covid tested post vaccination. The patient did not have known allergies. Follow-up attempts are completed. No further information is expected.
Expired Vaccine Adminitered by, LPN: Patient was administered first booster dose (0.25ml) Moderna (lot #058A22-2A) on 07/16/2022. This Moderna vaccine had an "expiration date" of 09/10/2022 and "beyond use date" of 07/13/2022. Therefore, this vaccine was expired by 72hrs.  I, was the Staff member and Team Lead on shift; however, the two LPNs assigned to draw up and administer vaccines on this day were:  - LPN  - LPN
suspects a possible AE situation; A Spontaneous report was received from Consumer concerning an unknown age, an unknown gender patient, who suspects a possible AE situation  The patient's medical history was not reported. Concomitant Medicines were not reported  On an unknown date, the patient received their first of two planned doses of mRNA-1273.  It was reported that the patient suspects a possible AE situation.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, was considered as unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
He got his vaccine while he was receiving chemo treatment.  He started that Friday night around 11:00 he started having chest pressure and a pounding heart beat.  After that he started vomiting and sweating.  His wife called 911 and they did an EKG and found that he was having a heart attack and he had a stent placed in the right coronary artery.  He was in CCU and yesterday he went back to the cath lab again and to have another sent put on the left anterior descending artery and was discharged last night.  He is taking now 6 more medications than he was taking before the vaccine.  He does not have a history of heart disease and never had any problems with his heart prior to the vaccine.  He had cataract surgery 4 years ago and was tested for cardiac issues with an EKG and everything was normal at that time.  He started chemotherapy in March of this year and he is getting it every 3 weeks and has had no problems, and his heart has had no issues until the vaccine.
Arterial clots in legs; This is a spontaneous report from a contactable consumer reported for self A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arterial clots in legs in Apr2021 with outcome of unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I had side effects from the COVID vaccine:  headache, muscle pain, fever of 101, tachycardia, chills, insomnia
With first dose - moderate headache and fatigue. Second dose - fever day one, severe headach with sensitivity to light, and fatigue. The headache took many week to reduce from severe to moderate. It has remained as a mild headache (almost constant). Also I have genital herpes as an adult and oral ulcers since a child. Usually the genital herpes only appears following stress. Since the second shot both oral and genital eruptions occur on a regular basis.    I would like to take an antidote to help my system resolve this response to the vaccine.