chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 130PM on 15NOV95;about 5PM same day, had wheezing, next AM had cough, sl fever, which progressed over next day or so & to URI sxs;27NOV still has clogged up head
Woke up deaf. Treatment was rest. No other treatment yet. Outcome - still deaf, day 3
Pain with range of motion to left arm and decreased ROM to left arm- onset 3 days after Tdap. Evaluated by Health Dept RN 10/11/11. TX: Ice, ALEVE, TYLENOL. F/U No erythema, edema, nausea, numbness or tingling associated.
Diarrhea Tuesday night feb 16 and Wednesday fever till feb 23. Feels tired and can't stay awake
Have only had first dose after an hr. & 15 min my throat started to swell making it hard to breathe.. by midnight I was experiencing body pains & chills including tiredness
Fatigue, joint pain, nausea, fever (100.4), dizziness, confusion, pain in right collarbone.
This case was reported by a consumer via call center representative and described the occurrence of back pain in a 79-year-old male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced back pain. On an unknown date, the outcome of the back pain was recovered/resolved. It was unknown if the reporter considered the back pain to be related to SHINGRIX. Additional details reported as follows: This case was reported by the reporter's wife. The wife called back for follow up on her previous reported events and mentioned during this call her husband, who was retired physician had his first shot of SHINGRIX in May and experienced back pain within about 12 hours of the injection. He took a hot shower and went to bed. He also used a heating pad for the pain. He was sedentary for a short while, no physical activity and the issue resolved. The reporter noted that the patient stated it was about a 5 out of 10 as far as pain goes. The patient plans to get the second shot. The patient had denied permission to contact their physician. The wife reported her husband being a retired physician directs the management. This case has been linked with US2018115098 and US2018GSK121406, reported by same reporter.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patient received an improperly stored dose of GARDASIL (Lot number, expiration date, dose and route were not reported). There was no concomitant medication reported. No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to unspecified number of 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 GARDASIL 9 lot # M013636 with expiration date: 15-FEB-2018 (dose and route of administration were not reported) that was not delivered on time to the office. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. On 26-OCT-2016 phone call to certified medical assistant who clarified four patients were administered improperly stored GARDASIL 9. Additional information has been requested.
Site: Pain at Injection Site-Medium, Systemic: Bell's Palsy-Medium, Systemic: pain in legs afteer shot, also numbeness in face-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
Information has been received from a health professional concerning a 12 month old male with no significant medical history and no immunosupression who on 07/03/2001 was vaccianted with varicella vaccine. It was noted that the pt had no recent varicella exposure. On 07/06/2001 the pt began to break out in a rash and over the next few days he developed greater than 200 lesions. It was reported that the lesions were resolving and that the pt had only "slight red marks" left. It was also reported that a specimen will not be sent for VZV ID program because there are not any "blisters or scabs remaining." Additional info has been requested.
3 days after my second dose, my hives increased severely/full body hives that are extremely itchy/full body itchiness; 3 days after my second dose, my hives increased severely/full body hives that are extremely itchy/full body itchiness; 3 days after my second dose, my hives increased severely/full body hives that are extremely itchy/full body itchiness; injection site got super red and itchy the day after my second injection; injection site got super red and itchy the day after my second injection; This is a spontaneous case received report from a contactable other hcp. A 23-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. Medical history included, seasonal allergy from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing. Concomitant medication(s) included fexofenadine hydrochloride (Allegra) taken for an unspecified indication, cetirizine hydrochloride (Zyrtec [cetirizine hydrochloride]) taken for an unspecified indication, isotretinoin (Accutane) taken for an unspecified indication, fluticasone propionate (Flonase [fluticasone propionate]) taken for an unspecified indication, ethinylestradiol, ferrous fumarate, norethisterone acetate (Minastrin 24 FE) taken for an unspecified indication. The patient reported injection site got super red and itchy the day after my second injection on 19Jan2021 that lasted several days as well. "The full body itchiness is unbearable and does not resolve with multiple antihistamines being taken. I have several pictures of the hives that I am willing to share if someone contacts me" Three days after her second dose, hives increased severely full body hives that are extremely itchy full body itchiness on 22Jan2021, injection site got super red and itchy the day after my second injection on 19Jan2021. The patient had recovered from the event of vaccination site erythema and not recovered from the events of vaccination site pruritus, pruritus, urticaria, while the outcome of the event condition aggravated was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored VAQTA lot # M002268 and expiration date: 20-SEP-2017; (route and dosage unspecified). No adverse effects were reported. It was reported that therapy was not discontinued. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt called pharmacy 1/18/21 to report sore arm the day of injection and new developing redness below injection site. Pt stated arm pain was so significant she left work to go home. Pt denied any other symptoms -fever, shortness of breath, swelling. RPh advised patient to use cool compresses and tylenol for pain and to keep arm moving.
Double vision with nausea and loss of appetite.   Went to ER had CT scan and MRI.  Diagnosed with Sixth nerve palsy with no known cause.    I don't know which flu vaccine was given, but it was not the double dose for age over 65.
I began having hot flashes three days after the first dose and my menstrual cycle has changed since. It is now much heavier than the month before the vaccine, and lasts half the amount of days.  I went from regular to light, seven day flow to very heavy, four day flow.
PT was in ED on 12/28 with 5 days of cold-like symptoms and was positive at that time.  He presented back and was admitted due to worsening shortness of breath and fever.
SEVERE BODY ACHE; JOINT PAIN; ARM PAIN; FEVER; NAUSEA; SEVERE HEADACHE; SEVERE FATIGUE; CHILLS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 07:15 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 17:15, the subject experienced chills. On 12-MAR-2021 20:00, the subject experienced severe body ache. On 12-MAR-2021 20:00, the subject experienced joint pain. On 12-MAR-2021 20:00, the subject experienced arm pain. On 12-MAR-2021 20:00, the subject experienced fever. On 12-MAR-2021 20:00, the subject experienced nausea. On 12-MAR-2021 20:00, the subject experienced severe headache. On 12-MAR-2021 20:00, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 102 F. On 13-MAR-2021 19:30, Laboratory data included: Body temperature (NR: not provided) 99.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body ache, and chills on 13-MAR-2021 19:30, and joint pain, arm pain, nausea, and severe fatigue on 12-MAR-2021 20:00, and was recovering from fever, and severe headache. This report was non-serious.
Around day 4, I began experiencing burning/sore armpit pain on left side (same side as injection), at day 6 I began to develop hives around the injection site, then swelling, tenderness around injection site; headache/jaw pain/neck pain/flushing and a cough and nausea.
Patient received 1st dose of Pfizer COVID vaccine and subsequently fainted roughly 5 minutes after receiving dose.  Patient never lost consciousness but did suffer a minor bruise on head once after fainting.
Headache, HYPERtension, C/o feeling "drowsy with intense chills." Afebrile. then c/o headache. Hx. HTN.  BP elevated. To ED for eval. Narrative: Intense chills, HX. HTN. @1130; 219/91, 83, 97% O2 sat. @1145 c/o HA. 234/103, 83, 97%O2sat. Chills improved. abdominal burning present but  improved. @1155 taken to ED for evaluation. 201/99, 92, Report to ED. 198/98 (manual BP).
received booster Covid-19 vaccine shot; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "received booster Covid-19 vaccine shot"; ILLNESS (non-serious), outcome "unknown", described as "sick".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Redness and swelling on arm and some swelling on back. PCP prescribed prednisone for reaction.
Within 12 hours of getting the vaccine, I had COVID.  You lied when you said it wasn't in the vaccine!!!
Rash on Lt thigh 1 wk after vaccine. Fever 2 days after vaccine. Mild local reaction x 1 wk. No intervention, self limited.
Extreme dizziness, and vertigo. Was incapacitated and taken to ER at AMNC for treatment. Still dealing with possible side effects.
Ran a fever 101 for 24 hours, diarrhea, soreness in infection spot.
Patient had a flu shot on Friday. During the weekend caregiver complaining of increased redness, pain and swelling to injection site. Area tender, with erythema and induration present. Antibiotics were prescribed.
Pt had complaint of arm soreness the day following vaccination. She said she has been having issues lifting her arm and is worried the pharmacist that gave her the vaccination administered it too high. I had her show me where the shot was given and it was in the place it should have been given. She showed me her range of motion with both arms. I told her if this does not improve to let her primary care doctor know.
felt confused/ sent emails and text which were very abnormal and confusing. Not making lots of sense; I was tired; mild headache; neck pain; acutely drowsy; completed several notes and had no memory of completing the notes at all; Unable to fall asleep to pain; Unable to fall asleep to pain; 1st dose of BNT162B2 on 23Dec2020/ received the second dose on 18Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the right arm on 18Jan2021 13:00 at a single dose for COVID-19 immunisation. Medical history included migraine headaches and depression. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on 23Dec2020 for COVID-19 immunisation (lot number EJ1685, right arm). On 19Jan2021 19:45, the patient felt confused, thought she was tired and was trying to push through and write notes, she knew something wasn't quite right. She experienced mild headache and neck pain. I was making a lot of errors while writing notes and I was aware. This night I also sent emails and text which were very abnormal and confusing. Not making lots of sense. I received text asking me "what?" Because what she was sending made no sense. She was acutely drowsy and fell asleep mid text. She woke up mid morning with severe neck pain unable to touch chin to chest. Unable to fall asleep to pain. Took Tylenol and muscle relaxer. Went to work as PA. She forgot she had written notes night before. Thinking notes were not complete logged into hospital to write notes and she completed several notes and had no memory of completing the notes at all. No treatment was received for the events. Events were reported as non-serious. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Outcome of the event mild headache was resolved on 21Jan2021, neck pain was recovering, while unknown for the other events.
2 hours after administration of HIB vaccine, my son demonstrated high fever (103), hoarseness, rapid heart rate and some difficulty breathing.  Upon calling doctor on call (Saturday) I was told it is not a reaction to the vaccine.
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 06-DEC-2012 (lot # H011350, expiration date 21-FEB-2015) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Patient returned to pharmacy on 12/22/12. Red spot at site of ZOSTAVAX injection & warm to the touch. (Area bout 6 inch in diameter). Patient referred to ER where she was treated with antibiotics.
21OCT97 when pt got up noticed red area in shot area about fifty cent piece in size;today is approx 10cm in size & very red & hot to touch;went to MD was seen;
Patient presented to the pharmacy for a flu shot and asked for ?regular dose?. Vaccine was ran for Fluarix Quadrivalent flu vaccine which is an age appropriate flu vaccine. Vaccine was prepared and label of vaccine was peeled off and placed on patient consent form, leaving the barrel of the  vaccine with no identifying information.  Before administration, patient asked if the vaccine was Afluria. Vaccinator replied yes and administered vaccine. After referencing the consent form, it was identified that vaccinator administered the Fluarix Quad flu vaccine, not Afluria. Patient had requested Afluria vaccine because of a previous reaction to Fluarix since it contained formaldehyde. The patient had previously answered ?no? on the consent form to ?Do you have any allergies to medications, food, a vaccine component, or latex?? and ?Have you ever had a serious reaction after receiving a vaccine?? Patient had no immediate reaction and will receive a follow-up call in 1 week.
Migraine with aura; Burning pain along her right side; prolonged nosebleed; bruise developed under right eye; mouth ulcer; Joint pain; Stiffness; Stomach pain; headache; arm soreness; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patients medical history included Bechet's disease. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 since having the vaccine. The patient experienced normal headache and arm soreness after 48 hours of vaccination and severe fatigue on 22Mar2021 and prolonged nosebleed, a bruise developed under her right eye, mouth ulcer, joint pain, stiffness, and stomach pain on 23Mar2021 and had another nose bleed on 24Mar2021 and migraine with aura and unusual burning pain along her right side on 25Mar2021. The patient did not receive any treatment for the reported events. The clinical outcome of the events headache, arm soreness, fatigue, nosebleed, bruising, mouth ulcer, joint pain, stiffness, stomach pain, migraine with aura and burning pain was not recovered.   No follow-up attempts are needed. No further information is expected.
Ct was given a TDAP by accident. Ct is pregnant. Ct is HIV positive.
Developed hives on my face, both arms and lasted. Started 10 after injection and lasted about three months. Was giving medication to treat it.
Patient admitted to hospital on 7/11/2021. He tested positive for COVID on 7/7/2021.
Patient at a birthday party, started to feel warm, as family began to leave, arms began shaking. Patient's muscles were clenched & he was shaking, but not not overly tense, jaw clenching & blood vessels in face were bulging. EMS arrived, seizure stopped. Temp 103.3. Patient eyes began to roll back & put in ambulance. Given Tylenol while in ED. Patient had a brief 10-15 second episode where he was unfocused & muscles clenching. Patient admitted & EEG done.
Gastrointestinal Bleed; low platelets; has sources of bleeding that have been active; This spontaneous case was reported by a physician and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Gastrointestinal Bleed), PLATELET COUNT DECREASED (low platelets) and HAEMORRHAGE (has sources of bleeding that have been active) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Liver disorder.    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 GASTROINTESTINAL HAEMORRHAGE (Gastrointestinal Bleed) (seriousness criterion hospitalization), PLATELET COUNT DECREASED (low platelets) (seriousness criterion hospitalization) and HAEMORRHAGE (has sources of bleeding that have been active) (seriousness criterion hospitalization). At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Gastrointestinal Bleed), PLATELET COUNT DECREASED (low platelets) and HAEMORRHAGE (has sources of bleeding that have been active) 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.   No concomitant medications provided. No treatment information provided.  Patient has sources of bleeding that have been active. They ooze minimally.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Developed a rash on her face and arms; took Benadryl 50 mg immediately when the rash emerged at 9:15 AM; she notified the Employee Health office of the rash at 9:45 AM and was immediately referred for evaluation by an Employee Health medical provider at 9:50 AM; she took Benadryl 25 mg at 7:00 PM and then went to bed; the rash was gone upon waking at 8:00 AM on 12-29-2020; she had a follow-up evaluation at 9:00 AM on 12-29-2020 with an Employee Health medical provider and was cleared to return to full duty and was discharged from care.
Starting on Saturday the patient has been having diarrhea; This is a spontaneous report from a contactable consumer. A 12-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 23Jul2021 at 10:15 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 24Jul2021, starting on Saturday, the patient had been having diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event diarrhea was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Pt walking to Observation:  RN reports "deer in headlights look" pt reports feeling dizzy, SOB, fatigue & weakness.  Pt brought to Triage in .   transferred to gurney, EMTs and MD at beside.  pt very tired.  BF gives hx of pt responding like this before. (nothing to do with vaccine.  No adverse effect with dose 1.)  Pt states she was born without inferior vena cava and has CA Stents.  States she "does this and then gets transferred to or my Cardiologists office."  Can't recall last episode.  14:30 EKG NSR, Pt weak BUE & BLE, cant move legs.  Pt states she has not eaten today but had 3 shots of Expresso.  14:31 IV started in R-hand, 200ml NS bolus.  BS 107 mg/dL.    14:58:  Decision to transfer patient to ER as not improving on weakness.  Transferred to  Hospital via AMB @ 15:01.
pt recv vax 7JUL95 & 8FEB97 pt exp chicken pox rash;No further details were provided
Fever after receiving  Tdap at 03/02/2009 . Temperature= 101 (Ty) control by Tylenol.
1 hr p/receiving flu vax pt reported hives @ inject site & the hives had spread all over body; Also c/o h/a, fever, nausea; Dad gave pt DPH no other tx obtained; No resp distress;
adverse reactions appears 5/21 after first dose received 5/9. Reactions include peripheral vasculitis, the size of a quarter, appearing above interior of right wrist. Site also has some pain similar to that of a bruise. Also had blood in urine, which did not reoccur after initial incident.
Patient passed out shortly after leaving the vaccination room. When emt's assessed the patient they determined it to be a stress response and patient was not sent to hospital.