chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness at injection site; sores on lips; pain and sores on lips; soreness at injection; This case was reported by a consumer via call center representative and described the occurrence of sores lip in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sores lip, lip pain, injection site pain and injection site erythema. On an unknown date, the outcome of the sores lip was recovered/resolved and the outcome of the lip pain, injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the sores lip, lip pain, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. LOT and expiry details were unknown. After receiving Shingrix, the patient experienced pain and sores on lips and soreness and redness at the injection site. The reporter did not consent to follow up.
Unsteady on feet; Aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Unsteady on feet), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced GAIT DISTURBANCE (Unsteady on feet), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills). On 20-Sep-2021, GAIT DISTURBANCE (Unsteady on feet), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient took appointment on 8 Oct 2021 to take second dose and said that no rash was experienced as a side effect.  treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Removed event Rash.
I connected the adverse reactions after having the booster, when it happened again. Herpes simplex virus activation- cold sore within 24 hrs of vaccine. Also, menstruated longer and heavier than normal after each covid vaccine. Itchy lump on my arm within 7 days of vaccine each time, lasting 2days .
The patient skipped day seven for the second dose of RabAvert; Case reference number US-BN-2022-002286 is a spontaneous case report initially received on 08-Sep-2022 from a health care professional (reference number: USBAV22-1310) and concerns a patient of unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On 18-Aug-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: unknown) at an unknown dose, via unknown route of administration, at an unknown anatomical site, for pre-exposure for rabies.   It was reported that the patient was not vaccinated with the second dose of RabAvert seven days after the first dose (explicitly coded as 'Missed dose').  At the time of this report, it was unknown if the patient experienced any adverse events.   Non-significant case correction performed for information received from Bavarian Nordic on 08-Sep-2022 to include the local case ID.  The case is linked with US-BN-2022-002285 and US-BN-2022-002287 due to the same reporter.; Reporter's Comments: A patient of unknown age was not vaccinated with the second dose of RabAvert seven days after the first dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age was not vaccinated with the second dose of RabAvert seven days after the first dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Pt received Moderna COVID Vaccine dose 1 on 3/8/21 but did not disclose this information.  Vaccinator discovered vaccine history on the Rover after Pfizer COVID  vaccine given.  Talked to patient where they confirmed that they received Moderna  and had cancelled 2nd dose appt.  Now, patient thought that receiving another brand would increase vaccine efficacy.
was found unresponsive & bleeding out of mouth by mom while both were in bed time approx 3Am as reported by mom;
Myalgia pain at site of injection, joint pain in entire arm on injection site (R). Malaise. Narrative:  difficulty getting dressed due to pain in right arm.
Became diaphoretic and pale, pulse rate 50 pt reclined, examined by MD. BP 100/62 Pulse-68 @ 3:25 pm. Oral fluids given. Patient states she had not eaten this day-12 oz Pedialyte, glucose tab 4 gm x 2 given. No further diaphoresis 4:35 pm c/o heaviness in left arm & mid thoracic back pain 4:45 pm BP 110/80 Pulse 72
pt had extreme chills, shivers late the day. slight temp of 100.5.  sore ribs the next day ( possibly from shivers?)
When depressing vaccine into muscle the vaccine rolled down the arm.  Looked like it came from the neck of syringe just below luer lock.  Gave patient another dose  Fluzone.
pt recv vax 14OCT96 & 12UAG97 pt devel chickenpox that consisted of 15-20 lesions on back & scalp @ the time of MD visit;tx w/DPH;
The adverse event was watery diarrhea for several days (Mon night through Thurs) I was concerned about it to call and talk to the nurse at my doctor's practice as I was supposed to go on another backpacking trip and I didn't want diarrhea in the backcountry. It is possible that this adverse event could be caused by contaminated drinking water from the weekend before on a backcountry backpacking trip.
-received Pfizer COVID-19 vaccine on 7/30/2021 @ 1125.  Patient reports the following adverse reactions: Pt stated she was light headed. I gave her some water. Pt stated she had a hx of seizures. Pt began to seiz. EMS called. Seizure began @ 1140 and lasted about 2 minutes. O2 via nasal canula started. VS were taken: B/P 209/96. P-81. O2 95%. 2nd set taken 5 minutes later. B/P  207/103. P-80. O2-95%. Pt taken to Hospital ER via emergency vehicle  7/30/21: Patient presented to the ED following 2 seizures today.  She also complained of mild headache and chest pressure.  She did have one 10 to 15 second seizure in the ED.  She remained vitally stable during the seizure and no intervention was needed.  Work-up here was overall unremarkable with normal initial troponin, urinalysis negative for infection, chest x-ray negative for any acute pathology.  EKG was nonischemic.  Head CT was not done as patient left prior to the study being completed.  She has been vitally stable throughout her time in the department, but mildly hypertensive around the 180s systolic.  She did not have any further seizures in the department.  She was given her home dose of zonisamide here in the department.
Soreness in the arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in the arm at the injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006CZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness in the arm at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment medication was not provided. Patient stated that after vaccination experienced soreness in the arm at the injection site. She stated It is starting to go away, but arm is still sore.
Typical signs for 3 days post vaccination (fever, headache, nausea, chills-worse than when had covid)  After 1 week since 1st vaccine starting having dizziness so bad that couldn't work. Headache persisted and nausea worsened with dizziness. rDVM state either long haul covid vs vx rxn; Pulmonologist stated sinus infection and started antibitics which responded to.
She reported feeling anxious and dizzy few minutes after getting the vaccination. She denied SOB, n/v. She admitted felt anxious prior and after vaccine. Felt well afterwards, left in stable condition.
At 29 minutes after vaccine administration, patient complained of tingling on the sides of her tongue.  She was speaking normally, breathing was regular and unlabored. Vital signs @ 1420 were: BP- 137/59, HR 61, RR 16 breaths/min, O2 Sat 97% Patient stated she was very anxious about getting vaccine and thought symptoms wee due to "nerves." We continued to observe.  At 1434 Patient stated,  "my whole tongue feles tingly and its hard to talk." She continued speaking with me without any change in voice, her breathing remained unlabored.   We gave patient one 25 mg tablet of Benadryl.  Vital signs were:  BP 152/63, HR 69, RR 12 breaths per minute, steady and unlabored, SpO2 99% At 1510 patient said she was feeling better.  Vital signs: BP 134/56, HR 60, RR 14, SpO2 98%.  At that point patient said she felt ok to leave.  She carries Benadryl and epi pen with her at all times for nut allergy and verbalized understanding of when and how to use her medications if needed.  She said she has a telephone visit set up with her allergist in August.  I told her she would need a note from her allergist to be receive 2nd vaccine.
Pt was given Varicella vaccine but it was #3 and not needed. Pt needed MMR#2. Pt received updated record and instructions on localized reactions with subcutaneous vaccinations. Pt's mother verbalized understanding. Pt was contacted after error was noticed and mailed record. Have been trying to contact for MMR#2 administration required for school.
This study case was received from the investigator in a trial on 26 September 2012. A 38 year-old male subject (medical history not available) was found to have an unspecified cause of encephalitis two days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax 2 (manufacturer, lot number, route and site of administration not reported) on 08 February 2012. Relevant laboratory and diagnostic testing was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Pt. complained of chest and stomach discomfort , states that she had a warm sensation from the top of her head through her chest and stomach. First ad called patient taken to the hospital via ambulance
Chills, fever 101.6F, headache, fatigue, nausea, diarrhea. Today she states she is feeling a little better but is still a little nauseated and fatigued. She states she's been taking Tylenol off and on.
8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions; This is a spontaneous report from a contactable consumer from medical information team. An elderly patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as single dose, for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: hypoxia (death), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions". The patient underwent the following laboratory tests and procedures: oxygen saturation: 60-80%. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200376657 the same reporter, product and similar adverse event in different patients; Reported Cause(s) of Death: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions
He underwent routine monitoring for his testicular cancer and had CT of his lungs on April 6.  He was found to have asymptomatic Pulmonary emboli. He was started on Eliquis 5 mg  bid
This spontaneous report as received from a healthcare worker-Office Manager refers to an unspecified number of patients. The office manager reported that multiple unspecified patients received Oral, ROTATEQ injection (confirmed Lot#K004795 and exp. 11-FEB-2016) (dose and route of administration not reported) that were improperly stored. No adverse effects reported. No adverse effects reported nor PQC was involved. Additional information has been requested.
swelling at injection site; Itchiness; Hard lump at injection site; Headache; Swollen lymph nodes; injection site along with itchiness and soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-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 13Mar2021 at 17:30 (at the age of 32 years old) as a single dose for COVID-19 immunisation. Medical history of the patient included migraines. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medication of the patient included verapamil HCL ER (MANUFACTURE UNKNOWN) for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The past drug history of the patient included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration and unspecified anatomical site on unknown date as a single dose for COVID-19 immunisation. On 13Mar2021 at 19:00, patient experienced swelling at the vaccination site along with itchiness and soreness, hard lump at the vaccination site, swollen lymph node/ hard lump in the armpit of the arm that did not receive the injection and headaches for two days. No therapeutic measures were taken as the result of these events. The clinical outcomes of the events swelling at the vaccination site along with itchiness and soreness, hard lump at the vaccination site, swollen lymph node/ hard lump and headache was not recovered.   Information about lot/batch number cannot be obtained. No further information is expected.
turned red; blotchy; hot; Temperature went up to 99.3; This is a spontaneous report from a contactable consumer (patient herself). A 36-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 08Apr2021 16:45 (at the age of 36-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included crohn's disease and known allergies: gluten, pollen, birch tree fruits from an unknown date and unknown if ongoing. Concomitant medications not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 18Mar2021 (at the age of 36-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks reported as yes (but not specified which medication/drug patient had received). Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that, on 16Apr2021 patient turned very red and hot the night after the shot. Then this happened again 8 days after her second shot. Temperature went up to 99.3. 12 days later she again turned red and blotchy and hot for about an hour and it went away. Temperature went up to 99.3. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 99.3; temperature went up to 99.3 on Apr2021. The outcome of all events was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 4/19/99; on 4/20/99 pt exp local erythema, swelling, warmth
Post vaccine pt has increased swelling to left lower arm, also is red at injection site 1 1/2 inches. Full ROM at elbow, below elbow warm to touch.
Pt received 2 month vaccines at scheduled 2 month well check.  However, mother had been on infusions during her pregnancy for inflammatory bowel disease.  I do not give live virus vaccines under 12 months of age if mothers are on immune suppressive medication during pregnancy due to theoretical risk of possible immune suppression in infant.  This baby did get the oral Rotateq vaccine, which is a live viral vaccine.  Baby has not had any known symptoms or adverse effects at this time. Mother has been notified of live vaccine being given.
04/07/2022 vaccination. 06/20/2022 I started to experience a sore throat. I was really tired that day. 06/24/2022 I was experiencing fatigue, sore throat, swollen glands, and a headache. This all accumulated during the week. I would take ADVIL during that week. COVID-19 negative. 06/25/2022 Symptoms persisted to include sneezing, congestion and coughing. Uncontrollable runny nose. COVID-19 positive. I contacted my PCM and she didn't recommend any antiviral. She felt like the side affects to the medication would be worse. I did contact telehealth through my insurance and he sent in order for a cough medication and an inhaler. I used the medication twice and inhaler maybe 4-5 times; albuterol and benzonatate. I still feel like there is something in my chest and pressure in my ears.
Severe chills, severe headache, body/muscle aches,  101+ degree fever, fatigue lasting 36 hours Sharp lower back pain on left side in the general area of kidney, dark yellow/brown urine output continues to present time.
Had Abdominal surgery to remove a colon stricture. Removed 2 feet of right colon and appendix. Developed post operative bilateral DVT and pulmonary emboli, documented by ultrasound and CT scans.
1) Immediately after receiving the shot, during the "waiting period" before being allowed to leave the clinic, I experienced slight light-headedness and then a feeling of great hunger pains in stomach ...  2) Woke up at approximately 1:00am on Sunday, 4/4/21 with a very hot sweaty clammy feeling, had a headache, body aches, temperature was 99.9  - symptoms then proceeded to worsen with a heavy headache (light over the whole head, with a slight sinus headache feeling & increased pain on Left side of sinus, eye, forehead, ear, behind ear, down back of skull), this headache 'pulsed' mostly on the Left side of head; felt nauseous, runny nose, sore throat (felt strep-like), fatigued (slept alot), body/muscle aches, strange dull aching in Left leg which seemed to move around the leg at different times  (had to keep moving positions of Left leg when sitting or laying down).  These symptoms lasted without break for approximately 4 days/nights at which it tapered off.  Also, on the morning of Sunday 4/11/21 I  noticed a vein that seemed to 'inflate' on my Left upper forehead and pulsed for a few minutes and then subsided with the feeling of a slight headache mostly on the Left side.
Leg where Kinrix was placed looked like she had been stung by bees. Fever elevated highest was 102. Had three seizures. Vomiting and abdominal pain.
Feel like nauseated; Eyes starting to be blood shot; Extreme tired/Third day a little better but still a bit offatigue.; Feel having fever; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 11May2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had known allergies to acetaminophen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 20:00, after the vaccination, the patient felt having fever. The patient was fine on the next morning before going to work. On 12May2021 at 07:00, the patient felt like nauseated and her eyes started to be blood shot. On 12May2021, the patient went home and slept almost all day, woke up to eat and went back to bed for hours. Next day the patient experienced same extreme tired and felt having fever but when checked, it was nothing. Third day, on 14May2021, the patient was a little better but still had a bit of fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event fever which included treatment with advil since the patient was allergic to acetaminophen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, felt like nauseated and eyes starting to be blood shot was resolved on an unknown date in May2021; while that of the extreme tired/fatigue was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever, myalgias, golf ball-sized lymph node in armpit on administration side.  Sore arm x6 days