chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 13-OCT-2014 the patient was vaccinated with the second dose of ZOSTAVAX (0.65 ml, frequency: single dose) (batch and lot # not provided) subcutaneous. On 13-OCT-2014, the patient received a second dose of ZOSTAVAX, after patient had received ZOSTAVAX two years earlier. No adverse effects were reported. The reporter declined to provide any patient identifying information. The patient called in to report that she filled out paperwork to receive a flu shot (name/dosage/manufacturer unknown) and she was accidentally given ZOSTAVAX. The outcomes of the events were unknown. The relatedness between the events and suspect drug was not reported. Additional information has been requested.
May have been exposed to somebody have COVID; still having the symptoms; Fever; I had got like low grade fever like in 90, 99; Stuffy nose; runny nose; Stuffy nose; runny nose; Headache; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: FC3182), dose 1 via an unspecified route of administration, administered in Arm Left on 03Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included edema and multiple sclerosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Caller is a consumer inquiring about testing positive for Covid after receiving the Pfizer Covid-19 vaccine. Caller reports she received Pfizer Covid-19 vaccine on Friday and was exposed to Covid-19 infection Tuesday. Caller states I am showing symptoms and just thought it was a reaction to the vaccine. Caller asks can I go get a Covid test or will be affected. Caller reports her symptoms include low grade fever, head cold, stuffy nose, and headache. Consumer stated, I am got this Pfizer vaccine on Friday and I just found that probably on Tuesday, I may have been exposed to somebody has COVID and I still having the symptoms and I got to have some side effect like fever all that I am just wondering if I needed to go get tested. When paraphrased the concern, Consumer stated, I work in kindergarten class and we just got to know one of our kid in the class tested positive probably Tuesday and on Saturday I started showing my symptoms, but I thought it was from my shot I got on Friday. The patient received treatment with Tylenol. The patient underwent lab tests and procedures which included body temperature: 90 on 04Sep2021, body temperature: 99 on 04Sep2021, sars-cov-2 test: positive on 07Sep2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Pt recvd a dose of Engerix-B on 7NOV91 & 9NOV91 devel rash, bumps & pimples on neck (no pain); pt visited a dermatologist; tx w/prescription meds (not specified); tx reported not to have any effect;
hair loss; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 13Sep2021 (Lot number: FC3183) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss".  Additional info- The patient reported that she has still hair loss and is going to be bald because clumps come out  No Follow-up attempts are possible. No further information is expected.
had malaise (mild) p/vax 7MAY83 devel mod severe h/a & inc t102-103; 19MAY  PM of 23MAY improved 24MAY-25MAY saw local PMD; 530AM w/ h/a 2 episodes emesis (bile);
Shingles; This is a spontaneous report from contactable consumer (patient) via the Pfizer-sponsored program. A (currently) 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 74-years-old) in Arm on 19Mar2021 (Lot Number: ER8727) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. She received her first vaccine and now she is diagnosed with Shingles and wanted to know she can get her second vaccine. Her doctor had said that the Shingles mess with your immune system and so does this Covid shot Pfizer. No treatment received for the event. The outcome of the event was unknown.
I developed Tinnitus in both ears.  It is consistent (24/7).  It has adversely affected my quality of life and prevents me from engaging in activities I enjoy, namely singing in a local choral society.
Hives/rash; Hives/rash; extreme itching, appearing on different locations of the body.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 14:15 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3, single. Relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, unknown lot number, 04:30 PM, administered on the left arm), administration date: 18Apr2021, when the patient was 61 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, unknown lot number, 04:30 PM, administered on the left arm), administration date: 09May2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021 14:15, outcome "unknown", described as "booster"; URTICARIA (non-serious), RASH (non-serious) all with onset 27Nov2021, outcome "unknown" and all described as "Hives/rash"; PRURITUS (non-serious) with onset 27Nov2021, outcome "unknown", described as "extreme itching, appearing on different locations of the body.". Therapeutic measures were taken as a result of urticaria, rash, pruritus. The lot number for bnt162b2 was not provided and will be requested during follow up.
c/o of light dizziness after taking the first dose of vaccine.  pt. has a history of allergic reaction to peanuts.  pt. has epipen and benadryl PRN.  V/S BP 132/62, P 81, R 18, SP O2 98%.  monitored pt. for 15 mins and she  verbalized feeling better prior to leaving the parking lot.  Adviced pt. to drink fluids and get some rest when she gets home.  pt. verbalized understanding.
Narrative: Patient presented to covid vaccine clinic for his first of 2 vaccinations. Received first show then next day: Patient called the nurse clinical call center reporting dizziness and sweating . Patient presented to ED with chills,sweating and dizzieness. Symptoms did resolve.
Child was given H1N1 nasal mist. Child had nosebleed immediately following administration. Left nostril bleed lightly for approx 20 min. Bleeding stopped with tissue and gentle pressure.
Passed out and seized for 10 seconds, patient was confused for about 5 minutes after incident.
This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and feeling bad. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the feeling bad was unknown. It was unknown if the reporter considered the sickness and feeling bad to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt pretty sick for a day or so and felt bad after the shot. The patient thought that he/she was the only one who felt bad after the shot but since then many of his/her friends had the same reaction. The patient stated that one should still get the vaccine but they should tell them that there were side effects for some people. The patient stated that the shingles would be worse than the reaction from the vaccine. The follow-up would not possible as no contact details were available. For 2nd dose tolerance, refer linked case US2021AMR266216, reported by the same reporter for same patient. This case also has been linked with cases US2021AMR266217 and US2021AMR266243, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR266216:Same reporter; US-GLAXOSMITHKLINE-US2021AMR266217:Same reporter; US-GLAXOSMITHKLINE-US2021AMR266243:Same reporter.
APPROXIMATELY 5 MINUTES AFTER RECEIVING JANSSEN VACCINE, PATIENT REPORTED FEELING FAINT AND ASKED TO HAVE A SEAT IN THE OBERSERVATION AREA.  PATIENT WAS MOVED TO OBSERVATION AREA, WAS INITIALLY SEATED, THEN WAS LAID ON THE FLOOR WITH FEET ELEVATED.  PHARMACIST REMAINED TALKING TO PATIENT FOR APPROXIAMTELY 5 ADDITIONAL MINUTES. PATIENT DRANK A SPRITE WHILE TRYING TO RECOVER FROM FEELING FAINT. PATIENT THEN SAT UP TO TALK TO HIS WIFE AND FELL BACK LOSING CONSCIOUSNESS.  WITHIN SECONDS AFTER LOSING CONSCIOUSNESS, PATIENT BEGAN GROANING/MAKING GARGLING SOUNDS AND GASPING FOR AIR AND SLOWLY MOVING APPENDAGES. 911 WAS CALLED.  AFTER 5-10 SECONDS PATIENT WENT COMPLETELY LIMP AND UNRESPONSIVE. PATIENT LOST ALL COLOR AND EYES WERE OPEN BUT ROLLED BACK INTO THE HEAD.  PHARMACIST ADMINISTERED EPIPEN.  WITHIN 15 SECONDS OR SO, PATIENT REGAINED CONSCIOUSNESS AND TRIED TO SIT UP ASKING WHAT HAPPENED.  PATIENT REPORTED FEELING HOT AND LIGHT HEADED.  FIRE TRUCK ARRIVED LESS THAN FIVE MINUTES LATER.  PATIENT WAS MOVED TO A SITTING POSITION AND RECOVERED AFTER APPROXIMATELY 10 TO 15 MINUTES AND LEFT THE PHARMACY STATING HE FELT BETTER.
Prolonged pressure and tightness in throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25May2021 (Lot number: EW0178) at the age of 19 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Alopecia areata" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Right), administration date: 03May2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: THROAT TIGHTNESS (medically significant) with onset 08Jun2021, outcome "not recovered", described as "Prolonged pressure and tightness in throat". The event "prolonged pressure and tightness in throat" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Nasal Swab. Therapeutic measures were taken as a result of throat tightness.  Clinical course: Prolonged pressure and tightness in throat present for 7 months starting 2 weeks after 2nd dose. No response to prednisone, or numerous other treatments. Patient received Prednisone, PPI, steroid injections, speech therapy as treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
The patient called today and stated he felt under the weather and had a fever of 99.5.
Left arm localized redness, induration at injection site of Influenza and pneumococcal vaccines. Fever started < 24 hours after injection. Treat with antibiotics for 10 days (KEFLEX).
Red itchy rash that is spreading over body. Rash started on my chest, neck, and arms. It is spreading to my face and down my trunk and back. I have generalized itching all over. I have taken Benadryl and Zyrtec and used Benadryl ointment on chest, neck, and face with little relief of symptoms.
21 y/o female received Janssen vaccine (Lot# 042A21A) @ 02:22 pm, while in the recovery area, @ 02:26 pm began to c/o (Dizziness and Feeling faint).  02:35 pm vitals: 120/90, 60, 99%. "I feel faint or dizziness  every time I get a shot or my blood drawn or if I'm in a doctors office  and it last for about 10 minutes and than I'm ok."  Patient instructed on deep breathing and posturing to relax.  Recovery Nurse worked w/patient to continue relaxed breathing, began to relax.  Remained in recovery until 02:57 pm, Patient left with family without  getting discharge vitals.
headache; body ache; This is a spontaneous report from a contactable consumer (Patient) via Medical Information team.   A 57-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On 18May2021, the patient experienced headache, body ache. Reported serious as no, reported that patient had the first dose of the Pfizer COVID vaccine yesterday. He wants to know if he can take Aspirin, Tylenol or Ibuprofen for the pain. Reported that reporter seriousness for Headache and Body Aches was Unspecified. Reported that patient experienced his headache and body aches began this morning. States he does not want to complete a report he wants to be transferred to health facility. Caller declined to complete report. The outcome of events was not recovered.  Follow up attempt needed. Additional information has been requested.
PENTACEL  expired on 10/1/2017  given today on 10/4/17, missed read the date backwards, and it was double checked by a provider as well. Will call pt. to come back and have shot again when we get the new order in.
left arm had been in constant pain / just a deep pain; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 24Sep2021 at the age of 25-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergy was none. The patient didn't received other vaccine in four weeks. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 03Sep2021 (Lot Number: Unknown) at the age of 25-year-old as single dose for COVID-19 immunization. On 03Oct2021, a week after the second dose, the patient's left arm had been in constant pain, not sore muscle pain, just a deep pain. No treatment was received. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Rash, pain inj site X3 days, lethargy X2 days. Day 8 developed rash at injection site resolved in 3 days Narrative:
Redness, swelling and pain indicative of cellulitis started 5-days after vaccination
This spontaneous report as received from a health professional via company (manufacturer control number 58348) refers to an elderly female patient of unknown age (over 65 years old). The patient did not have any known allergies. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route not reported, lot # K005797, expiration date 21-MAR-2015, or lot# reported as K007773, expiration date 01-MAY-2015). Concomitant medications were not provided. On 18-AUG-2014 the patient experienced redness, fever in the area upper arm and itching in the area from the last two vials of Pneumonia Vaccine. After a couple of days it went away on its own and the patient was okay. The healthcare worker stated the office already disposed one of the lot numbers that was used that was causing the issue lot # K005797. This is one of four reports received from the same reporter. Additional information has been requested.
PAIN AT SITE OF INJECTION, BLUE DISCOLORATION TURNED RED.  YELLOW SPOTS LOOKING LIKE INFECTION WITHOUT DISCHARGE FOR 16 DAYS.
Experienced a witnessed seizure at work (Paramedic) then became combative. (No hx of seizures). Subdued by use of versed and transported to. Received fluids. CT scan, labs, chest xray, and drug screen all normal. Remained in ER for observation for approximately 6 hrs then discharged.
This case was reported by a nurse via call center representative and described the occurrence of urticaria in a 50-year-oldf female patient who received FLUARIX quadrivalent (batch number 9X7LY, expiry date 29th June 2016). Previously administered products included Flu vaccine (no history of problems with previous Flu vaccinations). On 25th September 2015 12:00, the patient received FLUARIX quadrivalent .5 ml. On 25th September 2015 20:30, 8 hrs 30 min after receiving FLUARIX quadrivalent, the patient experienced urticaria and throat tightness. On an unknown date, the outcome of the urticaria and throat tightness were recovering/resolving. The reporter considered the urticaria and throat tightness to be possibly related to FLUARIX quadrivalent. Additional details were received as follows: On 28th September 2015, the patient was evaluated at the physician's office and they noted that urticaria and throat tightness were resolving. The reporter forgot to ask if vaccination was given subcutaneously, but the patient gave him no reason to think otherwise. The patient visited the emergency room.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a female patient of an unknown age 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 URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information have been requested
Initial case received on 23 February 2010 from a health care professional, who was also the patient's mother. It was retrieved from an online source. A 3-year-old female child received an injection of MENOMUNE (lot not reported) in 2001. The patient had a history of urticaria pigmentosa, and had a "negative reaction" after receiving MMR at one year of age. At the age of 2, she and her twin brother had experienced progressive loss of speech, ear infections, vomiting, diarrhea, constipation, migraine headaches, and dizziness, which had since resolved per the reporter. According to the patient's mother, the patient's father was a physician, and had bought the MENOMUNE "from a friend". The patient's father administered the vaccine at home. Two days post-vaccination, the patient complained of tiredness and developed a fever of 105 degrees. Her urticaria pigmentosa worsened, and she developed blisters in addition to facial swelling. She was transported to the emergency department, where she was treated with fluids and TYLENOL. Laboratory testing revealed an elevated white blood count. The patient improved, and was discharged to home the same day. She subsequently developed "issues with sensory dysfunction", including intolerance to loud noises, migraine headaches, and profuse nosebleeds. She was diagnosed with acquired dyslexia, which was ongoing at the time of the report. Documents held by sender: None.
This spontaneous report as received from a healthcare worker refers to a 13 unspecified patients of unknown age and gender who on an unknown dates received doses of improperly stored VAQTA (doses, route, lot# and expiration dates were not provided). No adverse effect reported. Additional information has been requested.
Information has been received from a registered nurse who reported that multiple unspecified patients received unspecified doses of improperly stored VARIVAX (lot # L045956, expired date 17-NOV-2017 or lot # L048463, expired date 02-DEC-2017; dose and route not reported). These vaccines were under 9.5 F for 3 hours and 26 minutes and then under 13.1 F for 1 hour and 24 minutes. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Redness, swelling of (L) upper arm, pain in upper arm into shoulder.  Slightly raised, reddened area (hive-like appearance).  Itching.  Given  Benadryl IM.
Patient had received two Sinovac COVID-19. On 1/27/22, patient given a Moderna booster dose of 0.5 ml
COVID breakthrough report. I received my booster shot on 11/16/2021 and my adverse event started on 05/12/2022 I had a scratchy throat in the evening at 05:00PM ET the next day I had fever, chills, sore throat, stuffy head, runny nose and a headache. I have COPD. I called my doctor and he prescribed me medication for COVID. He called in prescription for antiviral medication. On May 12/2022 I tested positive for COVID.
Developed a cough after an unknown amount of time. Ultimately died on 5/12/21 at 1631 hours.
This spontaneous report as received from a registered nurse refers to a patient of unknown gender, age range reported as 5 (units not reported). On 07-NOV-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number, route and frequency were not reported) that was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Patient had immunization was  given at 3:15pm, about 2 minutes later patient began to loose consciousness.  She appeared semi-alert but not fully conscious.  After3 minutes, patient was alert enough to speak and drink water.  Local EMS was activated and arrived at 3:35pm.  EMS did vitals as said the patient had no immediate emergency.  The patient's mother refused transport but said she would take her daughter to the local emergency department.  The patient left on her own power.  The same reaction/situation happened when the patient got her first shot on 5/19-2021.