chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme blurry vision; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 as a single dose (at the age of 56-years-old) for COVID-19 immunisation. The medical history included loss of ability to read as he had before receipt of vaccination. The patient did not receive any concomitant medications. The patient had known allergies to morphine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 01Apr2021 at 06:30, the patient experienced extreme blurry vision. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme blurry vision was not resolved at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
Patient called to report onset of sl fever, chills, achy beginning about midnight following vaccination for influenza earlier in day (patient did not know exact temp but states felt slightly feverish).
pt recv vax 18JUN96 & 19JUN96 pt devel hematoma @ the inj site & swelling & hardness @ the inj site;it was noted that the pt had no adverse events following the prev two doses of vax;
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 08-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002986: US-009507513-2104USA002980: US-009507513-2104USA002978: US-009507513-2104USA002981: US-009507513-2104USA002976: US-009507513-2104USA002988: US-009507513-2104USA002987: US-009507513-2104USA002983: US-009507513-2104USA002974: US-009507513-2104USA002982: US-009507513-2104USA002985: US-009507513-2104USA002973: US-009507513-2104USA002975: US-009507513-2104USA002963: US-009507513-2104USA002971: US-009507513-2104USA002984: US-009507513-2104USA002972:
bleeding; bit by ticks or fleas; rash all over; itching; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMORRHAGE (medically significant), outcome "unknown", described as "bleeding"; ARTHROPOD BITE (non-serious), outcome "unknown", described as "bit by ticks or fleas"; RASH (non-serious), outcome "unknown", described as "rash all over"; PRURITUS (non-serious), outcome "unknown", described as "itching". Therapeutic measures were taken as a result of haemorrhage, arthropod bite, rash, pruritus.  Additional information: She had a reaction to a previous dose - she stated last time she thought she had been bit by ticks or fleas from walking in the grass. She had a rash all over her body. It was itching and bleeding. She used lotion and ointment to sooth it.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the event bleeding  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201309622 Same reporter, same drug, same patient, different dose;
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (lot number M025867, expiry date 24-MAY-2018) (lot number M025870, expiry date 24-MAY-2018) (lot number M028551, expiry date 07-JUN-2018) (lot number M033906, expiry date 28-JUL-2018) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the VARIVAX experienced a temperature of -5.0 degrees Celsius (C) for 7 hours 55 minutes, -6.4 C for 4 hours 57 minutes and -9.8 C for 4 hours. It was reported that the lots underwent previous temperature excursion of -5.1 C for 3 hours 24 minutes except lot number M033906, expiry date 28-JUL-2018 which was not exposed to previous excursion as it was a newer batch. No adverse effects were reported. There was no product quality complaint was reported. The action taken with the therapy with VARIVAX and the outcome of the events was unknown. Additional information has been requested.
Accidently used a wasted extra dose that left in a Pfizer Vial and mixed it with 1.8 ml  Normal Saline. Thinking i was mixing an intact vial. A dose was withdrawn from the affected vial and administered to the patient.
Chills, rigors, fever to 102F, headache, myalgias. All began around 7pm, persisted throughout night, fever broke at ~5am.
soreness, joint pain at injection site Narrative: Soreness/Joint pain @ injection site. No redness/ swelling/ induration/bruising. Note injection given higher in the zone, closer to joint.
Body pain/diffused body pain throughout their entire body, in the muscles; Lethargic; Initial information regarding an unsolicited valid non-serious case received from a Pharmacist via Call Center (Phone) on 06-Dec-2020.  This case involves elderly patient who had body pain, diffused body pain throughout their entire body, in the muscles (pain) and was lethargic (lethargy), while the patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On 01-Dec-2020 (about 5 days ago now), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, after vaccination (unknown latency) patient experienced body pain (pain), diffused body pain throughout their entire body, in the muscles and was very lethargic (Lethargy). Reporter saw some information about that this was a possible side effect on the prescribing info but  just wanted to get a little more information that perhaps was not in the insert.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient concurrent conditions and medical history were not provided. On 28-DEC-2015, the patient was vaccinated with the first dose of VAQTA, intramuscular (dose, lot # and expiration date were not reported, then on 28-JAN-2016, the patient was vaccinated with the second dose of VAQTA, intramuscular, lot # L036449, expiration date 26-MAY-2017 (dose was not reported). No adverse effect nor product quality complaint were reported. Additional information has been requested.
Headache, Myalgia, Fever, NauseaVomiting, CHILLS, FATIGUE, VERYY SORE ARM Narrative:  Other Relevant History:
Patient would like it on record, patient had the Johnson and Johnson Covid Vaccine on Saturday 4/10, right after taking the vaccine, patient felt a sensation rush to the top of her head and throat, she got dizzy in the top of her head and had a loud noise in her left ear, patient states all symptoms subsided Sunday morning
Patient received COVID 19 vaccine and was in waiting area after administration, about 5-10 minutes after administration he fainted while sitting on chair in waiting area, fell off chair and hit head on floor. Very Brief LOC. Was pale, EMS was called to check on patient - while EMS was speaking to patients he fainted a second time (they caught him) - was taken to hospital for further evaluation as a precaution, do not know results of that evaluation. Patient admitted eating little and drinking little water that day.
Vaccine administered 0945 1/28/09 and patient was discharged 10:15.  In the evening hours at home, the patient noticed onset of pain, swelling around injection site.  On 1/29/09 patient went to primary care MD and received prescription for cephalexin. On 1/30/09 the patient went to E.R. with fever, chills, redness around injection site.  E.R. found leukocytosis with bandemia and admitted patient with right shoulder cellulitis and sepsis.  4/2/09  MR received for DOS 1/30-2/2/2009 with D/C DX:  REU cellulitis with sepsis.  CAD s/p stent placement.  Hx hypothyroidism.  Hx hyperlipidemia. Pt received Pneumovax prior to d/c 1/27/09 for coronary stent placement.  Returned 1/30/09 with c/o injection site swelling, pain and cellulitis worsening despite po abx ordered by PCP. Erythema extends to R chest. Pt with fever (T=101.7'F) and chills. Pt admitted for IV abx which resulted in rapid improvement. Only minor induration left at d/c.
Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 an unknown date in 2021 the patient experienced diarrhea. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event diarrhea was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received Janssen COVID vaccine 4/9/21 around 9 am. Patient reported to emergency department around 10 pm that day (4/9)- says tongue began swelling since 7pm, he took a benadryl at 8pm with no improvement. Per ED physician, patient had "tremendous amount of tongue swelling, I am not even able to visualize the palate he has fullness to his left neck as well". Patient intubated in emergency room to protect airway.  Patient admitted to ICU where he is still today (4/13). Per chart, the edema subsided on 4/12 and patient was extubated today (4/13). Patient received IV steroids from 4/9- 4/13 (discontinued this morning).  Of note: patient does take lisinopril 20mg daily (start date July 2020). There is concern the angioedema was caused by this medication. Patient received tranexamic acid and Berinert in the emergency department to assist in treating this potential etiology.
Complaint of sharp dull ache elbow to top of hand, whole arm noticed evening of injection.  Aggravated with picking up item, headsets as she is a hearing technician.  Took Motrin, no doctor visit.  12/02/2005 telephone call follow up - continues with dull ache from top of hand to elbow and some residual loss of strength.  No problem at injection site just ache.
Flu vaccination administered in Rotator Cuff, For the last 2 months increased pain, weakness and decreased mobility.
At the time of the vaccine, I had a headache, a couple days of fatigue. It went away. In July I had minor aches and pains, I had Charlie horse in my legs and arms. I ended up having a blood clot in my leg. I was prescribed a topical cream to apply on my leg. I also had an upper respiratory injection; I was so sick and in bed the who time. Everyone around me got sick. I lost my smell, taste and felt run down. I never went and got tested. Yesterday I was hospitalized briefly I was seen in the ER; they did a strep test and a culture, and they found a virus. They have prescribed me with Sudafed.
pt recvd vax & devel high fever of 103 following vax; No further details were provided;
Shaky & faint feeling 12 hrs p/vax recvd on 10MAR92; pt reports flu like sx 48 hrs p/vax; 18MAR92 8 days p/vax presented to ER w/h/a; Seen by MD 20MAR92 & adm to hosp had CAT Scan & given IV meds for h/a; d/c home next day 21MAR92;
Within hours severe arm pain, 24 hours later arm and torso rash developed along with lethargy and headache
new two shot vaccine / took the first one / got them; This case was reported by a consumer via(Facebook) interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (had them when the patient turned 50).   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 shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine. This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional details were provide are as follows: The case was reported by patient himself/ herself. The age at vaccination was not reported. The patient had shingles when he/she turned 50 and had the first vacation kept getting them. The patient stated that, out of new two shot vaccines, the patient received 1st dose of Shingles vaccine and got shingles again. The patient did not bother with the 2nd dose. The follow up would not be possible as no contact details were available.
I have arthritis and the shot seems to have made the pain worse and has lasted about 4 days.  Joint and muscle pain
Mother states on 6/20/01, child developed redness and swelling in left arm, extending from elbow to shoulder. Area warm to touch. Prior to this only a smaller area had been reddened. Child seen by NP who told mother an infection was present and ordered antibiotics (cephalosporin).
Pt. states she developed flu type symptoms the day of first vaccine. (joint and muscle pain, etc.)
Mother reported that on Saturday 10/26/19 pt vomited 1-2 times in the evening after receiving the vaccines an has not vomited since Saturday 10/26/19. Mother reports no other s/sx. Patient has not received any other vaccines other than the vaccines she received on 10/26/19
Pt. states that after receiving the 2nd dose of Phizer 02/24/2021, started experiencing symptoms intense pain at injection site, hard to the touch, and muscle pain. Self-treating, no Noted Primary visit.
The first time highest temperature about 101; Dizzy; felt like someone punched her ten times at injection site; fatigue; Muscle pain; joint pain had increased; arm pain; felt really hot and sweaty for 2 days; felt really hot and sweaty for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8732, first dose) solution for injection intramuscular in the left arm on 25Mar2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing autoimmune issues, ongoing psoriatic arthropathy, ongoing rheumatoid arthritis, appendix removed a few days before Christmas, joint pain, stops palpations or arrhythmias from mitral valve, replace thyroid hormone after hysterectomy, vitamin d deficiency. Concomitant medications included ongoing acetaminophen for arthralgia, ongoing atenolol for stops palpations or arrhythmias from  mitral valve, ongoing levothyroxine for replace thyroid  hormone after hysterectomy, ongoing alprazolam for anxiety, and ongoing vitamin D for vitamin D deficiency. Historical vaccine included flu shot and experienced unconscious. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had the first time highest temperature about 101, dizzy, felt like someone punched her ten times at injection site, fatigue, muscle pain, joint pain had increased, arm pain, felt really hot and sweaty for 2 days on 25Mar2021. The patient did not require a visit to ER or Physician Office for the events. Treatment for events fever and punched her ten times at injection site included acetaminophen. The outcome of the events fever, punched her ten times at injection site, fatigue, muscle pain, joint pain had increased, arm pain, felt really hot and sweaty for 2 days was recovered in Mar2021. The outcome of the event dizzy was recovered on 25Mar2021.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-JUL-2022.; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-JUL-2022.) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-JUL-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-JUL-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-JUL-2022.).    No concomitant product use was reported.  Patient received half dose.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  Vial did not undergone any temperature excursions.  No treatment information was provided.
"Sx started yesterday 3/11/21, heated up first and itchy, scratched area and worse from there, no opening on skin. States with low grade fever, arm swollen around injection site and toward elbow and hot to the touch, feels like band at top of arm and a bit numb, area is red -no drainage -temp 98.7 today, 1.5 hrs after 2 ibuprofen  remedies- only tried ibuprofen"
dint feel good; shaking; arm hurt a little bit; only the diluent portion of shingrix (2nd dose) was administered; only the diluent portion of shingrix (2nd dose) was administered; This case was reported by a nurse via call center representative and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise, tremor, pain in arm, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the malaise, tremor and pain in arm were recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the malaise, tremor and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The only diluent portion of Shingrix was administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patent was called back for another dose. The reporter was concerned that was it ok to give the 2nd shot again as the patient developed side effects to the diluent did not feel good shaking, arm hurt a little bit, no rashes and was fine at the time of reporting. The HCP was not comfortable in giving patient details and vaccine details was not available. The reporter did not consent to follow up.
Pt began to feel dizzy and anxious after receiving the vaccine. No swelling, rash, or difficulty breathing. Improved during ED observation