chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed Bells Palsy on the left side of my face almost 2 months to the day from my last Covid vaccine; having a severe ear ache in the left ear; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 14:30 (Batch/Lot Number: EK5730) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 week prior to the COVID vaccine. The patient received first dose of bnt162b2 on 18Dec2020 10:00 in right arm for COVID-19 immunization. On 26Feb2021, the patient started having a severe ear ache in the left ear. On 06Mar2021, he developed Bells Palsy (medically significant) on the left side of his face almost 2 months to the day from his last Covid vaccine. The Palsy has since totally resolved and his facial. The patient received treatment for the events: prednisone and anti viral medication for 7 days. The patient was not diagnosed with COVID19 prior to vaccination, and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered.   Follow up needed, further information was requested.
Pt received both vaccines and reports immediate swelling/pain of right arm; presented the next day with erythema to full upper arm, ttp, no fever,
Leg swelling, legs from the knee down swell up really bad; Hard of hearing; This is a spontaneous report from a contactable consumer or other non hcp.  A 71-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 (Age at vaccination 71 years old) (Batch/Lot Number: EW6199) as DOSE 1, SINGLE for covid-19 immunisation, warfarin (WARFARIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. Concomitant medication(s) included simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported.  Consumer sated, "she hard of hearing. Oh I had a reaction to both of the Pfizer shots, patient had her first on 25Mar2021 and the only thing that and she did not related to vaccination or the shot, she had leg swelling and it was about a week after she had the shot and both of her legs from the knee down swell up really bad and she just kind of passed it off with activity and all that and she went to her doctor and he put him on Lasix 40 mg on the 26th of April and went some blood work and it hasn't done anything (further clarification unknown) they are like, they look like logs. So, she have not got in touch with him but that started about a week after, she had nothing else, they are still swollen, there is no pain, they are just huge and like 'tree stuff'. Therapeutic measures were taken as a result of leg swelling, legs from the knee down swell up really bad (peripheral swelling). Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
2nd shot 7 months and 10 days after 1st; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 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 drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 9-JUN-2022 Reporter's Comments: The case was self reported by the patient via interactive digital media. The reporter wanted to know if he/she was protected after receiving 2nd Shingrix shot 7 months and 10 days after the 1st dose. Additional Supportive Information: The patient received 2nd Shingrix shot 7 months and 10 days after the 1st dose, which led to lengthening of vaccination schedule. Follow-up would not possible, as no contact details were available.
Alot of chest congestion, wheezing, fever, aches, stopped up nose, flushed. sore throat.
Extreme fatigue; Itchy eyes; Tingling in face; Tingly turned into burning; Face is red and itching and swollen.; Face is red and itching and swollen.; Face is red and itching and swollen.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the left arm on 01Apr2021 08:15 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included lupus, rheumatoid arthritis, obesity and cold urticaria. The patient was allergic to tramadol and imuran. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) 2.5 mg x 6, one weekly, folic acid (MANUFACTURER UNKNOWN) and multi (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. 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 01Apr2021 at 08:25, 10 minutes after injection, the patient experienced itchy eyes and tingling in face. Thought nothing of it since she could not see a rash. The patient experienced extreme fatigue 3 hours later and slept on and off. Tingly turned into burning and overnight face was red, itching and swollen. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure taken as a result of the events included antihistamines (MANUFACTURER UNKNOWN). The clinical outcome of the events itchy eyes and tingling in face, extreme fatigue, tingling turned into burning and overnight face was red, itching and swollen were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a doctor's nurse via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported). It was reported that the patient experienced injection site reactions after getting ZOSTAVAX. The patient had a red area, around the diameter of a tennis ball that started within 24 hours of the injection and lasted 10-12 days. He also experienced discomfort at the site that lasted about 3-5 days, and there was bruising that lasted for an unspecified length of time. The patient sought for unspecified medical attention. No treatment was given. On an unspecified date the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unknown patients of unknown age. On an multiple unknown dates, these patients were vaccinated with ROTATEQ (lot # M014318, Exp: 30-SEP-2017), orally. It was called because of Digital Data Logger. These vaccines were stored under 1.2 degree Celsius for one hour. There was no temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt had a high fever of 103.3 on 6/14/01 at 05:30. Pt given Motrin and fever 101.3. At MD office, temp was 102.4. Treatment is symptomatic care.
fever; achy; fatigued; felt like a very bad flu; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, pain, fatigue and influenza like illness. On an unknown date, the outcome of the fever, pain and fatigue were resolved with sequelae and the outcome of the influenza like illness was recovered/resolved.   It was unknown if the reporter considered the fever, pain, fatigue and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient stated that after receiving vaccine had a fever and was extremely achy and fatigued. The patient also felt like a very bad flu. The patient did not consent to follow up. This case has been linked with case US2019125909, reported by the same reporter.
History of Present Illness Patient office with tired dizziness and was positive Covid patient sent to ER because of mild tachypnea and dyspnea on exertion chest x-ray some left-sided pleural effusion with cardiomegaly patient admitted for further evaluation patient found to be Covid positive patient had been Covid positive before in the past 2 weeks ago  Subjective pt is afebrile today and on room air. Pt cleared for DC by pulmonary service. No other active co. ROS All other systems reviewed and negative except mentioned above. DISCHARGED ON 12/17/21
A non-serious spontaneous report of runny nose has been received from a consumer concerning a 41-month-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient's past medical history included asthma which was diagnosed in 2010. The patient had off and on wheezing problem. No relevant concomitant medications had been reported for this patient. The patient had not received asthma medication since May-2011. The patient received FLUMIST on 27-Sep-2011. The reporter stated that the patient's physician stated that the patient could get FLUMIST if he had not wheezed in the past six months. The patient developed a runny nose since receiving FLUMIST. The outcome of the event of runny nose was unknown.
Febrile Illness Discharge summary states irritable, stiff neck, rash. msv
Shortly after receiving the vaccination, patient complained of lightheadedness and nausea.  At 4:54 pm, VS: 98%-101 HR, 99% pulse ox.  Patient is pale in color and given emesis bag.  Encouraged to give some sips of water and granola bar.  After 10 minutes, BP: 132/84-HR 95- pulse ox 98%-99%.  She did complained that the first shot gave her a sore arm for 2 days.  She does take Zoloft and Xanax but not until the evening before bedtime.  She fully recovered and was able to walk out of clinic recovery after 30 minutes.
Vaccine given in error.  PCP ordered a Varicella vaccination and I administered a Zoster Vax.  Error identified on 1/22/2009.  Patient returned for PPD read on 7/30/2008.  Patient reported feeling "sluggish" and achy.  Temp recorded at 98.6.  No other symptoms reported.  Patient informed staff member she would call with any other symptoms.  Patient never called back.
FEVER OF 103.5 AND LEFT LEG SORENESS.  Motrin given for the fever and pain with the fever coming down.  Left leg remained sore.
1/31/23 started with headache, nausea, body aches 2/1 full body rash  took benadryl 2/1 rash still present will continue antihistamine treatment
Within thirty minutes post vaccination, participant complained of an itchy throat, shakiness, and difficulty swallowing. EMS on site continued to monitor participant and called for an ambulance to transfer to local hospital,
Shortness of breath and chest pain development 1 hour after shot.  Continued for 5 days afterwards.  Appeared to resolve then roughly two weeks after injection chest pain and shortness of breath returned along with cough.  Cough resolved. Shortness of breath and chest pain still prevalent one month after shot. Unable to engage in previous level of physical activity.
Violent vomiting. my son, now 18 months, has lost his ability to walk. This is detrimental to his health and life.
A 56-year-old male patient with a history of elevated cholesterol and a herniated disc received an intramuscular left deltoid injection of Fluzone (lot number U2524AA) on 22 October 2007. Approximately three hours post-vaccination, the patient began experiencing flu-like symptoms, including generalized body aches, nausea, and vomiting. The following day, he experienced a syncopal episode resulting in a fractured nose and chipped front tooth. He was seen in the emergency room, where he underwent an EKG, CBC, SMA7, C-spine, and Zocor, Lipitor, and Lopid. At the time of the report, the patient had not yet recovered.
2 second doses administered after exposure to room temperature greater than 24 hours; 2 second doses administered after exposure to room temperature greater than 24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 second doses administered after exposure to room temperature greater than 24 hours) and PRODUCT TEMPERATURE EXCURSION ISSUE (2 second doses administered after exposure to room temperature greater than 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 second doses administered after exposure to room temperature greater than 24 hours) and PRODUCT TEMPERATURE EXCURSION ISSUE (2 second doses administered after exposure to room temperature greater than 24 hours). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2 second doses administered after exposure to room temperature greater than 24 hours) and PRODUCT TEMPERATURE EXCURSION ISSUE (2 second doses administered after exposure to room temperature greater than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  Storage condition at the time of the excursion: refrigerated storage. Maximum temperature reached: 10 degrees Celsius. Excursion duration: 1 hour 20 minutes. Date vial(s) moved from freezer to refrigerator: 01-Oct-2021.   This case was linked to MOD-2021-374033, MOD-2021-373996, MOD-2021-374534, MOD-2021-373961, MOD-2021-374033 (Patient Link).
Immediately developed itchiness at site of varicella vaccine injection. No urticaria. Given 2.5 mg BENADRYL & ice pack.
Neural sensation/stinging inside left forearm,  intermittently for three (3) consecutive days, then it ended.
3-18-04, received call from Mom indicating infant was very fussy and temp. of 104 F was continuing.
Vaccine was given on 9/6/2015 at 5:10 PM and on 9/8/15 at/around 3PM she called and reported that she became sick with flu-like symptoms (nasal/chest congestion, cough, body aching, tiredness) she also went to hospital/ER.
memory issue; Got covid; Got covid; This is a spontaneous report from a non-contactable consumer. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN), 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 unspecified date, the patient was diagnosed with COVID and she just got out of hospital before day. The reason why the patient called was she was supposed to take the second dose next day. The patient was still under quarantine and her brother was supposed to get the shot. The patient cannot take him. The patient brother stayed with her cousin and he wanted to take the second shot. The patient was not underage but had some memory issues. The patients brother needed someone to be with him. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an 18 months old (age not reported) patient who was inadvertently injected with a dose of TYPHIM VI (Batch number, expiry date, dose, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error as the nurse inadvertently injected a 18 month old child with the TYPHIM VI. Laboratory test was not reported. It was not reported if the patient received a corrective treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Document held by sender: None.
Patient with seizure at home, no prior history of seizures, presented to ED, MRI done, patient found to have L transverse dural sinus thrombosis, underwent emergent thrombectomy, continues now on anticoagulation. Patient with no prior history of blood clots, no prior injury, surgery, travel, or other possible clot provoking factor aside from vaccination.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Mild, Systemic: Headache-Severe, Systemic: Lymph Node Swelling-Medium, Additional Details: patient experienced swelling mild swelling under right eye and more severe swelling on left side under eye, and left arm and left axillae felt like many hard marbles according to patient.
Caller reported she thinks he said 0.5mL but cannot verify that dose information at time of the call.; Urinary incontinence; This is a spontaneous report from a contactable pharmacist. This 61-year-old female contactable pharmacist(Patient) reported for herself that she received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL3302) at single dose for COVID-19 immunisation on 29Mar2021. Relevant history included Urinary incontinence. Relevant concomitant drug included estradiol (ESTRING) for Urinary incontinence, had been a few years already. The patient (pharmacist) said the dose of vaccine was 0.5mL but cannot verify that dose information at the reporting time. This patient stated the last few days the Estring had not been working; she did not know if they didn't put enough estrogen (1 count 2mg strength) in the ring or if the ring ran out of Estrogen, like at the end of the thing, or if the Estring not working was due to a defect. She clarified that the Estring has not been working because she has had 2 episodes of urinary incontinence, urinary incontinence outcome provided as worsened. First episode happened like 09Apr2021, and the second episode happened last night, 13Apr2021. These episodes were upsetting, annoying and embarrassing. This particular vaginal ring involved in this report was inserted intravaginally on 21Jan2021 and was still in place intravaginally. No change performed as of yet, but she was getting a new Estring today and is going to see if that one works. Because of Covid pandemic she had basically been home but she normally visited friends and may stay over and it would have been really embarrassing if she was staying over and had urinary incontinence episodes; she would probably have to wear a diaper if she stayed over which would be really embarrassing. The event was not considered as life-threatening.  The urinary incontinence outcome was not resolved (worsened). She was scheduled for her second dose of Pfizer-BioNTech COVID-19 Vaccine on 26Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Breakthrough case of COVID - positive test 06/01/2022. I traveled on 05/25/2022 and 05/27/2022 negative tests. I am currently out of the country and do not have access to medical attention. Had to reschedule with airline due to positive test. SX on set 05/31/2022 when I woke up in the middle of the night with a burning hot feeling on my chest, like a tingling sensation in my throat and a strong headache. Throughout the day on Tuesday, I had a heavy runny nose that was clear. I thought it was the change in weather. Then I started feeling feverish throughout the day. I had body aches and my joints started to bother me worse than usual. All of the symptoms continued to get worse. Tuesday, I started taking 800mg of ADVIL tablets that are prescribed. My headache went away. Wednesday I was pretty bad, and I was fatigued. I felt I had COVID at that point. I have stayed home since last Wednesday. I tested with a home on 06/02/2022 everything went from bad to worse. Right away the test showed up as positive. I continued taking ADVIL, Vitamin C a lot of water and fluids also drinking herbal tea. I have not had an appetite. On Friday I went to a pharmacy and the PCR test was confirmed positive and I bought some naproxen and I have been taking that ever since.
Seen next day 03/30/05, with a 2 inch diameter area of erythema, edema, warmth and itching on the left thigh at the immunization site. Patient treated with antihistamines, oral steroids and Motrin.