chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got shingles; Pain was not too bad; I had the first shot; Really miserable; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 5 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got shingles), pain (Verbatim: Pain was not too bad), feeling miserable (Verbatim: Really miserable) and incomplete course of vaccination (Verbatim: I had the first shot). The outcome of the shingles, pain and incomplete course of vaccination were not reported and the outcome of the feeling miserable was recovered/resolved (duration 2 weeks).   It was not reported if the reporter considered the shingles, pain and feeling miserable to be related to Shingles vaccine.     It was not reported if the company considered the shingles, pain and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she was too patsy. The patient stated that he/she received first dose of Shingles vaccine and  got shingles after five years  The patient stated that his/her after pain was not too bad so he/she was lucky. For two weeks the patient was really miserable. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
pt recv vax & pt exp low grade temp & vesicular rash that was painful away from the inj site;
5-6 hours later, rash started going down (R) arm. Achy joints. Rash on torso and neck started night of 4-8-15. Itchy, nausea, fatigue.
Since I have had my second dose. I have a lost of taste. When I eat the after taste is metal. When I drink something the after taste is metal. If I put moisturizer on my lips. They get a weird  filling. Like when you go to the dentist and the give you a shot of lidocaine. Then my lips start to itch. I thought the problem would go away. It is getting worse.  I am at the point. I hate to eat and drink. The aftertaste is awful.
PT felt dizzy/light headed. Pt was taken to EMS room to lay down. water and ice pack was provided.
Fatigue, Head ache, loss of appetite, back pain, some muscle pain in the upper back and arms. Took an Ibuprofen, which appears to be dulling the pain.
received an extra dose of ACTHIB with PENTACEL with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case via health professional. GMI number: 01228386  This case involves a 2-month-old male patient received an extra dose of HIB (PRP/T) VACCINE [ACT-HIB] with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunization; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization.  On 02-Aug-2022, the patient received 1st dose of suspect ACT-HIB vaccine at dose 0.5 ml once (lot UJ645AAA) via unknown route in the right thigh and received 1st dose of suspect Pentacel Vaccine at dose 0.5ml once (lot UJ673AAA) via unknown route in the left thigh both for prophylactic vaccination with no reported adverse event (extra dose administered) latency same day.  It was reported that "health care professional (HCP) called to report that a patient received an extra dose of ACTHIB. Caller states that a 2-month-old patient received PENTACEL and ACHIB at the same visit. Caller would like to know what the new dosing schedule for the patient would be. Caller reported that the patient has not shown any signs of an adverse event from the two doses of Hib received."    Action taken: Not applicable.  At time of reporting, the outcome was Unknown.   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 the guidelines. 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.
57 yof c/o SOB, throat tightness, R arm injection site itchiness/redness s/p Moderna # 2   Pt waited in observation area for 30 min d/t severe allergic reaction ~ 2 yrs ago d/t unknown med name + drinking ETOH Pt states she felt fine leaving observation area after 30 min Went to 2nd floor of clinic to schedule dtr's appt Came back down and started feeling SOB, throat tightness, R arm injection site itchiness/redness
Tinnitus, hearing loss in left ear since two days after receiving COVID vaccine in left arm. Symptoms began on 6/3/21 and I am still experiencing symptoms today, 6/9/21.
Influenza like symptoms, back pain 2/7/21, HTN 2/10 Narrative:
had episode 23FEB95 in afternoon-cold blue hands & feet, blinking eyes not quite himself lasting 2 mins (approx); no deviation of eyes, jerking arms or legs & no blue lips; also temp;
Following morning after immunization, complained of sore throat, feeling hot with sweating (did not take temperature), swollen glands in neck, mild productive cough-positive for blood tingles mucus (pinkish).  Denies headache, nausea or vomiting, myalgias or muscle weakness.  Three days after injection developed raised, pruritic "hive-like" rash that stared on right lower abdomen (at belt level) that spread across abdomen lower left up to include left upper quadrant with several spots on his right inner thigh and both feet.  He also complained of itchy painful lesion in his mouth.
Pt vax on 02Jul91;  16Jul91 titer for antibody was drawn and was neg.
pt in her home with hospice care; per death certificate, pt died in the home with cause of death being Complications of COVID 19 Pneumonia; pt with terminal dx of respiratory failure; COVID related pneumonia; DNR; on O2 in the home
Dizziness, nausea and vomiting, 10-15 minutes, post vax. Went to ER at 01:00 with temperature of 102F, shortness of breath and stayed until 07:00 Saturday on 10/28/00. Reports not knowing she is allergic to eggs, until now.
4/4/16 Patient received PREVNAR-13 vaccine. 4/6/16 Patient called and complained of headache and stomach cramps. 4/7/16 Patient went to MD.
had cold sores; This is a spontaneous report from a contactable nurse reporting different events under the same suspect product for 5 patients. This is one of 5 reports (2nd of the 2 additional reports). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as unknown, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient had cold sores after getting the COVID-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541866 Same reporter/ drug, different patients/ events
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter. It was reported that breakdown of doses is as follows- 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.
Pain in shoulders; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and ARTHRALGIA (Pain in shoulders) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In January 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ARTHRALGIA (Pain in shoulders). In 2021, HEADACHE (Headache) had resolved. At the time of the report, ARTHRALGIA (Pain in shoulders) had resolved.            Concomitant products were not provided. Treatment medication were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Child developed fever 102 degrees had febrile seizure 5 am 1-20-10.
Vomiting  on days 3 and 6 post injection 2/3 2/6 Diarrhea on day 3 post injection 2/3
One day post second vax, this pt experienced a red, painful, swollen arm (all the way to the elbow). ON an unspecified date the pt recovered.
Vaccinated with FLUZONE PFS 0.5ml at 8:10am. 8:20am rash around neck approx 4 inches wide occurred. Faint rash 2" medially from injection site but no injection site reaction. Pt. had Band Aid (latex free), slight rash under adhesive portion of Band Aid. Gave BENADRYL capsule 25mg at 8:25am. Monitored until 8:40 am. Pt. conversing with others in room. Went back to teaching at 8:40. Re-checked at 9:35am rash fading. Stated she felt better.
@ approx 915AM pt fell to floor p/having immun had grand mal sz x 2; pt remained consciousness & was taken to local ER by ambulance;
tested positive, she had no symptoms for COVID; tested positive, she had no symptoms for COVID; This is a spontaneous report from a contactable nurse, reporting for herself. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiry date: 30Apr2021), via an unspecified route of administration at the left deltoid on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient tested positive, she had no symptoms for COVID on 22Jan2021. The patient got the first dose of the COVID vaccine on 06Jan2021, and tested positive, she had no symptoms for COVID, but tested positive on 22Jan2021. She tested negative on 24Jan2021and again 28Jan2021, both negative. And she was due on 27Jan2021 for the next dose, but was told she had to wait 10 days, then 3 months, she doesn't know what to do, which was why was she calling. She wants the second vaccine, she was just not sure what the answer was. She didn't feel sick, she was ok, it was serious that she tested positive, yes, but she was ok. She added there were two doses in the vial, and she watched the nurse drew hers up. Added she was asymptomatic. The patient was tested due to presurgical testing, she was supposed to get her gallbladder out, and surgery needed to be canceled. She was asking if after testing positive, can she get the second dose and when can she get it. The outcome of the events was unknown.; Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
On 8/2/06, she was given the Menactra MCV4 vaccine during her physical. Around 3:35 PM, the vaccine was given in her right arm. About 3 minutes after the shot she said she felt dizzy and sick as we were walking to check out. We had continued to the car and she then said she was feeling numb. I told her we would get a bite to eat and she would feel better. My thinking was she was just shaken up from getting the shot in the first place. I drove about 1/2 mile down the road from the doctors office and she said "Mom I don't feel good" and I saw her hands shake and suddenly she stiffened up in the passenger seat and her head went back, eyes rolled back in her head, and her mouth opened. She had a purple/bluish tint to her skin. I turned the car around to go back to the doctors for help as I shook her arm yelling wake up, please breathe. She did not respond. I pulled into the doctors parking lot and she "came to" and said "Mom what happened to me" and she started crying. We hurried into the office and I told them what happened and the doctor gave her juice and crackers and to wait and see how she did. The doctor said that some teenagers do pass out and said she would be fine. About 10 minutes later we left. I was advised by several people (one of whom is a doctor) to have her be seen. And of her friends who are also entering high school and have received the Meningitis vaccine they had no such reaction.
no smell; headache; cough; no taste; congestion; I tested positive for corvid 19 and have mild symptoms congestion, headache, cough, no taste or smell.; 1st dose taken on 05Feb2021 and the 2nd dose was taken on 15Jun2021; 1st dose taken on 05Feb2021 and the 2nd dose was taken on 15Jun2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm right on 15Jun2021 13:00 (age at vaccination was 38-year-old) and dose 1 (Lot Number: EL3247 and Expiry date was not reported) via an unspecified route of administration in arm right on 05Feb2021 13:00 as a single dose for covid-19 immunisation. Medical history included drug hypersensitivity (Sulfur base drugs) from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient tested for COVID-19. Concomitant medications received within 2 weeks of vaccination included birth control pills, OTC, cetirizine hydrochloride (WAL ZYR) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Jul2021 at 03:00 tested positive for corvid 19 and have mild symptoms congestion, headache, cough, no taste or smell. Due to the events patient visit Doctor or other healthcare professional office/clinic visit. Treatment received for the events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test post vaccination: negative on 19May2021, negative on 25Jun2021, positive on 15Jul2021 by using nasal swab and covid test name was SARS-CoV-2 (APTIMA). The outcome of the events was unknown.
Nausea; vomiting; headache; joint psin; dose number: 3; dose number: 3; This is a spontaneous report from a contactable consumer or other non-health care professional (patient, reported himself). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FE3590), via an unspecified route of administration in Left arm on 03Oct2021 12:00 (at the age of 70-year-old)as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included Panhypopituitayanism from an unknown date and unknown if ongoing. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number En6201), via an unspecified route of administration in Left arm on 02Feb2021 01:00 PM (at the age of 65-year-old) as DOSE 1, SINGLE and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number En6208), via an unspecified route of administration in Left arm on unspecified date in Mar2021 12:00 PM (at the age of 65-year-old)as DOSE 2, SINGLE for covid-19 immunization. Patient had not received any other vaccine in four weeks and not received any other medications in two weeks. Patient had no known allergies. Patient not had covid prior vaccination and patient not had undergone covid tested post vaccination. The concomitant medication was not reported. On 04Oct2021, the patient experienced Nausea, vomiting, headache, joint pain. Patient had not received any treatment for the events reported. The outcome of the events was recovering and outcome of event dose number: 3 was unknown.  Follow-up attempts were completed. No further information was expected.
Moderna vaccine, lot # 048C21A was received at 5731 on 7/16/2021 and placed under refrigerated temperature. 3 vials were transferred to store where 20 doses were administered beyond use date.
Information has been received from medical records and a health professional concerning a 4 week old female infant with small heart murmur and varicella disease.  The infant's father used tobacco outside not at home.  On 23-OCT-2007 the infant was vaccinated with RECOMBIVAX HB.  Concomitant therapy included PREVNAR, PEDIARIX.  On 23-NOV-2007 patient was seen in the doctor's office for check ups.  The patient had diaper rash and upper respiratory tract infection (URI).  Mother used cod liver oil + DESITIN ointment for rash and it made it worse.  She was prescribed BACTROBAN ointment 30 grams to apply to rash four times a day.  The baby also had mild cough for last three to four days and her skin was dry. Nasal saline gtts with bulb syringe PRN was prescribed for URI.  Patient was to get follow up when she will be two months old.  On 26-DEC-2007 the infant came to doctor's office for check up and she had thrush.  She was prescribed NYSTATINS "BID".  The baby came for her three month check up on 17-JAN-2008.  She had URI and conjunctivitis.  She was treated with CILOXAN two gtts each eye TID for seven days.  Nasal saline gtts with bulb syringe was prescribed for URI.  She was also prescribed RONDEC DMD "30 ml" 0.25 ml PO Q 6 hours PRN.  She was to follow up as needed.  The patient's outcome was unknown.  Additional information has been requested.
CoughWheeze SOB, cough Narrative: Cough, SOB. Pt tested positive for covid on 1/4/21
p/ pt recv vax in 1997 in 1998 was exposed to varicella & who devel hives w/cefaclor (ceclor) pt broke out w/approx 15-20 pox over his face. pt sought m.d. attention
Information has been received from a licensed practical nurse concerning a 12 month old male patient with no pertinent medical attention or drug reactions who on 21-DEC-2009 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 into his thigh instead of PREVNAR. Concomitant therapy included the first dose of MMR II, the first dose of VARIVAX (Merck) and the fourth dose of ACTHIB (manufacturer: Sanofi). The nurse stated that this was a staff error only. No adverse effects were reported. No laboratory studies were performed. The patient sought unspecified medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Patient received Pfizer COVID vaccine on 3/25/21 and 4/15/21. On 9/8/21, patient admitted to our facility for COVID-19 pneumonia with acute shortness of breath.  Patient was discharged to home on 9/9/21.
About an hour after receiving the vaccine, I felt very tired and winded as if I was working out for hours on no food. I did eat that day. I felt dizzy and saw black dots in my vision and felt the need to sit down. I never made it to sit, rather fell flat on my face and passed out for a few moments before my cousin came and picked me up asking what happened. It was very embarrassing and I believe the fall on my face caused an infection in my jawline on the left side and a sinus infection. I was throwing up and blowing my nose from blood. Very scary sight to see.
Dad noticed that pts Right lower extremity was swollen especially around knee and upper thigh.  Pt denied pain.
Myalgia, Arthralgia, LLE PAIN LIKE SCIATA Narrative:  1ST DAY GENERALIZED MUSCLE STIFFNESS LASTING 4 HOURS. BEGINNING DAY 5 POST INJECTION LLE PAIN LIKE SCIATA LASTING 4 DAYS
Booster; Pneumonia worsened; This is a solicited report received from contactable reporter for a sponsored program. Other Case identifier(s): 21K-163-4191816-00.  Solicited report from the USA by a consumer of a 74-year-old elderly male with an event of fatal PNEUMONIA WORSENED with HUMIRA 40MG/0.4ML (ADALIMUMAB). There was no reported medical history. On an unknown date (2021), the patient experienced PNEUMONIA WORSENED. In 2021, the patient died. The cause of death was reported as PNEUMONIA WORSENED. It is unknown if an autopsy was performed. PFIZER BIONTECH COVID-19 VACCINE and COVID-19 VACCINE were also considered suspect. The patient died due to pneumonia. He did not take last scheduled dose due to failing health. He had taken Flu shot as well as COVID vaccines and booster. His pneumonia seemed to worsened as he took Humira. He was not taking any concomitant drugs. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. On 25Feb2021, he received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 25Mar2021, he received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 2021, he received COVID-19 booster shot.  Causality for HUMIRA 40MG/0.4ML: The reporter's causality for the event(s) of PNEUMONIA WORSENED with HUMIRA 40MG/0.4ML was a reasonable possibility.  RA opinion is that there is a reasonable possibility that the event of PNEUMONIA WORSENED is related to HUMIRA 40MG/0.4ML. Causality for Pfizer Biontech Covid-19 Vaccine with pneumonia aggravated (Pneumonia) was possible as per reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events immunization and pneumonia 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.; Reported Cause(s) of Death: Pneumonia worsened