chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 years old received the Moderna COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Patient initials, action taken updated
Fine blanchable papular rash over cheek/trunk/extremities upward the day after vaccination. No fever, no itchy. No history of allergic reaction.
The pt was seen on 2/14/01 had experienced symptoms for several days. The pt experienced lesions localized, dermatome, possible super imposed staph infection also.
Pt came in with redness, swelling, and hot to the touch. Vaccine was given 10-07-08. Pt's redness extends around entire (R) arm.
pt was exposed to a friend who was vax w/varicella 1JUL95&15NOV95 pt exp chills,fatigue&nausea;21NOV95 pt devel 1st lesion w/enlarged lymph nodes;23NOV95 to 26NOV95 cont to devel new lesions&devel 1000 chicken pox type lesions;t103
Moderna Covid-19 monovalent booster administered after 9/2/22.  On 9/16/22 monovalent booster administered, no adverse reactions noted, informed pt and counseled on 10/25/22.
Information has been received from a physician concerning a 52 year old male with no drug allergies and a history of renal disorder, type ii diabetes mellitus and hypercholesterolaemia who in approximately July 2004, was vaccinated with a completed series of Recombivax HB (manufacturer unknown). Concomitant therapy included Glipizide, exetimibe (+) simvastatin (MSD), AVANDARYL, PHOSLO, BUMEX, LASIX, LOTREL, vitamins (unspecified), aspirin and iron (unspecified). Subsequently the patient's labs confirmed negative hepatitis b antibody titer on 09-JUN-2007. Unspecified medical attention was sought. No product quality complaint reported. Additional information has been requested.
sore arm after administration; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 08Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of Feb2021 caller received the second dose of the Covid vaccine yesterday and stated that he did not have a reaction with either dose of the vaccine. Caller rates a 1 out of 10 for a sore arm after administration. Caller asked what it means when he does not have a reaction or side effect to either dose. Caller asked what the point is in receiving the vaccine if you don't know the duration of protection, if it will protect everyone, and you still must follow CDC guidelines of a wearing a mask and social distancing. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
developed diffuse tender adenopathy, weakness and fevers.  Admitted with severe neutropenia - ANC 0.
(2) 12/9/11 Fat necrosis - some worsening will likely need plastic surgery in future. (1) Given at routine physical on 8/5/11. Mom brought patient in for 2 yr physical (19/9/11) and mentioned a "hole" and "misshapen " leg.
Information has been received from a registered nurse concerning a 12-month-old female birth triplet with no known allergies who on 03-Feb-2004 was vaccinated in the left leg with a dose of varicella virus vaccine live (lot #644789/0329N). The nurse reported that on 03-Feb-2004, the patient experienced a local site reaction and developed hives at site immediately post vaccination. The patient was observed for 45 minutes and was treated with oral diphenhydramine hydrochloride (Benadryl). The reporter has requested a lot check. The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The nurse also reported that the patient's brother experienced a similar reaction after therapy with varicella virus vaccine live  (WAES #0402USA01433 and 0402USA01541). The nurse reported two other children who experienced a similar reaction after therapy with varicella virus vaccine live (WAES #0402USA01546 and 0402USA01547). It was noted that the triplets had the worse reaction. The nurse also reported two other children who experienced a similar reaction after therapy with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (WAES  #0402USA01554 and 0402USA01555).
Woke up on 10/27 at approx. 9 AM with severe dizziness, nausea, blurred vision, blacked out 2-3 times.  The events were short in duration lasting approximately 1 minute.  Went back to sleep for a few hours, woke up, no longer experiencing these adverse side effects.
flu like symptoms; fever; chills; tired; body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills, tiredness and general body pain. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, tiredness and general body pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, tiredness and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the salesman, reported that, after vaccination experienced influenza-like symptoms, fever, chills, tiredness and general body pain. The reporter planned for 2nd dose on a friday. This case linked with case US2020037903, reported by same reporter.
Pt given vaccines, left building with mom. Mom (a nurse) noted severe sneezing/cough. Brought back inside office. MD noted stridor, facial swelling. Epi pen 0.15 mg given 1045am BENADRYL, PRELONE given also. Cough resolved at 1105 AM. Stridor, sneezing again at 1130AM. Sent to ER via ambulance. Given PEPCID, PRELONE and BENADRYL in ER at 1240pm.
Minor blurred vision on the next morning and lasted about 6 hours then vision came back at late evening
4/17/23 I had lab work done that was already scheduled. I was called the next day to come in for an A1C test. The next day I was diagnosed as pre diabetic. I was told to see a nutritionist.
Patient felt that her arm was getting itchy that night.  In the morning when she took of her nightgown she saw that her arm was very swollen and red.  Patient placed a cold pack on the injection site and came to see a NP at the office.  The NP advised her to place hydrocortisone cream on the site and to call if it does not improve.  I talked to the patient on 10/1/15, the site is still red but improving.
I contracted COVID-19 on 05/30/2022 with symptoms of cough, congestion, chest tightness, sneezing, fatigue, and diarrhea. I was prescribed Paxlovid via phone visit with my doctor on 05/31/2022. The Paxlovid leaves a bad taste in my mouth, but I am already feeling better after taking it. My symptoms are beginning to resolve, but I have lingering symptoms of cough, and sneezing.
Patient contracted COVID after being fully vaccinated, no booster. Cough, fatigue, muscle aches, chills, headache
12 hours after injection I experienced chills for about an hour, then muscles aches and fatigue for the following 24 hours. 48 hours after the injection, my upper left arm became pink, tender, and slightly swollen; which lasted for about 48 hours.
exposed to chickenpox 14 days prior to onset of rash, fever, 8-9 papular vesicular lesions 4 torso, 1 face, 2 on back, 1 buttocks;no hx varicella titers;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or about late 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to  contract a persistent strain of herpes zoster. In late 2015, the patient developed a painful rash accompanied by persistent pain. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included ACTHIB (non-gsk); Sanofi; unknown; unknown given on 13 June 2012; PREVNAR 13 (non-gsk); Wyeth Labs; unknown; unknown given on 13 June 2012. On 13 June 2012 at 12:00 the subject received a dose of KINRIX (.5 ml, unknown route, right thigh) and experienced inappropriate age at vaccine administration and vaccine administered at inappropriate site. The subject was younger than the indicated age for KINRIX and the preferred site for administration is in the deltoid. KINRIX is indicated to be used for the fifth dose in the DTaP series and the fourth dose in the IPV series. The healthcare professional reported a second case with KINRIX. See case A0982926A for details. Follow-up information was received on 16 August 2012 via consumer. Concurrent medical history included low weight and length, the subject is in the 3rd percentile. The consumer reported, his son, the subject, received the KINRIX vaccine on 13 June 2012 at 10:00 (previously reported 12:00). The subject "should not have received it until he was 4-years-old (at time of vaccination he was 4-months-old). The reporter "felt his son's growth had slowed after receiving the vaccine according to the growth chart" [decreased growth rate]. The outcome of decreased growth rate was unspecified. Follow-up information was received on 05 October 2012 via physician. The physician attributed the events to the subject's height and weight percentile prior to receipt of KINRIX was at 77 percent at four days, 2.68 percent at 15 days, 3.79 percent at 2 months, 8.14 percent at 4 months, 3.83 percent at 6 months. The subject has been on the lower side of growth chart since birth. The physician reported the immunization series with KINRIX was discontinued and they have continued with PENTACEL.
Red "dots" on the front and back of her torso; Red "dots" on the front and back of her torso/ red, blistered "dots" on back and front of torso; Back pain; Tender rash; This case was reported by a physician via call center representative and described the occurrence of back pain in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date unknown) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. On 8th March 2020, 2 days after receiving Shingrix, the patient experienced back pain and painful rash. On 11th March 2020, the patient experienced red rash and blistery rash. On an unknown date, the outcome of the back pain, painful rash, red rash and blistery rash were recovering/resolving.   It was unknown if the reporter considered the back pain, painful rash, red rash and blistery rash to be related to Shingrix.  Additional details were reported as follows: The patient receive 1st dose of vaccine and experienced back pain and a tender rash for which she sought medical care. The patient also developed red, blistered dots on back and front of torso. The reporter consented to follow up. This case has been linked with US2020045154, reported by same reporter.
Pt presented to UC for facial swelling and throat closing sensation. Pt received Johnson and Johnson covid vaccine 4/9 and reports facial swelling, throat closing sensation, and throat pain immediately following vaccination; states she was transported to ER following that vaccine and treated with prednisone. Patient states she was doing well, but began to experience for facial swelling and throat closing sensation again today. Patient treated with 0.3mg epinephrine and 50mg Benadryl IM. Transported to hospital via EMS.
Tinnitus in both ears starting about 9:00 am. Intermittent  Fatigue starting about 5:00 am through 12:30 pm.
This case was reported by a other health professional via sales rep and described the occurrence of anaphylactic reaction in a adult female patient who received FLUARIX TETRA. On 16th September 2016, the patient received FLUARIX TETRA (intramuscular). On 16th September 2016, less than a day after receiving FLUARIX TETRA, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). The patient was treated with BENADRYL and SOLUMEDROL. On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. The reporter considered the anaphylactic reaction to be related to FLUARIX TETRA. Additional details were provided as follows: The sales representative reported on behalf of a health care professional. The age at vaccination was not reported. The patient received FLUARIX TETRA on the unknown arm. The patient was nurse therefore self monitored. The other health care professional had lot number if needed. This was 1 of the 3 cases reported by the same reporter.
Pt recvd vax & hrs p/vax had anaphylactic react by history; reporter indicated react was not witnessed @ facility; was seen by MD, treated w/Epi;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-NOV-2015 23:08, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.1 (2 hours 58 mins) and 2.3 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Submandibular lymph node swelling; Pain/swelling at injection site; Pain/swelling at injection site; Patient administerd dose 2 on 10-Apr-2021 and dose 3 on 31-Aug-2021; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Submandibular lymph node swelling), VACCINATION SITE PAIN (Pain/swelling at injection site), VACCINATION SITE SWELLING (Pain/swelling at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administerd dose 2 on 10-Apr-2021 and dose 3 on 31-Aug-2021) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 039A21A and 029A21A) for COVID-19 prophylaxis.     Patient did not had any known allergies.  Patient was never been diagnosed with or tested positive for COVID-19.  Patient did not had any acute illness at the time of vaccination and up to one month before. Patient did not had any chronic or long-standing health conditions.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administerd dose 2 on 10-Apr-2021 and dose 3 on 31-Aug-2021). On an unknown date, the patient experienced LYMPHADENOPATHY (Submandibular lymph node swelling), VACCINATION SITE PAIN (Pain/swelling at injection site) and VACCINATION SITE SWELLING (Pain/swelling at injection site). At the time of the report, LYMPHADENOPATHY (Submandibular lymph node swelling), VACCINATION SITE PAIN (Pain/swelling at injection site), VACCINATION SITE SWELLING (Pain/swelling at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administerd dose 2 on 10-Apr-2021 and dose 3 on 31-Aug-2021) outcome was unknown.            Patient did not had any prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination or at the time of the adverse event.  It was reported that the patient experienced pain or swelling at injection site and submandibular lymph node swelling in past COVID-19 vaccinations.  No treatment information was reported.   This case was linked to MOD-2022-642860 (Patient Link).
Pt's mom stated sylmptoms of redness and swelling @ injection site of left deltoid on 4/29/09 in the morning.  Arm felt hot to the touch Dr. prescribed Orapred.
Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient presented to hospital with fever and chills starting on day of vaccination. During oncology clinic visit two days prior to vaccination patient was jaundiced and fatigued. Patient admitted to hospital, diagnosed with autoimmune hemolytic anemia, received transfusions, steroids, folic acid, and iron. Fever and chills resolved, patient improved, and patient discharged medically stable.
Pt. was given flu vaccine at 2:30p on Thur. At 12:10a, pt woke with uncontrolled shivering, grunting, and SpO2 levels were in 60's, pt was transported via ambulance to local hosp and was admitted to PICU for monitoring. (Given TYLENOL over course). On Thursday October 23rd 2014 at 2:30 pm, Patient was given the flu vaccine at local Drs. Office. Vaccine was given in Left thigh with no immediate reaction. Patient proceeded as normal throughout the course of the afternoon and evening. Parents give TYLENOL prior to bedtime (6:50 pm) as a preventative for any fever. Patient was put to bed as normal at 7:30 pm with no complications. At 12:10 am, patient woke up grunting, and shivering out of control. Parents called to speak with Dr., however while waiting on the phone attached a Pulse oximeter and called Ambulance transport after Oxygen saturation readings were in the 60's (68) when they are normally in the mid-high 80s. Patient was taken to Hospital ER at approximately 1245am, and later admitted to the PICU under Intermediate Care Status for observation. Over the course of the next 12 hours patient was observed, and tested for flu, RSV, and other viruses or causes for illness. Patient was found to have a fever in between TYLENOL doses, but otherwise was acting normally. Patient was discharged from the hospital at 5pm on Friday October 24th 2014 with a conclusion of Flu Vaccine Reaction. No other adverse symptoms have been witnessed as of October 29th 2014 per parents. Patient has history of Hypoplastic Left Heart Syndrome with 15 surgeries including 2 Open Heart Surgeries has not been hospitalized since Early May of 2014. Patient had slight Upper respiratory complications after having a flu shot in the previous year (2013) however such reactions did not occur until more than 72 hours after the vaccine was given.
Fever, chills, nausea, general malaise, not eating in the past 48 hours, tachycardic, tachypneic.
Within 1 min itching at site and redness at site (Left deltoid). Within 5 min itching and redness developed over neck and chest and down arm. Within 9 min said "chest feels weird"-denies difficulty breathing. Gave 4cc BENADRYL orally 6 minutes after itching started. Gave 0.3cc EPINEPHRINE 1:1000 SC at 10 minutes after itching started.
Monitored pt as she was "worked up" about her husband who was being monitored as well post vaccine administration. vital at 0930, 175/88, 107, 16, 99% on RA. Pt refused any further treatment or monitoring and went home via ambulation w/ her husband at 0935
I believe that the shot caused me to develop a severe yeast infection.  I am not sexually and have not been sexually active for at least 22 years.  I never have yeast infections.  I purchased Monistat from the pharmacy.
Chills. fever, body aches, head ache, diarrhea, runny nose, sneezing  and red and sore arm.
Patient reported approximately 3 hours post vaccination that they experienced itching on top of their head. Approximately 6 hours post vaccination they reported the appearance of red bumps/hives on chest, upper arms, back, and ankle along with itching in these areas. Patient reported taking a Benadryl and noticed symptoms improved within 30 -45 minutes. The following morning patient reports itching occurred again but subsided after dose of Benadryl. Patient has spoken to two separate physicians about decision to receive second doses.
Pt. had a seizure and went to ER. No previous Hx of seizures.
Following the vaccination, individual ate lunch and then returned home. Later found deceased in chair in home ~8 hours after vaccine. No known symptoms. However no one was at home with individual for prolonged period of time during this time frame.
1 hour in a half later started sneezing and having a runny nose and flem in my chest and throat and now voice is completely gone if I speak I sound like I'm trying to bark. Constant slight fever up to 100.7. Sweating and feeling tired.
21 month old child who had only received his 2 month vaccines came to office on 7/23/12 to start to catch up on vaccines. Given 5 vaccines. 7 days later had febrile seizure.
Pt given vaccine by provider @1440. Pt to wait for 30 mins. After 20 mins (1500) Pt reported not feeling well. Pt given water and vitals checked. BP 110/60, HR:73, SPO2: 98%. zPt attempted to get up and move to exam room and then reported feeling like she was going to "pass out"/ Pt attempted to sit . About 30 seconds later pt was unconscious. Pts LOC lasted 30-60 seconds. Pt then seemed awake and reported she went to "dream land" and thinks she passed out. HR was med 70's, SPO2 99-100%. Pt moved to room by  LPN and physician. Pt seemed slightly out of it and state she felt weak , hot and dizzy. Pt reported having tingling in both arms and felt very tired. Pt laid on exam table and continued to monitor x 90 mins total. Vitals taken @1525 BP:108/62, HR:68, SPO2:100%. Pt continued to c/o tingling and numbness in all 4 extremities. Pt shaky and continued to look pale. Pt attempted to sit up and reported feeling lightheaded and weak. Pt contact husband to pick her up. Husband arrived and pt's vitals were continually WNL. Pt advised per physician to go to ER as she is unable to stand w/o feeling dizzy. Pt taken to ER via wheelchair by LPN and provider.