chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 05/07/1990 patient went to the Doctor and had a physical, which the doctor said he was in good health and doing well for his age and he also received 2 vaccinations MMR and DPT. He was congested and had a fever after receiving his shots. I gave him infant Tylenol during the day and before I put him to sleep. At 7am approximately 12 hours later I found patient in his bed not breathing and without a pulse. I performed CPR but patient died. The coroner determined that the cause of death was SIDS.
Bilat, transient, itchy rash on hands, thighs & shoulders. Only lasted < 24 hours.
Information has been received from a healthcare worker concerning a 22 year old female with no pertinent medical history and no allergies who no 12-AUG-2008 was vaccinated with the first dose of GARDASIL (lot # 0152X). There was no concomitant medication. On 12-AUG-2008 the patient experienced itching in 4 hours of receiving the first dose. The patient took BENADRYL, but it did not help the itching. On 14-AUG-2008 the patient called office. On an unspecified date the patient recovered from itching. Additional information has been requested.
Arm became edematous and erythematous. It is pruritic, painful. Symptoms worsened over time.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 21st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. In August 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on and experienced soreness in the arm which lasted for about a week. The reporter did not consent to follow-up. This case is 1 of 3 cases reported.
1 hour after vaccination, developed hives around injection site with itching. Site red, hard, warm, swollen. Induration 2 in x 1 in 1/2 hour later developed generalized itching lasting 24 to 48 hours. Took Zyrtec for 4 days. 3 days less swelling. Still hard, slightly red, slightly itchy.
Information was received on 15-OCT-2015 from a pharmacist reporting on a male patient (age and birth date not reported). On approximately 06-OCT-2015 or 07-OCT-2015 the patient received a dose of ZOSTAVAX (lot number, and dose not reported. ON 08-OCT-15 the pharmacist was at a flu clinic which the patient consulted her and told her he had developed "a few bumps around the injection site". The pharmacist recommended that he put some BENADRYL cream on the arm in case is experiencing an allergic reaction The patient was otherwise healthy and not in distress. The pharmacist did not know whether he was developing a rash and she believes that the patient may have received the dose of ZOSTAVAX intramuscularly rather than subcutaneously. The pharmacist had no other information on the patient at the time of the report as she works in another store and does not have access to the records. The outcome of the events is unknown. The reporter did not specify the relationship of the vaccine to the patient's events. Additional information has been requested.
Fever 103 on 4-4-07. Had vaccines x 3 on 4-3-07
MD called to say pt was seen in ER 12APR94 PM for hallucinations & high fever fo 105.5; 13APR94 today fever down to 102; given DT only from now on;
Redness, swelling, warmth, tenderness to right upper arm with redness extending down to approximately 1 inch above elbow and treated with Keflex for possible Cellulitis.
Nausea, Vomiting, Fever Chills Sore muscles and joints
pt recv vax 13NOV97 & devel papular rash localized over inj site on rt thigh;
Patient received vaccine via standard administration technique in left deltoid. Aftercare instructions [massage/lotion] and medication options were provided following the vaccination. Patient experienced localized discomfort at the injection site. She followed aftercare protocol but discomfort increased rather than diminishing. Patient attended primary care provider appointment. She received and proceeded to participate in physical therapy. The discomfort has lessened only to a minor degree. It poses a problem to function and activities of daily living.
H1N1 was recommended because I am a teacher and my partner had been exposed to the virus.  Exactly 1 week after the vaccine, I had an ultrasound that showed the baby to appear to be 9 weeks, as I was, but with no heartbeat.  I had a d&c the following day.
Nausea the evening of vaccination. Vomiting and diarrhea the following day. Also red arm with tenderness - 2 to 3" in diameter - almost all the way around the arm and lasted about 1 week.
Patient came in for vaccine and caretaker on 5/26 said it was their second dose and signed off on the forms when it was in fact their 3rd dose.  First dose was given on 2/10/2021.  Care taker did not disclose until after vaccine given that patient had received monoclonal anitbodies in January for Covid so vaccine should have been delayed 90 days.  Second dose was given after 90 day period from antibodies on 4/28/2021.  Caretaker insisted they wanted her to get another shot.  We declined until we saw guidance issued from US CDC or another organization.  Caretake instead came in as a walk-in and did not disclose the previous 2 doses, only 1.  Counseled on watching for additional adverse reactions.
Infant with ALTE event x2. First event, patient turned blue in lips and face for about 20 seconds. Later that day, mom drove infant to MDs for scheduled circumcision and when mom turned to take out of care he was blue and limp, he was rushed to clinic where stimulated and given blow by oxygen. Episode lasted about 4 min.
Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On 20-APR-2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed severe and painful itching on his face and within his eyes. Thereafter, he presented to a dermatologist and was diagnosed with shingles on his face and in both eyes. As a direct an proximate result of these malfunctions, 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, pain and suffering and other damages. Upon internal review, shingles in both eyes was determined to be medically significant. Additional information has been requested.
Vertigo - no treatment - 2 days  Shingles - no treatment -2 1/2 weeks  Cognitive compromise - 2-3 days
Yesterday Left upper arm redness at injection site (both Mother and daughter received shot same day-- same lot number different vials and had the same redness on their arms) However daughter had lip swelling (severe lip swelling-- took benadryl no epi's administered these are all 1-2 week post vaccine-- WE NEED TO KNOW SHOULD THESE PEOPLE GET THE SECOND SHOT???)
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 59 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
I had contracted COVID-19 on 12/08/2022 and I had a sore throat, chest congestion, nosy and eyes running, headache, fever, cough. The doctor did prescribe Paxlovid.
Pt felt weak and lethargic next day. Following days she felt tingling in left arm, very sore pain shooting up arm into shoulder area and face. Pt out of work and seeing Dr. They don't know if it's flu shot or pinched nerve (brachial neuritis).
This spontaneous report as received from a medical assistant regarding to a patient of unknown demographics. There was no information regarding concurrent conditions and historical medication. On an unknown date, the patient was vaccinated with ROTATEQ (dose strength, frequency and lot number was unknown) which was improperly stored. No concomitant medication was reported. No product quality complaint was not involved. No adverse effect was reported. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was hospitalized and diagnosed with COVID-19 on 4/14/21 after he received both doses of his Pfizer COVID-19 vaccines on 3/22/2021 and 4/12/2021
This spontaneous report was received from a physician regarding a 9 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 29-SEP-2016, the patient was vaccinated with PEDVAXHIB(reported as Hib) lot# reported as UI645AA with expiration date 21-JUL-2017 (dose, route and frequency were not reported) for prophylaxis when refrigerator was out of range (Incorrect product storage). Lot number UI645AA is an invalid lot number for PEDVAXHIB. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004566: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725.
CFS sxs started after AVA 1-3 while in foreign country and received the anthrax vaccine. Symptom: Restless sleep Symptom: Fatigue, Malaise >60 Days Symptom: Cognitive deficiency Symptom: Lymphadenopathy, anterior cervical chain Comment: with intermittent sore throats
Muscle aches, muscle weakness - hard time getting up/walking. Fatigue. Headaches. Shivering/chills. Facial swelling.
I am a healthy 50 year old male who competes in endurance events including 15 Ironman triathlons and many ultra endurance races.  I was diagnosed with acute Pericarditis 8 years ago, after 4 days in the hospital and a couple of weeks of rest at home all of my symptoms had subsided and I have had no reoccurrence of this condition since.  Approximately one week after receiving my second dose of the Covid 19 Moderna vaccine I began to experience chest pain.  8 days post vaccination the chest pain was radiating into my Left shoulder and arm, I had significant pain on breathing and was extremely uncomfortable lying on my back and could not lie on my left side due to pain.   I went to the ER  on the evening of May 6th, they performed a chest x-ray, 2 EKG's as well as 2 separate blood work panels.   While I did relate my history of having pericarditis and that this pain was very similar to what I had felt before, they, of course, were more concerned on if I was having a coronary event.  The EKG and blood work showed I was not so I was simply sent home with a "we don't know why your chest hurts but your are not having a heart attack."   After a follow up to a cardiologists almost 2 weeks later it was determined that it was more than likely a flare up of pericarditis but that it had subsided by that time.
Day 3-4 swollen and painful lymph nodes under arm; Day 3-4 swollen and painful lymph nodes under arm; Day 1-3 swollen and tender injection site.; Day 1-3 swollen and tender injection site.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 10:00 as dose 1, single (Lot number: FK9893) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 18Apr2022 at 22:00, outcome "not recovered" and all described as "Day 1-3 swollen and tender injection site."; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 21Apr2022 at 22:00, outcome "not recovered" and all described as "Day 3-4 swollen and painful lymph nodes under arm". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, lymphadenopathy, lymph node pain.  Additional information: Patient was not taken any other vaccine in four weeks, Day 1-3 swollen and tender injection site. Day 3-4 swollen and painful lymph nodes under arm. No COVID prior vaccination, Not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
fully vaccinated, had shingles/Suspected vaccination failure; Kidney infection; Shingles on back; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: fully vaccinated, had shingles/Suspected vaccination failure) (serious criteria GSK medically significant), kidney infection (Verbatim: Kidney infection) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on back) and pain (Verbatim: Painful).  The outcome of the vaccination failure was unknown and the outcome of the kidney infection, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, kidney infection, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, kidney infection, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported via interactive digital media. It was reported that patient had shingles, third time and was fully vaccinated.  They were painful and were present on patient's back this time. The patient had shingles right after kidney infection. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient states he was itching from shot. He then said he would take CLARITIN for it.-Followed up and he said itchiness "comes and goes" but its still there and he thinks from shot.
In Jun 2022 -Jul 2022 she got COVID/ She had rebound covid; In Jun 2022 -Jul 2022 she got COVID/ She had rebound covid; She received her Moderna series in Apr2020; In Dec 2021, she received the Pfizer COVID booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID:   A 42-year-old female patient received BNT162b2 (BNT162B2), on 26Dec2021 as dose 3 (booster), single (Lot number: FE3594, Expiration Date: Feb2022) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2020 as dose 1, single (Batch/Lot number: unknown) and in Apr2020 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pericarditis", start date: Sep2020 (unspecified if ongoing), notes: The pericarditis was in Sep2020, 5 months after moderna series. The doctor couldn't say if it was a direct result from the vaccine she received. There were no concomitant medications. Past drug history included: Sudafed, reaction(s): "allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Dec2021, outcome "unknown", described as "She received her Moderna series in Apr2020; In Dec 2021, she received the Pfizer COVID booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "In Jun 2022 -Jul 2022 she got COVID/ She had rebound covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: She was treated with Paxlovid. She had rebound covid from that; (2022) Positive, notes: In Jun2022 -Jul2022 she got COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course as follows: The patient got the initial series of Moderna. She got the COVID 19 booster by Pfizer. She received her Moderna series in Apr2020. In Dec2021, she received the Pfizer COVID booster (on 26Dec2021). She didn't have issues with that. Then, in Jun2022 - Jul2022 she got COVID. The doctor said that could be seen in a patient with COVID. She was treated with Paxlovid.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.,Linked Report(s) : PFIZER INC-202201222258 same patient, different suspect drug and event;
Severe headache 10/6/11, all over body itching 10/7/11 am, throat itching 10/7/11 am, facial swelling 10/7/11 pm.
Pt diagnosed with mile varicella 2/7/06 (was previously vaccinated).
Rt arm sore & knot came up, then area in armpit, down inner part of arm & below armpit became sore-very sore later the same night 5APR91; Also generalized fatigue & weakness, flu-like sx throughout weekend;
11/28/22, Chills approx. 9:00 pm 11/29/22, Approx. 2:00 am.   I woke up with headaches & tachycardia.  Heart Racing continued & I went to hospital for treatment.
Where the vaccine was shot is real red; real hard bump; Starting to itch; Swollen; hurting a little bit/ Sore; A spontaneous report was received from a 60 year old female consumer concerning herself who was participating in the mRNA-1273 Program and experienced where the vaccine was given red, sore, swollen and starting to itch and a real hard bump.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After the vaccine administration on 29 Dec 2020, patient experienced left arm pain/sorness. On 30 Dec 2020, patient experienced where the vaccine was given red, swollen and starting to itch and a real hard bump.  Treatment for the event included rubbing alcohol.   Action taken with mRNA-1273 in response to the events was not reported.   If it is known that the event occurred after the second dose of mRNA-1273, include:   The outcome of events, where the vaccine was given red, sore, swollen and starting to itch and a real hard bump, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Arm very sore, as if someone punched it very hard.  Very achy all over - legs ached really bad, very uncomfortable. Extremely tired
I got my vaccine in April. Since  August my periods became very unusual for me. Havier, longer and more painful. Nausea on the second day, feel like I am going to faint, cold fingers, tingling in the fingers, lack of breath. Lower abdomen pain.
I woke up the next morning with a very soar arm, a fever, chills and so achy.  The next day, the fever and chills were gone, but I felt worse.  Very weak, my legs felt as though they couldn't hold me up.  I was so exhausted.  I am still having issues.  I thought I was feeling better, I thought, but I am still experiencing  the issue with the weak legs, being so tired. I also feel light headed lately.  I did see my family doctor 2x and spoke with him on the phone a couple times.  He did blood work, all came back good.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The reporter stated that improperly stored doses of RECOMBIVAX HB were administered to an unspecified number of patients. Pertinent medical history and concomitant medications were unspecified by reported. No adverse effects reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Came to the ED for shortness of breath for the past 3 days; also claims was treated for anaphylaxis at other institution after receiving the vaccine (patient has schizoaffective disorder). Patient tested positive for COVID-19 on 3/20/21 and treated with remdesivir and convalescent plasma
Moderately severe tinnitus developed a few weeks after the shot. No prior bouts with tinnitus before shot. Tinnitus has not gone away after about a month.