chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My eldest daughter received her first DPT as an infant and came down with whooping cough immediately; This case was reported by a consumer via interactive digital media and described the occurrence of whooping cough in a infant female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, immediately after receiving DTPa vaccine, the patient experienced whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the whooping cough was recovered/resolved.   It was unknown if the reporter considered the whooping cough to be related to DTPa vaccine.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received DPT and came down with whooping cough immediately following. It lasted about two and half month and was terrible. The patient's parent was afraid to continue the vaccination but did eventually.
Day after Menactra developed photo phobia. Went to eye doctor who said it was iritis. Inflammation of Iris in eye. Pt to come to office to be worked up for inflammatory process. Dr does not think iritis from Menactra.
Inconsolable crying beginning approx 12 hours after immunizations, increased temperature beginning approx 12 hours after immunizations, and vomiting beginning approx. 20 hours after immunizations.  This form was completed at 24 hours post vaccination.  Treatment with Tylenol and Benadryl.
After receiving HPV vaccine patient lost consciousness.  Patient recovered approximately 10 seconds later to consciousness and reported nausea.  Patient was assisted to lay supine on the floor and provided with a juice drink.  Ten minutes later patient was able to rise unassisted and sit in chair and then stand.
Felt like she had the flu; After the Booster dose the rash got much worse; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu), RASH (After the Booster dose the rash got much worse) and ARTHRALGIA (Joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee operation. Concurrent medical conditions included Drug allergy (Promethazine, Betadine and Lovenox), Psoriatic arthritis, May-Thurner syndrome, Burning mouth syndrome, Hypothyroidism, Migraine and Immunocompromised. Concomitant products included BUPROPION for Anxiety, CLONAZEPAM for Burning mouth syndrome, METFORMIN for Digestion impaired, ATORVASTATIN for Hyperlipidemia, TOPIRAMATE for Migraine, OMEPRAZOLE for Stomach discomfort, LEVOTHYROXINE for an unknown indication.    On 25-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), RASH (After the Booster dose the rash got much worse) and ARTHRALGIA (Joint pain). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she had the flu) and ARTHRALGIA (Joint pain) had resolved and RASH (After the Booster dose the rash got much worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: negative (Negative) Negative: They couldn't detect what it was..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient is 5' 7" tall. Concomitant medication included Policarpine 5mg 3/4 times a day for Dry Mouth.  Patient did not tested positive for Covid-19 and she did not receive any other vaccine within 1 month prior to Moderna Covid-19 vaccine. Vaccine gave her a rash since day 1 and never went away.   Patient's chronic illnesses did not improve or worsening after the vaccination. Her Dermatologist took a biopsy and in the results, they couldn't detect what it was. Patient did not experience a similar event on the past. Only the rash was ongoing. Patient reported that she was a swimmer and that she was embarrassed to go the pool to swim.   No treatment information were provided.   This case was linked to MOD-2022-503106, MOD-2022-503094, MOD-2022-503108 (Patient Link).
About four weeks after the third dose of the vaccine I had a day where my wrists, back and hands were painful. My fingers were also puffy and I could not get my ring on and off. My back was hurting and I could barely sit without pain.  Six weeks after the shot I was experiencing some soreness and instability in my ankle. I had not had pain in that ankle since I sprained it as a child. I could not walk without it trying to roll on me. I had to wear a brace on my ankle to keep it stable when I walked. When I got my Flu shot, I also had the same problem with my fingers being puffy for one day and it started about ten days after the shot. I did not have any problems after the third dose of the vaccine.
Pt had mild tactile temp; fatigue; mild headache symptoms; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 17Aug2021 15:54 (Lot number: EW0185) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild intermittent asthma" (ongoing), notes: Verbatim: Mild intermittent asthma. The patient took concomitant medications. Vaccination history included: Hpv 9 (Lot:T029522, Route: Intramuscular, Anatomical site: Left deltoid), administration date: 12Aug2021, when the patient was 12 years old. The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "Pt had mild tactile temp"; FATIGUE (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "fatigue"; HEADACHE (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "mild headache symptoms".  Additional information: Follow up call made after 24 patient had mild tactile temperature, fatigue, mild headache, Symptoms were not different from what he experienced after first dose.  No follow-up attempts are possible. No further information is expected.
Mom states that pt woke up from nap @ approx 11AM p/immun given that AM & was shaky & skin appeared purplish blotchy color & lips appeared same; Was shaking & crying was taken to MD for eval; No sz occurred; temp unk Mom had given APAP;
Heart failure; Diabetes; Psoriatic arthritis aggravated; Site of vaccination painful; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4327104-00 (AbbVie).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single and intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1158968) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (medically significant), outcome "not recovered", described as "Heart failure"; DIABETES MELLITUS (medically significant), outcome "not recovered", described as "Diabetes"; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic arthritis aggravated"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Site of vaccination painful". The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of heart failure, diabetes, Pfizer BioNTech COVID-19 vaccine caused sore arm, right before taking Humira injection got psoriatic arthritis flare up unknown onset and right before taking Humira injection got psoriatic arthritis flare up unknown onset was not provided. AbbVie's opinion is that the event of heart failure is not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of diabetes, Pfizer BioNTech COVID-19 vaccine caused sore arm, right before taking Humira injection got psoriatic arthritis flare up unknown onset and right before taking Humira injection got psoriatic arthritis flare up unknown onset are related to Humira (Adalimumab).  The reporter's assessment of the causal relationship of the (Heart failure , Diabetes , Site of vaccination painful , Psoriatic arthritis aggravated) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
This spontaneous report was received from a nurse referring to a female patient of unknown age. The medical history, concurrent condition and concomitant therapies was not provided. On an unknown date the patient received the first dose of VAQTA (lot#, expiration date, dose and route were not reported) and 3 months after she received second dose of VAQTA 50U/1.0ml, lot # R031045, expiration date 18-NOV-2019 (dose was not reported) intramuscularly both for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Four days before I tested positive for COVID-19 my wife had tested positive. I was having a sore throat but because she was positive, I took a test, and it was positive. I then had a runny nose, a temperature of 99, and just had bad cold symptoms. After about three days in my primary care doctor and my cardiologist wanted me to take Paxlovid, the bad taste was horrible, but I was having horrible anxiety and an uneasiness taking it. About the second day I was having tooth aches and throbbing like sinus issues on the right side of my face. At that point I went to a walk-in clinic, and they gave me ten days of a Doxycycline but after four days of that it did nothing. I was now having that fogginess that comes with COVID. I ended up at my PCP and also at my dentist to see if I really had something going on with my tooth and that was causing my major pain, but they found nothing at the dentist and figured it had to sinus related. Soon after that the sinus pain moved from my right side of my face and to my forehead area and it was present in both places.  On day seven I was told to stop the Doxycycline and put onto Cefuroxime. This new medication eliminated the right side of my face pain, but it remained in the forehead area. I have this horrible fowl smelling slightly metallic smell and taste in my nose and mouth.  I now only have mild cold symptoms but have tested negative for COVID but I am taking Tylenol every day to feel better.
Within 24hr after receiving the 2nd dose, I developed chest tightness and mild chest pain. I experienced shortness of breath. I was able to continue with normal daily activities but the symptoms were very noticeable and persistent. Rest did not make the symptoms go away.
SEVERE MUSCLE CRAMPING AND PAIN THROUGHOUT BODY. PROLONGED FEVER OF 102.9 DEGREES. SEVERE CHILLS AND BODY SHIVERS. EXTREME HEADACHE. ENLARGED AND PAINFUL LYMPH NODE ABOVE LEFT COLLARBONE
Pfizer-BioNTech COVID-19 Vaccine EUA Swollen lymph nodes, right armpit
Sore during the day of the vaccinations. Woke up the next morning to swelling in the upper right arm.
Parent and patient reported today (3/28/23) that for over a week post administration, the patient had weakness of the right upper extremity preventing her from being able to pick things up. They were unable to give an exact number of days this lasted. Patient stated the left arm hurt the first day and then the right arm began hurting and feeling weak. The day of administration, patient reports she had dizziness, 'nearly passed out at school,' and mild nausea. Mother stated she picked her up from school post PE after receiving the vaccinations and she did not look good. These findings were not reported to the office until today when asked if the patient had any reactions to the last dose. She reports being back to normal at this time.
Symptoms of Bells Palsy returned. This included facial droop and pain in L side of face. Is taking Prednisone for symptoms.
Exact same reaction to first vaccine (4/10/2021): Approximately 14 hours after receiving the vaccine shot (both shots in shoulder muscle) my heart rate spike to over 160 BPM, then stayed around 100 -130 BPM for approximately 8 hours. Resting heart rate then stayed over 80 BPM for the remainder of the following day (5/2/2021); please note there was zero physical activity, thus a true RHR. Fever spiked late evening on 5/2 (101.0); fever broke early AM on 5/3. After the fever broker, heart rate levels have gone down closer to normal range. The side effects were identical for both shots, lasting almost the exact amount of time.
Child was 16 years old when the first dose was offered. Reporting RN did not give the vaccine. A volunteer vaccinator gave the vaccine.  Child experienced no immediate adverse events after vaccination.
Grand Mal seizure while still in the store where the pharmacy is located she became unconscious, fell to floor and had a grand mal seizure which last a little less than a minute.
Afebrile with posterior upper left arm area of erythema and swelling approximately 4 x 6 cm. + Fluctuant. From at shoulder and elbow. Distally NVI.
After receiving the vaccine or states he began to feel faint. Pt and Pt?s mother state this happens when he has blood drawn. Pt was seated in a wheelchair and moved to the exam area. Pts vitals are stable. Pt states he is feeling better and would like to leave. Pt?s mother states she is comfortable with leaving. Pt did not require transport to hospital.
01/07/06 Presented to ED with right arm swelling and pain. Area was marked an patient was started on Keflex 250mg QID and discharged. Patient received two doses of Keflex and returned to ED 01/08/06 with increased swelling outside marking and warm to touch. No fever. Admitted and discharged 01/09/06. Patient then returned to ED 01/10/06 refusing to take antibiotics. During this admit vomited repeatedly. Admitted and discharged 01/10/06 on Augmentin and Benadryl.  MR received detailing 3 separate ER visits between 01/07/2006 and 01/10/2007. Visit 01/07/2006-For c/o Right arm erythema and tenderness. DX: Cellulitis  Treated with Keflex and discharged on PO Keflex. Visit 01/08/2006- For c/o worsening erythema with marginal markings greater than at previous visit.  Admitted for IV antibiotics and discharged next day on Benadryl and po abx. DX: Cellulitis Visit 01/10/2006-For c/o repeated vomiting and refusal to take po abx.  Admitted for IV abx. Erythema reported to be 80% improved. D/C home on po abx and Benadryl. DX: Cellulitis. Per 60 day follow up: Polio virus vaccine noted and confirmed as allergy in patient's information.
At the time of the administration of the vaccine I felt a strong pain that I can describe in the whole body, since that day I started to feel bad, severe pain in the arm with swelling, pain in the breast and neck ... the pain is very acute, it has been increasing, I have visited the emergency room, emergency and my primary doctor and even to this day I am still the same, I have had not had improvement
Information has been received from a physician concerning a 9-year-old female with a history of chickenpox "when she was very young" who "sometime after that infection" was vaccinated with a dose of varicella virus vaccine live. On approximately 22-Oct-2003 the patient was seen in office and diagnosed with a rash caused by shingles. At that time, the shingles "was almost healed". PCR analysis was offered but declined because the doctor "did not believe a specimen was currently available". Unspecified medical attention was sought. There was no product quality complaint. The outcome was reported as recovered. Additional information has been requested.
I experienced severe soreness near the injection site. It lasted approximately three days. During the first 48 hours, I experienced tingling/numbness in my right hand (my injection was in my right arm) which felt similar to when your hand falls asleep. To help with this, I stretched my arms to get my blood circulating.
DAP injection given on the right arm approx given on January 2nd. The area became swollen, red and hard. Approx. 2 weeks later, the area was still swollen, red and began to itch. The itching lasted approx. 7 days. It is now 2/4/08 and there is still a pea-sized knot there which tends to be painful if touched.
pt recvd vax & 3 hrs later devel fever, also vaginal infect; 2 episodes of hypoglycemia & gross lethargy; pt seen by MD ;
Reporter attended American College of Gastroenterology convention 12-15OCT91 & mentioned that pts exp non-response w/Engerix-B;
14:00  PT C/O HEADACHE  ACROSS FOREHEAD AND SOME DIZZINESS. PT STATES HE DID NOT EAT THIS MORNING. PT GIVEN 1 PACK OF PEANUT BUTTER CRACKERS TO EAT. BP  114/76 HR 82 SpO2  96% 14:25 PM BP 148/77 HR 85 SpO2 96% PT STATES THAT HIS HEADACHE IS BETTER AND HE IS NOT DIZZY ANYMORE. DENIES CP AND SOB. D/C HOME WITH WIFE .
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Nov-2021 at 3:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 68.13. Concomitant products were not provided. On 27-Oct-2021, Excursion time was 09 AM, temperature was 29, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021, vial was moved to clinic on 27-Oct-2021. 2 vials were sent to clinic. Vaccine BUD date was 04-Nov-2021. On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 36, 9 AM: 36, 10 AM: 36, 11 PM: 35, 12 PM: 36, 1 PM: 37, 2 PM: 36, 3 PM: 36 and 4 PM: 37. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Child received a single vaccine, influenza 0.5 cc at 3:30 p.m. Parent and provider 10 minutes later notice non itchy urticaria, raised clear rash surrounded by erythema on neck and cheeks. Over 10 minutes this faded and progressed to forearms, upper chest and back. No wheezing. All bumps resolved by the time they reached home 15 to 20 minutes later.
Pain in arm increased until 17 May with difficult movement pain resolved 19 May. No fever, warmth, erythema.
area is swollen; area is red; itchiness in injection site; soreness; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itchiness in injection site), VACCINATION SITE PAIN (soreness), VACCINATION SITE SWELLING (area is swollen) and VACCINATION SITE ERYTHEMA (area is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C2SJ20-2A or 02SJ20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (soreness). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness in injection site). On 07-Jan-2021, the patient experienced VACCINATION SITE SWELLING (area is swollen) and VACCINATION SITE ERYTHEMA (area is red). On 01-Jan-2021, VACCINATION SITE PAIN (soreness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchiness in injection site), VACCINATION SITE SWELLING (area is swollen) and VACCINATION SITE ERYTHEMA (area is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Vaccination site pruritus, vaccination site pain, vaccination site erythema, and vaccination site swelling are consistent with the known safety profile of the vaccine.; Reporter's Comments: Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Vaccination site pruritus, vaccination site pain, vaccination site erythema, and vaccination site swelling are consistent with the known safety profile of the vaccine.
Developed moderate nausea, vomiting, diarrhea, chills and joint pain.
Information has been received from a health professional concerning an 8 yr old white male with no past medical history and no known drug allergies who on 07May02 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot 640821/1438L). There was no illness at the time of vaccination. On 03Jun04 the pt's mother noticed some small vesicles on red base on arms/legs. Subsequently, the pt was seen in the doctor's office and was diagnosed with chicken pox. The pt was treated symptomatically and recovered without complication. Follow up information indicated that on 03Jun04, the pt came home from school with about 5 vesicle like spots on his torso with a red base. He was seen in the office and chickenpox was diagnosed. The pt recovered without complications on 13Jun04. It was noted that the pt's vaccinated sister had developed chicken pox the day before (WAES0406USA02003). No further information is expected.