chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case report received from a healthcare professional on 08 October 2010 under the reference number 10-0688. A 30-year-old male patient with no reported medical history had received an intradermal dose of DECAVAC (batch number unknown) in the arm (side unknown) instead of TUBERSOL on 06 October 2010. The patient had a concomitant treatment with LORCET prn for back pain. In October 2010 (exact date not reported), the patient presented with red, hot and hard area on arm, with slight itching. The patient required doctor visit. At the time of the report, the patient had not recovered. List of Documents held by sender: none.
pt recvd vax;cont crying,started around 12:30pm;unable comfort or quiet;fever 103.2;did not take the bottle;jerky mvts;to MD about 5:30pm;apap given,pt nl by noon on 20sep94;
My throat started to swell; Swallowing became difficult. I had to force myself hard to swallow; my voice started to get tight.; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: fa7485) via an unspecified route of administration in Arm Left on 29Jul2021 11:15 (age at vaccination: 54-years-old) as  single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, drug penicillin allergies , thyroid disorder. The patient previously took cefdinir and ciprofloxacin and experienced known allergy. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; hydrocodone bitartrate, paracetamol (NORCO) taken for an unspecified indication, start and stop date were not reported. On 29Jul2021 20:45, patient experienced my throat started to swell and swallowing became difficult. I had to force myself hard to swallow and my voice started to get tight. I took two Antihistamines and was getting ready to call EMT, but it started to loosen up after 15 min. The clinical outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
I tested positive for COVID-19. I felt achy and had a bad cough with it. My head would go from being congested to having a runny nose. I had no energy. It wasn't great. I'm still dealing with low energy. I couldn't get rid of the cough and it felt like it was in my lungs so I was given a steroid for 7 days. The doctor thought there was some wheezing. They did a chest x-ray. Overall besides the energy and occasional coughing, I seem to be over it. I do still have the low energy at this time.
Headache, extreme anxiety, elevated blood pressure and heart rate, palpitations. After 6 weeks pt was feeling better. Pt was in and out of the ED getting checked for vitals and palpitations.
Acute pericarditis, Chest Pain, Atrial fibrillation, Pericardial effusion, Pleural effusion.
Patient received flu injection on 9/15/2020 and mom states on 9/19/2020 patient woke up feeling dizzy and light headed, patient explains it as a "dream" and her mind feels "foggy", along with confusion.
Information has been received from a registered nurse, concerning a 21 year old female student with asthma, polycystic ovaries and migraines, who on 18-DEC-2006 was vaccinated IM in the gluteal area, with the second dose, 0.5ml, of Gardasil (Lot #654540/1161F). Concomitant therapy included Yasmin, Zomig, Imitrex tablets and albuterol inhaler. The nurse reported that the patient complained of pain at the injection site. At the time of this report, the nurse confirmed that the patient had recovered (date unspecified). The patient sought unspecified medical attention. Additional information has been requested.
Patient called me on 12/1/13 @ 4:30pm describing that she has had a possible adverse reaction from the Fluvirin Preservative Free vaccination she received on 11/17/13.  She describes the pain in the arm where she received the vaccination along the deltoid muscle where the shot was given.  She states that the pain was severe and she had trouble lifting her arm.  The pain has since subsided, but is not completely eliminated.
Breakthrough covid case during pregnancy. Received dose 1 & 2 of pfizer vaccine in March of 2021 in late first trimester/early 2nd trimester of pregnancy. Came down with covid 2 months later (25 weeks pregnant) from close contact with infected covid partner. Experienced moderate covid symptoms and visited ER for chest tightness & cough. Tested positive for COVID in the hospital.
For 36 hours after the vaccine she had a low grade fever and chills. She also had fatigue and body aches that lingered for several days. 10 days after the vaccine she had an episode of partial loss of consciousness that was later diagnosed as a seizure and she has had 2 subsequent seizures and has now been diagnosed with epilepsy.
Patient fainted while sitting in chair immediately after receiving HPV, MCV4, Tdap, Hep A, Hep B, influenza and PPD used an ammonia inhalant to nose received immediately cool compresses to face head & nape of neck BP 90/60 P 60.
Patient experienced dizziness 12 minutes after administration.  Syncope occurred shortly after. Patient lost consciousness for a few seconds.  Pt bp and pulse stable,  normal after sitting for 15 minutes.
SHORTNESS OF BREATH, HIGH BLOOD PRESSURE, BLURRED VISION, DIZZINESS, AND  NUMBNESS
Local induration at site injection and surrounding inflammation and soft tissue swelling with tenderness over left upper chest wall and posterior shoulder.
Information has been received from a licensed practical nurse concerning a 39 or 40 year old female who on 14-MAR-2007 was vaccinated with a dose of ZOSTAVAX vaccine (Merck) instead of a dose of VARIVAX vaccine(Merck) (MSD). No adverse reactions were reported from the nurse. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/15/2007. Follow-up information was received from the nurse who reported that this was product confusion in how the vaccine is packed and that they are both stored in the freezer. The nurse reported that the physician have been asked to clarify the reason for each vaccine (i.e. chickenpox, shingles) to help identify the exact vaccine that is warranted for each patient. A system has been implemented so when each vaccine arrives, "chickenpox" or "shingles" is written on the outside of the vaccine box. The nurse confirmed that no adverse reaction occurred.
I had the following reactions 12 hours after shot.  Which lasted until about noon Saturday. Diarrhea four times Vomiting  three times Headache   Chills Nausea that lasted about most of the day
12/28 vaccination 1/2 afternoon started feel swelling in armpit, pain, L arm. Monitored 1/3 pain increased. Worried it was blood clot. Ultra sound @ urgent care. Put on antibiotic as precaution for 10 days. Lasted for 14 days.
three days after receiving the second dose, she began losing her vision; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (three days after receiving the second dose, she began losing her vision) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLINDNESS (three days after receiving the second dose, she began losing her vision) (seriousness criterion medically significant). At the time of the report, BLINDNESS (three days after receiving the second dose, she began losing her vision) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Concomitant medications and treatment medications were not provided.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
muscle ache; chills; high fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle ache), CHILLS (chills), PYREXIA (high fever) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (muscle ache), CHILLS (chills), PYREXIA (high fever) and HEADACHE (Headache). On 08-Mar-2021, MYALGIA (muscle ache), CHILLS (chills), PYREXIA (high fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JULY-2022   Reporter's Comments:  The reporter stated that patient received an expired dose of Havrix adult. Additional supportive information: The reporter consented to follow up. The patient received Havrix which was already expired in 20th May 2022 which led to expired dose administered.
I got kidney stones. I went to the ER that morning and they did a CT scan, as well as draw blood and urine test. They gave me pain meds and told me I have to wait until it passes. As I noted on the app, I don't think it is related to the shot, but it is a major enough event to document in case there is a connection.
Vaccine recipient w pain x 2.5 months in shoulder where vaccine was administered, starting on day of vaccination. Recipient was eventually diagnosed with vaccine-induced bursitis requiring treatment with steroid injection.
Patient received PPSV23 and influenza vaccines in office on 11/03/20. Patient contacted on call provider in the evening on 11/04/20 with complaints of redness and pain to site. Patient was instructed to take 600mg Ibuprofen, apply ice 20 minutes on and 20 minutes off and to drawn line around the redness. Patient came into the office to be evaluated on 11/05/20 - diagnosed with cellulitis - prescribed Clindamycin 300mg
Pain that radiates from the injection site to the chest and scapula. Patient states pain is unbearable and took Tylenol and Motrin for it. Patient also states that she could not sleep because of the pain.
Swelling in RIGHT hand, fever, chills, nausea, tightness in chest and back, joint pain
Patient mom called reporting (L) arm swollen, hard and red. "Pressure in head", fever (worse when standing and bending over). Mild erythema to (L) lat biceps. Dx with cellulitis and vaccine reaction. She was given KEFLEX, instructed to give BENADRYL and ibuprofen.
Information has been received from an article on the internet concerning GARDASIL. It was reported that "GARDASIL gave the silent faces of autism a voice". The internet article reported that "many parents of autistic children who regressed after vaccination episode, the mild, moderate, and supposedly "rare" side effects of vaccinations resemble post-vaccinal symptoms manifested by their child." At the time of this report, the patients' outcomes were unknown. Attempts to verify the existence of an identifiable patient have been unsuccessful. Upon internal review, worsening autism was considered to be an other important event. This is one of several reports from the same source. No further information is available.
syncopal episodes; Vomited 40+ times; blood pressure dropped to 70/40; Elevated bilirubin; elevated liver enzymes (ALT, AST); elevated liver enzymes (ALT, AST); This is a spontaneous report from a contactable other health professional (patient herself). A 25-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration on 28Dec2020 12:30 in right arm at single dose for covid-19 immunization. The patient had COVID prior vaccination.  Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced vomited 40+ times, syncopal episodes, blood pressure dropped to 70/40, elevated bilirubin, elevated liver enzymes (ALT (alanine aminotransferase), AST (aspartate aminotransferase)) on 28Dec2020 19:30. Events resulted in emergency room/department or urgent care. IV fluids were received for events. The patient was not tested COVID post vaccination. Outcome of elevated bilirubin was recovered on an unspecified date, and outcome of other events were recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope 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.
Patient received lower than authorized dose. Patient was 13 years at the time of administration, was supposed to receive adult formulation instead received pediatric formulation.
tension headache only when I cough; tension headache only when I cough; fatigue; This spontaneous case was reported by a patient and describes the occurrence of COUGH (tension headache only when I cough), TENSION HEADACHE (tension headache only when I cough) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (tension headache only when I cough), TENSION HEADACHE (tension headache only when I cough) and FATIGUE (fatigue). At the time of the report, COUGH (tension headache only when I cough), TENSION HEADACHE (tension headache only when I cough) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
After receiving the vaccine while in the waiting area patient began sweating profusely. The patient got up to go to the restroom and became light headed. We moved him to a chair and gave him fluids, and used ice packs to cool him off. We checked his BP and it was 92/55 with a pulse of 67.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 86-year-old female patient who received Influenza vaccine. On 15th September 2015, the patient received Influenza vaccine. On 15th September 2015, 2 hrs after receiving Influenza vaccine, the patient experienced shivering. On an unknown date, the patient experienced fever and tiredness. The patient was treated with ALEVE. On 15th September 2015, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the shivering, fever and tiredness to be related to Influenza vaccine. Additional details were provided as follows: Since many years, the patient had received flu vaccines every year and she did not experience any reaction after the vaccination. On 15th September 2015, at 4 pm, the patient received a flu vaccine. On the same day, at 6 pm, the patient started shivering and she was not able to get warm no matter how much she tried and then at 10 pm, it got resolved. The patient was fine. On 16th September 2015, Wednesday, in the evening at about 7 pm i.e. 27 hours after receiving Influenza vaccine, the patient's face started to get so hot that she felt like she was burning. Then, she took her body temperature and it was observed as 100.6 F. The patient had been indoors most of the days. The patient did not remember the last time she had temperature, usually it was 97 or lower. The patient took an ALEVE and went to bed. At the time of reporting, on 17th September 2015, less than a week after receiving the vaccine, the patient was fine but was only tired. The patient was scared to face the evening.
Information has been received from a Certified Medical Assistant concerning a 9 year old female who on 10-SEP-2008 was vaccinated with a booster dose of VARIVAX (Merck) (lot no., route, injection site not reported). After receiving the vaccination the patient developed a reddened area and cellulitis of arm. On 09-AUG-2000 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot no., route, injection site not reported). She has no fever but experienced itchiness in the arm. The patient's symptoms persisted. The patient visited office and sought medical attention. Additional information has been requested.
Erythema and swelling of 6.5 cm X 7.5 cm left arm.
Patient received doses of vaccines after a temperature excursion; No adverse effect were reported; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history.   On unknown date, the patient was vaccinated with a dose after a temperature excursion (product storage error ) with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rhA, lot number R030797, expiration date 20-APR-2020 for prophylaxis (strength, dosage, route of administration, and anatomical site were not reported). No adverse effects were reported. Administered dose of the vaccine experienced the temperature excursion of 35.9 degrees Fahrenheit (F) for 5 hours 54 minutes. Data logger was involved. There were no previous excursions reported.  This is two of three several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005327: US-009507513-1905USA005429:
Patient received a vaccine that under went a temperature excursion; No adverse event; Patient received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion).    Patients weight was reported as 35. Vaccine was administered on 10-Aug-2022 and site was reported as RQ. Concomitant medication list was not provided. It was reported that Moderna COVID-19 vaccine experienced one temperature excursion. Some vaccine was stored in the freezer and other vials in the refrigerator. 38 patients received Moderna COVID-19 vaccine that under went one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at the time of the temperature excursion.The excursions were picked up by state review of the temperature data logger 2 weeks later after the excursion. Storage condition at the time of the excursion was refrigerated storage. Date vial was moved from freezer to refrigerator was 08-Aug-2022. Maximum or minimum temperatures reached, as applicable was positive 14 degrees Celsius. Excursion duration was 3 hours and 5 minutes. They were administered and discarded. Proposed desired Use by date was 18-Aug-2022. Number of vials/ per doses impacted was 1 vial. The excursion occurred on 07-Aug-2022. The vials were not punctured until they were used for a patient and then discarded. No side effects were reported. Treatment information was not provided.
Left arm became swollen and red. Redness extended from her upper arm to several inches below her elbow.
administered with the vaccine beyond to 30 day use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Narrative:  No documentation located in chart regarding ADE of urticaria to tetanus toxoid as vaccine was given outside of the clinic.
pt recvd vax; unusual shrill cry(intermittent) 16nov94 1pm-4pm; fever 102 16nov94 pm; swelling & red rash at inject site 16nov pm;