chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Moderna vaccine under 18 years of age; mild arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 years of age) and VACCINATION SITE PAIN (mild arm pain at injection site) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 years of age) and VACCINATION SITE PAIN (mild arm pain at injection site). On 14-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 years of age) had resolved. On 16-Mar-2021, VACCINATION SITE PAIN (mild arm pain at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17year old) for mRNA-1273 ( batch no. 040A21A) with AE of Vaccination site pain. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
chills; left arm has been very swollen; red ever since; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), VACCINATION SITE SWELLING (left arm has been very swollen) and VACCINATION SITE ERYTHEMA (red ever since) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LZ0A) 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) (unknown route) 2 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 11-Mar-2021, the patient experienced CHILLS (chills), VACCINATION SITE SWELLING (left arm has been very swollen) and VACCINATION SITE ERYTHEMA (red ever since). On 11-Mar-2021, CHILLS (chills) had resolved. At the time of the report, VACCINATION SITE SWELLING (left arm has been very swollen) and VACCINATION SITE ERYTHEMA (red ever since) had not resolved.            Concomitant medication includes heart medications but no new medications. No treatment details were provided.
Approximately 10 minutes after receiving the vaccination, patient experienced intense palpitations and dizziness. This progressed into pallor physical weakness and fatigue within 10 minutes and lasting approximately four hours. No treatment was delivered as patient lived alone and fell asleep upon entering home.
Patient was given a moderna vaccine that was 51 hours after vial was punctured. Rescheduled patient to be re-vaccinated due to lack of effications. Patient with no symptoms
Patient was given her vaccine and immediately left the store but started vomiting and had a massive headache before getting to her vehicle. The patient called her brother-in-law/ brother to come, and he called 9-1-1 and they took her to the nearest hospital.
Vomiting began 30 minutes post-vaccination. Patient exhibited no other signs of adverse reaction to vaccine (i.e, no local reaction, no hives, no fever, no diarrhea). Clinical signs lasted about 12-18 hours. Patient was held NPO x 10 hours then slowly transitioned back over no normal diet over the next 12 hours.
Information has been received from a pharmacy technician concerning a male pt who on approx 10/5/05 was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine vaccine lot 650083/0749P). Subsequently, in Oct 2005, the pt experienced a local site reaction post vaccination. The pt called the office to report a red, raised, warm and achy area at the injection site. He was treated with cold compresses and acetaminophen Tylenol as needed. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Swelling, headaches, large rashes and bruises, discolored areas, fluid filled on left side of face. fatigued , nauseas, memory problems, a small amount of imbalance. dizziness. severe chest pains, myocarditis
experienced a sharp increase in blood pressure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "experienced a sharp increase in blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that after the second booster, experienced blood pressure (200/111). Patient had no side effects prior to this from the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
ACUTE DVT OF RIGHT POPLITEAL VEIN 12/6/2021 ANEMIA ACUTE DVT OF RIGHT POPLITEAL VEIN 12/6/2021 ABDOMINAL MASS OF UNSPECIFIED SITE ACUTE DVT OF RIGHT POPLITEAL VEIN 12/6/2021 ANEMIA
Had a very aggressive inflammatory breast cancer developing within 4 months of completing vaccination.  Patient noted no symptoms prior to screening mammogram 3/2/21.  Read as BIRADS 0,  noting R subareolar lesion. Compression studies incorrectly read as BIRADS 2 on 4/5/2021.  Punch skin biopsy on 7/1/2021 showed poorly differentiated cancer. U/s 7/6 with multiple lobulated nodes.
Spinning, head banging, lost language, not responding to his name, appearing to be death.
S: Patient, RN from TCC/CCU came to Covid vaccine clinic on 1/3/2020 for Covid vaccine. She received vaccine at 7:23 am. Received injection on left arm. At 8:12am, she reported heaviness on left arm, tingling sensation on left 3rd and 4th fingers, and metallic taste.  She denies motor weakness, sob, n/v, chest discomfort, palpitation, difficulty breathing, dizziness, headaches, blurry vision. Hx of HTN, mitral valve prolapse, asthma, migraine. Currently taking labetalol 400 mg bid, hctz/losartan 100/50 mg bid. Have not taken her BP medications this morning. She took benadryl 25 mg and tylenol 1000 mg at 6:35 am prior to coming to clinic. She is allergic to multiple medications.   O: At 8:12, VS: 177/104, 97%, HR 66. Reports paresthesia to L arm, metallic taste At 8:25, VS: 157/102, 98%, HR 62. Continues to experience paresthesia and heaviness, but it has gradually improved, metallic taste resolved  At 8:37, VS: 149/92, 98%, HR 64. Paresthesia and heaviness improved.  AAOx 4, follows command, speech clear, lung sounds clear, heart sounds normal, normal rate and rhythm. Motor strength +5/5 bilaterally. No facial weakness/facial drooping. Subjective paresthesia on left 3rd and 4th fingers that gradually resolved. Subjective heaviness on left upper arm. No angioedema. No respiratory distress.  A: Reaction to Covid-19 vaccine.  P: Employee was closely observed in clinic. Provided fluids. VSS. Symptoms gradually improved. Employee was advised to closely monitor her symptoms, if she experience any worsening symptoms, she need to call 911 or go to the nearest emergency room. She states that she has epi pen and benadryl in her purse, and understand signs and symptoms to monitor for and when to use it if needed. Employee left to return home at 8:45 am in stable condition.
Pfizer-Bioteen COVID-19 Vaccine.  Pt. developed a reaction to 1st dose of COVID-19 Vaccine.  symptoms.  Pt. has a history of HTN, takes miodipine medication.  Pt. states symptoms of feeling anxious and having sweating palms.  Pt. verbalizes feeling better and recovered.  No hospital care provided.  VS:  P 65 97, 86 P 98 O2.
Pt recv vax on 10/22/98; on same day pt exp hotness all over for 1/2 hr, entire arm painful.
Late 2nd dose/2nd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The 2nd dose of Shingrix had not administered to the patient till the time of reporting, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Fatigue, low grade fever up to 99.2, body aches general overall ache and localized joint pain
very strong itch all over my body; red balls that bulged until it bled.; This is a spontaneous report from a Pfizer sponsored program, from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on 20Jun2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not provided), on 30May2021, for covid-19 immunization. It was stated that, on an unknown date in Jun2021, five days after the second dose, the patient developed a very strong itch all over the body and small red balls that bulged until it bled. The outcome of the events was unknown at the time of report.  Information about batch/ lot number has been requested.
8th  day after injection, woke with small red rash on left arm below injection site. No symptoms. By afternoon, began feeling poorly, tired and achy. By evening,  felt much worse, checked arm, rash had gown and was  redder, hot to the touch, a bit itchy and arm hurt.  Awoke following morning with painful arm, rash much larger. Skin temp for area was 101.  Feeling fatigue, whole arm is achy. Put a call into my doctor. Resting pending call back.
Patient has not reported adverse event. Vaccine received 5/18/23. Called and spoke with patient on the morning of 5/19/23 and she stated that her arm was "a little sore" but she was not experiencing additional side effects.
05-03-06 Pneumococcal vaccine adm. 05-05-06 Pt. presents to clinic with s/s and diagnosis cellulitis at INJ site and surrounding area extending down to wrist. Pt had Levaquin treatment x10days with three office follow up visits before s/s resolved 05/15/06.
Sore throat, body aches temp 100.4. By 11/21/2009 fever 101.4 worse sore throat, headache. On date of vaccination, flushed, red face 1 hour after administration of vaccine lasted 5- 6 hours.
Tired; Sore after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and MYALGIA (Sore after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired) and MYALGIA (Sore after first dose). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency and CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRIN) at an unspecified dose and frequency. At the time of the report, FATIGUE (Tired) and MYALGIA (Sore after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned.
Patient complained of itchiness, hives, redness, and hotness on her right arm(same arm of vaccine) after receiving the vaccine. Zyrtec 10 mg given at 1647. After 15 minutes patient symptoms improved. Patient sent home per MD.
No additional AE; Inbound call from nurse prescriber who reports improperly stored VARIVAX was administered to 1 patient. Excursion occurred 7/7/2023 and product was administered 7/8/2023.    ?    Names of vaccines involved (including lot/exp) VARIVAX X002101 1/19/2; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medications included sterile diluent(MERCK STERILE DILUENT).        On 08-JUL-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # X002101with expiration date 19-JAN-2023, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). The temperature excursion occurred on 07-JUL-2023. The vaccines was exposed to a temperature of 47°F to 77 °F for 45 minutes and 5 seconds. There was not a previous temperature excursion. No additional adverse event (AE) was reported. It was reported that sterile diluent(MERCK STERILE DILUENT) was not involved in the temperature excursion.
"Pt feels throat closing, reports mild shortness of breath. Patient is alert and able to communicate clealry- Speech is clear. No stridor. Lungs clear. Patient is not in apparent distress. Patient is accompanied by her father.  11:14 am patient reports slight improvement of throat swelling. Reports resolution of dyspnea.  Discussed after care with patient and father-- follow up with PCP and ask for referral to allergist to clear patient for 2nd dose of Pfizer vaccine.  11:22 patient left via wheelchair with her father. Patient reports "less tightness of throat"" and resolution of dyspnea."
This initial spontaneous case was received on 25-Oct-2017, reported by other non-health professional (consumer), concerning a female patient of an unspecified age. The patient's historical drug included influenza vaccine for an unknown indication. The patient's historical condition included cellulitis at the injection site, which required the treatement with unspecified antibiotics. On an unspecified date, the patient was administered with INN Flu Vaccine (dose, route of administration, anatomical location, expiry date, batch number, manufacture and trade name: not reported). On an unspecified date (reported as last year), the patient had small blisters occurred at the injection site. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious.
She has developed Tinnitus; She has developed debilitating hives; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (She has developed Tinnitus) and URTICARIA (She has developed debilitating hives) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (She has developed Tinnitus) and URTICARIA (She has developed debilitating hives). On 05-Jan-2022, TINNITUS (She has developed Tinnitus) and URTICARIA (She has developed debilitating hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. Treatment information reported as Unknown.
Shivering, chills, sweating, headache, body ache. Lasted about 16 hours. Took ibuprofen.
Case previously recorded as MA2009-4542. Case report received from a nurse, on 18 NOV 2009. 2-year-old male patient was accidentally vaccinated with 0.5 mL of S-OIV FLUVIRIN intramuscular (batch no. 102126P1A, expiration date 31 MAR 2010) on 17 NOV 2009. No adverse events was reported. Reference no.: NA09-008426.
pt recvd vax & had hot flashes; pt face felt flushed; LA where vax was given swelled & hurt, followed by knots;felt queasy & was getting headaches;pt tossed & turned while sleep; pt had hair loss; to MD; stated serum rxn;
fever, muscle ache (even my teeth hurt), nausea (actually threw up in my mouth), dizziness, weakness, headache, shortness of breath, heaviness in chest, fatigue, pain lifting left arm.  Extreme discomfort.  Stayed in bed for 2 entire days.  If this had been my first shot, I would not have gotten a second.
25 weeks pregnant due January 7th 2019. Got shot 5:30 pm Tuesday 9/25. Began feeling ill Wednesday am 9/26. Chills, body aches, excessive sweating, sore throat, elevated heart rate, and extreme fatigue. Symptoms have persisted for 5 days. No fever. Saw a Dr. on 9/28- they administered a strep test and flu test, both came back negative. They believe it is just an extended reaction to shot. We are now on Sunday 9/30 and symptoms are no better.
2nd dose pfizer vaccine was given to patient on 07/08/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window. We reached out to pt on 07/10/21 to get the 2nd dose again. Patient will return to the pharmacy to repeat dose on 07/12/21.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 39 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: 28-OCT-2021) dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-OCT-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211139710.
Severe headache began at 3am on 2/4/2021 which was helped by taking ibuprofen. In addition, extreme fatigue and upper back and neck pain began around 9am and continued until evening.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was orthostatic hypotension
I was really sick; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received second dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number and Expiration Date were not reported) via an unspecified route of administration, on an unspecified date (age at vaccination: 57 years), as dose 2, single for COVID-19 immunization. The patient's medical history included thyroid cancer (2 stage thyroid cancer). The patient's concomitant medications included levothyroxine sodium (SYNTHROID) and liothyronine sodium (T3) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number and Expiration Date were not reported) via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. On an unspecified date, the patient stated that she was very sick.It was reported that I thought I may have some bones out that was my limb nodes to be backed up (Further Clarifications unknown). I took medicine for pain, used my inhaler, I used my heart medicine because the raising heart, I was getting very lightheaded. Possibly took Tylenol for headache, lorazepam, apparently heart medicine and then I take loprazolam. For the other medication I called to my cardiologist and she got me a heart manager to try catch what's going on. At that time I was not sure that it was related to a vaccine cause I do have heart conditions (Further Clarifications Unknown). consumer stated, "No, I have client to work # company and in another state, it is important. I just wanted to make sure you had it and now I understand what's going on so its getting better over time. I just wanted to make sure you have the data I truly appropriate the opportunity to got the vaccine, I regret what's so ever. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TOOK THIRD DOSE ON DAY 8; This spontaneous case (PVX2019-1113) was received from a nurse on 06-May-2019. It describes a female consumer who "took third dose on day 8", while being on Vivotif for an unknown indication.  Case report: The consumer did not take Vivotif doses according to the schedule. The doses were taken on 28-Apr-2019, 30-Apr-2019, and 05-May-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took third dose on day 8" was unknown.  Company's Comment: The causality of the event "took third dose on day 8" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 8" was considered as not applicable.
This patient presented to the emergency department 2 days in a row for chest pain fever.  Shira of tachycardic with chest pain.  She also complained of sore throat and diarrhea.  She was admitted to the hospital with Cardiology for further evaluation and treatment of possible myocarditis given her elevated troponin and chest pain in the setting of recent vaccination.
Chills, injection site pain, injection site swelling, injection site redness, joint pain, tiredness, body ache.