chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was considered medically important. Information regarding PREVNAR was received from a pediatrician regarding a male patient who received the third dose at 6 months of age and experienced pneumococcal bacteremia at 11 months of age. Relevant medical history was not provided. Product was administered in 2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. In 2007, the patient had received three doses of PREVNAR at 2, 4 and 6 months of age. During the first week of Feb-2008, the patient developed pneumococcal bacteremia (drug ineffective) with fever, irritability, a blood culture positive for penicillin-sensitive Streptococcus pneumoniae and a white blood cell count of 30,000. Treatment included ROCEPHIN, followed by levofloxacin. On an unspecified date in Feb-2008, the patient recovered. Blood culture (results: penicillin-sensitive Streptococcus pneumoniae) and white blood cell count (results: 30,000) were done in Feb-2008. No additional information was available at the time of this report.
Two days of fever greater than 102F, Lethargy, shallow breathing, rapid heartbeat
The first day my arm was not sore. I started feeling nauseous in the morning and it continued to worsen throughout the day. By late afternoon, I was throwing up. By early evening, I started having diarrhea. Over the next few days these symptoms continued. I was unable to eat solid food. After 3 days of symptoms, and 4 days of only liquids and resting, I started feeling better. I missed 4 days of work due to the reaction. My partner had the same exact reaction, only his started 1 day before mine. His symptoms also began on the first day his arm stopped hurting. We received vaccines at the same time from the same batch.
cellulitis, induration; t100.3 4cm x 3cm; Duricef;
Feels awful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels awful) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOF) and Olanzatine for an unknown indication.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 26-May-2021, the patient experienced FEELING ABNORMAL (Feels awful). At the time of the report, FEELING ABNORMAL (Feels awful) outcome was unknown.            Treatment information was not provided.
Headache and runny nose that started the day of the first vaccine and hasn't stopped since.
Knot formed at injection site; Redness around injection site, bigger than a quarter; Injection site is itchy; Injection site mild soreness; This is a spontaneous report from a contactable consumer, the patient. A 50-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the right arm on 13Mar2021 at 12:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol and type 2 diabetes. The patient was allergic to the drug flagyl. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN), synjardy (MANUFACTURER UNKNOWN) and black cohosh, all for unknown indications and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 20Mar2021, 7 to 8 days after injection, the patient developed knot at the injection site. The patient also developed redness around injection site, bigger than a quarter and was itchy with mild soreness. It was reported that this reaction occurred after the patient started exercising and was exposed to sun. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events injection site lump, injection site redness, injection site itchy and injection site mild soreness was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
pt recv vax lt upper arm on 21APR99 & mom found swollen  & erythematous in infected area this morning;came to clinic;
Patients arm was swollen and red. Patient applied ice, took ADVIL and an anithistamine.
Local pain to touch. Trouble lifting arm. Pain while injecting. Treatment: visit to urgent treatment center.
Initial report was received from the scientific literature on 02 October 2012. The following is verbatim from the aforementioned article: "A 19-month-old boy presented to the emergency department with asymmetrically distributed skin lesions that developed 2 days after immunization with MMR through the right thigh and the VARIVAX (Merck) and DTaP administered through the left thigh. He developed a fever to 39 degrees C the night of the immunizations but then remained afebrile. He had no preceding respiratory or gastrointestinal symptoms. Initially, pink papules were noted at and around the site of the injection of the left thigh, which then coalesced into larger plaques. Pink papules, many of which coalesce into larger plaques, on the left thigh. Pink macules and edematous papules developed later on the pinna, face, trunk, and right leg. A punch biopsy from the left thigh showed interface dermatitis with perivascular lymphocytes and histiocytes and rare neutrophils and eosinophils. These findings were read as consistent with GCS. A punch biopsy from the left leg demonstrated acanthosis, mild spongiosis, and spongiotic microvesicles containing few lymphocytes. There is prominent basal vacuolization, exocytosis of lymphocytes into the lower epidermis, and edema of the papillary dermis. There is a brisk perivascular infiltrate of mostly lymphocytes and histiocytes with rare neutrophils and eosinophils. These findings support the diagnosis of Glanotti-Crosti syndrome. Because the major site of involvement was at the site of the injection on the left thigh, we suspected that the DTaP or the VARIVAX was responsible for precipitating the skin eruption. Although GCS was initially described in association with anicteric hepatitis caused by hepatitis B, it has been more commonly associated with other viruses in the country. In addition to viral infections, GCS has been reported to occur after immunizations with live, killed and recombinant vaccines. Some authors have suggested that combined vaccinations carry a higher risk for precipitating GCS lesions. Other authors have suggested that the risk of developing GCS is greater when an active viral infection is present at the time of vaccination. It has been suggested that high T-cell reactivity due to preceding infection or preceding vaccination greatly increased the likelihood of developing GCS. Our patient had a history of fever immediately after the vaccination but no fever or other viral symptoms before or at the time of the vaccination. As the number of childhood immunizations increased and more combination vaccines are available, perhaps we will see further reports of this postimmunization phenomenon." The patient's outcome was not reported. Documents held by sender: None.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication:  Past adverse reactions to the above products included Allergy. Concurrent medical conditions included Asthma, Blood pressure high and Allergy to nuts.    On 04-Nov-2021 at 4:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19 immunization, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication of the patient was not reported. It was unknown if the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  On 24-May-2022 at 05:00, the patient had rebound of COVID-19 symptoms/positive COVID test. It was reported that for the rebound of symptoms the patient did not receive any treatments.  Company comment: This is a spontaneous case concerning a 51-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred approximately 6 months after the third dose of mRNA-1273 vaccine administration. The event was described as, approximately 188 days after the third dose of mRNA-1273 vaccine administration patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. Approximately 9 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid) patient experienced rebound symptoms with positive Covid-19 test. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 51-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious  event of Covid-19. The event occurred approximately 6 months after the third dose of mRNA-1273 vaccine administration. The event was described as, approximately 188 days after the third dose of mRNA-1273 vaccine administration patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. Approximately 9 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid) patient experienced rebound symptoms with positive Covid-19 test. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (23Nov2022) Negative, notes: Negative test On 23Nov; (25Nov2022) Positive, notes: positive test on 25Nov. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Return of congestion, running nose, slight sore throat, Mild cough, positive test on 25Nov after negative test On 23Nov; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201331809 Same patient, different product and event;
Case number PHEH2015US020381, is an initial spontaneous report from a pharmacist received on 09 Oct 2015. This report refers to a female patient of an unknown age. Historical condition and concomitant medications were not reported. The patient with allergic to latex was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly  on 15 Sep 2015. It was reported that the patient had been experiencing breathing problems and had to miss the work. The patient states this had been ongoing since she received the vaccination. Seriousness and causality of the event was not reported. Seriousness assessment of "breathing problems" was upgraded based on information in the source document.
Received Heplisav-B Instead of Hepatitis A Vaccine; Initial Report Received on 04-Aug-2020.  A certified medical assistant (CMA) reported that an 18 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) instead of Hepatitis A immunization.  No medical history or known drug allergies were reported.   No concomitant medications were reported.  On 04-Aug-2020, the patient went into the clinic to receive Hepatitis A immunization, but instead received a dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021, NDC # not reported) in the left deltoid from an advanced registered nurse practitioner.  At the time of the report, the patient did not have any adverse reactions to the injection.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
The patient was hospitalized for COVID-19 symptoms 7/14/2022- 7/18/2022.  Medications given included cholecalciferol 25mcg PO daily, zinc sulfate 50mg PO daily, ascorbic acid 1000mg PO daily, dexamethasone 6mg IV daily,
The patient received the Flumist at 1430 HRS and went to exercise immediately.  At around 1525 HRS, the patient experienced facial swelling with no difficulty breathing.  The patient went back to the clinic and was treated with Epinephrine, prednisone and benadryl. The patient was released to go home with prescribed after an hour.
Two days post vax, the pt had pain in hip, knee, and leg; standing caused severe pain-seen in February 2000 and still had pain with exertion.
Case number PHEH2014US022028 is an initial spontaneous report received from a health care professional on 31 OCT 2014. This report refers to a three years and two months old patient of an unspecified gender. The past medical history and concomitant medications of the patient were not reported. On an unspecified date, the patient received FLUVIRIN (batch number: not reported) in error but the patient should have received FLUZONE (other manufacturer, batch number: not reported). No adverse events were reported following this medication error (wrong vaccine administered).
pt recv vax & mom indicates pt devel t103 @ 6AM;fever of 012 1PM;referred to MD-mom states MD said pt is fine p/checkup;pt still running fever 101 this AM;
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old patient of unspecified race/ethnicity and gender received the first dose of TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received 1 dose of TRUMENBA at age 16 and does not come back for 12 months.
Episodes of shaking/tremoring (like chills) lasting few seconds, while awake since receiving 1st dose of H1N1 vax. No specific pattern and frequency decreased with time.
Pt stated he developed bilateral hand swelling the morning after his SHINGRIX vaccination on 9/19/18. I saw him at the Anticoagulation Clinic this morning and his hands were both still swollen and painful. Advised patient to consult his PCP if reaction does not resolve in 1 week (by 9/26/18).
"I received an order of hearing, vision and two vaccines for a 16 year patient. So first I did the hearing and the vision than I went to the refrigerator and I got the flu shot and the TRUMENBA instead of MENACTRA and then I went and got the VIS for the meningococcal and the flu shot after that I gave the vaccines and realized my mistaken after I have administered the vaccine and I was ready to chart. I notified the doctor and the attending. Than I notified my charge nurse."
3/6/16 noticed soreness... looked at area and noticed a reddened area around injection site.  3/7/16 noticed the reddened area had grown.  12:20pm 3/7/16 area is red about 2 inches by 3 inches and feels swollen. No treatment has been attempted at this time.
When she went back to bet, got a tremendous irregular tachycardia; Felt awful and felt she was going to die; Awful pain in middle of chest; Difficulty breathing; This spontaneous case was reported by a health care professional and describes the occurrence of TACHYARRHYTHMIA (When she went back to bet, got a tremendous irregular tachycardia), FEELING ABNORMAL (Felt awful and felt she was going to die), CHEST PAIN (Awful pain in middle of chest) and DYSPNOEA (Difficulty breathing) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Weight loss (unexplained weight loss during pandemic). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ALENDRONATE SODIUM (ALENDRONATE) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced TACHYARRHYTHMIA (When she went back to bet, got a tremendous irregular tachycardia), FEELING ABNORMAL (Felt awful and felt she was going to die), CHEST PAIN (Awful pain in middle of chest) and DYSPNOEA (Difficulty breathing). On 01-Apr-2021, TACHYARRHYTHMIA (When she went back to bet, got a tremendous irregular tachycardia), FEELING ABNORMAL (Felt awful and felt she was going to die), CHEST PAIN (Awful pain in middle of chest) and DYSPNOEA (Difficulty breathing) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Heart rate: high (High) Very strength pulse. This lasted for about 20 minutes. and normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow-up information received on 19-Jul-2021 and included updated information on concomitant medications, action taken, event onset and event stop date and primary dosage information. The medical history, lab test added and event feeling abnormal verbatim was updated.
This case was reported by a nurse via call center representative and described the occurrence of laceration in a adult female patient who received MENVEO (batch number X17031, expiry date April 2020). On an unknown date, the patient MENVEO. On an unknown date, immediately after receiving MENVEO, the patient experienced laceration and pharmaceutical product complain. On an unknown date, the outcome of the laceration and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The nurse was pulling the top off the vial and the vial broke a crumbled in her hand. She statedsthat the nurse did suffer a superficial cut. Caller states that there was no visible damage to the vial and no damage to the blister tray or carton. There was also no evidence of leakage in carton. The product was stored in the refrigerator, and the package appeared normal upon receipt. They no longer had the vial as it was disposed of in the sharps container.
Within 2 or 3 days had shingles for the first time. After a couple of weeks noticed arm range of movement was limited and severely painful if reaching out or to the back direction.  This is still ongoing at this. the second vaccination I changed to right arm. This arm also has the pain but not as severe.
Swelling right arm and hand with fever which ranged from 99F to 101F. Also, had a circular red area (quarter sized) around injection site. On 10/20/00, client said he was being treated for "nose infection" by PCP prior and at the time of pneumonia injection received on 10/19/00.
Patient reports itching began "a couple hours after I got the shot." Started on hands and legs eventually moving to feet, face and lips. Took a shower once she got home from work and itching continued. Eyes and lips became swollen from the itching. Patient took prescribed hydroxyzine HLC 50mg that evening and went to sleep. Reports she woke in the middle of the night with chills, low grade fever, body aches and headache.  The following day, itching had resolved. Reports she still had body aches and headache. Took ibuprofen for discomfort.  Patient did not seek outside medical treatment with PCP, urgent care or ER.
Was given the wrong dose (20 mcg instead of 10 mcg) of the Pfizer vaccine
18 hrs after injection, moderate headache and very sore ache in my hips.  During that day, continued headache and hips ached into the next day.  Exercised hips, not much help. Took tylenol alternating with ibuprofen every 6 hours
Allowance of covid vaccination that resulted in adverse lasting side effects.  Developed breasts.  Ongoing issues.; Test: Nasal Swab Result: Positive; Test: Nasal Swab Result: Positive; This is a spontaneous report from a contactable consumer (patient). This 18-year-old non-pregnant female patient received bnt162b2, via an unspecified route of administration, administered in arm right on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. Medical history included allergy/known allergies: yes. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Allowance of covid vaccination that resulted in adverse lasting side effects. Developed breasts. Ongoing issues. Developed breasts resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Hospitalization for 10 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination: covid test type post vaccination was Nasal Swab on 04Jun2021, result was positive. Treatment of event was unknown. The event outcome was not recovered. Information on Lot/Batch number has been requested.
One week after shot had chest pain on left side. Later the pain radiated to the right side and got worse. After a week of no improvement I went to ER and was diagnosed with pleurisy and pleural effusion. Currently taking antibiotics.
Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontaneous report from a contactable Other-HCP (patient). A 47-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at SINGLE DOSE for covid-19 vaccination. The patient's medical history and concomitant medications were not reported.  The patient experienced side effects after she got her 1st dose last 24Dec2020. On 26Dec2020, she had pain underneath arm and then whole lymph nodes were swollen up until her armpit 2 days after receiving the vaccine. Her 2nd dose is scheduled this Thursday and wants to know if she should get it. The outcome of the events was unknown. Information about lot/batch number has been requested.