chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist via Pfizer regarding to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient who was supposed to receive PREVNAR 13 but instead of that, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot# and expiry were not reported) for prophylaxis (wrong product administered and interchange of vaccine products). It was reported that, the physician wants the patient to get the PREVNAR 13 now, 2 months later instead of waiting for a year.
Vaccine underwent temperature excursions administered; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect product storage in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA642A, expiry date 30th November 2022) for prophylaxis.   On 31st May 2022, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 31-May-2022 Reporter's Comments: Menveo underwent temperature excursions was administered on 31st May 2022. Additional Supportive Information: The patient received dose of Menveo that underwent temperature excursions, which led to incorrect storage of drug. This case had been linked with case US2022AMR086924, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR086924:Same Reporter
Information has been received from a 52 year old female patient, reporting on herself, with penicillin allergy and a history of seizure from rubella as a child and mitral valve prolapse who on 22-JUN-2011 was vaccinated intramuscularly with a first dose of RECOMBIVAX HB (manufacturer, lot # and dose not provided). There was no concomitant medication. After getting the hepatitis B vaccine on 22-JUN-2011 the patient developed bruise on her back, had a fever, headaches, and tenderness at site of injection. Patient sought unspecified medical attention and no treatment was given. On an unspecified date the patient had a "titer" test done (results not reported). At the time of this report, the patient still had the fever and had not yet recovered (it was also reported that the AE improve after stopping therapy). Follow up information has been received from a physician concerning the 52 year old female patient who in the morning at 10:15 of 22-JUN-2011, was vaccinated with a dose of RECOMBIVAX HB subcutaneously in the left arm (Lot number AHBVC004AA is an invalid lot number for RECOMBIVAX HB. Concomitant therapy included TB-PPD). Follow up information has been received from a physician concerning a 52 year old female patient who in the morning at 10:15 of 22-JUN-2011, was vaccinated with a dose of RECOMBIVAX HB intramuscularly (Lot number AHBVC004AA is an invalid lot number for RECOMBIVAX HB. No further information is available.
pt brought to ED with heart failure exacerbation; initial COVID test was negative; treated with diuresis; pt then developed fevers and persistent hypoxia; on 8/24/21 the pt had a positive COVID test; treated with dexamethasone and remdesivir; O2 supplementation; increased need for O2; rapid respiratory response was called; pt transferred to SICU for BiPAP; pt intubated; pt status changed to DNR and transitioned to comfort care; he passed away in the hosital
Painful heavy periods starting with my first period after receiving first dose of Pfizer vaccine on 5/1/21.  My first period after first vaccine was also a few days late. I keep track of my periods in an app bc I?m not taking birth control and use natural family planning to prevent pregnancy. After the second dose my period was on time but noticeably heavier than ever and had painful cramps. This has now happened each month since. My period comes on extremely heavy and with very painful cramps. I did not have these symptoms before receiving the vaccine. I would like you to be aware of this and do more research on the connection with this, especially before approving these vaccines for young women. I have a 10 yr old and 3 yr old daughters.
This case was reported by a healthcare professional to a sales representative and described the occurrence of erythema multiforme in an 18-month-old female subject who was vaccinated with Havrix (GlaxoSmithKline). The subject's medical condition was considered "healthy." The healthcare professional did not report if the subject received any other vaccinations or concurrent medications on the date of the Havrix administration. On 22 October 2007 the subject received 1st dose of "pediatric" Havrix (unknown). On 27 October 2007, 5 days after vaccination with Havrix, the subject experienced rash or erythema multiforme. The subject was seen by a physician on 29 October 2007. The subject had also visited a pumkin farm following the vaccination. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were worse.
Patient started to have adverse effects a couple of hours after shot. Most prevalent was a fever that ranged from 101-102 that lasted 2 days as well as swollen lymph nodes on the arm that the injection was given and nausea. Pt experienced "coma like symptoms" as she stated that she would be sleeping for a long time and someone would have to wake her up and keep her awake she stated, almost like she was lethargic. She states that this last a couple of days and then she went back to normal around the 3rd-4th day.
Severe flu-like symptoms for 12 hours.  Then, achiness every afternoon since.
This is an initial spontaneous report by a contractible Physician. This Pfizer Sales Representative reported on behalf of a physician for an adult patient who began on PREVNAR 13 unknown dose intramuscular injection unknown frequency on upper arm for immunization  in APR 2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines taken on the same day or taken within the last four weeks were unknown. In APR 2013 while on PREVNAR 13 unknown dose unknown frequency patient experienced moderate redness, pain and swelling at the sit of injection, systemic reactions which she explained as vomiting, chills and fever. Therapeutic intervention taken in response to above mentioned events included TYLENOL. Relevant lab data was unknown. At the time of the report it was unknown if patient was still administering PREVNAR 13. At the time of the report patient had recovered from above mentioned events in APR 2013. The physician considered there was. a reasonable possibility that the above mentioned events were related to PREVNAR 13.  Follow-up (12-JUN-2013). Follow-up attempts completed. No further information expected.
A nurse reported that a 23-month old female received Acel-Imune and IPV (Aventis-Pasteur Sa) vaccine on 25-JAN-2001. Within 24 hours post-immunization, she developed an injection site reaction characterized by redness and swelling, that extended from her shoulder to elbow. Follow up information received from the physician 12-Mar-2001, stated that the child recovered.
On May 21, during a lot change on the vaccine floor, approximately 300 syringes of Moderna vaccine with an incorrect LOT NUMBER were issued. The error was identified and corrected. During this time period, approximately 900 guests received a vaccination. All guests received an appropriate dose of a non-expired vaccine. The error was clerical, in that the CDC vaccine card for these 900 guests MAY reflect an inaccurate lot number. The IIS was updated for all guests to reflect this. This error has been reported to the Commonwealth and the CDC.
face swollen; mild to moderate joint pain in knees and hip; Sore arm (injection site); This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not known), via unspecified route of administration in right arm on 15Mar2021 at 13:00 (at the age of 57-years-old), as a single dose for COVID-19 Immunisation. The Medical history included hypothyroidism. Concomitant medication included synthroid 75 ug QD for unknown indication from unknown-to-unknown date, and COVID vaccine on 22Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient had not been tested for COVID-19 Since having the vaccine. The patient experienced mild to moderate joint pain in knees and hip, face swollen, Sore arm (injection site) on 16Mar2021 at 6:00. No treatment was taken for the events. The clinical outcome of the pain in joint, swelling face and vaccination site pain was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
Per mom pts legs, bilateral, turned purple-blue.  From waist up normal colored.  Called EMS, per note from ER EMS stated that legs were blue, when they got to ER the ER reports that pt was not blue anymore, was warm, dry and pink.  On discharge from ER (per ER note) pt alert, smiling and playing with mom.
very mild tremor in my right index finger/ finger underwent stronger and more pronounced tremors/the neuropathy was more pronounced; an increase in foot spasms; discomfort in my feet concurrent with an improvement in sensation in my arches; a bit more stiffness and achiness in my knees; have noticed an increase in foot spasms and discomfort in my feet concurrent with an improvement in sensation in my arches; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN), via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunization. Patient relevant medical history included diagnosed with breast cancer three years ago and have some chemo-induced peripheral neuropathy in her hands and feet. The patient's concomitant medications were not reported. Since getting her first shot on March 4, patient have noticed an increase in foot spasms and discomfort in her feet concurrent with an improvement in sensation in her arches. She also had several instances of a brief, very mild tremor in my right index finger, which was where most of the residual neuropathy in her hand resides; when the neuropathy was more pronounced, that finger underwent stronger and more pronounced tremors, whereas what patient had this month is negligible. Patient also had a bit more stiffness and achiness in her knees (both of which have recovered from traumatic injuries), which had mostly leveled off before my second shot but then regained some severity after the second, which was on March 23. (Yes, a 19-day cycle my shots were administered by Hospital. It was unknown if the patient received any treatment for the reported adverse event or not. It was unknown that patient was tested for COVID-19 after the vaccination or not. The outcome of the events was unknown.  Information about on Lot/Batch number has been requested.
Headache; Nausea; Muscle aches; Exhaustion; This is a spontaneous report from a contactable other Healthcare Professional (patient) reported for herself. A 66-year-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6203, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 03Mar2021 (age at vaccination was unknown) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any allergies. The patient received concomitant medications within two weeks (not specified). On 03Mar2021, the patient experienced headache, nausea, muscle aches and exhaustion. The facility where the most recent COVID-19 vaccine was administered was other Prime Time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sore and tender breasts.  Saw PCP.  Abnormal palpable tenderness and firm area of tissue noted.  Referred for a mammogram and ultrasound.  R showed dense nodular parenchymal regionss with shadowing.  No cysts or solid lesions.  Axilla: fatty lymph nodes with thickening.  L showed nodular parenchymal regions.  Axilla:  fatty lymph nodes with a dominant axillary lymph node with thickeing. Axilla nodes: "potentially reactive given fairly recent vaccination history" Repeat in 6 mo
Pt developed a localized left deltoid edema and macula erythema. A follow up report received 10/26/2001 adds: Pt received Pneumovax vaccine to left arm and Fluvirin vaccine to right arm on 9/26/01. Reaction occurred approx 3 hours after vaccination-with swelling and redness of left arm. Pt was seen in MD's office on 9/27/01. No treatment was required. Pt fully recovered.
Allergic reaction/Anaphylactic shock; Hives; This is a spontaneous report from a contactable consumer. This consumer reported different events for two patients. This is 1 of 2 reports. A 21-year-old female patient (reporter's ((Name)colleague's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 04May2021 (Batch/Lot Number: EW0171) (at the age of 21-year-old) as 2nd dose, single dose for covid-19 immunization. Medical history included allergy with garlic. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date for covid-19 immunization. The reporter stated that on 04May2021 the patient got vaccinated with the second dose of vaccine and two days later i.e., on 06May2021 she had some hives, but she never had it before, and she developed an allergic reaction and was in an emergency room having anaphylactic shock and was hospitalized for 3 time and treated with Epinephrine (treatment). She went to an allergist and they checked, they said she did not have any allergy. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
2 month old male patient administered 0.5ml of the liquid component of the Pentacel vaccine, no AE; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a two month old male patient who received only liquid component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], (product preparation issue).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 23-Nov-2020, the patient received a 0.5 ml only liquid component of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ332AA and expiry date: 04-Jun-2021) via an unknown route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to product preparation issue (latency on same day).  Reporter relationship: HCP (health care professional), Product used: used, First time product used: no, Still using product: no  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Elevated fever (101); fatigue; elevated pulse and blood pressure; high blood sugar readings, excessive urination with very very limited fluid intake.
This is a spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a female patient of an unspecified age. On 16-Oct-2018 (reported as last week), the vaccine FLUCELVAX Quadrivalent touched 50F for about 90 minutes. It was the first temperature excursion. On an unspecified date in Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252674 and expiry date: 30-Jun-2019) which had undergone temperature excursion. No adverse event was reported. The reporter assessed the case as non-serious. Follow-up received from the reporter on 13-Nov-2018: The reporter refused to provide the patient's initials. The batch number (252674) and expiry date (30-Jun-2019) was confirmed. The onset date of the event incorrect product storage was updated as 16-Oct-2018. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative was amended accordingly.
rash started approximately 24 hours, spread to entire body, papular and erythematous, pruritic
Case number PHEH2014US022293 is an initial spontaneous report received from a physician on 04 Nov 2014. This report refers to a seven year old male patient. His past medical history and concomitant medications were not reported. On 04 Nov 2014, he received FLUCELVAX (batch number: 161207) intramuscularly at an age of seven years. No adverse events were reported following the medication error (inappropriate age at vaccine administration).
PATIENT DESCRIBED EXPERIENCING PAIN AND HEADACHE ON WEDNESDAY 9/30/2020, THEN ON THURSDAY 10/1/2020 SHE NOTICED REDNESS 2 INCHES WIDE & 5 TO 6 INCHES LONG AND ITCHINESS AROUND INJECTION SITE.  ON 10/2/2020, SHE WENT TO SEE HER DR, WHO PRESCRIBED HER CEPHALEXIN FOR POSSIBLE CELLULITIS. DR AND PATIENT HOWEVER DOUBT IT IS CELLULITIS. PATIENT HAD **NO** FEVER AND NO LABS WERE CONDUCTED. SHE JUST HAD A PHYSICAL EXAM. AS OF 10/3/2020, PATIENT SAYS THE REDNESS IS SUBSIDING AND SHE HAS NO OTHER UNUSUAL SIGNS OR SYMPTOMS.
Red rash on other side of arm and vaccine site. Patient will consult walk in clinic in the morning.
I had a breakthrough covid infection in February 2022. Sick for 2 weeks, fever, chills, sinus congestion, headaches, cough, body aches, loss of taste and smell, brain fog, and fatigue
a patient received the GARDASIL 9 vaccine on 19-JUL-2019. They have not received their second dose yet; No additional AE was reported; This spontaneous report was received from an administrator and refers to a 14-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 19-JUL-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. At the time of the report, the patient had not received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No additional adverse event was reported.
Vaccine was given on 2/13/23- vaccine use by date was 2/12/23.  No harm, no reports of negative side effects.  Contacted Moderna and given the following information: "Analysis of the vials associated with your storage excursion is complete. The vaccine administered on February 14, 2023 from lot number 015B22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration"
Redness, swelling, warm to touch (R) deltoid area. Tx: PO/IM Cortisone, ROCEPHIN 1gm IM, topical BACTRIM DS.
As of 09/03/2022 Monovalent MRNA vaccines was not authorized as booster doses for individuals 12 years and older. Need to use the Bivalent for booster.
Documenting patient received 2 doses of IPV in one appointment because the nurse gave wrong vaccines grabbed Pediarix instead of Dtap, so child received double dose of Polio immunizations.
Day 5 - my arm is still red and there is a 5 inch area around it that is sore and itchy.  It also feels warm to the touch.  I was under the impression side effects should be gone in 2-3 days.
Facial paralysis; This case was received via FDA VAERS (Reference number: 1389251) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of FACIAL PARALYSIS (Facial paralysis) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (diflucan) and Allergy (poppy seeds).    On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Facial paralysis) (seriousness criteria hospitalization and medically significant). At the time of the report, FACIAL PARALYSIS (Facial paralysis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. Treatment medication information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Skin Lesion Information has been received from a physician concerning a 4 year old male with no allergies who on 17-SEP-2002 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot#637976/0264M0. There was no concomitant medication. On 14-SEP-2005 the patient experienced lesions in the C6 dermatome. Unspecified medical attention was sought. There was no treatment given at the time of this report and no laboratory or diagnostic tests were performed. It was noted that the physician "may collect isolates for VZVID". The patient was recovering. The physician also reported that the patient was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD), diphtheria toxoid (+) pertussis vaccine (unspecified) + tetanus toxoid and poliovirus vaccine inactivated (unspecified) on the day prior to the onset of lesion (13-SEP-2005). Additional information has been requested.
Tinnitus- Current and continuous during all day beginning 2 days following 2nd injection.  Causes sleep disruption. Experienced almost daily, but not all day tinnitus beginning a few days after 1st injection.
Last night mom noticed redness and swelling on the patient's left leg. less swollen and red today. on exam today splotchy redness on nearly the entire anterior left thigh. not painful. slightly warm and raised.
Large spot of irritated skin at injection site that has grown over a period of 5 days; took Benadryl capsules by mouth and applied Benadryl ointment, cold compress to the site