chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Speech and communication issues, stopped eating, sleeping pattern changed, loss of balance. Stopped producing new words, stopped repeating words.
This spontaneous report as received from a pharmacy student refers to a 3 month old infant of unknown gender. Medical history and concurrent conditions were not reported. On an unknown date, the infant was vaccinated with PNEUMOVAX 23 (reported as PPSV-23) (dose, strength, route and lot number were not reported). Other suspect therapies included PREVNAR (dose, strength, route, lot number and indication were not reported). Concomitant therapies were not reported. On an unknown date, the 3 months infant received PNEUMOVAX 23 vaccine dose instead PREVNAR. Additional information is not expected because the caller does not want to be contacted for follow-up information.
2- 2.5 hrs post vax mom states pt cried continuously; No fever but seemed to be in alot of pain; Seen by MD-advised not to have DTP;
Generalized red rash over scalp and body. Arm red, warm and swollen at injection site. Given Orapred and Benadryl.
Patient called 7/26/18 to report experiencing wheezing, asthma attack, tingling in the fingers and fever.
began with mild edema and errythema L deltoid 1-17-21, progressively worse with pain, mod-severe edema of entire RUE and errythema of L upper arm, parasthesia of L hand and digits.  Sought care on 1-21-21, diagnosed with cellulitis, prescribed Keflex and Prednisone.  Symptoms fully resolved by 1-25-21.  Mild edema  and parasthesia of index finger and thumb returned 1-26-21.  Seen  1-27-21 and placed on longer course of steroids.
Information has been received from a 25 year old female consumer who on 29-MAR-2008 was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported). There was no concomitant medication. In "early April 2008", the patient experienced a severe acne breakout on her cheeks and forehead. The patient sought medical treatment in the office. She was initially treated with one month supply of doxycycline (unspecified), but the acne did not improve. On 09-MAY-2008, the patient was switched to prednisone (not further specified). At the time of this reporting the severe acne breakout has persisted. No further information is available.
NO additional adverse effect reported; patient was administered a dose of improperly stored Proquad; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 28-JAN-2020, the patient was administered a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, subcutaneously, lot # S012535, albumin status rHA, expiration date 20-OCT-2020 (exact dose and anatomical location were not reported) for prophylaxis. The vaccine was diluted with a properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion of - 14 degrees Celsius to - 10 degrees Celsius (-12.6 degrees Celsius) for 9 hours and 53 minutes. Digital Data Logger was involved. The vaccine underwent previous temperature excursion of - 14 to - 10 degrees Celsius (- 13 degrees Celsius) for 14 hours and 22 minutes. No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA001483: US-009507513-2002USA001480: US-009507513-2002USA001517: US-009507513-2002USA001358: US-009507513-2002USA001486:
Hip pain, fever, diarrhea, and COVID +, daughter in law tested positive on 7/30/2021
I was feeling under the weather. Generally with flu like symptoms. It actually started a few days before the vaccine, but got worse a few days after. My primary care physician could not get me in for a few weeks. I was seen at an Urgent Care a few times in the course of a few weeks. They did a Covid test, and Flu test which all came back negative. They also did a chest x-ray which warranted a CT follow up, they did not find what they thought, but did find chest nodules... they wanted me to follow up with a pulmonologist who ordered a PET scan. The PET scan showed that the nodules were "avid" or potentially cancerous. That lead the pulmonologist to do a bronchoscopy where they tested a tissue sample for malignancy and other issues. Those results have come back mostly negative. I have not received the results on T.B. I have a presumptive diagnosis of sarcoidosis. They discovered clear granulomas on my lungs which lead them to this assumption. Additionally, I have seen a neurologist and have an appointment to see a cardiologist to investigate whether the sarcoidosis has spread to other systems. I have also had an episode of heart palpitations on 2/8 that lasted 22 minutes. My pulse was at 235 BPM which was a new event that I have not experienced prior to the vaccine. I went to the E.R. where I was monitored over night. The palpitations did not return. They ordered me to wear a heart monitor for a week along with an echocardiogram and I will see the cardiologist for follow up in the near future. They advised that I see the neurologist due to numbness that I was experiencing on my right side while the sarcoidosis was at it's worse. Things have gotten better over all, but the neurologist has ordered MRI scans on my spine and brain which have come back normal. I have not yet received the lab results for the lumbar puncture that was done.
Rash with itching; Pain at injection site.; Pain and inflammation increasing on day 3.; Dose 1: 28May2021; Dose 2: 14Jun2021; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Jun2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28May2021 at 11:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jun2021 at 10:00, 24 hours after vaccination, the patient experienced rash with itching and pain at injection site. The patient stated that the pain and inflammation was increasing on day 3. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash with itching and pain at injection site and inflammation was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient tested positive for covid on 1/29/21. was hospitalized on 2/8/21  for shortness of breath, generalized weakness, nausea.
pt recvd vax at 6-8 wks old;pt screamed for 18 hrs non stop; MD did not give rest of shots; was stiff as a board the whole time;
This spontaneous report received from a patient concerned a 35 year old  male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-MAY-2021 to left arm for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 14-DEC-2021, the patient experienced headache with fatigue on 15-DEC-2021 and congestion on friday 17-DEC-2021 (coded under confirmed covid-19 infection). On 19-DEC-2021, the patient tested positive for Covid-19 (confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207983.; Sender's Comments: V0: 20211244701-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Moderna COVID-19 Vaccine EUA 1 day after shot was tired and sore in arm, went to work clinic and tested negative. was able to work next few days.  gradually gotten worse to the point of 5 days off of work so far, due to extremely tired, body aches, head aches, sore throat, cold even the body temp is normal when tested.
Covid positive after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid positive after vaccination) 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 SARS-COV-2 TEST POSITIVE (Covid positive after vaccination). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid positive after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     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.   No Concomitant Drug details were reported.  No Treatment information was provided.  Company comment:  This case concerns a female patient with no reported medical history who experienced non serious unexpected AESI of SARS COV2 test positive, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to nature of the event and unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with no reported medical history who experienced non serious unexpected AESI of SARS COV2 test positive, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to nature of the event and unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
An adult patients mother came in to ask about the patient getting the second dose of covid vaccine 9 days apart.  Patient has no signs or symptoms of getting 2 doses 9 days apart.  The mother was asking if the patient needed a third dose since she already got 2 doses.  I informed her no.  No other problems or side effects were noted.
Black flat round and irregular lesions appeared on both palms and back of hands.  Non-tender, unable to blanche, 10 on each hand/palm.
back hurts/"hit by a mac truck"; body hurts; Positive COVID test; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back hurts/"hit by a mac truck"), PAIN (body hurts) and COVID-19 (Positive COVID test) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VITAMINS NOS for an unknown indication.    Concomitant products included HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (BENICAR HCT), SIMVASTATIN and HYDROCODONE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started VITAMINS NOS (unknown route) at an unspecified dose. On 22-Apr-2021, the patient experienced COVID-19 (Positive COVID test). On an unknown date, the patient experienced BACK PAIN (back hurts/"hit by a mac truck") and PAIN (body hurts). The patient was treated with BAMLANIVIMAB at a dose of UNK dosage form. At the time of the report, BACK PAIN (back hurts/"hit by a mac truck"), PAIN (body hurts) and COVID-19 (Positive COVID test) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2020, SARS-CoV-2 test: positive Positive. On 22-Apr-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Other treatment medications include Steroids.
Redness swelling, tenderness @ area of ineject 3+ days; pt instructed OTC Antihistamine, ice rt deltoid;
Fever between 100-101 degrees for 24 hours; nausea and vomiting for 3 hours; extreme body aches and fatigue; moderate headache.
Approximately 5 minutes after vaccine administration patient reported feeling an itchy tongue and some swelling. I examined patients tongue and it did not appear swollen. Patient denied and shortness of breath or trouble swallowing. Patient states she had a reaction in the past to a medication that caused severe swelling of her tongue in which she now has a prescription for epi pens Vital signs were taken and were normal (BP 110/70, HR 80, O2 SAT 100%). Patient was given water and asked to sit for an additional 30 minutes. Patient reports itchy sensation had gone away and she believes it was more anxiety related.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (formulation, strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The vaccine doses were exposed to an unspecified temperature excursion for an unspecified time; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1705USA010555: US-009507513-1705USA012266: US-009507513-1705USA012267: US-009507513-1705USA012268:
Expired vaccine administered to two patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Very sore all over; Throwing up; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Very sore all over) and VOMITING (Throwing up) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Very sore all over) and VOMITING (Throwing up). At the time of the report, PAIN (Very sore all over) and VOMITING (Throwing up) 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.   No concomitant medication information was provided.  No treatment medications were provided.
diagnosed with leukemia; open wounds on her legs; This spontaneous case was reported by a consumer and describes the occurrence of LEUKAEMIA (diagnosed with leukemia) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus syndrome and Atrial fibrillation. Concomitant products included METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced WOUND (open wounds on her legs). On 14-Mar-2021, the patient experienced LEUKAEMIA (diagnosed with leukemia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 11-Mar-2021 due to LEUKAEMIA. At the time of the report, LEUKAEMIA (diagnosed with leukemia) and WOUND (open wounds on her legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Biopsy bone marrow: bone marrow was tested. On 14-Mar-2021, Biopsy bone marrow: leukemia.         Treatment information not reported.   Concomitant medications also included heart med, but full list not reported.  On an unknown date, after the 1st dose, patient had blood work done. After the 2nd dose, patient was then admitted to the hospital on 11-MAR-2021 due to the weird blood test results.  Company comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Injection site pain.  Lymph node pain same-side.   Headache.  Fatigue
Pt developed a 4 x 4cm area of redness, tenderness, & warmth around the vaccine site.  She was treated with KEFLEX for 10 days.
intense brain fog, concentration, and memory issues beginning 2 days post vaccine. It has been way more intense than after my first two doses of Moderna in spring 2021. Last time, it lasted 5 months.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 at 11:00 as dose 1, single (Lot number: EH9899), in left arm, on 19Jan2021 at 11:00 as dose 2, single (Lot number: EK4176), in left arm and on 25Sep2021 at 14:00 as dose 3 (booster), single (Lot number: PF2587) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 066K2VA), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive; (02Aug2022) Negative; (03Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Rebound positive COVID 5 days after completing Paxlovid. Negative COVID test 02Aug2022, then mild symptoms and positive test 03Aug2022. Took Paxlovid 25Jul2022 to 29Jul2022 after symptoms started on 23Jul2022 and positive COVID test on 25Jul2022.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported   events and the suspect drug cannot be excluded.
swelling near injection site; redness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling near injection site) and VACCINATION SITE ERYTHEMA (redness near injection site) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling near injection site) and VACCINATION SITE ERYTHEMA (redness near injection site). At the time of the report, VACCINATION SITE SWELLING (swelling near injection site) and VACCINATION SITE ERYTHEMA (redness near injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.
Lymphadenopathy  Very swollen, sore and red lymph nodes on the left side of the neck
Fever starting 10 days after MMR vaccine. Rash followed 2 days later.
This case was received on 16 May 2008 from a health professional, and is one of a cluster of ten patients. A female patient experienced received  an injection of ADACEL (lot number C2864AA), and subsequently experienced injection site redness and pain with swelling extending to the axillary area. No additional information was provided. The health professional also reported nine other patients who experienced similar events following administration of ADACEL. Those events are captured in cases 2008-01609, 2008-01610, 2008-01611, 2008-01612, 2008-01613, 2008-01614, 2008-01615, 2008-01616, and 2008-01617.
about 9-10 days p/vax c/o diffuse aching (myalgias), paresthesias of the hands & feet & inc weakness, unable to walk; no diff swallowing or breathing; BP inc proximal & distal BUE weakness L>R, BLE weakness L>R, reflexes dec;impression GBS
Red firmness at injection site, itchy and warm to the touch. two inch radius around arm. Patient self-medicated with anti-histamine and ibuprofen. subsided after 24-72  hours
Few scattered papules. Treatment - Diphenhydramine HCL for itching/swelling.
Patient had an eye injury/infection  the day before receiving his 2nd shot while in a field exercise. After receiving the shot the eye injury moved down his body and developed in to paralysis on his left side. He is still 6 months later in a wheelchair. He has seen so many drs so I assume it?s been reported already as required. He is now with a working diagnosis of Functional Neurological Disorder
Pain and redness in arm at injection site that radiates into neck and over collarbone. Hot flashes, chills, nausea. Cannot lift arm. As of 4/29, pain is now in bicep, hurts to straight arm. Overall-tired-haven't eaten since Monday.