chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Dosage text was reported as Additional Booster.   196 patients received 0.25ml of Moderna Covid-19 Vaccine, Bivalent. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications was provided. No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live NonSignificant follow up
Syncope following injection. Rash began 11/21/07. ER visit diagnosed as erythema multiforme on 11/22/07. Symptoms worsened and was admitted 11/23/07 (night). Follow up with family doctor. Lasted approx. 2 weeks.  04/09/2008 MR received for ER visit 11/22/2007 with DX: Erythema multiforme minor.  Pt presented with 2 day hx of rash which began on the hands and spread to the body. Pt also reports painful swelling of the hands.  PE (+) for diffuse, asymmetric , maculopapular rash.  Target lesions noted on palms, soles and extremities. Tx with benadryl and prednisone. 4/16/08 Additional records recd for admit 11/23-24/08 with D/C DX Erythema Multiforme.  Dehydration 2' to vomiting, resolved.  Pt presented with worsening rash,persistant vomiting, and significant swelling and pain in extremities. Pt had swelling of the lips. Temp 101. Presumed allergy to Minocin. Started on Z-pak for URI sx. D/C 11/24/08 and returned again 11/24/08 with worsening sx. Now developing mouth sores. PE (+) for lesions c/w Erytema Multiforme. PE (+) for shotty anterior cervical adenopathy and trace DTRs.  Admitted again for IVF and meds. Additional DX: of probable drug eruption 2' Minocin.
Scrubbing chart for clinic visit. noting pt with 2 entries for pneumococcal vaccine, both with same lot number and Merck as company, one with generic pneumococcal vaccine and other with Pneumococcal-7. Pt is 42 y/o and these were documented in 2013. Merck does not make Pneumococcal 7.
A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2 doses of the Moderna Covid-19 Vaccine; A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2 doses of the Moderna Covid-19 Vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2 doses of the Moderna Covid-19 Vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2). On 28-May-2021, WRONG PRODUCT ADMINISTERED (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2 doses of the Moderna Covid-19 Vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.  Patient already received their 1st and 2nd dose of the Moderna Covid-19 vaccine. 2nd dose was given on 03 May 2021. Patient came into the Pharmacy today for their Shingles vaccine but mistakenly went into covid-19 vaccination room where they were administered the Pfizer Covid-19 vaccine.
Sore arm; Fatigue; Headache; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 014B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). 01-Apr-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment for the event included acetylsalicylic acid.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-071416, MOD-2021-070988, MOD-2021-070997, MOD-2021-072067 (Patient Link).
Red rash at injection site and sore throat; Red rash at injection site and sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04Apr2021 at 16:30(at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, the patient experienced red rash at injection site and sore throat. 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. The clinical outcome of the event red rash at injection site and sore throat was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
rt arm ax lymph nodes tender 3 days p/vax;denies rash, fever, any other lymph node enlarged;
No adverse effect reported, patient was wanting the bivalent COVID Pfizer booster and instead was given the original vaccine.
brain zaps; dizziness; Desvenlafaxine anxiety medication did not work once I received the vaccine; This is a spontaneous report from a contactable consumer (Patient, Self-reported). A 29 years old female patient(who was not pregnant at the time of vaccination) received  first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8732 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 27Mar2021 09:00 AM(at the age of 29-years-old), as a single dose for COVID-19 immunisation at other facility where the most recent COVID-19 vaccine was administered. Medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient received Desvenlafaxine in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. On 04Sep2020 patient had been tested for COVID with test result: Negative. The patient reported that Desvenlafaxine anxiety medication did not work for her, On 27Mar2021  when she received the vaccine and the day after she had experienced with brain zaps and dizziness almost like she didn't even take the Desvenlafaxine (50 mg) for the day. The patient underwent nasal swab test and procedures which included SARS-CoV-2 antibody test: negative on 04-SEP-2020. Outcome of the events was recovering/resolving.   Follow-up activities are closed as no further information is expected.
Pt given HEP A (VAQTA) on 2/11/08 & 8/1/08 Today, mom reporting no local reaction.
6-8 hours after vaccination, pain, chills, nausea, localized tenderness (L) arm, fever 104 which lasted approx. 24 hrs - other symptoms lasted 72 hours. Did not seek medical attention. Pt fully recovered within 72 hours.
2 miscarriages, one on 3/12/21 and another on 5/1/21.
Pt was given DTP/HIB 6AUG91 & devel a fever of 104.2 that night; Mom gave APAP; Next day temp 99.6 w/very sore leg; Not seen by MD;
she's breastfeeding; A spontaneous report was received from a consumer concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- exposure during breastfeeding .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event- exposure during breastfeeding.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event- exposure during breastfeeding was considered unknown.
c/o dizziness, syncope, h/a, generalized malaise, pain & tenderness, lt side of body, weakness;
sore throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache). On 12-Apr-2021, OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant nor treatments medications were provided.    Reporter did not allow further contact
Patient stated her lips and tongue feel itchy.  Patient stated she is allergic to shellfish and gets anxious every time she gets a vaccine.  Vital signs within normal limits.  BP 128/74, HR 68, O2 sat 96%.  Patient took her own Benedryl PO.  Patient stated she is feeling better, and she wants to go home.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced confirmed immunological vaccine failure. The patient had took vaccine five week ago and when tested showed no antibodies to covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with PQMS no.90000176109.; Sender's Comments: V0:20210416558-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.
55 patients received a dose of a vial after 12 hours of initial puncture; 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial punctured on 11-Nov-2021, dose given and kept in refrigerator after puncture.  No treatment information was provided by the reporter.
No other adverse effects were reported in the patient.; Nurse reports that a patient received a dose of PROQUAD that was reconstituted with MENACTRA instead of sterile diluent.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies was not provided.  On 11-JUN-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage schedule, route of administration and anatomical location were not reported) (lot number S003188 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 07-APR-2021) for prophylaxis. The vaccine was reconstituted with meningococcal acywconj vaccine (dip toxoid) (MENACTRA), 0.5 milliliter (ml) (lot number U6585AA, and expiration date 11-APR-2021) instead of sterile diluent (product preparation issue). No adverse effects were reported.
After receiving vaccination patient c/o rapid HR and chills. Vital signs taken BP 155/92, HR 118. Reported not having anything to eat or drink this am prior to administration. Vitals monitored in total 40 minutes. Chills now resolved. HR 77 and BP 147/83 prior to departure. Offered option to be checked out in ED here at medical center. Patient declined. Given water, oj, and pastry per request. Denied itching, rash, or swelling of any kind prior to departure. Followed up with patient 3/26/21 at 1248 via number listed. Stated her symptoms had resolved and not returned after leaving medical center. No new symptoms reported. Discussed severe allergic reaction s/s and to go to nearest ED should they occur.
This case was reported by a healthcare professional and described the occurrence of lymph node enlargement in a 53-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 29 October 2010, after 13:00, the subject received 1st dose of FLULAVAL at 0.5 ml in the left arm. On 30 October 2010, 1 day (24 hours) after vaccination with FLULAVAL, the subject experienced lymph node enlargement. One day later on 31 October 2010, the "nodule" continued to enlarge and the subject experienced lymph node tenderness. The subject went to his physician, but was not prescribed anything. The outcome of the events was indicated to be better at the time of reporting on 04 November 2010. The reporter stated they were not completely resolved yet, but better. Follow-up details received the same day of the initial report, 04 November 2010, indicated that the subject experienced a similar reaction to the H1N1 vaccine in January 2010. No additional details regarding this event were reported. Follow-up information was received from the reporting healthcare professional on 03 January 2011: It was reported that this case had been reported to the Centers for Disease Control (CDC). The onset of the lymph node enlargement and lymph node tenderness was on 30 October 2010. As of 04 November 2010, the subject had a 1 centimeter palpable nodule above the left collarbone and the events were considered as improved. The subject was advised to call if symptoms worsened and no call had been received as of the time of reporting (22 December 2010). The healthcare professional also mentioned that the subject had a similar incident with a previous Flu vaccine - H1N1 vaccine (details unknown, Pandemic vaccine H1N1, unspecified manufacturer) in January 2010.
Patient was given Moderna vaccine instead of Pfizer. Should have received Pfizer due to age (16).
Received Flu mist 10/27 overnight into 10/28.  Developed abrupt onset of aches, chills, sore throat and fever approximately 11pm-midnight 10/28.  no known exposures to illness or influenza.
Shortly after getting vaccine (20min afterward) my left hand and forearm started to tingle and go numb. That sensation spread up my arm to my neck on the left side. Over night the tingling persisted and now my hand is very weak on the pinky and ring finger and the tingling /numbness is localized to the outside area of my left arm, neck on left side and the pinky side (half of my hand). Lifting is not normal and grip is weak. Also getting tingling in my jaw on left side.  Currently 10:12 am on the following day after vaccine- symptoms seems to be progressing in location.
Anemia; "debilitating reaction" / described it as "weakness or tiredness"; "Debilitating reaction" / described it as "weakness or tiredness"; Like when you have the flu; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of no adverse event (received on 25th September 2007).   On 12th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced weakness, fatigue, influenza-like symptoms and anemia. On an unknown date, the outcome of the weakness, fatigue and influenza-like symptoms were recovered/resolved and the outcome of the anemia was unknown.   It was unknown if the reporter considered the weakness, fatigue, influenza-like symptoms and anemia to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received 1st Shingrix Vaccine dose on the left arm and experienced a debilitating reaction which the patient described as weakness or tiredness. The adverse events of first dose was worse than the second dose and stated it was like when one had the flu. The patient stated that this reaction lasted for 5 days. At the time of reporting the patient took Thyroid medications and not received it when she took the Shingrix Vaccines. The patient also had anemia and fatigue problems. The reporter consented to follow up and also gave consent to follow-up with health care professional. For tolerance to the 2nd dose of Shingrix, refer case US2021AMR048204.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR048204:same reporter
Irregular heart beat Saturday night through all of Sunday. Headache Sunday to present day, nausea, low fever. Some irregular heart beats all days to present 9/29/2010 and continuing.
Major Tonic-Clonic (Grand Mal) Seizure while sleeping (lasted about 10 min total from onset until full consciousness regained). During tonic part of seizure, both shoulders dislocated and bilateral (left and right) proximal humeral fractures resulted. Patient was in bed during entire episode and did not fall... fractures and dislocations resulted only due to muscle contractions (spouse awoke to hearing the bones dislocating and fracturing). Patient was in great health and had no prior history with seizures. Patient was admitted to Hospital on 11/18/2015 for neurological testing and treatment of bilateral proximal humeral fractures with dislocation. Due to extent of humeral fractures, patient was transferred to another hospital on 11/18/2015 where neurological testing was finished and a closed reduction of the shoulders was performed. All neurological testing was clear and no cause could be found from the tests primary possible trigger was flu shot received 12 hours prior to seizure. Humeral fractures were subsequently repaired by Dr. during 8 hour surgery on 11/23/2015. Recovery path will be lengthy with potential future surgeries on both arms to stabilize shoulders due to damage caused by seizure. Patient is now on seizure medication as a precautionary measure to avoid any possibility of additional episodes while arms are healing.
Symptoms started with the baby not eating At 9PM that night he vomited.  He continued to vomit through the next day.  Red dots showed up all over his torso, neck and legs.  He did not eat any solid food until Sunday night, and very little at that point.  He ran a fever Friday, Saturday and Sunday.  (Today is Monday - still TBD about today.)
Fainted/Syncope episode shortly after receiving vaccination and getting up to check out. Had already received a blood draw and did not eat breakfast prior to coming to the site. Patient immediately recovered after fainting, alert and oriented, was aware of his surroundings. Did not remember falling to the floor.
Woke up, got out of bed and was very dizzy.  Reported symptom to clinic nurse who informed her this was a serious side effect of flu vaccine.  Patient/employee contacted Employee Health Nurse who asked clinic nurse to check BP which was WNL.  Instructed by Employee Health Nurse to hydrate well today.  Dizziness has lessened as day has progressed.