chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two weeks after receiving the first Moderna vaccine for COVID-19, patient started to have a fever of 102, muscle aches, extreme fatigue, and extreme joint pain bad enough that she is suddenly needing to use a walker and a wheelchair (5 days on from onset of these symptoms). ? ?She had received the shingles vaccine 21 days prior to the first Moderna vaccine (she was told it was ok if it was at least 14 days prior). ? ?She has been tested three times for COVID-19 (multiple strains) since the onset of her symptoms (all negative) and her doctor, sent her for a bunch of follow-up tests at  Hospital over the weekend (all normal).  Patient has only ever had slight osteo-arthritis starting in her hands before, so this issue with suddenly not being able to walk is coming completely out of the blue. ? ?Have you heard of any delayed reactions to the vaccine like this? ? ?Is it possible? ?
Numbness tingling in left finger tips, progressing up arm.   Few days later started in right arm.  Arm weakness.  Sharp shocking pain in neck and shoulders when arms raised.  Weak legs,  falling down, staggered walk.  Frequent urgent urination.  Constant tongue movement.
pt recv vax 20NOV97 & 22NOV97 pt exp a fever;the next day pt presented to an emergency room w/gen rash that consisted of approx 400 lesions all over mostly above the waist;A specimen of the pt lesions was analyzed via polymerase chain rxn
No additional AE reported; PROQUAD involved in multiple recent temperature excursions; This spontaneous report was received from a medical assistant and refers to a 12 months old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 18-OCT-2021, the patient was administered one dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # T014388, expiration date 24-OCT-2021 (strength, route of administration and anatomical location were not provided) for prophylaxis.   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had underwent a temperature excursion of 6.9 Fahrenheit degrees (F) for 1 hour and 31 minutes on 15-OCT-2021, 5.5 F for 1 hour and 59 minutes on 16-OCT-2021, 5.5 F for 1 hour and 24 minutes on 17-OCT-2021, 5.9 F for 1 hour and 31 minutes on 18-OCT-2021. There were no previous excursions reported. No additional adverse event was reported.
This spontaneous report as received from a consumer that spoke with a nurse refers to several patients with unknown age. On an unknown date the patients were vaccine with a dose of PNEUMOVAX23. Dose, route and lot number were not reported. No co-suspect and concomitant therapies were reported. On an unknown date several patients had a reaction in regards to the vaccine. At the time of this report the outcome was unknown.  The causality was not reported. This is one of two reports from the same source (other case MARRS # 1311USA001563). Additional information has been requested.
Hysterical screaming for four hours, fever, vomiting green frothy mucous. Not relieved by Tylenol or ibuprofen.
headaches  within 24 hours, blurry vision within 30 hours, and double vision in 48 hours
received vaccine reconstituted with water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 2295P, expiry date unknown) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 11th October 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 11th October 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, a baby received Rotarix vaccine reconstituted with sterile water. The reporter consented to follow up by email. Additional Supportive Information: The reporter reported that, a baby received Rotarix vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
High pitched inconsolable crying beginning 24hrs p/administration lasting 12hrs intermittently;
Felt fine the rest of the day.  I woke up the next morning and got so weak I thought I would pass out.  I even felt like I would pass out while I was laying down.
Mom reports fever on 8/25 & child did not feel well 8/26. Rash started 8/28 and child is 'fussy at night'.  The rash is raised, red, blotchy and mostly on the trunk and neck.
Patient reported tachycardia at rest. called cardio. cardio recommended to go to ER. ER stabilized and did observation. They could not find a reason for tachycardia. patient was discharged today after stabilized tachycardia
Patient did not indicate any precautions or contraindications on the Vaccine Administration Sheet.  Following the immunization she left the Personal Services Room to wait the required 15 minutes post vaccination observation period in the waiting area where there are chairs for the patient.  As the Pharmacist came back into the Pharmacy the patient, while standing in the waiting area by the chairs, complained of dizziness.   She then fainted and fell to the floor, hitting her head on a wall on the way down.  The Pharmacist had a technician call 911 and tended to her.  She was instructed to lay still on the floor in the position she was in on her back.  A nurse was in the area and also rendered assistance.  Patients blood pressure was checked and she was offered water.  The paramedics came and evaluated her.  She was later released to a family member who came and picked her up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: 048L21A CU511081) at the age of 57 years 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's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment for covid-19 Test; (Aug2022) Negative, notes: On day 8 after testing positive; (Aug2022) Positive, notes: On day 7 after testing positive; (Aug2022) Positive, notes: A rapid antigen test was only faintly negative; (Aug2022) Positive, notes: a rapid antigen test was strongly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  Clinical Course: It was reported that on day 7 after testing positive, her COVID symptoms were very minor and a rapid antigen test was only faintly negative. On day 8 after testing positive, her COVID symptoms resumed and a rapid antigen test was strongly positive. It is now day 9 and her symptoms and test results are still strong. The patient received treatment with Paxlovid from 14Aug2022 to 18Aug2022. The patient received other medication within 2 weeks of vaccination. The patient had no known allergies and no other medical history.
Pt called to c/o fever, chills, pain, redness, and swollen at site of injection (Lt Arm). Pt states pain 20 mins after receiving vaccines. Pt went to Dr and was given pain medication and prednisone. Meds. also includes Darvocet, Keflex.
Approximately 7 weeks post 2nd dose of the Moderna COVID19 vaccine, developed intermittent nerve pain evidently associated with T4/T5 nerve roots. Approximately 1 week later developed rash/pox consistent with Shingles (varicella zoster) confirmed by a visit to university health care. Doctor prescribed 2 weeks treatment with antiviral VALACYCLOVIR.
Patient came in today to receive her Covid-19 vaccine Pfizer dose #1 for a requirement for her EMS participation. She had a medical exception to Covid-19 vaccine in the past but her doctors recently decided that she could get the vaccine. She does report having a shellfish allergy with anaphylactic reaction so she was recommended to wait for 30 minutes post vaccination. She reports being nervous to get the vaccine due to the concern of having a reaction. Pfizer, 0.3mL Lot # 320308D was given at approximately 10:40am in her left deltoid. At 10:45 a.m. this was approached reporting that she was getting an itchy throat and tongue. She was escorted to a cot to rest and given 1 diphenhydramine tablet (25mg) orally with water at 10:45 am. Blood pressure was 167/119 and pulse 85. No flushing or paleness noted. She reports that her throat was starting to tighten some and feeling itchy, but she could still breathe without issue, "slowly". She chose to sit on the cot vs. lie down. Patient reports needing to keep her breathing calm to prevent anxiety from setting in. They offered to call the ambulance and she responded that she thought that would be good. 911 was called at 10:48 a.m. to dispatch ambulance. 10:50 a.m. She reports that her tongue also felt like it was swelling and her face was starting to feel itchy. She continues to deny increased difficulty with breathing. 10:54 a.m. BP was 165/124 and patient's face is now red/flushed. She reports increased numbness and it moving to her tongue, lips, sinuses/eyes and forehead. She adds that this is what it felt like when she reacts to shellfish. They can hear ambulance sirens, but then they go away.They discussed administering epinephrine to her and she states that she needs to have epi administered now since she is familiar with how her body reacted and felt with her shellfish reaction in the past. 10:59 a.m.they administered 0.3mg epinephrine IM in mid-outer left thigh. Patient reports that she is also feeling very cold now. 11:00 a.m. facility hears ambulance sirens again and the ambulance arrives with a minute or 2 after the administration of epi reports off to the ambulance crew who then took over her care and the ambulance took her away in their rig.
Swollen lymph node in armpit, red rash around swollen/tender area of armpit and just below armpit
During the night, extreme chills, then a fever of over 100, night sweats, and aches. Pain at the injection site,
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 year old patient who received a first dose of the Moderna Covid-19 vaccine as a primary series dose of the Moderna Covid-19 vaccine 24 hours after the Moderna Covid-19 vaccine was first punctured.) and NO ADVERSE EVENT (no adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2022 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022 at 5:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 year old patient who received a first dose of the Moderna Covid-19 vaccine as a primary series dose of the Moderna Covid-19 vaccine 24 hours after the Moderna Covid-19 vaccine was first punctured.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 year old patient who received a first dose of the Moderna Covid-19 vaccine as a primary series dose of the Moderna Covid-19 vaccine 24 hours after the Moderna Covid-19 vaccine was first punctured.) and NO ADVERSE EVENT (no adverse event) 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 considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (4 year old patient who received a first dose of the Moderna Covid-19 vaccine as a primary series dose of the Moderna Covid-19 vaccine 24 hours after the Moderna Covid-19 vaccine was first punctured). No concomitant medication were provided. The vial was initially stored in the refrigerator on 19-AUG-2022 and was first punctured on 30-Aug-2022 at 5:00PM. It was reported that neither, the punctured vial was stored in a cooler with Ice Packs in the cooler. Cooler was cold but there was no temperature monitor in the cooler so the exact temperature for the time that the vial was in the cooler was not known. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C equal to 46 degree to 77 degree F) was for 45 minutes. No treatment details were provided
PATIENT DESCRIBED PAIN IN ARMAT SITE AND ABOVE FOLLOWING THE INJECTION. THIS PAIN CONTINUES HER TO NOT BE ABLE TO LIFT RIGHT ARM WITHOUT PAIN . WENT TO URGENT CARE ON 11/2/23 AS HER PRIMARY DOCTOR COULD NOT  SEE HER. AT THE URGENT CARE SHE HAD AN XRAY DONE, WAS GIVEN PRED PACK AND MOTRIN RX.  AT THE TIME OF THIS REPORT SEH DOES NOT KNOW THE RESULTS OF THE X-RAY AND FEEL  A SLIGHT IMPROVEMENT BUT STILL IS PAINFUL.
Lost smell; Lost taste; Exposure to COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposure to COVID-19), ANOSMIA (Lost smell) and AGEUSIA (Lost taste) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 07-Dec-2021, the patient experienced ANOSMIA (Lost smell) and AGEUSIA (Lost taste). In December 2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposure to COVID-19), ANOSMIA (Lost smell) and AGEUSIA (Lost taste) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2021, SARS-CoV-2 test: (Negative) Negative.         No concomitant medication provided. No treatment information mentioned.  Patient reported that in DEC2021, they were exposed to COVID. On 07DEC2021, lost smell and lost taste.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
No adverse event; Received Moderna Covid 19 Bivalent booster instead of  second primary series; Patient recieved first dose on 25-Aug-2022 and second dose on 29-Oct-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster instead of  second primary series), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 25-Aug-2022 and second dose on 29-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster instead of  second primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 25-Aug-2022 and second dose on 29-Oct-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster instead of  second primary series), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 25-Aug-2022 and second dose on 29-Oct-2022) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster instead of  second primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 25-Aug-2022 and second dose on 29-Oct-2022).    Concomitant medication was not provided. The patient received the first dose on 25-Aug-2022 Treatment information was not provided.
Starting about 3 am on 6/2/21 she had a severe headache that lasted about 24 hours. During the day on 6/2/21 she noticed a lump on the left side of her neck that is tender to touch. This was diagnosed as a swollen lymph node.
Freezing chills/shaking; 10NOV92 weak, pressure in stomach-thought was going to die;
Pt vaccinated with MMR 15 min after administration developed urticaria, respiratory distress, wheezing treated w/Epi x2 & Proventil.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 01-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800; expiry date 24-MAR-2017 (dose, frequency, route of administration were not provided). The M-M-R II was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in between 47 degrees Fahrenheit (F) to 77 F (also reported as: "46.9 F") for 30 minutes. There was no previous excursion. The digital data logger was involved in recording the temperature excursion.; Sender's Comments: US-009507513-1712USA010650: US-009507513-1801USA002559: US-009507513-1801USA002560: US-009507513-1801USA002561: US-009507513-1801USA002562: US-009507513-1801USA002563:
Extreme pain at injection site and extending to elbow of affected arm; headache; chills or shivering.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: En6205), in left arm, on 30Mar2021 as dose 2, single (Lot number: Er8733), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: Fj8762), in left arm and on 14Jul2022 as dose 4 (booster), single (Lot number: Fm0173) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Bactria" (unspecified if ongoing), notes: Known allergies: Bactria. There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin", notes: Known allergies: Augmentin; Clindamycin, reaction(s): "Known allergies: Clindamycin.", notes: Known allergies: Clindamycin.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Sep2022) Positive, notes: Testing positive again and bad symptoms 4 days after finishing initial treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medication was received in 2weeks.
Initial information received on 26-Nov-2018 regarding an unsolicited valid serious case received from a consumer (reporter country, country of incident was not reported). This case involves a Child patient who experienced child who may have developed ITP (Idiopathic thrombocytopenic purpura) following flu vaccination, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a serious child who may have developed ITP (Idiopathic thrombocytopenic purpura) following flu vaccination (immune thrombocytopenic purpura) following the administration of Influenza Vaccine. This event was assessed as medically significant. (Other relevant tests included No lab data.) Final diagnosis was child who may have developed ITP (Idiopathic thrombocytopenic purpura) following flu vaccination. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for ITP (Idiopathic thrombocytopenic purpura). List of documents held by sender: none. Sender's Comments: This case concern a young Patient who presented with Idiopathic thrombocytopenic purpura after vaccination and got hospitalized for unknown days for the event. Time to onset is unknown. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
couldnt hardly move/went to sleep and didn't wake up until time to get ready for work; had to take off of work and slept the whole day unt; cant urinate properly; This spontaneous case was reported by an other health care professional and describes the occurrence of MOBILITY DECREASED (couldnt hardly move/went to sleep and didn't wake up until time to get ready for work), SOMNOLENCE (had to take off of work and slept the whole day unt) and DYSURIA (cant urinate properly) 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 MOBILITY DECREASED (couldnt hardly move/went to sleep and didn't wake up until time to get ready for work), SOMNOLENCE (had to take off of work and slept the whole day unt) and DYSURIA (cant urinate properly). At the time of the report, MOBILITY DECREASED (couldnt hardly move/went to sleep and didn't wake up until time to get ready for work), SOMNOLENCE (had to take off of work and slept the whole day unt) and DYSURIA (cant urinate properly) 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 was provided by reporter. No treatment information was provided by reporter.