chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. The patient had first dose of SHINGRIX in 2018. The patient did not recall them preparing dose in any special way which led to inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. The patient's arm was sore at the site of injection. This case has been linked to case US2019AMR033855, reported by the same reporter for the same patient.
Became pregnant 7 days after 2nd dose of the vaccine (13Jan2021). Viable pregnancy with heartbeat at 6 week ultrasound. Ended in miscarriage; Difficulty breathing; This is a spontaneous report from a contactable nurse (patient). A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on (at the age of 31-years-old) 06Jan2021 14:30 (Batch/Lot Number: EK4176) as DOSE 2, SINGLE  for covid-19 immunisation. Facility in which the vaccine was given was a Workplace clinic. The patient had no known medical history or allergies. Concomitant medications were not reported. Historical Vaccine includes bnt162b2 dose 1, Lot Number EH9899, On 16Dec2020 at 14:00 in Left arm. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient Became pregnant 7 days after 2nd dose of the vaccine (13Jan2021). Viable pregnancy with heartbeat at 6 week ultrasound. Ended in miscarriage on 23Mar2021. (medically significant). On 08Jan2021 at 20:00, 2 days after 2nd dose, sudden difficulty breathing, no personal history of asthma. Needed Primary Care Physician to order Albuterol inhaler, which I needed daily for 4 weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: (PCP Nasal Swab) negative on 19Jan2021, sars-cov-2 test (PCP Nasal Swab): negative on 23Mar2021.Events difficulty breathing and Miscarriage of pregnancy  required Emergency Room Visit and Physician Office visit. Treatment was given for the events which included Albuterol for difficulty breathing, D+C on 25Mar2021 for miscarriage. The clinical outcome of the events was unknown.
Joint inflammation, my whole body has been hurting since I received my second dose on 01/20/2021. My joints keep cracking and pain in joints, especially hips, knees, feet, and arms. My neck has been sore and stiff since day 2 of second shot series.
Mother noted following day child had hoarsness, "lack of voice", and diarrhea, and low grade fever.  Saw physician 6/30, no illness diagnosed.  Continues with hoarsness but appears to be resolving, 1-2 diarrhea stools/day at present.
AGE WRITTEN AS 12 YEARS ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOM. DATE OF BIRTH IN DATABASE IS DIFFERENT FROM DATE OF BIRTH PROVIDED. CHILD WAS TOO YOUNG TO RECEIVED VACCINE ON 7/12/2021.
12/9/2021 (Day after vaccination) Migraines and visual auras (3:00pm - 8:00pm) Stomach cramps (6:00pm-9:00pm) Seizure (11:50pm) Valtoco 10mg administered
Child ran fever 99 F (axillary)--> 100 axillary until 11:30 PM at which time temp went to 102 and infant had a seizure. 10/3/06 Received medical records from hospital which reveal patient seen in ER with history of eyes rolling back in head & becoming limp same day as received vaccines.  Parent reported patient had temp reamainder of that day & felt very hot immediately preceeding event.  Two more episodes of the same symptoms were witnessed in ER where temp noted to be 102.3. Patient had mild URI symptoms of sneezing & mild congestion prior to receiving vaccines.  Family hx includes one family member with seizure disorder.  Patient admitted for 24 hour observation, no further symptoms noted & was d/c to home in AM. Final Dx: febrile seizures./ss
Patient has not received 2nd dose yet; This spontaneous case was reported by a patient and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient has not received 2nd dose yet) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient has not received 2nd dose yet). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Patient has not received 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were unknown.  Patient has not received 2nd dose which was scheduled on 13May2021.   No treatment nor AE was reported.
feeling tingling in her hands and feet again; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the parent reporting for a patient (daughter).  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jun2021 (Lot number: EW0177) at the age of 15 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer, dose number: 1, lot number: EW0173, vaccine location= Left arm), administration date: 02Jun2021, when the patient was 15 years old, for COVID-19 immunization, reaction(s): "foggy brain", "tingling in hands and feet". The following information was reported: PARAESTHESIA (non-serious) with onset 15Jul2021, outcome "not recovered", described as "feeling tingling in her hands and feet again". The event "feeling tingling in her hands and feet again" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia.  Additional information: Known allergy was None. If other vaccine in four weeks was None. Other medications in two weeks were None. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that two weeks after the first dose, the reporter's daughter experienced "foggy" brain and tingling in hands and feet. Her pediatrician examined her and took bloodwork with normal results. The tingling lasted one week and then disappeared. She started feeling tingling in her hands and feet again this week with it being constant starting on the evening of 15Jul2021. The reporter reported it to her pediatrician again and she is to rest and stay cool.  Follow-up attempts are completed. No further information is expected..
Chills; Headache; Muscle pain; Fatigue; Loss of appetite; Injection site redness; Injection site redness, swelling, and pain; Injection site redness, swelling, and pain; Dose received 3; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm, administration date 28Nov2021 at 11:45 (Lot number: FJ1620) at the age of 60 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing), notes: Hashimotos and "Hypertension" (unspecified if ongoing). Concomitant medications included: CYTOMEL; LEVOXYL and RAMIPRIL. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: EP6955, Anatomical location: left arm, Administration time: 15:00, Route of administration: intramuscular), administration date: 24Mar2021, and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: EL3248, Anatomical location: left arm, Administration time: 14:00, Route of administration: intramuscular), administration date: 03Mar2021; both administered when the patient was 59 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 at 11:45, outcome "unknown", described as "Dose received 3"; CHILLS (non-serious), HEADACHE (non-serious), MYALGIA (non-serious), FATIGUE (non-serious), DECREASED APPETITE (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), all with onset 29Nov2021 at 06:00, outcome "recovering", all described as "Chills, headache, muscle pain, fatigue, loss of appetite, injection site redness, swelling, and pain". Therapeutic measures were taken as a result of chills, headache, myalgia, fatigue, decreased appetite, vaccination site erythema, vaccination site swelling and vaccination site pain and included treatment with ADVIL.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
mild respiratory symptoms including  sneezing; head congestion; coughing; scratchy throat; Overweight; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (mild respiratory symptoms including  sneezing), HEAD DISCOMFORT (head congestion), COUGH (coughing), THROAT IRRITATION (scratchy throat) and OVERWEIGHT (Overweight) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SNEEZING (mild respiratory symptoms including  sneezing), HEAD DISCOMFORT (head congestion), COUGH (coughing), THROAT IRRITATION (scratchy throat) and OVERWEIGHT (Overweight). At the time of the report, SNEEZING (mild respiratory symptoms including  sneezing), HEAD DISCOMFORT (head congestion), COUGH (coughing), THROAT IRRITATION (scratchy throat) and OVERWEIGHT (Overweight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from a licensed practical nurse refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 26-OCT-2015, the multiple, unspecified patients received improperly stored doses of ROTATEQ orally, lot # L008997 exp. 04-DEC-2016 (dose was not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Addiitonal information has been requested.
Patient became ill the day she received the vaccine. Has a localized reaction at the site. Did not get better and became short of breath, had bodyaches. Patient was seen 12/8/2021 and was given an inhaler,covid and CXR was ordered which both were negative.  Patient then had a low blood sugar lab come back at 47. A CT scan of chest was ordered due to the SOB.
Left arm swollen and red, hot to touch and itchy develped 24 hrs after shot R side of face red and itchy. Given-Per doctor-apply ice and give Benadryl-5cc tid.
The arm swelled on vaccine site and then throughout body and I ended up on Prednisone on April 22, it helps then for a few days then it hives start again. On May 11th I started prednisone again. June 12th I went to Urgent care and started prednisone again. The hives since the Moderna shot are different then my chronic hives. The hives hives from the shot affected my blood vessels, it's called Urticarial Vasculitis
Immediately after the shot was given patient experienced very fast heart beat and chest tightness. The heart rate calmed down shortly thereafter but the chest discomfort lasted about and hour 15 min before  resolving.
8-16-07 Petechiae and purpura noted by patient along with a sore throat. Throat culture done, result (4 d later) was negative AB strep. Because of low platelet count, admitted to hospital. Dx: ITP, Rx IVIG x 2 with later increase in platelet count.  10/01/2007 MR received for hospital DOS 8/16-18/2007 for D/C DX: Immune Thrombocytopenic Purpura.  Pt presented initially to PCP with c/o rash, excessive bleeding following a knee laceration, spontaneous nosebleed, and a new purple rash in the mouth.  PCP noted petechiae and  wet purpura on exam and labs done with a platelet count of 1000.  Sent to ER for eval. PE (+) for petechiae over entire body, palpable bruises as well as non-raised bruises, pharyngeal purpura and several lacerations. Discharge to F/U with hematologist.
Information has been received from a law office worker concerning an approximately 37 year old female with diabetes who on 19-NOV-2003 was vaccinated "in bottom part of deltoid muscle" with a second dose of Pneumovax 23 (lot 647634/0863N).  During the evening of 19-NOV-2003, the patient developed swelling and redness in her arm.  The patient reported that she had a "neuropathy disorder".  The patient also had pain and numbness in her shoulder after receiving Pneumovax 23.  The patient was treated with diphenhydramine HCl by her physician.  An electromyography and bone scan were within normal limits.  At the time of this report, the patient had not recovered.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complied with the standards of the agency and was released.  No further information is available.
Moderna COVID-19 Vaccine EUA, mild headache, achiness in neck, injection site soreness.  All for 36-42 hours from injection.  Took 2 Tylenol before bed 2nd night.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered a vaccine which is undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) 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)) (batch no. AS7171B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.  On 13-Mar-2023 at 10:00 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Feb-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 13-Mar-2023 at 10:00 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered a vaccine which is undergone temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered a vaccine which is undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        No concomitant medications were reported.    All in Freezer were still totally frozen.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Acute Onset of tachycardia. Resolved within 5 minutes following injection. Accompanied fatigue and feverish symptoms 1 day post vaccination,  resolved by day 3.
Patient reports myalgia and urinary incontinence, fatigue and weakness, chest discomfort. after receiving 3rd booster Moderna Covid vaccine on 10/19/21. PATIENT REPORTS SHE GOT THE FULL DOSE OF MODERNA COVID VACCINE AS HER 3RD DOSE BOOSTER.
This spontaneous report as received from a registered nurse, and refers to a patient of unknown age and gender. The information about patient's concurrent condition, medical and drug history and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), rHA, lot # S032825, dose: 0.5 milliliter, expiration date: 16-OCT-2021 as prophylaxis (route of administration and anatomical location were not provided) (Expired product administered).  No additional adverse event was reported.
Red- Swollen area around DTaP shot site- itchy- No treatment so far.
5 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (5 weeks pregnant) in a 25-year-old 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (5 weeks pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (5 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 25-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Patient described AE as only unusual and looked online for similiar reactions. Reaction was described as COVID vaccine flu; Joint pain but the pain was most pronounced in the area of both wrists where she had carpal tunnel syndrome; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Patient described AE as only unusual and looked online for similiar reactions. Reaction was described as COVID vaccine flu) and ARTHRALGIA (Joint pain but the pain was most pronounced in the area of both wrists where she had carpal tunnel syndrome) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030701) for COVID-19 prophylaxis.     The patient never had COVID and got vaccines early.  The patient's past medical history included Carpal tunnel syndrome, Surgery (had other surgeries, gynocological surgery) and Knee replacement.    On 27-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 28-Oct-2023, the patient experienced INFLUENZA (Patient described AE as only unusual and looked online for similiar reactions. Reaction was described as COVID vaccine flu) and ARTHRALGIA (Joint pain but the pain was most pronounced in the area of both wrists where she had carpal tunnel syndrome). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Oct-2023, ARTHRALGIA (Joint pain but the pain was most pronounced in the area of both wrists where she had carpal tunnel syndrome) had resolved. At the time of the report, INFLUENZA (Patient described AE as only unusual and looked online for similiar reactions. Reaction was described as COVID vaccine flu) had resolved.            Concomitant medication not reported.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reaction was described as COVID vaccine flu that caused her to be a vegetable for one day. Joint pain but the pain was most pronounced in both wrists where she had carpal tunnel syndrome. She was wondering if the affects may be more pronounced in post-surgical patients, and if this experience may not be unusual others who've had surgery. Patient used an Advil/Tylenol mix and recovered within 36 hours. Patient claims it was her 6th vaccine, put the choices in below only go to the 5th dose. It took about 8 hours for symptoms to show up.
P/recvd immun, slept for 3 hrs, then devel unconsolable crying for about 1 1/2 hrs associated w/unusual high pitched cry; there was some sl localized swelling @ the inject site; pt was always alert, responsive & afebrile t100;
Left side of tongue felt swollen; Had difficulty swallowing; Felt anxious; Blood pressure was a little high; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL9266) via an unspecified route of administration in the right arm on 02Mar2021 at 16:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included uterine cancer, radiation and complete hysterectomy in 2004, gallbladder removed in 2021, osteoporosis, high blood pressure, high cholesterol and allergy to computed tomography (CT) scan dye, red dye, muscle relaxants. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 16:15, the patients left side of tongue felt swollen, she had difficulty swallowing and felt anxious. The patient stayed onsite with paramedic checking vitals for 40 minutes, blood pressure was a little high. After the 40 minutes adverse event started subsiding. Unfortunately, the patient had filled out Vsafe as soon as she signed up thinking she was going to be fine. It cannot be revised once submitted. Days later the patient contacted her primary care physician (PCP) plus an additional doctor asking if she should get second dose of vaccine both advised her not to get it. The patients adverse event could have gone into anaphylaxis shock. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tongue felt swollen, had difficulty swallowing and felt anxious, blood pressure was a little high was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Fatigue, dizzy with positional change (referred that to PCP as there was previous hx); H/A worse than normal (has daily but pending vision screen in one month)
Started with scratchy throat, body aches, cough, sinus headache still experiencing. Advil cold & sinus, lozenges.
Swelling in arm from shoulder to elbow (L). Neck and both shoulders stiffness. All started 2/27/16.