chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anxiety; tinnitus in my left ear, tinnitus spread to both ears; a quarter-sized red welt appeared; Covid Arm; tongue felt swollen; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus in my left ear, tinnitus spread to both ears), SWOLLEN TONGUE (tongue felt swollen), ANXIETY (anxiety), URTICARIA (a quarter-sized red welt appeared) and VACCINATION SITE REACTION (Covid Arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ACETAMINOPHEN for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SWOLLEN TONGUE (tongue felt swollen). On 01-Apr-2021, the patient experienced URTICARIA (a quarter-sized red welt appeared) and VACCINATION SITE REACTION (Covid Arm). On 07-Apr-2021, the patient experienced TINNITUS (tinnitus in my left ear, tinnitus spread to both ears). On 21-Apr-2021, the patient experienced ANXIETY (anxiety). On 05-Apr-2021, URTICARIA (a quarter-sized red welt appeared) had resolved. At the time of the report, TINNITUS (tinnitus in my left ear, tinnitus spread to both ears) had not resolved and SWOLLEN TONGUE (tongue felt swollen), ANXIETY (anxiety) and VACCINATION SITE REACTION (Covid Arm) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-089166 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received on 07-Jun-2021: contains No New Information. On 19-Jul-2021: Follow up received on 19 Jul 2021 contains non significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089166:First Dose
COVID arm; Arm was swollen, could not touch shoulder; Red arm, redness down elbow to shoulder; Arm was hard; Injection really hurt; Developed 4 inch bruise; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (COVID arm), PERIPHERAL SWELLING (Arm was swollen, could not touch shoulder), ERYTHEMA (Red arm, redness down elbow to shoulder), INDURATION (Arm was hard) and INJECTION SITE PAIN (Injection really hurt) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, 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 experienced VACCINATION SITE REACTION (COVID arm), PERIPHERAL SWELLING (Arm was swollen, could not touch shoulder), ERYTHEMA (Red arm, redness down elbow to shoulder), INDURATION (Arm was hard), INJECTION SITE PAIN (Injection really hurt) and VACCINATION SITE BRUISING (Developed 4 inch bruise). At the time of the report, VACCINATION SITE REACTION (COVID arm), PERIPHERAL SWELLING (Arm was swollen, could not touch shoulder), ERYTHEMA (Red arm, redness down elbow to shoulder), INDURATION (Arm was hard), INJECTION SITE PAIN (Injection really hurt) and VACCINATION SITE BRUISING (Developed 4 inch bruise) outcome was unknown. Not provided          No relevant concomitant product use was reported.  Treatment details included clindamycin.
Pt presented back to clinic on 1/7/21 and shared adverse event of numbness/tingling on right side of face and right leg (same side as vaccine was given).  She was treated by PCP for potential bells palsy.
Day of vaccination, throat became swollen, chest pain in the evening that resolved. Also severe fatigue and nausea.
significant swelling of entire thigh;extreme irritability;prolonged cry (4hr);t102.5;excessive sleep following day;
Feel something spinning in my head/had the same reaction; I was sick in bed; This spontaneous case was received on 18-Jan-2021 from other non-healthcare professional (consumer) via Agency (reference number: AU22-000095) with additional information received on 18-Dec-2021 (reference number: AU22-000094) and on 19-Jan-2022 from Agency (refenrece number: SEQW22-00271) (being processed together), and concerned a female patient of an unknown age.   The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 22-Oct-2015, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; route of administration, dose, anatomical location: not reported) as flu shot. The batch number reported was11749211A.  On an unspecified day, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced feeling of something spinning in her head. Also, the patient stated that she was sick in bed for three months after receiving this vaccine. The patient reported that her neighbour had the same reaction.   The outcome of the events were unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A female patient of unknown age experienced spinning sensation and sickness after receiving influenza virus vaccine polyvalent. Elapsed time between vaccination and the onset of the events is unknown. Due to this lack of information regarding chronology, causality is unassessable.; Sender's Comments: A female patient of unknown age experienced spinning sensation and sickness after receiving influenza virus vaccine polyvalent. Elapsed time between vaccination and the onset of the events is unknown. Due to this lack of information regarding chronology, causality is unassessable.
Moderate lower right abdominal pain and moderate/severe vomiting. Vomiting lasted aprox 13 hrs. Abdominal pain lasted approximately 2 days.
Fatigue, extremely achy, chills, felt like my bones were hurting, slight fever, joints hurt, headache, and still ongoing after 53 hours after my shot.
From an initial report received on 01/04/2001, it was reported that an 18 year old male was given MEnomune vaccine on 09/27/2000. Pt reportedly "felt a little flu-like all day. 2 hours after shot give, felt "a lot worse."... head hurt/aches/cold shivers and perspired.17:45 came back to nursing station T99.6 skin warm, not perspiring 18:07 T99.7 will go home and take Tylenol or Advil for migraines and report to student health if further symptoms."
Narrative: Patient reported lightheadedness following administration of Pfizer COVID-19 vaccine. Patient required no intervention and was able to leave following normal monitoring period.
No additional AE reported; VAQTA being inadvertently being administered in an 8 week old female; VAQTA being inadvertently being administered in an 8 week old female; This spontaneous report as received from a registered nurse and refers to a 8-week-old female patient. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) 25U/0.5ml pediatric, prefilled syringe (route of administration and anatomical location were not provided; lot number T014835 was confirmed to be valid, expiration date was not reported but upon internal validation process, it was established as 17-JUL-2021) instead of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (wrong product administered). hepatitis a vaccine, inactivated (VAQTA) was registered to use for children and adolescent 12 months to 17 years, but was inadvertently administered to 8-week-old child (product administered to patient of inappropriate age).  No additional adverse event was reported, but it was planned to follow up with the parents of patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T014835; expirationdate: 17-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Client states "The night of the day I received the Hepatitis B vaccine I developed chills, then hot and nauseated." Client states "In the morning when I woke up I noticed a red, itchy rash on the same arm I got the vaccine and it extended onto my back." Client states "I took BENADRYL and rash left after a day or two." Client denies seeking medical care or other s/sx occurring. Client denies new medications or foods taken in same time period.
This gentleman was positive for COVID in 12/17/20. Got received convalescent plasma, dexamethasone, antibiotics and anticoagulation due to having pneumonia, and possible myocarditis. He was admitted for acute kidney injury and traumatic rhabdomyolysis.  Then he got his first Moderna vax a month later (1/19/21) and his second (2/16/21).  He then came up positive for COVID 19 again on 4/22/21 when he was hospitalized for a second acute kidney injury , confusion and pneumonia. His COVID was not treated any further. I believe he is a breakthrough case because he did not wait long enough after getting his BAM Tx
strange side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strange side effect) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (strange side effect). At the time of the report, VACCINATION COMPLICATION (strange side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021:
Wheezing began a few hours after receiving the administration. Next morning had swelling of face, started feeling nauseous and then passed out.
This spontaneous report as received from a pharmacist refers to a 69 years old female patient (reporting pharmacist's mother) with no drug reactions or allergies. The patient's medical history included previous case of shingles (date unspecified). On 23-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and exp. date were not reported). No other co-suspects were reported. No concomitant medications were reported. Pharmacist reporter that in August 2012, her mother developed injection site reaction that lasted a couple of days. It was reported that the patient's spoke to the pharmacist and no treatment was given for the patient's event. The outcome of injection site reaction was reported as recovered in an unspecified date in 2012. The relatedness for the patient's injection site reaction was not reported for ZOSTAVAX. Additional information is not expected.
6/17: two episodes of shortness of breath and heart palpitations lasting approx 30 mins each first one around 5pm 2nd around 10pm. 6/18: 9am shortness of breath and palpitations started again lasted over 2 hours. Pediatrician evaluated patient and ordered chest X-ray which was normal. Pediatrician referred us to ER for further evaluation. At the ER they did blood work, EKG, urinalysis. EKG was normal. Labs came back showing elevated D Dimer so they ordered a CT scan of her chest which came back normal. They also ordered a coagulation profile which came back normal. We were released from the ER and told to monitor if symptoms continued. She had no symptoms of shortness of breath or palpitations while at the ER. As of today she continues to have very short episodes of palpitations but has not had shortness of breath.
pt recv vax 10/1/97 & became preg LMP 9/97;pt devel diabetes during preg & was treated w/insulin;
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning an 20 year old female with 1 previous pregnancy including 1 spontaneous abortion (miscarriage) and no medical history or concurrent condition who was vaccinated with the third dose of GARDASIL (lot # 661846/1312X) on 27-JUL-2009 then became pregnant. Concomitant medication included PLAN B. Her estimated conception date was 10-AUG-2009 (LMP: 27-JUL-2009, EDD: 03-MAY-2010). Method of confirmation was unknown. Follow up information was received which reported that on 18-NOV-2009, 17-DEC-2009 and 05-JAN-2010, the patient underwent routine ultrasound and results revealed normal. On 28-FEB-2010, at 28 weeks from LMP, the patient delivered a liveborn infant with unspecified congenital anomaly (also reported normal). During labor/delivery, the patient experienced pre-eclampsia. It was also reported that the patient received PROCARDIA during this pregnancy for an unspecified indication. Upon internal review, infant born at 28 weeks from LMP was considered to be an other important medical event. Unspecified congenital anomaly was reported for the baby. The baby's experience has been captured in WAES 0909USA02628B1. Additional information has been requested.
pt recvd vax;devel black & blue mark approx size of a quarter at inject site & mild soreness; sxs resolved w/in 3 days;
Patient was given 2 MCV-4 (Menactra) vaccines. One should have been HPV (Gardasil).
2-hrs following shot could not lift left arm. I forced myself to move it as much as possible but I felt severe pain, I tried Ibuprofen and no relief. Finally saw nurse practitioner on Tues Nov. 20 and she gave me a steroid shot in right hip and prescribed a pain med LORTAB 7.5. On Thursday, November 1, 2012 at about 1:10 pm at pharmacy. I still cannot lift my left arm without severe pain after 26 days. I saw my internal med doctor's nurse practitioner on November 20th and she gave me a steroid shot, along w/a pain med, LORTAB. Nothing is helping. I am healthy; had no problems at the time of injection; been taking the vaccine twenty years now; never have had any side effects. Please tell me something can be done to help me.
Received the second dose Sunday, by Thursday I have lost the ability to walk/stand. Legs are consistently numb and feel like they are sleep.
Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination; Periods are heavier; Periods are more painful; Extremely irregular, worse than when i was teenager; I have gotten my menstrual cycle 4 times since Moderna's vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination), HEAVY MENSTRUAL BLEEDING (Periods are heavier), DYSMENORRHOEA (Periods are more painful), MENSTRUATION IRREGULAR (Extremely irregular, worse than when i was teenager) and POLYMENORRHOEA (I have gotten my menstrual cycle 4 times since Moderna's vaccination) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Menopausal symptoms, Hot flashes and Mood swings. Concomitant products included ESTROVEN for Menopausal symptoms.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MENSTRUAL DISORDER (Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination), HEAVY MENSTRUAL BLEEDING (Periods are heavier), DYSMENORRHOEA (Periods are more painful), MENSTRUATION IRREGULAR (Extremely irregular, worse than when i was teenager) and POLYMENORRHOEA (I have gotten my menstrual cycle 4 times since Moderna's vaccination). At the time of the report, MENSTRUAL DISORDER (Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination), HEAVY MENSTRUAL BLEEDING (Periods are heavier), DYSMENORRHOEA (Periods are more painful), MENSTRUATION IRREGULAR (Extremely irregular, worse than when i was teenager) and POLYMENORRHOEA (I have gotten my menstrual cycle 4 times since Moderna's vaccination) outcome was unknown.            No treatment medications were provided. The periods were heavier, more painful and extremely irregular, worse than when i was an teenager. Had been Menopausal seven months prior to this vaccination.
had a little bit of a fever that lasted maybe four hours after receiving the Pfizer Vaccine; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient had a little bit of a fever that lasted maybe four hours after receiving the bnt162b2 vaccine. The caller stated that the report could be completed if necessary, for her husband. The caller stated that she did not have Vaccine card of her husband. The caller stated that she really did not want to complete the reports, it was not pertinent to the caller to complete the reports, if not pertinent to the company. The caller would prefer not to complete the reports and stated she did not have any of the information to provide anyway. The outcome of the event was recovered.  Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
p/vax mom reported child exp projectile vomiting;@ office visit pt afeb;devel T103 & vomiting;seen by MD T101;had 6 or 9 episodes of vomiting;hosp & eval for sepsis;on admission pt irritable, mottling of extrem, T103 then 104.8; Discharge diagnosis: possible sepsis and evaluated for this. Rotazyme positive stool. Fever illness in a neonate.
This spontaneous report as received from a registered nurse refers to a currently 17 years old female patient. On an unknown date the patient was vaccinated with VARIVAX (Merck) (route, lot number, expiration date not reported). No other relevant medical history and no concomitant medications were reported. The reporter stated that on an unknown date the patient experienced an unspecified allergic reaction when she was younger to the preservative that was in VARIVAX (Merck). The outcome of the allergic reaction was reported as recovered/resolved. No further relevant information was provided. Additional information has been requested.
Had Johnson n Johnson Covid vaccine/Moderna shot made me sick /Pfizer shot did the same thing; Sick; Terrible aches/Pains; Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson n johnson (Dose number unknown), for COVID-19 immunization, reaction(s): "No adverse event"; Moderna (Dose number unknown), for COVID-19 immunization, reaction(s): "Sick", "Flu like symptoms", "Pains", "Terrible aches"; Flu vaccine (Dose number unknown, manufacture unknown), for immunization.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Had Johnson n Johnson Covid vaccine/Moderna shot made me sick /Pfizer shot did the same thing"; ILLNESS (non-serious), outcome "unknown", described as "Sick"; PAIN (non-serious), outcome "unknown", described as "Terrible aches/Pains"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional information: Patient had Johnson n Johnson COVID vaccine at beginning of pandemic. No negative effects at all. Moderna shot made me sick with terrible aches n pains n flu like symptoms for 24 hours. Pfizer shot did the same thing. Patient was asking as will there be a future vaccine that doesn't give u these horrible side effects. No other vaccines such as flu has ever made me sick. Patient was 68 in good medical shape.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse event reported. Pt was given Tdap on 05/02/2018 - wrong dose due to age.
Her Crohn's disease got really bad; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Her Crohn's disease got really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), ATORVASTATIN CALCIUM (LIPITOR), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and ALPRAZOLAM (XANAX) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced CROHN'S DISEASE (Her Crohn's disease got really bad) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, CROHN'S DISEASE (Her Crohn's disease got really bad) and INFLUENZA LIKE ILLNESS (Flu like symptoms) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Description: The patient experienced flu like symptoms and her Crohn's disease (medically significant) got really bad after receiving her first shot of the Moderna COVID-19 vaccine. The symptoms were better, but they were still there at the time of the call.  The patient took acetaminophen to help with the symptoms.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.