chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DRINKING COFFEE GAVE ACID REFLUX; SORE ARM AFTER COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (DRINKING COFFEE GAVE ACID REFLUX) and VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (DRINKING COFFEE GAVE ACID REFLUX). In 2021, VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE) had resolved. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (DRINKING COFFEE GAVE ACID REFLUX) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cortisol: elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported. On unknown dates, the patient experienced CORTISONE LEVELS ON BLOODWORK WERE  ELEVATED and DRINKING COFFEE GAVE ACID REFLUX. In 2021, the patient experienced SORE ARM AFTER COVID VACCINE. In 2021, the SORE ARM AFTER COVID VACCINE resolved. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of CORTISONE LEVELS ON BLOODWORK WERE ELEVATED was not provided. The reporter's causality for the event(s) of SORE ARM AFTER COVID VACCINE and DRINKING COFFEE GAVE ACID REFLUX with HUMIRA(ADALIMUMAB) was no reasonable possibility.   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.
Slight yeast infection after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL INFECTION (Slight yeast infection after the 1st dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FUNGAL INFECTION (Slight yeast infection after the 1st dose). At the time of the report, FUNGAL INFECTION (Slight yeast infection after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.
Became immediately hot, within 2 hours I was having issues breathing, blood pressure of 202/170.  Put on oxygen as my O2 dropped to 90%, Irregular EKG, blood work taken.
diarrhea/ Stools loose; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via an unspecified route of administration into the left arm on 30Jan2021 13:00 at a single dose for COVID-19 immunisation. Medical history included metastatic thyroid cancer and ventilator/oxygen/feeding tube dependent. Patient was not pregnant. Concomitant medication included metoprolol (METOPROLOL), furosemide (LASIX), valacyclovir (VALACYCLOVIR), bifidobacterium lactis (PROBIOTIC) and cetirizine hydrochloride (CETIRIZ). On 30Jan2021 13:30, patient experienced diarrhea; also reported as stools loose. The event was reported as non-serious and the patient was treated with loperamide. Outcome of event was recovering.
onset fever 23APR96 t max 103.8 24APR;febrile sz 25APR AM; seen by MD 25APR96 w/nl exam
I AM A FEMALE OF 77 YEARS OLD, WITH CONDITIONS OF HIGH BLOOD PREASSURE, COPD AND HYPOTHYROIDISM. I HAD MY 1ST SHOT OF THE PFIZER COVID 19 VACCINE, ON MONDAY FEBRUARY 8TH, 2021. ON THURSDAY, DAY 4, I DEVELOPED A PARTIAL FACIAL PARALYSIS ON THE RIGHT SIDE; MY PRIVATE DOCTORS IDENTIFIED IT AS THE BELL'S PALSY SYNDROME, DUE TO THE SIDE EFFECT OF THE VACCINE. I WAS IMMEDIATELY SUBJECTED TO A TREATMENT OF PREDNESONE OF 45 PILLS FOR 12 DAYS, AND SUBLINGUAL VIT. B-12. ON TUESDAY FEBRUARY 16TH 2021, I STARTED  FACIAL THERAPY FOR 10 DAYS. I DID NOT RECEIVED ANY SUPPORT FROM THE CLINIC WHERE I HAD THE VACCINE: THEY INFORMED ME. TO CONSULT MY PRIVATE DOCTOR! MY 2ND DOSE IS DUE THIS MONDAY MARCH 1ST, 2021. I WOULD LIKE TO HAVE SOME INPUT AND SUPPORT, AS TO, WETHER OR NOT TO TAKE THE 2ND DOSE OF THIS VACCINE. I WOULD APPRECIATE ANY INFORMATION YOU MAY PROVIDE! THANK YOU VERY MUCH.
Sudden congestion began in lungs.  Required coughing to clear throat and lungs.  The speed of congestion increased, requiring heavy, continuous coughing at times.  This continued for at least 4 hours. Congestion spread to head, and a headache developed. Eyes became scratchy, extremely bloodshot (no whites remaining), and were almost impossible to keep open because of the pain, even with the use of eyedrops.  This continued into the following day until around 5:00 PM when the redness started to clear.  Eyes continue to become dry quickly and occasionally into this third day. The physical feeling of being ill (no nausea, but out-of-sorts and weak) began at this time and continue also into this third day.   Heavy exhaustion and very low endurance has continued for these three days following, with improvement (50% or so) seen in this third day.
I have random twitches and involuntary muscle movement/spasms in my legs, calves, quads, ankles, feet, and toes and sometimes in my fingers and bottom. The date I've listed below was the 3rd Gardasil shot. The first shot was September 2007. Without looking at the doctor records, I don't have the date, but I remember the month and year. Also, the adverse affect was just sometime in between the first and 2nd shot in 2008  7/1/09 Consultant OB-GYN records received DOS 5/28/09 to 6/9/09. Assessment: Twitches. Twitches in legs and fingers. Concerns about infertility. Anxiety, panic attacks.
4 days after shot experienced nausea and diahreah; 4 days after shot experienced nausea and Diarrhoea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27May2021 10:45 (Lot number: Ew0172) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 01Jun2021, outcome "recovering", described as "4 days after shot experienced nausea and Diarrhoea"; DIARRHOEA (non-serious) with onset 01Jun2021, outcome "recovering", described as "4 days after shot experienced nausea and Diarrhoea". Therapeutic measures were not taken as a result of nausea, diarrhoea.   Additional information; The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Yes. Prior to vaccination,  the patient was not d diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.    No follow-up attempts are possible. No further information is expected.
Pharmacy error: The Moderna vaccine with lot # 003C21A that was sent out on 11/24/21 to our clinic should have the absolute expiration date of 12/17/21 and not
HPV Vaccine was inadvertently, unintentionally, administered to a 2y/o child ,no signs, and symptoms noted. I am following up w/ mom closely.730 pm today  3/12/21 I called mother yo check on the child . Mom said patient is doing ok, playful, no fever, no pain.
pt recv vax 5AUG98 5PM & ok all noc;got up 6AUG98 & running temp & vomiting;vomiting so bad can not keep APAP down;referred to MD;
lt arm @ inj site was 10cm wide, red & warm to touch;tx DPH, APAP ice x3 days;
flu-like sx are reported in pt who recvd expired flu vax w/30JUN93;
injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose No: 1), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "injection site pain".  Additional information: PQC Details: Product: Question: Caller explained he reported his son's AE to agent who referred him for medical inquiries about the Pfizer-BioNTech COVID-19 vaccine. E-transmitting as duplicate. Note that the father's AE below may not have being reported during the initial report. Reporter Subtype: Caregiver. 63-year-old caller explained that his 15-year-old son, Withheld, received the first dose of the Pfiz-er-BioNTech COVID-19 vaccine Wednesday and experienced side effects from the vaccine Thurs-day. He listed the following ones: "mild injection site pain, tiredness almost like weakness, sinus headache, felling unwell, a little nausea, and diarrhea". He specified his "son was not tired to the point of being bedridden" but it interfered with daily activities, and he didn't accept his invitation to go out. He added the weakness was not associated with any signs of anaphylaxis. He explained today, Friday, his son is "better in all these regards". He mentioned he experienced a "little short-ness of breath, the kind you get when you have to take a deep breath" when speaking. He explained they are accustomed to hot and dry weather from (with held) and have move to an area that is "hot and moggy". He specified it is "92 and humid today" and this may have caused the shortness of breath as his son is "overweight". Caller stated he had nothing after getting the first dose of the vaccine, but experienced side effects form the second dose only, as most people do. He specified having injection site pain. He asked if it is normal for his son to have experience side effects from the first dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 27FEB96 &  devel t102 & malaise;mom noticed redness & swelling of lt deltoid area;BP 108/54, p126;6x7cm area over rt upper arm in the area of deltoid which is erythematous, indurated & warm to touch & tender;dx cellulitis;
She is concerned about her pain in the tongue/ she has pain in the side of her tongue; She said that she is losing taste; She is freaking out; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on 13May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced that she was concerned about her pain in the tongue, she said that she was losing taste and she had pain in the side of her tongue as well and she is freaking out on an unspecified date in May2021. It was reported that she had pain in her tongue, however it was not swollen. The outcome of the events was unknown.   Follow up attempts are needed. Further information is expected. No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Very sore arm and not getting better; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Very sore arm and not getting better). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-OCT-2023 The case was received from the consumer via interactive digital media The patient received Arexvy and had very sore arm and not getting better. The follow-up could not be possible as no contact details were available. This case was linked with US2023AMR151214 and US2023AMR151220, reported by the same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR151214:Same reporter US-GSK-US2023AMR151220:Same reporter
Chronic dizzy/lightheadedness, head feels "empty" and slight vertigo. Happens whether I am sitting, standing, laying down, etc.
rash is going up both arms; both hands were covered with rash; rash on left hand; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on left hand), RASH (both hands were covered with rash) and RASH (rash is going up both arms) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included WARFARIN for an unknown indication.   On 12-Mar-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) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced RASH (rash on left hand). On 15-Apr-2021, the patient experienced RASH (both hands were covered with rash). On an unknown date, the patient experienced RASH (rash is going up both arms). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 15-Mar-2021, RASH (rash on left hand) outcome was unknown. At the time of the report, RASH (both hands were covered with rash) and RASH (rash is going up both arms) outcome was unknown. Not Provided          Action taken with mRNA-1273 was not applicable.   This case was linked to MOD-2021-038535 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021 and does not contain any new information
Pt said his arm and shoulder were sore the day after the immunization and he felt very weak, he reported he also felt this way after his flu shot last year
pt recv vax 12JAN96 & 19DEC97 pt presented w/20 fluid filled, varicella-like vesicles which were generalized all over body, as well as low grade fever;
Pt reported sensation down entire arm-length of vaccinated arm immediately after vaccine was given. The following day, she was extremely nauseous. Her arm was painful for the following week and was beginning to improve as of 09/28/15.
GBS (Guillain-Barre Syndrome) - onset a few days after vaccine.
This spontaneous report as received from the wife of a male patient of unknown age. Concurrent conditions and medical history were unknown. On an unknown date about a year ago in 2014, the patient was first vaccinated with ZOSTAVAX against shingles. On an unknown date in 2015, the patient was revaccinated with ZOSTAVAX (extra dose administered, off label use). No adverse events were reported. Additional information is not expected, as no reporter details were provided.
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. The patient received expired product on either 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Kinrix administered to pt. prior to 4th birthday. - Due for DTaP -  Administered on 9/1/22 - No adverse reaction occurred
Two hours after receiving Johnson &Johnson vaccine, she experienced severe vomiting for 4 hours and became lethargic to the point of almost passing out. She was taken to the emergency room and given I.v. Fluids along with zofran to stop vomiting.
This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from the mother regarding a 9 month old female patient who use to say words but now is simply making sounds, sporadically turns head when mother calls her name and tries to bite when nuzzling with mom, and a steady decline in development since receiving the first dose of the vaccine on Sept 19 2005. The patient also received the third dose of Act Hib (haemophilus B conjugate vaccine) (tetanus) on Sept 19 2005. Relevant medical history was not provided. Indication for Prevnar was immunization. product was administered on Sept 19 2005. Dose regimen was 1 dose 1 time per day (intramuscular). Additional suspect medication included Recombivax Hb (hep B vaccine), Tripedia (DPaT) and poliomyelitis vaccine inactivated. Concomitant therapy was not provided. Since receiving the Prevnar vaccine on Sept 19 2005, the mother noticed that her child is now simply making sounds (speech disorder) where before she would say words. the mother also noticed that the child sporadically turns head when she calls her name (abnormal behavior) where before she would turn her head every time her mother called her name. The child also tries to bite mom when nuzzling with her. Mother considers her child's development a steady decline (developmental delay). Events were persisting at time of report. No additional information was available at the time of this report.
No adverse effect .  was give dose for5-11 year instead of 12+ years old
Paresthesia in fingers, hands, legs. Brain fog, insomnia, fatigue, l'hermitte's sign.
Staff reporting that 1st vaccine she doesn't have any reaction.  2nd vaccine on 01/11/2021 1pm.  On 01/13/2021 noon time she started to feel extremely exhausted which last for 3 days.  Staff was so tired that she didn't want to open her eyes.  Staff said she is fine now. Denies COVID exposure.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. On 26-MAY-2015 the patient was vaccinated with one dose of PNEUMOVAX23 (dose and route of administration were not reported, lot # L003188 with expiration date 06-JUL-2016), which was improperly stored. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.; No adverse event; Administered expired Moderna Vaccine to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2023, 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 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.) 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 EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.).    No concomitant medications were reported. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date. The vial size was 2.5 ml.  The vial did not undergo any temperature excursions. No treatment medications were reported.  This case contains information for the 7th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:Patient 1
This spontaneous report was received from a healthcare worker regarding a 12 months old patient of unknown gender. There was no information regarding concurrent condition and historical medication. On 17-APR-2015, the patient was vaccinated with expired dose of PROQUAD (Merck), lot# J010159, expiration date-23-FEB-2015. No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.