chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An adolescent patient was inadvertently administered an 1 mL Adult Havrix dose in the Right deltoid; An adolescent patient was inadvertently administered an 1 mL Adult Havrix dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 16-year-old female patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 11-JUL-2023, the patient received Havrix adult (right deltoid) 1 ml. On 11-JUL-2023, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: An adolescent patient was inadvertently administered an 1 mL Adult Havrix dose in the Right deltoid) and inappropriate age at vaccine administration (Verbatim: An adolescent patient was inadvertently administered an 1 mL Adult Havrix dose). The outcome of the accidental overdose and inappropriate age at vaccine administration were 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: 12-JUL-2023 The reporter called to inquired that would they still required a second vaccine of Havrix and how to proceed with series. The reporter also asked that any reaction from getting the higher dose and what to look for. The reporter reported that an adolescent patient was inadvertently administered an 1 mL Adult Havrix dose instead of 0.5 Ml dose, which lead to overdose and inappropriate age at vaccine administration. The reporter did not consent to follow up.
p/vax rash noted, vesicular on abd, legs & back w/fever to 102 & listlessness;rash crusted;mom noted new sx of poor energy, inc sleep, anorexia, pallor;
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-JAN-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J006236, expiration date: 25-FEB-2016), dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Swelling in the injection area, and redness in the injection area. Right arm.; Swelling in the injection area, and redness in the injection area. Right arm.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Apr2021 at 12:30 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and hyperthyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), levothyroxine (MANUFACTURER UNKNOWN) and probiotics nos (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received benzoyl peroxide (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and experienced drug allergy and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 14:30 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. On 26Apr2021 at 07:00, the patient experienced swelling in the injection area and redness in the injection area right arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling in the injection area and redness in the injection area in the right arm was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
An hour after injection I tried eating some food and found that if I chewed and swallowed too quickly I began to have q tickle in my throat that led to coughing and vomiting, this symptom has begun to fade. I also started having pain in my right arm after a few hours, which I expected, but at roughly 2am the night of the injection, my right armpit also started feeling painful. It's now been 2 days and while most symptoms have abated, my right armpit is still incredibly sore.
Headache and very tired the night of the vaccine. At 12:30 AM that night I woke up to what felt like electric shocks going through my body (painful zaps) and in a full body sweat. No fever. I then started shaking uncontrollably and my heart rate increased to the 100s. The shaking and rapid heart rate lasted for 30 minutes. Woke up again multiple times with body sweats.  In the morning still lethargic but all symptoms resolved by noon.
Pfizer-BioNTech COVID 19  Vaccine  The day after receiving the vaccine, I had a slight headache and later that morning I had a site on my rump that was itchy.  Later I took a shower and I broke out with shingles rash, now two days later feeling achy.    It has been 2 yrs since I had an outbreak of shingles.  I tried to call Pfizer to see if I could safely take the Valtrex dosage for the outbreak and after an hour and a half the call dropped and I was not able to call them.  I did send them a report via the computer to their web address.
sick with side effects; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2022, the patient received Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-July-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient got the Shingrix vaccine this past Thursday, and has been sick with side effects for two days, but would take two days of side effects over getting shingles any time. The follow-up would not possible, as no contact, details were available.
My daugther has painful sore throat on the 4th day after 2nd vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (My daugther has painful sore throat on the 4th day after 2nd vaccination) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (My daugther has painful sore throat on the 4th day after 2nd vaccination). At the time of the report, OROPHARYNGEAL PAIN (My daugther has painful sore throat on the 4th day after 2nd vaccination) outcome was unknown.            No treatment medication was reported. No concomitant medication was reported.
Nurse injected the wrong vaccine and refused to let patient family to take picture of the vials and threw away all the vials before patient family could take a further look. In addition, even at the request of the patient family to have the nurse prepare the vaccines in front of our eyes and with such request agreed and noted by the doctor, the nurse and supervising nurse both did NOT follow.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Individual received the first dose of Moderna at the mall site. They received a second dose of pfizer at this site.
4-5 days following vax c/o nervousness-legs would just shake;problems w/sleeping;couple wk later c/o eyes hurting (did get glasses) 70 days later still problems w/sleeping, loss of appetite;
About 12+ hours after vaccination I began experiencing pain in the back of my right leg. On 4/14 my PCP sent me to the ER. After an ultrasound it was found that I had blood clots.
This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Recurrent UTI / REOCCURING URINARY TRACT INFECTION) and SKIN PAPILLOMA (WARTS / WARTS on face / hands / feet) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe Rheumatoid arthritis). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced URINARY TRACT INFECTION (Recurrent UTI / REOCCURING URINARY TRACT INFECTION) and SKIN PAPILLOMA (WARTS / WARTS on face / hands / feet). At the time of the report, URINARY TRACT INFECTION (Recurrent UTI / REOCCURING URINARY TRACT INFECTION) and SKIN PAPILLOMA (WARTS / WARTS on face / hands / feet) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The daily dose of Moderna was reported as 1 in 1 once.  It was reported that Patient developed warts she suspected it could be from Rinvoq. She desired to reduce rinvoq to once a week. She wanted to see how her blood work was without Rinvoq. She had warts on face, hands and feet. No remedy to help. It was unknown. It was unknown if patient was enrolled in COVID-19 vaccine trial. Treatment medication was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Significant live follow up was received. Concomitant drug information, case narrative updated. On 03-Jun-2022: Significant live follow up was received. Event information was updated ( The event of WARTS was amended to WARTS ON FACE/HANDS/FEET ).
Administered the vaccine much lower on her arm about 5 inches below where it was supposed to be injected; A spontaneous report was received from a nurse, concerning herself, a 71-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and administered the vaccine much lower on her arm about 5 inches below where it was supposed to be injected.  The patient's medical history was not provided. No concomitant medications were reported.  On 17-Jan-2021, prior to the onset of the event, the patient received her first of two planned doses of mRNA-1273 (lot number 029L20A) intramuscularly in arm for prophylaxis of COVID-19 infection.   On 17-Jan-2021, the vaccine was administered much lower on patient's arm, about 5 inches below where it was supposed to be injected. Treatment information was not provided  Action taken with mRNA-1273 in response to the event was not provided.  The event administered the vaccine much lower on her arm about 5 inches below where it was supposed to be injected was considered resolved on 17-Jan-2021.; Reporter's Comments: This case concerns a 71 year old female patient who received their first of two planned doses of mRNA-1273 (lot number 029L20A) intramuscularly in arm for prophylaxis of COVID-19 infection and the vaccine was administered much lower on patient's arm. There were no reported adverse events after the vaccine was administered in this case of incorrect route of product administration.
I have no known allergies.   On February 20th, eight (8) days after first (1st) dose injection on February 12, an inflamed, itchy rash measuring about four (4) inches in diameter appeared around the injection site, on left arm.  It is now seventeen (17) days since the injection and although the  rash is much smaller, measuring about 1.5-2.0 inches in diameter,  it is still itching on and off.  I am due for the second (2nd) Covid dose in 11 days.  I do not know what to expect with the 2nd dose.
PResented on 12/13 with shortness of breath and flu like symprtoms. Patient stated had tested + for Covid a couples days ago. Started on remdesevir and dexamethasone. Started O2 on 12/19 due to increasing oxygen requirements. Transferred to Critical care and intubated due to acute hypoxic respiratory failure secondary to Covid-19 on 12/22.  Sputum culture showed MSSA and given ancef therapy. Started disursis due to fluid overload but was then held due to poor kidney function.  12/28 acutely decompensated after coughing episode. Began to be tachycardic, hypotensive and hypoxic. Required mutiple vasopressors and maximum ventilator settings. Family decided on comfort care and expires 12/28.
Dose administered after 30-day Use By Date/gave 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/gave 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/gave 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/gave 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
Patient received the 3rd dosage of the Gardasil vaccination on 10/19/2012. Developed herald mark and diagnosed at phyisicans office with pityriasis rosea and swollen lymph node on 11/2/2012.
postherpetic neuralgia; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 02-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician assisstant for shingles and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles and postherpetic neuralgia was not recovered. The causality assessment was considered as related by the lawyer.
PEDVAX HIB had a temperature excursion and was administered; This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 10-FEB-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T020614 expiration date 12-MAR-2023 for prophylaxis (dose and route were not provided).         Digital Data Logger registered a temperature excursion of 35.4 Fahrennheit degrees along 15 minutes.
headache; Chills; Fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Headache with Flu shot.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced HEADACHE (headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting). On 01-Mar-2021, HEADACHE (headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting) had resolved.            Concomitant medication was not reported. Treatment information was not reported.  Reporter stated that headache and vomiting are the same symptoms patient experienced when they get a flu shot.   This case was linked to MOD-2021-333400 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Historical vaccine and events associated with it were updated.
Sore arm; fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in mouth at age 16, lasted one month). Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (also experienced fatigue after receiving 1st dose on an unknown date refer case US2021AMR165330).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and fatigue. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient decided to request and received Shingles vaccine shots at 60 days intervals. The patient reported that, after receiving 2nd dose of Shingles vaccine he or she experienced sore arm and fatigue symptoms, which only lasted one day. The patient stated glad he or she did, peace of mind. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR165330:same patient/reporter
I don't know if this is related I want to report symptoms that happened 4 weeks after 2nd dose. The thrush started around the May 18 and on May 22 seek care at the Urgent Care. I was prescribed Diflucan and Nystatin 3 days. The symptoms wasn't cleared I went to my PCP on May 28 she also prescribed more Diflucan and Nystatin. I had another visit on June 14 prescribed another dose Diflucan and Nystatin. I changed PCP providers saw new PCP he prescribed Diflucan to be taken that day and Nystatin. I went back to the PCP on July 4 my symptoms was till worsening was prescribed 14 days Diflucan.
Legs were weak starting 12-14 hours after shot. I thought that was related to long walks (longer than usual).  The leg weakness never truly subsided. Also, low grade fever almost 24 hours after shot. 2/1/2021 at bedtime I had a very serious calve cramp that lasted 5-7 minutes. 2/2/2021 around 3 am I had a thumb spasm that lasted over 4 hours.  Since then I have had muscle spasms (all over my body including chest, eyes & belly).  I also have joint weakness and numbness that sometime is on one side of my body (face, leg, arm & eye).  I also have lower back discomfort every time I bend over.
pt recv 18DEC98 & w/in 30min of vax pt devel hives on face, arms & legs;pt recovered w/o treatment;
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to be treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir and methylprednisolone (MEDROL) in attempt to curb her painful symptoms. On or about 28-MAR-2016, the patient received subsequent treatment from a physician for the diagnosis of post-herpetic polyneuropathy. The patient has been prescribed gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, post-herpetic polyneuropathy was determined to be medically significant. Additional information has been requested.
Mom reported that he seemed fine the day of treatment (09/19).  The next day, he complained that his arm was sore and stiff.  She examined the arm and found that it was swollen, red, and warm to the touch.  She marked the boundaries of the swelling with a marker on Friday (09/20) to keep track of it.  The next day, she did note that it had spread some.  I did advise her to get him examined when she called today (09/21), especially since the affected area seemed to be spreading.  I have not heard more since then.