chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient remained at the office for over 30 minutes with not obvious adverse effect; Medical Assistant calling to report accidental 4th dose of Gardasil 9 given to a patient. 1st dose given in 2012, 2nd and 3rd dose in 2014. 4th dose given today, then recognized as an error.; Medical Assistant calling to report accidental 4th dose of Gardasil 9 given to a patient. 1st dose given in 2012, 2nd and 3rd dose in 2014. 4th dose given today, then recognized as an error.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date in 2012, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, route of administration, dose and anatomical location were not reported) for prophylaxis. The patient received second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, route of administration, dose and anatomical location were not provided for both doses) on an unknown date in 2014 (inappropriate schedule of vaccine administration). On 11-SEP-2020 (reported as today), the patient received fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL (lot # 1637642, expiry date: 28-MAY-2022; route of administration and anatomical location were not reported) (extra dose administered). It was stated that system reported that the dose was needed and third dose was not seen in the file. Error was recognized after the fourth dose was given. The patient remained at the office for over 30 minutes with no obvious adverse effect. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1637642; expirationdate: 28-MAY-2022; 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
Information has been received from a licensed practical nurse (LPN) concerning a 6 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Patient received Pfizer gray cap for ages 12 and up instead of 5-11. No adverse reaction was noted a the time of injection, 2 hours after, or 25 hours later. PCG/Guardian was notified and educated on s/e and adverse reactions and who to report them to. Guardian verbalized understanding of the same. TCT to Pediatrician Dr. who reports Patient is under her care and gave the order for VN to visit in 24 hours to assess for adverse reactions. VN visited patient at 11 am on 4/14 guardian reports patient is fine playing and eating ok. Upon VN assessment vitals were stable, with no s/s of distress. Further education provided to guardian on s/s reportable and when to call pediatrician
STRONG METALLIC TASTE STARTING WITHIN 5 MINUTES. DENIES ANY OTHER SYMPTOMS
On the day of vaccine he had a horrible stomach ache, dizziness and headache. The following day all the same symptoms plus fever and muscle aches. 3rd day following fever up to 104, horrible headache, muscle aches, extreme fatigue.
4 1/2 X 4 cm left arm swollen with redness - ice arm every 2 hours per provider - RX given (TYLENOL).
Pain in arm at site and gets worse with movement. Sore throat and now has had blisters develop in back of throat that has not resolved as of 11/2/21
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Oct-2021 at 12:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 12:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 71.41. Concomitant products were not provided. On 27-Oct-2021, excursion time was 09 AM and 10 AM  and temperature was 29 and 32 respectively, total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 02 vial was moved to clinic on 29-Sep-2021 and 04 vials was moved to clinic on 05-Oct-2021. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021. Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM : 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Lump under the skin; Feels hot to the touch at the site; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump under the skin), VACCINATION SITE WARMTH (Feels hot to the touch at the site) and VACCINATION SITE ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 28-Dec-2020, 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 SITE MASS (Lump under the skin), VACCINATION SITE WARMTH (Feels hot to the touch at the site) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE MASS (Lump under the skin), VACCINATION SITE WARMTH (Feels hot to the touch at the site) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Within 20 minutes of receiving both doses, I developed a ravenous sense of extreme hunger, as if I hadn't eaten in weeks. But as soon as I ate, I was fine. Other than this, I experienced no side effects or immunological symptoms with either dose.
Information has been received from a physician concerning a 62 year old male, with no history of drug allergies or reactions, who on approximately 29-OCT-2007 or 30-Oct-2007 was vaccinated with a dose of ZOSTAVAX (lot #658604/1088U).  Concomitant therapy included CADUET.  On approximately 29-OCT-2007 the patient experienced burning, swelling, and warmth at the injection site.  The patient's burning, swelling, and warmth at the injection site persisted.  Unspecified medical attention was sought.  No labs were performed.  No product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Follow-up information from the physician indicated that the 62 year old males with penicillin allergy who on 29-OCT-2007 was vaccinated with a dose of ZOSTAVAX vaccine (Merck) (lot#658604/1088U) in the left arm. There was no illness at the time of vaccination. On that same day immediately after the shot, the patient also developed a sore and red arm at the injection site. The patient did not seek medical attention. On 05-NOV-2007 the patient recovered. Additional information has been requested.
aching arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aching arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (aching arm). At the time of the report, PAIN IN EXTREMITY (aching arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Sore arm; dizziness; hot and cold phases; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (dizziness), FEELING OF BODY TEMPERATURE CHANGE (hot and cold phases), VOMITING (Vomiting) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01932A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (dizziness), FEELING OF BODY TEMPERATURE CHANGE (hot and cold phases), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (dizziness), FEELING OF BODY TEMPERATURE CHANGE (hot and cold phases), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Tender Supraclavicular Lymphadenopathy on the Left arm where vaccine was given
Patient came to the pharmacy on 1/28/22 per suggestion from his doctor to report adverse events following his initial COVID-19 vaccine with Johnson & Johnson as well as booster with Moderna. Per patient, he experienced numbness in his fingers and toes following the J&J shot that lasted several weeks. After the booster, he reported tingling down the length of both legs. As of date of reporting, patient is still experiencing loss of sensation when he is standing or walking, and his legs and feet feel cold when sitting.
Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Peach, plumps, cherrys, melon). Concomitant products included PROGESTERONE and ACETYLSALICYLIC ACID (ASPIRIN PROTEC) for Pregnancy, FOLIC ACID for an unknown indication.    On 26-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Jun-2020 and the estimated date of delivery was 13-Mar-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2020, Pregnancy test: positive (Positive) Positive.     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.   On ??-???-2020, lab test also included APT down diamniotic; however, the result was negative and RH positive.  Patient had two prior pregnancies.   Patient delivered first neonate on 22-Oct-2009, which resulted in live preterm birth of baby within the duration of 35 weeks with 6 days. Patient delivered second neonate on 18-Dec-2019, which resulted in live preterm birth of baby within the duration of 36 weeks with 6 days.  Number of fetus was found to be one.  Treatment information was not provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
See previous description of events on page one. My concern is that this very "healthy" 73 year old, still working despite her COPD currently has a very sudden, very invasive pneumonia post covid vaccines. Her pulmonologist said she was perplexed as to how her CT looked pretty horrible with the patient not showing signs of more severe, chronic build up to what is being seen on the CT. It is concerning that at this point we are not considering the Covid shot as the culprit.
Information has been received from a consumer concerning her 21 year old daughter with allergy to penicillin and all cillins and a history of Lyme disease who in Summer 2007 was vaccinated with her first dose of GARDASIL, IM; second dose in Fall 2007, and third dose in March 2008. Concomitant therapy included ALLEGRA, Montelukast sodium (MSD), PANELOR and ESTROSTEP. Subsequently "soon after receiving 3rd shot" the patient experienced occasional tingling in her hands and feet, and numbness in her arms and legs. Laboratory tests included blood work checked for MS, lupus and other diseases (results not reported), and will have an MRI in November. At the time of this report the patient's symptoms persisted. The patient sought medical attention with the physician. Additional information has been requested.  12/23/08 Reviewed rheumatology eval of 8/19/2008. FINAL DX: arthralgia, muscle spasm Records reveal patient experienced Raynaud's phenomomen of fingers & toes; paresthesias of hands & feet x 3 mo; joint pain hands.  No other medical records available at this time.
This spontaneous report was received from a nurse regarding to 8 patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (data digital logger) (Lot # L019127, expiry: 27-MAY-2017. The vaccine was exposed to temperature: 21.7 F for a time frame of 24 hours. No adverse effects were reported. There was no previous temperature excursion reported. This is one of 4 reports received from the same reporter. Additional information has been requested.
A male patient received Oncotice therapy in 1999.  In October 2002 he was found to have a positive PPD test.  He is otherwise asymptomatic.  There is not baseline (pre-BCG) PPD for comparison.  He has not been evaluated by an Infectious Disease Specialist.
All locations of previous arthritis pain became extremely painful. Most joints were better within 2 weeks. Knees, especially right knee , stayed painful for 3 months, frequently extremely difficult to stand or walk, with limited response to ibuprofen or rub-on lotions. Knees and ankles swelled visibly. On June 25th, met with Dr because swelling wasn't going away overnight. She ordered an ultrasound of the leg veins due to concerns of blood clot(s). Diagnosed with popliteal cyst. As of this report, knees are still more painful than prior to shot but are not longer extreme.  Slight swelling still on right knee.
Fever of 103; chills; sweating; body ache; nausea; vomiting; diarrhea; headache; couch; chest pain; This is a spontaneous report from a contactable consumer for herself. A 17-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07May2021 17:00 (Lot Number: EW0176) at single dose for COVID-19 immunisation.  Medical history was none. No allergies to medications, food, or other products.  The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (lot number=EW0153) in left arm on 15Apr2021 04:00 PM for COVID-19 immunisation. The patient experienced fever of 103, chills, sweating, body aches, nausea, vomiting, diarrhea, headache, couch, chest pain on 08May2021 13:00 with outcome of not recovered. Events were resulted in doctor or other healthcare professional office/clinic visit. No treatment received. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19.
Vaccinee experienced fever (101 degrees), achiness (lasting for 7 days), & sinus fullness 1 day post 1st engerix-B inject 19SEP90; Events lasted for approx 7 days.
Passed out; Lips got blue; Hands got sweaty and clammy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), LIP DISCOLOURATION (Lips got blue) and HYPERHIDROSIS (Hands got sweaty and clammy). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), LIP DISCOLOURATION (Lips got blue) and HYPERHIDROSIS (Hands got sweaty and clammy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred on an unknown date after the first dose of Moderna COVID-19 Vaccine. The rechallenge was negative for event of loss of consciousness. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-348085 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2021: Follow up received included patient demographics, suspect vaccine details and adverse event details. Case was upgraded.; Sender's Comments: This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred on an unknown date after the first dose of Moderna COVID-19 Vaccine. The rechallenge was negative for event of loss of consciousness. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
I was required to get the vaccine to keep my job even though I was very nervous about the effect it could have on a fetus and was trying to get pregnant so I decided to get it when ovulating as I knew I was not pregnant (this is important as a mutation could have happened during conception) then ended up getting pregnant that cycle and my second shot, also required to keep my job, was when I had just got my positive pregnancy test 2 days prior. My edd based on lmp was 5/21 changed to 5/30 at first ultrasound due to fetus measuring small. At 20 week ultrasound she was found to have a heart defect and a choroid plexus cyst. Then at 37 weeks I was induced due to the baby being iugr. She was born with syndromic features and spent a month in the nicu where it was found that she had a chromosome deletion on her fifth chromosome or cri du chat syndrome. I fully believe that this could have been caused by the vaccine as the syndrome most often is a random event during early embryonic development.
Nausea, diarrhea, vomiting. Chills, headache, body aches, and low grade fever on and off.
Patient had reaction to Moderna had hives around lips. Patient denied SOB and closing of throat.  Administered benadryl 25mg po per protocol.  Patient outcome stable. Advised patient to go to urgent care for further evaluation.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient were vaccinated with improperly stored PROQUAD which had lot # M015698 with expiry: 26-SEP-2017 and lot # L051102 with expiry: 17-JUN-2017 (dosing details not reported). No adverse effects reported and no further information reported. This is one of the two reports received from the same reporter. Additional information has been requested.
After initial injection Right arm became sore and developed palm sized redness, raised, swollen and warm to touch. Fever 101, chills, body aches, malaise lasted about 24 hours. Palm size Redness of Right arm lasted 12 days. When the reddened swollen area finally started to fade the area became very itchy and resolved.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 10-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (lot 3 J001180, expiry; 18-AUG-214) which was exposed to a temperature excursion that was not supported (75F for 56 hours). It was unknown if this was the first or second dose of PNEUMOVAX23 that this patient has been administered. No adverse effect reported. Additional information has been requested.