chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11 hours after receiving vaccine, pt reported a "scratchy" sensation in her throat with sensation of throat closing. Within 5 hours all her symptoms resolved without intervention. She noted no hives/wheezing/angioedema.
product storage error; Patient were given dose of the Moderna COVID 19 after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient were given dose of the Moderna COVID 19 after 30-day Use By Date) and PRODUCT STORAGE ERROR (product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient were given dose of the Moderna COVID 19 after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). On 07-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Patient were given dose of the Moderna COVID 19 after 30-day Use By Date) had resolved. At the time of the report, PRODUCT STORAGE ERROR (product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
After 8 hours of my second dose, I started feeling weak. My lower back and my right arm where I received the shot felt really sore. I went to bed very early and soon I began to shiver in my blanket. I measured my body temperature however I didn't have any fever, but for the entire night I was shifting between shivering and sweating... It was awful. The second day I still felt muscle sore and still didn't have any appetite for food, thus I had headache that might be caused by having not eaten anything from the night before.   The side effects didn't go away until 2:00pm the second day, which was 28 hours after my vaccination.
(+) Red papules, some excouated, some with dry white heads.  Mostly on trunk and on extremities.  Some on head and blue and mucosa.
Dose administered 24 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours after first puncture) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours after first puncture). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours after first puncture) had resolved.        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.   Concomitant medications were not reported. Treatment details not provided. Pharmacist stated that a vial of Moderna COVID-19 Vaccine was first punctured on 10Jun2021 at around 11 am and got a dose from that vial on 11Jun2021 at around 11 am, more than 12 hours after the first punctured. Pharmacist provided consent for safety team to contact patient on her phone number.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II single 0.5ml dose (rHA, lot # L024265, expiration date 01-JAN-2017, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion for four times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of -13 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the third time was 16 hours with the lowest recorded temperature of 8.5 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the fourth time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested
A MA reported that a pt received an injection of Pnu-Imune 23 in 9/00. Subsequently, the pt developed an injection site reaction characterized by a "large" red, swollen area that was "hot to the touch". The swelling extended from shoulder to elbow. The pt recovered. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information information is provided.
Received a 3rd dose of Rotarix; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a infant male patient who received Rota (Rotarix lyophilized formulation) (batch number K33EZ, expiry date 31st July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Previously administered products included Rotarix (received 2 doses of Rotarix on an unknown date ).   On an unknown date, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was 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: 2-Feb-2023 Reporter's comment: The date the vaccine was administered was unknown.  Field representative stated that it could had been one or two days ago but this was not confirmed.  At the moment of the report to GlaxoSmithKline field representative, the parents had not been notified.  Parents had not reported any adverse event as well until now. The reporter consented to follow up. Additional supportive information: The patient received the 3rd dose of Rotarix mistakenly, which led to extra dose administered.
MENACTRA was given 3-2-15. Developed headache, dizziness, and "blind spot" in his vision on 3-4-15. Spoke with DOH, unsure if related.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021 at 1:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 1:22 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 73.44 for dose administered on 17-Feb-2021. No concomitant medications were reported. Batch number 022M20A underwent temperature excursion on 17-Feb-2021 with temperature 20 degrees Fahrenheit at 08:00 AM and 22 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 11-Feb-2021 and beyond use date for the vial was reported as 13-Mar-2021. Product moved to clinic on 17-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Pt received pediarix no. 1, HIB no. 1 and prevnar in AM of 3-26-04 and pt developed temp.101 degrees with very fussy, screaming episodes that afternoon until approximately non the following day.
came to the ED 12/18 with chest pain and SOB. Came to the hospital ~10 days after testing positive. Type 2 DM, CAD, HTN. Placed on 4L NC. bilateral pnuemo. admitted for care - currently still in hospital
Mom noticed some redness at swelling in left anterior thigh, no fever, not fretful when area is touched. No infection mom states. Advised to apply cool compresses to area.
Adverse Event: (1) Hot feeling (2) Dizzy, blurry vision (3) Vomiting. Treatment: B.P. checked (normal), cold drink, ice pack.
could not raise arm; swelling; fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of JOINT RANGE OF MOTION DECREASED (could not raise arm), SWELLING (swelling) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032L0A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Lupus syndrome.    The patient's past medical history included Tobacco user (2 packs per day 1963-2006) from 1963 to 2006, Back surgery (Back surgeries) in 1985, Hysterectomy in 1985, Hiatal hernia repair in 1985, Brain stem stroke from 09-Feb-2006 to 2010, Cataract (Both eyes) in 2014, Abstains from alcohol since an unknown date, Neuropathy, Nerve damage (Having numbness on legs and throbbing pain on feet) and German measles. Concurrent medical conditions included Thyroid disorder NOS (unspecified), Lupus erythematosus systemic, Congestive heart failure, Migraine, Increased blood pressure, Stomach pain and Drug allergy (codeine allergy manifested by swelling of lips and eyelids/throat closes/itchiness). Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA) for Blood pressure high, LACTULOSE for Bowel movement irregularity, ACETYLSALICYLIC ACID (ASPIRIN CUPAL [ACETYLSALICYLIC ACID]) and FUROSEMIDE (LASIX [FUROSEMIDE]) for Congestive heart failure, ERYTHROMYCIN for Digestion impaired, ROPINIROLE HYDROCHLORIDE (REQUIP) for Legs restless, BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Migraine, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and TRAMADOL HYDROCHLORIDE (ULTRAMED [TRAMADOL HYDROCHLORIDE]) for Pain, DICYCLOVERINE HYDROCHLORIDE (BENTYL) and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Stomach ache, FUSION PLUS for Supplementation therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, unspecified.   In 2019, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 07-Jan-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (could not raise arm), SWELLING (swelling) and FATIGUE (fatigue). In January 2021, JOINT RANGE OF MOTION DECREASED (could not raise arm), SWELLING (swelling) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   2019 The patient experienced off label use and injection site stinging while using Humira.  25-Mar-2021 It is reported that the patient experienced wrong injection technique and device issues in regards to Humira injection.
swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. The symptoms of the swollen lymph node show in the mammograph   Treatment information was not provided.
Yeast infection after first shot. Had virtual appointment with my doctor to order a yeast infection pill by prescription.  After both shots:  Fatigue, slight fever, pain in arm, overall awful feeling. Took a couple days to recover.  Few weeks after second shot, I got really sick and my nose was swollen and sore. My doctor told me to come in. She thought my sickness was the common cold and was unsure what happened to my nose, but thinks it was some trauma unrelated to the cold symptoms.
Tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted over 18 hours
This spontaneous report as received from a pharmacist refers to an approximately 63 year old patient. On 14-MAY-2014 the patient was vaccinated with ZOSTAVAX lot # J013451, Expiry: 24-JAN-2015, 0.65 ml, subcutaneous. The pharmacist reported that post vaccination he asked about the history of shingles. The patient reported that he/she has shingles now. It was also reported that there is no adverse effects. The outcome of shingles was unknown. The causality was unknown. Additional information has been requested.
No additional AE reported; administration of improperly stored vaccine/ (-14C) for 30 Minutes; This spontaneous report was received from a nurse navigator/registered nurse referring to a 4-year-old patient (a private doctor) of unknown gender. The patient's pertinent medical history, concomitant condition, drug reactions/allergies and concomitant medication were not reported.  On 19-AUG-2022, the patient was vaccinated with one improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) (lot # U031564, expiration date: 06-APR-2023; dose details, strength was not provided) Intramuscularly in the left deltoid for prophylaxis. The vaccines underwent temperature excursion of minus 14 degrees Celsius (C) for 13 mintes (product storage error). The previous temperature excursion was not reported. The vaccine was discarded and only given to this one patient post temperature excursion. The patient did not take any medications. The patient did not have any other vaccinations within 4 weeks prior to this one. The health care provider office was a combination of a private practice and a public health clinic. No other adverse event (AE) was reported (no adverse event).
I felt terrible; headache; chills; weakness; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced malaise, headache, chills and asthenia. On an unknown date, the outcome of the malaise, headache, chills and asthenia were not recovered/not resolved.   It was unknown if the reporter considered the malaise, headache, chills and asthenia to be related to Shingrix.  Additional information was provided as follows: The patient received second dose of Shingrix two days before the time of reporting. The patient felt terrible the first night with headache and chills and weakness.
At approximately 1600 on 6/14/19, nurse administered three vaccinations to patient: Menveo, Bexsero, and Gardasil-9. The last vaccine administered was Gardasil-9. Upon receiving the third vaccine (Gardasil-9), patient describes immediately becoming dizzy and then "blanking out." Her mom describes her then slumping forward while sitting, and continuing to fall forward off of the exam table. This was witnessed by patient's mother and nurse. She was partially caught during her fall, but her nose did hit the floor leading to a hematoma. Mom describes 2 or 3 upper body "jerks" immediately after falling. Within several seconds, patient regained consciousness and tried to stand up very quickly, at which time she hit her head on the exam table affixed to the wall. At this time, myself (patient's pediatrician), and other ancillary staff arrived in the room. Patient's SBP blood pressure was initially 70s. Upon examination, she had a regular heart rate in the 60s, She was conversing well, c/o mild dizziness, and had pallor and diaphoresis. She was given juice and upon feeling able, she was assisted back to the exam table and layed supine with legs elevated. Her blood pressure was cycled every several minutes and within 20-30 minutes of observation BP was back to baseline 119/80s. Patient describes a feeling of "feeling odd and dizzy" before losing consciousness. Upon coming to, she felt dizzy and had soreness of her nasal bridge. She was given 800mg of ibuprofen and an ice pack for a hematoma and swelling of her nasal bridge. She was observed closely for 1 hour after the adverse event, at which time patient denied headache, dizziness, lethargy, or fatigue. She continues to endorse nasal pain and swelling. Patient will be referred to ENT to evaluate her nasal trauma. I will be in contact with her mother over the next few days. She ambulated with her mom out of the office without incident. All questions were answered.
Rash, heat, swelling, prickly itching on arm. Tingling tongue and face
pt recvd vax & exp muscle & skeletal pain in the back & nausea; pt states that nausea is greater the last 3 wks;
erythematous & had redness extending posteriorly around the triceps area & anteriorly in the lateral margin of the deltoid;
Sore arm for a few days. Then about 9 days later developed a large circle rash that was burning, itching and swollen. I thought it was a bug bite because it had a particularly itchy spot. But the circle got larger. So far this has been for 4 days and still there.
Patient came in today (11/1) complaining of stiffness in her shoulder joint - specifically that she's unable to reach her arm up or grab things without assist from her other arm. Patient says when she received the shot it hurt and she yelled - she also said her injection went in to her arm much higher than she's ever received a shot before. She showed me a "hole" in her arm (light brown spot patient says is where her injection was administered) which was very high up on the shoulder. Patient says she thought the pharmacist hit bone when administering the PREVNAR. I asked if she's been to a doctor and she has not, but did tell me she's been taking ibuprofen 800 mg to relieve the pain/discomfort, however she still cannot lift her arm up without assistance.
62 years old received Fluzone High-Dose/no AE; 62 years old received Fluzone High-Dose/no AE; Initial information was received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA062083 and 2020SA065018 via same reporter.  It was reported that 62 years old patient(unknown gender) was vaccinated with  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE](product administered to patient of inappropriate age),(overdose) on an unknown date for prophylactic vaccination [lot number, dosing details, expiry date, route and site of administration not reported].   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   At the time of reporting, it was not reported whether adverse event was experienced or not..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
A week after receiving the shot I woke up with severe itching and a 2 to 4 inch long set of hives on my injection site.
Left arm became red, swollen. Developed fever, chills. Given Keflex 500 tid for 5 days with Benadryl.
verything tastes like metal.  nothing is good to eat, everything tastes bitter or like it's gone bad.  a metal taste lingers in my mouth.  doubt it's anything important, but wanted to mention it for data collecting sake as i'd not heard of it from anyone else.  other side effects were fever and achiness, however it seems to be more severe in my case than in others I personally know with their 2nd shot, probably not statistically worse than the general population if I were to guess at it, however.
03/09/05:  Received 6 month shots on Tuesday, March 8, 2005 at 10:45am.  Mother of child noticed child's leg (left thigh) swollen with palpable nodule under skin at 8:00 pm.  Leg remains swollen with induration today.
patient developed hive on her right leg (1).  mom stated that child has history of anaphylaxis as a child under 6 due to dairy products. administered 10ml of children's benadryl and monitored for 30 minutes. patient had no other symptoms. mom stated that patient has never received other vaccines
Headaches; Migraines; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. In February 2022, 2 days after receiving Shingrix, the patient experienced headache and migraine. On an unknown date, the outcome of the headache and migraine were not recovered/not resolved.   It was unknown if the reporter considered the headache and migraine to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix and 2 days later started experiencing headaches and migraines. Consent to follow up was not possible as no contact details were available.