chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exposed, below freezing, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The pharmacy resident reported that Flulaval which was exposed to temperature below freezing (24.4 Fahrenheit) was administered to 5 employees. The vaccine administration facility was the same as primary reporter. The reporter did not had any other details but agreed to follow-up via email only. The reporter consented to follow-up. This is one of five linked cases reported by same reporter for different patients. Additional supportive information: The patient received Flulaval after temperature excursions, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR152067:Same reporter US-GSK-US2022AMR152066:Same reporter US-GSK-US2022AMR152065:Same reporter US-GSK-US2022151428:Same reporter US-GSK-US2022AMR152065:Same reporter US-GSK-US2022AMR152066:Same reporter
Initial weakness, paralysis of extremities, Guilian Barre Syndrome with medical complications, hospital admission commencing 11.09.18 until death, 12.22.18.
arm painful; arm red; COVID arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (arm painful), ERYTHEMA (arm red) and VACCINATION SITE REACTION (COVID arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm painful), ERYTHEMA (arm red) and VACCINATION SITE REACTION (COVID arm). At the time of the report, PAIN IN EXTREMITY (arm painful), ERYTHEMA (arm red) and VACCINATION SITE REACTION (COVID arm) outcome was unknown. Not Provided      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.   No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non-significant follow up
that they gave me, SVT my heart rate went 230 beats a minute and normally it's 77; Now I got a new virus yesterday since I got it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose 1), for COVID-19 immunization, reaction(s): "never had any problem"; Moderna (Dose 2), for Covid-19 Immunization, reaction(s): "never had any problem"; Moderna (Dose 3), for COVID-19 immunization, reaction(s): "never had any problem". The following information was reported: SUPRAVENTRICULAR TACHYCARDIA (medically significant), outcome "unknown", described as "that they gave me, SVT my heart rate went 230 beats a minute and normally it's 77"; VIRAL INFECTION (non-serious), outcome "unknown", described as "Now I got a new virus yesterday since I got it". The patient underwent the following laboratory tests and procedures: Heart rate: 230 beats a minute; 77, notes: normally. Clinical course: I had 3 Moderna shots and never had any problem, the Booster shot that they gave me, SVT my heart rate went 230 beats a minute; Now I got a new virus yesterday since I got it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3/11/10 @ 1350 "stomach hurts". Sent by nurse to clinic to rest. PHN to clinic - for monitoring pt and her S/Sx. Pt reported then slightly nauseous and anterior thighs/posterior calves tingling. V S normal. Pt then clearing throat, reporting "feels scratchy". Administered BENADRYL 50 mg PO and called mom. No SOB. No swelling, no itching. Scratchy throat resolved. Pt home with mom.
Redness and soreness at site of injection the circle of redness about 1 inch radius around the injection mark. Area feels like a bruise and itches sometimes. It hurt as the injection was given.
found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some; found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some; found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some; This spontaneous case was reported by a nurse and describes the occurrence of RASH ERYTHEMATOUS (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some), RASH PRURITIC (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some) and VACCINATION SITE PAIN (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-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 RASH ERYTHEMATOUS (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some), RASH PRURITIC (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some) and VACCINATION SITE PAIN (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some). At the time of the report, RASH ERYTHEMATOUS (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some), RASH PRURITIC (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some) and VACCINATION SITE PAIN (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
This spontaneous report was received from a register nurse concerning a patient of unknown age and gender who on 02-AUG-2012 was vaccinated with the third dose of GARDASIL subcutaneously (lot number and expiration date were not provided). No adverse event were reported. Additional information had been requested.
Felling really bad; has been in bed for 2 days, only goes to the bathroom and straight to bed again.; Usually has difficulty breathing but once she takes her inhalators she can breath better again, this is not happening now, the difficulty is ongoing/felt like an elephant foot on my chest, when breathing; Diarrhea; stomach sick, cannot eat; Feels very very weak; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felling really bad), IMPAIRED WORK ABILITY (has been in bed for 2 days, only goes to the bathroom and straight to bed again.), DYSPNOEA (Usually has difficulty breathing but once she takes her inhalators she can breath better again, this is not happening now, the difficulty is ongoing/felt like an elephant foot on my chest, when breathing), DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (stomach sick, cannot eat) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD (She has COPD and usually has difficulty breathing but once she takes her inhalators she can breath better again). Concomitant products included LOSARTAN and LORAZEPAM for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MALAISE (Felling really bad), IMPAIRED WORK ABILITY (has been in bed for 2 days, only goes to the bathroom and straight to bed again.), DYSPNOEA (Usually has difficulty breathing but once she takes her inhalators she can breath better again, this is not happening now, the difficulty is ongoing/felt like an elephant foot on my chest, when breathing), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (stomach sick, cannot eat), ASTHENIA (Feels very very weak) and HEADACHE (Headache). At the time of the report, MALAISE (Felling really bad), IMPAIRED WORK ABILITY (has been in bed for 2 days, only goes to the bathroom and straight to bed again.), DYSPNOEA (Usually has difficulty breathing but once she takes her inhalators she can breath better again, this is not happening now, the difficulty is ongoing/felt like an elephant foot on my chest, when breathing), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (stomach sick, cannot eat), ASTHENIA (Feels very very weak) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included unspecified pain medications (as needed, not daily) and inhalers (unspecified). The patient received treatment with "peptize".
SORE ARM AND RED AND ITCHY ARM THEN ACHING IN COLLARBLADE AREA LYMPH NODE SWOLLEN AND MOVES
very tired; headache; muscle pain; This is a spontaneous report from a contactable other HCP (patient, self-reporting). A 52-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3249, expiration: not reported), via an unspecified route of administration in arm right on 28Jan2021 10:30 as second dose, single for covid-19 immunisation (at the age of 52-years and the patient was not pregnant) at Hospital. The patient medical history and concomitant medications were not reported. Historical vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and expiration: not reported), via an unspecified route of administration on unspecified date, as first dose, at single for covid-19 immunisation. No other vaccine in four weeks, no other medications in two weeks. No COVID prior vaccination, no COVID tested post vaccination. No known allergies. On 28Jan2021 patient had a headache, muscle pain and was very tired. No treatment taken for events. The outcome events were not recovered.   Follow-up attempts are completed. No further information is expected.
Patient was diagnosed with Covid prior to arrival to the ER.  Patient fell at home causing low back pain and bilateral hip pain.  Patient also has a history of dizziness.
This spontaneous case reported by a nurse, describes the occurrence of inappropriate schedule of product administration (patient took Moderna first dose on Jan 28, 2021 and second dose on Mar 5, 2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 013M20A and 007M20A) for COVID-19 immunization. No medical history reported. On Jan 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 5, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 5, 2021, patient experienced inappropriate schedule of product administration (patient took Moderna first dose on Jan 28, 2021 and second dose on Mar 5, 2021). At the time of the report, inappropriate schedule of product administration (patient took Moderna first dose on Jan 28, 2021 and second dose on Mar 5, 2021) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2022-612869 (patient link).
Within one hour pt began feeling "weird" and developed right sided pain.  Went to local fire department and was transferred to hospital with severe right side pain. On 3/26 underwent removal of galbladder. Discharged to home 3/27 Has since consulted her liver sp3cialist regarding the galbladder attach and her liver failure and the effect of the vaccine on her condition
PT EXPERIENCED ITCHING AND EDEMA AT INJECTION SITE OF TETANUS TOXOID ADSORBED.4 MO LATER, PT DEVEL SWELLING AROUND EYES AND UPPER RESP. DIFFICULTIES ASSO. WITH FOOD. PT REPORTEDLY RECEIVED TETANUS INJECT ONLY 3 YEARS EARLIER.PT HOSPITALIZED
symptoms (massive rash) got worse; symptoms (neurologly issues,numbly,muscle soreness, skin it gets inflamed and tingling in her hands) got worse; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONDITION AGGRAVATED (symptoms (neurologly issues,numbly,muscle soreness, skin it gets inflamed and tingling in her hands) got worse) and RASH (symptoms (massive rash) got worse) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced CONDITION AGGRAVATED (symptoms (neurologly issues,numbly,muscle soreness, skin it gets inflamed and tingling in her hands) got worse). On 30-Mar-2021, the patient experienced RASH (symptoms (massive rash) got worse). The patient was treated with FLUOXETINE HYDROCHLORIDE (PROZAC) at an unspecified dose and frequency; CORTISONE for Rash, at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (symptoms (neurologly issues,numbly,muscle soreness, skin it gets inflamed and tingling in her hands) got worse) and RASH (symptoms (massive rash) got worse) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Magnetic resonance imaging head: inconclusive (Inconclusive) inconclusive. On 03-Feb-2021, Magnetic resonance imaging neck: inconclusive (Inconclusive) inconclusive. On 03-Feb-2021, SARS-CoV-1 test negative: negative (Negative) negative.         The symptoms got worse after the second dose of vaccine. Treatment activities for event was done with muscle relaxers, steroids. The action taken for mRNA-1273 was not applicable.   This case was linked to MOD21-065644, MOD21-065708 (E2B Linked Report).; Sender's Comments:  MOD21-065644:MOD-2021-062151 - 1st Dose of Vaccine- For Wife MOD21-065708:AE of Husband
Patient came into pharmacy on 11/11/19.  Patient stated she had pain in her left arm to fingertips and left side of chest for 4 days.  After the four days the pain subsided and she developed hives and rash on various parts of her body, very itch and irritating.
No treatment. Vomited right after administering ROTATEQ within 1 minute.
Approximately 2 weeks after the administration of MMR and Varicella vaccines (given 10/4/10) pt developed bilateral (R>L) inguinal lymphadenopathy.  Since receiving further vaccinations (DTaP, HIB, PCV7 on 12/14/10) the mother of the child notes that the size of lymphadenopathy has increased (no other lymphadenopathy on exam). On exam today he has tender, mobile inguinal lymph nodes bilaterally - Right measures 2cm x 1 cm, left 1cm x 0.5cm.  Also 2cm diameter tender induration without erythema/warmth/fluctuance at each vaccine injection site from 12/14/10 vaccines.
nose bleeds, headaches sudden onset after first shot continued after second and third shot third shot 6/9/08 fatigue, end of July received meningits vaccine sept started pain, cyst on ovaries,then nausea,vomiting,pancreatitis,gastrointestinal disorders,dizziness,pnenmonia,lactating,hypersensitivity,8 weeks in hospital still sick  1/27/09 Link with 338052.  2/2/09 Received hospital & clinic medical records for 9/18-12/10/2008. FINAL DX: Pancreatitis Records reveal patient seen in ER 9/18 for RLQ flank/abdominal pain with nausea, fever & cough x 2 days.  Improved w/meds & d/c to home.  Returned w/severe pain.   Hospital admit 9/20-9/22/2008.  FINAL DX: right flank pain, resolving; pneumonia, resolving.  Records reveal RLQ flank/abdominal pain improved.  d/c to home on continued oral antibiotics for pneumonia & w/GYN f/u.  OB/GYN records of  10/7 & 10/8 & Operative report of 9/24/2008. FINAL DX: RLQ pain w/bilateral ovarian cysts Patient had laparoscopic aspiration of ovarian cysts as same day surgery.  Had continued post op RLQ abdominal pain.  US was WNL.  referred to PCP for additional GI w/u.  Returned to ER 10/23/2008 W/persistent RLQ pain.  Labs all WNL & d/c to home.  Returned to ER 12/10/2008 w/nausea, vomiting, dry heaves x 1 day, diarrhea x 2 weeks.  Had recently been d/c from higher level of care w/dx pancreatitis & was on TPN.  Found to have ileus.  Tx w/meds & d/c to home.  2/17/09 Received hospital medical records of 11/21-12/3/2008. FINAL DX:allodynia w/abdominal wall pain improving; hyperlipasemia, etiology uncertain; galactorrhea & hyperprolactinemia secondary to Lexapro; marked disability in association w/chronic pain; intermittent, frequent belching/retching related to disability & chronic pain. Records reveal patient experienced RLQ pain.  Had been transferred from outlying hospital where she had been admitted 10/15/08 & extensive medical record review of that hospitalization included.  Endocrine, pain mgt, psych consult done & meds adjusted.  Tx w/TPN.  Improved & d/c to home w/continued TPN, pain meds, PT, psych counseling & serial labs.
Diarrhea; Nausea; Headache; Sore muscles; Sore joints; Stuff sore arm; Chills; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732), via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included vitamin C (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN); all for unknown indication started from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 02Mar2021 at 10:00 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 22:00, the patient experienced stuff sore arm, chills, diarrhea, nausea, headache, sore muscles and joints. Therapeutic measures were taken as a result of adverse events and included treatment with ADVIL and TYLENOL. The clinical outcome of stuff sore arm, chills, diarrhea, nausea, headache, sore muscles and joints was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
A headache starting 4 AM  Treated with 600MB Ibuprofen and later with 1000mg Tylanol  Extra water
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Weakness-Mild, Additional Details: approx 10 minutes after the vaccine pt felt light headed then fainted.  she was unresponsive at first then she woke up.  i gave the patient orange juice and used checked her bp. her blood pressure came back 115/75 i asked if the pt has taking any meds and pt said no.  when pt fainted she fell on the floor scractching her forehead and upper lip.  no other problems
This was only after booster done the pt developed swollen up of loiter LE. Venous US as well as EKG and labs symptoms improved over the next few weeks
Breakthrough COVID infection. Symptoms of shortness of breath, cough. Onset of symptoms 07/08/2022. Tested COVID negative 7/10/2022 with PCR test. Retested 07/18/2022 with COVID PCR test and resulted positive.
It is probably just a coincidence, since this would be a DELAYED reaction.  On the 8th day after first vaccine, I woke up with moderate muscle soreness all over, but especially in back and trunk area.   Also had a moderate headache.  No fever. Very uncomfortable all day, movements slow.  Much fatigue.  I took two naps, which is very unusual.  Next day, today, still with symptoms, but improved.
p/vax pt began spitting up p/feedings; did not spit up p/feedings before was given feedings
The patient received her COVID vaccine and flu vaccine in the same arm, an inch apart from each other. The patient went to urgent care due to inflammation in her arm and received prescriptions for Norco and Ibuprofen. The redness and swelling did not resolve so she later went to another urgent care where she was given antibiotics and her symptoms resolved days later.
Numbness of the tongue; Tingling of the fingers; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numbness of the tongue) and PARAESTHESIA (Tingling of the fingers) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Numbness of the tongue) and PARAESTHESIA (Tingling of the fingers). At the time of the report, HYPOAESTHESIA ORAL (Numbness of the tongue) and PARAESTHESIA (Tingling of the fingers) outcome was unknown. Not Provided          No concomitant product was reported. No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Site: Redness at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: severe rash size of cell phone 8 days after vaccination-Medium, Additional Details: pt states severe rash but pt is ok to give second dose
The patient was given the incorrect dose 0.25mL instead of 0.3 mL.