chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines given after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) for prophylaxis, flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Fluarix Tetra 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Pediarix, Pediarix Pre-Filled Syringe Device and Boostrix. On an unknown date, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Fluarix Tetra 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Pediarix, Pediarix Pre-Filled Syringe Device and Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 20-FEB-2023 Reporter's comment: The reporter calling about Infanrix, Fluarix Tetra 2022-2023 season, Kinrix, Havrix, Rotarix lyophilized formulation, Pediarix and Boostrix vaccines that had been exposed for 69 days at a temperature of 63 degree F.  She was looking for guidance as the vaccines had been administered to patients.  The vaccine administration facility was the same as primary reporter. The reporter did not have accurate lot numbers or expiration dates and it was not known at this time how many patients received the vaccines. The reporter consented to follow up via postal. Additional Supportive Information: The patients received Infanrix, Fluarix Tetra 2022-2023 season, Kinrix, Havrix, Rotarix lyophilized formulation, Pediarix and Boostrix vaccines that had been exposed for 69 days at a temperature of 63 degree F, which led to incorrect storage of drug.
Sore Arm after her second booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm after her second booster dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm after her second booster dose). At the time of the report, PAIN IN EXTREMITY (Sore Arm after her second booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Disease States: Lupus. No treatment medications was reported.   This case was linked  (Patient Link).
Sharp pain in the left chest. Pt. given 12 Lead EKG (-) result Pt. refused any further treatment. Language line utilized. Pt. monitored for 30 minutes post vaccination. HR-75    SPO2: 99      RESP: 18      BP: 141/80 Seen by EMT on site. D/C'd at 10:10 am
viral infection bronchitis; wheezing; severe allergic reaction; swollen eyes; hives; felt weird; itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 16:15 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BRONCHITIS VIRAL (non-serious) with onset 19Jan2022, outcome "not recovered", described as "viral infection bronchitis"; WHEEZING (non-serious) with onset 16Dec2021, outcome "unknown", described as "wheezing"; HYPERSENSITIVITY (non-serious) with onset 16Dec2021, outcome "unknown", described as "severe allergic reaction"; EYE SWELLING (non-serious) with onset 16Dec2021, outcome "unknown", described as "swollen eyes"; URTICARIA (non-serious) with onset 16Dec2021, outcome "unknown", described as "hives"; FEELING ABNORMAL (non-serious) with onset 16Dec2021, outcome "unknown", described as "felt weird"; PRURITUS (non-serious) with onset 16Dec2021, outcome "unknown", described as "itchy". The events "viral infection bronchitis", "wheezing", "severe allergic reaction", "swollen eyes", "hives", "felt weird" and "itchy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient mentioned the reaction started kind of late. It was the next morning. Her eye got swollen, wheezing, felt weird, itchy, and breaking out in hives. AE(s) did not require a visit to emergency Room. Today she went to the doctor and has viral bronchitis. Prior Vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Family Medical History Relevant to AE(s) both of her parents got Johnson and Johnson vaccine and both of them got pretty sick. Outcome of Event reported was it has made it into bronchitis.   The lot number for bnt162b2 was not provided and will be requested during follow up.
AFTER RECEIVING VACCINES, CLIENT FELT DIZZY. PATIENT OFFERED WATER AND HAD HER HEAD DOWN BETWEEN HER LEGS AND COLD COMPRESS APPLIED TO BACK OF NECK. AFTER RAISING HER HEAD UP AND VERBALIZING SHE FELT BETTER SHE BLACKED OUT FOR A FEW SECONDS. CLIENT WAS NOTED TO BE PALE AND CLAMMY. PATIENT WOKE UP AND ASSISTED TO FLOOR, WITH LEG HIGHER THAN HEART POSITION. CLIENT HAD VERBALIZED THAT SHE FELT LIKE SHE WAS IN A DREAM STATE. CLIENT FANNED WITH BOOKS FOR COOLER AIR AND CIRCULATION. HAD CLIENT STAY ON FLOOR FOR ABOUT 7 MINUTES AND SLOWLY SIT UP FOR ABOUT 5 MINUTES UNTIL CLIENT VERBALIZED THAT SYMPTOMS WERE GONE. MOM AND CLIENT ADVISED ON HAVING SOMETHING TO EAT AFTER LEAVING HEALTH DEPARTMENT
Patient received first dose of Moderna COVID-19 vaccination at 0930 on 01/29/2021. Patient waited at clinic for 30 minutes after receiving the vaccine. At 1020 patient called the clinic stating she was having swelling of her lymph nodes on left side of her neck/throat and tingling of her tongue. Patient was advised by myself and the provider to go to the ER. Patient went to Medical Center.  At the ER patient was given 125 mg of methylprednisolone sodium succinate, 50 mg of diphenhydramine HCl, 20 mg of famotidine, and 0.3 mg of epinephrine IV. Patient was sent home in stable condition with a prescription of prednisolone (60 mg PO daily for 5 days).
Hospitalized on 9/24/05 due to possible meningitis. Headache, general Start: 9/20/05 10 days post vaccination. Fever 9/20/05. Erythema 9/20/05, end 9/30/05, drainage at SPV site. Follow up 6/06: patient states he fully recovered with no residual effects. Discharge summary states pharyngitis. msv Medical records state photophobia, bacterial infection. msv
Patient presented to pharmacy on 10-18-08 stating he had cellulitis from his shot and wanted to know what we were going to do about it.  Verified per VAR firm that it was the PNEUMOVAX-23 in the left arm.  Arm was red, swollen and marked off with marker from the ER doctor.  Filled prescription for generic Keflex 500mg and generic Bactrim DS.  Patient paid for them.
sudden urge to pee-all day long felt intense pressure of having to pee that continues on 10mar2021; felt like she was going to explode; she was up six times to use the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of MICTURITION URGENCY (sudden urge to pee-all day long felt intense pressure of having to pee that continues on 10mar2021), FEELING ABNORMAL (felt like she was going to explode) and POLLAKIURIA (she was up six times to use the bathroom) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     Concurrent medical conditions included Varices esophageal (can only drink water, no juice, no caffeine, no coffee).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MICTURITION URGENCY (sudden urge to pee-all day long felt intense pressure of having to pee that continues on 10mar2021), FEELING ABNORMAL (felt like she was going to explode) and POLLAKIURIA (she was up six times to use the bathroom). At the time of the report, MICTURITION URGENCY (sudden urge to pee-all day long felt intense pressure of having to pee that continues on 10mar2021), FEELING ABNORMAL (felt like she was going to explode) and POLLAKIURIA (she was up six times to use the bathroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported No treatment information was provided. The patient did not have water on her drive to the vaccination site 35 miles away, nor any water after the vaccine. The patient made it home and all day long felt intense pressure of having to pee that continued on 10 Mar 2021. .
First and second Covid Vaccines: Pain at injection site. Headache and lethargic for a couple days.  Third injection felt paralyzed in bed and could not move limbs, headache, stomach issues, vomiting. The headache and stomach issues lasted a week. The effected by the Paralysis during the night after injection.
Swelling and redness at site of vaccination on 1/18/2013. Pt. took IBU / BENADRYL. 1/19/2013 Slight fever 100 degrees  -> then 99 degrees -> per mom have IBU / TYLENOL. 1/20/2013 Fever and redness in afternoon went to urgent care.
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 06-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number reported as 0567AE, dose and route unspecified) that had expired on 04-APR-2013. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Prior to giving Tdap, pt was totally alert/oriented. Vaccine screening completed per protocol. After confirming pt information, administered Tdap IM (L) delt. Pt then became faint, discolored (pale), and slowly lost consciousness. Pt took a few minutes and started to "seize", yet breathing. Administered ammonia via nasal x2 pt then slowly regained consciousness.
began crying immed p/getting home 1/2 hr, refused lunch, t102, wanted to be held all day, sore leg, did not sleep until 3PM following day; 2 1/2 hr straight crying & sobbed, irritable & miserable 2 days; unable to console
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Guardian stated, patient seemed to be passing out and slowly fell on her side to the cement floor. Abrasion on chin and on 2 fingers of each hand noted. 911 was called and paramedics evaluated the patient and patient was transported to Medical Center via ambulance.
2 big blotches; very itchy; blotches on her left shoulder; breakout on stomach above waist; "Covid arm"; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (2 big blotches), PRURITUS (very itchy), RASH MACULAR (blotches on her left shoulder), HYPERSENSITIVITY ("Covid arm") and RASH (breakout on stomach above waist) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HYPERSENSITIVITY ("Covid arm"). On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH MACULAR (2 big blotches), PRURITUS (very itchy), RASH MACULAR (blotches on her left shoulder) and RASH (breakout on stomach above waist). The patient was treated with CORTISONE at an unspecified dose and frequency and Manual therapy (Ice) for Rash macular. At the time of the report, RASH MACULAR (2 big blotches), PRURITUS (very itchy), RASH MACULAR (blotches on her left shoulder), HYPERSENSITIVITY ("Covid arm") and RASH (breakout on stomach above waist) outcome was unknown.            Concomitant product use was not provided by the reporter.    Treatment for the event included topical cortisone cream and ice.  Action taken with mRNA-1273 in response to the event was not applicable
Heptavax (Engerix B) given in R and L deltoids IM. On 5/31/2007 patient reported bilateral rash and pruritus. No discoloration observed on patient's dark skin but several raised areas palpated bilaterally. Reports intermittent itching at both sites diminishing today.
MILD ACHINESS IN SHOULDERS; This spontaneous report received from a patient concerned a 79 year old female. The patient's weight was 135 pounds, and height was 62 inches. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included the patient was not pregnant at the time of report. The patient is allergic to certain antibiotics. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced mild achiness in shoulders. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild achiness in shoulders on 27-JUL-2021. This report was non-serious.
Inflammation in the right arm at the injection site, leading to tendonitis (persisting from soon after injection and ongoing at the time of this report). This (flu) vaccine was injected in the same arm that was still in pain from a tetanus injection over 6 months prior (filed under separate VAERS). A similar reaction resulted from a COVID injection in the left arm over a year prior (filed under separate VAERS).
Facial numbness; Tingling on the right side; "I am breastfeeding"; "I am breastfeeding"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Apr2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Loss of control of legs" (unspecified if ongoing), notes: experienced numbness and loss of ability to move my legs during an epidural with my first child.; "Breast feeding" (ongoing); "Numbness" (unspecified if ongoing), notes: experienced numbness and loss of ability to move my legs during an epidural with my first child. Concomitant medication(s) included: FLUTICASONE PROPIONATE. The following information was reported: HYPOAESTHESIA (non-serious) with onset 18Apr2021 13:15, outcome "not recovered", described as "Facial numbness"; PARAESTHESIA (non-serious) with onset 18Apr2021 13:15, outcome "not recovered", described as "Tingling on the right side"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 18Apr2021, outcome "unknown" and all described as ""I am breastfeeding"". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia.  Additional information: 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 vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101154267 mother/baby case
Chills started at about 7 pm after shot. Fever followed and shot up to over 102 degrees.  Fever lowered over next 2 days, but temperature didn't return to normal for 2+ days.
HAD A SORE THROAT; TROUBLE BRETAHING; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced sore throat and difficulty breathing. On an unknown date, the outcome of the sore throat and difficulty breathing were unknown.   It was unknown if the reporter considered the sore throat and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced symptoms sore throat and trouble breathing 4 hours after having the 2nd dose of Shingrix.
a little tired; This is a spontaneous report from a contactable consumer (reported for herself). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via intramuscular route of administration on 13Feb2021 (at the age of 80-year-old), as dose 2, single in upper left arm for COVID-19 immunization at Pharmacy/drug store. The patient's medical history was reported as none and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), via intramuscular route of administration on 21Jan2021 at 12:30 (at the age of 80-year-old), as single dose in upper left arm for COVID-19 immunization. On 14Feb2021, the next day after receiving the second dose, the patient felt a little tired, but not fatigues at all. The clinical outcome of the event was unknown.  Follow-up attempts are needed. Further information has been expected.
Patient reported redness at site of injection 2 weeks after receiving 1st dose of the Moderna vaccine. Also indicated she had a slight headache. She has emailed her PCP as well.
Moderna COVID 19 Vaccine EAU - mild allergic reaction started about 30 minutes after vaccine received. Started as a few sneezes then my throat and ears started itching. Coughing started next and I could feel my throat constricting. I was able to get home and take a Benadryl Liquid Gel and symptoms went away
Patient was given two doses of DTAP and IPV on same day. No signs or symptoms at time of vaccination today around 2 pm. Follow up phone call with mother at 5 pm, child without signs or symptoms.
On November 24,2010 at night, I noticed skin rashes all over my body. Since the Doctor offices are close for the Thanksgiving holiday I took some Benadryl capsule and watched for severe reaction to see if I need to the emergency room.That Monday Novemeber 29,2010. I called Dr's office and ask if he could see me that day and got an appointment for 2:00 p.m. He gave me a steroid injection and cortisone pills to take and took it until it was finish.
Fully vaccinated with COVID breakthrough infection.    Asymptomatic test with inpatient hospital stay.
This case was reported by a other health professional and described the occurrence of feeling bad in a 62-year-old female patient who received FLUARIX (batch number UI159AB, expiry date 30th June 2015). The patient's past medical history included breast cancer. Concurrent medical conditions included lymph node excision. On 26th September 2014, the patient received the 1st dose of FLUARIX (injection). On 26th September 2014, 4 hrs after receiving FLUARIX, the patient experienced feeling bad, shuffling gait, vomiting, skin burning sensation and hives in patches. On an unknown date, the outcome of the feeling bad, shuffling gait and vomiting were recovered/resolved and the outcome of the skin burning sensation was recovering/resolving and the outcome of the hives in patches was unknown. It was unkown if the reporter considered the feeling bad, shuffling gait, vomiting, skin burning sensation and hives in patches to be related to FLUARIX. Additional information: Nurse reporting at employee flu clinic, an employee (RPH) was administered vaccination in right arm. Within 4 hours, the pharmacist began feeling bad. At unknown time period, the pharmacist was displaying a shuffling gait, and said she couldn't drive. She refused to seek medical treatment. She also started vomiting. Pharmacist told nurse that she had a reaction in her left arm (which did not receive the vaccination). It began developing a red, burn like appearance, and felt really hot. Patient also developed hives in patches here and there. Patient continued to work and finished shift, and did not seek medical advice or go to ER. The nurse saw the patient today and noted that the patient said arm was improving despite still appearing red, with a burn like appearance and feeling warm.
Pt recv vax on 12/14/98; 15 min post vax pt exp overall itching w/ hives, chest tight; tx=Benadryl
Fever of 104.2 deg. F. started 48 hrs after vaccination. Fever controlled with Ibuprofen. Fever lasted 3 days at time of this report. No other symptoms.