chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range), PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2022 at 11:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2022 at 11:53 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range), PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range. Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Swollen arm; skin hot to touch; mimics effects of bee sting; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (non-pregnant) received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), dose 2 via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:00 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included atorvastatin, metformin. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in Arm Left on 31Jan2021 (37-year-old) 16:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have covid prior vaccination and no covid tested post vaccination. The patient had no known allergies. On 22Feb2021 09:00 the patient experienced swollen arm, skin hot to touch, mimics effects of bee sting. The patient did not receive any treatment for events. AE resulted in Doctor or other healthcare professional office/clinic visit.  The outcome of the events was unknown. Follow-up attempts completed. No further information expected.
Subcutaneously  instead of Intramuscularly; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 27pa5, expiry date unknown) for prophylaxis.   On 17th July 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 17th July 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient patient was administered shingrix Subcutaneously  instead of Intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up. This case was linked with case US2021137216, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021137216:Same reporter
Swollen, red arm, itchy,hot to touch about the 3 inches in diameter, 12 hrs after injection, lasted for 48 hr, on day three, improved however still remains red, itchy and slightly swollen, however not hot to touch and improving. Day two,  moderate dizziness, which has subsided completely. None of these symptoms where present the day of injection.
Patient received Moderna vaccine on 6/25/2021 at age 14.  She should have received Pfizer.  The patient developed a high fever after vaccination.
forty three children were administered varicella virus vaccine from a shipment that was stored out of the refrigerator for 5 days; This spontaneous report has been received from unspecified reporter via company representative concerning a children of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The reporter stated that the patient was vaccinated from a shipment that was stored out of the refrigerator for 5 days.   This is one of 45 cases reported by the same reporter.
Left arm became swollen, erythematous and warm from injection site to elbow. Small wheals/from injection site of DaPT.
mini stroke prior to second dose; Second dose outside 42 day window; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini stroke prior to second dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini stroke prior to second dose) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Second dose outside 42 day window). The patient was hospitalized on 13-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini stroke prior to second dose) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Second dose outside 42 day window) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No concomitant medications reported. No treatment information was provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Patient said her whole arm swelled and turned red and had turned back to normal today 5/9/14, it was also painful.
Pt. reported on 10/13/16 (rec'd on 10/11/16) 3" area of redness, excessively "sore and painful. Give pt. Ibuprofen 200mg, BENADRYL 25mg and ice pk to alleviate symptoms.
hearing loss in the right ear; This is a spontaneous report from a contactable consumer, the patient, and a non-contactable consumer, the patient's sister. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 23Mar2021 between 13:00 and 13:30 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history includes ringing in ears, problem with hearing out of the other (left) ear. Concomitant medications were none. There were no additional vaccines administered on the same date, or within 4 weeks of BNT162B2. On 24Mar2021, the patient experienced hearing loss in the right ear and sometime between 19:00 - 20:00, the patient could not hear out of the right ear for a day. The patient never had a problem with this ear. No emergency room or physician's office visit was required. The patient got up the next morning and her hearing was back. The clinical outcome of hearing loss in the right ear and could not hear out of the right ear was resolved on 25Mar2021.   Information on the lot/batch number has been requested.
Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 06Feb2021 04:45 PM (age at vaccination was 31 years) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication included fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6); Multi Vitamin taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 07Feb2021, 01:00 AM 12 hours after the vaccination the patient experienced Injection site pain, Tiredness, Headache, Muscle pain, Chills, Joint pain, and Swollen lymph nodes. No treatment was received for the event. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected
At 12:35 patient complained of feeling dizzy, light headed, nauseated and of having difficulty moving her arms or opening her eyes. She was diaphoretic at the onset of symptoms she was able to follow commands and answer questions but that became increasingly difficult. Symptoms worsen and patient started to vomit. Ambulance was called but patient refused to go with them. Felt better approximately 40 minutes after being vaccinated. Left accompanied by her husband.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender with no pertinent medical history, drug reactions and allergies reported. On 01-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (route, dose and lot number were not provided). Concomitant therapy was not reported. On 30-JUL-2015, the patient was vaccinated with the second dose of GARDASIL (route, dose and lot number were not provided). No adverse effects were reported. Additional information is not expected because the reporter denied consent for follow up.
PT DESCRIBED A RED SWOLLEN PAINFUL RIGHT HAND TWO DAYS AFTER GETTING THE IMMUNIZATIONS. IT DID NOT RESPOND TO TYLENOL, SO THE PATIENT CALLED HIS PCP THE NEXT DAY. PT RECEIVED A DIAGNOSIS OF STAPH INFECTION AND WAS STARTED ON ANTIBIOTICS. PT HAS A FOLLOW UP APPOINTMENT WITH PROVIDER THIS AFTERNOON.
Migraines, dizziness, nausea, blurred vision about 10 days after vaccination. Very unsteady gait, sensitivity to light, numbness and tingling in my face, both sides, some vomiting. Still to this date, I feel numbness on my face, more common on the right side of my face.  Arm pain, no swelling.
12/29 vaccination Felt like I had a cold. I get bronchitis easily. Urgent care, tested for COVID; positive. Provided vitamins.  *COVID +, bronchitis, upper respiratory infection  **REST
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 24-OCT-2017, the patient was vaccinated with ZOSTAVAX, 19400 plaque forming units, intramuscularly into deltoid muscle, lot # N021171 with expiration date on 01-NOV-2018 (dose was not reported), using a subcutaneous needle. No adverse effects were reported.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On 23rd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were received as follows: The lot numbers was unknown at the time of reporting. The patient reported pain at injection site after vaccination with SHINGRIX. The reporter did not consented to follow up. For 2nd dose refer case US2019017438.
A huge, red, hot to the touch swollen  circle  of skin at the injection site. It?s about 2 inches in diameter.
she reports not feeling like herself all day; jaw pain; her whole left side is painful and heavy; she has numbness in her jaw on the left side and her ear feels heavy and numb as well.; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that patient received the first dose of the Pfizer Covid-19 vaccine yesterday, in which patient reported not feeling like herself all day and developed jaw pain on the same side as the injection was administered. Stated her whole left side is painful and heavy. Stated that she has numbness in her jaw on the left side and her ear feels heavy and numb as well. Stated that she feels better today but is worried about getting through the weekend and doctor's offices being closed. Reporter asked if this was normal to experience. The reporter considered the events non serious. The outcome of the events she reports not feeling like herself all day, jaw pain and her whole left side is painful and heavy was reported as recovering and she has numbness in her jaw on the left side and her ear feels heavy and numb as well was reported as recovered on an unspecified date.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
On 3/25/03 associate went for routine blood pressure check with primary care physician.  Her B/P was noted to be unusually elevated with complaint of headache.  B/P was repeated on 3/26 150-160/100.  Past B/P's have been approx. 130/84.
MIGRAINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient is also a health care professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine was not reported. This report was non-serious.
Spoke with pt and she received a pneumonia vaccine on Tuesday,  9/24/13, she states that her arm turned red, painful, and she had difficulty raising it. She called Dr's office to report it, and was instructed to take Benadryl, and warm compresses to area. She was here today for labs, and asked to have someone take a look at it. Her left upper arm approx 3 inches above elbow area red, edematous, warm to touch. The area is approx 6 inches long, and 3 inches wide. Pt states " it is better than yesterday". Dr examines pt, and instructs pt this is a histamine reaction, that needs warm compresses, and Benadryl or Allegra. Area is marked by Dr, and pt instructed to return if redness goes outside of lines. She verbalizes understanding, and ambulates out of the clinic without difficulty.
Complaints of burning and itching between her elbow and shoulder and then it went across her chest above her breast, onto her neck and into her right upper arm down into elbow; Complaints of burning and itching between her elbow and shoulder and then it went across her chest above her breast, onto her neck and into her right upper arm down into elbow; This is a spontaneous report from a contactable consumer (patient herself). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in left arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included fibromyalgia, allergic to benadryl and migraine (She only tolerates steroids in baby doses, and she does this when she gets a shot for migraines that is going to knock her out). The patient's concomitant medications were not reported. She went to the medical center yesterday to get it. She has a lot of medical allergies. On an unknown date, the patient complaints of burning and itching between her elbow and shoulder and then it went across her chest above her breast, onto her neck and into her right upper arm down into elbow. The patient had taken Meclizine and Tylenol as treatment for the events, and it has calmed down. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient developed 3 days of atraumatic right first metatarsophalangeal pain (day 1 of symptoms was 7 days after vaccination), redness, and swelling that improved with ibuprofen. Pain gradually improved but was still lingering at time of encounter.
Right upper arm swollen/uncomfortable --extends to shoulder area. Warm to touch with pruritus. Seen by doctor 2 days after injection.
-Common severe fatigue for roughly 36 hours -low grade fever resolved hour 40 -rash covering trunk front and back beginning at approx. hour 42, itchy and red -elevated HR noticed at hour 48 (100BPM)
10/21/02 Patient complained of feeling funny, blurred vision/went black, complete loss of vision. No loss of postural tone or LOC. Shaking per school staff. Pallor noted when mom arrived. Continued with complaints of vision loss at office but positive response to visual threat and other visual challenges, though also claimed unable to see at times.
This spontaneous report was received from a 66 year old male patient referring to himself. Other demographics were not reported. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot number and expiration date were not reported). Concomitant therapies included TPAD, and pneumococcal vaccine (manufacturer unknown). The patient stated that on an unknown date he experienced chest pain and a feeling like he was going to die, after receiving ZOSTAVAX. No further information was provided. The outcome of chest pain and feeling like he was going to die was reported as recovered/resolved on an unknown date. Additional information is not expected, because no contact information was provided.
Received #3 Anthrax in left arm - Reported Deep left arm pain and pink scaly lesion on left, upper thigh on 4-23-07 - states he had same pain and lesion (on right leg) with #1 Anthrax given 12/18/06 but not Anthrax #2 given 1/22/07. Took Ibuprofen 800 gm 3x/day for 2-3 weeks. Developed ecchymotic lesion on abdomen about 5/2/07 - Seen by Med MD, workers comp (not same as above) on 5/4/07 as well as MD - Dermatologist both state resolving. On follow up 5/22/07 totally resolved.
The patient is a 51-year-old male with a history of medicine urticarial lesions temporally correlated with receipt of anthrax vaccine and relieved with BENADRYL. Per chart review the patient was seen at 1730 on the day of vaccine receipt, and in addition anthrax he also received a PPD. He presented with a complaint of generalized pruritus developing within 30 minutes of vaccine receipt but no urticarial lesions were observed. He had no other systemic symptoms and he was treated with diphenhydramine 50 mg IM and released.
This spontaneous report was received from a registered nurse referring to a patient of currently 60 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
A pharmacist reported VARlVAX was improperly stored and administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unspecified date, the product varicella virus vaccine live (Oka/Merck) (VARIVAX) was improperly stored and were exposed to a temperature excursion of 41 degree Fahrenheit during a time frame of 24 hours. No previous temperature excursions were reported. Digital Data Logger was not involved.  On 26-JUN-2021, the patient was vaccinated with a dose of this improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (mL), frequency reported as once, for prophylaxis (lot number T028306, that was verified to be valid with and expiration date reported and established to be 22-AUG-2022) (route and anatomical site of administration were not provided)(product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA000111: US-009507513-2107USA000029: US-009507513-2107USA000236: US-009507513-2107USA000238:
chills, fever - overnight  swelling, redness and pain at/near injection site (Covid arm) - ongoing as of Sunday June 12
Patient had received an expired vaccine that was reported by Pfizer by a labeling error. no adverse reactions when speaking to the patient and they will come back for the second dose with a current vaccine