chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. On unknown dates in 2016 (between 30-JUN-2016 and 20-JUL-2016), the patients received doses of PNEUMOVAX 23 (Lot# reported as M006141, expiry date: 20-MAY-2017) that were improperly stored. Temperature/Time: Multiple excursions between 30-JUN-2016 and 20-JUL-2016. Freezer: maximum 30.6F, cumulative time 96 hours, 51 minutes. Refrigerator: 31.3F minimum/maximum 49.4 for cumulative out of range: 35 hours 9 minutes. Data logger was involved. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. On unknown dates, two doses of improperly stored ZOSTAVAX (lot # L015416, expiration date reported as 01-AUG-201, dos, frequency and route were unknown) had been administered to patients. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
tiredness; stress; feeling terribly; This is a spontaneous report from a contactable consumer (patient).  A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date Apr2021) intramuscular on 31Dec2020 11:30 at single dose in the left arm for COVID-19 immunisation. The patient had no medical history.  There were no concomitant medications. The patient called for information about if severe tiredness and stress are symptoms reported for the administration of the Pfizer's COVID-19 vaccine and how to properly manage them. The patient reported that she was administered with the Pfizer's COVID-19 vaccine on 31Dec2020 and since then she has been experiencing severe tiredness and stress (31Dec2020). The patient reported that she has spoken with her physician and he could not provide guidance about how to proceed with this particular situation. She received the first dose of Pfizer Biontech Covid vaccine on 31Dec2020. She was feeling terribly, she has severe, severe tiredness that comes over her and stress. She was overwhelmed by what was happening to her and she was asking if anybody else has experienced this. Her second dose was supposed to be on 21Jan2021. The outcome of the events severe tiredness, feeling terribly and stress was not recovered.
This spontaneous report was received from a medical assistant and refers to an unspecified amount of patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates (since July 2014 till at least the end of January 2015), the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot #, expiration date, dose and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red dots/circles all over body but primarily on torso, arms, & back. At least 20 spots.  Some fever.
Moderna vaccine was administered but an undetermined amount of vaccine leaked from injection site down patient's arm. Patient was concerned she did not receive the full 0.5ml. Pharmacist on site contacted Moderna help desk for recommendation and it was unclear whether additional dose needed to be given at this time. Pharmacist also contacted CDC for guidance and CDC has no guidance on partial dose given at the time of the vaccination visit.   Clinic attempted to follow-up with patient's question  and left messages for patient to call back.  Per timing of first dose, pt was advised not to repeat 1st dose at this time. if patient were to repeat that would be more equivocal to three doses, which is not recommended by Moderna.
TINGLING IN THE LIPS, 25MG PO X 1 DIPHENHYDRAMINE DID NOT RESOLVE. SENT TO ER FOR OBSERVATION AND VITAL SIGNS NORMAL, NO PROBLEMS OR INTERVENTIONS.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient was lightheaded after vaccine administration, passed out for a brief moment and was back to normalcy after lying down and then drinking water.
This spontaneous report was received from a healthcare worker (Administrator) refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medications were not reported. On 16-AUG-2016 at 04:03 pm, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection, Lot#L0435128 (expiry date: 14-SEP-2017) (dosage not reported). The (Oka/Merck) VARIVAX was exposed the current excursion of a maximum of 10.3F for 3 hours and 45 minutes and a minimum of 7.3F for 33 minutes. The (Oka/Merck) VARIVAX was also exposed to three previous excursions described as: "The first excursion was on 22-JUN-2016 for 7 hours exposed to a maximum 26.63F, the second excursion exposed to a maximum of 24F for 64 hours and a third excursion ranging over a 6 day period of temperatures ranging from minimum 7.6F to  maximum 12.4F for a total of 3 hours and 5 minutes." No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Patient was due for the 2nd dose on 26 Feb 2021; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) and PRODUCT DOSE OMISSION ISSUE (Patient was due for the 2nd dose on 26 Feb 2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ), INSULIN GLARGINE (LANTUS), GABAPENTIN, METFORMIN, SIMVASTATIN and CARVEDILOL for an unknown indication.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced COVID-19 (Tested positive for COVID). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient was due for the 2nd dose on 26 Feb 2021). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient was due for the 2nd dose on 26 Feb 2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown  with no associated AEs. COVID-19 in this patient is unlikely to be due to the  Moderna (mRNA-1273) vaccine.
Area shot was given on arm was very red and enlarged & hardened & hot to touch. Site looked more inflamed than usual after an injection.
5 doses were administered (all booster doses of 0.25 ml) from expired vials; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were administered (all booster doses of 0.25 ml) from expired vials) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were administered (all booster doses of 0.25 ml) from expired vials). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 doses were administered (all booster doses of 0.25 ml) from expired vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No Treatment information was provided by the reporter.  It was reported that Vials were taken out of freezer on 27Oct2021. Vials were thawed and administered on the same day.Vials were stored properly, no temperature excursions involved.   This case was linked to MOD-2021-380859, MOD-2021-380860, MOD-2021-380834, MOD-2021-380857 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Numbness/numbing on his hand/finger tips like getting numb; Tickles in the finger tips/tickles/tickles in his hand/tickles in his fingers and also his mouth/tickling in my chin/feet as well (referring to the tickles); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness/numbing on his hand/finger tips like getting numb) and PARAESTHESIA (Tickles in the finger tips/tickles/tickles in his hand/tickles in his fingers and also his mouth/tickling in my chin/feet as well (referring to the tickles)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053G21A, 0R0M20A and 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALSARTAN (DIOVAN) for Blood pressure, LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROXYCHLOROQUINE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness/numbing on his hand/finger tips like getting numb) and PARAESTHESIA (Tickles in the finger tips/tickles/tickles in his hand/tickles in his fingers and also his mouth/tickling in my chin/feet as well (referring to the tickles)). At the time of the report, HYPOAESTHESIA (Numbness/numbing on his hand/finger tips like getting numb) and PARAESTHESIA (Tickles in the finger tips/tickles/tickles in his hand/tickles in his fingers and also his mouth/tickling in my chin/feet as well (referring to the tickles)) outcome was unknown.            No treatment medication were reported   This case was linked to MOD-2021-377936 (Patient Link).
Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated with a dose of GARDASIL (dose, route and lot # not reported). The patient now was planning to have surgery ovarian cysts removed. The nurse did not state this was due to GARDASIL. It was unspecified if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Upon internal review, ovarian cysts was considered to be an other important medical event. Additional information has been requested.
Approx 11hrs post-injection felt fatigued. At 12hrs post-injection, felt feverish and severe muscle tremors. Symptoms mirrored covid infection from two months prior, although these tremors were significantly more severe. Fever intensified and continued throughout the night, and had broken sometime before waking.
Softball size, bright red, raised, and itching around injection site. Started 7/18/13. States is bigger this morning 7/19/13 than yesterday.
Received a shingles vaccine "shortly" after the Moderna vaccine; Appointment for second dose is not within 30 days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION ERROR (Received a shingles vaccine "shortly" after the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Appointment for second dose is not within 30 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION ERROR (Received a shingles vaccine "shortly" after the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Appointment for second dose is not within 30 days). At the time of the report, VACCINATION ERROR (Received a shingles vaccine "shortly" after the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Appointment for second dose is not within 30 days) had resolved.            Concomitant medications were not provided. Treatment information was not reported.     Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Possible NNI
Pt has generalized rash all over body and has febrile episodes. Treatment with Tylenol and Benadryl. Rash lasted three days at time of report.
COVID-19; COVID-19; MARKETING PROGRAM NAME NOT AVALIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4515639-00 (AbbVie).  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (ongoing) (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Unknown Results. The action taken for upadacitinib was dosage not changed.  The reporter considered "covid-19" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided and known drug safety profile, the causality between the suspect drug BNT162B2 in the occurrence of the event   Drug ineffective , Suspected COVID-19 cannot be excluded.
Generalized severe muscle aching from 11pm on 11/05/2021 to waking up on 11/07/2021.  Injection site soreness from 5:30pm on 11/05/21 to waking up on 11/08/2021.
This spontaneous report was received from a licensed vocational nurse and refers to a 24-year-old female patient. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 31-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # N004799, expiration date: 15-NOV-2019, intramuscularly in the right arm (dose was not reported) against human papillomavirus. Other suspect therapy included DEPO-PROVERA (dates unknown). On 01-AUG-2017, the patient experienced a flesh colored rash with 1 mm raised papules on her arms (bilaterally), neck, and chest with itchiness. On an unknown date, the patient experienced alopecia with the use of DEPO-PROVERA. The patient contacted a physician and she was given an unspecified treatment for the events of rash papular and rash pruritic. The action taken with GARDASIL 9 was not applicable. The action taken with DEPO-PROVERA was not provided. The outcome of rash papular and rash pruritic was reported as not recovered. The outcome of alopecia was unknown. The casual relationship between the events and suspect therapies was not provided. Additional information has been requested.
Supraclavicular lymph node swelling on left-side 24 hours following vaccination in left deltoid.
Acute tachycardia, rate up to 105 bpm accompanied with a rise in blood pressure with a maximum reading of 155/98. My normal blood pressure reading is 130/80 with a pulse rate of 70 bpm. Accompanied with a body wide tingling sensation like an adrenal release.
necrotic tissue/Necrotic tissue at the injection site/Surgery to remove necrotic tissue; with a bump in the middle at the injection site; Red circle/Changing color; developed a a red circle hot to the touch; burning; This serious case was reported by a consumer via call center representative and described the occurrence of necrosis in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-SEP-2023, the patient received Arexvy (intramuscular, left arm). On 28-SEP-2023, 1 days after receiving Arexvy, the patient experienced necrosis (Verbatim: necrotic tissue/Necrotic tissue at the injection site/Surgery to remove necrotic tissue) (serious criteria GSK medically significant and clinically significant/intervention required), injection site swelling (Verbatim: with a bump in the middle at the injection site) (serious criteria clinically significant/intervention required), erythema (Verbatim: Red circle) (serious criteria clinically significant/intervention required), feeling hot (Verbatim: developed a a red circle hot to the touch) (serious criteria clinically significant/intervention required) and burning sensation (Verbatim: Changing color and burning) (serious criteria clinically significant/intervention required). The patient was treated with doxycycline. The outcome of the necrosis, injection site swelling, erythema, feeling hot and burning sensation were unknown.   It was unknown if the reporter considered the necrosis, injection site swelling, erythema, feeling hot and burning sensation to be related to Arexvy.     It was unknown if the company considered the necrosis, injection site swelling, erythema, feeling hot and burning sensation to be related to Arexvy.   Additional Information: GSK Receipt Date:16-NOV-2023 The reporter was the patient who stated that she received Arexvy and the next morning she developed a red circle hot to the touch with a bump in the middle at the injection site. The reporter applied cold compresses then the red circle started changing color and burning in the following days. According to the patient she visited her primary doctor who prescribed Doxycycline and referred her to a wound doctor who did a surgery on her arm to remove some necrotic tissue on 03-NOV-2023. The patient still had 4 stiches that supposed to get removed tomorrow. The reporter consented to follow up.
had an immediate reactions of hives; This is a spontaneous report received from consumer reported for herself. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6200, Expiration date: not provided) dose 1 via an unspecified route of administration on an unknown date as 1 ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that on unspecified date Immediately after the first dose, the patient had reactions of hives.  She was given an intramuscular injection of Benadryl and the hives resolved.  She stated that she had side effects that occur afterward that she was not concerned about and were normal, however she was concerned about the immediate hives.  She reported that it was an immediate non severe reaction.  She enquired if she could get the second dose. She was referred to HCP to determine if her reaction was a severe allergic reaction or not and if she should receive a second dose of the vaccine. The outcome of event was recovered.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Urticaria cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Received 2nd Pfizer vaccine at approximately 1500 on 5/14. That night, I experienced mild site injection pain. Started to experience myalgias throughout upper and lower extremities, and mild headache at  approximately 0700 on 5/15. Symptoms progressed and included chills  at about 0900. I took 1000 mg of acetaminophen around 0930 and symptoms lessened. Symptoms began to return at about 1300 but this occurrence included moderate left knee joint pain and moderate-severe injection site pain.  I took 400 mg of ibuprofen. Symptoms lessened then again returned at 2000. I took 1000 mg of acetaminophen and now going to sleep.
Employee felt like her throat was swelling with a pins and needles sensation associated with it.  Employee began coughing and had a runny nose.
Patient states that he has pain in his left upper arm since receiving the vaccine at the Employee Health Clinic. He did not report this until 12-21-2017. Pt. presents to clinic stating that his left upper arm has hurt ever since he received the flu shot in October. Date of influenza vaccine was 10/26/2017 in the afternoon. He was also in a cast for a fractured wrist prior to this and undergoing PT while complaining of the pain in his left deltoid area. He states that he has sharp pain in the deltoid muscle area of the left arm with range of motion and also especially with abduction of upper extremity and supination of forearm/wrist. Has good radial/ulnar pulses on left, no palpable masses or tenderness of deltoid muscle on left. FROM of left upper extremity but is painful to patient. Some crepitus palpated with abduction to 90 degrees. States that he has been doing band exercises in PT with arms flexed at elbow at 90 degrees and extension laterally which may also be causing some inflammation to area.
Pt stated arm swelled up at SubQ injection site and down arm. Pt also states arm was red. Pt states she also felt ill for 3 days. Immunizations were given 11/12/14. Pt presented to clinic 11/17/14 symptoms resolved.
Patient started to lose vision and ears were blocked about 3 minutes after receiving vaccination. Patient complained of chest pain. Patient was diaphoretic, BP dropped to 70/50s, and HR was in the 40s. Gave patient Benadryl and was immediately more aware and awake