chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID after vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID after vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID after vaccine). At the time of the report, COVID-19 (COVID after vaccine) 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.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.  Company comment: This spontaneous case concerns a patient of an unknown age and gender with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the dose of mRNA- 1273 vaccine, dose number unknown. Information regarding schedule of vaccination was not disclosed. Very limited information is available regarding this event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Reporter's Comment : How long should one wait to get the booster vax after having the covid infection   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the dose of mRNA- 1273 vaccine, dose number unknown. Very limited information is available regarding this event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "known allergies Compazine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid: Treatment start date: 03Jan2023, stop date: 08Jan2023 for covid-19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Itching, and rash with extreme dry, rough, and flaky skin on my sons right wrist.
Myalgia Narrative:  reports soreness in 1 arm (ipsalataral side from vaccine) for 2 mo after #2 dose. Vaccine administered in r deltoid #1 and #2 . She reports this today 1/24/22. This had occurred for a few months after #2 dose of moderna, and she states she has no pain in either arm at present. She states she has h/o superficial thromvophelvitis in 1 ue year ago. Is followed by her pcp.
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves two child patient who received vaccine IPV (VERO) [IPOL] lot number not reported via unknown route in unknown administration site on an unknown date after a temp excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that she called about viability of Ipol and was told not to use it so she put it in another refrigerator and told the other nurse to put a note on it but it was during the Christmas break and it was used for 2 children. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Severe swelling to arm, chest, armpit, shoulder and back on left side. Most of these were also point tender. Extreme pain in left arm, general weakness throughout arm. Pain in joints. Lethargy and diminished appetite. Stomach pain. High blood pressure (150/95) and excessive sweating. I usually have blood pressure of 106/60. Significant edema and bloating. Swelling after exercise and point tenderness in left chest 7 days after vaccination.
Five minutes after vaccine patient stated she was having pulsating vision, and upset stomach.  Immediately started vitals,  BP:  113/73, HR: 85, R:16, O2 sat:98 . Patient remained A/O x 4 at all times.  Continued to monitor, another set of vitals taken after 10mins. BP: 107/69 HR:82 R: 17 O2 sat 99.  All reactions subsided after 15minutes. Monitored for an additional 15mins after all reactions subsided. Patient stated she was okay, and felt better before leaving.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. After receiving SHINGRIX, the patient had pain in her arm at the injection site and felt tired. This is 1 of the 5 cases, reported by the same reporter. The gender of the patient was captured as male as per narrative, whereas it is reported as female in the file.
Septicemia; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program (Patient's wife reported).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single; patient also received dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The Patient's wife reported that her husband was in the hospital with septicemia on an unspecified date before the booster. Patient was over it now. Two weeks after he recovered on antibiotics and fluids. He was fine, the reporter stated. Seriousness was reported as hospitalization and medically significant. Outcome of event was recovered on an unspecified date.  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-202101400475 Same patient and drug, different event separated in time
Patient had the vaccine in the arm for approximately 1 minute before becoming pale and beginning to shake. The patient had a representative that stated he was a diabetic and did not eat before the vaccine, believing that his glucose was dropping. He was given a shot of glucose before having an episode similar to a seizure. Diphenhydramine and an Epipen were obtained but were not needed to be administered as the side effects subsided. The patient wanted EMS to be called. EMS arrived at the facility and the patient was assessed. Patient left on his on will.
Patient received 4 vaccines in this order: Pfizer BioNtech and fluzone quad in the right deltoid, then Adacel followed by Gardarsil-9 in the left deltoid. Within one minute of final vaccine administration patient had a syncopal episode while seated that involved myoclonus (aproximately 10 seconds). Patient regained consciousness and remained seated. Patient was dizzy for approximately 5 minutes. An ice pack was applied to the back of the neck while they drank a refrigerated fruit smoothie beverage.  Patient recovered fully by the end of the15 minute post vaccine observation period. No other side effects or injuries were noted.
After receiving seasonal "flu shot" experiencing pain and limited movement of left shoulder/arm. Disrupted sleep and chronic pain, exacerbated by moving arm back which has persisted for 5 months and has not subsided.
Pericarditis. Presented with chest pain, shortness of breath, and exertional syncope starting two days after the vaccine. Started on course of ibuprofen. Patient to follow up with cardiology.
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 22-MAR-2013 was administered a dose of GARDASIL (lot # H011350 and expiration date 21-FEB-2015) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 28-DEC-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
3 hrs s/p DTP, became pale & limp, "catatonic" according to mom; poor eating, seen in ER @ hosp; CBC drawn-nl; pulse oxymeter monitoring, BP taken, observed in ER x 3 1/2 hrs; color improved & eating well, sent home 1230AM 24APR;
pt recv vax;was pale,sweaty,body was shaking x 30 sec;breathing hard,eyes moving up & down;p/ event,seemed sleepy;
(Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (COVID arm). At the time of the report, RASH (COVID arm) outcome was unknown.        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 reported.   No treatment medications were provided
there was a big red, hot spot on the arm of the injection; red hot spot began to hurt and itch; red hot spot began to hurt and itch; headache; chills the progresses to shaking; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (there was a big red, hot spot on the arm of the injection), VACCINATION SITE PAIN (red hot spot began to hurt and itch), VACCINATION SITE PRURITUS (red hot spot began to hurt and itch), HEADACHE (headache) and CHILLS (chills the progresses to shaking) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Flu vaccination.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (there was a big red, hot spot on the arm of the injection), VACCINATION SITE PAIN (red hot spot began to hurt and itch), VACCINATION SITE PRURITUS (red hot spot began to hurt and itch), HEADACHE (headache) and CHILLS (chills the progresses to shaking). The patient was treated with IBUPROFEN for Symptomatic treatment, at a dose of 600 mg. At the time of the report, VACCINATION SITE ERYTHEMA (there was a big red, hot spot on the arm of the injection), VACCINATION SITE PAIN (red hot spot began to hurt and itch), VACCINATION SITE PRURITUS (red hot spot began to hurt and itch), HEADACHE (headache) and CHILLS (chills the progresses to shaking) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Concomitant medications was not provided by the reporter.
Right side of body ache; right side of body ache- Arm shoulder, kidney, hip, and upper leg.; right side of body ache- Arm shoulder, Kidney, hip, and upper leg.; right side of body ache- Arm shoulder, Kidney, hip, and upper leg.; This is a spontaneous report from a contactable reporter (consumer and non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in right arm , administration date 17Nov2021 at 13:15 (Lot number: FF2593) at the age of 49 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Toe amputation" , and "Foot amputation"; notes: 5th toe amputation and part of top of left foot. Concomitant medications included: FLU taken for Immunisation, start date: 18Oct2021, stop date: 18Oct2021. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot No: FG3590, vaccine location: right arm, Administration time: 10:00), administration date: 23Oct2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 17Nov2021 at 13:30, outcome "not recovered", described as "Right side of body ache"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 at 13:30, outcome "not recovered", described as "right side of body ache- Arm and upper leg"; ARTHRALGIA (non-serious) with onset 17Nov2021 at 13:30, outcome "not recovered", described as "Right side of body ache- hip and shoulder"; RENAL PAIN (non-serious) with onset 17Nov2021 at 13:30, outcome "not recovered", described as "Right side of body ache- Kidney". Therapeutic measures were not taken as a result of pain, pain in extremity, arthralgia and renal pain. Additional Information: The patient had no known allergies. 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
aching and sore to touch left upper chest/left breast; aching and sore to touch left upper chest/left breast; This is a spontaneous report from a contactable nurse. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via intramuscular in arm left on 04Apr2021 at 12:30 PM (at the age of 76-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history included COVID-19. The patient's concomitant medications were not reported. The patient stated that, one day post vaccine aching and sore to touch left upper chest/left breast on 05Apr2021 at 12:30 PM, that lasted approximately 24 hours. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. Prior to vaccination, the patient was diagnosed with COVID-19. The reporter classified the events as non-serious. Treatment received for the events was reported as unknown. The outcome of the events was recovered on an unspecified date in Apr2021.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from registered nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 29-OCT-2013, the patient was vaccinated with the first dose of GARDASIL lot # J006236, expiration date 25-FEB-2016, for prophylaxis (dose and route of administration were not reported) and on 19-DEC-2013, received a second dose of GARDASIL lot # J006850, expiration date 31-MAR-2016, for prophylaxis (dose and route of administration were not reported). Subsequently, on 10-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot #L038503 expiration date 18-DEC-2017, intramuscularly, for prophylaxis (dose was not reported) and on 22-SEP-2017 received a second dose of GARDASIL 9 lot # N004799 expiration date 15-OCT-2019, intramuscularly, for prophylaxis (dose was not reported). No adverse effects were reported.
Patient came in for a PPD test.  Instead of Tubersol, staff member drew up 0.1ml of IPOL.
Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; She didn't know what but it is itchy, it hurts or a combination of both; She didn't know what but it is itchy, it hurts or a combination of both; My arm hurts/her arm felt like a little sore; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) via an unspecified route of administration, on 06Jan2021 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medications included metoprolol and lisinopril, both for high blood pressure. Patient stated that she got the Pfizer vaccine on 06Jan2021. The regular reaction to it like her arm hurts and that was it, it lasted like for three days and it went away. Not yesterday, but the day before (15Jan2021), her arm felt like a little sore. Yesterday (16Jan2021), when she was in the showering, she noticed that the around the site of injection, it was like a red circle like a size of an inch that was (sentence incomplete). She felt like a little warm to her. She didn't know what but it was itchy, it hurt or a combination of both, it didn't bother her unless she touched it or rubbed against it but it was there. So, she just wanted to know whether that was a reaction to the injection or what that was, is that common or is that not common. Patient said she still felt it. As treatment, patient took a paracetamol (TYLENOL). She took one paracetamol this morning (17Jan2021) and one yesterday (16Jan2021). Outcome of arm hurts/arm felt like a little sore was recovered, outcome of other events was not recovered.
day after: tired; felt a little "off" 2 days later: rash all over trunk and both arms. Swollen, sore and itchy at site/general area of injection, little headache.
Vaccine received on 12/23.  Pt reports diarrhea on 12/25.  On 1/2, injection site became swollen, warm, and itchy.  on 1/3 the swelling greatly increased and PCP was notified.  PCP saw patient on 1/4 and gave her a steroid shot and antibiotics for possible cellulitis.
very sensitive to alcohol; Severe chills; Night sweats; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ALCOHOL INTOLERANCE, CHILLS, HYPERHIDROSIS, and MYALGIA in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALCOHOL INTOLERANCE, CHILLS, HYPERHIDROSIS, and MYALGIA. At the time of the report, ALCOHOL INTOLERANCE, CHILLS, HYPERHIDROSIS, and MYALGIA outcome was unknown. Not Provided.          This case was linked to MOD-2021-071440.   Reporter did not allow further contact. Sender's Comments: MOD-2021-071440.