chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(Infanrix XG942 Exp 08/22/2022) was administered by error in the left deltoid of an 11-year-old patient instead of a Tdap vaccine.; (Infanrix XG942 Exp 08/22/2022) was administered by error in the left deltoid of an 11-year-old patient instead of a Tdap vaccine.; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a healthcare professional representative. The reporter was a medical assistant and vaccine coordinator The patient received DTaP vaccine by error in the left deltoid instead of a Tdap vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. No additional adverse event was reported. The reporter consented to follow up.  The reporter provided consent to follow up with healthcare professional.
Heart rate gets very high when exercising. I was put on a calcium blocker and then changed to Acebulotil after a month. It was not being controlled with first med. I am still having trouble after being on 2nd drug for almost 2 weeks. I will be having a cardiac catheterization on April 4.
Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, with no drug allergy and no pertinent medical history concerning a 16 year old female patient with no who on 28-OCT-2011 and 19-JAN-2012 was vaccinated IM with her first and second dose of 0.5 ml GARDASIL (both lot # not reported) at another facility, respectively. On 19-JUN-2012, the patient was vaccinated with the third dose (lot # 667194/1271Z, expiration date 11-DEC-2012). There was no concomitant medication. Subsequently the patient took a home pregnancy test which showed that she was approximately 7 weeks pregnant. Her last menstrual period (LMP) was approximately on 09-MAY-2012, and estimated delivery date (EDD) was on 13-FEB-2013. The patient had sought medical attention by contacting the physician(method unknown). All telephone attempts to obtain follow-up information have been unsuccessful. Three attempts were made for pregnancy outcome with no response (2 phone calls and 1 fax). The case is lost to follow up. Additional information is not expected.
No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 4th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and RASH (Rash) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced PRURITUS (Itchy). At the time of the report, PRURITUS (Itchy) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Chest pains, lymph node under arm, woke up with right eyelid swollen, irritated and in pain
Treatment TAMIFLU 75mg BID x 5 days onset cough. Fever 101.5, body ache, SOB.
Blurred vision; It is very itchy on and around the injection site; Severe headache; Severe swelling on and around the injection site; Redness on and around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), VACCINATION SITE PRURITUS (It is very itchy on and around the injection site), HEADACHE (Severe headache), VACCINATION SITE SWELLING (Severe swelling on and around the injection site) and VACCINATION SITE ERYTHEMA (Redness on and around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VISION BLURRED (Blurred vision), VACCINATION SITE PRURITUS (It is very itchy on and around the injection site), HEADACHE (Severe headache), VACCINATION SITE SWELLING (Severe swelling on and around the injection site) and VACCINATION SITE ERYTHEMA (Redness on and around the injection site). At the time of the report, VISION BLURRED (Blurred vision), VACCINATION SITE PRURITUS (It is very itchy on and around the injection site), HEADACHE (Severe headache), VACCINATION SITE SWELLING (Severe swelling on and around the injection site) and VACCINATION SITE ERYTHEMA (Redness on and around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: Follow up received include an additional event swollen shoulder after receiving the vaccine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
OUT OF SPECIFICATION PRODUCT USE; VACCINE PLACE IN THE FRIDGE LONGER THAN THE 6HR PERIOD; This spontaneous report received from a pharmacist 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, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced out of specification product use. On 09-JUN-2021, the subject experienced vaccine place in the fridge longer than the 6hr period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and vaccine place in the fridge longer than the 6hr period was not reported. This report was non-serious.
started scratching and now the holes are open on areas to her chest; stated that the left side of her face is hard as a rock; Has rash on left side of face down to chest with blistery spots; could not breathe/cannot catch her breath every now and then; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 60-year-old, dose 1 via an unspecified route of administration, administered in right arm on 17Apr2021 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included high blood pressure; and bad feet since 2004. The patient's concomitant medications were not reported. The patient had first vaccine on 17Apr2021. On 18Apr2021, she had a reaction, could not breathe. She cannot catch her breath every now and then and had to use the Epipen. Has been using nebulizer. Has more Epipens in case something else happened. Stated that she has a rash on the left side of her face down to her chest with blistery spots and that the left side of face was hard as a rock on 19Apr2021. Stated that the rash was worst on her chest. Has put some cream on the rash but it burns. Had a pain cream called Volten that she put on it because the rash was painful but that made it worst. Stated that she started scratching and now the holes are open on areas to her chest on 21Apr2021. Stated that she had to wear low shirts because her shirts were rubbing her chest. Stated that she was told by her doctor not to take the second shot that was scheduled for 17May2021. Stated that she has scheduled doctor's appointments that were fine. The patient wanted to know if she could get something in writing to submit with her passport stating the she could not have the second shot. The outcome of the event could not breathe/cannot catch her breath every now and then was recovered with sequel, and for the rest of the events was not recovered.
someone who has been diagnosed with CLL and in stage 1; a reduction of my white blood cell count/my white blood cell count dropped from approximately 120k to 99k; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization; Bnt162b2 (Dose 4 (Booster)), for COVID-19 immunization. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant), outcome "unknown", described as "someone who has been diagnosed with CLL and in stage 1"; WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "a reduction of my white blood cell count/my white blood cell count dropped from approximately 120k to 99k". The patient underwent the following laboratory tests and procedures: White blood cell count: Dropped 120k to 99k, notes: My lab results shortly after the vaccine resulted in a reduction of my white blood cell count. In my most recent lab results my white blood cell count dropped from approximately 120k to 99k; reduction of my white blood cell count, notes: noted that my lab results shortly after the vaccine resulted in a reduction of my white blood cell count.  Additional information: I am writing to inform you that I have been vaccinated 5 times with the Pfizer/biontech COVID vaccine including boosters and as someone who has been diagnosed with CLL (Chronic lymphocytic leukaemia) and in stage 1, I noted that my lab results shortly after the vaccine resulted in a reduction of my white blood cell count. In my most recent lab results my white blood cell count dropped from approximately 120k to 99k. Needless to say, I don't know why the decrease happened, but I thought that information may be helpful in guiding your cancer research scientists to examine a link between your COVID vaccine and CLL to a potential pathway that would result in either slowing the trajectory of the disease or hopefully finding a cure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  SUSPECT PRODUCT is under agreement with BIONTECH SE.
Entire right upper arm red except for injection site, sore, achy and welts, unable to lift up arm. Symptoms started on Saturday (7/15/2017).  Took ibuprofen in the morning and Advil in the evening. On Monday 7/17/17. pain is 4-5/10 on a 1-10 pain scale. 1 (least)- 10 (worst pain ever). Monitor symptoms and if does not continue to get better to call doctor's office.
The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided
Burning sensation in the injection site; Feeling dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Burning sensation in the injection site"; DIZZINESS (non-serious), outcome "unknown", described as "Feeling dizzy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 4:30pm - burning in her chest, hard to breathe, coughing a lot.  Outside taking daughter to dance.  Around 7pm - body ache, neck ache, headache.  8pm - took Ibuprofen.  Eyes red.  Temp 100.4.  No other treatment, slept and still has slight neck ache, body aches.  T-97.9 this morning.  Given Ibuprofen.
Large local reaction left deltoid 16cmx10cm redness, swelling, tenderness, and itching. Started almost 24 hours after injection.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE RIGHT FACIAL PALSY SEPTIC PULMONARY EMBOLISM
Initial unsolicited report received from consumer on 10 October 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849 and 2016SA188851. (Same vaccine) This case involves 68-year-old female patient who was vaccinated with first dose of Flu Shot (Batch number, expiration date, dose, route and site of administration were not reported) on an unspecified date. Patient medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had pneumonia. On an unspecified date patient was hospitalized. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none. Sender's Comments: This is poorly documented case as patient take flu shot and had pneumonia. Time to onset is unknown, additional information regarding patient medical history, immune status, past vaccination history and its tolerance are needed to further assess the case. Patient was admitted twice for pneumonia. Based on available information the role of vaccine cannot be assessed.
Information has been received from a nurse concerning an 18 year old female patient with no medical history who on 20-AUG-2007, was vaccinated IM with a second 0.5ml dose of Gardasil.  After receiving the vaccine, the patient developed itching and a rash that covered a 3 inch area at the injection site.  The patient was given BENADRYL and the rash was clearing up.  It was reported that the patient did not have a reaction to the first dose. No product quality complaint was involved.  Additional information has been requested.
Around 11:35 PM on Thursday March 12, my father dropped his dish and drinking glass. Awokened by the noise, we rushed to him and noticed that his speech was slurred and he was not walking well.  His SpO2 was 94 and his heart rate was in the 140's. His blood pressue was elevated. He has suffered a stroke in November 2020 and he was acting like he did on that day. Once he sat down, he could not get himself up. The paramedics and my brother had to help him into the ambulance where they administered oxygen. The paramedics took him to the hospital, where he was admitted to the ICU. An MRI did not reveal any damage to the brain. He was diagnosed with a TIA and discharged from the hospital on Sunday, March 14.  I am not sure if the vaccine had anything to do with this episode, but I thought it should be reported just in case.
Swelling and Pain at injection site. Upper Right arm. Swelling and joint pain in Right elbow, wrist and shoulder. Severe Headache. Joint Pain. Extreme Fatigue. Fever 101.5 for 24 hours. Nausea.
Injection pain, bone pain in the left hand, chills/fever for over 4 days, heart felt warming, chronic cough
Gradual Pain that worsened hr by hr peaking at day 3 and continuing into now day 6... pain as such that daily care of self was limited* husband had to cook clean and do physical care, also got temperature the following afternoon of 100.
No additional AE/PQC reported; GARDASIL 9 was administered on 5/8/2023.; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 08-MAY-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # W015188 with expiration date of 06-JAN-2025, for prophylaxis (route of administration was not reported), that had a temperature excursion (product storage error). Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was supported after being evaluated. No additional event reported.   The vaccine underwent in temperature excursion of 10.7C, time frame 2 hours 10 minutes 0 seconds, no previous temperature excursion occurred.   No further clarify.
No adverse event; We gave a patient 1 dose of Moderna Covid-19 vaccine Bivalent BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave a patient 1 dose of Moderna Covid-19 vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave a patient 1 dose of Moderna Covid-19 vaccine Bivalent BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave a patient 1 dose of Moderna Covid-19 vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave a patient 1 dose of Moderna Covid-19 vaccine Bivalent BUD).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter
Initial report received from a health care professional on 31 May 2007. An 11 year old, male patient (with a history of asthma) developed cough after he received Adacel (lot number C2572AA) intramuscularly in the right arm on 26 October 2006. He did not have any illness at the time of the vaccination. On 17 May 2007, he was seen at the physician's office where a nasal pharyngeal culture was done to rule out pneumonia versus pertussis. On 25 May 2007, the report showed positive Bordetella pertussis. He was treated with Zithromax for 5 days and it was reported that he recovered.
This spontaneous report was received from a registered nurse regarding an unspecified number of female patients of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. In approximately July 2016 (reported as "after June 2016"), the patients were vaccinated with VARIVAX injection, subcutaneously, lot # L050956, expiration date: 17-DEC-2017(strength, dose and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse events were reported and no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.