chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received regarding a case in litigation from a lawyer, the spouse, and a 62-year old female patient referring to herself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The female patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 06-FEB-2012, the patient was administered the ZOSTAVAX by a healthcare provider at a clinic (lot number, dosage and route of administration not provided). In 2015, the patient was treated by a physician at the clinic for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
At the 36 hour mark after the vaccination.  I had a severe skin reaction.  My face, chest and back were covered in a raised, red,  itchy and painful rash. This was accompanied by fever and fatigue.  I applied cold compresses and took Tylenol. I had to travel out of the country the next day. This is when I began to take Benadryl. This started to give some relief.  Today is one week post vaccination. I was able to stop Benadryl yesterday. I am recovering but still have itchy skin and fatigue. I can send photos of the reaction if helpful.
Information has been received from a physician concerning a patient who was vaccinated with a first and second dose of varicella virus vaccine live. Subsequently, the serum varicella virus antibody test indicated that titers done were undetectable. Unspecified medical attention was sought. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: NORTREL [LEVONORGESTREL] taken for contraception; OMEPRAZOLE taken for gastrooesophageal reflux disease; WELLBUTRIN; CYMBALTA; TRAZODONE; CONCERTA; MIRALAX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive; (24Jul2022) Negative; (26Jul2022) Negative; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had received other medication in 2weeks. Patient had received Paxloid treatment from 19Jul2022 to 24Jul2022. Patient had no known allergies. It was reported that Tested positive on 19Jul2022. Started Paxloid in the evening Finished on 24Jul2022. Symptoms stopped 22Jul2022. Tested negative on 24Jul2022 and 26Jul2022. Runny nose and coughing on 29Jul2022. Home kit positive.  Follow-up attempts are completed. No further information is expected.
Soreness and swelling at injection site, full body rash starting 24 hours after injection.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 15 month old child patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Red swollen area around where the shot was given. Bruised in the middle. Some pain similar to what it felt like when the shot was given.
pt called c/o arm swollen & itchy @ site & sl down from site; pt nervous; MD suggested antihistamines, DPH, APAP or oral steroids; pt declined all tx; MD also suggested cool compresses;
achy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (achy). At the time of the report, MYALGIA (achy) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided by the reporter.
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 56-year-old adult female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019). The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805016) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
12/24/2020 (day  after): Nausea, headache, fever, achy, pain and hot at injection site - took Advil throughout the day.  12/25/2020 (today): Symptoms have lessen and fever seems to be gone but still achy, slight headache and nausea and pain at injection site.
About 4 hours after receiving the TRUMENBA Vaccine the patient's right arm started to tingle and hurt, she started vomiting, complaining of headache, body aches, roaring in ears. She also felt dizzy, weak, and felt like fainting and had a temp of 102.4 degrees F. She was advised to go to the ER. Mother took her to Urgent Care. An EKG and strep test was performed and both were normal. BP sitting, standing, and lying were reported normal. She was sent home from urgent care. She felt bad for a few days after but is feeling better today 07/23/2018.
pt devel swelling, erythema & pruritus of the upper arm (inject site) p/receiving vax; pt was given vax following needlestick injury; rxn resolved in 3 days;
Client's mother called cliinic 7/30/08 reporting bilateral swelling of deltoids, arms, hands, feet & face of client. Client's "face feels fat". Hand & feet itchy & burning; client's tongue swollen & client having difficulty talking. RN counsel to call 911 or take to emergency care immediately; give Benadryl. 7/31/08 mother reports that client was given shots in hospital & kept for observation but released same day. Also given RX for medication (unknown). All SxS gone.
Adverse local reaction to Adacel injection.  Left arm pain, left arm cellulitis.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:52 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 48.19.  Concomitant products were not provided.  On 03-Apr-2021, excursion time was 09 AM and temperature was 34 respectively, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vial was moved to clinic on 03-Apr-2021. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM : 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient received a first dose of his COVID-19 Moderna vaccine and 10 minutes post administration said he felt very hot and visible perspiration was covering his body. He felt just very anxious right after the vaccine. I gave him water and asked if he wanted to lay down to ensure he was not going to faint. Once he was down on the ground, he said he felt 100% better and realized it was just anxiety.
hair started to fall out from the roots;started 30JUN97 p/vax;pt is still loosing hair but not as much as following vax;pt estimates lost about half of hair;pt is loosing hair not in spots but all over the head equally;
Day of vaccination, fatigue, aches, headache, dizziness, diarrhea, severe arm pain at injection site. Diarrhea has persisted since hours after the vaccine, almost a month later including painful stomach cramping. These gastrointestinal symptoms were not present beforehand and appeared at the same time as the other side effect but the GI issues have not resolved or even lessened. I may need to seek medica attention if it persists.
This case was reported by a nurse and described the occurrence of chest heaviness in a 36 year old female subject who was vaccinated with influenza virus vaccine for prophyylaxis. On 11/07/2005 at 1:05 pm, the subject received 1st dose of Fluarix in the left deltoid. On 11/07/2005 at 1:10 pm, 5 minutes after vaccination with Fluarix, the subject experienced chest heaviness, tingling body and headache. At 1:10 pm, the subject's blood pressure was 104/70 mm Hg, heart rate was 80 and respiratory rate was 14. The subject was "observed for 1/2 hour." At approximately 1:40 pm on 11/07/05, the chest heaviness and body tingling resolved, blood pressure was 108/70 mm Hg, heart rate was 76, respiratory rate was 12 and temperature was 98.2  degrees F. The headache "lasted for 4 hours" and resolved at approximately 5:10 pm on 11/07/05.
This spontaneous report as received from a nurse practitioner refers to a 15 year old male patient. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 03-AUG-2015, a 15 year old patient was vaccinated with a dose of PROQUAD (Merck) (strength, dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Patient received vaccine and walked into waiting area.  He states that he leaned over a few minutes after sitting and became dizzy.  He doesn't remember what happened then, but a witness reported that he fell out of his chair to his left hitting his head and face on the floor.  After about 20 seconds he was alert and started to try to stand up, but was encouraged to stay sitting.  BP 118/62, P 72, R 16, SpO2  99.  Alert and oriented.  Speech was clear.  Pupils PERRLA.  Reports tenderness to forehead,  hematoma and redness noted.  Redness noted to nose.   Reported event to PCP.  Orders received to go home with a driver. Observe for s/s of concussion such as nausea, vomiting, lightheadedness, dizziness, head.  If symptoms worsen, develop confusion, needs to report to ER.
Patient started complaining of intense chest pain around 5:30 PM on Saturday. Then she said it was getting hard to breathe. We called her pediatrician who spoke to her and advised she go to ER. Once there, they ran an EKG and took an X-ray. They diagnosed her with vaccine related Pleurisy. She is suffering to this day with chest pain and exhaustion.
Initial report received on 13 November 2007 from a health care professional. A 35-year-old female patient, with no concurrent illnesses, or pre-existing medical conditions, had received a right deltoid dose of Decavac, lot number U1961EA, on 06 November 2007. The route of administration was not provided. The following day, the patient presented to the emergency room with complaint of headache, neck pain, temperature of 101.5 degrees Fahrenheit, nausea, and diarrhea. She was treated with intravenous fluids, Rocephin, and Toradol, and was diagnosed with viral gastroenteritis. A lumbar puncture was completed and was negative for meningitis. The patient was discharged to home the same day with Vicodin for her headache. At the time of this report, it was "unknown" if the patient had fully recovered. The reporter for this case is the same as for case 2007-03867.
Relapse of Cellulitis, I have had Cellulitis twice before in the same leg, left. Hospitalized the first time, second time a course of Linezolid 600mg 10 days. On a course again finishing 02 Apr 2021
Had cold before 2nd shot; I have been not normal since; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Had cold before 2nd shot) and FEELING ABNORMAL (I have been not normal since) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Had cold before 2nd shot) and FEELING ABNORMAL (I have been not normal since). At the time of the report, NASOPHARYNGITIS (Had cold before 2nd shot) and FEELING ABNORMAL (I have been not normal since) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-261628 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Additional event was added.
Received influenza shot at 10:15 am then at 12:30 am (midnight) noticed acute onset of wheezing or shortness of breath and then developed bloody nose. Bedtime hot and flushed and light headed with continued wheezing and nasal congestion. Next day felt very fatigued. Asthma symptoms resolved on own.
Experienced lesser side effects; This case was reported by a nurse via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patient received Shingrix stated that the doctors at her workplace are stating that it was their general finding in their clinical setting that patients who got the 2nd dose further apart from the 1st dose experienced lesser side effects. The reporter consented to follow up. This case linked with US2020AMR014606 and US2020013944, reported by same reporter.
patient is 7 days from 2nd covid 19 vaccine. patient has upper lip swelling and stated the day prior her lower lip was swollen. states face feels funny and has wondered if it was a bells palsy reaction? no changes in home or new foods/medications.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-405865 (Patient Link).
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-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 11-Jan-2023, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients).    Concomitant medication was not reported. Moderna COVID19 vaccine bivalent, dosage given in ml.  Treatment drug was not reported. This case was related to patient number 20 out of 100 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
This spontaneous report was received from a medical assistant and refers to a 9-week-old patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies was provided. On 10-NOV-2017 at 10:30 in the morning, the patient inadvertently received RECOMBIVAX HB 10/1.0 micro-g/ml injection, 0.5 ml (route of administration was not reported) adult formulation for prophylaxis instead of the intended pediatric formulation. No information about concomitant therapies was provided. No adverse effects were reported. Product quality complaint was not involved.
OBSTRUCTIVE SLEEP APNEA ACUTE DVT OF BILAT PERONEAL VEINS ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA 1/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Hives, nausea, vomiting; epi 0.5ml sq administered; EMS arrived and gave Benadryl.
This spontaneous report as received from a vaccine coordinator refers to unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ with lot number M007124 and expiration date of 05-OCT-2017, orally (strength and dose were not reported), which was stored at 47.5 Fahrenheit degrees for 1 hour and 32.9 Fahrenheit degrees for  hour. There was no previous temperature excursion. The temperature excursions were detected by a data logger. There were no concomitant therapies reported. No product quality complaint was involved. This is one of several cases form the same reporter. Additional information has been requested.