chrisvoncsefalvay/vaers-outcomes huggingface dataset:
other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68-year-old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 01-JAN-2016, the patient was administered zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) at a pharmacy, for the long-term prevention of shingles and zoster-related conditions.         Subsequently, on an unknown date, the patient was treated by healthcare providers for the following injuries resulting from zoster vaccine live(ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was unknown.  The reporter considered herpes zoster and other zoster-related conditions to be related to Zoster Vaccine Live(ZOSTAVAX).
Rash red & splotchy, pt screaming uncontrollably. Rash appeared on left leg.
Information has been received from a registered nurse concerning a 79 year old male who on 27-JUN-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant therapy included NIZORAL. On 04-JUL-2007 the patient developed swelling of the eyelids and face. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint. Additional information has been requested.
3 days after receiving flu vaccine, started to experience severe incapacitating myalgia and weakness - CPK > 1,000 Dx with Rhabdomyolysis - No Rx at this time - monitoring blood work.
After 10 minutes of the vaccine pt was feeling, faint, weak, light headed, nausea, flushing, hot very pale and ashy
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Feb-2022; Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Feb-2022) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2022 at 2:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Feb-2022 at 2:41 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported. Patient received booster vaccine past its 30 day expiry date. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Reporter no longer possess this lot number. On 26-Feb-2022, the patient took the booster dose of the vaccine. No treatment information was provided by the reporter.
I verified vaccine hx with Immtrac2 and noted no previous dose of seasonal flu, since patient requested, and she was eligible I went ahead and administered it.  Upon finishing documentation on TWICES it was noted that there was a previous dose that was administered in October 2022. No adverse reactions noted or voiced by patient as of today 6/6/23
5-6 cm area of swelling, erythema, warmth. Lasted 3 days. Then bruising lasting 5 weeks.
Cough; Lethargy; Vomiting; Nausea; Slight fever; Injection site soreness; Presented with the red, very swollen, very tender lips; Presented with the red, very swollen, very tender lips; Presented with the red, very swollen, very tender lips; This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171) via an unspecified route of administration in the arm left on 22May2021 at 11:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included heart palpitations and acid reflux. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received amoxicillin (MANUFACTURER UNKNOWN), KEFLEX and morphine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The first day after vaccine the patient was feeling normal. On 24May2021, the patient had injection site soreness. On 24May2021 at 00:00 upon awakening on the second day the patient presented with the red, very swollen, very tender lips and slight fever and went to the primary care physician and was told to take 50mg Benadryl and go to bed and rest. Upon awakening on the third day on 25May2021, the patient presented with nausea, vomiting, cough, slight fever, and lethargy. The patient was still taking Benadryl for reaction along with Zofran for nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with Benadryl 50mg along with Zofran for nausea. The clinical outcome of the events injection site soreness, very swollen lips, tender lips, red lips, slight fever, lethargy, nausea, vomiting and cough were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
a very sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a very sore left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020821A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, METHIMAZOLE for Asthma, OMEPRAZOLE for GERD, TRAZODONE for Insomnia, GABAPENTIN for Mood change.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a very sore left arm). At the time of the report, PAIN IN EXTREMITY (a very sore left arm) outcome was unknown.            both the vaccines were administered on left shoulder as mentioned.  No treatment product was reported   This case was linked to MOD-2021-035969 (Patient Link).
Presented wtih increasing SOB; dx with covid 1/22/23; Tx with Decadron, maxipime, heparin, eliquis, Rocephin, The pt was admitted to the hospital on  2/9/2022 because of acute hypoxic respiratory failure and post COVID syndrome.  The patient was seen by Pulmonary.  IV steroids increased.  Eliquis was continued.  Decadron 10 mg 3 times a day continued.  Oxygen was gradually weaned.  Patient on 3 L of oxygen now.  Decadron to be slowly tapered 3-4 weeks per pulmonary recommendation.
Information has been received from a healthcare worker concerning a 25 year old patient who on 16-APR-2009 was vaccinated with ZOSTAVAX vaccine (Merck) for chickenpox instead of varicella virus vaccine live (Merck) due to human error. No adverse effect was reported. Follow-up information has been received from the administrative staff who administered the vaccines to the patients. The administrative staff confirmed that the 25 year old female patient received ZOSTAVAX vaccine (Merck) (lot # 662755/1621X) on 01-APR-2009 (not 16-APR-2009 as previously reported) instead of chickenpox. Follow-up information has been received from a healthcare worker that on 01-APR-2009 the female patient with no illness at the time of vaccination was vaccinated with a dose of ZOSTAVAX vaccine (Merck) instead of varicella virus vaccine live (Merck) in error. The patient's arm was red and swollen at the vaccination site. At the time of reporting the outcome for the patient's arm being red and swollen at the vaccination site was reported as recovered. No further information is available.
Developed diffuse body rash on 3/17/13. Appeared worse on face.
Very sore arm for one week. on 11/3/2022, swelling of neck with pain in throat. CT determined a salivary infection and inflammation in the area.  IV antibiotics for 3 days, released. Taking Amoxicillin for 14 days. Lactobacillus for 12 days. As of 11/15/2022, still some swelling, pain, and blockage of salivary duct.
J96.00 ACUTE RESPIRATORY FAILURE 10/26/2022 SEIZURE, UNSPECIFIED R09.02 HYPOXIA 10/26/2022 SEIZURE, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 10/26/2022 ATRIAL FIBRILLATION, PERSISTENT R09.02 HYPOXIA 10/26/2022 ATRIAL FIBRILLATION, PERSISTENT
PATIENT STATES RIGHT ARM STILL IN PAIN AND UNCOMFORTABLE 8 DAYS POST VACCINATION WITH COMIRNATY AND BOOSTRIX.
1 x 2 1/2 cm elevated raised area on left ant (LAT) thigh.
10 min after inj. started with tingling at inj site, progresses down arm then to other arm and across chest, started to feel tingling in throat. Initial BP was high at 152/86 P94. Pt asked to defer Benadryl as was driving and symptoms were already lessening. No flush no chest pain denied other symptoms. Next BP 115/78 P85. Then 10 min later 113/81 P80. After watching, pt discharged to home with instructions.
No adverse effects; inadvertently administered an expired dose of VAQTA; This spontaneous report as received from a physician refers to a 11-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 08-JUN-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R034339, expiration date 23-NOV-2019 (dose and route of administration was not reported) for prophylaxis. There was no adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R034339; expirationdate: 23-NOV-2019; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pt presented on 10/25/2021 for Pfizer dose number two. Mother reported patient having significant chest pain 5 minutes after administration of first vaccine on 07/26/2021. No medical treatment was needed. Pt stated pain subsided after 30 minutes. Patient and mother deny any anxiety or contributing factors at time of first dose. Pt and mother encouraged to follow up with cardiologist prior to any further Pfizer Covid vaccine administration.
*Hard, red, swollen, hot, and sore injection site. *Bad headache, mostly on both sides of my temples, feeling like there is something tied or tightening on my head. *Body aches in my arms, top of back, shoulder, legs, neck. *Fatigue *Very swollen lymph node on left side of neck/top of chest at clavicle ( on injection site side)
ARM SWOLLEN @ INJECTION SITE; RAISED SPOT & REDDISH IN COLOR. SIZE INCREASED TO GRAPEFRUIT SIZE (REPORTED VERBALLY BY PATIENT). PHYSICIAN PRESCRIBED ANTIBIOTICS AND STEROIDS
This spontaneous report as received from a nurse refers to an unspecified amount of patients of unknown demographics. Information regarding the patient's concurrent conditions, medical history and drug reactions/allergies was not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, which had lot # L008034 and expiration date 05-AUG-2016 and lot # L027726 and expiration date 10-MAY-2017 (dose was not reported). There were no concomitant medications provided. The reporter stated that there was a previously temperature excursion of 9 Celsius (C) for 10 hours. On an unspecified date, the ROTATEQ were exposed to 15 Celsius (C) for 120 hours. There was no data logger was used to capture the excursion. No adverse effects had been reported. This is one of several cases from the same reporter. Additional information has been requested.
The patient is not immunocompromised and received a 0.5 mL of Moderna for 1st booster making this a Med Error.
blood pressure has also been higher; nausea; vomit; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (BNT162B2, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 13Mar2021 as single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 16Mar2021, the patient started to experience nausea and vomiting, both with an unknown outcome. She has been taking care of herself, drink tea, eat soup, fruits, vegetables and was eating correctly, but she eats and throw up (as reported). Her blood pressure has also been higher lately with outcome of unknown. The patient underwent lab tests and procedures which included higher blood pressure measurement.  Information on the lot/batch number has been requested.
Patient reported feeling itchy at 11:50 am. Generalized redness noted to skin. Given 50mg benadryl PO at 11:55am. VS stable throughout. No SOB, angioedema, or hives noted. Reports hx of multiple skin reactions to various foods and medications. At 12:20, reports that symptoms were resolved.
At first it was just a pain in my arm where the booster was given on the upper shoulder but the next day I started feeling a horrific pain on the other side of arm as well. Today (day 2) I have pains in all those places plus in my muscle areas in my arm. And raising my arm hurts  a lot. This does not feel right at all. (I also went through fever and chills but that's normal when I get a Covid shot apparently since this is my 2nd booster and it always happens) I am starting to worry and I think the person Pharmacy guy administered might have done it too high.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: eye pupile was dialated-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild, Additional Details: pt got these symtops for about 10 mints then the ambulance came. after min he was good. they checked him with no any issues
A report has been received from a Health Professional concerning a, Male subject, who had been receiving Nasal FLUMIST QUADRILVALENT, 0.2 Millilitres, Once/Single administration. FLUMIST QUADRILVALENT started on 23-Dec-2015. The vaccine was inadvertent administration to wrong age group which started on 23-Dec-2015. FLUMIST QUADRIVALENT was discontinued on 23-Dec-2015. The outcome of the event of inadvertent administration to wrong age group is unknown. The report was considered to be non-serious.
URTICARIA; HEADACHE; HYPERTENSION; BURNING SENSATION; PRURITUS Narrative:
Headache, Myalgia, NauseaVomiting, Chills Narrative:
34 hours after vaccinations, patient started vomiting and developed severe diarrhea. No fever accompanied this. 72 hours later, patient had seizure, which lasted maybe 1 minute. She stopped breathing and needed CPR. In ER most of day for tests and on IV for dehydration due to vomiting and diarrhea. She was stabilized after 5 min. Doctor at ER determined seizure was febrile , either caused by vaccines or fever, which patient did not have.
A spontaneous report has been received from a consumer. The report concerns a female patient of age 10 years, height 54 in, weight 31 kg. No medical history was reported. No concomitant products were reported. The patient started treatment with FLUMIST QUADRIVALENT (batch number(s) Unknown), nasal, on 06-OCT-2018 for flu prevention. The report described a medication error for FLUMIST QUADRIVALENT. On 15-JAN-2019, the patient experienced diagnosed with influenza type A (preferred term: Influenza). Treatment with FLUMIST QUADRIVALENT was not changed. At the time of reporting, diagnosed with influenza type A was ongoing. Company physician assessed diagnosed with influenza type A to be non-serious. The event was considered non-serious.
When she woke up at 1/28/21 had the general body aches, headache, and chills.  Then today that has resolved, but is having a stabbing, throbbing head pain in one spot.  Had been taking regular Tylenol but took Tylenol with Codeine as it is limiting her to what she can do.  Had trouble sleeping last night due to it.  Just hoping that it goes away.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Patient felt faint, had increased heart rate, and a pressure at back of neck. Stated he felt some minor tightness on and off at throat area. No difficulty breathing.-Mild, Systemic: Nausea-Mild
numbness in left hand, specifically finger tips and palm area ...persistent and similar to frostbite
Patient reported that he had inflammation of the chest. Patient and mother went to the hospital and they said the reaction should subside in a few days. The patient was told to take tylenol and advil. Unknown if the patient stayed in hospital or had further tests or medications provided.
Pfizer Vaccine lot #FJ1611 was affected due to out of temperature range. No adverse reactions from patients.  43 patient's affected.
Extreme soreness on injection site, fever/weakness in legs. Pain all over body. Cannot walk without assistance. Cannot stay awake.
Information has been received from a licensed practical nurse a 9 weeks old white male (weight 13#, height 24.25") with medical conditions, birth defects and allergies reported as none who on 30-APR-2007 at 11:30 am was vaccinated with the first dose of Rotateq (lot # 656193/0023U), oral. On that same day the patient received concomitant therapy which included PREVNAR (lot #B08689H), IM in the right thigh, Hib conj vaccine (lot # 655079/01435F), IM in the right thigh and PEDIARIX (lot #AC21B110AB) IM in the left thigh. No illness was noted at the time of vaccination. On 07-MAY-2007 (about six days after getting the Rotateq), the patient woke up early one morning screaming in pain, no fever, very pale, very watery diarrhea and refused to eat. The patient would get stiff as a board and curl knees to abdomen which lasted for about a day and a half. Subsequently, the patient recovered from screaming in pain, very pale, very water diarrhea, refused to eat, stiff as a board and curl knees to abdomen. Additional information has been requested.
Information has been received from a registered nurse concerning an 18 year old female with no past medical history who on 07/06/2000 was vaccinated with a first dose of hep B vaccine recombinant IM in the left deltoid. There was no illness at the time of vaccination. On 07/08/2000, the pt experienced facial twitching right side of face. Upon exam no facial movement was observed by the registered nurse. No medical intervention was ordered by the physician and no laboratory tests were done. The pt was informed to report to the ER if symptoms worsened. Subsequently on 07/09/2000, the pt's facial twitching resolved. It was reported that the pt refused to complete the rest of the series. No further info is available.
soreness. He attributes this to his walking a lot; This spontaneous case was reported by a physician and describes the occurrence of PAIN (soreness. He attributes this to his walking a lot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced PAIN (soreness. He attributes this to his walking a lot). At the time of the report, PAIN (soreness. He attributes this to his walking a lot) outcome was unknown. Not Provided    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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Updated reporter type to physician, Health care professional yes, email address added.
Pt was previously vaccinated 11/19/2021 and therefore received current vaccine 12/4/21 too soon. Father of pt was called and was advised that pt will need to be revaccinated 21 days from today or after 12/26/21,  Father was receptive of recommendation and will return for repeat vax as stated after on or after 12/26/21.
Vaccine was accidentally drawn up from an undiluted vial, so patient received 0.2ml of vaccine without diluent added.  Patient had no significant side effects reported.
Patient developed ache in arm immediately after injection. The next day she was weak and sweaty and her arm was painful. She could hardly move it. On 4/8/01, she went to hospital ER and was diagnosed with shingles under left arm and on chest.
Case number PHEH2014US024984, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 69-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
pt recvd vax & began sz 1 wk after vax; conts to have szs disorder; undercare of MD;