chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 26-OCT-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-JUL-2013, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I went into the hospital on 03/08/2023, while in the hospital it was discovered that I had several enlarged nodes in my abdomen when they did a CT scan. They did a biopsy to find out if the nodes are cancerous. I was feeling a bit fatigued but not too much. I am awaiting the result of the biopsy, to see where we are to proceed.
Arm was red in shape of Bandaid. Patient removed Bandaid on 11/7 and came to pharmacy to show pharmacist. Patient felt a "little sick" to stomach and not sure if due to flu shot.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (body aches and chills after receiving 1st dose on 3rd February 2018, see case US2018GSK118703). On 24th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, 2 days after receiving SHINGRIX, the patient experienced headache, general body pain and chills. On an unknown date, the outcome of the headache, general body pain and chills were recovered/resolved. It was unknown if the reporter considered the headache, general body pain and chills to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The patient experienced the same symptoms which he experienced after 1st dose of SHINGRIX. All his symptoms lasted for about a week. He did not know the specific dose given. The patient reported the contact details of the physician. This case has been linked with US2018115928 (patient's sister-in-law), reported by the same reporter.
left arm-site of injection-huge red circle encircling site with bright red dots in the circle (bull's eye)-only slight itching but not enough to be uncomfortable. Initial itching was a little more.
Local reaction.  Right leg 1 1/2 inch raised red area.  Treatment: Benadryl every 6hrs for 24-48 hours.
First time I became aware of symptoms was at visit for 2nd COVID vaccine on 8/17/21, at this visit patient reported significant numbness and pain in right deltoid area around area of injection starting 4 days post vaccine, no redness or swelling of area noted, denies fevers, numbness persists and has pain in right shoulder when she lays on it at night so now cannot lay on right shoulder. No past shoulder pain reported. States that right arm suddenly loses strength off and on since vaccination. No numbness or tingling in lower arm. Denis any immediate tingling or pain or burning sensation after vaccine.
Tecived Pfizer booster after inital treatment with Janssen vaccine on 4/3/2021. Upon recieving the Pfizer booster on 1/28 began experiencing adverse symptoms.Tightness in chest. Cramping in upper right chest and back/shoulder pain. Tires easily and finds self out of breath quickly.
Child developed large area of redness around site of injection (5 cm) 2 days after injection. Swelling of arm but no fever, no pain, no induration, no discharge.
This spontaneous report as received from a health professional refers to a 17 year old patient of unknown gender. On 22-JAN-2016, the patient was vaccinated with a second dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the left arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Additional information is not expected, as all required correspondence was received.
The day after this first vaccine the muscle soreness started to set in.  That was expected.  I felt soreness in my hands that i've never experienced before.  It moved up to include the forearms.  I've been dealing with this pain ever since.  i've been through 2+ months of physical therapy.  That doesn't seem to be curing it.  I'm heading to an Ortho doc next week.  My GP ruled out carpal Tunnel Syndrome.
Having seasonal allergies and it made them exponentially worse; Having seasonal allergies and it made them exponentially worse; Swollen tonsils; Pin inside ears; Swollen lymph nodes in my neck; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 31Mar2021 at 12:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies which was ongoing. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 19:00, after vaccination the patient's seasonal allergies became exponentially worse. The patient also experienced swollen lymph nodes in neck, swollen tonsils and pin inside ears. The events resulted in doctor/other healthcare professional office/clinic visit. The patient's doctor believed that the events were related to vaccine administration. The patient received treatment with steroid and other unspecified pain relief pills. The clinical outcome of the events vaccine made seasonal allergies exponentially worse, swollen lymph nodes in neck, swollen tonsils in neck and pin inside ears was not resolved at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 19-AUG-2014 the patient was inadvertently vaccinated with an expired dose of MMR II (dose was not reported, subcutaneously, HSA; lot # H014977, expiration date 09-AUG-2014). No adverse effects were reported. No PQC (product quality complaint) was involved. This is the one of two reports received from the same reporter. Additional information has been requested.
at site of injection very hard, raised (hive) like bump. Also itching at site. Reaction happened within 10 minutes of administration.
After second vaccine patient developed one wart on hand. It was treated and resolved. After third vaccine, patient broke out prolifically with warts across knuckles and fingers of both hands. Multiple treatments have not been successful.
not to pain, less pain due to vaccines; had my 2nd shingle shot 5/19/22, got shingles last Thursday; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th May 2022, the patient received the 2nd dose of Shingles vaccine. On 2nd June 2022, 14 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient received 2nd shingle shot on 19th May 2022 and he/she got shingles last Thursday. The patient said the vaccine was not to painful but thinking less pain due to vaccines. Less than 3 weeks after vaccination, the patient experienced pain. Follow up would not be possible, as no contact details were available
Pt. passed out in lobby after receiving vaccine, pt. said hit head on floor.  Sent to ER for treatment.
On Sunday you started getting a headache, cough and runny nose. I was able to still do my daily activities at the time. By Wednesday I was not feeling as well so I took a home COVID-19 test and it came back positive.
Pt. states that after receiving the 2nd dose of Moderna 03/15/2021, started to experience symptoms 03/17/2021 of right arm soreness radiating down to the elbow, still experiencing pain currently. Tingling and numbness of the (outside) fingers on/off, thumb feeling of tingling traveling up through the hand. Primary visit 03/24/2021 recommendations to see a Neurologist regarding the numbness.
patient claims she received an expired second dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient claims she received an expired second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043821A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient claims she received an expired second dose). On 21-May-2021, EXPIRED PRODUCT ADMINISTERED (patient claims she received an expired second dose) had resolved.            No concomitant medications were reported  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow up document received contained No New Information.
Patient started to c/o itchy face about 9 mins after covid 19 Pfizer 1st dose vaccine . Vitals taken at 1044 BP 134/86, O2 98, P 82 at 1050 Dexamethasone 4mg IM lot 7051558 Expiration 02/2022 and Diphenhydramine 50mg IM lot 080008 Expiration 08/2022 was given, vitals at 1052 BP 138/96 O2 98% P80 at 1105 patient stayed she felt better no more itching reported. Vitals at 1105 VP 124/90 O2 99, P78. Patient was examined by doctor.
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; Patient received expired vaccine that was administered on 15-March-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medications were reported.  Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
Intussusception 8/7/08-records received-6/10/08-emesis and bloody stool. Laparscopic reduction of intussusception 8/7/08-records received-6/10/08-emesis and bloody stool. Laparscopic reduction of intussusception after multiple attempts to reduce using air barium contrast enema. Reduction incomplete and intussuception remained in ascending colon.8/28/08-DC Summary received for DOS 6/10-6/11/08-DC DX: Intussusception. Presented to ED with C/O bilious emesis and bloody stools, yesterday began spitting up more, fussy and taking less formula, bloody stool this morning, refuses to take formula.
Information has been received from a registered pharmacist concerning a 27 year old female patient who on 29-JUN-2009 was vaccinated with a dose of GARDASIL that was improperly stored. The vaccine was left out for 7 days in an air conditioned room (specific temperature unknown). The vaccine was picked up by the patient on 22-JUN-2009 from the pharmacy (the vaccine was stored in the fridge properly until the patient picked it up). The patient  was not experiencing any known symptoms. Follow up information was received from consumer. She stated the injection site where the GARDASIL (first dose) was given is now red and swollen. She had not yet been given the second or third dose. Additional information has been requested.
I felt anxious after the shot, but that night felt ok. Morning was another story. I woke up with pain in my muscles from the waist down and found it difficult to walk. My eyes started to hurt. I had blurred vision. Around 2:00 I went by the mirror and saw that my eyes were blood red. I laid down and rested. About 2 hours later I got up the most of the redness was gone but then I had a headache.  The next  morning a persistent cough and the sneezes started.  The headache would return every time that I coughed or sneezed. It was very painful- as if someone hit me with a hammer.  Even though the pain only lasted a few minutes, it hurt a lot. I sneezed and cough a lot. Finally, Sunday morning I was walking better; however, I felt I had the flu. Normally, I would have gone in and got ready for a sub, but I wasn't able to. I rested on the couch. Then took a 2 hour nap. Finally, I felt better around 6 pm except for the painful headache that returned every time I coughed or sneezed. It has been a week. I thought the worse would be over by now. I guess I will have to go in and talk to my doctor on Monday because the sneezes and coughs are still quite painful. When will it end?
About 5 minutess, post vax, pt's legs around injection site, turned blotchy red. Area rubbed with alcohol and ice placed on it. About 15 minutes, post vax, doctor examined pt lungs and they were clear. Pt denies respiratory distress or itching. Pt remained another 15 minutes without any changes. Per call to mother on 8/3/00, she states the pt is fine, redness is gone and denies any other adverse effects.
Site swollen up immediately after IM injection. Observed approximately 3 minutes. Asked to patient to monitor for additional swelling, itching or anything unusual or painful. It looked as if some of the swelling went down before he left.
Progressive weakness, of forearms and legs, numbness and tingling left side of arm and left side of face, nerve pain
Fever elevated to 104.7 starting on Fri 5/13/22 evening at 9:00pm through Sat 5/14/22 , then reduced to normal on Sun 5/15/22. Mom alternated with  Tylenol and Advil for fever . Left deltoid was reported as swollen and warm by Mom. She did not observe any seizure activity. Patient returned to baseline on Sun 5/15/22.
Employee got the Pfizer lot EL1284 on 01-04-2021 in left arm.  There is now a bump about quarter of an inch high.  It is not painful or itchy.  Will keep an eye on it, use ice and Tylenol as needed.
Palm-sized, raised red area - pt described as "non-severe" mildly itchy, treated with hydrocortisone 1% cream appeared night of vaccination disappeared in 2 days - reaction occurred several inches below injection site (pharmacist verified).
Large local reaction with DTaP site of 5 1/2 x 6 1/2cm of erythema, warmth, induration.
A few hours after receiving the vaccines I had burning in the back of my left arm just above the elbow. A few days later I developed deep aching pain and weakness in my left elbow and left forearm. This pain and weakness is still present to the extent it hurts to hold a cup of coffee. I am unable to do normal lifting activities with my left arm. Weakness & pain in left arm lasted over 4 months, but is now gone.
onset of body aches w/1 daily episode of diarrhea x 5 days; took Kaopecktate 28OCT95 stools now more formed; fluids & APAP
Local reaction L upper arm with 8cmx8cm erythema, warmth and slight swelling.
Patient states that her arm was hurting, she went to see the doctor and the doctor said she may have soft tissue damage. The technician that gave the shot states that only about half of the vaccine went into the arm (thinks he maybe hit bone). The pharmacist then consulted the patient and came to an  agreement that she would take another 1/2 dose of the vaccine.
I am not having any complication but it's just under arm, where I had a shot hurting a little; I am not having any complication but it's just under arm, where I had a shot hurting a little; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  on an unspecified date the patient experienced had not having any complication but it's just under arm, where had a shot hurting a little. Patient wanted to know Is it okay for him to put alcohol on it. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
In November 2021 I began to have shortness of breath and tightness it my throat.  It is almost a sensation of a lump in my throat although no lump has been found.  This has gotten progressively worse since February.  I began having heart arrhythmias in April or May of 2022.  They were occasional.  However, recently, the heart palpitations have gotten worse.  It seems that it is related to physical exertion when it gets worse and happens more often.  I saw my doctor in March for the throat issues and shortness of breath.  I had an ultrasound in June on my thyroid.  I learned that is not what is causing my throat issues.  Since June I have seen my doctor about my heart, but the EKG did not show anything because I was not having palpitations at the time.  I also saw my allergist.  He said now I may have asthma.  I learned that I have an allergy to mold.  I have an endoscopy scheduled for the end of September 2022 as advised by my doctor.
10:21 Patient complained of mild difficulty breathing, heart racing and slight chest tightness (denied chest pain - difficulty taking a deep breath) after administration of first dose of Moderna vaccine (Lot # 010A21A, exp. 8/14/21). Vaccine was administered at 9:55am. Denied itching or tightness to throat.  BP 180/100 Speaking without difficulty.  Hx: asthma and MS; Allergies: morphine - vomiting, hydrocodone, codeine, azithromycin and "other antibiotics" - difficulty breathing, bees - anaphylaxis; patient was observed in clinic x 30 minutes after receiving vaccine due to history of anaphylaxis. 10:22 Physician to assess patient. Patient denied anxiety. No visible edema to face, throat, neck or tongue, lungs CTA. States she has asthma and MS and "feels like this sometimes, but it seems a little worse than normal" BP 182/98. HR 82. Patient had albuterol rescue inhaler with her and took two puffs.  10:30 BP 170/88 HR 80 Pt c/o continued shortness of breath, slightly increased and also c/o mild itching to face underneath mask, but "thinks it might just be her mask". Continues to deny anxiety, but stated inhaler made her jittery and her heart race more. Mask removed. 10:35 Patient developed wheezing upon auscultation, and dyspnea with increased respiration rate worsening itching to face and erythema and edema around mouth.  States tightness to chest persists and now feels tightness in her throat.  Denies chest pain.  Legs elevated.  BP 160/80 HR 82 EMS and code blue called. Husband called into clinic from vehicle. 10:36 EPI pen 0.3mg IM right anterolateral thigh administered through pants per Physician.  Patient's difficulty breathing improved 30-60 seconds after administration of epinephrine. 10:42 EMS arrived and patient transferred.
Patient stated she had redness down to elbow. Did not complain of any swelling or pain.
Extreme fatigue with fever which lasted for about 24 hours.  Nose runny until took Coricidin.  Highest temp was 100 degrees.  Took 1  Coricidin in evening then 2 Tylenol about midnight.  After 24 hours was feeling fine.
Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 19-JAN-2010 by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 16-MAR-2016, the patient was treated at an Urgent Care Center for a blistering vesicular outbreak that was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.