chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine Headaches, Severe Nerve Pain in the Left Arm at injection site.; Migraine Headaches, Severe Nerve Pain in the Left Arm at injection site.; Migraine Headaches, Severe Nerve Pain in the Left Arm at injection site.; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8734), as dose 1, single and dose 2, single (Lot number: ER8735), both via unspecified routes of administration, in left arm on 07Apr2021 (at the age of 67-years-old), for COVID-19 immunization. Medical history included chronic lower back pain due to osteoarthritis and codeine allergy. Concomitant medications included atorvastatin, clonazepam, tadalafil (CIALIS) and fluticasone propionate (FLUTICASON). No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced migraine headaches, severe nerve pain in the left arm at injection site on 07Apr2021. Both the doses were reported to be given on the same date. The event resulted in doctor/ other healthcare professional office visit and disability or permanent damage. The patient received treatment for the event which included Imitrex and Neurontin. The outcome of all events was not recovered.
sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) through social media on 22-Nov-2020 .  This case involves patient of unknown demographic who had was sick(illness), while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and  concomitant therapy were not provided.   On an unknown date, the patient received suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after being vaccinated with  INFLUENZA VACCINE, the patient was sick (illness) which continued for 2 weeks. The patient also reported that the same thing happened every time the patient is vaccinated with the  INFLUENZA VACCINE and that since the patient had stopped receiving the vaccine, the sickness had stopped.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was resolved on an unknown date.    There will be no information available on batch number for this case.
After receiving the Moderna vaccine. I experienced a small swelling and reddening on my left arm. It was approximately 1 1/2? x 2 1/2 to 3 inches in shape at the injection site. It disappeared within 48 hours.  Eight days later it reappeared. I experienced swelling of the arm in the exact shape and size as the 24 hours following the injection. The swelling was red, protruded slightly from the skin, was warm to the touch, and was itchy. I did not contact a healthcare provider. I used a cool compress to calm the itching the evening of March 10. The swelling disappeared within 48 hours of reappearing.
08/06/2022 I went to a doctor thinking I had a kidney problem. I had stomach distension. They checked my bladder, and it was fine. The doctor told me I needed to go to the Emergency Room.  While checking me out at the Emergency Room, they saw a blood clot in the lower part of both lungs.  Bilateral Embolism was my diagnosis. I was admitted to the hospital and had intravenous fluids hooked up for dehydration and Heparin for the blood clot. When they discharged me, they gave me a prescription of Eliquis. I was then referred to facility on 10/24/22.  The doctor gave me a month?s worth of samples of Eliquis. I will go back to see him in February after staying on Eliquis for 6 months.  On 10/29/22 I had distension of the stomach and severe upper quadrant pain and went to the Emergency Room. They gave me morphine for the pain.  They suspected acute kidney injury, but it turned out to be Hypertensive Chronic Kidney Disease unspecified Stage 1-Stage 4, , cyst of kidney, benign prostatic hyperplasia, myalgia, pre diabetes; Barrett?s Esophagus without dysplasia.  I went to see my PCP. She did bloodwork and said my kidneys were okay and if I have another gall bladder attack to have them take it out.  I changed my diet.   I am now having issues with diarrhea for 2 weeks.  I had a virtual visit yesterday and they think I need more bloodwork.
I tested positive for Covid 19 on December 1, 2022 I experienced runny nose, achy, restless, congestion, cough, headache; nausea, loss of appetite; I was taking prednisone; cough suppressant; to help with symptoms.
3 hours after receiving dose 2 of ENGERIX Hep B on accelerated scheduled (0, 7d, 21d, 1 yr) and dose 1 of IXIARO client experienced nausea, vomiting, temp less than or equal to 104 degrees (-) diarrhea (-) rash (-) airway swelling. Symptoms relieved by taking ALEVE.
pt recv vax JUN or JUL96 & had a positive pregnancy test;f/u info revealed that the pt had an elective abortion on an unspecified date;
Skin infection-redness, painful. Seen by her family physician. Given prescription for CEPHALEXIN. Talked to patient on 9/28, 10 AM, condition fine, cleared up.
9/16/21: CHILLS, STUFFY NOSE, TASTE SLIGHTLY OFF, HEADACHE
Full Rheumatoid Arthritis flare; Inappropriate age at vaccine administration.; Knuckle on her left index finger felt a little "poofy'' / the joints of the middle finger of her right hand flaring; This case was reported by a consumer via other manufacturer and described the occurrence of rheumatoid arthritis flare up in a 45-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included TOFACITINIB CITRATE (XELJANZ).   On an unknown date, the patient received the 1st dose of Shingrix. In January 2022, less than 6 months after receiving Shingrix, the patient experienced swelling of fingers. On an unknown date, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant) and inappropriate age at vaccine administration. On an unknown date, the outcome of the rheumatoid arthritis flare up and inappropriate age at vaccine administration were unknown and the outcome of the swelling of fingers was recovered/resolved.   It was unknown if the reporter considered the rheumatoid arthritis flare up and swelling of fingers to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR031138  Additional details were provided as follows: The patient self-reported this case. The patient received a dose of Shingrix earlier than recommended age, which led to inappropriate age at vaccine administration. The patient had full rheumatoid arthritis flare up with after 1st Shingrix in the fall. Less than 6 months after receiving Xeljanz, the patient had her middle knuckle on her left index finger felt a little poofy prior to early January when she started school and the joints of the middle finger of her right hand flaring due to increased typing. The patient stated that she missed a week of Xeljanz 5 mg due to forgetting to bring her medication on a trip and she believed this was the week of 28th January 2022. The action taken for Xeljanz was unknown. No additional details were reported. The reporter did not considered event caused by Xeljanz. The reporter did not consented to follow-up. For tolerance of 2nd dose of Shingrix, refer case US2022AMR031138.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR031138:Same Reporter
6 mos. old rec'd PENTACEL, PCV7, ROTATEQ. That evening with fever to 101.4 and bulging out fontanelle but acting well. Following morning came to our office with tense/bulging fontanelle but nl exam otherwise. Sent to ER: CT negative, LP with lots of rbc. Fontanelle flattened before LP.
The patient developed hepatitis with jaundice on 09/21/2001. The patient had an abnormal liver function test on 10/12/2001.
About 10 min after vaccination, patient began to experience a faint headache.  During assessment, patient noted a history of similar headaches with no mental variation.  Vital signs within normal limits.  Symptoms improved
I had been have a pain in my arm but the first one, I knew they say that the arm would be sore/I had been have a pain in my arm; took it on my left arm and it had been sore; I have been getting some like bit itchy like throbbing pain in arm; I am just continuing to get this throbbing pain in my arm like from the top of the way to my head; I have been getting some like bit itchy like throbbing pain in arm; I am just continuing to get this throbbing pain in my arm like from the top of the way to my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had been have a pain in my arm but the first one, I knew they say that the arm would be sore/I had been have a pain in my arm; took it on my left arm and it had been sore"; PRURITUS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "I have been getting some like bit itchy like throbbing pain in arm; I am just continuing to get this throbbing pain in my arm like from the top of the way to my head".  Additional Information:Consumer stated, "I have a question. I have taken both Pfizer shot and the second one to that to tomorrow would be two weeks and I had been having a pain in my arm but the first one, I knew they say that the arm would be sore. I had got the shot, took it on my left arm and it had been sore. I have been getting some like bit itchy like throbbing pain I arm. But I still county of associated with that private general lawn. So, I took the second one and I am just continuing to get these throbbing pain in my arm like from the top of the way down to my head and I just wanted to know if, you know, if there is anything to get that checked out. If I needed to be concerned about that. You know, I wake up, it wakes me up throughout. You know sometimes during the day it's not as bad and like it just sometimes, it's been like wake up to sleep, it's just totally numb. So, I just needed to know if I needed to be concerned about that."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe arm pain, decreased ROM, could not sleep due to pain, vomited, fever.
Mom states patient (her son) called her from the movies c/o a stiff neck, headache, and pain going down his spine on night of 05/06/22 approximately 5-6 hrs after vaccines. He also had c/o feeling dizzy. Mom took him home and gave him a dose of Tylenol 325mg tablet & Dramamine tablet on Sat 5/7/22. He continued to have dizziness on Sunday 5/8/22 per mom, but was able to attend school on Monday 5/9/22 without any symptoms. He was not seen by any medical professional
weakness; fatigue; shortness of breathe a little not bad; muscles ache; body ache; This is a spontaneous report from a consumer or other non-healthcare professional. A 55-years-old female patient received second dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown) on 23Apr2021 as single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. Patient previously took bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for COVID-19 immunization. Patient didn't have anything after the first dose. On 24Apr2021, patient experienced fatigue, weakness and shortness of breathe a little not bad, Patient mentioned that even standing was making patient exhausted. On an unspecified date, patient experienced muscles aches and body aches. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
My arm turned red and became very swollen & painful. I could not stand to touch the arm from shoulder level to elbow. The pain interfered with sleep the night of 11-22. I was very weak and tired the evening of the 22nd and all day on the 23rd, so tired that I slept 3x during the day & had to go to bed at 6:30 p.m. Now, it's 3 days later & some swelling persists. I did not seek medical help.
Blood pressure high; he has had a high amount of anxiety and suffers from regular panic attacks.; anxiety; throat swelling; couldn't breathe; The patient experienced an anaphylactic reaction immediately after the shot was administered.; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3Y7P4) for prophylaxis.   On 31-OCT-2023, the patient received Arexvy (intramuscular). On 31-OCT-2023, immediately after receiving Arexvy, the patient experienced anaphylaxis (Verbatim: The patient experienced an anaphylactic reaction immediately after the shot was administered.) (serious criteria GSK medically significant), throat swelling (Verbatim: throat swelling) and difficulty breathing (Verbatim: couldn't breathe). On 01-NOV-2023, the patient experienced panic attack (Verbatim: he has had a high amount of anxiety and suffers from regular panic attacks.) and anxiety (Verbatim: anxiety). On an unknown date, the patient experienced blood pressure high (Verbatim: Blood pressure high). The patient was treated with epinephrine (Epi Pen). The outcome of the anaphylaxis was unknown and the outcome of the panic attack and anxiety were not resolved and the outcome of the throat swelling and difficulty breathing were resolved and the outcome of the blood pressure high was not reported.   It was unknown if the reporter considered the anaphylaxis, panic attack, anxiety, throat swelling, difficulty breathing and blood pressure high to be related to Arexvy.     It was unknown if the company considered the anaphylaxis, panic attack, anxiety, throat swelling, difficulty breathing and blood pressure high to be related to Arexvy.   Additional Information: GSK Receipt date: 06-NOV-2023 A patient reported that receiving an Arexvy vaccine at a local pharmacy.  The patient experienced an anaphylactic reaction immediately after the shot was administered.  The pharmacist was able to administer an Epi Pen immediately and the patient regained consciousness.  EMS was called and the rescue squad arrived within 2 minutes.  Blood pressure was high 2 times and after 25 minutes, the patient was able to walk out of the store and went home.  The patient reported that since the anaphylaxis event, he had a high amount of anxiety and suffers from regular panic attacks.  The reporter consented to follow up.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, patient was inoculated with Zoster Vaccine Live(ZOSTAVAX) (dose, route of administration, anatomical location, lot# and expiration date were not provided), as prescribed and/or administered by a healthcare provider at hospital, for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to patient's Zoster Vaccine Live(ZOSTAVAX) inoculation, patient was treated by a healthcare provider at a hospital, for shingles. As a direct and proximate result of patient's use of the Zoster Vaccine Live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
VACCINE ADMINISTERED TO INAPPROPRIATE AGE GROUP; OFF LABEL USE; This spontaneous report received from a patient via a company representative concerned a 13 year old male. The patient's weight was 150 pounds, and height was 176.784 centimeters. 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, batch number: 041A21A expiry: 09-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced vaccine administered to inappropriate age group. On 08-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to inappropriate age group and off label use was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Information has been received from a female consumer reporting on herself, who on 18-MAR-2011 was vaccinated with a 0.5 ml dose of ZOSTAVAX (Merck), 0.5 ml, subcutaneously, (Lot number not reported). The consumer reported that she experienced injection site redness on 20-MAR-2011. It was unknown if the patient sought unspecified medical attention. At the time of the report the consumer had not recovered. No further information is available.
completed 2 dose series in 2019, shingles in 2022; shingles; He developed a rash was diagnosed with shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chicken pox (Had chicken pox as a child).   On 29th October 2019, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 29th August 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 07-Sep--2022 Reporters comment:  The reporter reported that the patient received both shingrix vaccine and experienced shingles. Both doses were given intramuscularly in the deltoid. Reporter did not have the lot numbers for the SHINGRIX vaccines which were administered but did provide the pharmacy contact information. The pharmacy should had the lot numbers on file. Both shots were given at the same pharmacy. Vaccination Failure- Patient completed Shingrix 2 dose series in 2019 yet developed shingles in 2022. (He developed a rash was diagnosed with shingles and had been prescribed a medication to treat it).  The reporter consent to follow-up. Additional Supportive information: Valacyclovir coded as treatment drug for shingles .
Covid19 breakthrough.  1st Vaccine received on 03/26/2021.  Pt presents with chronic cough, nausea, vomiting and less responsive than usual.  Given IV abx.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Sore arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Post vax, in July 2000 the patient developed erythema multiforme. Unspecified medical attention was sought. Additional information has been requested.
A consumer report has been received. The report concerns an 11 year old, male patient. No concomitant medication or relevant medical history has been reported. The patient received FLUMIST on Sep or Oct-2012. The patient's mother reported concerning her child, who received FLUMIST sometime during Sep or Oct-2012, and experienced flu on 17-Jan-2013. Child experienced fever 101.5 degrees F, cough, and achiness. Pediatrician did not test for influenza. At the time of reporting the child was feeling better and temp was 99.6 degrees F. At the time of reporting, the event of flu was improving. The report was considered to be non-serious by the reporter.
Stoke like symptoms per the EUA we have to report when the patient is admitted to hospital after vaccination. The patient was COVID-19 positive
Severe visual aura on left side obscuring vision. 2 days after vaccination. I had exactly the same symptoms after the first shot except 5 days later (first shot was 04/28/21 lot number EW-0172, migraine 05/03/21 around 6:30pm).  That time the aura was worse and was accompanied by a very severe headache with nausea. Auras were abnormally severe in comparisons with those I had previously experienced.
pt recvd MMR vax on 16AUG91 & on 24AUG91 pt exp eye pain when moved them fr side to side; 26AUG91 devel a fever, cough, drainage from eyes & inc sensitivity to light;
17 years old and received the booster but does not have side effects.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the booster but does not have side effects.) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-21) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer shot (Dose 1, Lot number: ER8736) on 24-Apr-2021, Pfizer shot (Dose 2 and Lot number: EW0186) on 13-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer shot and Pfizer shot.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the booster but does not have side effects.). On 18-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the booster but does not have side effects.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No Treatment medication was provided.  It was stated that reporter had a patient that does not turn 18 until October of 2022. She was given a Moderna booster.  Patient  stated that she  was did not experienced any side effects on 18-JAN-2022