chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blacked out twice; Sore arm/ sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out twice) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2007, Angioplasty in 2007 and Stent placement in 2007. Concurrent medical conditions included Chronic obstructive pulmonary disease, Blood pressure abnormal, Gastroesophageal reflux disease and Psychosis. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA RESPIMAT) for Chronic obstructive pulmonary disease, METOPROLOL and ASPIRIN [ACETYLSALICYLIC ACID] for Heart disorder and Blood pressure abnormal, VILAZODONE HYDROCHLORIDE (VIIBRYD), DESVENLAFAXINE, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), IPRATROPIUM BROMIDE and SALBUTAMOL SULFATE (ALBUTEROL SULFATE) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (blacked out twice) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Sore arm/ sore left arm). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out twice) and PAIN IN EXTREMITY (Sore arm/ sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included psychosis medication (not specified).  The patient had sore arm and  was blacked out twice after the vaccine. According to the patient, his sore left arm went away for two days and again came back after a week and then went away. Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-148160 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female 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 pain in arm. Rechallenge with Shingrix was negative. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced sore arm. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020093468.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020093468:Same patient
1 wk following vax pt began to feel lethargy, sense of not feeling well, muscular weakness, muscle aching, sense of not being able to ventilate adequately, fatigue progressive during the day; pt recvd vax 7OCT94-felt better 28OCT94;
Pt explained that she woke up this morning to leg pain and cramping. She has done nothing different in her daily routine to cause the pain. She had noticed the pain is better when moving and is worse when she sits.
A non-serious spontaneous report of cough has been received from a consumer, patient's mother, concerning a four-year-old female subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient received H1N1, Intranasal, nasally on 22-Oct-2009. On 23-Oct-2009, the patient experienced cough. The outcome of the event was unknown.
pt screamed for 4-5 hrs p/vax; leg was swollen & red @ site of shot;
Patient reported weakness approximately 25 minutes after receiving vaccine.  Assisted to supine position with lower extremities elevated.  Approximately 10 minutes later complained of all four extremities and joints aching.  BP 80s to 90s/50s with HR 70s.  No wheezing or shortness of breath.  Respirations unlabored.  Oxygen administered along with IM epinephrine and IM Benadryl.  Symptoms resolved over approximately 10-15 minutes.  Patient evaluated by paramedics and taken to Emergency Department by parent.  Discharged by Emergency Department to home same day.
Information has been received from a physician concerning an 84 year old female with irritable bowel syndrome, Crohn's disease, hypertension, diverticulitis, microscopic colitis, osteopenic arthritis, who on 05-NOV-2008 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (SC, lot # 663194/1415X) at a local pharmacy. Concomitant therapy included corticosteroids (unspecified) for Crohn's disease. The patient developed shingles on her trunk under left breast. The diagnosis was made in the office 25-MAY-2010 upon exam. She was prescribed VALTREX, NORCO 5/325/mg, and amitriptyline for treatment. Patient was described as mildly immunocompromised due to long term corticosteroid use. The physician sent a sample away for independent PCR analysis and was awaiting the result. The patient had contacted office for medical attention. At the time of the reporting, the patient had not recovered. Additional information has been requested.
As early of May, I had post menopausal bleeding. I also had a low grade fever not more than a week. I had in September a complete hysterectomy. I called the gynecologist and I was having a lot of bleeding and he brought me in, he did a DNC, lab work and biopsy and referred me to an oncologist. My adipose tissue generates fat and that is way I got cancer. They told me that I had stage 1 cancer and I am still recovering and I have not been back to work.
19 week old received the Flulaval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-week-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 9E5KE, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced inappropriate age at vaccine administration (Verbatim: 19 week old received the Flulaval).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2023 The healthcare professional reported that a 19 week old received the Flulaval which led to inappropriate age at vaccine administration. No reactions reported. No additional information provided. The reporter consented to follow up via mail.
Rash; Body pains; covid injection reaction red itchy and swollen; Itchy; swollen/ swelling in lower back; Hives; Inflammation in hip; Swelling in leg, right thumb; Swelling in both ankles, left wrist; Intentional misuse in product use duration; Nail Psoriasis; Psoriasis; Local swelling; Sickness; Headache; Vaccination site swelling; Vaccination site erythema; General body pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), PAIN (General body pain), RASH (Rash) and MYALGIA (Body pains) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), PAIN (General body pain), RASH (Rash), MYALGIA (Body pains), HEADACHE (Headache), ERYTHEMA (covid injection reaction red itchy and swollen), PRURITUS (Itchy), SWELLING (swollen/ swelling in lower back), ILLNESS (Sickness), URTICARIA (Hives), ARTHRITIS (Inflammation in hip), PERIPHERAL SWELLING (Swelling in leg, right thumb), JOINT SWELLING (Swelling in both ankles, left wrist), INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), NAIL PSORIASIS (Nail Psoriasis), PSORIASIS (Psoriasis) and SWELLING (Local swelling). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved, PAIN (General body pain), HEADACHE (Headache) and SWELLING (Local swelling) was resolving, RASH (Rash), MYALGIA (Body pains), ERYTHEMA (covid injection reaction red itchy and swollen), PRURITUS (Itchy), SWELLING (swollen/ swelling in lower back), URTICARIA (Hives), ARTHRITIS (Inflammation in hip), PERIPHERAL SWELLING (Swelling in leg, right thumb), JOINT SWELLING (Swelling in both ankles, left wrist), INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), NAIL PSORIASIS (Nail Psoriasis) and PSORIASIS (Psoriasis) outcome was unknown and ILLNESS (Sickness) had resolved.        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.   This case was linked to MOD-2021-140772, MOD-2021-140772 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received
Mid day on April 2, I suddenly developed vaginal bleeding then within 8 hours bleeding stopped. In the meantime, that afternoon I went to see Dr.  and I was still bleeding when I went there. He did a biopsy and scheduled me to get a Vaginal ultrasound the next week. He also gave me some hormonal pills but my bleeding had stopped. For the next 25 days, I had no spotting, no bleeding or anything at all. At around noon time, on April 26, I began bleeding again but this time it wasn't bright red but it was a light brown color. By that afternoon, it had stopped. In the next 5 days, I had similar episodes but it got very light until it faded. Later on May 17, I had a very light yellowish brown discharge. Since then, this has been it.
Inflamed and sore lymph node under left arm, achy, feverish, nauseated
The date I listed here was the date of my COVID booster shot (Pfizer).  But since the original shot and follow-up shot I have had a loss of taste not completely but enough to contribute to the lack of enjoyment of meals etc.  I was hoping that the booster would not exacerbate this condition, but it has I am thoroughly disappointed in the vaccine but had to protect myself as I have several issues such as age and chronic conditions that will not be helpful if I did get COVID.  If I had to scale this loss of taste, I would say on a scale of my taste being 100% I now have very little taste proably about 20.. This may sound silly but when I eat, I believe I tend to "remember" what these foods taste like versus enjoying the taste at the moment .
Pins and needles /Tingling sensation in her left arm after the 2nd dose; Lips were really bright red after the 2nd dose; Cheeks got flushed and pink after the 2nd dose; Burning and discomfort in her left arm after her 2nd dose; Burning and discomfort in her left arm after her 2nd dose; Not feeling good after the 2nd dose; Feeling nauseous after the 2nd dose; Chills after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning and discomfort in her left arm after her 2nd dose), FEELING ABNORMAL (Not feeling good after the 2nd dose), PARAESTHESIA (Pins and needles /Tingling sensation in her left arm after the 2nd dose), LIP ERYTHEMA (Lips were really bright red after the 2nd dose) and FLUSHING (Cheeks got flushed and pink after the 2nd dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL, LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and SIMVASTATIN for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced FEELING ABNORMAL (Not feeling good after the 2nd dose), NAUSEA (Feeling nauseous after the 2nd dose) and CHILLS (Chills after the 2nd dose). On 27-May-2021, the patient experienced BURNING SENSATION (Burning and discomfort in her left arm after her 2nd dose), PARAESTHESIA (Pins and needles /Tingling sensation in her left arm after the 2nd dose), LIP ERYTHEMA (Lips were really bright red after the 2nd dose), FLUSHING (Cheeks got flushed and pink after the 2nd dose) and LIMB DISCOMFORT (Burning and discomfort in her left arm after her 2nd dose). On 26-May-2021, FEELING ABNORMAL (Not feeling good after the 2nd dose), NAUSEA (Feeling nauseous after the 2nd dose) and CHILLS (Chills after the 2nd dose) had resolved. At the time of the report, BURNING SENSATION (Burning and discomfort in her left arm after her 2nd dose), PARAESTHESIA (Pins and needles /Tingling sensation in her left arm after the 2nd dose), LIP ERYTHEMA (Lips were really bright red after the 2nd dose), FLUSHING (Cheeks got flushed and pink after the 2nd dose) and LIMB DISCOMFORT (Burning and discomfort in her left arm after her 2nd dose) outcome was unknown.            No treatment information provided.
This case was reported by a healthcare professional, via a GSK representative and described the occurrence of pertussis in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (Glaxosmithkline). On 16 May 2008 the subject received unspecified dose of BOOSTRIX (details unknown). On 18 May 2009, 12 months after vaccination with BOOSTRIX, the subject developed pertussis. It was reported that others in the subject's family may also be infected and that the health department has been contacted. The family was being treated. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 18 June 2009 indicated that the subject was a 12 year old female. She received BOOSTRIX and developed pertussis, whooping cough and or cough. The events resolved and were considered by the reported to be unrelated to treatment with BOOSTRIX. MENACTRA was administered concurrently on 16 May 2008.+
Rapidly spreading rash all over body. Low grad fever x 24 hours and itch.
Redness; Headache; Nausea; 16 year old received second dose of PREVNAR 13; This is a spontaneous report from a contactable healthcare professional via Pfizer Sales Representative. A 16-year-old female patient received first dose of pneumococcal 13- valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that after first dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), the patient had redness, headache and nausea. The outcome of the events, redness, headache and nausea was recovered as the symptoms lasted for about 12 hours. After her second dose on an unspecified date, she only had about 1/2 the amount of redness on the arm and that was all. On an unspecified date, it was realized that the patient experienced inappropriate dose of vaccine received as the 16 year old patient received second dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein).  Information on the batch number has been requested.
30th January 2021-Am-rash-size od baseball, chills, HA-is this his from his tooth or COVID-19-he wonders, PM-freezing & hot body. 31st January 2021-more of the same-chills, HA, hot body- freezing, rash still present on his left deltoid area 1 February 2021-less chills, moving slowly,  Left deltoid less hot, not as freezing Taking Tylenol, motrin.  Reminded IF he gets worse-go to the ER.  Reminded him-does he need to contact his PCM-do so.
I was at work that morning and started feeling like I had congestion. Within 2 hours I had a splitting headache. It was so bad I felt I should hardly drive. When I got home, I began to feel worse and just went to bed. I was coughing pretty badly when I woke up. I called the doctor, and they didn't think that I sounded that bad. Wednesday when I started feeling really bad and my cough was so bad, I was unable to sleep lying down I had to sleep in a chair. I called my doctor and he prescribed PAXLOVID and a cough medication. I was already taking over the counter cold medications. My symptoms became tolerable, but I still didn't feel better better. I am still coughing sometimes.
1 1/2 days later rt arm ws hurting to point couldn't move it; h/a since 3 hrs p/vax; feverish feeling; t98.7; small pain in rt side under rib cage;
Eight days after I received the first dose I experienced redness and swelling around the injection site. It continued to get larger over the next two days, measuring 4 inches in diameter. It was associated with mild pruritis. There was diffuse swelling of the area but no discrete fluid collection. I couldn't lift my left arm above shoulder height by the end of the second day. After discussion with our infectious disease doctor and an internist we decided that since the area had continued to get larger that I should have a steroid injection. I received 40mg IM solumedrol two days after it appeared and it markedly improved 6 hours later with resolution of symptoms about 24 hours later.
Information has been received from a consumer concerning her 4 year old daughter, who is a twin, with asthma and no drug reactions/allergies who on 31-JUL-2006 at 15:30 was vaccinated with a dose of Varivax. Concomitant vaccination the same day included a dose of MMR, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine. Other concomitant therapy included FLOVENT. On 31-JUL-2006 by 19:00, the patient developed petechiae and a red rash on her face around the eyes and mouth areas, ears and neck. On 01-AUG-2006 the patient was seen by the doctor who did not treat the rash and told the patient's mother it should go away on its own. As of 10-AUG-2006 the patient was recovering. The rash had diminished but the mother "can see that it has turned brown". No lab Diagnostic tests were performed. There was no product quality complaint involved. The patient's twin brother (0608USA02605) had a similar experience following vaccination with Varivax. Additional information has been requested.
dose of fluzone high dose quadrivalent was inadvertently administered to a pregnant patient with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 34 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in context of dose of fluzone high dose quadrivalent was inadvertently administered to a pregnant patient with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported dose of fluzone high dose quadrivalent was inadvertently administered to a pregnant patient with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 24-Oct-2022, the patient received 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation and strength not reported; lot UJ928AA and expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for prophylactic vaccination.  On 24-Oct-2022, (latency: same day) a dose of fluzone high dose quadrivalent was inadvertently administered to a pregnant patient with no reported adverse event (exposure during pregnancy) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, a dose of FLUZONE HIGH DOSE QUADRIVALENT was inadvertently administered to a pregnant patient.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
I had a PMR (Polymyalgia Rheumatic) flare up the week following my vaccine. Treated with prednisone (with a taper) for two weeks. Helped temporarily. When I came off the prednisone I had a worse flare up. Went on prednisone (with taper) for almost 3 months. Again, there was temporary relief, but as I came off the prednisone, the muscle aches returned. My shoulders are more sore than they have ever been. I've been receiving PT (for shoulder and neck pain), acupuncture, and therapeutic massage. I also have injured my left shoulder.
After patient received the vaccines, about 5 minute, she became weak and fainted sideway while sitting down. Visible spasms in legs. Was not responding to my inquiries for about 10-15 seconds. When I was getting ready to give Epipen, she came back to consciousness, but was still confused for about 10-15 seconds. Gave her water.
When making way to the bathroom, patient got dizzy and fell head first onto hardwood floor injuring her face and her knees.  This bruised her entire face except a portion of her left cheek.  She had already been having muscle and joint pain in her arms and shoulders and had been light headed since her 2nd vaccination.   Patient did not make appointment.
Patient fainted after immunization given, closed eyes, laid down, fluids, sugar, cool cloth applied to forehead, crackers with peanut butter. Start to finish 20 min.
Pressure/Pain on both legs starting the night of vaccine injection. Has continued each night, for the past 2 weeks, during sleep hours causing sleep interruption due to uncomfortable feeling.  Pressure/Pain has increased in intensity and now is constant throughout the day. Cannot sit for long periods of time due to pressure/pain and uncomfortable feeling in the legs, specifically behind the knee area.
During my 15min wait (about 5 minutes after the injection) I started to become very hot and sweating profusely.  My ears started ringing and the noise in the room sounded like it was in slow motion.  I started to feel dizzy and clammy like I was going to pass out.  I got up and walked over to the paramedic and he sat me down and took my vitals.  All of my vitals were fine and I started to come out of the feeling of passing out.  After waiting another couple of minutes I went outside to get fresh and was able to go home.  I felt very tired and just not quite right the rest of the day and slept most of the day.  I was ok after that with just a fatigue and headache in the following days.
Rash - diagnosed 11/16/09 as Gionatti-Costi.