chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a consumer on 17 October 2014. A 70-year-old female patient had received an intramuscular dose of FLUZONE HD vaccine (lot number and dose number not reported) in left arm on 13 October 2014. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as controlled asthma and nasal allergies. On 14 October 2014 i.e. one day after vaccination patient had experienced red, puffy, itchy area that has progressed from shoulder to elbow on her left arm. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was recovered on an unknown date. Documents held by sender: None. Follow up information received from consumer (patient) on 26 Jan 2015. The patient had received a CLARITIN 10 mg once and Triamcinolone 0.1 % twice as a corrective treatment. The patient had no laboratory investigations.
viral outbreak S1/S2 dermatome, ddx zoster vs. HSV (history of genital HSV). simultaneously had recurrence of genital HSV.
Blurred vision; This is a spontaneous report from a contactable pharmacist. A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0161 and Expiry date: Jul2021) dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 at the age of 29-years-old as 0.3 ML single dose for Covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. On 02May2021, the patient experienced blurred vision. The caller was looking and didn't see where blurred vision was a side effect. The caller wants to know if it is okay for the patient to received the second dose. The patient can still see, the patient went to the doctor about this event and the doctor said it should go away with time. The outcome of event was not recovered.
patient had stroke on the evening of 3/19/21 between 5-9pm. Pt currently admitted to hospital
Partial seizure evening after DTaP #5. Sat up in bed; side of face twitching.
after almost two months after injection, pt still experience arm pain at injection site. no redness and swelling on the site
Non-luerlok needle/syringe combination malfunctioned such that an unknown qty of dose escaped at the connection point between needle and syringe.
Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effected reported
This spontaneous report as received from a physician via field employee refers to a 56 year old female patient. On an unknown date in March 2013 the patient was vaccinated with ZOSTAVAX vial 19400 PFU. Dose, lot and expiry date were unspecified. On an unknown date in approximately 2013, the patient developed a full blown case of shingles after receiving ZOSTAVAX. The patient had shingles on her hips and buttocks and had received a nerve shot 2 days prior developing shingles. The physician had informed that patient sought medical attention by office visit. Unspecified antiviral medications were given as treatment for the event. The outcome of event was reported as recovering/resolving. VZVIP packed faxed. Additional information has been requested.
Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!
caller can not think; caller is postponing second dose of vaccine; very very terrible pain all through her body; caller can not sleep; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced caller cannot think, caller is postponing second dose of vaccine, very very terrible pain all through her body and caller cannot sleep. The pain had stated that it was down a little bit but she could not sleep through the night and is taking really strong pain medication, even the one that that they talk about advertised on TV and her pain is still there. It is in her neck from her back to her neck and her body. The patient could not see herself taking the second one. The patient had to see her primary doctor to see if she was having pain through her entire body, she did not have anybody there who is with her. The patient looked forward to it but she could not in this pain, so she was checking with her primary. At her age, she has to be careful with her health. The patient just wanted to know and did not see the number where she had the sht. The first vaccine she took she think this was set up for them to come, and she was trying to find the number but was in so much pain. The clinical outcome of the events was unknown.  PSCC Communication: caller advised to contact hospital, physician, or where she received first vaccine. The patient does not want to complete report at this time. No further transfer.  Additional information has been requested and will be provided as it becomes available.  Follow-up attempts completed. No further information is expected.
Eyes started twitching then rolled in the back of her head. Nose, lips, arms, fingers, feet started moving fast at the same time like a seizure.
Hand and feet went numb. Tongue tingling and hard to swallow and short of breath. Felt faint. Took Benadryl and Tylenol. Next were headaches, chest pain, shortness of breath and dizziness. Went to doctor 2 weeks after vaccine and received and anti inflammatory shot.
This spontaneous report was received from a 79-year-old female patient. The patient's concurrent conditions included allergic reactions to DOXAFIN, hydrochloride (unspecified), doxycycline, latex, LEVAQUIN, TESSALON, ZITHROMAX, candicidin, methylchloroisothiazolinone and methylisothiazolinone. In the past, on an unspecified date, the patient took penicillin and could taste it on the tip of her tongue. Concomitant therapies included SYNTHROID. On 17-OCT-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # was not provided), 0.5 milliliter, intramuscularly to prevent pneumococcal disease. The patient stated that within a second after vaccine administration, she could taste the vaccine on her tongue, and that after a while, her tongue started to feel numb. The patient began to feel dizzy and developed a severe headache. She mentioned that she was unable to read writing because the letters were fussy. The patient received unspecified treatments for her experience, however, no laboratory diagnostics were performed and did not seek for medical attention. At the time of the report, the outcome of dysgeusia, visual impairment, headache, dizziness and hypoesthesia oral was reported as recovering. No causality assessment was provided.
fatigue that has lingered since, as well as arm tingling sensation of bilateral arms and upper chest
AFIB; A spontaneous report was received from a nurse concerning a 71-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced AFIB (Atrial fibrillation).  The patient's medical history including COVID-19. Concomitant product use was not provided.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient was hospitalized for two days with atrial fibrillation. The patient received Cardizem IV, converted back to sinus rhythm and discharged home two days later on Lopressor PO.   Treatment for the event included Cardizem IV and Lopressor PO.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event AFIB was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of atrial fibrillation. This event occurred 1 days after first dose of mRNA-1273, lot # 013L20A.  Treatment included Cardizem iv and Lopressor po. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Moderna was inappropriately given to an individual <18 years of age. No adverse reaction to the vaccine.
This spontaneous report as received from a registered nurse who read a story of a patient of unknown age on a website. On an unknown date the patient was vaccinated with GARDASIL (dose, lot no and route not reported). On an unknown date the patient experienced seizures after vaccination. The outcome of seizures was unknown. Upon internal review, seizures was determined to be medically significant. This is one of several reports received from the same source. Additional information is not expected.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: panic attack-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe
Small purple spot first noticed months earlier (unsure when) on left calf had grown to 3 cm at time annual exam visit 8/5/21 to Dr. Soon discovered that large areas of skin on pelvic floor were affected and new spots were developing on buttocks and lower abdomen. Returned to Dr. who performed skin biopsy 9/16/21. She referred me to dermatology. Diagnosis: purpura anularis telangiectodes.
swollen glands, fatigue, headache, stiff joints, sore throat since vaccination on 3-31-22
Mother reports baby had become limb, pale, sleepy, clammy, and sweaty after 1 hour after receiving vaccines. Stated the episode lasted 16-18 hours, his resp seemed slower also. All symptoms lasted 16-18 hours. Low grade fever noted but responded to Tylenol. No loss of consciousness, no seizure like activity.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 06-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Shortness of breath 4 days after vaccine. Severe shortness of breath and heart palpitations  8 days after vaccine which led to ER visit.  Tests were all negative. Continued difficulty with some shortness of breath, severe anxiety, suicidal thoughts  and some depression afterwards for several months.  Never had anxiety or depression before this.
5-10  minutes after receiving the vaccine I started to get pins and needles on the left side of my face from my lip to my ear and my left ear started to get really hot. I received a Benadryl from the nurse on standby at the vaccination site and it seemed to resolve later that evening. Two days later on Sunday evening I began to get Menstrual cramps. At first I didn't think anything of it as I thought I was just ovulating because I had just had my menstrual cycle ending on April 5. The next day, Monday during the day I begin to get severe cramping and a feeling of nausea because the pain was so severe into Monday night and Continuing Tuesday Into the night.  Wednesday morning was more of the same and the pain seemed to lessen a bit by Wednesday evening.   The amount of blood was definitely more than a ?normal? For me.
Real sore.  Little bit of chills, No swelling or redness. Left arm/pneumonia shot.
104F fever from 1am to 1pm  chills  sweats  nasal congestion
-Swelling, Redness, Pain to vaccine site a day after vaccine given. -Patient was seen here on 9/5/19 for evaluation of Redness and swelling. -Patient started on Bactrim Suspension twice a day - Symptoms Resolved on 9/9/19 on F/U visit.
Pt. called in to report an adverse reaction to her recent shingles vaccine. She stated the day after she rcd the injection, she noticed her arm swollen on the side she received the injection.  Then she believes she had hallucinations, seeing things out of the corner of her eye.
Woke up the morning after the first shot with a sagging face on the left, watery eyes, runny nose. Was taken to the hospital May 30 to get checked and was diagnosed with Bell's Palsy, given antibiotics, steroids, and and eye ointment. As of June 16th he still has not recovered.
after receiving the 1st dose / uncomfortable feeling on the back of her legs; This case was reported by a consumer via call center representative and described the occurrence of leg discomfort in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dizziness. Concomitant products included gabapentin.   In October 2019, the patient received the 1st dose of Shingrix. In October 2019, immediately after receiving Shingrix, the patient experienced leg discomfort. On an unknown date, the outcome of the leg discomfort was not recovered/not resolved.   It was unknown if the reporter considered the leg discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but could be 74 or 75 years. The had been taking 300 mg gabapentin every 4 hours which causes some dizziness. The patient had the 1st dose in in left arm. Shortly after receiving the vaccine she started to experience an uncomfortable feeling on the back of her legs 3 quarters of the way up to her buttocks. There is no rash or redness present. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020AMR204346.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR204346:same patient (2nd dose)
tenderness of injection site  Narrative: 12/16/20 Assessment note  at23:45: Right deltoid covid site tender to touch but no redness. Patient is  afebrile, 97.6, no complain of pain. 12/17/20  Assessment note at14:16: Patient denies any chills or mobility changes, with  minimal tenderness only per patient, no change in LOC or behavior. Right deltoid  administration site without any skin discoloration or any visible issue. 12/17/20  Assessment note at22:35: Vaccine site is  intact, no complain of pain, no redness noted.
This case was reported by a health professional and described the occurrence of influenza in an unspecified number of subjects age and gender who was vaccinated with influenza virus vaccine (manufacturer unspecified). The reporter stated that she had no specifics on these subjects. On an unspecified date the subject received unspecified dose of influenza virus vaccine (unknown). At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced influenza and vaccination failure. At the time of reporting the outcome of the event was unspecified. This case was assessed as medically serious by GSK. The nurse reported that over the years she had seen subjects develop the flu even after receiving the flu vaccine. The nurse reported that over the years she had seen subjects develop the flu even after receiving the flu vaccine but she had no specifics on these subjects nor which vaccine they received.
arm was throbbing and hot; Itchiness; Redness; pain; swelling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness), PAIN (pain), SWELLING (swelling) and PAIN (arm was throbbing and hot) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness), PAIN (pain) and SWELLING (swelling). On 05-Mar-2021, the patient experienced PAIN (arm was throbbing and hot). On 03-Mar-2021, PRURITUS (Itchiness), ERYTHEMA (Redness), PAIN (pain) and SWELLING (swelling) had resolved. On 08-Mar-2021, PAIN (arm was throbbing and hot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment information was reported as Benadryl, Topical ointment.
Patients spouse describes that patient had numbness and tingling in feet and legs and was unable to walk unassisted several hours after receiving dose. Symptoms are starting to resolve and patient is ambulatory, but still having some numbness and tingling
Left upper thigh red with 2 injections marks, lateral one firm, 4x5cm mass, laterally erythema at mark of other injection.
Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about October 4, 2013, administered by a pharmacy, 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 September 9, 2016, the patient was treated by a physician for a painful outbreak that was diagnosed as herpes zoster, or shingles. The patient has been prescribed ZOVIRAX for management of his 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, patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
The vaccine appears to have been delivered subcutaneously, not IM as prescribed.  The  individual was short, stood behind me, and I did not feel the needle enter the muscle as I had during my first injection.  I assumed they were more skilled or I was more relaxed during the injection, so I didn't think anything of it.  The next day, there was a small bruise at the injection site and a raised red area emanating from the injection site anteriorly approximately 1 inch over the anterior deltoid.  The raised area could be palpated just under the skin and on top of the muscle and took nearly 2 weeks to resolve.  This was very different than my first vaccine injection experience approx. 3 weeks prior, when I felt the needle enter the middle deltoid muscle,  resulting in a round raised red area about the size of a quarter that felt deep in the muscle the next day, and which resolved in a few days.  No other signs or symptoms noted.     I called the  Health Department, as well as Pfizer to advise them of the incident and to request advice.  Both suggested filing a report but neither offered any advise other than to contact my MD, who also had no advice to offer.  Questions:  Given the temperature requirements of the Pfizer vaccine, and if it was not injected into the muscle, would a slower uptake  impact my immunity?  What is suggested to assess my current immunity status?  Might a booster shot may be indicated?  Any advice would be sincerely appreciated.
This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms, injection site pain and product supply issue. On an unknown date, the outcome of the fever, influenza-like symptoms, injection site pain and product supply issue were unknown. It was unknown if the reporter considered the fever, influenza-like symptoms and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever and bad flu-like symptoms and was in bed for 3 days. The patient also experienced an extremely sore arm at the area of the injection. The patient mentioned that there was a shortage of SHINGRIX and time was running out for his 2nd dose. Because of the adverse events experienced after 1st dose, the patient did not want to have the shot three times (if the patient miss the 2nd dose within the 6 month window). The patient was asking if there was any way possible to make sure that people who had gotten the 1st dose (especially the ones who had a reaction) were at the top of the list for the 2nd dose and if there was any way to assure the patient could get the 2nd dose before the end of September. The patient stated there must be many people in this situation.
99 degree fever and headache began 8 hours after injection and continued until 20 hours after injection when fever increased to 101. Fever peaked at 102  approx 30 hours post injection.  Also, extreme headache, fatigue, muscle aches, chills began around 15 hours post injection. All symptoms ended 36 hours post injection.
Swollen left arm 9:15 am 10/5 red, swollen especially at elbow. Was seen by physician around 1 pm - gave her an antibiotic.
Several weeks after the second dose I had extreme pain at the sight of the shots.  It lasted for about two weeks.
Started having itchiness on both hands and around ankles 1/17/2021 notice itchiness  started to go to my arms and legs than I notice little bumps on my inner arms itchy and red; than my legs stared getting bumps didn't notice redness yet until Wednesday but both legs where real itchy, and my back itch a little bit, but my hands, arms and legs are the worse.1/21/2021 Today I went to get some Hydrocortisone Cream with vitamins & Aloe and I did take Benadryl also. I contacted my Primary Physician still waiting on her response of what I need to do.
pt recv vax & pt wife reported pt had well physical 3wk prior to vax;all bloods counts WNL;p/vax pt had unk rxn;3wk later pt began bleeding through pores & in urine;pt dx w/leukemia;pt expired d/t liver problems in OCT95;
Approximately 36 hours after vaccines to left leg, pt developed 10 cm x 10 cm area of redness and swelling. Slight tenderness.
Severe pain in right deltoid ever since receiving flu shot over three weeks ago.  Cannot sleep at night because of the pain. Increased pain when lifting over head.
Patient felt faint.  Was helped to the floor.  b/p 102/60 PSO2 100% pulse 62 Respirations 16.   Patient felt Immediately  better, had water and a protein snack.