chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an approximately 14 or 15 year old female patient who approximately three weeks ago, on approximately 13-SEP-2010 was vaccinated with a dose of VARIVAX (Merck). Concomitant therapy included GARDASIL (MSD) and MENACTRA. Within hours of immunization, the patient had a bad reaction of cellulitis at the site of injection probably around 8 cm with pain, swelling, tenderness, warmth and redness around the injection site. The patient was treated with BENADRYL, however her symptoms did not go away. At the time of the report the patient had not recovered. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Interior of my mouth swollen, tongue felt larger, currently skin in interior of my mouth peeling. This has been an ongoing problem since the vaccination.
In error PNEUMOVAX 23 was administered to patient instead of PREVNAR. Patient has not had any adverse reactions.
Sports massage, treatment, muscle relaxant. Diagnosis of leaky gut. I had a complete change in diet. I work with a dietitian. So, dietitian consults. I see a chiropractor to work on the nerves parasympathetic nervous system. The joint pain evolved into a condition called leaky gut and the joint pain is just a symptom of that. I see two chiropractors a dietitian and my two doctors. It just showed up as knee pain at first and then all these other symptoms occurred while being treated. I also got three sets of sinus infections. Those were just treated; antibiotics did not work so I treated them with Nyquil.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen) and JOINT SWELLING (all the way down to my elbow three inches from the elbow and out to the side) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 020821A and 001A21A) for COVID-19 vaccination. No Medical History information was reported.On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PERIPHERAL SWELLING (arm is swollen) and JOINT SWELLING (all the way down to my elbow three inches from the elbow and out to the side). At the time of the report, PERIPHERAL SWELLING (arm is swollen) and JOINT SWELLING (all the way down to my elbow three inches from the elbow and out to the side) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant medication was reported. No treatment medications were reported. This case was linked to MOD-2021-400108 (Patient Link).
pt recv vax 650Am 29OCT97 @ work site started itching @ inj site approx 10AM arm felt hot by evening;felt hot & sweaty like had fever but did not check temp;redness/warmth in upper arm kept inc;MD felt lump in it;
This case was reported by a consumer via call center representative and described the occurrence of blindness in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced blindness (serious criteria GSK medically significant). On an unknown date, the outcome of the blindness was unknown. It was unknown if the reporter considered the blindness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced blindness after receiving SHINGRIX vaccine.
herpes zoster (shingles) noted involving lt arm (c6 & c7 dermatomes) following use of varivax;tx w/oral acyclovir;rash was painful & typical in appearance & distribution
No adverse events.  Medication error, early 2nd dose, 15 days.  Patient monitored for 24 hours.  No sequalae.
Very fussy on 10/3/2013, fever up to 103, developed a cough and congestion on 10/5/13. She was seen in our office 4 times for concerns, the last time was on 10/8/13. Her reflux may have worsened a bit as she was coughing a lot. She returned with a new illness of fever on 11/1/2013
Fever, chills, upset stomach, extreme fatigue, muscle aches over entire body, pain at injection site (arm)
Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of GARDASIL 9 (lot # L016428 with expiration date of 30-JUL-2017; strength, dosage, frequency and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
First vaccine, woke up next day and couldn't move her legs, they felt numb.  Fell back asleep for a few more hours.  When she woke up again she had trouble moving her legs.  Fell back asleep again.  Had a really hard time waking up.  Burning in armpits.  This finally resolved after about a half a day.  She was tired and staggering.  The next day she was much closer to normal.  The second vaccine she got this past Friday.  Friday night she could not sleep due to excruciating pain in her legs all night (from the waist down).  Nothing helped it (tried tylenol, CBD cream).  Pain lasted until yesterday.  Did find a higher dose CBD cream that was helpful.  Next day she again had staggering gait which lasted until yesterday.  Also had burning in armpits.  Today finally feeling better.
Herpes zoster dx at hospital in a one-dose varicella vaccine recipient. Painful rash on upper left extremity and hand. Lasted about 2 weeks. Treated with valacyclovir.
pt had 101 fever and aches for 1 day   Localized reaction reducing from 1 weeks ago --3 in diameter area of swelling
Headache, extremely thirsty, trouble breathing over night where I could not lay down or sleep, dizzy, fatigue.
Body aches and neck pain, 6 hours after vaccine administration. Patient took acetaminophen with minimal relief.
Left arm (deltoid) with 5cm X 5cm area of redness and swelling. Dx'd with cellulitis.
ENT diagnosed him with a virus; drug ineffective; inappropriate schedule; Acute Encephalopathy/ Patient started to fall (unable to walk)/ Dizziness/ confusion/ jerking of the hands/ Anxiety; This spontaneous report was received from the patient's parent and refers to a 15-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-AUG-2011, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # 0963AA with expiration date on 11-SEP-2013 (dose, route of administration were unknown) for prevention of human papillomavirus. On an unknown date in October 2011, couple of days after the vaccination, the patient started falling and was unable to walk, experiencing confusion, and jerking of the hands, dizziness and anxiety. The patient was taken to the emergency room and a lumbar puncture along with (EEG (Electroencephalography) were performed. No results were reported. The patient was not admitted and was sent home. On an unknown date, based on the symptoms, the patient was diagnosed with acute encephalopathy. The patient received aripiprazole (ABILIFY) for anxiety and  clozapine (CLOZARIL) and  divalproex (DEPAKOTE) as treatment (also reported that the patient did not received any treatment). The patient was also referred to the psychiatrist. On an unknown date, the patient was prescribed meclozine hydrochloride (MECLIZINE) (dose, frequency, route of administration, lot # and expiration date were unknown) for dizziness, but it did not work. Action taken with meclozine hydrochloride (MECLIZINE) was unknown. On an unknown date, between 2011 and 2012, the patient was referred to a neurologist and ENT (Ear, Nose, Throat) and he was diagnosed with an unspecified viral infection.  Therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was discontinued, the patient did not complete the series.  The outcome of encephalopathy was reported as not recovered as the patient' symptoms would come and go. The outcome of viral infection and drug ineffectiveness was unknown. The causality assessment was not reported. Upon internal review, the event of acute encephalopathy was considered to be medically significant.
symptoms of polyarthralgia (both hips, both upper legs, both shoulders, both upper arms).  Self medication with aleve, advil for 3 months, currently on 15 mg Meloxicam 1/day and by twice monthly PT. Possible PMR.
On 5/12/2021 developed burning and tingling right breast and rheumatologist told her to restart Enbrel and methotrexate that evening;  and next day developed classic shingles blisters; restarted her acyclovir that she has on hand for herpes simplex outbreaks; on 5/14/2021 developed URI symptoms with fever 99-100 with mild SOB; today 5/18/2021 gabapentin and albuterol sulfate inhaler rxs are sent
Started with nausea at 1:30AM on 3/20/2021 and feeling unwell. At 10:00AM ON 3/21/2021 started having pain in/behind left ear. This continued  up to the time when on 3/24/2021 at 6:45AM my left eye was blinking slower than the right eye and the left-side of my mouth showed signs of drooping. I was admitted to the ER for possible stroke due to symptoms I was having  but test results showed Bell?s Palsy. Treatment is acyclovir, ketorolac, prednisone and artificial tears ointment
sore arm/pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) at the age of 32 years as dose number unknown, 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 27Mar2021, outcome "recovered" (Mar2021), described as "sore arm/pain in arm". Therapeutic measures were not taken as a result of pain in extremity. Additional information: The event lasted about a whole 24 hours.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355594 Same reporter, drug and event; different patient.
Slight fever ( 99, face turning red); Slight fever ( 99, face turning red); Skin allergic reaction sites ( adhesive bandages allergy); injection site arm pain; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199), via an unspecified route of administration on 07Mar2021 at 10:30 (at the age of 29-years-old), in left arm as dose 1, single for COVID-19 immunization. Medical history included Overactive immune system, Hashimoto thyroiditis, allergies to medications, food, or other products: adhesive bandages, lemon grass, allergy to pea plant not peas. Concomitant medications included Levothyroxine 50 mcg, Diflucan 150 mg. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 before vaccination and patient had been tested since vaccination. On 07Mar2021 at 10:30, the patient experienced slight fever (99, face turning red) as soon as the shot was given and lasted for 1 hour. Got the same symptom once a day for 7 days straight. Skin allergic reaction sites (adhesive bandages allergy) that healed 2 months ago have reappeared the day after the shot. On an unspecified date in Mar2021, injection site arm pain that lasted for 36 hours. On 12Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test negative: negative. Treatment was given as skin rash control for the event skin allergic reaction sites (adhesive bandages allergy). The outcome of events slight fever (99, face turning red) was recovered on 07Mar2021 at 11:30, skin allergic reaction sites (adhesive bandages allergy) and injection site arm pain was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
8/13 - 8/20 - extreme fatigue, all over body aches, cough, h/a's -- Pt. treated by PCP (Pt. was treated for bronchitis shortly after PNEUMOVAX prior to onset of above sx).
Patient reports  mild itching to her arms and farce, no rash or hives, no other symptoms. Patient was seen and cleared by EMS BP; 134/77, pulse :80, Spo2 100%
Had a cold with a bad cough, headache and congestion. Took a Home COVID-19 test and was positive. Contacted doctor and was prescribed Paxlovid. Felt better a couple of days later.
Patient recieved the Moderna vaccine at age 16 while it only EUA approved for age 18 and up. No reactions were observed in the 15 minute time frame that the patient was observed. Patient's doctor was informed of the incident. Provider said that he specifically directed the patient to  obtain the Moderna vaccine and not the Pfizer vaccine even though it was not approved. Patient is told to report any side effects that may occur to  VAERS, the Pharmacy, and Doctor's office.
Received First Dose With Heplisav-B, and Second Dose With Engerix; Initial Report Received on 18-Oct-2022  This is a spontaneous report, received from a clinic manager regarding a 29-year-old female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported.  Concomitant medications were not reported.  On 07-Jun-2022, dose 1 of HEPLISAV-B (Lot #937229, expiration date 13-Sep-2023, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.  On an unspecified, the second dose of a hepatitis B vaccine administered was Engerix-B.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
The first day after shot arm around shot site hurt and skin all over body felt hot and I was very fatigued. Second day shit site was very large, red and hot to the touch.
swelling; 3 bumpy, lumps; arm had strange reaction; pain; had little chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), VACCINATION SITE MASS (3 bumpy, lumps), VACCINATION SITE REACTION (arm had strange reaction), PAIN (pain) and CHILLS (had little chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced SWELLING (swelling), VACCINATION SITE MASS (3 bumpy, lumps), VACCINATION SITE REACTION (arm had strange reaction), PAIN (pain) and CHILLS (had little chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, SWELLING (swelling), VACCINATION SITE MASS (3 bumpy, lumps), VACCINATION SITE REACTION (arm had strange reaction), PAIN (pain) and CHILLS (had little chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Administration of an expired dose of vaccine ROTATEQ; No Additional adverse event; This spontaneous report was received from a office manger referring to a 6-month-old female patient. The patient's current condition, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 14-FEB-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742457 and expiration date reported as 16-JAN-2022 but upon ) dose 1, oral for prophylaxis (expired product administered). No additional adverse event and no product quality complaint reported.
Redness swelling and tenderness 2 inches by 3 inches at left deltoid area. Fever with chills and achiness. Taking ibuprofen and Tylenol.  2nd phone call on. After 36 hours, redness had doubled and fever 101.7.  States "I just don't feel well".
Vials expired on 13-May-2022 and were stored in refrigerator on 17-May-2022; Vaccine expired on 13-May-2022 and was administered on 08-Jun-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 13-May-2022 and was administered on 08-Jun-2022) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 and were stored in refrigerator on 17-May-2022) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 034F21A, 043B21A and 039A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 10:23 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Jun-2022 at 10:23 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 13-May-2022 and was administered on 08-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 and were stored in refrigerator on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 13-May-2022 and was administered on 08-Jun-2022) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 and were stored in refrigerator on 17-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 13-May-2022 and was administered on 08-Jun-2022) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 and were stored in refrigerator on 17-May-2022).    No concomitant medications were reported.   The health care professional thought that Moderna had an extension like Pfizer, and though it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022 and they realize this on the 08-Jun-2022.  Vials did not undergo any temperature excursion.  The event did not cause the patient to seek medical care. There were no other potential causes reported.  No treatment details were reported.   This case was linked to PR-MODERNATX, INC.-MOD-2022-586794 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-586794:Master case
fluttering in her chest; felt like she was going to pass out; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101698105 (Pfizer).  A 66 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: CARDIAC FLUTTER (medically significant), outcome "recovered", described as "fluttering in her chest"; PRESYNCOPE (non-serious), outcome "recovered", described as "felt like she was going to pass out"; DIZZINESS (non-serious), outcome "recovered", described as "Dizzy". Clinical course: Caller stated she had some kind of reaction after her second vaccine and she was wanting to know if it was safe for her to have the booster. After the second shot of the vaccine, clarified about 10 days after the second shot, she developed fluttering in her chest and the sensation went instantly to her head where she got dizzy and she felt like she was going to pass out. It was random and it was intense. She stated it tapered off after about 3 months.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Local reaction left arm to DTaP. Arms red and swollen. Redness about size of large apple.
Flu-like symptoms:  body and joint ache, headache, fever/chills, sensitivity to touch,  sore  eyes and backache.  Symptom on-set morning of July 30, symptoms dissipated morning of August 1.
No adverse effects; multiple patients were administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information concerning the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies provided. On 23-APR-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R023513, expiration date: 16-AUG-2020, subcutaneously)(exact dose was not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The administered dose of vaccine experienced a temperature excursion between -9 degrees Celsius (°C) to 8°C (-3.2C) for 5 hours 30 minutes. Digital data logger was involved in capturing the temperature excursion. There were no previous temperature excursions reported. No adverse effect was reported. This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA006376:
While sitting on a chair in front of the pharmacy after the shot, patient briefly  lost consciousness as he slipped down the chair before his girl friend caught him, thereby preventing him from falling to the floor
Pt experienced hot, red, swollen area in left arm starting the day after she received her Pneumovax 23 injection.  She received Boostrix in her right arm the same day and did not have any problem with that.
Massive weakness in joints , temperary temperature, joints continually effected are knees and hands. They are the worst
The day after the third dose I started to feel feverish and loopy. My legs were a little shaky, so I went home from work. After the third dose of the vaccine my left armpit was swollen and the veins that ran toward my breast were very swollen. I could feel nodules in my armpit. I started to get some chest pain which was very localized. It was a bruising pain in the center about a week after the shot. My chest was very tender to the touch.  I was diagnosed with Costochondritis on 09/21/2021. My cardiologist said my cartilage was inflamed. I am supposed to see my doctor for further treatment. I am taking Celebrex for the pain for seven days currently.  Dose 1 03/05/2021 EN6204 Dose 2 04/22/2021 EP655
PREVNAR vaccine administered on this date. Later it was discovered patient had already received the vaccine from physician (despite patient attestation to the contrary).
Pt. admitted to the hospital on 22 Jan 21 with Acute on chronic combined systolic and diastolic congestive heart failure; CHF (congestive heart failure); Chest pain, unspecified type; Coronary artery disease involving native coronary artery of native heart without angina pectoris; Debility; Ischemic cardiomyopathy; Shortness of breath; Systolic and diastolic CHF, acute on chronic Still admitted as of today
Injection site pain Narrative:  Event lasted 48 hours after vaccination  Other Relevant History: