chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided   This case was linked to MOD-2021-375313, MOD-2021-375329 (Patient Link).
start having a seizure; continued to cry for headaches; the doctors say she has thyroid; bacterial meningitis; then viral meningitis; autoimmune encephalitis; vomit a few times; chills; headaches/continued to cry for headaches; This is a spontaneous report from a contactable consumer or other non hcp (parent). An 18-year-old female non-pregnant patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 02Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation at the age of 18-year-old.  The patient medical history was none. No covid prior vaccination. The patient previously received dose 1 (Batch/Lot number was not reported) on 12Aug2021. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced chills and headaches on 02Sep2021, vomit a few times on 05Sep2021, start having a seizure and continued to cry for headaches on 08Sep2021, the doctors say she has thyroid, bacterial meningitis, then viral meningitis, autoimmune encephalitis on 08Sep2021. The patient was hospitalized for 13 days and hospitalization was prolonged as a result of the events. Therapeutic measures taken as a result of events included steroids, IVIG etc. Outcome of events was not recovered. Covid tested post vaccination with unknown result. The clinical course was reported as: On 02Sep202, after the patient took it she got the chills, headaches continuously until she vomit a few times on the Sunday at her dad 05Sep2021 and then she went to work on 08Sep2021 she start having a seizure the ambulance brought her to (Hospital Name Withheld) they released her then she continued to cry for headaches now she is at (Hospital Name Withheld) the doctors says she as thyroid, bacterial meningitis, then viral meningitis now autoimmune encephalitis all that reacted from the vaccine as per doctors. The events resulted in Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage.  The lot number for, BNT162B2, was not provided and will be requested during follow up.
Case number PHEH2015US004136 is an initial spontaneous report received from medical assistant on 27 Feb 2015: This case refers to a 06 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch numbers: U5036CA, U501BAA, U5018AA, UI173AB, UI207AB, UI2O7AB, 14511F) at a dose of 0.5 ml intramuscularly on 16 Feb 2015, which reached 31 degree Fahrenheit for two hours. No adverse event was reported following this administration error.
This spontaneous report was received from a certified medical assistant via a company representative refers to a patient of unknown age and gender. On unknown dates the patient was vaccinated with doses of GARDASIL (lot#, expiration date and route not reported) late. No adverse effects reported. Additional information has been requested.
Hangover feeling which continued the next day; I have had random fleeting dizzy feelings; Unusually tired; Had a dizzy spinning feeling when I looked up in my closet/ A week later had another spinning episode while shopping.; Almost lost my balance; Woke next day with headache/  Headache which lasted all day and night; Aches and pains; Sensitive skin; Low temperature; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included Barrett's oesophagus, GERD, anxiety, hyperlipemia, osteoporosis, gastric ulcer, insomnia and irritable bowel syndrome (IBS). The patient previously took codeine (MANUFACTURER UNKNOWN), tramadol hydrochloride (ULTRAM), pseudoephedrine hydrochloride (SUDAFED) and zolpidem tartrate (AMBIEN) and experienced drug allergy. The patient received medications (unspecified) within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021, the patient experienced headache, aches and pains, sensitive skin and low temperature. On 30Mar2021, a week later, the patient experienced a dizzy spinning feeling when she looked up in her closet and almost lost her balance which lasted maybe for 25-20 minutes. On 06Apr2021, a week later, the patient had another spinning episode while shopping, headache which lasted all day and night with a hangover feeling which continued the next day. Since then, she has had random fleeting dizzy feelings and unusually tired. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event almost lost her balance was recovered on 30Mar2021 and headache was recovered on an unknown date in Apr2021. The clinical outcome of the events aches and pains, sensitive skin, low temperature, dizzy spinning feeling when she looked up in her closet, spinning episode while shopping, with a hangover feeling, random fleeting dizzy feelings and unusually tired was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recvd vax & exp elevated liver enzymes, fatigue, fainting; events occured between MAY & SEP92 & all sx have subsided; No further info is available;
Headache pain in both deltoids, neck pain, chills. Received 3rd dose and flu vaccine this morning Narrative:
Mild shortness of breath during first sleep period following vaccination.  Next moring no shortness of breath  including during intense excercise
Pt recv vax on 3/12/99; 2 min post vax pt exp dizziness, unresponsive x 30 sec, pallor x 5 min; tx=feet elevated, cold compress to forehead
Large amount of swelling around area and severe pain lasting 7-8 days. Still experiencing soreness around the injection site.
Client came to clinic for Men B #1.  Sibling also came to clinic for Men B #1, Hep B #3, and MCV4 #2.  Client was accidentally given Hep B dose that sibling was supposed to get.  Informed client of error.  Client reported no problems after receiving Hep B.
This spontaneous report as received from a pharmacist refers to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection, lot # M037655 with expiration date of 29-NOV-2017, lot # M041087 with expiration date of 03-JAN-2018 (dose and route of administration were not reported), which were reconstituted with properly stored sterile diluent (manufacturer unknown). Administered doses of the vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 15 hours and 50 minutes. There were previous temperature excursions for zoster vaccine live (ZOSTAVAX) lot # M037655 of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 hours and 45 minutes and 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour. ZOSTAVAX lot # M041087 experienced a previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 7 hours and 45 minutes. Digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA006761:
Chills and flu-like symptoms first 24 hours, then a few days later digestive symptoms (a lot of air, gas pain, some diarrhea).  I had these same symptoms after the second vaccine very bad and they lasted about six weeks - worse in first three weeks then gradual improvement. This time the digestive symptoms weren't quite as intense but still bothersome. Then at about day 11 or 12 - I started to get a very itchy body all over.  My groin area itched terribly and when I scratched it it became very red and huge hives developed.  Then my back started to feel like it was on fire.  Then my scalp.  Then my wrists.  I felt like my whole body had been bitten by fire ants.  I could not keep myself from scratching and as I scratched I got worse and almost felt nauseous. I contacted my doctor who said this delayed reaction of hives was a common occurrence after the Moderna booster and to take some Zyrtec, Benadryl and Pepsid.  The Zyrtec has helped to keep the itching to a bearable level but nothing has improved.  If I stop the medicines the hives come back in full force and are unbearable.  The medicine doesn't last very long before I need to take another.  It has really stopped me from being able to do anything for the last few weeks. It's a very difficult situation that I wish there would be an answer for or at least some help to those of us who have it.  I belong to a social media group of over two thousand people who have the exact same reaction to the Moderna booster. There are pictures on that page which are identical to the hives that I am experiencing and I also have photos. There is also a lot of information about this on the website pages. I also still have awful digestive symptoms - I feel like what is happening with the hives on my skin is the same thing that is happening inside my digestive tract.  The Pepcid has helped some.
Pt vaccinated with OPV/DTP/HIB given vaccination at 10AM, 2:30 PM had episode of cyanosis listlessness, unarousable, CPR administered by Mom - not breathing briefly.
I am having trouble walking, especially left foot. I felt I had stroke. I have severe pain in spine, feels like knife is stabbing me up where bra line is. Never had back problems.  All my nerves are throbbing, never had before. Feel very, very weak my strength  has gone way down. I did not feel like this before this shot.  I have extreme pain throughout body. This all started  about 20 hours after shot. It?s been 42 days now and I am having so much trouble walking and spine is not the same. I talked with my doctor, she said take Advil, which I did but doesn?t do anything. I went to urgent care, xrayed left foot,  Found some arthritis top foot, but  I didn?t have pain before there and now underneath my foot is so painful.Blood work was done.  Foot gets swollen and has some discoloration.  I feel like my body had such a bad reaction and I?m still suffering. I feel so depressed now.
her arm started to hurt; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 01Jun2021 as 1st dose,0.3 ml single dose for COVID-19 immunization. Medical history included lipoma from an unknown date and unknown if ongoing she has a lipoma in that arm since it doesn't bother her. The patient's concomitant medications were not reported. On an unspecified date the She thought of it later that day when her arm started to hurt and she rubbed it. So know she was not sure if the vaccine was injected into the muscle or her lipoma. She should like to know if she should get another shot or just oto continue with the series as planned. Response received as Read from PI LAB-# Revised: 19May2021. The outcome of even was unknown.  Information about batch/ lot number has been requested.
Dizziness, Headache, NauseaVomiting, Lightheaded Narrative:  Patient was given 2nd Moderna Booster. Immediately he started to complain of being lightheaded, dizzy with nausea and some pressure in his sinus area. He stayed in the clinic room for approx an hour with none of the symptoms resolving. VS's were taken- 130/92, HR 99, and O2 sat 96%. He had no airway difficulties, no slurred speach or trouble with vision notted. I contacted his PCP, who was out of office for the day. I then contacted a nurse for the team, LVN to see who would be able to see the patient as a walk in. She spoke with Dr. who suggested the patient go to the ER so in the event his condition worsened they would be able to care for him appropriately. I spoke with the patient about this suggestion and that I would need to call 911 for an ER visit and he declined. Stated he did not feel bad enough to go to an ER and would prefer to go home. He left the COVID clinic in no distress per steady gait ambulation to go discuss the situation with his supervisor.
I got both my Pfizer shots but it only took one to injure me.   One day after my first shot I started noticing severe tinnitus in my right ear (same side as shot)  There are no real treatments out there for tinnitus, but I know in my heart of hearts that the "vaccine" caused it. I went from having never had tinnitus in my entire life to now having a very loud persistent ringing in my ear to this day.  It was extremely noticeable the next night after I got my first shot. It has persisted since.  I've tried lipoflavinoids, ginko baloba etc, none of that actually works.  Over a year later I am still suffering from severe ringing in my right ear since the day after I got my first shot.
Information has been received regarding a case in litigation concerning a 1 day old male (birth weight 8lbs 13ox), with a family history of three siblings, two older girls, age eight and nine who have speech problems. The mothers brother also had some speech difficulty which was said to be related to hearing problems. On 5/16/1996, the pt was vaccinated with hepatitis B (dose not reported). Concomitant therapy included MMR vaccine 10/24/1997 and 10/18/2001 (dose not reported). Other concomitant therapy included varicella virus 6/14/1997 DPT 7/19/1996 10/5/1996 12/14/1996, Dtap 10/24/1997 and 10/15/2001, poliovirus live oral OPV/IPV 7/19/1996 10/5/1996 12/14/1996 and 10/15/2001 and Hib Conj vaccine Hib Titer 7/19/1996 10/5/1996 12/14/1996 and 10/24/1997. In 1998 the pt was diagnosed with autism. In 1998-99, the pt was coded as a student with developmental delay. On 3/23/1999 and educational assessment was performed due to concerns with the pts speech and language development. On 5/19/1999, an neurological evaluation was performed results reported were that the pt has a speech and language delay. The pts hearing had been checked and it was normal. There was a history of these developmental problem in other members of the family. On 6/24/1999, Fragile X syndrome test was performed with normal results (25-40 CGG repeat size). On an unspecified date, a psychological assessment was performed, questioned. The pt did not demonstrate an interest in a variety of toys. The had multiple developmental delays and he met the DSM IV criteria for the diagnosis of autistic disorder. On 2/4/02, and educational evaluation was performed results reported were that an IEP was developed with the following services, speech language, cognition and motor. Upon internal review, autism was considered to be an other important medical event (OMIC). Information received on 9/12/06 contained the following adverse experiences, eczema and dry skin rash 11/9/1996, fever and diarrhea 4/21/1997 which was treated Pedialyte, viral URI 5/17/1997 which was treated with pediacare, acetaminophen (Tylenol) and pseudoephedrine hydrochloride (Dimetapp), cold, cough and runny nose 10/28/1997, viral URI 1/2/1998, bilateral conjunctivitis and URI 6/15/1998, and borderline normal hearing to a mild hearing loss 12/17/2001. No further information is available. All available medical records will be provided upon request. Follow-up information received 4-16-08. Vaccine recipient did not recover from the adverse events reported for this vaccination. There are no residual symptoms listed.
had a little bit of a cold dissipated over a couple of days; left shoulder pain; felt a mass in his left arm pit; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (had a little bit of a cold dissipated over a couple of days), SKIN MASS (felt a mass, left arm pit), and ARTHRALGIA (left shoulder pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff tear and Surgery (Spine) in January 2021.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced SKIN MASS (felt a mass in his left arm pit) (seriousness criterion medically significant). On an unknown date, the patient experienced NASOPHARYNGITIS (had a little bit of a cold dissipated over a couple of days) (seriousness criterion medically significant) and ARTHRALGIA (left shoulder pain) (seriousness criterion medically significant). The patient was treated with Surgery (On 11-Aug-2021,surgical excision of the lymph node which was the size of an egg (6cm x 3cm x 3cm)) for Skin mass. At the time of the report, NASOPHARYNGITIS (had a little bit of a cold dissipated over a couple of days), SKIN MASS (felt a mass, left arm pit), and ARTHRALGIA (left shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Biopsy: negative Biopsy of surgically excised lymph node was negative. In June 2021, Computerised tomogram: abnormal showed a mass. In June 2021, Diagnostic aspiration: inconclusive for lymphoma were inconclusive. In June 2021, Ultrasound scan: abnormal ultrasound biopsy that looked like lymphoma.         Relevant concomitant medications were not provided. 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 events, a causal relationship cannot be excluded. No further information is expected. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. No further information is expected.
Information has been received concerning a 6 year old female pt who on 02Jul1997 was vaccinated with a dose of varicella virus vaccine live. The pt developed a moderate case of chickenpox. It was noted that there was an outbreak of chickenpox at a local elementary school. Unspecified medical attention was sought. Subsequently, the pt recovered. There was no product quality complaint reported. It was also reported that three other pt's developed a similar reaction. Additional information has been requested.
body feels heavy; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (body feels heavy) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (body feels heavy) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISCOMFORT (body feels heavy) and FATIGUE (fatigue) had resolved.            Concomitant medications include unspecified statin and vitamin medication.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Event outcomes and duration updated.
Myocarditis from 2nd dose of initial Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 at 09:00 as dose 2, single (Batch/Lot number: unknown) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, vaccine administration time: 09:00 AM, Lot number: EL0140,, Anatomical Location : Left arm), administration date: 19Dec2020, when the patient was 26-year-old, for Covid-19 Immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis from 2nd dose of initial Pfizer vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Myocarditis and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
FEVER; BODY ACHES; CHILLS; This spontaneous report received from a consumer (patient's wife) concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: 25-03-2021) dose was not reported, administered on 07-MAR-2021 at 01:00 am, to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021 at 10:00 am, the subject experienced fever, body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches and chills was not reported. This report was non-serious.