chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus; other vaccine same date vaccine date=16Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Monoclonal Gammopathy" (unspecified if ongoing), notes: Monoclonal Gammopathy Kappa over the Lambda; "Known allergies: Nylon" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE; MAGNESIUM; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1, at 12:00 PM, in Left arm), administration date: 23Feb2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 16Mar2021, outcome "unknown", described as "other vaccine same date vaccine date=16Mar2021"; TINNITUS (non-serious) with onset 31Mar2021, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient received other vaccine product (PFIZER) on 16Mar2021, lot number unknown, dose number was reported as dose1, at right arm. Facility type vaccine in Hospital. No other vaccine in four weeks. Other medications in two weeks included Loratidine 38 c Magnesium 1.86 Vitamin d3. Covid tested post vaccination was reported as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shortness of breath beginning immediately after vaccine, ongoing now for 3 weeks; fever, ongoing now for 3 weeks; tachycardia, ongoing now for 3 weeks; heart palpitations; headache for 3 weeks; tremor; paraesthesia; nerve pain; extreme fatigue; acid reflux.
Patient says his arm aches especially at night. He is not able to sleep on his left side. He cannot lift his left arm above his shoulder. Patient is concerned that vaccine wasn't given in proper location or at the correct angle.
About 7 to 10 days after receiving the vaccination the patient noticed a pink raised bump the size of a pimple with a scabed point. It does not hurt and is not tender unless pulled by clothing. No change in appearance or size over a 2 week period. Patient saught care from PCP on 1/3/19 and was prescribed mupirocin 2% ointment and referred to a dermatologist.
Low fever; Fatigue; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 11Apr2021 at 12:45(at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included treatment for breast cancer and the patient had adhesive allergy. Concomitant medications included paclitaxel (MANUFACTURER UNKNOWN), loperamide hydrochloride (IMODIUM), diphenhydramine/ paracetamol/ phenylpropanolamine hydrochloride (BENADRYL), trastuzumab (MANUFACTURER UNKNOWN) and plochl (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 21Mar2021 at 12:45 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 09:00, the patient experienced low fever, fatigue and joint pain. Therapeutic measures were taken as a result of events included treatment with ibuprofen (MOTRIN) and paracetamol (TYLENOL) for fever. On 13Apr2021, the patient underwent nasal swab (Sars-CoV2 test) and the result was negative. The clinical outcome of the events low fever, fatigue and joint pain was recovered in the year Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After getting COVID (Pfizer) vaccine, patient came out of the room feeling dizzy. People around her said she needed help. The pharmacy staff rushed to help her. She sat down, then she fainted a few seconds. She felt completely fine right after that. We called 911 just in case, but she didn't want any help. Patient stated because she saw the needle she passed out. It happened to her before as well.
Mom states patient broke out with splotchy - hives around injection sites and arm, legs, and trunk areas.  She administered BENEDRYL - hives were gone mom thinks it was flu vaccine.
Vaccine shot on 22MAR2021 Chills, fatigue, gi upset, headache and very sore arm 24MAR2021 All symptoms then I thought went away. 30MAR2021 sore arm started again and noticed red splotch around injection site.
had an immediate reaction in regards to a fast heartbeat; A spontaneous report was received from a health care professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, fast heartbeat Ever since she got the vaccine, she had an immediate reaction in regards to a fast heartbeat, but notes that her heartrate has been high still following the vaccination.    The patient's medical history were not provided.   Relevant concomitant medication were not provided.   On 23Jan2021 prior to the onset of the events, fast heartbeat, the patient received their mRNA-1273 (lot/batch: not provided) Implant route for prophylaxis of COVID-19 infection.    Laboratory details were not provided .    She took no medications in regards to her reaction.  Action taken with mRNA-1273 in response to the events was not reported.      The outcome of  reported event, fast heartbeat was recovering/resolving.  The reporter assessment for the event(s) fast heartbeat was not provided.
full body rash started 12 days p/recv vax; still has rash at time of rpt
Began with a chest sensation and grew over three weeks; ER visit 1/14/22 Diagnosis of heart arrhythmia with premature ventricle contractions Unresolved
This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored dosed of PROQUAD (doses, route of administration, anatomical location, lot# and expiration were not reported). Administered dose of PROQUAD experienced temperature excursion of 35 degree Fahrenheit for 6 days, on an unknown date. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several report from the same reporter. Additional information has been requested.
My son developed encephalitis and then autism, symptoms included diarrhea, loss of appetite, small red bumps all over body, fever, lethargic.
Horrible pain in arm and pain traveled up to my shoulder I still can't lift my arm over my head yet
Muscle pain in left deltoid, vomited at 1:22am. No treatment taken
Next day bladder infection, trouble urinating, went to urologist's office. They gave him medication (antibiotic), and problem cleared up within a few hours. Fine within 2 days.
48-72 hrs after the first injection I became ill. This included flu-like symptoms, excessive and violent coughing, extreme fatigue and chest pain. It got so bad I was honestly afraid for my life; I've never been so ill. I called my insurance's nurse care line and was advised that I need to report to the ER. I went to the ER, I was tested for COVID and told it was negative. I was told I may be having a reaction to the COVID vaccination I'd received the week prior.  On 21 Sep 2021, I made an acute care appointment w/my PCM because I'd coughed so hard that I hurt my ribs (right side). My PCM said I may have torn something or bruised the ribs due ot the violent coughing I'd been doing for the past 11 days. She gave me more medications.
Tactile fever several hours after immunizations.  Slept well, woke in am listless, vomiting, ns, horizontal nystagmus.
one week after second dose, patient developed fevers, chills, cough and SOB.  multiple SARS-COV 2 tests were negative,  mulitple abx courses were ineffective CT Chest showed B ground glass consolidations patient underwent bronchoscopy which showed neutrophil predominance, but negative culture patient was treated with steroids and recovered
No adverse reactions noted.  Client received Pentacel and Pediarix at same visit and is doing well.
Symptoms occurred within 3 hours or less of injection. Elevated B/P, dizzy, chills (temp 95.5), achy. Went to M.D. Given med for dizziness, B/P medicine. Still having symptoms of chills and achy with dizziness as of 10/11/12.
It started with cramping in my legs, then became pain numbness and tingling in my hands arms and feet.
Information has been received from a physician concerning an 86 year old healthy male retired physician with no known allergies who on 20 Oct 2006 was vaccinated in the right deltoid with a dose of Zostavax. The patient was not receiving any immunosuppressive agents. On 01 Nov 2006, eleven days after vaccination, the patient developed 3 small red papules and 1 early lesion which were clustered in an area approximately 3 cm in diameter on the right buttocks. It was noted that the patient had pain which was rated as 3 (scale of 0-10). The physician suspected herpes zoster and has prescribed VALTREX. Unspecified medical attention was sought. Subsequently the patient recovered. It was reported that the patient had a history of childhood chickenpox. No recent exposure to chickenpox or shingles was noted. There was no product quality complaint involved. Additional information has been requested.
10/28/17 admitted to hosp. for E. coli UTI sepsis, fever, atrial fib new onset, cough. Doctor doesn't think related to HD flu vaccine, but wanted reported.
1:50 p.m. slight headache, took Tylenol. fatigue, nausea, achy the entire 53 hours after shot,  took Aleve, Slept a lot, probably half the time between dose and Wednesday at 7 pm. Around 1 pm or 2 pm, on Wednesday, 04/01/2021, I started having extreme ringing in my ears. It was extremely loud and I felt as if my head was throbbing. That lasted about 4 hours and then just disappeared around 7 pm Wednesday evening. I do have very slight ringing in my ears anyway, but this was intense. I did not vomit; however, I did have some slight Diarrhea for a couple of days.
Arm was initially red the day of the injection and then the redness improved by the next day but the entire upper arm developed a papular rash that itches and persisted for 7 days. Is not improving.
severe nausea, abdominal pain, gas, felt feverish, aching all over, nausea 2 hrs p/vax; next day abd pain & gas, shaking (tremors) next few days severe nausea, gas & abdo pain; feel hot, loss of appetite;
Had a breakthrough of COVID virus after being vaccination. Prescription antibiotics. COVID turned into pneumonia. I was in the hospital for 6 days. I also went into AFIB at this time.
BILATERAL ARM SORENESS SHIVERING, BAD HEADACHE, MUSCLE ACHES, FATIGUE (L) ARM SWELLING, RED, WARM - SEEN BY m.d. X 4 DAYS
gave a 0.25ml dose from the wrong vial (blue cap with a purple border); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event) in an infant female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (gave a 0.25ml dose from the wrong vial (blue cap with a purple border)). No concomitant medications were reported.  The medical assistant states that they gave 0.25ml dose to children under 5 year old from a vial that was meant for children 6 to 11 years old or as booster doses to adults. The vial had a blue cap and with a label with a purple border. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2022-637085 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-637085:Crosslinked case CMOD22-03640.
The next day i also have swelling in my left lymph node and it still hurts; The next day i also have swelling in my left lymph node and it still hurts; tingling; numbness in both my legs and feet for several hours; booster; booster; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 43-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 07Nov2021 at 12:00 (Batch/Lot Number: FH8020) as DOSE 3 (BOOSTER), SINGLE (at the age of 43-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination. Historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 01Mar2021 (at the age of 42-year-old) as dose 1, single and second dose of bnt162b2 PFIZER BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 22Mar2021 (at the age of 42-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive other vaccine in four weeks. On 07Nov2021, the patient got all the same symptoms reported from first shot and adverse event plus tingling and numbness in both my legs and feet for several hours. The next day on 08Nov2021, the patient had swelling in left lymph node and it still hurts, that was patient observing. It was unknown if Covid tested post vaccination or not. The patient underwent lab tests and procedures which included blood test: unknown result on an unspecified date. The outcome of events reported as recovering.  Follow-up attempts are completed. No further information is expected.
pt recv vax 4JAN96 & 1FEB98 pt devel a rash on trunk & scalp;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 03Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tests had faint positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment with Paxlovid from 23Mar2023 till 28Mar2023. Patient had not allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300144811 same reporter/patient, different product/AE;
Severe total body pain, fever for 102.7, vomiting, nausea, headache. Got sick at 930 PM; shots about 230PM. Red arm at injection site.
Urticarial rash that started within the first five hours of receiving the booster. Described as an itchy erythematous rash, like hives, that started in the back and spread to arms and legs the following day. Received treatment with Bendadryl and Zyrtec without improvement of symptoms. No previous similar episodes with other vaccines or medications. Patient with No known allergy.
Breakthrough case admission after 2 vaccines Moderna 4/26/21 Lot# 044A21A;  Moderna 5/24/21 Lot# 018B21A
Pain and swelling  and itchiness at injection site, hot to touch. Today it?s less red, still swollen and it feel really hard bump.
Woke 8A with leg pain, some difficulty walking. 730p - developed small bumps mom felt were hives, child said throat tight - given 4 tsp BENADRYL, rash resolved. Spoke with Dr 9:10p, recommended ER, mother called 911. Paramedics felt child fine. No further symptoms.
2 month old in for immunizations.  Began administration with oral RotaTeq.  Infant had not even taken the entire amount when she began vomitting.  At first just on herself and her clothing, but then projectile vomitted the remainder of her stomach contents.  Could audibly hear stomach upset, and a few dry heaves after stomach was empty.  Mother reports that infant does not have regular issues with spitting up or vomitting, has had no signs or symptoms of illness.  Took temperature with thermal scan on forehead and rec'd 98.8 reading.  Infant's stomach settled within 5 minutes.  Did then administer remainder of immunizations that were due.  Advised mother that we will not administer any add'l doses of RotaTeq to this child.
Within 7 minutes I had a reaction of dizziness, nausea, increased blood pressure, increased heart rate, retching and extreme fatigue. I was taken to the Emergency Room via. Ambulance. In the ambulance I was given an IV and IVY Zolfran - which seemed to make the symptoms worse, at the Emergency room they gave me  Phenergan.  I had a chest x-ray that didn't show anything unusual.   I was then give Meclazine for the naseau and headache and a full bag of IV fluids.  It was enough to get me standing on my own so I could go home after spending several hours in the emergency room. 3/5/21 - 3//21 - still had symptoms - every time I moved I got nauseous and dizzy.   Followed up with my PCP's office on 3/9/21 as I was still very dizzy, nauseas, and had brain fog- I have been on Zolfran and Motion sickness medicine - since the 9th. At that time blood tests were done.  I  had another appointment with my PCP on 3/16/21- as I am still having nausea and while there - got very nauseas while tracking . This is 11 days after the 1st vaccine.   I was referred to Otolarynology on 3/17/21.  The PA I saw there determined it wasn't an ear issue and has referred me to Dr. for an ENG test which is scheduled for 3/31/21 with a follow up with Dr. on 4/13/21.   I have also been in touch with my allergist - who told me to postpone my allergies shot that were scheduled on 3/19/21.
Within half hour: Searing pain of medicine going to each limb one by one, Dizziness, nausea, headache. By next day: Fever for two days, Chest Pain, headache, baseball sized bruises with two purple bruises in right arm near injection site. For a month after second shot; chest pain and nausea lasted for a month. Did not seek medical help due to staying quarantined.  Outcome resolved by itself eventually in about a month or so.
Dizziness, Headache, Myalgia, Arthralgia, dry mouth; muscle spasmss Narrative:  1/12 received 2nd COVID-19 vaccine 6:45 AM. 1/13 0500 onset of symptoms. Diarrhea x 3, weak, knee joints ache, back aches, headache, dizzy, dry mouth and muscle spasms. Denies Fever, N/V. He was exposed to a patient who tested positive with moderate risk level. Will test for COVID-19 today (1/13). COVID-19 test is negative on 1/13. 1/14 - feeling better - everything resolved except mild muscle aches.
P/2nd DTP had fever 103 w/APAP; Seen by MD-bronchitis; p/3rd DTP on 3MAY91 had fever 104 w/APAP for 2 days; MD ordered Ped DT;
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown gender and age. The patient's medical history and concurrent conditions were not reported. In 2015, between 20-MAY-2015 and 14-JUL-2015 the patients were vaccinated with improperly stored doses of PROQUAD (Merck), 0.5 ml, subcutaneous, lot number K004860, expiration date 04-OCT-2015. There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same reporter (case # 1507USA007010). Additional information has been requested.
No appetite, upset stomach, and vomiting. Pt had an abdominal U/S and phenergan inj.
Injection site: very sore, swollen, big red circular rash. Symptoms even after 43 hours post injection. Muscular aches over whole body -shoulders, legs, arms, fingers, brushing hair. A little better after 43 hours. Headache - symptoms still after 43 hours.
pt recv vax 31MAY95 & 03JUN95 exp gen varicella-like rash & head to toe lesions; No further details were provided;
After 1st dose patient experienced like a burn in the left arm and back; Itching under the skin real bad without rash; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (After 1st dose patient experienced like a burn in the left arm and back) and PRURITUS (Itching under the skin real bad without rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced BURNING SENSATION (After 1st dose patient experienced like a burn in the left arm and back) and PRURITUS (Itching under the skin real bad without rash). On 26-Feb-2021, BURNING SENSATION (After 1st dose patient experienced like a burn in the left arm and back) and PRURITUS (Itching under the skin real bad without rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-657196 (Patient Link).
I contracted dermatographia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) 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: MECHANICAL URTICARIA (non-serious) with onset Jul2021, outcome "unknown", described as "I contracted dermatographia".  Additional information: Patient had COVID-19 vaccine in late Jun2021 and beginning early Jul2021 and contracted dermatographia. Patient was just seeing if anyone else had been experiencing these side effect.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Immunizations on 11/8/18. Mother noticed knot in leg 12/12/18, exam c/w subcutaneous fat necrosis on left thigh. No redness or warmth. Mother reassured. Seen 1/14/19 with abscess left anterior thigh. (Redness for past 2-3 days). Tx BACTRIM, U/S obtained 1/15/19 and 1/16/19 sent for I and D. I and D on 1/17/19. Scheduled for removal of drain on 1/23/19. Unsure if this is secondary to vaccine, but parents relate to it.