chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had shingles after the first covid vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced had shingles after the first covid vaccine on an unspecified date. On her second shot she had taken an unspecified antiviral medication as a prophylaxis and then she took her second shot and didn't have any reaction. She is scheduled for the third and she is wondering if it will interact with Repatha. She is wondering if it is safe to take with her third dose. They told her when she took the first, she went to the ER. They don't think it was related, they said it was because of the smallpox vaccine. She doesn't know if it was a coincidence it happened the same day. She went to the dermatologist and they told her to take the antiviral before the second covid shot and 7 days after. Patient stated that the COVAX US Support agent said the hives was one of the side effects. That is the only reason she brought up if shingles is one the side effects. Event resulted to visit emergency room. The outcome of the event was reported as unknown.   Follow-up attempts are completed. No further information expected.
Funny taste in mouth, then tongue and lips started tingling and feeling weird like when Novocain wears off at the dentist. Took Benadryl which solved the problem. Very tired and sore arm.
Information has been received from a physician concerning a 32 month old patient who was vaccinated with a dose of varicella virus vaccine live.  On 01/30/1997 the patient experienced a case of breakthrough varicella.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.
Patient came in for MD visit 4/8/2009, with complaint of on and off neck pain.  Patient and pt's mother feels pain started after HPV vaccines, HPV vaccine series given 5/17/2007, 8/31/2007 and 1/17/2008.  Neck pain reported first on 12/22/2007 MD visit, stated neck pain for 4 months.  5/26/09 Medical records received DOS 2/3/07 to 5/7/09. Seen 9/21/07 for c/o sharp LLQ pain. Assess:  Abd pain.  Seen 12/22/07 for c/o several month hx of neck pain. Tight traps on PE.  MIP joint tenderness noted. DX:  Cervicalgia.  R arm numbness/tingling noted 12/31/07.  Neck pain continues through 4/2009. Post vaccination: Eczema, deltoid muscle pain, torticollis, neck pain, runny nose, rash lower extremities and right arm / hand, decreased hearing, back pain, myopia, hallux valgus,
p/vax pt w/diarrhea, fatigue, general body pain, frequent urination, t99;called MD & advised to report sx to hlth dept;
Swollen, red and hot left arm. Ongoing as of 11/05/23. Left lip and left side of face swollen and numb on 11/02 to 11/03 2023
Flaccid, cyanotic, semi-responsive to stimuli 5 hrs p/immun; adm to ped ICU; CT scan brain; nl; LP neg; lab studies nl; condition improving next AM;
1st 15-30 mins - dyspnea, dysphagia, numbness and tingling of hands and feet. Tx: 50 mg Benadryl, 0.5 mg epinephius - Sx's improved, but persistent paresthesias and weakness 72 hrs later.
5 days after second shot soreness in left arm persisted in muscle where given , daily for ten days straight. Then subsided for four out of seven days, then pain in arm started flaring up thoughout day intermitenlly throughout day as if i just got shot in arm. On third month i noticed pain transferring to left arm intermitenlly and right arm itermitenlly throughout week at work. Now pain tends to come and go in both arms simotaniously at periods of time lasting between one to four minutes at a time, approximately two to three times a day max. I liken the pain to a tetnus shot. Location of pain is excatly same spot in each arm ,which is the shot location of my vac series. To illistrate amount of pain during occurance
2 shingles vaccinations 7 months apart; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment:  The patient reported that he/she received both the Shingles vaccine 7 months apart. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule. Follow-up would not possible as no contact details were available.
Kidney Function dropped to 50% as of 4/19/21, diagnosed with Stage 3 Kidney disease; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old female patient received bnt162b2 via an unspecified route of administration, administered in right arm on 19Apr2021 (Lot Number: Er8735) as dose 2, single at the age of 37-year-old for covid-19 immunization. Historic vaccine was bnt162b2, via an unspecified route of administration, administered in right arm on 29Mar2021 (Lot Number: Er8734) as dose 1, single at the age of 37-year-old for covid-19 immunization. The patient was not pregnant. Medical history included graves disease (in remission) from an unknown date. The patient had not gotten period since 19Mar2021, even after taking medroxy progesterone prescribed by OB/GYN to start period. The patient had known allergies to adhesives, zolpidem tartrate (AMBIEN), and codeine. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lurasidone hydrochloride (LATUDA), aripiprazole (ABILIFY), lorazepam, eszopiclone (LUNESTA), and paracetamol (PA.), all taken for an unspecified indication, within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Kidney function dropped to 50% as of 19Apr2021, diagnosed with Stage 3 Kidney disease on 19Apr2021 (pending clarification). The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included renal disorder kidney function dropped to 50% as of 19Apr2021. The outcome of events was not recovered.; Sender's Comments: Based on currently known drug safety profile, the reported event more likely represented intercurrent illness, but not related to bnt162b2.  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 RAs, Ethics Committees, and investigators, as appropriate.
Stroke.  Treatment with blood thinner and anticoagulent.  Outcome is partial paralysis on right side of body, speech and language loss.
11 PM 8-3-11, Flu like s/s (? fever) (R) deltoid - size of silver dollar, red swollen area, needle mark noticed, 8/8/11 spoke via phone states s/s lasted 2 days, much better today, area at deltoid just pink.
Information has been received from a registered nurse referring to a 4 month old male patient with no drug reactions/allergies. The patient's medical history included respiratory syncytial virus infection. On 22-DEC-2015 the patient was vaccinated with a dose of ROTATEQ (oral, lot# L035636, expiration date: 21-MAY-2017, dose was unknown). There was no concomitant medication. On 27-DEC-2015 the patient began to have diarrhea and vomiting. On 28-DEC-2015 the patient was taken to the emergency room at an unspecified hospital and received an unspecified amount of an unspecified type of intravenous fluid and failed an oral challenge with PEDIALYTE. The patient then began to have increased vomiting and bloody diarrhea. The patient was admitted on 28-DEC-2015 to the unspecified hospital and had an ultrasound performed which found intussusception. The intussusception was reduced with an air enema. The patient was currently recovering. The causality was not reported. Additional information has been requested.
pt recv vax & 4 days post vax devel a big, red, round swollen rash @ the site of inj;this is one of two pt from this site to devel inj site rxn p/vax;
Vomiting multiple times  - over 20 mins  Alternating Chills/sweats, started about 14 hrs after vaccine administration
Pt recvd 3 doses of Engerix-B & failed to seroconvert;
PATIENT COMPLAINED OF CRAMPING FINGERS AND COULD NOT LIFT UP HER LEFT THUMB AFTER THE SAME DAY OF VACCINATION
Unknown of vaccine lot numbers as the vaccination was placed by an outside facility. Patient had vaccine Shingles and Pneumonia to placed in  right arm on 1/28/2020 at another facility. Today 1/29/2020 patient had a specialty appointment with foot doctor and asked for provider to see the right arm. Patient reported it is  warm to touch, sensitive to area and painful.
Patient given vaccine on 4/19/22 with a beyond use date of 4/14/2022. No adverse reaction was reported. Patient has not been re-vaccinated yet. She has been notified of error and asked to revaccinate per our consultation with Pfizer regarding temperature excursion.
entire family got flu shot a month ago. Right now, 3 of the 4 are sick as a dog, with the flu; Initial information received on 02-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics whose entire family got flu shot a month ago. right now, 3 of the 4 are sick as a dog, with the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the entire family got flu shot a month ago. right now, 3 of the 4 are sick as a dog, with the flu (vaccination failure) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Regulatory authorization  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (entire family got flu shot a month ago. Right now, 3 of the 4 are sick as a dog, with the flu).  At time of reporting, the outcome was Unknown for the event; Sender's Comments: Sanofi company comment dated on 10-Nov-2022:This case involves a patient of unknown demographics whose entire family got flu shot a month ago. right now, 3 of the 4 are sick as a dog, with the flu while receiving vaccine INFLUENZA VACCINE. Furthermore information regarding medical history, past medical treatment, vaccinations, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Rheumatoid arthritis flair on 3/3, Flu like symptoms and hands had lots of pain with joints feeling sticky, not wanting to open if closed and not wanting to close if opened. I had a Televisit on 4/2 with Doctor, participant sought advice about the rheumatoid arthritis flair. I was in extreme pain during this experience. Sunlight contributed to a lupus flair up too.  Kidneys were very tender during this time as well. There was a kidney infection in august 9 2022.
My mom is 78 years old, healthy and with no medical issues, no medications, exercises daily and has a well balanced healthy diet. She felt tired all day yesterday, 12 hours after 2nd dose of Moderna, had little appetite. In afternoon, she felt better and we went for walk. After an hour she felt lightheaded and could not take a step. She swirled for about 10 seconds and I brought her to ground. She never lost consciousness nor did not hit anything. I am a physician and her neurologic exam was normal with strength and sensations preserved, no deficits noted. The only concern was that her blood pressure was 150/70 and remains high until now although lower, 135/65. She has never have blood pressure issues and usually runs low. She also had a headache which has improved. She continues to eat and feels better today.
Resident uneventful evening/night. Ate breakfast, baseline status. Found by staff to be unresponsive at 0945 this AM, almost 25 hrs after vaccine administration. BP at that time 77/30, recheck 81/35. No respiratory distress, oxygen saturations WNL. Remianed afebrile. Over the next hour, she did open her eyes once, but remianed non responsive to staff. Daughter at bedside. Over the next few hours, slowly responding. Was awake and responsive, eating ice cream. PCP has been notified, ongoign onitoring to occur. Spoke to Physican associated with RCAT Care Center. She does infact feel this was an adverse/significant side effect of the vaccination as manifested thru extreme fatugue and exhaustion.
exhausted / Fatigue; she could hardly sleep; Mild sore throat; Headache; No energy; Myalgia; Arthralgia; This is a spontaneous report from a contactable physician. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 16Apr2021 at 18:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing asthma, attention deficit disorder, and depression. Concomitant medications included ongoing methylphenidate hydrochloride (CONCERTA) for attention deficit hyperactivity disorder and ongoing bupropion for depression. Family history included brother had Covid. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Apr2021, the patient developed headache (important medical event - IME), no energy (disability), myalgia (disability), arthralgia (IME), and mild sore throat. On 18Apr2021, she could hardly sleep and exhausted/fatigue (disability). The patient had no shortness of breath, even though she has asthma and it was not an anaphylactic reaction. The patient took TYLENOL for the events which helped somewhat but didn't relieve it fully. It resolved as time passed. The outcome of the events headache, no energy, myalgia, arthralgia, mild sore throat was recovered on 18Apr2021. The outcome of the events could hardly sleep and exhausted/fatigue was recovered in Apr2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine and known product safety profile, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE0 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.
Inc temp 105-106 3 days p/ 1st series of Immunizations admitted to hospital. Mom stated infant Rx w/ antipyretics and ATB
Bleeding for 30 seconds followed by swelling of injection site (5mm diameters). Bleeding stopped and swelling reduced in 15 minutes.
This spontaneous report was received from a nurse, referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 25-JAN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # M017983 expiration date 30-MAY-2018 (strength, dose and route were not provided) for prophylaxis. It was reported that, on an unspecified date, the vaccine was exposed to a temperature between 32 Fahrenheit degrees and 36 Fahrenheit degrees for 12 hours. The was no previous temperature excursion. No adverse effects were reported. The call was placed because of a Digital Data logger. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA007839.
Aluminum nano particle poisoning starting with Hep B shot on 04/19/2013 (Day 2 of birth) culminating with MMR vaccine on 04/18/2014 CUMULATIVE aluminum injected directly into blood through vaccines is close to 2 milligrams. Apart from that my child got over 20 times safe limits of ethyl mercury, polysorbate80, bovine serum, foreign pig DNA, LACTOSE. Lost eye contact, irritable, learning disabled Diagnosed with AUTISM. My child is non-verbal and needs lifelong care. Vaccines damaged my child. Doctors did not give us any help and attributed everything to AUTISM and only recommended therapies. My child suffered Aluminum and mercury poisoning due to giving too many vaccines too soon.
Note; Pt had her shingles vaccine yesterday. She is having a reaction pain all over her body, aches and pains, type of pain and she has a fever near the area where the shot was given. Her instructions on the paper work from pharmacy were to call the doctor if she had side effects.
4 x 5 cm hot red tender area on left thigh 3 days post vaccine
Seen at pediatricians office 6-27-07 for fever 102 that morning and redness at injection site -> left deltoid 1" over redness, right deltoid 3" area redness-returned to office 6-28-07 -> right deltoid with 7 cm area at redness with pinpoint pustule in center-incised and cultured drainage-started on Clindamycin
29MAY 24 hrs post vax pt devel nausea & vomitting; 30MAY next day pt exp vertigo in addtn to N&V; 31MAY uncontrollable tremors of the arms & legs occurred which caused the pt to be hospitalized on 1JUN-4JUN92;
This 75-year-old female relates she has not felt well since her H1N1 shot that was received on 12/11/2009. She started to feel fatigue and body aches the next day and somewhat chilled and sweats at times, but no fever. Starting the next week she was starting to have some temporal headaches and jaw aching and some throat aching in particularly the lymph nodes. She has not had and productive cough or shortness of breath. I was unable to see her Friday when she came in as a walk-in and she was seen by the physician assistant and started on cephalexin. That did not help her and she was seen Immediate Care on Sunday, the 20th. They mentioned TMJ and she saw her dentist yesterday who felt like that was unlikely. She continues with quite a bit headache. She takes TYLENOL.
On Dec 2nd the left side of my face lower parts of the chin begin to swell & my left eye begin to swell I went to the Doc. He thought I might had a strock but instead I got Bells palsy & blisters on my stomach. It took me about a month to get over this with predisone.
Arm is tender now; Pain in her arm was uncomfortable, bothered me for 10 days; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm is tender now) and VACCINATION SITE PAIN (Pain in her arm was uncomfortable, bothered me for 10 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.   No Medical History information was reported.  On 18-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Arm is tender now). an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in her arm was uncomfortable, bothered me for 10 days). The patient was treated with MENTHOL, METHYL SALICYLATE (SALONPAS [MENTHOL;METHYL SALICYLATE]) at an unspecified dose and frequency. At the time of the report, TENDERNESS (Arm is tender now) and VACCINATION SITE PAIN (Pain in her arm was uncomfortable, bothered me for 10 days) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The patient reported that she received the first dose of the Moderna COVID-19 vaccine on 18-Feb-2021 at 2:30PM, in her upper left arm. 11 hours later, her arm was quite sore. She described the pain in her arm to be very uncomfortable and bothered her for 10 days. She used a Salonpas patch tp help alleviate the discomfort. At this time, her arm is still tender. She does not take any other medications. She wanted to know whether Moderna advises on a specific needle size to use for the injection of the vaccine.
skin itchy, red, painful and "swollen to the size of a golfball." symptoms resolved on their own.
The pt received seasonal influenza IM right arm on 12/1/09 and H1N1 mist on 12/8/09 without immediate adverse reaction. The pt was healthy at the time of the vaccinations. On 12/20/09 the pt awoke and noted right lower facial weakness (drooping and the sensation of being stretched) and difficulty speaking which lasted several seconds. She reported having similar episodes each day, increasing in frequency (2-4 episodes/day) and continuing to last a few seconds. Beginning 12/23/09 the pt also noted right arm weakness and numbness associated with the facial symptoms. On 12/30/09 she noted that the episodes increased to about 6/7 per day and lasted 45-60 seconds. She was evaluated by a neurosurgeon who is a family friend. She was treated with anti-inflammatory medication and vitamin B complex IM (without improvement in the pt's symptoms). On 1/11/10 the pt experienced about 22 episodes of right sided facial weakness and right arm weakness. Additionally, the pt experienced facial pain (10/10). The pt was seen in the ER. Evaluation included a CT of the head and MRI of the brain (see below). The pt was evaluated by neurology on 1/12/10 and had a normal PE except for 1+ DTRs UE. EEG and LP performed (see below). IV SOLU-MEDROL 1gm qd for 3 days initiated without impact on the pt's symptoms. Per neurology on 1/21/10: "The MRI is more suggestive of MS than ADEM/post vaccinial encephalomyelitis considering the involvement of the corpus callosum as well as the presence of other nonenhancing lesions and overall mild symptomatology. The lack of possible presenting symptom of the underlying demyelinating disorder." Rebif initiated on 1/25/10. Pt had resolution of facial and arm symptoms within 2 weeks. Symptoms: disturbance of skin sensation, symptom, facial weakness, disturbance, speech NEC, paralysis, transient, limb.