chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I that noticed my son shaking like he was shivering but he wasn't cold.(tremors) I overlooked it at first and convinced myself that he was doing it on purpose until I noticed him, doing it while he slept. I reported it to his pediatrician and went in for blood work. I also brought him to a naturopathic doctor who treated him. The tremors have stopped since he has been on a detox regimen.
Chills, fever, headache, fatigue. Muscle weakness and eye pain within 24 hours  Continued headache with fatigue and eye pain. New symptoms include back pain, dizziness, Numbing and tingling of arms, legs, and faces within 72 hours
COVID arm, red splotchy rash around injection sight about 3 inches, hard at first and warm to touch
Received seasonal Influenza shot in the LEFT arm - no specific information available at time of this report.  Pneumovax  was injected into my right upper arm. Was unable to lift the right arm. Experienced serve pain / discomfort / bodily chills from approx 7:30 pm through the night and into the next morning. During Friday (Oct 2nd)  pain in right arm and during right arm movement continued at time of this report.
Guillain-Barre syndrome; This is a spontaneous report from a contactable physician based on information received by Pfizer from Amgen, manufacturer control number US-AMGEN-USASP2021163339, license party for etanercept (ENBREL). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via unspecified route of administration as dose number unknown, single on an unspecified date for covid-19 immunisation. Co-suspect medication included etanercept (ENBREL), via unspecified route of administration and dose from an unspecified date to an unspecified date for an unspecified indication. No historical medical condition was reported. No current medical condition was reported. No concomitant medications were provided. The patient began Enbrel on an unknown date. On an unknown date, the patient was taking Enbrel and took the Coronavirus disease 2019 (COVID-19) vaccine which was mandated by the company. The patient received the COVID-19 vaccine while on Enbrel and developed Guillain-Barre syndrome. Subsequently, the patient had been taken off Enbrel by the physician on unspecified date. No treatment information was received. Action taken with Enbrel was withdrawn for the event Guillain-Barre syndrome. The causal relationship between the event Guillain-Barre syndrome and Enbrel was not provided by the physician. At the time of this report, the outcome of event was unknown. Amgen comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.; Sender's Comments: Based on the limited information provided the causal association between the event Guillain barre syndrome and the suspected drugs BNT162B2 and Enbrel cannot be meaningfully assessed and excluded. Case will be reassessed if any new information is available. 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.
Fever; cough; muscle aches; headaches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 07Apr2021 at 09:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included overweight, high blood pressure and chronic breathing issues from COVID-19. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), telmisartan (MANUFACTURER UNKNOWN) 80 mg and multivitamin (MANUFACTURER UNKNOWN). The patient is not allergic to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had COVID-19 in Dec2020 or Jan2021. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 12:00, the patient felt a mild version of how she felt during her month with COVID-19 and experienced fever, cough, muscle aches, headaches and fatigue. 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. The clinical outcome of the events fever, cough, muscle aches, headaches and fatigue was resolving at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Large local reaction on R ant. thigh, Tx 11 1/2 cm. some? warmth to touch, some pain, but no bruising.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2012 (reported as on or about 2012), the patient was inoculated with ZOSTAVAX by a pharmacist to obtain permanent prevention and protection against shingles and zoster-related conditions (dose, route, lot # and expiry date not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 03-DEC-2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, injuries, pain and suffering (emotional distress) and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
Information has been received from a 32 year old female who in 1980 was vaccinated with 2 doses of MMR II at age 2 and at age 28 (in 2006), had a negative antibody titer to measles, mumps, and rubella. The patient sought unspecified medical attention. At the time of report the patient had not recovered. No further information is available.
bad sore throat; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "bad sore throat"; RHINORRHOEA (non-serious) with onset Mar2021, outcome "not recovered", described as "runny nose".  Additional information: Patient was scheduled to receive the second dose tomorrow, 23Mar2021 but she developed a bad sore throat and runny nose. Patient was asking whether she should proceed with the second dose as scheduled.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upset stomach and headache 2 days post vaccine. Evolved to diarrhea  and throwing up 3 times on the 4th day post-vaccine. Resolved 6 days post-vaccine.
At 1:30 pm started having wheals and urticaria. Treating with Benadryl.  Vaccine paperwork is incorrect. Shows HiB,  Pneumoconjugate,  and Rotavirus (unknown trade names) given on 07/07/2020 when the vaccines were administered on 07/09/2020.
Pt state 2 days after he received the H1N1 vaccine he began to break out in a rash. The rash is on his trunk and legs/feet. There are visible areas of redness noted but the areas look to be drying up-01/12/10. The pt saw an MD on "1/12/10" and was told to take Allergy relief medication.
Aug 2013: Experienced Complete Blindness w/ Exertion. Chest pain/Tachycardia/Dyspnea/High Blood Pressure/Headaches/Extreme heart Burn/Difficulty concentrating/focusing. March 2014: Symptoms worsened to include extreme fatigue, dyspnea progressed to having to rest after minor exertion. IBS potentiality. Vit D deficiency. Found melloadrenal hyperfunction. MIBG scan shows holding of adrenaline in kidneys. Anxiety. Put on Metoprolol 100mg for Heart Rate/BP. Zantac and Prilosec for heart burn (Hiatal Hernia found). 50,000U cap of D2 for Vit D deficiency. Tried multiple anxiety medications to no prevail. Nov 2014: MEB started. No overall diagnosis. MEB package states "Inappropriate Tachycardia/ Melloadrenal Hyperfunction/ Idiopathic Blindness" as diagnosis' found within Dec 2013-Nov 2014. All listed as Chronic conditions.
This patient received Tetanus Diphtheria 11:30 AM on 03/08/01. She took a nap, on awakening she noticed welts all over her body, that were itchy.
PT. stated she was hot and may pass out while she was receiving the vaccine. PT. moved to private Treatment area via wheelchair. PT. monitored for 30 mins. with vitals and history obtained. PT. Stated she felt better after approx. 5 mins. Color had returned. After 30 mins. pt released and advised to call 911 w/any further problems.
She mentioned that they have a vaccine for more than 14 hours.; She mentioned that they have a vaccine for more than 14 hours.; small red bump on injection site; Booster; This is a spontaneous report received from contactable reporter(s) (Pharmacist) for a Pfizer sponsored program.  A 38-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Oct2021 11:18 (Lot number: 032F21A) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation; Bnt162b2 (Second dose), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 31Oct2021 11:18, outcome "unknown", described as "Booster"; PRODUCT STORAGE ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "She mentioned that they have a vaccine for more than 14 hours."; INJECTION SITE ERYTHEMA (non-serious) with onset 02Nov2021, outcome "unknown", described as "small red bump on injection site". It was unknown if therapeutic measures were taken as a result of injection site erythema.  Follow-up attempts completed. No further information expected.
Muscle twitching every 3-5 minutes. Started in the deltoid (injection site) then moved into my bicep, where it is predominantly. However, within the last week it has moved to my entire body.
Fatigue, headache, breathing problems, tingling in throat causing nose stuffiness and chest congestion simultaneously.
I was diagnosed with COVID-19 on 1-19-2022. Three weeks prior to be tested I came down with strep throat. I got better from that and a week later I got sick again. I had mucus, congestion, and cough. It felt different from sinus infection and the strep throat, so I called my PCP. He tested me for COVID-19 and it came back positive. I did not get tested though when I had the strep throat. I am still coughing, but I did get a negative test result this week.
have bruising in the inside of the not at the site of my shot arm since last night; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 23Mar2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 25Mar2021, the patient experienced have bruising in the inside of the not at the site of my shot arm since last night. Patient asked is it is a side effect and could not find anything online about it. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient reported constant itchiness under the armpit.
Pt recvd vax & exp exhaustion, generalized aching, skin felt hot to touch;
Mother notice redness 24 hr after injection ambulating with difficulty. Did not c/o pain. Mom notice swelling 48 hr later. Has not applied any med or warm or cold packs.
Headache; Chills; Lightheaded; Nausea; Vomiting; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 12:45(at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medication included birth control (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 13:30(at the age of 26-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 02:00, the patient experienced headache, chills, lightheaded, nausea, vomiting and body aches. Therapeutic measures were not taken as a result of adverse events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, chills, lightheaded, nausea, vomiting and body aches was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
10 days following shot I developed over the next few days (now day 3 or 4) a growing red rash with darker red bumps in it, very itchy the size of a navel orange.  I put topical Benadryl on it and it is less itchy after thatt.
Body aches over total body Fever:  100.9 Nausea and vomiting  Headache Sore left arm
02/01/21  Patient called and states that she had low blood pressure and fatigue for 3 days approximately 6 days after she received the COVID Vaccine.  She states that on approximately 01/20/21 she started to have a "tingling" or "pin prick" sensation in her back.  The sensation has continued to happen at different times and in different places on her back, gluteus area, arms, and legs.  I recommended that she speak with her private physician about her symptoms and also whether she should receive the 2nd dose of COVID Vaccine.  CA/RN
This spontaneous report was received from a Licensed Practical Nurse refers to a 47 years old female patient. The patient's medical history and concurrent conditions were not reported. On 13-JUN-2o16 at 12:45, the patient was vaccinated with a dose of improperly stored VARIVAX subcutaneous, lot number L025210, expiration date 07-JUL-2017 (anatomical location and dose were not reported). It was reported that freezer was out of range for 4  hours, lowest temperature was 18 degree on 13-JUN-2015. The patient was notified to come back for Varicella titers and blood tests. Concomitant therapies were not reported. No adverse effect was reported. This is the one of several reports from the same reporter source. Additional information has been requested.
One day after receiving the vaccine, injection site became very erythematous, indurated, swollen, painful and remained so for a week. Still hasn't completely resolved. Have not tried any treatments, just letting it resolve on its own. I am concerned that because I was covid positive less than 90 days ago that is why I had this reaction. Never reacted this way to a vaccine before.
administration of Infanrix to an 11 y/o patient instead of Boostrix; administration of Infanrix to an 11 y/o patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 28-JUL-2023, the patient received Infanrix. On 28-JUL-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: administration of Infanrix to an 11 y/o patient instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: administration of Infanrix to an 11 y/o patient).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-SEP-2023 The reporter was a medical assistant. The reporter reported the administration of Infanrix to an 11-year-old patient instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Right thigh swollen, noticeably bigger than left thigh to knee. No redness or warmth at site, right thigh is slightly warmer than left. No fever, mild discomfort (mother reports "it isn't slowing him down). Seen by physician's assistant on 6/14/00. No treatment ordered. Family to contact doctor if swelling increases. Too early to know if recovered yet.
Muscular pain in right arm injection site continued for several weeks and is ongoing. I saw my primary care physician today (06/04/2021) who explained that muscular injury may be the adverse reaction. She recommended  physical therapy  and if that does not help possible steroid injections.
Initially just hives on left cheek after waking from nap.  Hot skin in area of flu shot injection. Motrin administered. Over next hour hives slowly started spreading to other parts of body as itching sensation increased. Administer Zyrtec while waiting on Dr call back at 07:02 pm.
Developed rash on left hand and on lower legs. C/o respiratory symptoms. EMS was called and patient was brought to ER where she was evaluated and discharged with diagnosis of "thrush".
Information has been received from a registered nurse concerning an 8 year old healthy female with no known allergies and no past medical history who on 08/15/1997 was vaccinated subcutaneously in the right arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot#622750/0545E).  There was no illness at the time of vaccination.  On 04/30/2004 the patient presented with 20-25 "insect like bites" on her neck, back, chest, and upper extremities.  The patient was afebrile.  The patient was treated with calamine lotion and diphenhydramine hydrochloride.  No other information was available.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information received from a nurse practitioner indicated that on 04/30/2004, the patient developed 20-25 lesions and a maculopapular rash on her neck, back, chest, and upper extremities.  The outcome was reported as recovered. No further information is expected.
Swollen lymph nodes, left and right sides. Patient complaining of "knot in throat".
Pfizer COVID shot 1st dose on 8/23.  Acute MI and VF arrest on 8/24 - defibrillated x2.  Drug eluding stent x1 to left anterior descending artery that was 99% occluded.  Patient awake, alert, but forgetful.  Currently resting in Cardiac ICU at local Hospital.
Severe vomiting (10/13 & 10/14), moderate fever, chills, and joint ache/discomfort for about 30 hours - too sick to go get treatment - I waited it out.  Never had flu-like symptoms in my life and had them <2 hours after shot.  Previous years' flu shots have not caused any reaction.
Initial feeling when you get a shot; Diarrhea; Weird taste after the dose; Following the second dose had a sore arm which was just sort of starting/Arm soreness; Low grade fever of range between 100.5 to 102 degrees Fahrenheit; After it had been punctured >24 hours ago/Administered expired vaccine dose after it had been; Room Temperature and never went back in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Following the second dose had a sore arm which was just sort of starting/Arm soreness), VACCINATION COMPLICATION (Initial feeling when you get a shot), DIARRHOEA (Diarrhea), TASTE DISORDER (Weird taste after the dose) and PYREXIA (Low grade fever of range between 100.5 to 102 degrees Fahrenheit) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anaphylaxis.On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 05-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After it had been punctured >24 hours ago/Administered expired vaccine dose after it had been) and PRODUCT STORAGE ERROR (Room Temperature and never went back in the fridge). On 06-Nov-2021, the patient experienced PAIN IN EXTREMITY (Following the second dose had a sore arm which was just sort of starting/Arm soreness), TASTE DISORDER (Weird taste after the dose) and PYREXIA (Low grade fever of range between 100.5 to 102 degrees Fahrenheit). On an unknown date, the patient experienced VACCINATION COMPLICATION (Initial feeling when you get a shot) and DIARRHOEA (Diarrhea). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (After it had been punctured >24 hours ago/Administered expired vaccine dose after it had been) and PRODUCT STORAGE ERROR (Room Temperature and never went back in the fridge) had resolved. At the time of the report, PAIN IN EXTREMITY (Following the second dose had a sore arm which was just sort of starting/Arm soreness) had not resolved, VACCINATION COMPLICATION (Initial feeling when you get a shot), DIARRHOEA (Diarrhea) and TASTE DISORDER (Weird taste after the dose) outcome was unknown and PYREXIA (Low grade fever of range between 100.5 to 102 degrees Fahrenheit) was resolving.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 06-Nov-2021, Body temperature: 100.5 to 102 (High) 100.5 to 102 Degree Fahrenheit. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.This case was linked to MOD-2021-377155 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 09-Nov-2021: Significant follow up received on 09 Nov 2021. New events were added upon receipt of follow up.