chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had an allergic reaction to the first dose of the Moderna vaccine; anaphylaxis; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (had an allergic reaction to the first dose of the Moderna vaccine) and ANAPHYLACTIC REACTION (anaphylaxis) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (had an allergic reaction to the first dose of the Moderna vaccine) (seriousness criterion hospitalization) and ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criteria hospitalization and medically significant). At the time of the report, ALLERGY TO VACCINE (had an allergic reaction to the first dose of the Moderna vaccine) and ANAPHYLACTIC REACTION (anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported.  It was reported that, because of this anaphylaxis, the patient has been disqualified from taking the second dose of the vaccine. The patient's HCP recommended that patient receive the Pfizer vaccine for a second dose. The patient went to a vaccination clinic where they refused to give a dose of the Pfizer vaccine. The patient is concerned because she needs documentation showing 2 doses of vaccine to participate in school.  The patient does not want this reaction to prevent her from attending school. The patient has also followed up with her HCP after being declined by the vaccination provider who was steadfast in their recommendation to receive the second dose of the vaccine.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received which included updated narrative, seriousness criteria and treatment information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient was contacted on 2/28/22 about making an appt. for his second Shingrix vaccine.  He stated that approx. on 12/4/21 he started to experience leg pain, cramps and stiffness so severe that he had to visit the ER.
Vaccinee developed small red tender/painful spot under tongue on day 3 post-smallpox vaccination. Over next two days, lesion progressed from what was described as bubble like into an ulcer. Mouth lesion progressed much faster than vaccination site lesion.  Appearance and progression consistent with aphthous ulcer, although vaccinee did not report history of similar mouth lesions.   No fever. Mild "sinus congestion" reported. Brief episode of bilateral hand "puffiness" and knee discomfort which resolved in less than a day.  Aside from vaccination site, no other skin lesions. No history of skin disorders/eczema/atopic dermatitis.   Mouth lesion resolved by day 11. Vaccinee had documented major reaction. No other unusual symptoms reported.
Pt recvd vax 20OCT92 & 12 hrs following vax on 20OCT92 pt devel urticaria & pruritus; report indicated that the pt had recvd med @ work; pt had not been examined by MD;
I had swollen throat glands, sore throat, headache, cough, body aches, and serve fatigue. I also had brain fog. These lasted for about 10 days. The fatigue lasted for 3 weeks. I still have the coughing. I tested for Covid-19 on Jan 25th.
My adverse event started on 02/14/2023 in the morning. I had sore throat, exhaustion, dry mucus, and I  couldn't sleep. I lost my voice for few hours.  On  the 02/16/2023 I took 2 COVID-19 tests which were negative. I went to my doctor's office  on 02/17/2023 . My doctor gave me all kinds of tests such as RSV, STREP, FLU and COVID-19,  which were all  negative. My doctor said I don't need any medication . She advised me to drink fluids that has glucose and take rest. I recovered from the known virus without medication.
This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. Since 23-MAR-2016, the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L033697, expiration date-28-FEB-2017. No adverse event was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. Temperature was 30.09F for 6 hours. Previous temperature excursion was 47.2F for 2 hours 44 minutes. Temperature was not logged by data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Have swelling of an axillary lymph node; Fatigue; Muscle aches; This is a spontaneous report from a contactable consumer (patient). This report was received from a sales representative. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. The patient reported have swelling of an axillary lymph node, fatigue, and muscle aches following her second dose. These side effects lasted for several days and then fully resolved. The outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
21JUL92 9AM recvd 1st Engerix-B vax & that same day became feverish, achy w/general malaise, complete fatigue & joints were achy;
he had temperature; slight fever; chills; body ache/muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE (he had temperature), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body ache/muscle ache) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE (he had temperature), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body ache/muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE (he had temperature), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body ache/muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant drug was given to patient no treatment was received by the patient   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Followup received on 12-JUL-2021. It provides no new information.
No further AE details provided/ The patient did not experience medical adverse events because of temperature excursion; HCP called to report that a dose of PROQUAD was administered to a patient after a TE.; This spontaneous report has been received from a nurse, regarding a 5-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 22-MAY-2023, the vaccine freezer was open to allow for scraping ice from sides. The door was left open too long, a temperature excursion of 12.8 degrees Fahrenheit for 25 minutes occurred and was inaccurately reported to manufacturer. The temperature excursion did not occur as a result of a reading from a Data Logger.   On 20-JUN-2023, the patient was vaccinated with an improperly storage second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters once administered subcutaneously in the left arm (lot number W024552 was determined to be valid, with an expiration date on 31-JAN-2024) (strength was not reported), in combination with a sterile diluent; with the fourth dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (BOOSTRIX POLIO), administered intramuscularly in the right leg, lot number 5AY2J (dose, strength, formulation, and expiration date were not provided), both vaccines administered as prophylaxis (product storage error). The vaccines were administered by a healthcare professional and according to the instruction leaflet and it was not available for return/evaluation.   On 11-JUL-2023, the vaccine was properly reported to manufacturer and seemed safe for use. The patient did not experience medical adverse events because of temperature excursion. The vaccine was no longer in stock. There was a no previous temperature excursion reported.  This is one of four reports from the same reporter.; Sender's Comments:  US-009507513-2307USA002368: US-009507513-2307USA002433: US-009507513-2307USA002154:
Patient called 2 days after administration. She had onset of injection site reaction 24hours after flu vaccine administration. Advised to use cold compresses and BENADRYL (if appropriate).
Pt came into pharmacy 11AM on 9/3/16. Pt complained of pain in her injection arm. I notice some slight redness. I recommended: Ibuprofen, Diphenhydramine, and to go to ER if condition worsened. Pt came in 9/4 around 12 noon. They said they had gone to ER and the doctor treated the allergic reaction with dexamethasone, diphenhydramine, and ibuprofen. With instructions to come back if condition worsened. At the time the pt visited the pharmacy their injection arm was still somewhat swollen and red.
1/7 I started having breast pain. 1/8 I had a fever and chills, breast redness and diagnosed with Mastitis in my right breast.  I had severe fatigue and was prescribed a 7 day antibiotics and within 3-4 days I begin to feel back to normal. On 1/8 I had a COVID test which was negative.  My breast milk supply went down on the right breast until the mastitis was resolved.
Woke up at 7 am on 01/06/2021 and realized she had been scratching/itchy throughout her sleep.  She states her eyelids were swollen, her left hand was swollen and she had tingles in her left hand.
I get the shot which I'm allergic/ended up in the hospital with a severe reaction it was bad; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (reported as Covid vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated when she got the Covid vaccine she ended up in the hospital with a severe reaction it was bad, she was in the hospital now. The covid vaccine the way it was developed was using the H1N1 strand of virus and every time she called to get ingredients they show some but not all the components both Pfizer and Moderna they both don't show. Patient stated "My mom has severe dementia and my sister got sick with covid she was full time caregiver for my mom and my mom needs 24 hour care I went to all facilities and I won't be able to see my mother unless I get the shot which I'm allergic or she lives with me". The event outcome was unknown.  Information on the lot/batch number has been requested.
PT REPORTS DIZZINESS AND LIGHT HEADED. PT STATED THAT HE DID NOT EAT BEFORE COMING. CRACKERS AND COLD WATER WAS OFFERED AND PATIENT FELT BETTER AFTER 15MINUTES
Case number PHEH2014US025021, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 55-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Expired Dose of Heplisav-B was Given; Initial Report Received on 04-Aug-2021  A pharmacist  reported that a 27 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No medical history was reported other than an allergy to Bactrim.    No relevant concomitant medications were reported.  On 03-Aug-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933622, expiration date 01-Aug-2021, NDC # 43528000301, and serial number not provided). The route and site of injection were not provided. No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Red rash around the place where shot was given, firmness of area, no pain, but swelling and hot.  Second day  getting better.
Slight headache-no aching out of ordinary. 9/13/02 at 12:15am seizure, 3:15am seizure.
A few hours after getting my flu shot, I started to break out in a hive-like rash on my arms, chest, on my ears/head/face. Over the next few days, the rash went down but I still have itchiness on and around my ears and chest. I called my primary's office and the people on the phone said it was nothing to worry about, but I still have remnants of the rash almost 2 weeks later.
Within just a few minutes of receiving my first dose, I begant to feel nauseous. I sat down and began to have trouble breathing. My vision became splotchy and my ears plugged up. My chest began to hurt and my trouble breathing became worse, to the point of gasping for air. I was sweating a lot despite being indoors.  This lasted about 10 minutes.
Pt came to my office today for evaluation of itching and swelling around mouth starting 1 hour after getting her first dose of Pfizer Covid 19 vaccine.  She did not have hives but rather papules.  In the office her rash had resolved with the exception of mild erythema. She also complained of an itchy throat but had onset of rhinorrhea and sneezing yesterday.  She took benadryl yesterday which made no difference.  She had no cough, wheezing, difficulty breathing, hives, vomiting or diarrhea.
Site of Hib vaccine on lateral right thigh with large area (4 x 6cm) of induration and erythema with mild tenderness. No fever. No treatment except advice for application of warm compresses.
Pain in arm radiating to shoulder. Tingling in fingers. Pt reported to pharmacy to inquire treatment.
Intermittent internal vibration/Buzzingsensation in right lower leg (outer calfarea mainly, sometimes radiating upto knee); This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received single dose of BNT162B2 (Pfizer- BioNTech Covid-19 Vaccine, Solution for injection, Lot number: EL0140, exp date not reported), intramuscular (vaccine location: left arm) on 22Dec2020 20:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included rheumatoid arthritis and cancer wherein patient received radiation and chemo (patient was a cancer survivor 10 years post radiation and chemo). The patient was not pregnant. The patient had no known allergies. Concomitant medication (other medications in two weeks) included etanercept (ENBREL) and atorvastatin (LIPITOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced intermittent internal vibration/buzzing sensation in right lower leg (outer calf area mainly, sometimes radiating up to knee) beginning 31Dec2020 16:00 (4:00 pm), 01Jan2021, 02Jan2021, and 03Jan2021. Patient was also started feeling this sensation in left foot on 02Jan2021. Further stated that if feels like a massager was on her leg/foot.  No treatment was provided for the events. The reporter considered the events as non-serious. The patient did not have Covid prior vaccination. The patient was not Covid tested post vaccination. The outcome of the events was not recovered.
Patient has had several ED visits, including on 3/20/21, 3/21/21, 3/22/21, 3/25/21, 3/26/21, 3/27/21, 4/1/21, 4/4/21. On 4/6/21 patient was hospitalized for c5 cervical fracture. Patient had second vaccination on 4/14/21. Patient presented to the ED on 5/23/21 and was subsequently hospitalized for acute gallstone pancreatitis and acute hepatitis. These visits are all within 6 weeks of receiving COVID vaccination.
Patients right arm is swollen from deltoid down to 3/4 the biceps and it is red from the deltoid to the elbow and it's warm to the touch and puffy.  Patient states that it doesn't and there are no limitations in her mobility.
Unusually large amount of bleeding from fibroid tumors two months later.  I do have some bleeding, and for all we know this could just be related to the estrogen pills, but the bleeding was significantly heavier and lasted nearly 6 weeks.  Since limited menstrual related info is collected, and anecdotal evidence of odd periods was reported, this seemed worth sharing. It is not my job to decide what is relevant.  I talked to my dr, switched to a lower dose of the pill and will wait to see if there is a change for the better, and if not, I will have an appropriate procedure to stop this.
I had headaches, had a single event of lip swelling, upper lip. I had a cardiac issue, having PVC, pre-ventricular contractions.  I had work up done.  I had to get an IV of magnesium.   I still have those symptoms intermittently and I am being followed up with my cardiologist.
flu like symptoms, sore joints and body aches, welt at injection site, frozen shoulder, bursas on the elbow (water on the elbow for no reason), shoulder, arm and neck pain is still occurring.  Started seeing a physical therapist in October 2019
PT CALLED HEALTH PHARMACY REPORTING: RECIEVED VACCINE ON 4/29/21. SLEPT 18 HOURS AFTERWARDS. WOKE UP NEXT DAY WITH CONSTATNT HEADACHE. HAS CONTINUED THROUGHOUT ENTIRE TIME. IS RELIEVED SOME WITH TYLENOL THEN RETURNS. STILL HAS TODAY.
Patient started complaining of a sore throat and general body soreness approximately 12 hours after receiving MMR/V Vaccination. Acetaminophen has been administered on the appropriate time schedule to ease side effects. Patient is showing much improvement in symptoms approximately 24 hours after vaccination.
Patient's left arm became red and warm from her shoulder on down to her elbow. Patient had also had fever for approximately 3 days post injection. Patient was prescribed KEFLEX and received an injection of ROCEPHIN.
rash all over arm that looks like chicken pox; body ache; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over arm that looks like chicken pox), MYALGIA (body ache) and VOMITING (throwing up) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over arm that looks like chicken pox), MYALGIA (body ache) and VOMITING (throwing up). At the time of the report, RASH (rash all over arm that looks like chicken pox), MYALGIA (body ache) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
lt arm ached for a couple of days;it was very sensitive & sl swollen on upper arm;came down w/severe depression on 26OCT97;broke out w/hives on evening of 26OCT97;itchy;
Mother phoned on 3/1/00 stating pt had a red mosquito rash on posterior left thigh the day after vaccines. Rash progressed to anterior thigh and left arm. Rash still present on 3/1/00. Mother took pt to private MD on 2/29/00. MD dx as immunization reaction to HIB.
Redness, swelling to left arm injection sight starting on 8/15/21 - 2 days after injection
Tuesday am: I woke up the next morning after the shot, feeling fine. I went to have my hair done around 10am and then by 11am it hit me hard.    It began with vomiting and then I passed out.  The next thing I recall I was on my home couch around 8pm feeling very weak.  I'm told my husband came to get me.-      It wasn't until today, Saturday, that I am starting to feel somewhat better. Still a little weak, but able to take of myself.
he had fever and headache; he had fever and headache; This is a spontaneous report from a contactable consumer (patient's mother). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration, administered in left arm on 07Jun2021 at 11:00 (at the age of 14-years-old) as single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number unknown) administered in left arm on 17May2021 at 11:00 as single dose for COVID-19 immunization and did not had reaction to it. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and did not administer additional vaccines on the same date of the Pfizer suspect. On 08Jun2021, the patient experienced fever (at 14:00) and headache. The fever was resolved shortly thereafter and was not much of a concern. It has been 4 days and the headache still persists. The consumer described that the headache happened when he moved his head. When he sat down or laid down, it didn't hurt. The consumer gave him Tylenol. No other treatment given. The pain would go away then it and came back. She was very worried. She wanted to know if that was normal and what she should do about it. She did not know the patient's weight but reported that he was skinny. The patient did not have a doctor (primary healthcare provider). The adverse event did not require a visit to emergency room or physician office. There was no family medical history relevant to adverse event. The patient did not undergo relevant tests. The outcome of the event pyrexia was resolved and headache was not resolved.  Information on the lot/batch number has been requested.
When I went for a regular eye exam on 01/25/2022, the doctor saw that I had plaque in my retinal arteries. He told me I was a walking stroke risk and I had a telehealth appointment with my PCP on 01/26/2022. They wanted me to have a carotid ultrasound done and I had that done on 01/27/2022. I did blood work and an echocardiogram on 01/28/2022. I saw a Vascular surgeon on 01/31/2022 and I saw the cardiologist on 02/04/2022. The cardiologist put me on Crestor 5mg just in case, but there were no indications among any of the scans/tests that plaque was present in my heart. I will follow up with the cardiologist on 08/05 and I will have repeat bloodwork in July.
Rash, welts, itching noted 11/14/02 4pm. Went to physician 11/15/02-symptoms got worse after Decdron-relief with Benadryl. Went to ER 1pm 11/16/02. On Medrol dose pack.
At site of injection, developed a red raised/hard circle about 3 inches in diameter.  Warm to the touch and painful. Looks to be ?covid arm? . Also Experiencing loss of appetite, chills, low grade fever, body aches.