chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Reaction) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Reaction). At the time of the report, ADVERSE REACTION (Reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Reaction) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Reaction). At the time of the report, ADVERSE REACTION (Reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Pungent malodor deep in sinus cavity starting on 7/12/2022 evening, until 7/14/22 early afternoon. Became less pungent starting 7/15/2022. Trailed off to just a faint smell every once and awhile while eating or drinking. Still occurring as of 8/24/2022.
This case was reported by a consumer via patient support programs and described the occurrence of nausea in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease (started from 20 years before the time of reporting). Concomitant products included fluticasone propionate, salmeterol xinafoate (Advair Diskus). In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. In October 2018, less than a month after receiving Influenza vaccine Quadrivalent 2018-2019 season and an unknown time after starting Advair Diskus, the patient experienced nausea, pain, fatigue, fever, influenza-like symptoms and diarrhoea. On an unknown date, the outcome of the nausea, pain, fatigue, fever, influenza-like symptoms and diarrhoea were unknown. It was unknown if the reporter considered the nausea, pain, fatigue, fever, influenza-like symptoms and diarrhoea to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: This case was received from a consumer via the vaccine patient assistance program. The age at vaccination was reported. The patient started Advair Diskus 20 years before the time of reporting. The last week before the reporting date the patient received the Flu shot and started experiencing flu like symptoms of nausea, soreness, fatigue, fever and diarrhea.
On 10/27/00, had a fever. Fever stopped on 10/29/00 and he broke out in a rash. No treatment needed.
developed Covid.; developed Covid.; terrible sore throat; stuffy nose; sinus pain; aches; fatigue; still had an annoying cough.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 59 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "developed Covid."; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "terrible sore throat"; NASAL DISCOMFORT (non-serious), outcome "unknown", described as "stuffy nose"; SINUS PAIN (non-serious), outcome "unknown", described as "sinus pain"; PAIN (non-serious), outcome "unknown", described as "aches"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; COUGH (non-serious), outcome "unknown", described as "still had an annoying cough.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. He did not have to go to the hospital, but suffered and tested positive for 10 days. After 3 weeks, he still had an annoying cough.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I contracted COVID-19 on 06/22/2022 with symptoms of headache, congestion, fatigue, myalgia, sore throat, fever, cough, chest tightness, brain fog, and diarrhea. I was prescribed a Z-pack, and Prednisone. My symptoms have begun to resolve, but I am not fully recovered as of yet.
Painful injection. Arm immediately went numb. 15 mins later feeling restored. 6 hours later got chills fever muscle aches frequent urination twitching from muscle spasms. Face felt like it was on fire,  sweating, headache however body pain was so so bad. My heart rate stayed around 128-130 bpm for 6 hours. Tight chest heard to breathe
The site of the shot is warm, reddish, a little swollen and hard to the touch. And is still tended when touched.
Painful leg at injection site with slight swelling - nausea/vomiting, chest discomfort with racing heart, left arm pain symptoms started evening of injection day and subsided 36 hrs later.
p/recv vax pt exp arm swelling; warmth & a fluid sac in inj arm;
Blotch on her arm that was orange pinkish; A Spontaneous case was received from consumer, concerning a female patient and age 77, who received Moderna's COVID-19 vaccine experienced Vaccination site rash/ Blotch on her arm that was orange pinkish .  The patient had a medical history of cancer. The Patient's concomitant medications were cancer medications  On 25Jan2021 , prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number : 030L20A) via unspecified route for COVID-19 infection prophylaxis.  On 09Feb2021, she noticed a blotch on her arm that was orange pinkish looking on the injection site..  The action taken in response to the events, Vaccination site rash was unknown .  The outcome of the event Vaccination site rash was considered to be unknown.  No treatment medications were reported to be taken by the patient.
Developed swelling down upper arm. Approximately 2.5 inch by 6 inch area.
lips started swelling; can hardly talk; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on Apr2021 as a single dose for COVID-19 immunization.  Medical history included lip fillers, anxiety and depression all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient had no known allergies. Concomitant medications  included escitalopram oxalate (LEXAPRO); quetiapine fumarate (SEROQUEL) and spironolactone (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 27Apr2021, at 08:00 about 2 1/2 weeks the patient's first dose, her lips started swelling. They are now so swollen that the patient can hardly talk and was now going to urgent care. The patient received prednisone injection as treatment for the events. The events resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. The event were reported as non-serious. The patient recevied the second dose of bnt162b2 on Apr2021 on the left arm for COVID-19 immunization.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Lip swelling and speech disorder cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On unknown dates the patient was vaccinated with each of the 3 doses of GARDASIL. Lot # and administration route were unspecified. After the 1st GARDASIL injection, the patient experienced fainting and a metallic feeling in the mouth. After the 2nd GARDASIL injection, there were no adverse effects. After the 3rd GARDASIL injection, the patient experienced headache and a metallic feeling in the mouth. The adverse effects occurred on the same day that the respective GARDASIL injection was given, and the patient quickly recovered that same day that the adverse effect started. The patient did not seek medical attention. Additional information has been requested.
Client already received 2 doses of Sputnik vaccine on 2/24/21 and 3/18/21. Client received first of Moderna series, based on CDC guidelines.
Throat swelling, shortness of breath, light headedness.  Occured approximately 15 minutes after shot.  Contacted pharmacist, who referred to Emergency Room.  Emergency Room Doctor prescribed antihistamine and steroid via IV line.   Prescribed  Benadryl and Prednisone for 3 days.
Pt accidentally received bivalent pfizer vaccine as his first dose series.  Patient was panicking before I administered the vaccine and wanted to grab the vaccine card and not receiving the actual shot. I refused to do that and explained that the vaccine has more benefits than side effects. At the pharmacy we confirmed with patient that he is receiving his booster bivalent vaccine and he acknowledged that with us. After Patient was administered the booster he stated that he never received his first or second series.
This case was reported by a consumer via sales rep and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, sickness and fever. In April 2018, the outcome of the sickness and fever were recovered/resolved. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles, sickness and fever to be related to SHINGRIX. Additional details were reported as follows: The patient was sick with fever for 3 days, then on the 4th day after vaccination, the patient broke out with shingles. The patient requested to help and asked what was happening to her. The patient stated that she had no insurance and paid over 300 dollars out of pocket and she was a senior citizen. The patient asked, if it would not going to help, and obviously made things worse, then she would like to get refund. The patient had send the receipts from the vaccines given by the pharmacy. For tolerance to next dose, refer case US2018GSK143781.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX lot # L028283 (expiry date: 28-OCT-2016) (route and site of administration not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at 42F for a time frame of 10.5 hours and administered to the patients (incorrect product storage). Previous temperature excursion was reported to be 40F for 9 hours. It was also mentioned that the call was not a result of "data logger". No adverse effects reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the two reports received from the same reporter.
Fever to 103.4, malaise,weakness; treatment tylenol supportive care, O2 to 3L
Pt reported is currently being treated for a staph infection in the injection arm. was started on bactrim ds 08/03/21
Incorrect vaccine administered, patient planned on receiving Meningitis A vaccine. Patient completed MMR series in past. No adverse outcome, medication error.
Swelling of Lt. upper arm with redness moving from injection site down arm, several inches below elbow. Painful, hot, red, shiny, fever and malaise. Required antibiotics (KEFLEX).
Following covid 19 vaccine client reported sweating with obvious pallor.  He was cold and clammy.  He was unresponsive prior for approximately 30 seconds with mild seizure activity with spontaneous movement of eyes with jerking.  He was monitored by EMS and evaluated by a Dr.  His car seat was reclined, no Epi pen given .  Blood Pressure was 82/48 initially with pulse 65 and RR 12.  He was transported to EMS vehicle on site and monitored then released home.  He was advised to follow up with ER for further treatment if needed.
Child became anxious and stated not feeling well around 12 a.m on 2/25/11. Around 1:00 a.m. started hallucinating seeing people who were not there, snakes and lizards crawling on her and biting her, screaming and crying lasted approximately 10 hrs. On 2/27/11 right arm became red with rash to upper arm and warm to touch.
Breakthrough case admission after 3 vaccines Pfizer 2/24/21 lot# EL9267;  Pfizer 3/17/21 lot# EN6205;  Pfizer 12/20/21 lot# 33130BA
I had COVID Nov 2020, vaccine recreated all the same symptoms,  but in a reduced manor and timeliness, over 4 days, severe migraines, chills, difficulty breathing, muscle and joint aches, congestion in lungs,  diarrhea, and runny nose.
Rash at injection sit, 25 mg PO Benadryl given. Rash began resolving.
Information has been received from a physician concerning a 4 year old male who on an unspecified date was vaccinated with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 659428/1589U). Concomitant vaccination included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), poliovirus vaccine and measles-mumps-rubella vaccine (manufacturer unspecified). After receiving the dose of varicella virus vaccine live (Oka/Merck) on 14-FEB-2008, the patient developed redness, itching and a slight rash around the injection site. There were no laboratory or diagnostic studies performed. On an unspecified date, the patient had recovered. A product complaint was not reported. Additional information has been requested.
3wk p/vax pt presented w/petechial rash & thrombocytopenia;pt recv IVIG w/normalization of platelet count;
Information has been received from a pharmacist referring to a 38 year old female patient. No relevant medical history or concurrent conditions were reported. On 31-AUG-2015 (reported as 256 days ago), the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). The reporter stated that, according to an unspecified doctor, the titers were not significantly increased (antibody test negative) (event onset date was not reported). The outcome of the event antibody test negative was not reported. Causality between antibody test negative and PNEUMOVAX 23 was not reported. Additional information has been requested.
L arm above elbow 13 cm vertical x 18 cm circumference erythema, warm to the touch, mild swelling.
Information has been received from a doctor of pharmacy concerning a 33 month old male patient with sickle cell anemia who on 04/22/2003 was vaccinated in the thigh with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M).  Subsequently on approximately 04/22/2003, the patient developed pain in the same leg that was vaccinated.  The patient did not want the leg touched and he was not bearing any weight on that leg.  The pain was "not sickle hurt". Unspecified medical attention was sought, but no treatment was given.  The reporter also mentioned three other patients that had adverse experiences post vaccination with pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M) (WAES # 0304USA02307, 0304USA02519, 0304USA02520).  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
Patient received the vaccine at pharmacy 11/2/18. Came to office 11/5/18 with rash over back, abdomen and chest. Began taking BENADRYL- was seen in office again 11/12/18 and prescribed prednisone. Provider feels it was likely allergic reaction- patient had history of egg allergy now resolved. Parent requested VAERS be completed.
The next day I woke up with severe muscular pain and joint pain, fever of 100 degrees, dizziness, headache, appetite loss. Took 2 Tylenol and it improved. 6 hours later I took another 2 Tylenol because the headache came back strong. I sleep a couple of times during the day, and also slept well during the night. The next day felt a little bit better but still in bed, but was able to eat better. The next day went to the Dr. and he prescribed me Meloxicam and 6 hour later Tylenol, after that is getting better.
received 1st dose of covid vaccine and 7 - 10 days later tested positive for covid virus.; received 1st dose of covid vaccine and 7 - 10 days later tested positive for covid virus.; This spontaneous report from a Pfizer-sponsored program  from a contactable pharmacist.  patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via unspecified route of administration, on unknown date, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date after the vaccination 7-10days later, the patient tested positive for COVID virus. The reporter wanted to know when the patient can receive 2nd dose of vaccination. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product Comirnaty to the reported 'COVID 19' cannot be completely excluded
"Black and blue'; Muscles spasms; "my neck ,legs, i feel pangs and my head"; "my neck ,legs, I feel pangs"; "my neck ,legs, I feel pangs"; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 27Apr2021 at 10:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS).Concomitant medication was not reported. 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. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 RNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 06Apr2021 at 10:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 03May2021, the patient reported black and blue and her neck, legs, she felt pangs and her head and muscles spasms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events "black and blue" and "neck, legs, she felt pangs and her head" and muscles spasms were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
PROQUAD vaccine was administered to 13 year old child, appropriate age was suppose to be at 12 years of age. Prior to administering vaccine, I asked the age, mother stated that she is 12 years old. Later I checked the medical record and discovered patient is actually 13 years of age. Action plan repeat MMR and Varicella vaccine administration as separate doses.
Last month my heart was racing from the time I went to bed until I woke up. This has been going on since I took my 2nd vaccine. All of them were Moderna. I went to a cardiologist but he cleared me that I am fine, however I randomly get these sporadic heart rate increases, a fib, for no reason. I been to the ER sometimes and given me medications to bring it down, and I was even admitted for observation for 1 night. I am still on the medication now, its called diltiazem 24 ER CD 180mg and a blood thinner. This problem has been constant since my vaccines last year. I have no idea if this is vaccine related or not, I do need to watch my blood pressure.
BILATERAL UNDERARM LYMPH NODE SWELLING; TIREDNESS; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, penicillin allergy, non alcohol user, and non smoker. The patient was not pregnant at the time of reporting. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin, and levofloxacin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injection site swelling. On 10-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced bilateral underarm lymph node swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and injection site swelling, and had not recovered from bilateral underarm lymph node swelling. This report was non-serious.
PT RECEIVED PCV23 AND INFLUENZA ON R ARM PER PT REQUEST SECONDARY TO LEFT ARM "NERVE ISSUES AND PAIN".  24 AFTER ADM. PT CC: BODY ACHES, N/V, PAIN.  PT CAME TO HEALTH CENTER AND ASSESSED BY NP-FINDING INCLUDED ERYTHEMA, PAIN RADIATED TO NECK AS WELL.  AREA RED SWOLLEN (R DELTOID) PT UTILIZED ADVIL FEELING BETTER, +CMS.