chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19 Breakthrough Case  I received my 1 booster shot on 11/06/2021. I  was confirmed COVID  positive on 01/09/2022. My reactions of the COVID  started on 01/05/2022.. It started  with a sore throat, it went  till 01/07/2022. then all of a sudden i started d to have a runny nose. it felt like bad allergies.  on the 01/09/2022 along with runny nose I  had a bad headache. I  wanted to find out if it was flu, sinus infection, or COVID . i tested positive for COVID. they gave me steroids' and z-pack . I took it for 7 days . then I started felling better.
severe fatigue since 12/01/2021 still ongoing,  swollen eyelids, itchy eyes, dry nose and throat, chills, skin dry and peeling especially eyelids and lips
Patient stated the day after recieving vaccine that arm was swollen, warm to touch and could not move arm at all.
Massive area of redness and induration measuring 9cm in diameter to right thigh. Center 7cm of the reaction area has dusky gray appearance. Child has severe pain and guarding of the entire area. Entire reaction area is very hot- much more than skin around the area of reaction. Injection site is centrally located in the area of reaction, with additional injection site on the lateral periphery of the ring. Injection sites on opposite (left) thigh are normal and no redness, swelling, heat, or skin color changes are noted. Child referred to emergency room for further treatment.
pt recv vax & w/in the first 1 1/2 hr p/vax pt broke out w/hives;no resp diff noted;
all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; headache; so tried; unable to sleep; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 on unspecified date for COVID-19 immunisation. It was reported that received her 2nd dose yesterday (22Jul2021), patient experienced all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy on 23Jul2021. It was reported that from night patient had been aching and she was wondering if she can Tylenol or Ibuprofen. because she got headache and ache. Reporter stated that she went back in her room, she needs to write a number down. she woke up and so tried, unable to sleep. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
tested positive for Covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (tested positive for Covid) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (Completed treatment).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) positive. On 20-Sep-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  It was reported patient was 73 and just completed treatment for breast cancer  This case concerns a 73-year-old patient of unknown gender with a relevant medical history of Breast cancer with recent treatment, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 5 months after the second dose of mRNA- 1273 vaccine, exact schedule of vaccination was not reported. SARS-Co-2 test was positive. Very limited information regarding clinical course was provided. After 17 days, SARS-CoV-2 test turned negative. The rechallenge is not applicable due to the nature of the event.  Patient´s age and Breast cancer may be confounders, since they could be risk factors for severe COVID-19. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 73-year-old patient of unknown gender with a relevant medical history of Breast cancer with recent treatment, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 5 months after the second dose of mRNA- 1273 vaccine, exact schedule of vaccination was not reported. SARS-Co-2 test was positive. Very limited information regarding clinical course was provided. After 17 days, SARS-CoV-2 test turned negative. The rechallenge is not applicable due to the nature of the event.  Patient´s age and Breast cancer may be confounders, since they could be risk factors for severe COVID-19. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
bump at the injection site; bump warm; bump is hard; bump itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (bump at the injection site), INJECTION SITE WARMTH (bump warm), MASS EXCISION (bump is hard) and RASH PRURITIC (bump itchy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE MASS (bump at the injection site), INJECTION SITE WARMTH (bump warm), MASS EXCISION (bump is hard) and RASH PRURITIC (bump itchy). At the time of the report, INJECTION SITE MASS (bump at the injection site), INJECTION SITE WARMTH (bump warm), MASS EXCISION (bump is hard) and RASH PRURITIC (bump itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: NNI TCR attached.
This is a spontaneous report from a Pfizer sponsored program Pfizer RXPathways. A contactable physician reported that a 79 years old patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. It's reported ''Diagnosis: Essential hypertension''. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Indigestion; gas; Loose stools; had my heart checked out after my first vaccine because it comes along with chest pain as well and that came back clear; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that after first shot developed digestion issue, indigestion, gas and loose stools and it took about 3 weeks to go away. Patient had heart checked out after first vaccine because it comes along with chest pain as well. Outcome of events was recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was given an amount of 0.3 mL of undiluted Pfizer vaccine. Patient was monitored for one hour, patient states he is feeling well. Patient verbalized understanding of possible increase side effects and reactions, verbalizing will go to the hospital if he is feeling worse. Patient states that he is feeling well before leaving the clinic.
Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, chills, fever of 100.2, injection site left arm throbbing, tired and weak,  slight headache and nausea.  Tired and weak, achy and slight headache when woke up on 3/18.  Still somewhat painful to take a deep breath and injection arm painful.  Tylenol 2 tablets at 8:30 am and 2:30pm on 3/18
Pt received 3 immunizations on 7/6/04. Site of injections on LL was red, swollen, hard and hot to touch. Viewed on 7/8/04 by RN
Suspected vaccination failure/Got the vaccine, still got shingles, vaccine doesn't prevent it; Shingles (horrible)/ still got shingles and they were horrible; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The case was received from the patient's children via interactive digital media. The patient got the vaccine and she still got shingles and they were horrible. The reporter stated that so the vaccine did not prevent them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Rash near groin, itchy, occurred 2 days after vaccination-patient things it is shingles.
This spontaneous report refers to a 77 year old female consumer reporting on herself with skin lymphoma and drug allergy to MACRODANTIN. The patient was vaccinated with ZOSTAVAX on 01-AUG-2012 (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included DIOVAN, spironolactone, ARIMIDEX, digoxin, CRESTOR, verapamil, warfarin, alprazolam, metronidazole and LAC LOTION. It was reported that on 03-AUG-2012, a large white pimple formed on the patient's chest that itched very bad after she received ZOSTAVAX. No treatment was given for the adverse events. On an unknown date, a sample of the pimple was taken for testing (results not provided). The patient sought medical attention, it was an office visit. The outcome of the large white pimple formed on the chest that itched very bad was reported as not recovered/not resolved. The relatedness for the large white pimple formed on the patient's chest that itched very bad was not reported for ZOSTAVAX. Additional information is not expected.
Severe pain in arm where shot was administered. Shooting pain going down arm whenever I try to move it. Five months later, the pain is still there.
This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 21-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports from the same reporter. Additional information has been requested.
Woke up after feeling very hot, entire body broke out into a sweat then got freezing cold (all within a 10 minute period), felt incredibly nauseous, blurry and darkened vision, hands were extremely shaky, then collapsed back asleep because I felt zapped of energy. Woke up three hours later and felt completely normal.
left leg has been bothering him since the injection; experienced one episode of vomiting/additional episode of vomiting today; given expired dose of ACTHIB (expiry date-01-Mar-2021); Initial information was received on 16-Mar-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a one-year-old male patient who experienced (limb discomfort) and one episode of vomiting/additional episode of vomiting today (vomiting) after he received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); HEPATITIS A VACCINE (HEPATITIS A) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  On 05-Mar-2021, the patient received a fourth dose of suspect HIB (PRP/T) VACCINE (lot number unknown, expiry date- 01-Mar-2021) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious left leg has been bothering him since the injection (limb discomfort) and one episode of vomiting/additional episode of vomiting today (vomiting) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  It was reported that, the reporter had a question regarding side effects following administration of expired dose? And also stated that she was contacted by medical practice to return for additional shot. Date: 01Mar2021   It was an actual medication error due to expired vaccine used. (latency: at the time of vaccination)  Details of laboratory data were not reported.  At the time of report, it was unknown if the patient received any corrective treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
I had inflammation and pain in my left eye. I saw an optometrist who diagnosed Iritis. I was treated with a tapering dose of prednisone acetate 1% eye drops for 16 days. I have completely recovered from my symptoms.
I contracted COVID-19 on 07/29/2022 with symptoms of congestion, cough, mild fatigue, and diarrhea. I was prescribed PAXLOVID on 07/29/2022. I was ill for 3 days before my symptoms began to improve, but I am not fully recovered as of yet. I have not finished the PAXLOVID round of anti-viral yet.
The first issue the left lymph notes was swollen to the collar bone till today. Post menauposal bleeding on the 27 Dec2020. Got a hysterectomy. High anxiety.
A report was received from a healthcare professional on 5 November 2003 concerning a vaccinee of unspecified demography who received expired Fluvirin on 1 October 2003. On 1 October 2003 the vaccinee received expired Fluvirin. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 February 2004. A follow up report was received from a healthcare professional indicating that a 52 year old male vaccinee received expired Fluvirin on 02 October 2003.  No adverse event had occurred at the time reporting. No follow up pending, all information received.
Within 15 minutes of the injection, I developed moderate tenderness in the injection site in my right arm muscle area. I also developed at the same time moderate pain and tenderness in my right breast between my arm pit and the right side of my right breast. The breast tenderness continued from 15 minutes post injection on Monday 4-12 until Saturday 4-17, 2021.  On the morning following my first injection of Pfizer Covid-19 vaccine, approximately 24 hours post injection, I developed red, itchy blotches over my face. I also developed hot, deep red itchy skin on BOTH arms, from mid upper arm continuously to the tops of my hands. Both palms were also red and itchy. BOTH kneecaps were itchy and red. BOTH feet were itchy and red on the tops and bottoms. Symptoms continued for approximately two and a half hours before dissipating.  At this point I called the hospital for guidance regarding my reactions to the vaccine.
30 minutes following the second Vaccination of the right arm, fingers of the left arm were cold, tingled and went numb for about 15 minutes. Arm pain at the injection site followed and persisted for about 48 hours. Approximately 13 hours after the vaccination, strong tremors/shaking alongside chills ensued for one hour at 3:15 am. Severe neck, back and joint pain for also onset for about 48 hours. Strong migraines and lethargy accompanied the symptoms for the 48 hour period. At 72 hours most of the pain has subsided. Minor lower back pain remains as of today.
Received the first dose of the Pfizer covid 19 vaccine then contracted covid twenty days afterwards; Received the first dose of the Pfizer covid 19 vaccine then contracted covid twenty days afterwards; This is a spontaneous report from a contactable Other Health Professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received the first dose of the Pfizer covid 19 vaccine then contracted covid twenty days afterwards. The patient enquired about receiving the second dose of the vaccine since it has been almost two months since his receiving his first dose. The patient was also wondering about receiving other vaccines. The outcome of events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient presented to UF Health Jacksonville ED with R knee pain and joint swelling for past 5 days. Patient reported that is started 10 hours after receiving COVID-19 vaccine. Pain described as severe, throbbing, constant with a sudden onset; decreased range of motion. Per chart review, patient concerned that knee pain related to COVID-19 vaccine.
Pain at the site of the injection starting at the time of the injection and worsening throughout the day, with limitation of range of motion.
She had chills; Aches; Low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Mar2021 10:30 (Lot number: EN6208) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: EN6202, Given about 8:30am,in the left arm,), administration date: 25Feb2021, when the patient was 70 years old, for Covid-19 Immunization, reaction(s): "sore arm". The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "She had chills"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Aches"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "Low grade fever". Therapeutic measures were taken as a result of chills, pain, pyrexia.  Additional information: Patient stated that after the second dose, she had chills, aches, and a low grade fever.  She took Tylenol 500 mg, went to bed and woke up the next day and was fine. The same thing happened that next evening after shot. She took another Tylenol and when she woke up that was the end of it. The events lasted for a couple days, but not all day just in the evenings. Patient did not receive any other vaccine within 4 weeks prior to covid vaccination.  Follow-up attempts completed. No further information expected
dizzy; feel like throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and VOMITING (feel like throwing up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy) and VOMITING (feel like throwing up). At the time of the report, DIZZINESS (dizzy) and VOMITING (feel like throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Information has been received from a 62 year old female consumer with no pertinent medical history and no known drug reactions/allergies who in June 2008, "2 years ago", was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). There was no concomitant medication. After a week to 10 days of receiving ZOSTAVAX (Merck), the consumer began to experience tingling and prickling on her scalp, as well as frequent itching to the point of loss of sleep. The consumer sought unspecified medical attention. At the time of the report, the consumer had not recovered. Additional information has been requested.
Developed a painful red and itchy lump at injection site. Has shot at 320pm on March 3 2021, lump developed the size of quarter by 8pm. As of March 5th 2021 at 9pm, the lump is the size of a golf ball and is spread out about 4 inches wide by 3 inches tall.