chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described the occurrence of an injection site reaction in a 5 yr old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 02Sep05 the subject received the 5th dose of Infanrix in the left arm (lot DTPA592A9). On 02Sep05 the subject was also vaccinated with measles mumps and rubella virus vaccine (MMRII) and inactivated poliomyelitis virus vaccine (Ipol) at unspecified sites of admin. On an unspecified date after vaccination with Infanrix, on or after 02Sep05 and on or before 06Sep05, the subject experienced an injection site reaction characterized as redness and swelling. The injection site reaction resolved on an unspecified date on or after 02Sep05 and on or before 06Sep05. The nurse considered the injection site reaction to probably be related to vaccination with Infanrix.
Pt received vaccine at 830am. Within 1 hr started feeling bad. That evening pt had dizziness, chills, lethargy, joint pain, fever, & nausea. Lasted for 72 hours. Visited PCP & missed 3 days of work.
Missed second shot, about 4 months post first shot; Bad Headache after first vaccine; Chronic Fatigue came back after first vaccine; Joint pain came back after first vaccine; felt like had the flu after first vaccine; had no strength after first vaccine; Brain Fog came back after first vaccine; Chronic Migraine came back after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine) and PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic fatigue syndrome, Foggy feeling in head (Brain fog), Chronic migraine (25 Days a month from a virus since 20 years), Joint pain and Fibromyalgia. Concomitant products included TOPIRAMATE (TOPAMAX) for Migraine.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine), HEADACHE (Bad Headache after first vaccine), FATIGUE (Chronic Fatigue came back after first vaccine) and ARTHRALGIA (Joint pain came back after first vaccine). On 31-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot). At the time of the report, INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine), PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot), HEADACHE (Bad Headache after first vaccine), FATIGUE (Chronic Fatigue came back after first vaccine) and ARTHRALGIA (Joint pain came back after first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       He did not take the second dose because of side effects of first dose but as his family have no side effects he is tempted to take the second dose of vaccine. Treatment information was not provided.
Headache; Right arm really hurt; Felt lite headed; not feeling well; This is spontaneous report from contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247, Expiration date: May2021), via an unspecified route of administration, in right arm on 25Feb2021 13:10 (Age at vaccination 56 Years), as 1ST DOSE, SINGLE for covid-19 immunisation. Not pregnant at the time of vaccination. Th patient was allergic to medications, food, or other products mushrooms, bactrim and cephalexinctrim. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination includes rosuvastatin calcium 5 mg tab. The patient experienced Headache, Right arm really hurt, Felt lite headed and I was not feeling well on 26Feb2021 05:00 AM. Treatment received was Tylenol. Seriousness reported as non-serious. The most recent COVID-19 vaccine was administered in workplace clinic. The outcome of the events was reported as unknown.  Follow-up (03Mar2021): New information received from same consumer reported that on 26Feb2021 around 5:00 am EST that I was not feeling well and reported the adverse event later that day.  No follow-up attempts are needed. No further information is expected.
Right arm was sore for a couple of days and warm. now has redness, warm to touch, and swelling at injection site.
Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.
Pt vaccinated without incidence on 11/22/21 in the vaccination center (including her 15 minute post-vaccination wait time). She came back to the center later in the afternoon complaining of hives and pruritis bilaterally on the medial thighs and that her left arm (vaccinated) was tingling and cold down to her fingers. She denied having a swollen tongue or difficulty breathing. Reported allergy to ibuprofen where she develops hives. No previous problems with other vaccines other than getting "very sick" after a flu shot (described as fever, couldn't eat, dehydration, headache). I felt her hands and the left was colder to the touch than the right. Advised to her call employee health - she did so in the center and was advised to go to the emergency department for further evaluation. Pt left the center to go to the ED.
Tested positive for Covid-19 7/26/2021, not admitted to hospital for Covid-19 S/S
Right arm swollen the next day after pneumonia injection. Vascular scan. medication- 400 mil tab of Etodolac every 4 hours. Heating pad intermittently.
the patient was nonimmune; he first dose {1ml) was administered on 9/23/2022, second dose {1ml) was administered on 1/10/2023,; The caller said the patient inadvertently received a 0.5ml dose of RECOMBIVAX HB for the administered on 5/15/2023; The first dose {1ml) was administered on 9/23/2022, second dose {1ml) was administered on 1/10/2023; first dose of RECOMBIVAX HB on 4/5/2002, second dose on 6/4/2002, and third dose on 12/10/2002; first dose of RECOMBIVAX HB on 4/5/2002, second dose on 6/4/2002; This spontaneous report was received from a nurse referring to a currently 21-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 05-APR-2002, the patient was vaccinated with her first dose of Hepatitis B Vaccine (Recombinant) (HBVAXPRO HB) intramuscular injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for hepatitis b vaccination. On 04-JUN-2002, the patient was vaccinated with her second dose of Hepatitis B Vaccine (Recombinant) (HBVAXPRO HB) intramuscular injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for hepatitis b vaccination (inappropriate schedule of product administration). On 10-DEC-2002, the patient was vaccinated with her third dose of Hepatitis B Vaccine (Recombinant) (HBVAXPRO HB) intramuscular injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for hepatitis b vaccination (inappropriate schedule of product administration).  On an unknown date, the patient had a titer done that showed that the patient was nonimmune (hepatitis B surface antibody negative) thus the patient was vaccinated with 3 additional doses of Hepatitis B Vaccine (Recombinant) (HBVAXPRO HB). On 23-SEP-2022, the patient was vaccinated with her first dose of Hepatitis B Vaccine (Recombinant) (HBVAXPRO HB) intramuscular injection (1 ml; strength, route of administration, anatomical location, lot#, and expiration date were not reported) for hepatitis b vaccination. On 10-JAN-2023, the patient was vaccinated with her second dose of Hepatitis B Vaccine (Recombinant) (HBVAXPRO HB) intramuscular injection (1 ml; strength, route of administration, anatomical location, lot#, and expiration date were not reported) for hepatitis b vaccination (inappropriate schedule of product administration). On 15-MAY-2023, the patient was vaccinated with her third dose of Hepatitis B Vaccine (Recombinant) (HBVAXPRO HB) intramuscular injection inadvertently (0.5 ml; strength, route of administration, anatomical location, lot#, and expiration date were not reported) for hepatitis b vaccination (inappropriate schedule of product administration and incorrect dose administered). The outcome of hepatitis B surface antibody negative, and the causal relationship between the event and Hepatitis B Vaccine (Recombinant) (HBVAXPRO) was not reported.
Information has been received from a physician concerning a 14 year old female who on 28-AUG-2007 was vaccinated with the second dose of Gardasil.  On 29-AUG-2007 the patient experienced hives, had a really bad stomach ache, throat was tight and had trouble breathing, and by the next day had hives all over.  The patient sought unspecified medical attention.  The patient's hives, really bad stomach ache, and tight throat, and breathing trouble persisted.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Unspecified medical attention was sought. The patient's hives, really bad stomach ache, and tight throat, and breathing trouble persisted. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Caller and her husband had Covid vaccines are the same day except for one.; Caller and her husband had Covid vaccines are the same day except for one.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6202, Expiration Date: Jun2021), on 21Mar2021 as dose 2, single (Lot number: ER8727, Expiration Date: Jul2021), on 17Aug2021 as dose 3 (booster), single (Lot number: EWO172) and on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation. The patient's relevant medical history included: "stent in heart", start date: Jul2016 (not ongoing); "high blood pressure" (unspecified if ongoing); "Blood cholesterol abnormal" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller and her husband had Covid vaccines are the same day except for one.". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Reporter's husband. Reporter knows there are only 2-4% of rebound cases, but she happened to be one of them. Calling to report. This was happened to herself and her husband. This report was for reporter's husband. Reporter and her husband had Covid vaccines are the same day except for one. He had different symptoms than reporter , but they got sick at the same place. He was on high blood pressure and cholesterol medication. Had been taking Coricidin High Blood Pressure. He was really healthy. Reporter's dad has had three open heart surgeries so reporter watches what her husband eats. The vaccines given and they didn't put any expiration. Reporter and her husband had a harder time getting the vaccines. Yes there was a product complaint to report. sample of the product was available to be returned, if requested: not provided. Packaging sealed and intact: not provided. Consumer, patient, caregiver: not provided.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300128478 Same patient, different product, different event;US-PFIZER INC-202300128590 same reporter/product, different patient/events;US-PFIZER INC-202300128494 same reporter/product, different patient/events;
Welts; Burns; Scabs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts), THERMAL BURN (Burns) and SCAB (Scabs) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Welts), THERMAL BURN (Burns) and SCAB (Scabs). At the time of the report, URTICARIA (Welts), THERMAL BURN (Burns) and SCAB (Scabs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   Treatment medications were not reported.
This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF FOREIGN BODY (felt like she had a lump in throat) and VACCINATION SITE RASH (rash below injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced SENSATION OF FOREIGN BODY (felt like she had a lump in throat) and VACCINATION SITE RASH (rash below injection site). At the time of the report, SENSATION OF FOREIGN BODY (felt like she had a lump in throat) and VACCINATION SITE RASH (rash below injection site) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.    This case was linked to MOD-2021-018467 (Patient Link).
About two days after my Moderna booster, my under arm became swollen and sore. Two weeks later, still some swelling. Pain persists under both arms and some pain in groin area. I'm guessing lymph nodes but concerned it has lasted this long. Did not have this reaction with the 1st and 2nd vaccine.
Same evening had fever of 100.6 F. and chills for 5-6 hours.
Pt had redness and swelling at injection site on right arm at time of onsite. Mom took pt to ED on 10/26/12 at 1920 area of redness was 2"x4" at time of visit. He was treated for cellutits by taking Keflex 200mg PO BID for 7 days, and to take OTC Motrin and Claritin. Pt f/u with PCP on Monday/Tuesday and improvement noted.
8JUL92 pt feverish by 3AM 9JUL t105 R pt observed by mom shaking briefly; contacted MD by phone; APAP dosage inc; temp dec to 101 R; by 10JUL temp gone;
A report has been received from a Health Professional concerning a 3 year old, Female subject who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT started on 22-Jan-2014. It was reported that forty two patients were administered with expired FLUMIST QUADRIVALENT which started on 22-Jan-2014. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Unknown adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Unknown adverse event) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ADVERSE EVENT (Unknown adverse event). At the time of the report, ADVERSE EVENT (Unknown adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller sent an email to report an Adverse Event on February 2021, but nobody called back. The caller did not want to provide more information because "is tired to provide the same information all over and over again". Did not provide the names of the adverse events.
I noticed the injection site was sore, swollen and warm. As the day progressed headache, fatigue, joint, legs aching and feeling heavy tires. Also had a fever of 101.2.Around 9:30 pm on 12/16 started to feel better fever was down.
Patient hasn't received 2nd dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non significant follow up information. No new information
COVID after first vaccine; COVID after first vaccine; This is a spontaneous report from Pfizer sponsored program. A contactable consumer (patient's son) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Solution for injection, via an unspecified route of administration (dose: 01) on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the reporter mentioned that after the vaccination the patient had COVID-19. The outcome of the event was unknown.  No other new information reported. Information on the lot/batch number has been requested.
Severe headaches which resided after 2 days. On the third day, I began to experience ringing in my ears which has not resolved.
I am a very active, healthy 42 year old female. After the first shot it took me until April 25th before I felt 100% better (2 weeks and 3 days). My symptoms for the first and second are in alignment, however, they have been even more intense for the second. I am miserable. I am thankful I have a strong support system. I am suffering. Every night I have weird nightmares and am "water tortured" where I wake feeling as though a gallon of water has been dumped on me as my "phantom fevers" break. They break through the day as well but not as often. I have been taking my temperature around the clock as my biggest complaint is my head. I feel as though I have a high fever but I actually haven't had a fever even once. My head has an awful manufactured feeling and makes me feel ichy. I have done little else than lay horizontal in bed or on the couch. Last week I was sleepy but as of the 4th I'm not sleepy during the days anymore. I have 2 thoughts: 1. I have a sensitivity to one of the ingredients in the vaccine. 2. Although my symptoms are ever present they subside slightly as the day goes on and I'm convinced it's because I am taking in so many fluids on a daily basis to try and combat this thing. Any suggestions or thoughts on which ingredient has caused me so much angst are appreciated.
10 Days after Varivax 9/18/07 at started red itchy rash on trunk that extended centripedal over 3 days. Did have recent.
Patient developed a rash on bilateral legs and a lump at injection site on left thigh. Grandmother will continue to monitor & RTC with worsening of symptoms. Is returning in 2 weeks for recheck.
Patient developed Cellulitis, patient was given Clindamycin at the Hospital and discharge with prescription for Clindamycin
After 12 hours, I had a strong pain all over my body muscular and joint pain, nausea, headache.
At 7 days after the first dose, I had itching in the injection site, it became red and swollen, it formed a little hard ball without pain. By the next day the redness started to disappear and went away, but the inflammation lasted around 5 days, in the mornings was more swollen and then in the afternoon was less swollen. I took antibiotic since I noticed the symptoms for 6 days.
Pt presents for COVID-19 vaccination at. Janssen vaccine given per protocol.  Patient informed to wait in observation area for 15-30 minutes.   After 5-6 minutes of observation, pt reported feeling faint and appeared diaphoretic. Per facility staff, pt just admitted into rehab facility and may be going through alcohol withdrawal. Pt then started slumping over the chair and became unresponsive. Facility staff called 911. Upon waiting for paramedics, nurse and staff laid pt down onto the floor. Pt became responsive and started talking again. Respiration and heart rate within normal limits. Monitored pt until paramedics arrived. Pt taken to ER for further evaluation.
got a rash all over my cheeks and chin and chest with a severe headache. 2nd day rash went to bottom half of my body and still on cheeks and chin with itching with red mark and swollen lymph nodes.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient states after second dose (first dose was 12/8 and no adverse event) she had welts/rash/red bumps and lots of itching start from elbow of immunized arm all the way to her whole back could potentially be allergic reaction told her to go to her primary care provider to make sure it is nothing else
Pt devel a large area of erythema @ inject site 8 days p/Td;
Case number PHEH2016US025982, is an initial spontaneous report received from a nurse on 05 Oct 2016. This report refers to a 02 year old female patient. Medical history and concomitant medication were not reported. The 02 year old patient was vaccinated with single dose FLUCELVAX QUADRIVALENT (batch number: 185886) at a dose of 0.5 ml intramuscularly on 09 Sep 2016. No adverse event was reported following this medication error (inappropriate age at vaccine administration). The seriousness of the event was reported as non serious.