chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Side effects after vaccination; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION COMPLICATION (Side effects after vaccination) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after vaccination). At the time of the report, VACCINATION COMPLICATION (Side effects after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment details were provided.
Improperly stored; Did not experience any symptoms; This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On an unknown date, the patients were vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date of 17-OCT-2020 and lot # S032055 with expiration date of 09-NOV-2020 (strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis. Other suspect therapies included pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S012244 with expiration date of 09-FEB-2021 (strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis; rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S006053 with expiration date of 07-DEC-2020, and  lot # S006050 with expiration date of 12-DEC-2020 (strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis  The vaccines were exposed to a temperature above 47 °F, during a time frame of 40 minutes and 10 seconds. No previous temperature excursions reported. No adverse events reported.
This is a spontaneous report received from a contactable reporter (healthcare professional). Patient (no qualifiers provided) received meningococcal group B rlp2086 (MENINGOCOCCAL GROUP B RLP2086), administered in arm left, administration date 14Jun2021 (Lot number: CN1583, Expiration Date: Aug2022) as dose number unknown, 0.5 ml single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Left upper arm soreness and erythema". No follow-up attempts are possible. No further information is expected.
ADMINISTERED THE ENTIRE 5 DOSE VIAL OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a physician concerned an 87 year old female. The patient's weight was 81 pounds, and height was 60 inches. The patient's concurrent conditions included allergic to sulfa drugs, abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use. there was family history of any disease (relevant to vaccination) or allergy. The patient experienced drug allergy when treated with roflumilast.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) .5 ml, administered on 02-APR-2021 08:10 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced administered the entire 5 dose vial of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered the entire 5 dose vial of the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210408236 and 20210421606.
first noticed burning in left leg, especially in a band around ankle, then leg cramped/spasmed/froze. continued intermittently. has since noticed increased burning band around ankle, that is almost always there, and similar sensation in a 1.75"x3" oval shape on soft tissue throughout body. she has also noticed significant muscle weakness, feeling sore like she was hit with a baseball bat, especially in legs, and more age spots.
I became quite ill about 12 hours after the vaccine- fatigue, fever, severe chills for about 18 hrs.  Then I had a frontal headache daily for 1 month- during the day and also at night (which I never have).  I still get more frequent headaches than I have ever had in the past- I have never had nightime headaches and now that happens 3-4 times/week where I need to medicate during the night with aspirin.
This case was reported by a health professional and described the occurrence of limb swelling in a pt who received DTAP (Infanrix) for prophylaxis. On an unspecified date, the pt received Infanrix. At an unknown time post-immunization, the pt experienced limb swelling. The outcome of the event is unknown. On 07/28/03 the reporter stated that she could not identify the pt. Therefore no further information was available.
Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately and hotness around site for three days, heaviness in chest all the way through to back, shortness of breath
I suffer from tinnitus and immediately after the shot my ears started roaring! Stayed that was for almost two weeks. I visited my doctor over it and she said make sure and report it to CDC so here you go!
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA and FLATULENCE in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA and FLATULENCE. At the time of the report, DIARRHOEA and FLATULENCE outcome was unknown. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas; Fever; Tightness in jaw; Sore arm and muscles; Sore arm and muscles; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 12Jan2021 08:40 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness in jaw within one hour after vaccination and noticed on her way home, sore arm and muscles on 12Jan2021, fever last night (13Jan2021). Her body was aching from her groin and going down, especially in both thigh areas on 13Jan2021.  It woke her up. She didn't take anything for it. She laid there until she went back to sleep. It was gone now. The patient also experienced a headache on an unspecified date and chapped lips on 14Jan2021. The outcome of the events chapped lips and headache was unknown, tightness in jaw was not recovered, body is aching from her groin and going down, especially in both thigh areas were recovered while other events were recovering.
it was rpt fr HCP concerning pt who was vax & subsequently pt had arthritic complaints & dx w/juvenile rheumatoid arthritis. addl info requested
Fever, flu like symptoms, body aches, arm where vaccine administrated red and swollen.
Extreme fatigue; Dizziness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 01Apr2021 at 13:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, sleep apnea, hypotension, history of CA (cardiac arrest), penicillin (Pcn) allergy and sulfonamide (sulfa) allergy. The patient received unspecified medications as concomitants within two weeks of vaccination. The patient previously took emycin and iodine and experienced allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 05:00, the patient experienced dizziness, extreme fatigue and headache. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dizziness, extreme fatigue and headache were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
On June 14 I woke up with dry and sore throat  the next day ears, eyes,head and body ache started.  I waited 4 days and didn?t feel any better  decided to visit my Dr. She didn?t find any infection she still gave antibiotics just Incase after two sets of antibiotics and pain medication I still feel the same I am hurting all over and am extremely tired all the time I have sharp pain shooting from back of my neck to the bottom of my scalp and my shoulders.  My legs are heavy and tired. Over all I don?t feel good at all.  It has been a month and not much improvement.  I tested negative for covid about two weeks ago.
Mild soreness  at injection site-started after injection. Mild headache-started day after injection. Mild tiredness-started day after injection.
Enduration hard knot; Pain / pain under the skin at the site of injection; Injection site knot; This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABX747AA, expiry date 29th February 2020) for prophylaxis.   On 23rd April 2019, the patient received Bexsero (intramuscular) .5 ml. On 23rd April 2019, less than a day after receiving Bexsero, the patient experienced injection site induration, injection site pain and injection site lump. On an unknown date, the outcome of the injection site induration, injection site pain and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the injection site induration, injection site pain and injection site lump to be related to Bexsero.  Additional case details were reported as follows: The patient received vaccine on right arm. On the day of vaccination, patient experienced enduration hard knot and pain under the skin at the site of injection.  At the time of reporting, the patient still experiencing it. This case had been linked to the case US2019086320, reported by same reporter.
3:00 AM the next morning had hot temperature, temp was 99.2-100.7, fever, fatigue for 24 hours straight.
About 12 hours later, I had fever, severe body aches, shortness of breath, headache, thought I was going to die! I felt bad. I was extremely tired. It lasted for 72 hours and then the symptoms were gone. I took Tylenol the first day. The second and third day, I took Ibuprofen. I called the Dr on the second day - he told me it had to run its course.  I still have residual shortness of breath - I had COVID at the end of July and had severe scarring in my lungs from the lung.
INTENTIONAL PRODUCT MISUSE; OFF LABEL USE; THERAPY PARTIAL RESPONDER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-hodgkin's lymphoma (since 2013), and immune compromised. The patient was previously treated with bnt 162 for prophylactic vaccination (first dose received on 24-Feb-2021 and 2nd dose received 4 weeks later (exact date unknown). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  The reporter stated that, the patient underwent antibody test on an unspecified date and resulted as negative after receiving the bnt 162 vaccine so her physician recommended to receive a dose of the Janssen covid 19 vaccine (coded as revaccination). On 09-AUG-2021, the patient had an antibody test post Janssen covid-19 vaccine and the results were 19. The patient reported her physician wanted the patient to have higher number for protection since the antibody results weren't as high as (coded as therapeutic response decreased) her physician would like to protect against the delta variant. The patient's physician prescribed a second dose/booster of Janssen covid-19 vaccine" to help her antibody levels. The patient had not yet received a second dose of Janssen covid-19 vaccine at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the therapy partial responder, intentional product misuse and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210829022 -COVID-19 VACCINE AD26.COV2.S- Therapy partial responder. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Not sure which Tdap vaccine was given.  He lost consciousness, hitting his face on window of reception.  Placed on floor until woke up and then monitored for a short time and given juice.
This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age. On 18-AUG-2014, the patient was vaccinated with a dose of VAQTA, 0.5ml, intramuscular injection (dose number, lot/batch number, expiration date and indication were not reported) that was improperly stored. No adverse events were reported. No product quality complaint (PQC) involved. Additional information has been requested.
"she's having major back pain since sunday, after she got the 2nd covid shot."; This is a spontaneous report received from contactable reporter(s) (Other HCP, Consumer or other non HCP and Physician) for a Pfizer sponsored program (141003).  A 71-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ XR taken for rheumatoid arthritis, start date: Sep2020. Vaccination history included: Bnt162b2, for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as ""she's having major back pain since sunday, after she got the 2nd covid shot."'  Additional information: It was reported that, Case is from Marketing program but suspect product(s) are not part of the case Suspect product Xeljanz XR updated to  Pfizer covid 19 Vaccine as per the events reported and Xeljanz XR considered as Concomitant product coded via CDD. spouse reported md discontinued xeljanz "about 2 weeks ago, "because it just wasn't working, her inflammation seemed to be getting worse".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 14 after vaccine have red skin a vaccine site, extending to 3 inches round vaccine site.  Previously only had arm soreness with no redness until day 14.
Within 24 hours started feeling tired, headache, chills.  Within 72 hours had same symptoms but feeling worse.  Only relief was aspirin taken every 3 hours.  The morning of day 5 I woke up early so I could go have blood work done.  Felt overly tired and a little light headed on the drive almost like I jumped up to fast and was just not awake.  Lab took my blood pressure, it was 109/72.  By the time I got home i was extremely light headed and dizzy.  I took BP at home, 110/74.  Felt extremely bad, very dizzy.  Almost like I was going to faint.  I finally drank some tomato juice ate Greek olives, other salty snacks to try to get my BP to come up. By the time I went to bed my BP went up to 135/81 had headache & dizzy. Day 6 (today) Still have headache & dizziness.  BP was 131/80 when I woke.
On day four after the first, 99.5 temp, up to 100.8. Fever, head ache, joint pain. Second vaccination, fever 102, headache, and joint pain. Chills. Migratory migraine. Second vaccine Jan 8th.
Pt recvd 3 doses of Engerix-B on 8MAY91, & 5JUN91, & 11NOV91 & 11NOV91 immed p/3rd inject pt exp burning while inject was being given which cont for a few hrs;
Narrative: Felling tingling in tongue, taken VS: 0914 B/P 138/76 P 55; 0925: BP 151/73 P 55 monitor 30mins Patient feeling better, given bottle water/snack, feeling ok. No tingling or swollen. Left @ 0926 Symptoms: & tongle timling Treatment:
Itchy; It's very red; Painful; Swelling at the insertion site in her arm; A spontaneous report was received from a non-health professional concerning a 78-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed itching (vaccination site pruritic), pain (vaccination site pain), swelling (vaccination site swelling), and redness (vaccination site erythema) at the injection site.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 30 Dec 2020, approximately seven days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 06 Jan 2021, the patient developed swelling at the insertion site. It was very red, painful, swollen, and itchy. No treatment information for the event was provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, itching, pain, swelling, and redness at the injection site, were unknown.; Reporter'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.
May 2,2021 I got my first period after D&C last March 2021.. After the shot,I immediately got a high fever but did not take medication.. Had muscle pains and the following morning felt the pain on my right pelvic,unexplainable pain but were able to tolerate it for 3 days..on May 6-pain was intolerable, and decided to wait until May 7 4:30 am to go to ER.. The ultrasound showed inflammation on my tubes ,ovaries and other organs. Was put on antibiotics and said it was PID but I kept on saying that it started when i got the covid shot. They told me I am fine after 3 days without explanation so I decided to go home since they are not explaining what happened and if the vaccine has something to do with it. I got the vaccine at pharmacy and not sick or ill during the time I got vaccinated.
Skin redness; started having whole body hives; Face allergy which never have before; started having whole body hives which is like your body is like burning and itching; started having whole body hives which is like your body is like burning and itching; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number EW0170, expiration date unknown), via an unspecified route of administration administered in Arm Left on 22Mar2021 at 12:00 am as single dose for covid-19 immunization (at the age of 31-years-old). The patient medical history and concomitant medications were not reported. The patient previously took penicillin [benzylpenicillin] (can be Penicillin) and had Known allergy. It was stated that, after her first dose vaccine which was received on 22Mar2021, she started having whole body hives which is like your body was like burning and itching and It got worse almost every day and mentioned that she was having this allergy and she started to have skin redness, body hives, face allergy which never have before which experienced on 28Mar2021 at 01:00 am. The patient also stated that she never got any side effect from any vaccination before this Pfizer COVID vaccination and after this she started to have hives and it got worse almost every day. She did not get anything from any vaccination, and she did not get any allergies of skin and after this vaccination her system went very down. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test which was negative. The outcome of all the events was not recovered.  Follow up needed, further information has been requested.
Initial report was received on 07 May 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. This is one case in a series of 228 pertussis cases received during the surveillance period from 01 January 2010 to 07 May 2014 respectively (routes and sites of administration not reported). Two days after the last dose, on 29. A case of pertussis disease in a six month old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS). The subject's vaccine history included three doses of PENTACEL received on 05 December 2013, 29 January 2014 and 27 March 2014, the subject developed a catarrhal illness. Nine days later, the subject developed a cough and a paroxysmal cough with whoop. The subject also experienced apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 10 April 2014. Chest x-ray findings were negative for pneumonia. Corrective treatment included Azithromycin stated on 11 April 2014 for five days. The subject was not hospitalized. At the time of final contact on 05 May 2014, the subject's cough had stopped after 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient entered vaccine clinic requesting Covid vaccine. States that he had a vaccine while he was in jail but wasn't sure what the vaccine was. Registrar queried immunization record, but it did not bring up a Covid vaccine so patient was registered and requested J&J. Vaccine administered and then registrar lead came to vaccine clinic supervisor. I queried the statewide "alerts" system and see that patient had Covid J&J shot on 3/17/2021. After reentering the chart and submitting again, the documentation popped into the record. Patient has now received 2 J&J vaccines when only one was indicated. This patient received the  $100 gift card incentive prior to knowing that they indeed had a previous vaccine and had already left the facility. Registrars have been notified that they need to pause and allow the system time to refresh to see if vaccinated.