chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had covid after the second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid after the second dose of the Moderna vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced COVID-19 (had covid after the second dose of the Moderna vaccine). At the time of the report, COVID-19 (had covid after the second dose of the Moderna vaccine) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-377137, MOD-2021-377148 (Patient Link).; Sender's Comments: This case concerns a male patient, age unknown, with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. Information on vaccination dates was not provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
FAINTED; NOT ABLE TO GET UP OUT OF CHAIR; NAUSEA; HEADACHE; FEELS UNDER THE WEATHER; MUSCLE ACHE; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 14:45 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, after getting vaccine, patient fainted (dizziness) and immediately woke up. On the same day, he experienced nausea, headache, feels under the weather, muscle ache and he was not able to get up out of chair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on 07-APR-2021, and nausea, and muscle ache in APR-2021, was recovering from headache, and feels under the weather, and the outcome of not able to get up out of chair was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416848-Covid-19 vaccine ad26.cov2.s-FAINTED. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Extreme headache and body ache after vaccine.  36 hours after I received an early menstruation that is not expected for another 2 weeks. I am very regular, this is out of sync.
10:06 pt received vaccines, c/o feeling dizzy. EMS initiated at 10:08 A. No loss of consciousness, no SOB, no itchiness or hives. Positive alert, positive responsive. 10:08 A B/P = 107/64, P-58; 10:13 A, B/P 91/48, P=60, 10:15 A, B/P 122/78, P=80. Pt cleared by EMT at 10:27 A.
pt describes sl soreness in lt arm 25OCT97 devel a hard knot 26OCT97;27OCT97 has baseball size hard red, warm area on lt deltoid w/discomfort;down into forearm;
After initial vaccination patient reported experiencing metallic taste in tongue and tingling. the tingling sensation persisted several weeks and the patient visited an allergist for further assessment. upon evaluation allergist noted sloughing on the tongue 4 weeks after the initial vaccination. patient was deemed ineligible for 2nd vaccination per recommendation from allergist.
I didn't sleep well; Pain; Every joint and muscle in my body is on fire; Every joint and muscle in my body is on fire; Vision is terrible; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) 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. On an unspecified date the patient experienced I didn't sleep well, pain, every joint and muscle in my body is on fire, every joint and muscle in my body is on fire, vision is terrible. The outcome of the events poor quality sleep, pain, arthralgia, myalgia, visual impairment was unknown.  Information on the lot/batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (Refer case US2018GSK144869). On 31st July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced sleepiness. On 2nd August 2018, the patient experienced headache. On 3rd August 2018, the patient experienced fever. On an unknown date, the patient experienced pain, heaviness in limbs, swelling arm, chills, injection site pain, feels awful, multiple allergies and injected limb mobility decreased. On an unknown date, the outcome of the headache, chills, feels awful, sleepiness and injected limb mobility decreased were unknown and the outcome of the pain, heaviness in limbs, swelling arm and multiple allergies were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the fever was recovering/resolving. It was unknown if the reporter considered the headache, pain, heaviness in limbs, swelling arm, chills, injection site pain, feels awful, multiple allergies, sleepiness, injected limb mobility decreased and fever to be related to SHINGRIX. Additional details were provided as follows: The reporter was unable to provided batch number or expiry date. NDC number was provided as 58160-0823-11. The patient received her 1st dose of SHINGRIX on 20th April 2018 and 2nd dose on 31st July 2018 around 12.30 pm at her local Pharmacy, in her left arm and within 14 to 16 hours of the 2nd dose she experienced cold chills although she did not feel sick. The patient slept most of the day on 1st August 2018 and when she woke up that morning, she had horrible headache, she was uncertain if it was allergy related but it resolved that morning, she overall felt horrible with aches and pains that are not normal. The reporter stated that her left arm felt heavy, almost lead like and it hurt to lift the arm, and that her arm was swollen and she had ongoing pain or soreness around injection site. The patient woke up on the day of reporting with a slight fever. Permission was given to contact Pharmacy and primary health care professional. No further information was provided. This case has been linked with case US2018GSK144869 reported by the same reporter for the same patient.
NUMBNESS IN RIGHT HAND AND FINGERTIPS OF RIGHT HAND; FEELING FATIGUE INTERMITTENTLY; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced feeling fatigue intermittently. On 31-MAY-2021, the subject experienced numbness in right hand and fingertips of right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling fatigue intermittently, and numbness in right hand and fingertips of right hand. This report was non-serious.
Moderna COVID --19 Vaccine EUA   Lot 047A21A  Large 3" x 3.5" redness, swelling and itching at injection site  My arm was extremely sore for 3 - 4 days but did not notice any redness or swelling until 6 days later.  Currently using benadryl and cortisone cream .
Presented to clinic with urticarial rash on arms and legs as well as significant swelling around the left eye which was progressive this morning and reported starting to feel scratchy/tight throat.  Determined to be having an anaphylactic reaction which is suspected to be related to his maternal booster he obtained within the last 24 hours
Shoulders and back hurt like I'd been hit with a hammer, for about 36 hours. Took Aleve, did not help.
Significant swelling, erythema, pain.  He was not seen until 10/22/09 at 12:00 PM.  He required multiple follow-ups.
Information has been received from a pharmacist concerning a 12 year old female with graves' disease and no known allergies, who on 05-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml intramuscularly. On 06-NOV-2007 and on 08-MAR-2008 was vaccinated with a second and a third dose of GARDASIL vaccine (yeast) respectively. There was no concomitant medication prior to vaccination with GARDASIL vaccine (yeast). The pharmacist mentioned that the patient had experienced headaches since the first dose of GARDASIL vaccine (yeast). She had already completed the series. The headaches had persisted since September 2007, the degrees of the pain changed from dull to severe pain, but had never fully resolved. The patient had been seen by a neurologist. Scans of her head were performed and all results were negative. The pharmacist mentioned that the neurologist believed that the headaches are "tension headaches". The patient had been on several medications and pain medications without relief. Her endocrinologist took her off all the medications and prescribed her a muscle relaxer at bed time. This also did not seem to provide the patient with relief. The patient sought medical attention. She contacted the pharmacist. There was no product quality complaint. Additional information has been requested. 10/1/08 Reviewed PCP medical records of 8/11-9/2/08. FINAL DX: Records reveal patient experienced chronic HAs.   10/17/08-records received for DOS 2/5-10/6/08-follow-up visits for Grave's disease diagnosed 1/8/07. Visit on 2/5/08-headache waxes and wanes began in early September 2007-occurring daily ever since. Visit on 5/6/08- C/O feeling tired and malaise worse in morning. Intermittent headache per another physician they are tension headaches. Intermittent tremor. Brittle nails. Visit 10/6/08-Continues with headaches for last 13 months. No longer feeling tired or malaise.  11/6/08-records received-DOS 1/2/08-C/O continued headaches since 11/7/07-CT scan of head and sinuses normal. Some sensitivity to light. 1st Gardasil received 9/8/07-lot#1061U. 2nd dose 11/6/07-lot#1267U. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. The nurse stated the patient described her headache as centrally located pushing out towards ears. She also experienced some dizziness. In follow up information the nurse provided the lot numbers for GARDASIL: first dose (658558/1061U), second dose (659439/1267U) and third dose (659964/1978U). The patient sought medical attention: She contacted the pharmacist. There was no product quality complaint. Follow up information was received from a pharmacist concerning a 12 year old female with grave's disease. The patient experienced persistent and chronic headache since first week of September 2007. The AE required ER/DR visit. At the time of reporting the patient had not recovered. No further information is available.
Lips tingled; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Lips tingled) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (recovered from Covid).    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PARAESTHESIA ORAL (Lips tingled) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Lips tingled) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Heart rate: increased (High) Elevated heart rate.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter.  Patient had lips tingled and an elevated heart rate. She /he was told by the facility where she/ he got the first shot not to get the second since had a reaction.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Next day had seizure- while taking a nap-lasted 2 1/2 min another 10-15 until he started to awaken about 2-2 1/2  hours until back to normal. No obvious fever beforehand.  Temp 102.5 in E/R. Had CT scan (normal) following day developed red raised well left deltoid with rash back of neck
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE, start date: 25Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication in 2 weeks was Prednisone. Anti viral details included COVID 19 Treatment, brand was Paxlovid started on 25Jan2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Localized site reaction.  Positive pain, positive swelling, 2x3cm induration, negative pustule, positive red, positive warm to touch, positive full ROM.
Low grade fever, chills, hot flashes, body aches, soreness at injection site, swelling under left arm
Patient was given a dose 2 days after the BUD. No adverse effects reported. Valid dose and no need to revaccinate per clinical studies
HSV1 outbreak; This is a spontaneous report from a contactable consumer (Patient).  A 37-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), an unspecified route of administration, administered in Arm Left on 02Mar2021 at 16:00 (Batch/Lot Number: EM 6022) as 1st dose, single dose for covid-19 immunization. Medical history included herpes simplex from 2004 to an unknown date. The other concomitant medication within two weeks included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and probiotics. The patient did not take any other vaccine in four weeks. The patient did not had Covid prior vaccination and not tested for Covid post vaccination.On 04Mar2021, the patient had Herpes simplex virus type I reactivation. It was reported that patient had contracted HSV1 around 2004 and he had not any outbreak since 2017. It was reported that two days after having the first dose of the Covid vaccine patient had an HSV1 outbreak. The patient did not receive any treatment for event. The outcome of event was not recovered.  No follow up attempts are possible. No Further information is excepted.
Diverticulitis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: diverticulitis (medically significant). The clinical course was reported as follows: The patient reported that she received the first dose of the vaccine on 25Jan2021. The patient was scheduled to take the second shot on 15Feb2021. The patient contracted diverticulitis and mentioned that it was "nothing serious" and was prescribed with "common" antibiotics such as metronidazole and "cipro" (ciprofloxacin).  Therapeutic measures were taken as a result of diverticulitis. The clinical outcome of the event, diverticulitis, was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash). At the time of the report, RASH PRURITIC (Itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Reported by caregiver that child had an episode of body "shivering" about five times and than head would hang down.  This occurred over about two minutes.  The child returned to normal activity right after shivering episode.  This happened at about 1:00 on March 12, 2007.
I was not feeling well after does #1. After Dose #2 I woke up at 2am with a fever of 103. The morning after I had generalized symptoms of all over achy and exhaustion.  These symptoms minus the fever lasted for 8 weeks. I was also having very bad flank aching on the right and left side. Once I fully recovered from the vaccine, every 4-6 weeks I would get a relapse of chills, flank ache and extreme exhaustion that would last about 5-7 days. It was very debilitating.  I kept feeling like I was about to go into full blown fever type of thing. I never had any other symptoms such as runny nose, sore throat, trouble breathing, something that would make me think I was getting a cold or the flu. I thought I was getting a kidney infection.   This went on for about a year or more. Then out of the blue on August 11th, 2023, I woke up at 2am like I did the night of my vaccine in a full blown raging fever of 103.5, The next day I was just exhausted. This again lasted 6 weeks before I felt normal again. I went to the doctor and all they found was a high CRP which I never had before. I was put on Doxycycline for 7 days. The other thing of note, is that after the vaccine, my kidney values changed. they went from being normal in MArch 2021 to high creatinine out of range and low eGFR out of range. This first happened in early 2022.  I never had abnormal values before.
Per mother vaccine given on 10/22/02. Three days later she noticed dry cracked lips increased thirst and urination. Seen again in office on 10/29/02 for temp 100.3 and cough x three days-diagnosed with viral URI. No treatment given. Seen on 11/20/02 for dehydration-admitted and diagnosed with diabetes. Per 60 day follow up: Pt has not recovered. Ongoing treatment for insulin dependent diabetes. Annual follow up on 02/26/04: "Pt did not recover from adverse events. Still being treated for diabetes. Parents declined any further immunizations, only had one Hep B."
Left upper arm between axilla and frontal side with patches of raised, warm erythema medial to injection sit 1) 5cm x 2.5cm 2) 2.5 x 1cm 3) 1.3cm diameter round.
Left axillary lymphadenopathy; headache; letarghy; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 08:30 (Lot number: ER87310) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Polycystic ovary" (unspecified if ongoing); "congenital neutropenia" (unspecified if ongoing); "contraception" (unspecified if ongoing), notes: Contraceptive. The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 20Apr2021 18:00, outcome "recovering", described as "Left axillary lymphadenopathy"; HEADACHE (non-serious) with onset 20Apr2021 18:00, outcome "recovering", described as "headache"; LETHARGY (non-serious) with onset 20Apr2021 18:00, outcome "recovering", described as "letarghy". Therapeutic measures were not taken as a result of lymphadenopathy, headache, lethargy.  Additional information: No known allergies reported. No covid prior vaccination and not tested for covid post vaccination. Patient did not take other vaccine in 4 weeks.  No follow-up attempts are possible. No further information is expected.
Patient developed Urticaria  approximately 10 to 20 minutes post injection and was treated with benadryl and transported to the hospital.
The vaccine was recommended to the patient by his hematologist.  After receiving  the first dose the patient experienced fatigue, headache and his thrombocytes  level dropped from 111,000 to to 91,000, then fro 91,000 to 61,000.  At that point  his doctor increase the prednisone from 10mg to 20mg daily. The patient will continue to be monitored closely by his doctor.
Two days later I woke up with my lungs very sore, having a hard time breathing, nose was stuffy, I felt dizzy - thought it was just a delayed reaction but when it didn't go away after a few days and it worsened - I went to the urgent care clinic to get antibiotics - they didn't work.  They then gave me albuteral and advair - it didn't work - they then gave me steroids.  It took me about three months to get better and my left arm would have sudden pain in the injection site for about 6 months after, now that side of my arm/neck can hurt a little from time to time. When I went to the Urgency clinic the second time my blood pressure was elevate at 130.  The last time I went (last month) it was 140!  I suddenly developed hypertension stage 2. I know I am in the age where such things can happen, but I have 4 older siblings that are a decade or more my senior and none of them developed this - I am the only one to get the J&J shot.  I had NO reaction with the later moderna booster.