chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Herpes in genital area. This spot is where i generally have a herpes outbreak, but it was different this time.  The lesion bleeds. Feels just like other herpes lesions. I am not sexually active, and have not had a herpes outbreak for a long time. When i had the first shot, which was 3/19/21, Moderna through, lot #037A21B, about a week after the first immunization, i developed a rash on my right abdomen, just below the rib cage. It was fine, closely spaced red bumps, very itchy. I thought at first it was  chiggers, but the weather is cool and seems in the wrong place for chiggers. It seemed to become tiny blisters, and i started wondering if it was  shingles. It stung and hung on for several days, weeping a little blood.  but it cleared up quickly. While it was scabbing over, i had a larger blister on my right wrist. It looked almost like a fire ant blister, but  again no ants.  Felt very itchy, tingly, like the rash below my ribs. Within a day, the blister burst and bled. It took three or four days to heal. I thought these were weird at the time, but did not connect them to the vaccination, until i had the second dose, and my genital herpes blister bled.  This is not yellowish pus, it is bright, arterial style blood, thin, but definitely blood.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (some of our sites administered Moderna vaccines beyond the use date and or expired) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about 1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (some of our sites administered Moderna vaccines beyond the use date and or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about 1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (some of our sites administered Moderna vaccines beyond the use date and or expired) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about 1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Her arm was still sore; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (COVID-19 Vaccine), via an unspecified route of administration on 24Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included retinol (VITAMIN A), vitamin b complex (VITAMIN B), ascorbic acid (VIT C), ergocalciferol (VIT D), and furosemide (LASIX). The patient's arm was still sore from last night after getting the COVID vaccine on 24Jan2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
About 45 min after injection, patient returned to office because area of influenza vaccine was red, blotchy and pruritic. Extended from deltoid injection site to chest advised ZYRTEC 5 mg. About 36 H later, he complained of tongue itching so went to ER for eval - Given BENADRYL.
Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/she got the vaccine and it gave him/her the shingles. The patient stated he/she would never take it again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
slight fever; fatigue for a day; aches; my urine has a strong smell, smells like bad deli meat; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. On an unspecified date, patient had a slight fever, aches, fatigue for a day and noticed that urine has a strong smell, smells like bad deli meat. Outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
NO SYMPTOMS BUT GIVING THE WRONG VACCINE.  SHOULD HAVE BEEN HEPATITIS B AND INSTEAD WAS HEPATITIS B.
Caused hard changes in my period also in both my daughters periods age 12 and 13; Caused hard changes in my period also in both my daughters periods age 12 and 13; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), MENSTRUAL DISORDER (non-serious), outcome "not recovered" and all described as "Caused hard changes in my period also in both my daughters periods age 12 and 13". Therapeutic measures were not taken as a result of menstruation irregular, menstrual disorder. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110603 Same reporter, Different patient
Fainted, within 1-2 minutes after vaccine administered. Cold compress to neck and cold water.
This is a spontaneous report from a contactable nurse. An 81-year-old female patient was accidentally administered PREVENAR 13 intramuscularly into the right shoulder at 1400 hrs on 01Nov2011 for immunization along with a dose of FLUZONE intramuscularly, into the left shoulder. Relevant medical history included hyperlipidemia, hypothyroidism, glaucoma, and cardiac dysrhythmia. Relevant concomitant medications included XALATAN eye drops and ALPHAGAN P for glaucoma, ZOCOR 40mg for hyperlipidemia, levothyroxine 100mcg for hypothyroidism, aspirin 325mg, vitamin E, MOTRIN and calcium. No adverse event was reported. The outcome of the event was unknown.
Skin rash whole and flare; lower eye lid: have some erythema and swelling.
-First 4 days after the vaccine, I had a severe headache that wouldn't go away. -I've had a debilitating headache daily ever since.  I've been taking Excederin or Advil a couple of times a day to be able to function.  Note:  In my entire life, I had previous to the vaccine only experienced a headache twice.   -A month after the vaccine, (April 2021),  I could feel a dump & divet in the front part of my head, which continues to expand this date.  I now have a dent that is expanding to my forehead.   -In late June, I experienced a type of shoulder paralysis.  Nothing that I did contributed to this. - A day later, I sought out a Chiropractor and she was able to get it where I could move it, but the pain was still there and now in my back shoulder blade area going up my neck.  This is the first time I had experienced anything like this. -I went back a second time and she took x-rays.  On my third visit, she said that the x-rays showed a tumor in my upper right arm.  At that point, she was concerned about treating this without additional information.  She recommended that I see my Physician.  I do not have Healthcare and don't have a Physician. -I've been back a number of times, just to get a little relief.   -The headaches have gotten much worse with little relief and the divet is now a dent in my head, expanding to my forehead.  The tumor in my arm seems to be getting more pronounced.
right eye twitched and fluttered for 3 days and then on day 3 right jaw and part of right eye started going numb, even causing a little speech stuttering; later on day 3 right arm and shoulder also went numb and was painful. went to ER because doctor on demand instructed to. due to possibility of a stroke; ER dr ruled out stroke and diagnosed bells palsy; signs/symptoms completely resolved next day
No adverse event; Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022).    No concomitant medication was reported.  It was reported that 4 doses of the Moderna Covid-19 vaccine were administered on 18-JUN-2022. 3 doses of Moderna Covid-19 vaccine were administered on 22-June-2023. No treatment information was reported.  This case contains information for patient 1 out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-731896, US-MODERNATX, INC.-MOD-2023-731899, US-MODERNATX, INC.-MOD-2023-731901, US-MODERNATX, INC.-MOD-2023-731900, US-MODERNATX, INC.-MOD-2023-731898, US-MODERNATX, INC.-MOD-2023-731897 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731896:Patient 2 (18-JUN-2022) US-MODERNATX, INC.-MOD-2023-731899:Patient 5 (22-JUN-2023) US-MODERNATX, INC.-MOD-2023-731901:Patient 7(22-JUN-2023) US-MODERNATX, INC.-MOD-2023-731900:Patient 6 (22-JUN-2023) US-MODERNATX, INC.-MOD-2023-731898:Patient 4 (18-JUN-2022) US-MODERNATX, INC.-MOD-2023-731897:Patient 3 (18-JUN-2022)
Breakthrough COVID case 27 July 2021 for 14 days Five days of high fever treated with Tylenol. No hospital stay. Lost smell, which returned a couple of months later. No loss of appetite. Extreme fatigue. After 14 days, returned to normal.
Patient came into pharmacy on 10/31/2020 and stated his arm was still hurting from his flu shot on 10/17/2020. He said he felt the pain immediately upon getting the injection on 10/17/2020.  He took photos of the injection site and called his physician, who said it might possibly be SIRVA. Patient has not been physically seen by a physician at this time. He states he still has pain in the shoulder  and movement that is restricted by pain
Pt approximately 20 minutes after vaccine was light headed, had seizure for 5 seconds. Pt was still in office.
Stomach ache, intense headache, faint, sweating, paleness,  drop in body temperature.
She also mentioned that the first shot hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She also mentioned that the first shot hurt) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032MZ0A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    On 19-Mar-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 VACCINATION SITE PAIN (She also mentioned that the first shot hurt). At the time of the report, VACCINATION SITE PAIN (She also mentioned that the first shot hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Tylenol and Ibuprofen were used as both concomitant and treatment medications   This case was linked to US-MODERNATX, INC.-MOD-2021-081232 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081232:CROSSLINKED WITH DOSE 2
Pain in lower lungs, diaphragm, and/or abdomen when breathing; fever; chills; fatigue.
Patient demonstrated signs of dizziness, nausea and feeling chills roughly five minutes after administration of vaccine. Patient became dizzy enough to lose balance and fall after attempting to stand up. At this point, EMT services were called in as a precaution. As EMT services arrived, patient felt potential difficulty breathing. After discussion with EMT team, epinephrine was not administered immediately; patient received an injection of Benadryl and then was transported to hospital.  From second hand information obtained , the patient has been stabilized and is feeling better following their trip out to the hospital. No official paperwork or direct contact with the patient has been made at this time.
Shortness of breath and increased heart rate started 3 days after vaccination. Symptoms after a week, continues.
Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, VACCINATION SITE REACTION (Covid arm) 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
Pt seen in office for 11yr PE. Requiring 5 vaccines. Mom wanted to pt to receive them all. All 5 admin. pt told to wait x 15 min post vaccine. Pt stood up and walked to other side of room. 1 min later pt fell over & hit head on wall. Eye deviation & circumoral cyanosis, came to quickly after MD in to assess. Rescue called. Take to ER.
Patient received fluzone HD at 9:30AM on 9/22/21. Experienced redness and swelling at injection site that was 2 inches in diameter. 24 hr later had uncontrolled vomiting and diarrhea and chills. Pt called ambulance and was assessed by EMS, but was not taken to hospital. She called today and said symptoms had improved to some degree.
DIED AFTER RECEIVING THE JAB; HEART DAMAGE; This spontaneous report received from a consumer via social media  from a company representative concerned a female of unspecified age, race and ethnicity. 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 (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that patient (reporter's great aunt) experienced " heart damage and died after receiving the jab". On an unspecified date, the patient died from unknown cause of death and it was unspecified whether an autopsy was performed.(Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of heart damage was not reported. This report was serious (Death). This case, from the same reporter is linked to 20211260953, 20211261664  and 20211261168.; Sender's Comments:  20211260743 -covid-19 vaccine ad26.cov2.s- Died after receiving the jab. This event(s) is considered unassessable. The event(s) 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(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
I took the shot on Friday, 11/9/00, and on Saturday, 11/10/00, I got up to go to work at 11:15 and I was dizzy and had a bad headache, which lasted several days and still comes back sometimes in the morning when I awake. I had double vision, which is still with me. I was admitted to the hospital and had tests. 60 day follow-up states the pt's right eyeball is still sore to the touch. The pt has a tendency to cry when he gets emotions. The pt now has to the restroom during the night.
welts; injection site redness; injection site pain; headache; A spontaneous report was received from a consumer concerning a 57- year old-white-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site urticaria,injection site erythema,injection site pain and headache.  The patient's medical history was not provided.No relevant concomitant medications were reported.   On 11-Jan-2021,prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch 026L20A) intramuscularly on right arm for prophylaxis of COVID-19 infection.  On 11-jan-2021,the patient experienced injection site was red and was very sore and had a welt. she did get a headache then everything went away and she felt great. Then on the 20Jan2021 the site became red again but was not sore but the size became the half dollar. No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the events injection site urticaria,injection site pain and headache was considered as resolved at the time of the report.The outcome of the event injection site erythema was considered as not resolved at the time of the report
red bumps/ looked fluid filled.; Red bump; Burning sensation all over skin; very tired; itchy all over; small bumps on her arm; fever; under the weather; This case was reported by a nurse via sales rep and described the occurrence of generalized pruritus in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2021, the patient received the 1st dose of Shingrix. On 7th August 2021, 30 min after receiving Shingrix, the patient experienced generalized pruritus, papular rash, fever and feeling unwell. On 8th August 2021, the patient experienced burning sensation, tiredness and red rash. On 9th August 2021, the patient experienced vesicles. On an unknown date, the outcome of the generalized pruritus, papular rash, fever, feeling unwell, burning sensation, tiredness, vesicles and red rash were unknown.   It was unknown if the reporter considered the generalized pruritus, papular rash, fever, feeling unwell, burning sensation, tiredness, vesicles and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced itching all over and small bump on arm 30 minutes after vaccination. By evening very itchy with fever and under the weather. Next day the same. Burning sensation all over skin, very tired.  Then red bumps appeared on both arms. Two days after vaccination, the bumps spread to torso, abdomen and back and looked fluid filled.
Pneumococcal 23-valent vaccine (MFR Merck Co, Inc.; LOT K021881; EXP 07/30/2016) administered via intravenous injection (IV push) into left hand peripheral IV, rather than intramuscular injection (IM).  No reactions/adverse events documented in the medical record or reported to pharmacy by nursing.
Narrative:  COVID infections following completion of COVID vaccine series 02/16/21 COVID vaccine dose #1 03/09/21 COVID vaccine dose #2 06/11/21 COVID preop test - COVID NEGATIVE 07/24/21 COVID preop test - COVID POSITIVE; asymptomatic 08/04/21 Pt remains asymptomatic; quarantine end
Large, red swollen area about 3 inches in diameter located below her deltoid muscle. She said she was experiencing pain 05/05/2018 Saturday after receiving the shot, but the pain had improved some. She also stated that it feels hot.
random on and off nose bleeds since receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (random on and off nose bleeds since receiving the vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Cancer (cancer survivor.). Concomitant products included FLECAINIDE, ATORVASTATIN, MONTELUKAST SODIUM (SINGULAIR), METFORMIN, RABEPRAZOLE SODIUM (ACIFIX [RABEPRAZOLE SODIUM]), TELMISARTAN, SEMAGLUTIDE (OZEMPIC), RIVAROXABAN (XARELTO) and LIRAGLUTIDE (SAXENDA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (random on and off nose bleeds since receiving the vaccine). At the time of the report, EPISTAXIS (random on and off nose bleeds since receiving the vaccine) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.       No treatment medication was reported. Patient inquired about side effects which she experienced after receiving both doses of Moderna COVID-19 vaccine. The patient mentioned that she never had nose bleeds in her life. The patient spoke with her doctor once back in April-march2021 and the doctor said it might be a result of dry weather. The patient would be seeing the MD in 2 weeks.
Severe chills, fever, headache, vomiting, flu like symptoms, unable to eat or get up