chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cellulitis; post herpetic neuralgia; left ear pain; recurrent outbreaks of herpes zoster dermatitis; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 18-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered painful rash on right arm and has been diagnosed with recurrent outbreaks of herpes zoster dermatitis, left ear pain, cellulitis and post herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events recurrent outbreaks of herpes zoster dermatitis, left ear pain, cellulitis and post herpetic neuralgia was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events recurrent outbreaks of herpes zoster dermatitis, left ear pain, cellulitis and post herpetic neuralgia to be disability.  Upon internal review, the event cellulitis was determined to be medically significant event.
Patient with history of Acute Gastroenteritis 1/12/09-hospital records received for DOS 5/2-5/9/08-DC DX: Gastroenteritis. Urinary tract infection. Presented with C/O vomiting.
(L) upper arm to elbow red, swollen, painful, growing. Given BACTRIM & BENADRYL & see MD 1-2 days.
3 days post vaccination patient says she could not move her arm. She reported to her MD. Called the pharmacy 11/25/19
Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  Heplisav-B in prior hepatitis B vaccine nonresponders: a case series. Medicine.  24 September 2021. https://doi.org/10.1093/milmed/usab397  In a case series (2021), patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and with results of post-vaccination tests were collected from existing health records within the system.    Patient ID 3 received an initial hepatitis B series at 37-years-old and a second hepatitis B series at 41-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 43-years-old, the patient received the initial dose of Heplisav-B. The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Swelling, erythema, induration rt deltoid tender. Localized cellulitis Cephalexin 25 mg TID x 10 days.
Soreness at injection site; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported) via an unspecified route of administration, on 20Jun2021, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness at injection site on an unspecified date. It was reported that they expected the event and they knew about the arm tenderness at the injection site. The outcome for the event was unknown.  Information on batch/lot number has been requested.
Severe sore throat, runny nose, congestion, cough, body aches, weakness. "I've never felt this bad in my whole life".
been very confused; found myself having difficulty in remembering anything; low blood pressure is due to aneurysm; difficulty with breathing; difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back; don't have strength to lift anything; mouth is full of bumps; sore tongue; stomach is involved in the way that it is not getting enough oxygen supply; i am still stuck; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing) and RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing), RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back), ASTHENIA (don't have strength to lift anything), ORAL PAIN (mouth is full of bumps), GLOSSODYNIA (sore tongue), ABDOMINAL DISCOMFORT (stomach is involved in the way that it is not getting enough oxygen supply), FEELING ABNORMAL (i am still stuck) and FATIGUE (fatigue). At the time of the report, CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing), RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back), ASTHENIA (don't have strength to lift anything), ORAL PAIN (mouth is full of bumps), GLOSSODYNIA (sore tongue), ABDOMINAL DISCOMFORT (stomach is involved in the way that it is not getting enough oxygen supply), FEELING ABNORMAL (i am still stuck) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   This case was linked to MOD-2021-081681 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: The follow up received does not contain any new information.; Sender's Comments:  MOD-2021-081681:Second dose
Tdap vaccine was inadvertantly administered instead of DTap vaccine. No reactions noted at this time.
03/25/2021 That evening I had injection site discomfort. I also had aching muscles and exhaustion. It lasted for about 2-3 days after the shot. I continued having exhaustion for several weeks.
shakes, body aches, fever, pain in arm pit of the same arm vaccine was administered, neck pain,  pain shooting down arm with tingling in fingers (if arm vaccine was administered), pain in eyes, fatigue, headache
no adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. Patient received Moderna vaccine beyond the 30 day beyond use date. Beyond use date for lot was 17-Feb-2022 and patient received vaccine on 04-Mar-2022. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Non Significant follow Up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Redness and swelling at injection site after 4 hours. Pain extended from there down arm and then severe headache began within 8 hours. Muscle aches started in neck and went south around midnight on day of vaccination. Fever for 36 hours and only a few hours sleep over 48 hours.  Spent the entire time in bed. Better today, but feel weak.
Covid 19 breakthrough.  1st Vaccine received 03/12/2021.  Pt presented to ED from SNF with Rapid Afib, low potassium and +Covid19 infection.  Treated with IV ABX/Steroids.
Information has been received from a physician concerning a 7 year old female who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt had previously been vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and then received hep A virus vaccine inactivated for the second dose. Subsequently, the pt experienced swelling and inflammation. The physician reported that the pt sought unspecified medical attention. Additional information is expected.
soon after receiving first shot I started having issues with hearing clearly.  I could not understand conversations on phone.  I went to see my regular doctor about it and she referred me to ENT to have my hearing check.  I explained to them that my ears were making all sorts of sounds that no one else heard, again had a hard time hearing over phone which made my job diffcult.  I purchased some head sets to cancel out noise.  I was told I didn't have hearing loss but slight in right ear but doctor went on to explain that I have Tinnitus.  In my 62 years  I have never had anything like this.  This truly has effected my life in a negative way
Patient states there is a circle on her upper arm which is red. She also feels a lump under the  skin.
expired dose was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was administered) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was administered). On 25-Mar-2021, EXPIRED PRODUCT ADMINISTERED (expired dose was administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 010A21A)  with no associated AEs.
Achy; felt like she was getting the flu; Chills; some nausea; Patient did not sleep well; Her left injection site arm is still sore today/The patient had a sore arm; Patient was tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achy), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), POOR QUALITY SLEEP (Patient did not sleep well), VACCINATION SITE PAIN (Her left injection site arm is still sore today/The patient had a sore arm) and FATIGUE (Patient was tired) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 019H22A and A571853) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jul-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In July 2023, the patient experienced POOR QUALITY SLEEP (Patient did not sleep well), VACCINATION SITE PAIN (Her left injection site arm is still sore today/The patient had a sore arm) and FATIGUE (Patient was tired). On an unknown date, the patient experienced PAIN (Achy), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), CHILLS (Chills) and NAUSEA (some nausea). At the time of the report, PAIN (Achy), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), CHILLS (Chills) and NAUSEA (some nausea) had resolved, POOR QUALITY SLEEP (Patient did not sleep well) and FATIGUE (Patient was tired) outcome was unknown and VACCINATION SITE PAIN (Her left injection site arm is still sore today/The patient had a sore arm) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-734471 (Patient Link).
1550 c/o "not feeling well" Dry mouth light headed, chest pressure. VSS BP 221/110 HR regular 78, oxygen saturation 99%. Denies Hx of Htn. Refused Emt transport to the hospital. Waited 10 mins chest pressure, dry mouth, and lightheadedness resolved, BP remains elevated 195/112. Manual BP 187/110. Continues to refuse transport to the ER. Client husband present he states he will take client to the ER for evaluation. Client refused offer of W/C stated she is ok to walk. Client left with her husband
This spontaneous report was received from health care worker referring to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II which had not # L027591 and expiry date: 23-JUL-2017 (dosing details not provided). The vaccine had unspecified temperature excursion on 19-JUL-2016. No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
So I mean it was a while after but anyway, I got up in the morning on March 22 2021 and I just fainted. A few hours later I got nauseas and I felt like the room was spinning. I kept throwing up and I went to the ER. I stayed at ER and they diagnosed me with BPPV (basically vertigo).  I followed up with PCD and cardiologist and i went to physical therapy. I am also scheduled to see an endocrinologist. At the ER i was on necklozine and anti nausea meds.
1 hour post vaccine-felt "wierd", 24 hours later-myalgia, headache, nausea, soreness in neck, pain behind eyes, skin hurt, 48 hours after vaccine-headache, nausea (Rabies post exposure dose #1) Second dose on 11/09/2003- only slight neck soreness day following vaccination.
headache; chills; dizziness; Fatigue; unable to drive; This is a spontaneous report from a contactable consumer (daughter).   A 46-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 07Mar2021 11:30 am (Batch/Lot Number: EN6199) as single dose at the age of 46-year-old for COVID-19 immunisation, administered at School/Student Health clinic.   Medical history included ongoing diabetes mellitus, ongoing obesity. Family medical history included: asthma, diabetes, blood pressure. The patient's concomitant medications were none. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 14Feb2021 16:45 (Batch/Lot Number: EN5318) as single dose at the age of 46-year-old for COVID-19 immunisation and experienced chills, fatigue, headaches, dizziness and unable to drive on 14Feb2021 until the second day and recovered on 16Feb2021.  No prior Vaccinations. The patient experienced headache, chills, dizziness, fatigue, and unable to drive on 08Mar2021, all with outcome of recovered on 09Mar2021. No treatment received for the events. The patient underwent lab tests and procedures which included x-ray: knee cup bad shape on Mar2021 Being evaluated for knee surgery.   The course of events was as follows: Both times day after the shot was administered the body felt chills, Fatigue, headaches, dizziness unable to drive until the second day. No symptoms were present 2 days after the shot was administered.  No follow-up attempts are needed. No further information is expected.
Mom noticed 1st redness and swelling 9/16/03 and states much worse this AM - 10 x 7cm red hot area on arm at injection site.
5 days post vax, itching and rash after 4. Red at site. 1-2 mm raised papules with red cneter on upper back, chest, L thigh, abd.
receive as the 2 dose only a half dose; 1 dose: 1/15/2020 and 2 dose: 3/5/2021; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th January 2020).   On 5th March 2021, the patient received the 2nd dose of Shingrix. On 5th March 2021, unknown after receiving Shingrix, the patient experienced underdose and drug dose administration interval too long. On an unknown date, the outcome of the underdose and drug dose administration interval too long were unknown.   Additional details were reported as follows: The pharmacist reported a patient claimed to receive as the 2 dose only a half dose of SHINGRIX later than the recommended interval, which led to underdose and lengthening of vaccination schedule. The patient reported this situation now.  While being on hold pharmacist hang up, tried to call but didn´t answered.  The reporter consented to follow up.
pt who has a history of migraines felt earlier in the day that she may have a migraine coming on, so she took tylenol - post-covid-19 administration, she felt pain in the back of the neck and felt the aura worsening; I gave pt 2 ice paks and observed her for 15 minutes after which she started feeling better and rejoined her husband who had her purse and her migraine medicine in it.
Narrative:  01/20, Moderna, dose #1 02/16, Moderna , dose #2 11/03, Moderna , dose #3 10/04 pt cc: dyspnea, cough exposure: unknown 10/12 COVID swab, result: detected 10/14 clinically resolved
Following administration of vaccines, nursing noted that patient's face appeared red.  She looked like she was going to pass out.  Mother picked her up.  She appeared pale and was not responding.  Mother stated this lasted about 15 seconds.  She returned back to her baseline.  She was monitored in clinic, and appeared well.   She was sent home.
7cm area of swelling, redness, tenderness, and calor overlying deltoid at injection site
pt recv vax; claims a tumor has devel which is 2 square inches from vax site;
Pt experienced back pain, lump/ hardness under left armpit and sore arm the morning after her vaccine.
This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that it is possible that M-M-RR II (dose strength, route, was not reported) dose was administered to the patients on an unspecified date after a cumulative temperature excursion of 123 hrs at 10C. No adverse effect reported. The outcome of the events reported is unknown. No product quality complaint was involved. Nurse also informed that with multiple excursion for three different sites with the vaccine reported. Nurse requested letter of evaluation data by e-mailed to her. It was also reported that adverse event was filed as one site may have administered product involved in cumulative excursion. 51 hours at 10C M-M-R II No1.2C for 11 hours M-M-R II No excursion. This case is linked to the cases 1404USA015151, 1405USA005087, 1405USA005086 via same reporter link. Additional information is not expected.
Patient receiving rotavirus, hib, pcv13 and pediatrix at the same time, this morning. Reported redness and swelling of both legs.
This spontaneous report received from a pharmacist concerned a 67 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, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced incorrect product storage. On 03-JUN-2021, the subject experienced vaccine administered past the 6 hours frame inside the fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered past the 6 hours frame inside the fridge and incorrect product storage was not reported. This report was non-serious.
By april 2021 she started manifesting  nonspecific constituinal symptoms of runny nose, sore throat, fever, sneezing, recurrent till by 7/2021 primary physician did test for vasclitis relapse. pt had active urine sediment and  P anca levels were very  high at 1:640 and MPO was 27.  By  August  4, 20201, creatinine was up further to 1.2-1.3 gfr 47-59 when her baseline cr was 0.7-0.84 gfr 81. kidney biopsy was done on 8/6/21 sowed focal crescentic GN, pauciimmune type.  She relapse 17 years after being in remission. At age 15, she had prior epidose of P anca GN
5 days after receiving first dose of vaccine became extremely nauseated to the point of almost vomiting. From day 5 to the current day 8 I am dizzy and lightheaded throughout the day and find it hard to focus. I remain nauseated all day as well.