chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ash developed in same arm and about my back and upper chest/all on the same side as that 2nd injection; Skin tenderness/all on the same side as that 2nd injection; ash developed in same arm and about my back and upper chest/all on the same side as that 2nd injection; Post herpetic neuralgia; diagnosed as shingles; This non-serious case was reported by a consumer and described the occurrence of injection site rash in a 62-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 03-JUL-2023, the patient received the 2nd dose of Shingles vaccine (right deltoid). On 07-JUL-2023, 4 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: diagnosed as shingles). In AUG-2023, the patient experienced post herpetic neuralgia (Verbatim: Post herpetic neuralgia). On an unknown date, the patient experienced injection site rash (Verbatim: ash developed in same arm and about my back and upper chest/all on the same side as that 2nd injection), injection site tenderness (Verbatim: Skin tenderness/all on the same side as that 2nd injection) and rash (Verbatim: ash developed in same arm and about my back and upper chest/all on the same side as that 2nd injection). The patient was treated with gabapentin and paracetamol (Tylenol). On 04-AUG-2023, the outcome of the shingles was not resolved. The outcome of the injection site rash and rash were resolving and the outcome of the injection site tenderness and post herpetic neuralgia were not reported.   It was unknown if the reporter considered the injection site rash, injection site tenderness, shingles, post herpetic neuralgia and rash to be related to Shingles vaccine.     It was unknown if the company considered the injection site rash, injection site tenderness, shingles, post herpetic neuralgia and rash to be related to Shingles vaccine.   Additional Information: GSK receipt date: 4-Aug-2023 This report was submitted via the online direct entry reporting system. The patient received the 2nd injection and had skin tenderness developed 72 hours later under that arm. Rash developed in same arm and about her back and upper chest. All adverse event occurred on the same side as that 2nd injection.  The physician diagnosed as shingles and treated the patient as such.  Rash is healing but the patient had severe post herpetic neuralgia and was concerned that it would last a long time.  The patient was convinced the vaccine gave her shingles. The reporter consented to follow-up.
Information has been received from a registered nurse, for the pregnancy registry for GARDASIL concerning a 26 year old female with drug hypersensitivity to AMOXIL who on 26-JUL-2007 was vaccinated with the first dose of GARDASIL (lot n. 657868/0523U), 0.5 mL, intramuscularly.  On 30-JUL-2008, the patient was vaccinated with the second dose of GARDASIL (lot n. 0250X) 0.5 mL, intramuscularly.  On 12-SEP-2008, the patient experienced cramping and bleeding.  The nurse reported that the patient had a miscarriage after receiving GARDASIL.  LMP occurred on 08-JUL-2008.  On 17-SEP-2008, an ultrasound was done with no fetal heart beats.  She "passed" the fetus on her own.  The patient saw the physician.  A pregnancy blood work was done but the results were not provided.  Subsequently, the patient recovered on an unspecified date.  Upon internal review miscarriage was considered to be an other important medical event.  Additional information has been requested.
In the days after my first covid shot, the number of bowel movements started to climb from 15 a day to over 30 a day.  I also developed difficulties with urination and a sense of urgency.  By the time of my second shot, I was seeing blood in my stool.  The first shot may have triggered an infection or sever inflammation in my small intestines, as I had my large intestine removed in 2015.  My doctor asked me to report this as other of his patients have seen similar issues.
Just a very sore arm for a while, lasted of couple a weeks; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (just a very sore arm for a while, lasted of couple a weeks) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced MYALGIA (just a very sore arm for a while, lasted of couple a weeks). At the time of the report, MYALGIA (just a very sore arm for a while, lasted of couple a weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) High- Before vaccination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient said that last summer went to ER because a problem with intestines and that white blood cells high (before vaccination) so was taking medication for that. Patient did not take medication to treat symptoms. No Concomitant medications were provided.
It seem to really aggravate weak spots in body. Felt like a horse kicked me in back of neck where I had spinal stenosis surgery.; It seem to really aggravate weak spots in body. Felt like a horse kicked me in back of neck where I had spinal stenosis surgery.; Just tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 15:15 (Lot number: EB6203) at the age of 67 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Azythromycin, reaction(s): "azithromycin allergy", notes: Yes, arithomyacin. The following information was reported: FEELING ABNORMAL (non-serious), NECK PAIN (non-serious) all with onset 20Feb2021 20:00, outcome "recovered" (21Feb2021) and all described as "It seem to really aggravate weak spots in body. Felt like a horse kicked me in back of neck where I had spinal stenosis surgery."; FATIGUE (non-serious) with onset 20Feb2021 20:00, outcome "unknown", described as "Just tired". Therapeutic measures were taken as a result of feeling abnormal, neck pain included Ibuprofen and it was fine next day. Therapeutic measures were not taken as a result of fatigue.  Additional information: Patient had no covid prior vaccination and did not take any vaccine with in the four week of vaccination.  No follow-up attempts are possible. No further information is expected.
Vomiting & fever up to 101. Vomiting last less than 12 hrs fever lasted 24 hours - treated with TYLENOL. She was put on clear liquid diet for 24 hours.
pt presents to ED with c/o generalized weakness, cough, fever, chills, myalgias x 1 wk; tested positive for COVID in ED; treated with Decadron; developed bilateral pneumothoraces and mediastinal emphyysema; required intubation as condition worsened; developed a PEA arrest with ROSC time of 10 min; required operative repair of a bleeding vessel (right hemothorax); pt's condition deteriorated; was made a DNR and expired shortly afterwards.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored LIQUID PEDVAXHIB (lot # K016964, EXP date 17-JUN-2017, dose and route not reported). No adverse effects was reported. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse practitioner via a field employee referring to a 12 years and 4 months old patient of unknown gender. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot#N026814 with expiration date 15-JUL-2020, dose detail and route were not reported) for prophylaxis. On the same date, an unspecified amount of time after received GARDASIL 9, the patient experienced fever, vomiting and lethargy. The outcome of events and the causality assessments between the events and GARDASIL 9 were not reported.
Given Dtap and Varicella in right upper arm on 7/18/17 followed by local erythema and induration over a 4-5 cm area of upper arm. No Systemic fever. Reaction seems to be subsiding with less redness and puffiness. Also has had diarrhea for 1-2 days.
WITHIN 48HRS DEVELOPED LOCALIZED REDNESS AND SWELLING IN RIGHT ARM, FEVER, MALAISE, MYALGIAS. REACTION OCCURED AT THE SITE OF PNUEMOVAX INJECTION
Patient reports burning inside her head with periods of zapping equivalent to the feeling of nerve pain inside her head. Burning sensation also radiating how her neck and into her shoulders. However burning sensation and zapping in head has been present since 1/23/2021. Pt also stated right temporal tenderness after vaccine that has not resolved.
It was discovered the pfizer vaccine was not removed from the freezer to the refrigerator after 14 days in the freezer.  After contacting Pfizer, the vaccine was not viable after 17 days.  The vaccine was administered to the patient after the 17 day timeframe.
Pharmacy administered vaccine that had been refrigerated for over 30 days, max recommended by Moderna. The vaccine lot was placed in the refrigerator on April 13, 2021 and administered on 5/25/21, 42 days after 1st placed there. Pharmacy called Moderna but was given no further information about stability and no recommended course of action. Patient was notified of the event, and there has been no adverse reactions to the vaccine. Pharmacists on staff decided not necessary to revaccinate the patient for that 2nd dose.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 27-SEP-2016, the patient was inadvertently administered with a dose of PROQUAD, (route: subcutaneous) and a dose of M-M-R II. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Redness on arm around area MCV-4 was injected. Place warm compress on arm every 4 to 6 hrs PRN.
Patient or patient's representative registered online to receive their first dose of Moderna Covid19 vaccine. The patient was 16 years old, rather than the minimum age of 18 required to receive the Moderna brand vaccine. Pharmacist administering vaccine did not realize patient was under the required age and administered the dose. Patient did not experience side effects from the vaccine. Local Department of Public Health contacted the pharmacy 3 days later to point out the error after reviewing the local Immunization Registry. Pharmacy contacted patient's father to explain error and prepare them to select the Pfizer vaccine when registering for their second dose. Patient's father was understanding. Pharmacy subsequently updated their online form to show eligible patient age range in parentheses for each brand of Covid19 vaccine offered.
Extreme chest pain, shortness of breath. 800 milligrams of Motrin every 4 hours. Pain was relieved after treatment.
shortly p/receiving vax pt exp urticaria followed by fever, chills & diarrhea; local soreness @ inject point;
weakness and fallsNarrative:  95 yo male w/ a PMH significant for Afib, legal blindness, Hx of CVA, cognitive impairment, GERD, HTN, pseudogout, BPH, chronic knee infection, and DJD who received his first dose of the Moderna COVID-19 vaccine on 01/08/21. The pt's COVID-19  screening questionnaire prior to receiving the vaccine was negative. The pt presented to the ED on 01/13/21 for weakness and m  PCR test on ultiple recent falls (since receiving his first dose of the COVID-19 vaccine). The pt's COVID-19 01/13/20  was positive and he was admitted. He was started on treatment with remdesivir + dexamethasone on 1/14. The pt initially required supplemental oxygen via low-flow NC, however his oxygen requirements increased to 100% NRB. On 01/16/21 his MPOA elected for hospice care.  The pt passed on 01/17/21. Unclear if the COVID-19 vaccine attributed to the patient's hospitalization and eventual death, or whether these events occurred from COVID-19 itself, however this case is being reported the FDA since this vaccine is under an emergency use authorization (EUA).
pt stated "i took shingles vaccine and pneumonia and either had a reaction to vaccines or caused psoriasis to act up. it caused extreme itching all over including scalp. it took about 3 weeks to settle down." no other information available at this time
Cluster of cold sores on the exterior corner of the mouth; This is a spontaneous report from a contactable consumer (patient).   A 38-years-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205, age at vaccination 38 years), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 as 1st dose, single for covid-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination and covid tested post vaccination. On 11Mar2021, the patient experienced Cluster of cold sores on the exterior corner of the mouth appeared about 36 hours after the shot. It was reported that patient did not have history of cold sores or fever blisters. Did not run a fever. Treatment medications include Abreva topical. The outcome of event resolving   No follow-up attempts are possible. No further information is expected.
1. Heart inflammation for about 1 month after the 1st shot. It was occasionally quite painful to fully inhale. 2. Heart palpitations for about 3 days. Some skipped beats followed by big pumps.  Both symptoms started ~3 days after the 1st shot. I did not get a 2nd shot due to these severe side effects.   I also experienced flu-like symptoms about 18 hours after the vaccine, but those completely went away after another 12 hours.
Headache;fever;nausea;vomiting;body aches;exhaustion; Was seen by Emergency Room Department-given IV to start hydration and Zofran. Saw Family Doctor for Lump under right arm - could be due to vaccine -have a  scheduled mammogram & ultrasound as follow up on Lump.
Red in face, head jerking, foaming at mouth, limp x 5 minutes.
pt devel inconsolable high pitched screaming for approx 5 hrs p/vax; inject site were not reddenned; no temp; mom gave APAP q 4 hrs;
The pt experienced blisters on left leg and arms on 3/6/00. The pt received immunizations on 3/1/00. Instructed to monitor and notify us if worsens. May use Caladryl topically.
Day #3 post vaccine 12/2/03: headache/sore throat. Day #4 post vaccine 12/3/03: body aches and fever. Day #5 nasal discharge/chest congestion.
I suddenly broke out in a total body rash which started on my arms and then went all over my body. Sudden and very itchy and red like I was on fire. I took 50 mg of Benadryl and slathered myself in cortisone 10 cream   After an hour now it is still very itchy and red although less so.  I have not ate or drank anything different. I have not used any different detergents, soaps, etc.
ACTIVATED KIDNEY CANCER STAGE 4; PARALYZED AFTER TAKING JANSSEN COVID 19 VACCINE; JANSSEN COVID 19 VACCINE JUST TOOK LIFE; LOST WEIGHT; This spontaneous potential legal report received from a patient concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 19-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: left kidney removed, and concurrent conditions included: kidney cancer stage 4, and kidney cancer metastasized into right hip. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total, dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, Laboratory data included: Computerized Tomography (CT) scan normal which showed no activity with the tumor. On an unspecified date (after receiving the vaccine), the patient was paralyzed for a whole week and he had lost weight. On an unspecified date (within 4 months after vaccination), the patient experienced growth of full additional tumors from the original one and had a feeling that cancer got activated (activated kidney cancer stage 4). The patient also reported that he felt as Janssen Covid-19 vaccine just took his life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralyzed after taking janssen covid 19 vaccine, and the outcome of activated kidney cancer stage 4, janssen covid 19 vaccine just took life and lost weight was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211033874-COVID-19 VACCINE AD26.COV2.S-Activated kidney cancer stage 4. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY V0 20211033874-COVID-19 VACCINE AD26.COV2.S-paralyzed after taking janssen covid 19 vaccine. 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).
28 hours post vaccination, patient developed a generalized varicella like rash. She describes the rash as not being itchy but the lesions sting. no other symptoms noted. as of 10/05/2007, she continues to develop new lesions. Some of the lesions are fluid filled, others just red and raised. her family doctor prescribed famvir.
pt recvd vax; devel mycobacterial pneumonia;f/u md stated rxn not related to vax;md clarified that pt devel mycoplasma pneumonia;
Initial nurse report received on 16 Dec 2009: This child (under 4 years) inadvertently received a 0.5 ml IM dose of FLUVIRIN on an unspecified date. No adverse effects were noted upon administration.
Muscle ache in left arm/soreness in left arm; heaviness in left arm; headache off and on on right side,brain hurt in the back left side of head; muscle tension in left side of neck; 2 boil in buttocks; This is a spontaneous report from a contactable healthcare professional (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date not reported), intramuscular at the left arm on 29Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included high cholesterol, obesity and arthritis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 03Feb2021 03:00, the patient experienced muscle ache in left arm, heaviness in left arm, soreness in left arm, headache off and on on right side, brain hurt in the back left side of head, muscle tension in left side of neck and 2 boil in buttocks. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 11Jan2021. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering.
pt recv vax 11FEB98 & on 18FEB98 devel itching, redness 8 1/2" x 3", swelling to inj site, mild pain, able to walk;given in lt buttock;no fever;severe local rxn;
UTI (Urinary Tract Infection); A spontaneous report was received from a 79-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (UTI).  The patient's current history included fibromyalgia and lymphoma. No relevant concomitant medications were reported.  On 30 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch No.007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date (weeks after the vaccination), the patient experienced urinary tract infection after receiving first dose of vaccination. On an unspecified date, she also reported that she felt better.  Action taken with mRNA-1273 in response to the event was unknown.  The event, urinary tract infection, was considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.  Elderly age, female gender and underlying lymphoma are considered risk factors.
Several hours after injection, started feeling like coming down with something (a little scratchy throat). For the 2 wks since, have been dealing with achy joints on and off, H/A early on, congestion, runny nose. 2 weeks later, still have dry non-productive cough, stuffy ears. Felt fine prior to vaccine.
Large red, hot lump at shot site, fever, fussiness, vomiting, behavior change such as sudden screaming for no reason (not hurt from falling or something). Treated with warm bath, Tylenol, holding him and trying to keep him calm.
Fever, body aches, severe pain in the injection site for over 24 hours, axillary pain and swelling and general malaise
Swelling arm; Hardness; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling arm), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling arm), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE SWELLING (Swelling arm), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
swelling upper eyelids; redness to the upper eyelids; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING OF EYELID (swelling upper eyelids) and ERYTHEMA OF EYELID (redness to the upper eyelids) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) from 04-Feb-2021 to an unknown date for an unknown indication.    On 19-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 SWELLING OF EYELID (swelling upper eyelids) and ERYTHEMA OF EYELID (redness to the upper eyelids). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, SWELLING OF EYELID (swelling upper eyelids) and ERYTHEMA OF EYELID (redness to the upper eyelids) had not resolved.        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.