chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling; numbness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness). At the time of the report, PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter.  Company Comment: Very limited information regarding these events have been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow-up information included the addition of an additional serious event which initially indicated that the case should be upgraded, however, AI confirmed to remove the serious event. Narrative updated accordingly.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
Face was red and blushy; face was warm to the touch; Itchiness all over body; Pain at injection site; Felt coldness/chills; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face was red and blushy), FEELING HOT (face was warm to the touch), PRURITUS (Itchiness all over body), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Felt coldness/chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Sulfur), Type 2 diabetes mellitus and Drug allergy (allergic to Macrobid). Concomitant products included METFORMIN for Type 2 diabetes mellitus, LEVOTHYROXINE SODIUM (SYNTHROID), POTASSIUM CITRATE, ALLOPURINOL, HYDROCHLOROTHIAZIDE and METHENAMINE HIPPURATE for an unknown indication, METOPROLOL SUCCINATE.    On 08-Jan-2021 at 7:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced FLUSHING (Face was red and blushy), FEELING HOT (face was warm to the touch), PRURITUS (Itchiness all over body), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Felt coldness/chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 08-Jan-2021, FLUSHING (Face was red and blushy), FEELING HOT (face was warm to the touch), PRURITUS (Itchiness all over body), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Felt coldness/chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient and husband had the same vaccines. Felt fine afterwards. By the third, she had some soreness, progressively got worse to the point where she couldn't lift her arm. Very uncomfortable. Pain went down arm to the fingertips. Thought that it could have hit a nerve. The spot at the injection is sore into the left breast. She has had a double mastectomy. Feeling kind of lumpy in the arm.
lethargy, fever, vomiting, currant jelly colored mucousy stools / confirmed proximal transverse colon intususception. 09/02/2008 MR received for DOS 8/7-8/2008 with D/C DX:  Intussusception. Pt presented with 1 day hx of fever, vomiting and dark colored emesis as well as dark, foul smelling stool. In ER had Guaiac (+) currant jelly stool. Transfered to higher level of care.  IS of the transverse colon was dx and reduced by air contrast enema.  Pt remained stable, po progressed and d/c next day.
A Pharmacist reported that over the weekend an expired dose of MENACTRA was given to a consumer with no reported adverse event; Initial information received on 15-May-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old patient of an unknown gender and a pharmacist reported that over the weekend an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] was given to a consumer with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in May 2023, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE for solution of injection (strength, frequency: not reported and expiry date: 24-apr-2023, lot: U7273BB) via intramuscular route in the arm NOS for immunization and a pharmacist reported that over the weekend an expired dose of menactra was given to a consumer with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No relevant concomitant medications were reported. On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccine was administered. Reporter was not aware of any AEs after the vaccines were given. No treatment medication reported.   This case refers to patient-14 out of 26 patients.
Within 15 minutes of receiving vaccine pt felt itchiness at injection site, after about 9 hours pt started to feel swelling, redness, itchiness, pain, headache, temp of 99.4F and lymphadenopathy in left armpit lymph node worsening over past 19+hours w/ history of similar local site reactions to flu shot, mgc vaccine, and most recent rabies/jev vaccines in preparation for upcoming deployment. pt took atarax prior to receiving vaccine w/o any relief.
Starting two days after the first shot I had tingling in the hands and feet for 2 weeks. As well as daily migranes (while I do suffer from migranes they were never this bad) i also started to get back pain. After 2 weeks passed the tingling went away and the migrane frequency went back to somewhat normal. However I developed Massive neck pain to the point I couldn't turn my head without pain. After a month of different medications including steroids they had me try physical therapy. After a few weeks in physical therapy the pain started to go down. I was still suggested by my doctor to get the second dose (got the 2nd beginning of June) That set me back a week or two of physical therapy because the pain shot right back up again (proving the vaccine caused these issues). I had physical therapy for almost 2 months. It got it down to the point where the pain was almost gone and I could atleast turn my head without being in hellish pain. That was around the end of July. However a new problem arises now that the muscle swelling is down, everytime I move my arms or head I get a popping in my spine and neck. By the middle of august the neck pain is starting back up again. I never in my life had this pain before. I never had these issues before until I took the vaccine.
Sore arm; Itchy 3"x2" rash around location of injection; Itchy 3"x2" rash around location of injection; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8730) via an unspecified route of administration in the left arm on 26Mar2021 at 10:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took macrobid and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, one week post vaccination, the patient experienced sore arm for 3 days and itchy 3"x2" rash around the location of injection which lasted for about 4 to 5 days. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore arm was resolved on 05Apr2021 and itchy rash around the location of injection was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Information has been received regarding a case in litigation from a lawyer and the spouse of a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, as recommended for routine adult health maintenance for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of persistent strain condition of herpes zoster/shingles and ZOSTAVAX did not prevent shingles as intended is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The patient died on 07-JAN-2017; cause of death not provided. It is unknown if an autopsy was performed. Upon internal review, death was determined to be medically significant. Additional information has been requested. Reported Cause(s) of Death: Death.
Arrived home at 5pm and felt sluggish and wife commented that I didn't seem to be in a good mood. About 9:00 pm I got chilled and went to bed at 9:30, the chilling and headache continued and I got up about 3:00 am. I took 1000 mg of acetaminophen. I took my temp and it was 101 degrees. My chilling and fever gradually subsided until around 730 am. Not much sleep last night!
Pain, bruising and hardness to an area on my medial lower thigh.  It was a blood clot in my leg. I never had a blood clot. I saw a vascular surgeon and started wearing compression socks. The bruising is still there but the pain and hardness went away.
TINGLING IN RIGHT LEG AND FOOT; NUMBNESS ON RIGHT LEG AND FOOT; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced tingling in right leg and foot. On 06-APR-2021, the subject experienced numbness on right leg and foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in right leg and foot, and numbness on right leg and foot. This report was non-serious.
redness at injection site; warm at the injection site; red arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 3rd July 2019, the patient received the 1st dose of Shingrix .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and erythema of extremities. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site erythema, injection site warmth and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient was asking about how to manage a very large red and warm patch at the administration site. The redness was about 4 inches by 3 inches wide and it started where the vaccine was administered and going down her arm. The pharmacist recommended Tylenol.
BAD REACTION; This spontaneous report received from a consumer concerned a female 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious.
nausea, chills, fever, diarrhea, classic flu sxs, h/a for 48hrs p/vax
A couple days after receiving the vaccine, I started getting small red bumps on my back arm pits and upper chest area. I thought it was heat rash, but it kept getting worse I have had heat rash, but this was clearly different. It turned out to be shingles it was itchy and stung and filled with pus and then it scabbed over. I figured it had to be more than heat rash. I called two doctors which they verified that it was. Doctor which prescribed the ointment cream. I understand that shingles can come on its own I feel that I am too young to get it. I don't know anyone that had shingles and I wasn't around anyone to even catch. I saw that it was documented in medical journals for women with autoimmune disorders to get shingles after the vaccine. It's interesting to know that the cream is used for spiked protein. My natural doctor tried to keep the spiked protein down. I understand that vaccine doesn't produce the virus but activates it. Thankfully I was able to treat it within month, but I was taking medications and the topical creams together to treat the shingles. I had at least 30 band aid all over because of the ruptures. I did everything. I am unlikely to get a booster because of shingles.
Case number PHEH2014US018497, is an initial spontaneous report from a pharmacist received on 14 SEP 2014. This report refers to a 75-year-old male patient. Historical conditions were not reported. No concomitant medications was reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) subcutaneously on 14 SEP 2014. No adverse reactions had occurred since the maladministration (inappropriate route of vaccination).
Received five vaccines IM on 12/26 then developed flu-like symptoms the following day. Expired on the AM 12/29 at home.  Nurse follow up on 06/21/04 states: "Fever, URI, Rhinitis."
lightheadedness; soreness; itching; redness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), PAIN (soreness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIZZINESS (lightheadedness), PAIN (soreness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, DIZZINESS (lightheadedness), PAIN (soreness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sore arm shortly after administration.  Soreness continued into evening and developed headache within a few hours. Sleeping was uncomfortable due to sore arm and restlessness. Next day very sore, headachy and tired.  Stayed home from work and slept a lot. Headache and sore arm subsided within a 3-4 days. Next days following some minor headaches and tiredness.
first dose > 35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). On 26-Mar-2021, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product were reported  No treatment information was provided.
This case was reported by a healthcare professional via sales representative and described the occurrence of not responding to therapy in several subjects of unspecified ages and gender who were vaccinated with ENGERIX B. On unspecified dates the subjects received complete series of ENGERIX B (unknown). At an unspecified time after vaccinations with ENGERIX B, the subjects experienced not responding to therapy. Six weeks after completing the ENGERIX B vaccination series, the subjects titers were drawn and did not show antibodies (hepatitis B antibody negative). At the time of reporting the outcome of the events were unspecified.
Pt is roughly 7 weeks pregnant and has been experiencing 4 weeks of local pain (10/10) with decreased  ROM. I evaluated her virtually and there is no: swelling, bruising, or skin/ joint abnormality. Passive ROM was not evaluated given the exam was done virtually.
The patient was given 0.3 ml of undiluted Pfizer vaccine on 10/27/21. The patient was notified 11/4/21. He reports that he had fatigue the following day on 10/28/21. No other symptoms. Continues to do well now.
I now have Lyme disease and a permanent arthritic condition because of Lymerix vaccine. All of above started shortly after Lymerix shot. Nurse follow up on 05/19/04 states: polymyalgia rheumatica (MYALGIA), leg cramps (CRAMPS LEG)
p/vax pt devel an inj site rxn characterized by redness, swelling & warmth;
I am experiencing a strong tingling in my left arm where I got the JJ vaccination. While its tingling my upper arm feels as if its being squeezed and I feel pain when it happens. Also it becomes numb to the point my arm is weak, and hard to lift. This happens through out my day, for the last 2wks.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On multiple unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB, following a temperature excursion (48 hours at 0 Celsius degree) that occurred in February 2015. A digital data logger (DDL) was used to track the temperature. No previous temperature excursion occurred. No adverse effects were reported. Additional information has been requested. This is one of several reports received from the same source.
Patient passed out twice while in office. No head injury noted. Observed in office for 15 minutes to ensure she recovered and was safe to leave. Note: Patient has history of syncope.
This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine (haemophilus B conjugate vaccine (diphtheria crm197 protein conjugate) injection) was received from a consumer regarding a male patient who experienced high mercury reading in blood. The patient received the third dose on unspecified date. Relevant medical history was not provided. Indication for Hib-Titer Vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine (diphtheria/tetanus toxoid/acellular pertussis vaccine) (Acel Immune) 3 doses. Concomitant medications were not reported. The patient experienced high mercury reading in blood (metal poisoning). No additional information was available at the time of this report. The reporter decline to grant permission for follow-up investigation.