chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THE DAY  FOLLOWING VACCINATION I EXPERIENCED FATIGUE AND SORENESS AT THE INJECTION SITE.  THIS CONTINUED FOR FOUR DAYS.  AFTER FOUR DAYS MY RIGHT WRIST BECAME SWOLLEN AND PAINFUL. OVER THE NEXT FOUR WEEKS MY NECK,  RIGHT ELBOW, KNEES, LEFT WRIST, LEFT HIP AND RIGHT FOOT BECAME PAINFUL.  I DEVELOPED EDEMA IN MY RIGHT FOOT.  THESE SYMPTOMS ARE ARE GOING AND I CAN NOT CONDUCT ACTIVITIES SUCH AS PREPARING DINNER OR DRIVING.
I started having issues with my skin. I have been getting fungus infections, and black dots that I have never had to deal with ever in my life. I made an appointment with my primary care physician who referred me to the dermatologist. The dermatologist removed two of the black spots, said that we need to keep an eye on the one spot. They gave me an antibiotic ointment for the skin fungus and my belly button.
Gum bleeding, tooth pain, lower right jaw pain,  right side occular pain, right side ear pain. Painful to eat on right side of mouth.
Donor got Rabies immunization at 1:10pm. Went to wait 15 min in pherevis area after shot. Donor got up to walk away and fell on floor hitting head in two spots. Phleb tried to catch donor before he fell but was unable to catch him. Donor was staggering when walking.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 10-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided. No treatment information was provided.  The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed removed
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 27Mar2021 as dose 2, single (Lot number: ER8730), in right arm and on 13Sep2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Apr2022 at 14:00 as dose 4 (booster), single (Lot number: 003K21-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea" (unspecified if ongoing), notes: sleep apnea treated with CPAP; "obese" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: Antigen and PCR(friday swab) positive on Saturday; (04May2022) Negative, notes: Antigen and PCR negative on Wednesday. Felt fine; (05May2022) Positive, notes: Antigen positive on Thursday after last PAXLOVID does; (29Apr2022) Positive, notes: Antigen and PCR(friday swab) positive on Saturday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; No further information is expected.
On the 8th day following the vaccination, an itching was first noticed side effect, then as the day progressed,  a red circular mark on the upper left arm appeared..  A hardness to the spot was later noticed.  Over the next five days, the redness seemed to fade but the area expanded to approximately 3"x4".  Today, 9 days before my second Moderna shot, the pink mark is almost invisible.  There was never any pain, just itching.
expired doses administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Dec-2021 and was forwarded to Moderna on 15-Dec-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 05-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (abnormal) antibody numbers were in the 800-900 range..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided
had chickenpox disease 3 1/2wk p/vax reported 25+- fluid filled lesions w/subsequent scabbing;
Running nostrils; itching throat/ears; coughing and loss of voice; headache.
numbness; tingling; soreness; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 1st dose of Shingrix. On 29th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On 30th November 2019, the patient experienced numbness in feet and tingling of extremity. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the numbness in feet and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, numbness in feet and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of the Shingrix vaccine and experienced soreness and redness at the injected site, which resolved in a few days.  On 30th November 2019, she started to feel numbness and tingling in the right foot which had been ongoing.  No additional information provided. Did not consent to follow-up.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; PAIN; CRAMPING; DIZZINESS; SWELLING JOINTS; WEAKNESS; EXTREME FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 31-AUG-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-SEP-2021, the patient experienced pain, cramping, swelling joints, extreme fatigue, and headaches that went away four days after, and patient also experienced dizziness, weakness and fatigue that lasted for about a month. On 25-DEC-2021, the patient experienced headaches, cough, itchy throat and weakness (suspected clinical vaccination failure, and suspected covid-19 infection). On 20-JAN-2022, the patient tested positive (twice) for a covid-19 using an antigen rapid test (BinaxNOW).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain, cramping, swelling joints, and headaches on 05-SEP-2021, and dizziness, weakness, and extreme fatigue, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213333.; Sender's Comments: V0: 20220139800-COVID-19 VACCINE AD26.COV2.S-Suspected clinical Vaccination failure. 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: SPECIAL SITUATIONS
Headache, nausea, weakness, shakiness from about 4-5 days after immunization. Immunization date is estimated, as vaccination was administered at primary care office "about a month ago." Malaise persists and nausea is improved but persists. Since flu vaccination pt had 3 visits with different providers at primary care. Pt was told the rash was "not hives." Rash persists & she will go to dermatology today. Upon my request that practice submit a VAERS report, I learned there is no documentation of any adverse events, rash began before the vaccine was administered and other symptoms are not documented.
AFTER 2ND DOSE ONLY: Fever - 100.9, Tylenol, stayed about 24 hours Body Aches, Tylenol, remained about 24 hours Racing heart, started when fever started to come down, rested, remained about 1 1/2 days Swollen glands under right arm after second shot Itchy inside my arm (not a rash), took Zyrtec on Monday Sore arm at the injection site, hot to touch, lasted about three days  Just overall feeling weird, not feeling well for almost 3 days - no real symptoms - just weird, or lazy feeling
Headache 15-20 minutes after first  injection. Lasted from June 28, 2021 to September 10, 2021.   Extreme muscle weakness in legs, mild weakness in arms, started 15 to 20 minutes after first injection and is still present.
pt recvd 2nd dose of vax 14JUn93 & exp nausea, achiness & frontal h/a;
This case was reported by a healthcare professional and described the occurrence of nausea in an adult subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX at 1.0 ml in an unknown arm. Immediately after vaccination with HAVRIX, the subject experienced nausea. At the time of reporting the outcome of the event was unspecified. In the reporter's opinion nausea was probably related to treatment with HAVRIX. It was noted that the occurrence of nausea following administration of HAVRIX happened with three different subjects. The reporter requested replacement of three packs of vaccine (ndc 58160-826-48). All three vaccinations in question had the same lot number and expiration date. Linked cases include A0931343A and A0931347A. According to information received on 09 August 2011 via GSK Quality Assurance, this report involved an adverse event only (no product complaint).
Reddened, itchy, circular patch on injected deltoid area approx 3 1/2" diameter
Neuropathy; Tingling in feet and legs; Pain in legs; This serious case was reported by a nurse via sales rep and described the occurrence of neuropathy in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In JAN-2023, an unknown time after receiving Shingrix, the patient experienced neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), tingling of extremity (Verbatim: Tingling in feet and legs) and leg pain (Verbatim: Pain in legs). The outcome of the neuropathy, tingling of extremity and leg pain were unknown.   It was unknown if the reporter considered the neuropathy, tingling of extremity and leg pain to be related to Shingrix.     It was unknown if the company considered the neuropathy, tingling of extremity and leg pain to be related to Shingrix.   Additional Information: GSK Receipt date: 04-AUG-2023 The reporter informed GSK representative that a patient received Shingrix vaccine and since January the patients had experiencing neuropathy, tingling in feet and legs, also pain in legs.  The reporter consented to follow up. This case had been link with US2023106293, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023106293:Same reporter, different patient, same events
patient with CID vaccinated with MMR;   Information has been received from the authors of a published literature article, titled as stated above, regarding a 12-year-old female patient.  The patient's concurrent conditions included hypogammaglobulinaemia, T-,B-cell  lymphopenia, and combined immunodeficiency (CID). The patient's medical history included recurrent herpes simplex virus (HSV) gingivostomatitis, bacterial pneumonia, and cutaneous abscesses. Concomitant therapies were not reported.  On an unknown date, the CID patient received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (route, dosage information and lot number were not provided) (product use in unapproved population).  A copy of the published article is attached as further documentation of the patient's experience
This spontaneous report was received from a physician and refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. 15-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot# M029229, albumin status of recombinant human albumin (rHA) (exact dose, route of administration, anatomical location and expiry date were not reported). The dose of the vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Administered dose of vaccine underwent a temperature excursion of 48 degrees Fahrenheit (F) for 30 minutes. Digital data logger was not involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all information has already been obtained. This is an amended report, as corrected. The reference type for US-009507513-1704USA000587 was changed to Linked Report (previously reported as company number). Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587: US-009507513-1705USA012939: US-009507513-1705USA012940: US-009507513-1705USA012941: US-009507513-1705USA012938: US-009507513-1705USA012937: US-009507513-1705USA012935: US-009507513-1705USA012934: US-009507513-1705USA012932: US-009507513-1705USA012933: US-009507513-1704USA000587: US-009507513-1705USA012953: US-009507513-1705USA012954: US-009507513-1705USA012955: US-009507513-1705USA012956: US-009507513-1705USA012963: US-009507513-1705USA012964: US-009507513-1705USA012965: US-009507513-1705USA012966: US-009507513-1705USA012967.
Patient complained of a hot flash type feeling, sweating, back pain, and back muscle spasms.
Swollen lymph nodes in arm pits and they are painful; Swollen lymph nodes in arm pits and they are painful; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported) , via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  Consumer stated, "I am just calling because I have like swollen lymph nodes in my arm pits and they are like really painful. I think it's a reaction to the vaccine. I got not this on Monday but just the past, the Monday before (incomplete sentence and further not clarified) I got it, that's when I got it. I don't know if I should go see my doctor or not. It's like normal or it's like I should go see someone?". Outcome of the events was unknown.   Information on the Lot/Batch Number has been requested.
Pt presented to ER with shortness of breath and a low-grade fever (100F); irritable; right leg (whole side of leg) swollen with golf ball-sized lump; tender and hot to the touch.
Within 5-10 minutes, mom stated patient started having cough and runny nose. by the time mom got him home his face was swollen, he complained of chest hurting and had welt like blisters on face and lips were swollen. Went to ER; treated with Benadryl and Prednisone. Area around MMR site was red and swollen. Other sites not affected.
Pt. states that approximately 12 hours after receiving influenza vaccination, her eyes began to itch and her throat felt scratchy. States area around injection site is red and warm. States that today (10/01/09) she has a rash on her face and neck.  States her scalp feels "itchy".  Eyes are swollen.  Has taken OTC Benadryl x3.  Has not contacted her physician or ED.  Denies ever having difficulty breathing.
administrated only the diluent portion; administrated only the diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2021, the patient received Shingrix. On 2nd November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was administrated by error only the diluent portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional claimed they had further details on lot number, expiration date and age of the patient because at the moment of the call they were not at the work facility were it happened. Agreed to be contacted follow-up or to provide further information. No further events were reported The reporter consented to follow up.
Nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, her friend's husband received dose of Shingrix and next day after vaccination experienced nausea. The reporter stated that, the nausea resolved in 1 day. The reporter did not provide additional details. For the tolerance of 2nd dose, refer case US2019167038, reported by same reporter.
Dizzy, sore throat and mucus in throat, uncontrolled chewing motion.
Stomach ache  after 2nd shot; Headache after 2nd shot; Nausea  after 2nd shot; Low grade Fever 100F  after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache  after 2nd shot), HEADACHE (Headache after 2nd shot), NAUSEA (Nausea  after 2nd shot) and PYREXIA (Low grade Fever 100F  after 2nd shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache  after 2nd shot), HEADACHE (Headache after 2nd shot), NAUSEA (Nausea  after 2nd shot) and PYREXIA (Low grade Fever 100F  after 2nd shot). On 08-Feb-2021, ABDOMINAL PAIN UPPER (Stomach ache  after 2nd shot), HEADACHE (Headache after 2nd shot), NAUSEA (Nausea  after 2nd shot) and PYREXIA (Low grade Fever 100F  after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) Low grade Fever 100F for 2 days.         No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-373647, MOD-2021-373660 (Patient Link).
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 11-NOV-2014, the patient was vaccinated with an improperly stored dose of (23-valent) PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015), dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the (23-valent) PNEUMOVAX had a temperature excursion for 72 hours, with the lowest recorded temperature was 28F (-2.2 Celsius) and 40 hours with the highest recorded temperature 47 F (8.3 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
low grade fever for about 1 day; left arm was red, swollen, and warm to the touch starting 11/3/2020 and continued through 11/4/2020 (date of report); redness on back of neck and chest
Patient experienced extreme swelling, bruising, redness and itching at injection site starting approximately 24 hours after injection.  No other vaccines given on that date. Itching continues through today 11/20, more than 72 hours after vaccine given