chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very dizzy; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He is calling about the Pfizer Covid vaccine. He got the vaccine on Saturday. He woke up this morning on 25Jan2021 very dizzy. He is asking what to do or if he can take Tylenol. The outcome of event was unknown.  Information about lot/batch number has been requested.
Administered Pfizer vaccine to patients right arm, upon completion of vaccination as nurse pushed hub/plunger of syringe the attached needle remained in patients arm, no adverse effect noted. No complaint of pain, needle removed without incident.
8th day- 5? circle of itchy rash arm Headache & severe pain in bad left ankle ( broken in Nov 2020) No energy Chills No appetite  Blurry vision still to today
3 inch diameter itchy red warm erythematous rash resolved with Benadryl/triamcinolone 0.1%.
Swollen lymph node above the left collarbone, and it felt warm. Tightness in my shoulder up to the neck. I had swelling on my left side and tenderness. Was not given any medication for it, was just told to leave it alone. I took TYLENOL and did ice it. The swelling went down in about 5 days. Still a bit tender, but not hurting much anymore.
Reddened, swollen, warm area, 2x3" behind (L) arm, sl itchy, sl tender.
ON 2/17/22 patient was administered covid vaccine that had expired on 2/12/22.
Information has been received from a physician concerning a female patient with no pertinent medical history and no drug reactions/allergies who was vaccinated IM with the first 0.5 ml dose of GARDASIL. Right after getting the vaccine the patient experienced seizure like activity. It was unknown if the patient sought medical attention. There were no lab diagnostic studies performed. Within 15 minutes the patient recovered. Upon internal review, seizure like activity was determined to be an other important medical event. On 08-SEP-2009 and 14-SEP-2009, telephone attempts to obtain additional information have been unsuccessful. On 10-SEP-2009 the physician called back to say that she did not report this AE and know nothing of this case, she would speak with her staff to see who it was that reported it. On 14-SEP-2009 the Merck representative stated that the initial reporter was the Office Manager. On 14-SEP-2009 follow-up information received from the Office Manager indicated that on the day the Merck rep came in, it was mentioned in passing that a patient had a seizure like activity event out at the check out window. The patient "sat down for a bit then left the office under her own power". No treatment was necessary. The name of the patient had been forgotten. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, date of vaccination/therapy, lot number, and date of event. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 24-MAR-2017, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter.  Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Patient developed difficulty breathing, light-headed, dizzy  skin-diaphoretic,pale  nauseated-felt like she was going to faint.  Symptoms started 2-3 minutes after vaccination.
IgA nephropathy; This is a literature report.   Inclusion of patients with kidney disease in COVID vaccine trials remains low. It is important to report association of disease exacerbation so that patients may undergo post vaccination monitoring. The authors hereby present a case of worsening IgA nephropathy temporarily associated with COVID vaccination. A 63-year-old female with past medical history of hypertension, psoriatic arthritis presented to the hospital with gross hematuria for 6 weeks starting 3 days after 2nd dose of Pfizer COVID vaccine. Her PCP had sent her to ER 5 days after onset of hematuria as had noted a creatinine (Cr) of 1.6 with 3+ protein and greater than 20 RBCs on urinalysis suspicious for nephritic syndrome. On review she had serum Cr of 0.5 about 4 months ago with no proteinuria or hematuria before. In the ER she was given antibiotics for urinary tract infection and outpatient referral for nephrology. She could not make the outpatient appointment and with continued gross hematuria for a month, she presented to the ER again where she was noted to have Cr of 10 mg/dl and urine protein:cr ratio of 7.3gm/gm. Renal imaging including CT urogram was normal. Renal biopsy showed IgA nephropathy, M1S0E0T1C1 with a fibrocellular crescent and acute tubular necrosis likely secondary to lyzed red cells in setting of multiple RBC casts in the tubules. She was put on 250 mg Solumedrol for 3 doses followed by 1 mg/kg of Prednisone with eventual downtrend in Cr to 4.5 in 15 days.  There have been 2 cases reported in literature with known IgA nephropathy who developed gross hematuria post COVID 19 vaccination. SARS- COV 2 vaccines use nucleoside modified purified mRNA which does elicit higher neutralizing antibody titre and strong cluster of differentiation response leading to production of several proinflammatory cytokines. Thus, there is a concern that vaccines might exacerbate immune mediated glomerular diseases. IgA1 is involved in the pathogenesis of IgA nephropathy and patients with IgA nephropathy have higher than normal IgA1 response to other vaccines like influenza. Also while studying the antibody response to COVID 19 illness patients with IgA nephropathy are known to express higher IgA response compared to IgG and IgM along with reports of concurrent worsening of the glomerulonephritis. Nephrologists should closely follow patients with IgA nephropathy to establish the frequency of disease activation post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101562750 Same article/drug/ event; different patient.
She had pin and needles tingling feeling in her fingers on the first day. She went on for 3 days and still has not gone away. Went to dr and was told to monitor the situation.
After receiving my Johnson and Johnson COVID vaccine I experienced a lack of motor function in my throat. Approximately 40 minutes after having received the shot, I lost the ability swallow. A tingling sensation took the back of my throat and eventually felt as though it moved into my head. The whole experience lasted a couple of minutes. Since that time all other symptoms have been normal, sore, slight fever, etc.
Patient complained of an itchy rash on his left arm in the area of his elbow.  Rash appears round and slightlyl red like a hive.
Extreme vertigo with nausea, diarrhea and vomiting lasting 2-3 days.  Required a telephone consult with doctor's office and medication to reduce vertigo. Unwell for about 2 weeks.  Unable to work for almost a week,  Weakness persisting for about a month. Lingering anxiety from extreme vertigo episodes and fear of it returning.
The night of the vaccine, patient experienced immobility and severe pain in arm/shoulder. Pain was so unbearable, "I had to sleep with my arm straight out - I couldn't bend it, move it... it was STUCK". Patient feeling like her shoulder and upper arm is being twisted at the bone. Patient hearing popping at bone.
Discharge summary "This is a 64 YO  male  with history of HTN, T2DM, CKD St3, hyperlipidemia, CAD, depression, PVD, Bil BKA,  who presented with generalized weakness and diarrhea for several months. Patient seen and examined and was noted to be awake, alert, and oriented x 4, conversant, in no acute distress. Patient reports feeling weak for the last few months with associated watery diarrhea, loss of appetite, generalized abdominal pain, nausea and vomiting. Describes pain as punch-like pain, all over his abdomen with no pain radiation. Denies recent international travels. Patient could not quantify the number of watery stools in one day. Kept saying " a lot" .Patient states that he had chest pain and shortness of breath which resolved but still with productive cough for the last few weeks. Denies sick contacts. Denies fever, chills, headache, dizziness, rectal pain, rectal bleeding, dysuria. Reports he was just released from the the hospital 2 weeks ago and also had diarrhea before and after hospitalization.     Patient given because COVID positive on 03/27 without any respiratory symptoms.  He was ready for discharge but his facility did not have isolation next so he was kept overnight and discharged on 03/31 in stable condition.  "
pt recv vax; severe local erythema & tenderness at site of vax starting hr p/ adm; moderate fever (prompting hosp due to asplenia & hematologists protocol for fever management);
patient was inadvertently administered a second dose of flu vaccine with no reported adverse event; Initial information received on 23-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 68 years old male patient who reported patient was inadvertently administered a second dose of flu vaccine with no reported adverse event while receiving vaccines influenza quadrival a-b vaccine [Fluzone Quadrivalent] and influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (boostrix); varicella zoster vaccine rge (cho) (Shingrix) and tozinameran (Pfizer Biontech Covid-19 Vaccine) for Prophylactic vaccination.  On 01-Dec-2021, the patient received an unknown dose of suspect influenza quadrival a-b vaccine (strength, formulation was unknown,  lot UT7336MA and expiry date: 30-Jun-2022) in the left deltoid in unknown administration site for prophylactic vaccination. On 02-Mar-2022, the patient received 0.7ml dose once of suspect influenza quadrival a-b high dose hv vaccine prefilled syringe (strength, formulation was unknown, lot UJ769AB and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid in unknown administration site for prophylactic vaccination.  On 02-Mar-2022 the patient inadvertently administered a second dose of flu vaccine with no reported adverse event (extra dose administered, Latency: 3 months 1 day) following the administration of influenza quadrival a-b high dose hv vaccine and influenza quadrival a-b vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (  Outcome: unknown  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
1st dose 28May2022, 2nd June2022; received the second Havrix vaccine in June 2022, in the left arm at the recommendation of the pharmacy; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 83-year-old female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   In June 2022, the patient received the 2nd dose of Havrix (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. In June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short and off label use. On an unknown date, the outcome of the drug dose administration interval too short and off label use were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's Comment: The reporter was a pharmacist. The patient reported that she received 1st dose of Havrix vaccine on 28th May 2022 and in June 2022 she received 2nd dose of Havrix vaccine at the recommendation of the pharmacy. The patient wanted to know if she covered for Hepatitis A and if not to please call her. Caller would also contact her HCP. The reporter did not consent to follow up. Caller did not give permission for GlaxoSmithKline to contact HCP. Additional supportive information: The patient received 2nd dose of Havrix early than recommended time frame, which led to shortening of vaccinations schedule. The patient received the second dose of Havrix vaccine in June 2022, in the left arm at the recommendation of the pharmacy, which led to off label use. This case had been linked with US2022181002 by same reporter for different patient.; Sender's Comments:  US-GSK-US2022181002:Same reporter
Provided Pfizer vaccine but was later informed patient had completed a different vaccine overseas but was not indicated on the paperwork patient had to fill out.
Our policy states to keep the child for the first Gardasil injection for 20 minutes to monitor, this was his second injection and he had no adverse reaction the first time. However after leaving, mom called and said he was nauseous, and felt faint. He had not eaten, and she was going to get him fed.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # M023169 with expiry date: 13-JUN-2018 (dosing details, anatomical location and route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 9C to 25C (9.9C) for a duration of 13 hours and 15 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 9C to 25C (11.5C) for 7 hours and 45 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009985: US-009507513-1708USA009988: US-009507513-1708USA009987: US-009507513-1708USA009986:
Starting day after vaccine was administered patent's arm was swollen, red and very painful. The pain was severe enough to require one dose of ibuprofen.  This continued for two days. On day three arm is starting to hurt less. Redness is gone and swelling has decreased.
pt recv vax 18AUG97 & had 1010cm erythema,  induration, warmth rt deltoid;21AUG97 had fever to 101-102;rx motrin chlortrimeton, medrol dosage, keflex 25AUG;
Pain in upper arm, with numbness down arm to fingers, unable to sleep in affected arm without feeling pain and numbness.  Can't lift arm up, across body or behind back.
Patient's arm was swollen with raised red area surrounding injection site. Patient's arm was fixed/stiff and only had movement in her fingers. Patient was referred to see a doctor.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 64 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 (dose number in series 1) (suspension for injection, route of admin, and batch number not reported) dose was not reported,1 total, therapy start date was not reported for prophylactic vaccination. No adverse event reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported,1 total, administered on 15-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-DEC-2021, the patient administered expired vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211235341.
localized itching, erythema, & edema day 1-3, resoved on 1/5/2021, erythema & edema returned on 1/6/21 Narrative:
On 5/15/2000, Mom called and stated that around 5 days post vax (5/4/00) she noticed red bumps at the injection site to the left thigh. She states bumps lasted 3 days and did not come to MD because infant did not run a fever. Mom denies problems.
Woke up next morning after shot and arm couldn't move . Arm is hot red swollen and painful even 3 days later.  Pt feels nauseous continuously.
On 12/04/2001 at about 1hr after receiving flu shot her lips began to tingle, has to clear her throat frequently and her breathing "is not quiet right" Was advised to to to ER if symptoms get worse.
I did not suffer with constant angina issue  before the vaccination.  I am experiencing  constant ongoing chest pain, which I never had  a problem with before as well my throat and neck swelling, causing me to have  swallowing problems. I still not get any relief for these issues.
Persistent high blood sugar (350-450 mg/dL) lasting from ~24 until ~36 hours after shot. Did not respond typically to additional insulin. I administered an additional ~20 units of insulin over the course of the night. Typically, dosage is 1 unit per 35-50 mg/dL reduction, so 5-7 units would be needed to correct from 450 to 100 mg/dL. No issues noted with insulin pump or infusion set.
swollen lymph nodes on the same side on the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on the same side on the injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on the same side on the injection). In March 2021, VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on the same side on the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that the day after the first dose they got swollen lymph nodes on the same side on the injection, and they considerate the nodes in the neck an immune reaction and not an adverse event that lasted for 10 days.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-417787 (Patient Link).
On March 15 my blood pressure spiked even taking my medication. My BP was out of control even with medication. I contacted my Dr. asked me to double my high blood pressure medication and has worked since. I do have a follow up appointment with her. Prior to the vaccine I was taking one BP pill with no issues for 8 years.
tender. reactionary lymph node  by right clavical present 24 hrs after administration of MCV vaccine  completed xray WNL  completed ultrasound confirmed small lymph node, slightly mobile tender.  denies any other symptoms at this time
Pediatric (6month/11year old) Moderna Covid Booster 0.5mL immunization given instead of Moderna/Spikevax covid booster 0.5mL (full dose). PCP notified and stated patient would be ok and do not need further action since patient has received the adult dose. Patient has been notified as well and verbalized understanding. No further questions or concern from the patient. Pediatric (6month/11year old) Moderna Covid Booster's formulation vials are overfilled 0.5mL. Patient received the full dose 0.5mL.
This spontaneous report was received from a pharmacist via company representative and refers to a 70-year-old female patient. The patient received unspecified medication for hypertension. It was unknown if the patient had any drug reactions or allergies. On 25-SEP-2017, the patient was vaccinated with ZOSTAVAX, subcutaneously for prophylaxis (dose, lot# and expiration date were not reported). Other suspect therapies included sterile diluent (dose, frequency, route of administration, lot# and expiration date were not reported). On 25-SEP-2017, (also reported as "immediately after administration"), the patient felt lightheaded and developed a red, itchy knot at the injection site. Consequently, the pharmacist called emergency services. The emergency services personnel responded to the pharmacy and evaluated the patient. The patient was found to be stable, did not require treatment, and did not require transport to a hospital. The pharmacist added that the patient did not take her usual medication for hypertension prior to going to the pharmacy at the vaccination day. The patient did not receive any treatment for the events. There was no laboratory test performed. Product quality complaint was not reported. The outcome of felt lightheaded and red, itchy knot at the injection site was reported as recovered in approximately September 2017. The relatedness between the events and ZOSTAVAX was not reported.
Flu like symptoms; Headache; Body ache; Chills; General malaise; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL 9261), via an unspecified route of administration in the left arm on 20Jan2021 at 11:15 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  On 21Jan2021 at 04:00, the patient experienced Flu like symptoms that lasted about 8 hours, headache, body ache, chills, general malaise. The patient stated he had no fever. The patient did not receive any treatment for the event. The clinical outcome of the Flu like symptoms, headache, body ache, chills, and general malaise was recovered on an unknown date in Jan2021.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Reported fever tmax 104 degrees (F) within 30 hours of receiving his 6 month vaccines. Also diarrhea, decreased oral intake. He was seen in local emergency department on 5/11/21. He was then seen in pediatric clinic on 5/13/21, diagnosed with otitis media then. He is improving, not fully recovered yet, still had fever.