chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hyperhidrosis; hyponatremia due to excessive sweating?; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "Hyperhidrosis"; HYPONATRAEMIA (non-serious), outcome "unknown", described as "hyponatremia due to excessive sweating?".  Additional information: It was reported that patient would like to know if there has been any reported cases of Long term, short term hyperhidrosis after receiving the booster dose or any dose of Pfizer BioNtech covid vaccine. or hyponatremia due to excessive sweating.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Burning in arm right after injection. Lip swelling (lower lip) about 30-45 minutes after injection.  Experienced high fevers (103), intense chills, body aches, and exhaustion for two days.  My husband called the ER and they said to take Tylenol and Ibuprofen and cold baths to reduce fever.
Antibody test came back negative; Antibody test came back negative; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 2 different patients. This is 2 of second reports. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 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. It was reported that, "caller, after asking if the agent was a physician, stated that he administered the Pfizer Covid vaccine to two patients approximately 5 weeks ago. However, their IgG/IgM antibody test came back negative, and wanted to know if these patients have developed immunity". Outcome of the events was unknown. No PQC present.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116439 same reporter/drug, different patient
Exactly two weeks after my moderna booster shot I developed a histamine outbreak with hives on my groin area, arms, chest, thighs, and lower neck.  The come for about 30 minutes and then go away and come back. I can run my finger nail across my skin and swelled line will appear for a while. My hands can sometimes feel a little swollen and tingle. After my shower I have fed lines and dots on my arms and shoulders. Goes away after a few minutes. This has been going on for about three weeks.
2600 hrs aftr injection,  light headache,  100.3 temp. 6 hours after that  all symptoms resolved.
Case number PHEH2013US021744, is an initial spontaneous report received from the health care professional on 16 OCT 2013. This report refers to a child female patient. Her medical history and concomitant mediations was not reported. She was vaccinated with initial application of MENVEO (batch number: A11082) in the left deltoid at a dose of 0.5 ml intramuscularly on 31 MAY 2013 at 15:30 PM. TI was reported that the vaccine was compromised due to refrigeration malfunction (temperature error). She was revaccinated on 30 AUG 2013. No adverse event was reported following this administration error (incorrect storage of drug).
Following immunization, patient was standing in hallway while his younger brother was being vaccinated. His grandmother asked if he was okay and I went into hallway to find him on his knees with his forehead resting on the wall. I moved him into a semi-fowler's position and noted that his face and lips were pale. He was verbally responsive and oriented. 911 was activated for further evaluation and they responded promptly. Blood pressure while lying down was 102/64. Reassessed after standing @ 96/56. Grandmother agreed with emergency responders that transport to hospital was not indicated. Episode was deemed syncope following vaccine administration.
Patient was given Moderna Monovalent after communication was sent out 4/20/23 to discontinue administration of the Monovalent series.
developed rash around ankles 2 weeks after getting 2nd vaccine. schamberg's capillaritis, dianogsis  had arthritis pains about a month later, reported to pfizer. Had booster shot day after thanksgiving.
This spontaneous report was received from a nurse referring to a unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose and route of vaccination were not reported, lot # L005297 with expiration date : 17-AUG-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pancreatitis confirmed by lipase >40,000 and CT imaging. Symptoms began on 4/30/21, which was 6 days following vaccine administration. The patient was hospitalized for 5 days and discharged in good condition. No cause was identified of pancreatitis. Patient has no history of pancreatitis and does not drink alcohol.
Approx. one month after the vaccine, I noticed a white rash on the center of my back but did not think it was anything and ignored it. I had been in the sun a couple of times and thought it was just tan lines. I had a skin check done in September, and was treated for possible tinea versicolor. After a few weeks, I noticed the white spots were spreading  to my shoulders and I went back to the dermatologist. Two skin biopsies were taken and sent to pathology where it was confirmed to be vitiligo. I have never had any skin or auto-immune issues in my life. I've never even had a flu shot. I am concerned that the covid vaccine has caused this diagnosis.
Injection site warmth; injection site itching; Injection site rash; Injection site tender; raised red oval rash at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash), INJECTION SITE PAIN (Injection site tender) and INJECTION SITE ERYTHEMA (raised red oval rash at injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 010H20A) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism (Since age 20).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash), INJECTION SITE PAIN (Injection site tender) and INJECTION SITE ERYTHEMA (raised red oval rash at injection site). In January 2021, INJECTION SITE ERYTHEMA (raised red oval rash at injection site) had resolved. At the time of the report, INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash) and INJECTION SITE PAIN (Injection site tender) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report as received from a registered nurse refers to a two patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot numbers and expiration date were not reported) 0.5 ml, intramuscular. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Anaphylactic reaction; This spontaneous case was received on 22-Jul-2021 from a pharmacist via Med Communication (reference number: SEQW21-01510) and concerned a 69-year-old female patient.  The patient's medical history and concomitant medications were unknown.  On 16-Oct-2013, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number was not reported. The vaccine might have been Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine) or Flucelvax (influenza vaccine, subunit influenza virus vaccine polyvalent) vaccine, but the reporter was not entirely sure.  On the same day, after receiving influenza virus vaccine polyvalent, the patient experienced severe anaphylactic reaction.   The reporter stated that the patient was hospitalized, but was not sure. The reporter did not provide any further information regarding the adverse event.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of anaphylactic reaction was considered to be serious due to hospitalization and medical significance.  Company comment: A 69-year-old female patient developed anaphylactic reaction on the same day after vaccination with the suspect product influenza virus vaccine polyvalent. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on suggestive time relationship, causality for the reported events is assessed as possibly related. With limited information present Brighton Collaboration criteria for anaphylaxis could not be assessed.; Sender's Comments: A 69-year-old female patient developed anaphylactic reaction on the same day after vaccination with the suspect product influenza virus vaccine polyvalent. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on suggestive time relationship, causality for the reported events is assessed as possibly related. With limited information present Brighton Collaboration criteria for anaphylaxis could not be assessed.
Crohn's flare needing treatment with steroids. Flare of autoimmune disease that has been controlled for several years now
facial palsy (facial weakness); This is a literature report.  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant), outcome "unknown", described as "facial palsy (facial weakness)". The patient underwent the following laboratory tests and procedures: Pain assessment: 3, notes: After 1st dose.  The reporter considered "facial palsy (facial weakness)" related to BNT162b2.; Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect vaccine BNT162B2, the company cannot completely exclude a reasonable possibility that the suspect vaccine BNT162b2 may have contributed to the onset of the event "facial palsy (facial weakness)". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300017736 Same article/Drug and Different patient/event;US-PFIZER INC-202300053481 Same article/drug and different patient/event;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of (wistar ra 27-3) M-M-R II lot # L029266 (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
POTS; autoimmune, autonomic, and neurological diseases; autoimmune, autonomic, and neurological diseases; autoimmune, autonomic, and neurological diseases; This initial spontaneous report was received from a lawyer and the consumer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On unspecified dates, the patient received dose 1, 2 and 3 of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) administered as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). Plaintiff was 21 years years old when she received her first dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  On an unknown date, following her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, Plaintiff began to suffer abdominal pain, dizziness, loss of appetite, and irregular heart rate. As the months progressed, so did Plaintiff's injuries. She was seen by multiple physicians and specialists for her complaints which now included: abdominal pain, rapid heart rate, dizziness, no appetite, fainting, and tingling in extremities. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, Plaintiff had been unable to engage in activities that a normal young person would enjoy. She has been unable to work, engage in any strenuous exercise, and her condition had impacted her ability to drive a car. Based upon her chronic and severe post-Gardasil symptoms, Plaintiff has been diagnosed with various medical conditions, including but not limited to, Postural orthostatic tachycardia syndrome (POTS). As previously discussed, the medical literature has documented other patients who, like Plaintiff, had suffered serious autoimmune, autonomic, and neurological dysfunctions, and who experienced similar side effects as those Plaintiff has suffered, and who were diagnosed with Gardasil-induced autoimmune, autonomic, and neurological diseases. As a proximate result of Merck's wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of Gardasil, Plaintiff had suffered and continues to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. Plaintiff also has a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The outcome of the events was reported as not recovered.  The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the events was reported as related. The reporter considered the events to be disabling.   Upon internal review, autoimmune disorder was determined to be a medically significant event.
Patient was given COVID Pfizer Bivalent Booster instead of the second dose of COVID Pfizer primary series vaccine.
Erythema left arm, induration, hot.  With myalgias and temp 99-100.2 F. Patient seen I clinic on 9.12.2016 and treated with 800 mg Motrin.
sick; severe fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), FATIGUE (severe fatigue) and NAUSEA (nausea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), FATIGUE (severe fatigue) and NAUSEA (nausea). At the time of the report, ILLNESS (sick), FATIGUE (severe fatigue) and NAUSEA (nausea) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non- significant followup
first dose: upper right arm muscle was very sore; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FW0171, Expiration date was not reported), dose 1 intramuscularly, administered in upper right arm muscle on 29Apr2021 (age at vaccination 61 years) as dose 1, single for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced first dose: upper right arm muscle was very sore on 06May2021. He was unable to get second dose as scheduled today on 20May2021. Reporter stated, when he got the shot, he was fine except for his arm, right arm. they gave it to him in his upper right arm muscle and it was very sore for a week. his wife got the same shot on the same day right after him and she had no symptoms whatsoever. Caller asking does he have a time frame, today is two weeks, that he had the first shot. It was also reported that caller confirms he received his first dose of the Pfizer Covid vaccine on 06May2021 at 1555 and it began hurting later that afternoon towards the evening. Caller states he has an appointment today at 1555. Caller states he's going to try to call and try to get it for Sunday, he just needs to know if that's going to change the potency of the shot. The outcome of upper right arm muscle was very sore was recovered on 13May2021, missed dose outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Arm - lymph nodes swollen. Affected side of chest wall red/painful. Injection site - No problem area.
Client didn't call and notify is of reaction, ov for next series stated arm, swoll up, very red and warm to touch, local reaction.
This spontaneous report as received from a other health professional refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, 19400 DF, subcutaneous for prophylaxis. On an unknown date the patient experienced herpes zoster. The outcome of herpes zoster is unknown. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005366:
Continous headache that started 3 to 4 hours after my second Covid shot on July 29th. Would go between a 2 and an 8 on the pain scale.  Never would go completely away. On August 6th the pain was so bad had to go to the Emergency Room for a CT scan and medications ( Benadryl, Toradol,  Reglan and IV fluids) and today followed up in my Probst clinic.  Day 12 of headaches... got medication adjustment and increased medications
Pustular rash-suspected staphylococcus aureus infection 08/23/2006 on both thighs.
Sore arm for day or two; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EL9266) via an unspecified route of administration on 25Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took gadolinium and experienced drug hypersensitivity. On an unspecified date the patient experienced sore arm for day or two. The patient stated that well the patient had a very specific question, he/she went on February 25th for him/her first shot, Pfizer, had no issues with it just a sore arm for day or two. He/she was scheduled to go back on March 18th for him/her second shot. Now in the meantime he/she needed to have an MRI done on my abdomen area. They want to do the MRI with a contrast dye called Gadolinium (captured as unspecified medication) which he/she happened to be allergic to. What they have recommended and prescribed for him/her was that over a course of 13 hours prior to the MRI they want him/her to take a total of 150 mg of Prednisone (consumer have not received the medication yet, hence not captured as suspect). Now he/she known that the Prednisone could affect the ability of his/her body to produce sufficient number of antibodies that the vaccination was supposed to help him/her with. His/her question as would be should he/she hold on for MRI until after his/her second shot. If he/she go before his/her second shot how far before his/her second shot would he/she need to do it and if he/she did it after his/her second shot how far after his/her second shot would he/she need to do it.Patient also stated, that was correct yes the first one with Pfizer had it in, the second one going to be Pfizer on March 18. It felt the same as if he/she were getting a Tetanus shot (Further clarification was unknown if consumer felt adverse event from Tetanus Shot, hence Tetanus Shot was conservatively captured as suspect). The seriousness of the event was reported as non-serious. The clinical outcome of the event was unknown.  No follow-up attempts are Possible. No further information is expected.
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a county health dept nurse regarding a 3 year old female pt who was found to have insufficient Immunogenicity against the Prevnar serotypes. The pt received the third dose on an unspecified date. The pt has a past history of upper respiratory tract infection (described as chronic) and pharyngitis streptococcal. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. On an unspecified date, the pt underwent immunologic testing for all childhood vaccines, and was found to have insufficient Immunogenicity against the Prevnar serotypes (decreased immune responsiveness). The child had no adverse events at the time, and has had no pneumococcal infections. The pt had received a total of 3 doses of Prevnar, the first dose given at 12 months of age. No additional information was available at the time of this report.