chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sick stomach; headache; bruised injection spot and swollen; bruised injection spot and swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EN6198) via an unspecified route of administration, administered in arm left on 13Feb2021 14:15 as single dose for COVID-19 immunization. The patient medical history was not reported. Patient has no known allergies. Patient is not pregnant. Concomitant medications included Fluoxetine, Estrodial, calcium carbonate/colecalciferol (VITAMIN D 2000), magnesium sulfate, fish oil. The patient experienced sick stomach, headache, bruised injection spot and swollen on 13Feb2021 15:45. No treatment received. There is no other vaccine received in four weeks. The patient did not have COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovering.    No follow-up attempts are possible. No further information is expected.
This non-serious medically confirmed report (initial receipt 02-May-2014) concerns a male patient who had a medical history of egg allergy and would experience a rash with any unspecified injection. On an unspecified date, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed a rash after receiving the flu vaccine. Outcome was not reported. Reporter comments: The health care practitioner reported that the patient would experience rash with any unspecified injection and this was not related to vaccinations.
Pt. states that after receiving the 1st dose of  Influenza Fluarix 10/01/2021, started experiencing symptoms 10/07/2021 of right leg cramps. Chiropractor visit 10/11/2021 recommended reporting/ Primary communications recommendation of Hot/Cold pack for pain. Still continuing to experience symptoms.
Chills; Fever; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 20Apr2021 at 11:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 30Mar2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 19:30, the patient experienced chills, fever and body aches 8 hours after vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, fever and body aches was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt developed weakness, inability to ambulate, fever, nausea, vomiting x 1, diaphoresis. Pt went to ED on 8/6/15 and was admitted to hospital.
Chills, joint and muscle pain from 1:00 a.m.  on 3/24 until 7:00 p.m. on 3/24.  Treated with acetaminophen and naproxen.
tested positive for COVID; mild cough; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID), COUGH (mild cough), FATIGUE (extreme fatigue) and HEADACHE (headache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced COUGH (mild cough), FATIGUE (extreme fatigue) and HEADACHE (headache). On 31-Dec-2020, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID), COUGH (mild cough), FATIGUE (extreme fatigue) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was advised to take Vitamin B and Zinc as treatment medications.  No Concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Reporter contact information updated; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
This literature report (initial receipt 07-Jun-2016) concerns a 77 year-old female patient who had chronic kidney disease stage III and hypothyroidism. On an unspecified date, the patient received influenza vaccination (manufacturer and batch number not provided). On an unspecified date, four weeks later, the patient presented with falls from generalized weakness in the setting of a diarrheal illness.  The patient developed endorsed non-bloody watery diarrhea twice a day for the past nine days, without vomiting, pain, or fever. She developed lower extremities (LE) weakness and numbness one day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non-tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5; straight leg raise both 2-3/5; hand grip both 2-3/5; triceps both 2/5; and biceps both 3/5), and areflexia. Laboratory results showed leukocytes 6.4,000 /uL, hemoglobin 10.3 g/ dL, platelets 475,000/uL, creatinine 1.23 mg/dL, and normal TSH, B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre syndrome (GBS). Cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1 /uL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric IVIG (intravenous immunoglobulin) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands, consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome was not reported (recovered for salmonellosis and diarrhea). Reporter comments: The authors reported that the trigger for her GBS was likely her antecedent Salmonella infection. Sender's Comments: Listedness: Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine GBS and associated neurological events are listed. Falls and generalised weakness are unlisted as they are complication of GBS.  Spinal (intervertebral degenerative) changes, salmonellosis and all l haematological abnormality (low haemoglobin platelet count) are unlisted.
Approximately 215pm 9/19/07 c/o flushed, light-headed, dizzy, after 30 minutes. C/O "not being able to get deep breath." Tx - lying down, resting. 430pm Mother called again. Feeling slightly better.
Patient camped at a Boy Scout camp the night of his vaccinations.  Shortly before 3:00 AM, he woke up and felt like he needed to have a bowel movement and throw up; however; he did not succeed in either.  He was released from the camping activity.  During the ride home, he continued to feel like he needed to throw up; at times he also hyperventilated and reported tingling in his hands. At home, he went to sleep and slept in a couple hours past his usual waking-time. However, when he woke up he ate his normal breakfast and drank water, and kept it down.  At 10:05 AM on Saturday the 18th he had a fever of 101.5 (non-contact IR thermometer), but seemed to be acting normally.
Dizziness; head feels like its numb; feels like he is in "drunk mode"; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), HYPOAESTHESIA (head feels like its numb), SOMNOLENCE (feels like he is in "drunk mode") and NAUSEA (Nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (Dizziness), HYPOAESTHESIA (head feels like its numb), SOMNOLENCE (feels like he is in "drunk mode") and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), HYPOAESTHESIA (head feels like its numb), SOMNOLENCE (feels like he is in "drunk mode") and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient reached primary care professional (PCP) who advised him to wait for 48 hours for events to subside. No treatment was taken by the patient.
I experienced increased muscle and joint pain for several months following my 2 vaccines. Three months after my vaccines, I started noticing discoloration on my forehead and a crease in my forehead and skull.
I had chest pains   I am still having some.  I went to the ER.  They ran tests and found nothing wrong with my heart. The only thing I could think of was the shot since it started after the shot.
Initial misuse report received on 07 October 2013 from a health care professional. A child, whose medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (lot number, expiry date and site of vaccination was not reported). It was reported that the child received 0.25ml of FLUZONE QIV on 10/3 and another 0.25ml on 10/7. No reaction was reported. List of documents held by sender: none.
Employee received 1st dose of COVID vaccine on 12/30/20-Pfizer/Lot# EJ1685.  She received 2nd dose on 1/20/21-Pfizer/Lot# EL3247.  She came to work and went through asymptomatic screening testing on 3/18/21.  Her test was positive.  During call she reported symptoms starting on 3/12/21 and an exposure to COVID from a family member.
Firm feeling rash, slightly pink, slightly itchy I think it started yesterday with firmness at vaccination site but size significantly increased today   Injection site is redder and slightly raised. Larger firm raised patch below  - nickle sized   Smaller pink firm spot below that.
Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
Information has been received from a nurse concerning a 14 month old female who was vaccinated with all three doses of ROTATEQ (dates, route and lot numbers unspecified). The nurse reported that patient weighing 14 pounds was hospitalized for "failure to thrive". While in the hospital the baby got rotavirus. The outcome of the patient is unknown. Additional information has been requested.
This spontaneous report as received from a physician via a field representative refers to an unspecified number of patients. On an unknown date the patients were vaccinated with the third dose of 0.5 ml GARDASIL (strength and lot# unknown) intramuscularly (also reported as immunization). An unspecified number of patients reported an increased severity of pain with the third injection of GARDASIL, compared with the first and second doses on an unknown date. None of treatment was given for adverse event. The field representative confirmed with physician that these doses were administered correctly. Additional information is not expected.
5th day gum bleeding, skin itching, red dots on the skin.  2nd day joint pain, fatigue, body aches
This patient had a bump at his injection site approximately 1 cm x 1 cm with severe itching,. Appears 1-2 times a month. The follow-up states,"partially recovered and still gets small bumps that come and go in the evening with mild itching."
Diagnosed with COVID; Aches/pains; flu like symptoms; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID), PAIN (Aches/pains), INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (sore arm) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, MONTELUKAST SODIUM (SINGULAIR) and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 22-Jan-2021, the patient experienced PAIN (Aches/pains) and INFLUENZA LIKE ILLNESS (flu like symptoms). On 29-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 22-Jan-2021, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, COVID-19 (Diagnosed with COVID), PAIN (Aches/pains) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, COVID-19: covid (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that his AE lasted for about 18 hours.  Treatment included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: fallow up received on 29-jun-2021 - outcome  of the events was updated  form unknown to recovered resolved
Sudden onset of weakness/paraesthesia of LE.  Possible Guillain-Barre.
patient is stating aside from arm pain their whole left side is in pain and feels like they are being stabbed by a nail, total vaccination side pain, arm, legs, buttocks
1130AM shot given by 2PM pt was screaming like never heard, pt was convulsing & either passed out or went to sleep ont he 15 mile ride to hosp-couldn't tell had to drive in traffic;
07/08/22 presents to Emergency room for "leg swelling and fatigue". PMHx of "liver cirrhosis, nephrolithiasis"
Developed a Urinary Tract Infection; little soreness at the injection site; A spontaneous report  was received from a consumer, a 64-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed urinary tract infection and little soreness at the injection site/vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient developed urinary tract infection after the vaccine and she was prone to get urinary tract infection. The patient went to the doctor and received antibiotics. The patient also had little soreness at the injection site on an unknown date.  Treatment for the event of urinary tract infection included cefuroxime axetil.  The action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, developed urinary tract infection and little soreness at the injection site were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Patient being prone to develop urinary tract infection was considered a confounder for the event of urinary tract infection.
Subcutaneous administration; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a child male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix (subcutaneous) and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was 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: 12-OCT-2022. Reporter's Comments: The reporter stated that the patient had a Kinrix vaccine given via subcutaneous route. HCP disconnected chat prior to providing any product details (Lot number and expiration date, date of administration). HCP disconnected prior to being asked about consent for follow-up by Safety Team. Adverse event submitted with data provided during chat, prior to disconnection by HCP. Additional Supportive Information: The patient received Kinrix vaccine via subcutaneous route which led to intramuscular formulation administered by other route.
I started having COVID symptoms on 07/20/22, and my PCR test was positive for SARS COV 2 on 07/21/2022. I encountered COVID when I was out of country.
This spontaneous report as received from a consumer refers to her daughter a 17 year old female patient. In 2008, the patient was vaccinated with the first dose of GARDASIL (injection) (lot#, dose and route not reported). On an unspecified date, the patient within a few days got a red rash around the injection site. The patient went to see an allergies and several test (unspecified) were completed including a yeast test. All the test results were negative. The outcome of red rash around the injection site was unknown. The relatedness of the event with GARDASIL was not provide. Additional information is not expected.
Rash; Tenderness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 20th May 2020) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash and injection site tenderness. On an unknown date, the outcome of the injection site rash and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site rash and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The reporter stated that, the patient experienced rash around injection site, down her arm, and tenderness. The reporter declined to give patient information. This case has been linked with case US2019GSK105365, reported by the same reporter.
Arm pain resolved in 24 hrs. a few days later, I'm feeling fatigued, brain fog, and sad (the symptoms still persist). It's hard for me to focus on my work and enjoy what interests me.  I'm not sure whether the vaccine triggered something in my body; that's why I suffer from these symptoms. My second dose is in a week; not sure what is going to happen!!!
mom brought pt to hlth dept w/rt leg sore, warm to touch @ inject site, red (2" round); pt had no problem walking, or moving leg;
Child received MMR, VZV and Prevnar vaccines on 8/10/03. On 8/20, he developed a rash from head to toe sparing only his palms and soles. It looked like measles. No other symptoms. Acts well. This is the 3rd rash reaction to probably MMR we have had this month.
Information has been received from a female consumer concerning her 16 year old female who in June or July (specific date unspecified, year unspecified) was vaccinated with VARIVAX (Merck) at the age of 16 years old (route, dose not reported). Two weeks later the patient got her period and very bad cramps. It was unspecified it the patient had sought medical attention. At the time of the report, the outcome was unknown. Follow up information has been received from a medical assistant who stated that it was a certain patient who got her period after getting VARIVAX (Merck) and had very bad cramps. Follow up information has been received from a physician who reported that on 18-JUL-2001 the patient was vaccinated with her first dose of VARIVAX (Merck) (route, dose and lot# unspecified). On 26-AUG-2009 the patient was vaccinated with her second dose of VARIVAX (Merck) (route, dose and lot# unspecified). The patient had experienced intermittent abdominal cramping and vomiting since receiving her second dose of VARIVAX (Merck). At the time of the report, the outcome was unknown. The physician did not think this was related to receiving VARIVAX (Merck). Additional information has been requested.
Information has been received concerning a 23 year old white female who in approx. 1984 was vaccinated with MMR II and subsequently the pt experienced a high fever (103F), brightly erythematous eruption on the face, prostration, sore throat, dry cough, myalgia, loss of appetite, occasional vomiting without diarrhea. The symptoms emerged 5 days after her return to the US from Calcutta, India where she worked for 2 weeks, at an orphanage where children had measles. The pt had completed her IZ's as a child, including 2 doses of MMR, at age 15 months and 7 years, and she received the recommended prophylaxis before traveling. Three days after the onset of fever, vomiting and upper respiratory tract complaints, the pt was admitted with facial erythema. She was tachycardic and had a fever of 104F, but her BP was normal. Fine erythematous papules spread down the anterior of her neck and nape and tiny white papules consistent with Koplik's spots were seen on the buccal mucosa. Pharyngeal congestion, nonpurulent conjunctivitis, and submandibular lymphadenopathy were also noted. After the pt started treatment with doxycycline and ceftriaxone, the erythematous macular eruption spread progressively over the trunk and extremities and became confluent and pruritic and subsequently desquamated. The fever and constitutional symptoms subsided with desquamation. After a 3 week period, the pt recovered completely without adverse sequela. The differential dx is measles, despite 2 doses of MMR II vaccine. No further information is available.