chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reports that she is still having pain in R deltoid when lifting her arm or bearing weight. Pain is worse when she moves arm back. Pain is very sharp, pin pointed pain. 10/10 and is better with rest.
pt awake disoriented crying requesting daddy in room now; pt then went limp to floor; pt exp generalized shaking; pt scared;
Pt has localized redness and swelling at site of injection approximately 6x6cm area near deltoid
Pain at injection; headache; fatigue; nausea; chills; brain fog; diarrhea; joint pain; This is a spontaneous report from a contactable other healthcare professional (hcp). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), intramuscular on 18Dec2020 16:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included depression, anxiety, and known allergies to IVP dye. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications (reported as other medications in two weeks) included bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT) and unspecified multivitamin. The patient had no other vaccine in four weeks. The patient previously took cefalexin (KEFLEX) but had known allergies. On 19Dec2020 08:00 AM, the patient experienced pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain. No treatment received in response to the events. The patient was not tested for COVID post vaccination. The outcome of the events pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain was recovered on an unknown date.   Information on the Lot/Batch Number has been requested.
Rash; Hives; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (Rash) and URTICARIA (Hives) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 10-Dec-2021 and Rash (She experienced a rash while she had COVID-19).    On 13-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced RASH (Rash) and URTICARIA (Hives). At the time of the report, RASH (Rash) and URTICARIA (Hives) outcome was unknown.            It was reported that rash and hives comes and goes and sometimes happens after a shower or when patient is out in the rain. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-611776 (Patient Link).
Did not have to wait 15 minutes after the shot, was told to leave right after. Felt faint while driving home and passed out while driving. Woke up shaking. Almost crashed and woke up on opposite side of the road by the grace of god was ok.
FEVER; SLIGHTLY TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced slightly tired. Laboratory data included: Body temperature (NR: not provided) 37.6 maximum. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 29-MAY-2021, and slightly tired on 2021. This report was non-serious.
Difficulty breathing,leg weakness, can't walk more than 30 feet without getting winded, needing to sit down.
Macular popular rash on chest arms stomach and back. Onset 2 days after vaccine. Resolved in about 10 days with topical steroid prescribed by dermatologist
General n/v began about 1700 progressing from general nausea to severe muscle pain.  Anything that required muscle use, urinating, breathing, moving fingers, joints, chills, fever. Injection site red, warm to touch, swollen, about a 6-7 inch red swollen area, stops above the elbow.  11/28/2012 s/s improving.
Immediate headache, periorbital itching and swelling. c/o of itching all over. No localized reaction at injections site. Given Solu-medrol and Benadryl in ambulance.
Swelling and aching at injection site.  Onset of Fever, chills, aches, vomiting  on Saturday night.  Vomiting ended on Sunday.  Fever broke on Monday morning.  General fatigue lasting through Monday night.
Per the administering nurse's report: Pt received first dose of Moderna  from a different Curative location, had to reschedule due to a personal conflict, used the call center to set up new appointment for second dose. Appointment was set up at different location where the site has never had Moderna.  Administering nurse administered a Pfizer dose, resulting in a medication pass error.
Shaky, dizzy, weak, lightheaded about 4 hours after the vaccine and a blood sugar drop
Admitted for debility s/p fall. Imaging studies negative. COVID+ but did not require O2. Pt. Found to have elevated BP, bacteriuria, hematuria with urinary retention. Tx w/ Lisinopril 40mg, Ceftriaxone and Bethanechol. Foley placed from 1/1-1/3 but was unable to spontaneously void after foley removal. Pt. Sent home with an indwelling catheter in stable condition w/ 24hr home health care and to follow up with urology.
Stiff neck starting 26 hours after administration. Progressing to sever pain needing ER intervention on day 3 following vaccine. Arthralgia of neck. Extreme pain at base of skull.  Extremely limited range of motion. Inflammatory markers present in blood sample. CT scan normal. Symptoms still present day 6 but lessening greatly.
Causing DRESS syndrome; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Causing DRESS syndrome) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Causing DRESS syndrome) (seriousness criterion medically significant). At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Causing DRESS syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  Company Comment: Based on the current available information and no temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  More information has been requested.; Sender's Comments: Based on the current available information and no temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  More information has been requested.
Pt recvd 2nd dose of Hep B vax 26APR91 & pts urobilinogen level went from 0.1 to 4;
Covid-19 vaccine series given on 5/12/2021 and 6/24/2021. Staff member gave booster on 11/5/2021 which is earlier than the 6 month period.
Palpitations, mild dyspnea, injection site red painful and swollen. Febrile 100°, bone pain
COVID arm:  swelling & redness approximately 4 inches in diameter. This lasted for 2 weeks.
Patient received PREVNAR 13 on 11/15/2016 and she has been having constant pain/redness and soreness in the injected (L) arm despite the lapse in time. The symptoms have not resolved as of now.
Information has been received from a consumer, concerning her 20 year old daughter with a sulfonamide allergy and drug hypersensitivity to cephalosporin, who was vaccinated with the first and second dose of Gardasil (date and lot # not reported). Concomitant therapy included YASMIN. In December 2007 ("about four weeks ago"), her daughter developed swollen glands on both sides of her groin area. Diagnostic blood tests were obtained (specific test and results not provided). At the time of this report, the outcome of the event was unknown. Additional information has been requested. 02/10/2010 On 06-FEB-2008, a computed tomography (CT) scan of the abdomen and pelvis revealed subpleural reticular change in the left lower lobe of the liver, which was at the upper limits of normal, and several borderline enlarged bilateral inguinal lymph nodes, which were nonspecific. ON 07-FEB-2008, the pathology report for a left femoral lymph node exision, indicated on lymph node with reactive, lymphoid hyperplasia. Also on 07-FEB-2007, a flow cytometry immunophenotypic report indicated "no immuniphenotypic abnormalities detected." At the time of this report, the outcome fo the events was unknown.  Additional information has been requested. All available medical records will be provided upon request.
Shortness of breath and chest pain 10 hrs after vaccination.  Chest pain and shortness of breath worsened over the next 2 days. Went to ER on July 5th. Blood work,EKG and chest X-ray done. Sent home with 800mg IBU
throat was swollen; allergy; he could not breathe; This is a spontaneous report from a contactable consumer. This consumer reported events for 2 patients. This is the first of 2 reports. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that his friend (patient) after second dose and 9 days later, his throat was swollen and he ended up in the hospital 3 times because he could not almost breathe. He went to the ER and he put some injection for allergy and he was getting better but now in the process to figure out why he had that reaction. He was in the middle with the doctor with the allergist trying to find out what caused him that reaction they still have not given the answer about what caused the reaction in him. The events was considered serious medically significant. Outcome of the events was recovering.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021534586 same reporter/drug, different patients/events
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-APR-2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-AUG-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt describes developing a productive cough with thick, yellowish/greenish sputum 6 days post vaccination. Pt also developed full body itching 6 days post vaccination. Itching is worse on the head, neck and shoulders, especially when wet.
I visited my daughter in the another country, and I returned home on March 15, 2023. On the day I returned I had cold like symptom. My first symptoms were scratchy eye and sinus congestion. I developed a scratchy sore throat, fever of 100 degrees, and a cough. So, I tested for COVID-19 on the March 16, 2023, and the test was positive. The doctor prescribed Paxlovid and I began taking it the same day. The symptoms improved by the 3rd day, but I still had the cough, runny nose, congestion and runny eyes. I retested on the 21st and I was negative. Then I started feeling bad again and I retested for COVID and started to feel bad again. I had an additional COVID-19 Test 2 days later. I tested negative on April 1st. The doctor diagnosed me as having a rebound case of COVID-19. I currently have sinus like symptoms, but I am testing negative.
Since having my second booster I have had three teeth that just became loose and had to be pulled by my dentist. The teeth never hurt and I have not had any problems in the past.  Now I have another tooth that is becoming loose and is needing to be pulled.
5 yr old male received #5 DTaP, #4 IPV, #2 MMRV, #1 PV7, and #1 HIB and #1 Hep A. Mother reports she took child to clinic on 4/27/07 with an allergic reaction. The child had wheals (hives) on his entire body. He was dx with allergic urticaria at clinic. She reported she gave Benadryl for a month after this reaction. He had another allergic reaction 9/47/07 to cough medication.
This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). Pertinent medical history, drug reactions or allergies were not reported. On 08-JUN-2014 the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot number: J011548, expiration date: 19-DEC-2014, (dose, route not reported). No adverse effects reported. This is one of several reports received from the same reproter. Additional information has been requested.
the vaccine was administered to a patient 8 days after the expiration date, no adverse event; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2-month-old female patient who was vaccinated with a 0.5 ml dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA and expiration date 30-Jan-2020) via an intramuscular route in the left thigh on 07-Feb-2020 for prophylactic vaccination.  Medical history was not reported and the patient did not receive any other vaccine.  It was an actual medication error case due to expired vaccine used.  No adverse event was reported at the time of reporting.  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 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.
PATIENT WAS INADVERTENLY GIVEN 2 DOSES OF MODERNA VACCINE THOUGH SHE WAS 17 YEARS OF AGE. SHE DID NOT REPORT ANY ADVERSE EVENTS OR SIDE EFFECTS FROM RECEIVING THE VACCINE.
Fluid in her stomach; Fluid in her legs; Still experiencing pain in her arm where she received the dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Fluid in her stomach), OEDEMA PERIPHERAL (Fluid in her legs) and VACCINATION SITE PAIN (Still experiencing pain in her arm where she received the dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Fluid in her stomach), OEDEMA PERIPHERAL (Fluid in her legs) and VACCINATION SITE PAIN (Still experiencing pain in her arm where she received the dose). At the time of the report, ABDOMINAL DISCOMFORT (Fluid in her stomach), OEDEMA PERIPHERAL (Fluid in her legs) and VACCINATION SITE PAIN (Still experiencing pain in her arm where she received the dose) had not resolved.            No Concomitant medication were reported.  No treatment medication were reported.  Patient had never taken medicines or had any surgeries. She did not drink or smoke.
Patient called pharmacy and stated that she received the Shingrix vaccine on 8/13/2020.  She reported that on 8/15/2020 she woke up with a rash on both ankles.  She reports swelling in one ankle which started at the same time but she had previously injured that ankle earlier in the month so she believes the swelling may be unrelated but she went to her doctor for both symptoms.  Per the patient the doctor recommended ice and elevation for the swelling which helped along with compression.  Per the patient as of 8/21/2020 she still has no improvement on the rash and will be returning to the physician for reassessment.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 73-year-old patient with unknown gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 21-FEB-2017, the patient was treated by a physician at healthcare facility/hospital for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to self and economic losses. The outcome of Shingles was unknown. Causality assessment for shingles was considered as related to ZOSTAVAX. Additional information has been requested.
Estimated due date: 06/03/2021  All the common symptoms chills, body aches, nausea and fatigue started the next morning. I was a little feverish: 99.9 to a little before 100F.  Then on Saturday I had a pain on my left side from my arm all the way up to my neck, and it was really hurtful. And I also had it on my right side not so strong as the left side.
Pt received Anthrax 07/17/03, complained of swelling, rash (+) itching since 07/19/03. Symptoms better today. Tx included elevate, rest, Motrin 800 mg, Benadryl and f/u in 2 days.
Pfizer-BioNTech COVID-19 Vaccine EUA - About 5 minutes after receiving her first dose of the Pfizer covid-19 vaccine, pt experienced lip swelling in the observation area.  A pharmacist was standing by with an epi-pen should the need arise.  As a result of pt request, she was given cold water to drink.  Pharmacist offered to call EMS and pt was reluctant at first.  She contacted her husband who is physician and he recommended that EMS be called.  Pt was released to EMS upon their arrival and no other incident was noted.
Muscle ache in left upper arm. Warm to touch at times. Difficult to lift with arm due to increased pain.
fatigued; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) and NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigued) and NAUSEA (nauseous). At the time of the report, FATIGUE (fatigued) and NAUSEA (nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Patient had severe pain in left arm, unable to move it around, down to left elbow.  Interesting he didn't have pain at injection site, but just distal to.  Redness and swelling, adding nearly and inch in diameter to his arm circumference (by patient measurement at home) with erythema.  Most of the redness and swelling was medial surface just of arm proximal to elbow. By 9/23, it was improving but still present.  Treating with OTC pain mediations, ice and heat were also suggested 9/24 seen in office and some residual erythema to medial arm just above elbow but had significantly improved.  Normal ROM present
Approximately 2-3 hours after getting the shot, my right arm started to become itchy, burgundy and warm. Before going to bed, the swelling was about a quarter-size. When I woke up this morning, the swelling doubled in size.
1 day post vax, child began to scream, unconsolable, lasted several hrs. Taken to ER per drs request. Told that if resolved by 2/5 reaction due to Pertussis. Not to receive Pertussis again.
Injection site pain,  Redness ,Swelling  Fever  Headache  Nausea Fatigue
At 8:30 pm , sudden increase in Blood pressure 192/90 , pulse rate at 108  Palpitation  Lasted for 30-45 min then gradual decline to normal at 130/80 Laid in bed & drinking water
Pt was administered lot EW0151 that had expired 7-31-21.  He had been in ultra cold freezer until a few hours prior to administration.  The Pfizer manufacturer and the CDC were notified.  The recommendation is that the patient be revaccinated. Pt has been notified and given this information.
Very weak; Felt like a fever; Shaking; Cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), ASTHENIA (Very weak), PYREXIA (Felt like a fever) and CHILLS (Shaking) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold), PYREXIA (Felt like a fever) and CHILLS (Shaking). On 08-Mar-2021, the patient experienced ASTHENIA (Very weak). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, q6h. At the time of the report, NASOPHARYNGITIS (Cold), ASTHENIA (Very weak), PYREXIA (Felt like a fever) and CHILLS (Shaking) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Injection site redness; rash on arm near injection site; fever in arm; chills; nausea; This is a spontaneous report from a contactable other health care professional. A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJ1686), intramuscular on 31Dec2020 07:30 at single dose at arm left for COVID-19 immunization. Medical history included GERD, ovarian cysts, obesity, and anxiety. Concomitant medications included fluoxetine, omeprazole, and folic acid. On 11Jan2021 07:00, the patient experienced Injection site redness, rash on arm near injection site, fever in arm, chills, nausea. The patient did not receive treatment for the events. The outcome of the events was recovering.