chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pulmonary insufficiency; A spontaneous report  received from a Consumer concerning, an unknown age male patient who received a second dose of the Moderna COVID-19 vaccine and experienced pulmonary insufficiency.   The patient's medical history was not included. Patient's concomitant was not included.   On unknown date, the patient received their Second dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Reporter stated her daughter's friend apparently developed a severe reaction a day or two after receiving the second dose of the vaccine resulting in pulmonary insufficiency. He had just traveled  on vacation. He is now in an ICU at a U.  Medical Center  and may be moved into a respirator soon because of clinical deterioration. Reporter stated two days of steroids apparently have not helped. Other treatment information was not provided/unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/ not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Heart attach-like symptoms within a week's time of the vaccine injection, ER visit with admission for observation at hospital.  An echocardiogram revealed heart ejection fraction at only 20%, down from a previous low of 40%.  The patient was placed into the Palliative Care program at hospital.
Patient stated her vaccine hurt really bad going in and she is still having trouble moving her shoulder without pain.  She has stiffness and limited range of motion without pain.  Since she has had problems with a "frozen shoulder" in the past, she has physical therapy stretches and is taking occasional ibuprofen to help with pain. I explained it may take several weeks to recede with a previous injury in that area and advised her to take vaccines in the right arm from now on when possible as to not irritate the shoulder again.
administered Fluzone High Dose to a patient who is 64 years old, with no reported adverse event; administered Fluzone High Dose to a patient who is 64 years old, with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from other health professional and physician via  Medical Information (Reference number: 00812383) and transmitted to Sanofi on 19-Oct-2021 in the .  This case involved a 64-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On 18-Oct-2021, the patient received a 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test 0.7ML, Strength: standard except for fluzone HD, lot UJ759AD, expiry date: 30-Jun-2022] via an intramuscular route in the left deltoid for prophylactic vaccination  This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose.  It was reporter " Doctor calling to find out what side effects could occur from the FLUZONE HIGH DOSE QUADRIVALENT. Caller stated that he accidentally gave the vaccine to a patient that was 64 years old. Caller wanting to know comparison of flu vaccines as well."  No other vaccines.  At the time of this report the patient was fine and had no adverse events after the vaccination.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.
Swelling, hotness, redness of injection site. In a triangle almost, put Bendaryl gel on it overnight and nothing changed.
Rash on left arm noticed about 10 days after first shot of 2. Also felt a lump in throat right under jar bone. Consulted by phone with primary care giver's office and got a return call from nurse relaying conversation with Dr. Described as minor reaction and go ahead with planned second shot. Rash slowly disappeared. 2nd shot on 01/13/2021 and rash began appearing by end of next day. Rash area continued to enlarge and no lump in throat this time. Very itchy and rash on larger area than with 1st shot and is more solidly red. Plan on continuing to watch but no medical attention seems necessary at this time.
Since my vaccination, I have had extreme, debilitating menstrual cycles, including severe cramping, nausea, fatigue, and heavy blood flow. It has happened each month since the vaccine. My menstrual cycles prior to the vaccine were mild.
02:15 on 10/4/23 I woke up in the middle of the night to excruciating burning in my hands, most notably on my palms. At 0300, the burning had stopped but I had lost all sensation in bilateral hands. I also experienced serious orthopnea and tachypnea that lasted until I got out of bed for the day. The complete loss of sensation in my hands lasted until approximately 1900 on this same day 10/4/23. I was finishing my shift at work and had discovered that I had feeling again in my hands. I never lost function or movement of my hands. I have no residual numbness or burning in either of my hands at time of writing.
Redness and mild itching at injection site that spread down arm over at least 4 days. No signs of infection or systemic allergic reaction so no treatment was given. Outcome implied resolution.
Headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wanted to know if it was possible to send the patient some medical information about the side effects of the vaccine and time of duration. The patient experienced headache on an unspecified date. The outcome of the event was unknown.  Information on lot/batch number has been requested.
I received the Moderna vaccine on Jan 8. I had some soreness in my arm for a couple days. Then about 4- 5 days in, I developed a large local reaction with redness, pain, hot to touch, and itching. This persisted and worsened over the ensuing week. The itching was pretty severe and the area was very hot to touch and painful. On Saturday, I developed some tongue itchiness- very strange sensation. I treated it with some Benadryl and Ibuprofen with some relief but not resolution.
site of injection pain, body aches, headache, pain behind eyes, fever-100.9, nausea, not able to eat took motrin 800 after abt 8 hrs ...most symtons went away except pain at injection site and headache
A report was received from a healthcare professional on 30 October 2003, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unspecified number of vaccinees under 4 years of age inadvertently received Fluvirin.  No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 01 December 2003. Follow up information received from a healthcare professional indicated that a 2 and a half year old male vaccinee inadvertently received Fluvirin on 18 October 2003 and had not experienced any adverse event at the time of the report. No follow up pending, all information received.
Pt. had vaccine (Tdap) given at 3:30 pm and two hours after shot she started feeling pain on site. That night she stated feeling site of vaccine warm, red and a little swollen. Ibuprofen 600mg TID x 3 days, BID x 3 days-ice, BENADRYL.
10/3/03 received vaccine. Followed up with doctor at work the following Monday. 2 weeks later pain worse; went back to work. Physician told possible nerve damage. One week ago, severe pain; went to own physician. The medical records received on 12/31/03 states numbness, multiple sclerosis, and demyelinating plaque. 60-day follow up on 01/12/04: "The vaccine recipient is unknown to have recovered from the adverse events that were reported for this vaccination.  You may want to follow up with her employer.  I sent you their information when I reported.  She has not been back to our facility."
Immunization 9-1-09 and on 9-2-09 mother noted non-vesicular rash on neck and itching. Left arm and shoulder are red and warm to touch today (9-3-09) and rash has spread to abdomen and upper and lower extremities - Temp is 99 degrees F and child "feels feverish". Rash became less red when given some BENADRYL PO - called family doctor and mother was told it was probably the varicella vaccine.
Approximately 20 hours after flu shot given, developed migraine headache, pain back and legs, nausea, no vomiting, decrease appetite - treated with Tylenol, rest and heating pad. Did not seek medical attention. Symptoms lasted approximately 36 hours, still does not feel better.
Information has been received from a physician concerning a 20 year old female with no pertinent medical history or concomitant medication use, who in August 2007 was vaccinated intramuscularly (site not reported) with 0.5ml GARDASIL (lot# not reported). Two weeks post vaccination, the patient developed a mild, red rash on her arms and legs. The patient also had a mild, transient, swelling in her throat that caused slight difficulty breathing. The patient sought unspecified medical attention and at the time of this report was recovering. Additional information has been requested.
Patient is having pain in his left shoulder joint where vaccine was administered. There is also muscle weakness that has been there for 15 days now. Patient has an appointment with an orthopedist on 9/20/2016.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck virus vaccine live PROQUAD (lot # N035171 exp date 09-JUN-2019) (dose and route not provided). The vaccine was reconstituted with properly stored sterile diluent. Data digital logger was reported. The vaccine was exposed to a temperature of 6 °F to 14 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source; Sender's Comments: US-009507513-1806USA006474: US-009507513-1806USA006475: US-009507513-1806USA006476: US-009507513-1806USA006477: US-009507513-1806USA006478: US-009507513-1806USA006479.
body aches; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (Headache) and FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 04L20A) for COVID-19 vaccination.     The patient's past medical history included Thrombocytosis (High blood platelets) since 2010. Concomitant products included HYDROXYUREA for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN (body aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            This case was linked to MOD-2021-016528 (Patient Link).
Pt had injection site soreness the next day.  On day 2 post vaccination, pt developed a golf ball size knot.  Five days post vaccination, the knot is gone but injection site still sore.  Pt took ibuprofen as needed and Benadryl at night.
Body aches, nausea, and fatigue were the first adverse symptoms, followed by a 100 degree fever a few hours later with extreme injection sight pain.
Evening 1/17:  Stomach pain and diarrhea Mid-day 1/18:  Anaphylactic reaction (airway constriction, dizziness, sore throat, general malaise and involuntary tremors in upper arms); Required visit to urgent care where doctor gave patient 125MG IM Solu-Medrol and symptoms immediately subsided.
Received J&J vaccination on 8/20/2021.  Felt feverish with 102.8  F the next day. The next following day I recovered.  In the next two weeks I have been experiencing hand pain and weakness.  I took notice of it on 9/2/21 and the effects comes and goes throughout the day.  Currently of 9/9/21 I am still feeling hand weakness and pain.
Fever 2 days, then on day 5 got widespread hives, doctor advised going to ER but currently waiting and taking Benadryl.  Was forced to choose elsewhere on this form that I went to doctor when I only got her advice over the phone.
Pt given HEP A dose 2 in our office mom called 1 hr later & stated child's eye lids are swelling has call into MD.  Child has seasonal allergies.
Patient presented to pharmacy 11.20.17 with upper arm pain and complaint of range of movement loss. She could only raise her left arm to a certain point. She mentioned that she thought the immunization location was higher up on the arm than she had been accustomed to. I recommended that she consult with her physician or similar caregiver (express/urgent care) and to please keep me informed as to what was happening and if she got any suggestions/recommendations related to the pain/discomfort. She presented to the pharmacy a second time on 11.24.17 and informed me that she had her arm checked and was told that she had a bacterial infection in her upper arm (between the left shoulder and elbow) and was prescribed cephalexin and prednisone. She has a regular visit with her provider coming up and will keep us abreast of the situation.
Patient was in normal state of health when receiving Pfizer booster on 11/24/2021.  Went to bed in normal state of health after eating dinner.  At 1 AM, developed severe epigastric pain, noted blood pressure to be elevated with systolic pressures in the 240s.  Came to the ED for further evaluation.  Noted to be hypertensive, tachycardic.  Symptoms improved with treatment of blood pressure, also given GI prophylactic medication.  Patient did have mildly elevated troponin of 0.06 on presentation, felt to be secondary to elevated blood pressures.  Unclear how Covid booster contributed to significantly elevated blood pressure.  She did require hospitalization for further work-up and, at the time of this report, currently hospitalized.
Sore throat; Constipation; Intense abdominal pain; Fatigue; Nausea; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 19:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, vitamin D deficiency and 4 months postpartum. The patient was allergic to adhesive. Concomitant medication included colecalciferol (D3 (5000IU)) taken for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 20:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 03Apr2021, the patient experienced fatigue, nausea, sore throat, constipation and intense abdominal pain. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fatigue, nausea, sore throat, constipation and intense abdominal pain. The clinical outcome of the events fatigue, nausea, sore throat, constipation and intense abdominal pain were not resolved at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
stomach aches, lose stools, headache, left arm pain/soreness, lasted two days
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/8/2021, 3/29/2021, and 9/23/2021. Patient tested for COVID at clinic on 10/19/2021 which resulted positive. Presented to ED on 10/20/2021 with complaints of cough, nausea, vomiting, diarrhea and weakness for 10 days. Admitted for acute kidney injury and requiring oxygen supplementation 3-4 L nasal cannula.  Received: dexamethasone, full anticoagulation, remdesivir, broad spectrum antibiotics, paralytics, pressors, and nitric oxide. Transferred to ICU for chest pain and hypoxia. Developed pneumothorax, chest tube placed and intubated.
1732: Pt administered the vaccine. 1735: Pt had SOB, Dizziness, Chest tightness .1739: VS noted as BP 200/100, SPO@ 97% on RA, HR 92 1745: Pt developed hives on chest, shoulders. 1746: Epipen was administered 1749: Benadryl 50 mg IM was administered. 1751: VS noted as BP 200/130, SPO2 99% on RA, HR 89 1756: Solumedrol 125 mcg administered IM. 1758: 20G RAC IV inserted by RN. 1800: VS noted as BP 218/130, HR 72, SPO2 98% on RA. Pt complained of chest tightness again, 2 liters of oxygen via NC administered. 12 lead EKG performed, EMS arrived at the scene and Pt. transferred to Hospital
Pt had likely partial complex seizure 10 minute after vaccine so went to ER. No prior seizure.
This spontaneous report as received from a Licensed practical nurse refers to a "male patient" of unknown age. On 20-MAY-2002, the patient was vaccinated with his one and only dose of M-M-R II, intramuscularly (indication and lot were not reported) which was six days before his first birthday. No adverse effect reported. The outcome of the events were unknown. Additional information has been requested.
Vertigo, nausea and vomiting, ear pain, aches in back and knees, 100.5 fever, brain fog? the aches and brain fog are still present today. I also had covid back in January of 2021.
This spontaneous report was received from a 68 year old female patient with glaucoma, Graves' disease and vitiligo reporting on herself. The patient was experiencing recurrent itchiness (reported as that "come and went") on back, neck and chest in the past. The patient had no reactions or allergies to the drugs. On 16-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency and lot #: not provided). Concomitant therapies included levothyroxine sodium (manufacture unknown), temazepam (manufacturer unknown), alendronate sodium (manufacturer unknown and timolol maleate (manufacturer unknown).  On 16-JUL-2014 reported as "right after she received" ZOSTAVAX, she remembered that in the past (date unspecified) she had experienced the itchiness started. The patient reported that the symptoms of itchiness on back, neck and chest that came and went, recently got worse and she was unable to sleep if she did not use CORTIZONE 10 PLUS cream nightly to relive the itchiness. No laboratory test was performed. The patient did not seek medical attention. The outcome of itchiness gotten worse was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
I was feeling weak. I had a headache, tired, and my whole body felt drained, I could barely walk. I had a loss of appetite, and I was super tired. I went to the ER on 1/12/2022 and they said I had COVID-19. They kept me there for 5 days. They gave me some medicine intravenously. The doctors were concerned about my breathing because my oxygen level was low.
about 24hr p/vax pt noticed redness & swelling;pt was seen about 72hr p/vax & had a 13cm x 9cm area of erythema & warmth;darker red central area 2cm x 2cm;tx w/DPH;
Pt developed macular erythematous rash on face and eyelids immediately following vaccine. No swelling, no respiratory distress. Pt received benadyl. Rash resolved 15 - 20 minutes later.
Information regarding PREVNAR was received from a pediatrician regarding a 6-month-old patient who experienced diarrhea. At 6 months of age, the patient received a dose on an unspecified date. The patient experienced diarrhea. No additional information was available at the time of this report. See related cases: US-WYE-H07067108 (adverse event, non-expedited); US-WYE-H07073908 (adverse event, non-expedited); and US-WYE-H07074108 (adverse event, non-expedited)
As described by the patient in her words, a hard/raised red knot (between the size of a dime and nickel) formed almost immediately at the injection site. After approx. 10 days, the spot became irritated and infected/developed pus. The patient treated it with a medicated cream given to her by her husband who she says is a physician-assistant. After 3 weeks, it started to heal and scab over. When the patient came back to the office for her second dose, a small scar was still visible. The patient reported that she experienced no other adverse side effects. She received her second dose in the same left arm a few inches above the original site and was informed to call our office if she had any similar or other reaction.