chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received moderna vaccine on 1/22/21, 2/22/21 and 5/24/22. Presented to ER on 7/4/22 and found to be COVID positive.  Patient is a 71-year-old female who on the date of admission had a mechanical fall and sustained injury as noted in the H and P as well.  She was admitted and was tested for COVID and found positive.  She remained asymptomatic throughout her hospital stay and was appropriately isolated and monitored for hypoxia.  Was continued on home medications.  Underwent surgical repair of her femur fracture as documented in the associated operative note.  Tolerated the procedure well and was initiated with physical and occupational therapy status post the procedure.  She did drop her hemoglobin with the greater than expected acute blood loss anemia and was transfused with 1 unit and hemoglobin remained stable throughout the rest of her hospital stay.  Was continued on home medications for her chronic issues including hypertension and SVT.  It was felt would benefit from rehab in a skilled nursing facility setting and was discharged on 7/13/22
Chills, headache, fever, fatigue, muscle aches, abdominal pain, congestion beginning 2230 on 09/07/2021.
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 04-NOV-2013 at 16:30 the patient was administered with MMR II (lot number J002867, expiry date 08-MAR-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the MMR II was exposed to approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Information was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 16-MAY-2017, the patient was vaccinated with a dose of M-M-R II, for prophylaxis (dose, route of administration, lot number and expiration date were not reported), and on 25-MAY-2017 the patient was vaccinated with VARIVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Other suspect therapy included sterile diluent (DSM STERILE DILUENT).   On 25-MAY-2017, the pharmacist called to report that a patient received 2 live vaccines too close together. It is unknown if there is relevant lab work. As of 25-MAY-2017, it was unknown if the patient would continue on the M-M-R II or VARIVAX. The pharmacist stated she would discuss with the patient that according to information provided to her, the VARIVAX would be considered invalid and that the patient would need to be redosed in 28 days. Additional information has been requested.
Febrile seizure morning after vaccine.  Seen in ED. Quickly resolved.  Only given antipyretics.
Patient reports that approx 5 hrs after vaccine he felt feverish and had pain in his (R) arm from shoulder to elbow across (R) chest down th axilla. Over the next 24 hrs the pain intensified, he had fever, shaking, chills and drenching sweat. The pain was so intense he was unable to lift his arm. He reports the injection site was red and warm to touch, he isn't sure if it was swollen. Patient reports he no longer had fever, chills, sweats but arm was still sore.
Pt had a temp about 100 F. Pain at injection site not subside > 1 week after injection. Arm feels numb and site is tender at touch.
Patient reports that one week after receiving her first Pfizer Covid vaccination that she began to experiencing migrating pens and needles sensation.  She reports that the sensation happens all over her body.   Occurs at random times.  She said that it has even awakened her from sleep and at times can be very painful more like a stabbing pain.  When she experiences these sensations they do not last long,  at most seconds to short minutes.    Symptoms are still persistent 4 weeks post vaccination.
For a couple of days before having a fever, she was complaining about not feeling good and being dizzy and having headaches. Then one day she woke up with a sore throat, fever, and congested. We gave her a COVID-19 test, and it was negative. She started getting a little better. We sent her to school and got a phone call stating that she was unable to make it through the school day. I took her to the doctor and the did a COVID-19 test and flu, and it came back Influenza A. We did not want to give her TAMIFLU because she had her symptoms past the 48-hour mark, so we decided to give her ADVIL cold and flu.
pt recv vax & next day approx noon tongue was sore/painful & by 20OCT96 it had a furry, black coating on the entire tongue which gradually disappeared over the next 4 days;
This spontaneous report was received from a mother referring to her 16 months year-old son. The patient had no medical history, drug reactions/allergies or concomitant medications to be reported. On an unknown date, the patient was vaccinated with M-M-R II; VAQTA; and VARIVAX, all recommended to avoid disease (prophylaxis); the doses, lot# and expiration dates were not reported. On an unknown date (reported as "when he was about a year old"), the patient stopped sleeping at night. The patient did not seek medical attention or received any treatment. He neither did undergo tests regarding his inability to sleep at night. On 14-DEC-2017 (reported as today), the clinic that administered the vaccines contacted the patient's mother to tell her the vaccines the patient received had been stored improperly at the time they were administered. The patient was currently 2 and a half year old and his status at the time of the report was reported as "healthy" so the outcome of insomnia was recovered. The causality assessment between the aforementioned vaccines and the event of insomnia was not reported.
Pt received Fluzone vaccine 9/23/13 at 9 PM - 9/23/13 AM noted pain and bruising. 9/25/13 - redness to site and slight swelling at injection site.
My husband tested positive for covid on Sunday. Then I caught it on Tuesday. I had a headache, congestion, exhaustion, dizziness, and I lost my voice. Thursday and Friday were the really bad days. Then it started to get better. I just took some Zinc, and I was drinking Vitamin C shots. When I had went to see my doctor they prescribed me with Ibuprofen 600mg, Fluticasone, Loratadine, Azithromycin 500mg, and Benzonatate as needed.  I didn't take the Benzonatate though because my cough never got that bad. A few days after getting well I still had a little bit of dizziness. It also took a while for my voice to come back to normal for a couple of weeks.
pt stated that had a reddened, hot area, lt upper arm;measured approx 3-4" in width;devel lt arm stiffness which spread to lt upper back & lt side of neck;stated couldn't lay on rt side or lt lt arm very high;c/o aching deep inside lt arm
@nd shot of Moderna on 03/10/2021. Next day 03/11/2021 left arm  at injection site  red, swollen pain full and extreme itchy all at same time. Pain lasted four days, red swollen rash was extremely itchy for seven days. Red and discolored blotches still on left arm injection site after nine days and still slightly itchy.
Immediate severe vertigo, blurred vision, and quickly following headache. A few hours following injection onset of joint pain and stiffness, tongue swelling, extreme injection site swelling. Following morning (10-30), severe joint (every single bodily joint in agony) and nerve pain impairing daily tasks and activities, pain induced nausea, vertigo, swollen tongue, sinus congestion. Took diphenhydramine "sleep aid" not containing PEG around noon 10/30 and experienced some symptom relief. Pain returned in a few hours. Additional diphenhydramine taken that night. Morning of 10/31 most symptoms had improved, with some lingering joint and nerve pain and swelling. Most symptoms have subsided by time of reporting (11-2).
ACTHIB was administered to an 11 year old patient/ no AE; Initial information was received on 21-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional via Regulatory authority (Reference number- 00691458) and transmitted to Sanofi on 21-Jul-2021.  This case involves a 11-year-old male patient reported that HIB (PRP/T) VACCINE [ACT-HIB] was administered to an 11-year-old patient with no adverse event (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 20-Jul-2021, the patient received 0.5 ml (total) second dose of suspect HIB (PRP/T) VACCINE [lot UJ404AA and expiry date 04-Oct-2021] via intramuscular route in right deltoid for prophylactic vaccination.  It was reported that, "1st one was in 2010. Product used: Used. First time product used: No".  It was a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  At the time of reporting, patient had no adverse event.  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.
This non-serious consumer spontaneous report (initial receipt 05-Dec-2014) concerns a 69 year-old male patient who had no known drug allergies. He had received flu vaccines in the past (unknown brand). On 04-Dec-2014, the patient received intramuscular AFLURIA (batch number not provided) 0.5 mL. On 04-Dec-2014, following the vaccination, the patient developed a rash of red spots/blotches on his chest and back which they noticed on 05-Dec-2014 for the first time. The rash was not painful or itchy. The patient's physician was aware and instructed him to take diphenhydramine. At the time of the reporting, the patient had just started the diphenhydramine and did not know if it was helping with the rash. Outcome was not yet recovered. Reporter comments: the reporter assessed the events as 'related' to the AFLURIA vaccine.
Patient started complaining of palpitation and body heat about 20 minutes after receiving the shot. She also complained of scratch throat. She was given Benadryl and heart rate was checked. We called emergency responders and the paramedics stayed and monitored her symptoms  for about 30 minutes until she was symptom free before she left with her mom.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # K008873 with expiration date on 06-FEB-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit for 1 hour. There was a previous excursion of 33 degrees Fahrenheit for 74 hours reported. Data logger was not involved. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1605USA003943.
Day 23(post IZ) scab detached leaving a flat raw area at site. Day 30,10 mm site area became swollen, tingly and itchy with 3-4 pinpoint yellow spots visable. Some sorenes with pressure. There was no drainage.  Another scab developed and then detached 9 weeks post IZ.
DTaP given right shoulder. 48hrs later, right shoulder became swollen, firm and tender and no fever. Resolved completely 24 hours after Keflex.
Increase pulse; increase B/P;  headache;  light headed; unsteady lasting from 1/11/21-1/20/21.
Patient presented with redness and inflammation on the vaccine site. Patient was given immunization at 9:40 and came back into our clinical room at 10:20 to be evaluated.
4 hrs after vaccine pt began to have pain @ injection site. She was seen in walk-in with muscle relaxed given without IS. XRAY negative. Pin with decreased ROM due to pain.
This prospective pregnancy case described the occurrence of trisomy 13 in a patient. The 30-year-old mother was a subject enrolled in a open label study. The subject received Flu Seasonal QIV Dresden on 24th September 2015. Concomitant product exposures included Prenatal Vitamins and Probiotic. The mother's last menstrual period was on 9th August 2015 and estimated date of delivery was 22nd May 2016. The patient was exposed to Flu Seasonal QIV Dresden at week 6 of gestation and during the first trimester of pregnancy. The pregnancy was ongoing. The patient was diagnosed with trisomy 13. Serious criteria included congenital anomaly. Additional event(s) included trisomy 18 (serious criteria congenital anomaly), trisomy 21 (serious criteria congenital anomaly) and maternal vaccine exposure. The outcome of trisomy 13 was unknown. The outcome(s) of the additional event(s) included trisomy 18 (unknown), trisomy 21 (unknown) and maternal vaccine exposure (unknown). It was unknown if the investigator considered the trisomy 13, trisomy 18 and trisomy 21 to be related to Flu Seasonal QIV Dresden. See case US2015136932 for details regarding the mother case. Additional details were provided as follows: The patient's mother had no known relevant medical histories. The patient's mother received a dose of FLUARIX QUADRIVALENT at 6 weeks and 4 days of pregnancy. On 11th November 2015, the mother's non-invasive prenatal test (NIPT) showed trisomy 21,18, 13 which were classified as low risk. On 17th December 2015, the patient's mother's ultrasound showed an isolated echogenic focus in fetal left ventricle. Fetal cardiac anatomy appeared normal. On 10th February 2016, at 25 weeks of gestation, the follow up ultrasound showed a 4 chamber heart with echogenic focus, no further details give or follow up recommended. The pregnancy progressed normally. The baby was not yet born. The reporter did not administer the vaccine to the patient at her facility. She presumably got it elsewhere.
Pt recvd 2 doses of Engerix-B & 11AUG92 devel lymphadenopathy on rt side & a fever; took a day off from work;
Tingling - much like the sensation of novocain wearing off - from the injection site on my left shoulder to my left cheek. The sensation is most noticeable on my left shoulder ( injection site), left neck, and left cheek (from jaw to cheekbone)
Metal taste in mouth 15 minutes after vaccine administered, lasting several hours Headache Fatigue
GI upset; nausea; abdominal pain; extreme tiredness; This is a spontaneous report from a contactable other HCP.   A 73-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 21Feb2021 14:30 as SINGLE DOSE for covid-19 immunization.  Medical history included scleroderma and gastro esophageal reflux disease. Concomitant medications included omeprazole, metoprolol, crestor, zetia, and multivits. The patient previously took epinephrine and experienced drug hypersensitivity. On an unspecified date, the patient experienced GI upset. nausea, abdominal pain, and extreme tiredness. The outcome of the events was reported as recovered.
Tiredness; This is a spontaneous report from a contactable consumer. A male patient of unknown age received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 29Mar2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 30Mar2021 the patient experienced tiredness. The clinical outcome of the event tiredness was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 23-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
2 day severe headache. Vomiting-6 hrs, 12-15 hrs after shot. No appetite even 1 week later. Slept 16+ hours on first 24. Usual sore arm-total body fatigue.
After the vaccine was administered, the patient immediately experienced dizziness and nausea. The patient was sent home after symptoms improved, but started vomiting later at home that day. The patient complained of pain gradually getting worse at the site of injection, which had lasted about two weeks when reported to the facility. The provider instructed giving ibuprofen as needed for the pain, and afterward the parent reported the ibuprofen has helped with the pain and the patient is feeling better. Second follow up with parent reports the patient is doing well.
This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (Issue with lungs exacerbated after second shot), CONDITION AGGRAVATED (Issue with lungs exacerbated after second shot), COUGH (Coughing a lot/ There is nothing that comes up when she coughs), PAIN IN EXTREMITY (Pain in her arm) and PAIN (Pain that lasted the whole day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She was sick with flu like symptoms, flu, high temperature) in December 2019 and Voicelessness (Voice was gone all of a sudden for a week.). Concurrent medical conditions included Lyme disease, Asthma and Pulmonary function impairment (Lost lung capacity and not been able to sing.) since 2019. Concomitant products included LEVOTHYROXINE and LORATADINE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced LUNG DISORDER (Issue with lungs exacerbated after second shot), CONDITION AGGRAVATED (Issue with lungs exacerbated after second shot), COUGH (Coughing a lot/ There is nothing that comes up when she coughs), PAIN IN EXTREMITY (Pain in her arm), PAIN (Pain that lasted the whole day), FEELING ABNORMAL (Did not feel good at all/Felt like a mini case of COVID.), PYREXIA (The second shot gave her a temperature/ highest her temperature got was 100.8), MYALGIA (Pain in muscles was for 24 hours) and HEADACHE (Headache that lasted for three days). On 29-Apr-2021, MYALGIA (Pain in muscles was for 24 hours) had resolved. On 30-Apr-2021, HEADACHE (Headache that lasted for three days) had resolved. At the time of the report, LUNG DISORDER (Issue with lungs exacerbated after second shot), CONDITION AGGRAVATED (Issue with lungs exacerbated after second shot), COUGH (Coughing a lot/ There is nothing that comes up when she coughs), PAIN IN EXTREMITY (Pain in her arm), FEELING ABNORMAL (Did not feel good at all/Felt like a mini case of COVID.) and PYREXIA (The second shot gave her a temperature/ highest her temperature got was 100.8) outcome was unknown and PAIN (Pain that lasted the whole day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 100.8 (High) 100.8.         Other concomitant products included inhaler and A-L Complex.  No treatment information was provided.
I received the shot in my left arm. Tingling in left side of face on cheek bone started shortly after I received the shot. I let the pharmacist know and I waited a bit longer. I thought it was maybe from anxiety and I was clenching my teeth. Throughout the morning the tingling spread throughout my left cheek and top and bottom jaw on left side, felt some numbness. Also felt some tingling and numbness in my left hand and lower part of left arm. Off and on tingling went through back of neck into my head on my left side. Tingling in cheek hung around all day and is still there this evening.
Headache, fatigue, chills, diarrhea, no appetite, and fever. No treatment. Symptom's on 5/12,5/13,and 5/14. Patient now complains of fatigue and just not feeling well.
Involuntary shaking of my body. My legs were especially affected. I couldn't stop them from shaking & contracting.  This started w/in 12 hours of getting the vaccine.
Patient presented to office on 10/18/10 with bilateral leg weakness with numbness. Bilateral numbness in arms and hands. Unsteady gait. SOB with exertion. Dizziness. Back pain. No respiratory distress. Dr.  consulted with hospitalist and agreed to direct admit patient with working diagnosis Gullien Barre Syndrome.
I woke up in the morning and felt extremely dizzy and lost my balance. It felt as if I had been drinking but I had not. I called and made an appointment to see my doctor. I had to use a wheelchair to get into the doctor's office I could not use my legs. She diagnosed me with vertigo and prescribed Antivert 25mg to take three times a day and some exercises to do to help realign the crystals in my inner ears. I am currently patiently waiting for the vertigo to go away. I have propped up the head of my bed to help me sleep, the nausea has subsided, I am able to read and I can "chair walk".
pt stated she began having significant pain in the front and back of both legs.  She had bruising under both eyes and right knee pain.  She developed swollen in lymph nodes in the groin area.  [On November 18th, 2021 she was prescribed Augmentin for a dog bite.] On Nov 30th 2021, she got a steroid dexamethasone shot in right knee. She went to her PA and they did lab work and US of her abdomen which showed both sides of groin were enlarged.  She later had a CT of the abdomen.   On 12/13/21  Lab work showed her vitamin D was extremely high reading over 150.   On December 21st, 2021 she had a injection of monovisc in right knee.   She was taken off her vitamin D medicine.  She had a repeat on her labs  6 weeks later on 1/20/2022 and vitamin D numbers were still elevated at 112.   At this time she was still having pain in both legs which seems to be more of an ache than a sharp pain like she had in the beginning.  She also still has the bruising under both eyes which seems to be slightly improving  and the swollen lymph nodes in her groin area.   She has been referred to an orthopedic doctor and had an MRI which showed increase in arthritis and worsening generative scoliosis especially L2/3 and L4/5.  She will FU w/ PCP in May and if her lymph nodes in the groin area  are still swollen she will have another US.  1st dose of Covid Vaccine was 12/31/2020 Moderna Lot 011J2A and 2nd dose was Moderna 1/29/2021 Lot 029L20A.