chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Placed follow up call to patient relative on 4/5/2021 at 1:04pm: reported that the patient  is feeling much better today. All his ADE has subsided.   Patient rcvd Janssen vaccine on 4/3/2021 at 11:15am in Right IM Deltoid, and at approx. at 7pm that same night patient experienced lightheadedness. The next day on 4/4/2021 patient had a fever, chills, rash on back and swelling on the face and lips. Patient relative reported that she gave the patient Mortin last night (4/4/2021) for his fever as recommended and his fever broke this morning. She also reported that she gave the patient Benadryl as recommended, and this helped cleared up the rash last night (4/4/2021). She reported no contact was made to patient's PCP regarding ADE experienced.   Advised  if she or the patient have additional information to contact the COVID-19 Information Line back.
This spontaneous report as received from a registered nurse refers to five patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. The nurse reported that patients received improperly stored (Merck) PROQUAD (lot number L008353, expiry date 11-SEP-2016, 0.5 ml, subcutaneously). Four doses were administered on 17-AUG-2015 and one dose was administered on 20-AUG-2015. No adverse effects were reported. Follow up information has been received on 02-OCT-2015 that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received from the nurse on 08-OCT-2015. The nurse reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to an 8 year old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with the dose of improperly stored (Merck) PROQUAD. Temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested. The patient details and narrative was updated.
Narrative: Patient reported he was concerned because he had a headache on Saturday the 4/16, 10 days after the vaccine. He sated it was "behind my eye" and he does not have headaches like that. He did report that the headache resolved the next morning on the 4/17.
Initial severe upper left arm pain after about 20 hrs,  body aches, significant tiredness and flu like symptoms for 3-1/2 days.  Subsided on fourth day with exception of arm pain which has persisted until present day-over 3 months.   Can no longer sleep on left side, excruciating pain at times when dressing when twisting arm above my head and CONSTANT deep ache in my left arm persists.  Over the counter pain relief provides some temporary relief.
Mild injection site pain; Flu symptoms; slept for up to 23 hours; Pressure in the legs and hips; Fever (101F); Nausea; Generalized sore and achy joints; Severe Headaches; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), SOMNOLENCE (slept for up to 23 hours), LIMB DISCOMFORT (Pressure in the legs and hips), PYREXIA (Fever (101F)) and NAUSEA (Nausea) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, AMLODIPINE, SIMVASTATIN, METOPROLOL and ALLOPURINOL.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-Apr-2021, the patient experienced INFLUENZA (Flu symptoms), SOMNOLENCE (slept for up to 23 hours), LIMB DISCOMFORT (Pressure in the legs and hips), PYREXIA (Fever (101F)), NAUSEA (Nausea), ARTHRALGIA (Generalized sore and achy joints), HEADACHE (Severe Headaches) and VACCINATION SITE PAIN (Tenderness at injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild injection site pain). On 19-Apr-2021, INFLUENZA (Flu symptoms), LIMB DISCOMFORT (Pressure in the legs and hips), PYREXIA (Fever (101F)), NAUSEA (Nausea), ARTHRALGIA (Generalized sore and achy joints) and HEADACHE (Severe Headaches) outcome was unknown. At the time of the report, SOMNOLENCE (slept for up to 23 hours), VACCINATION SITE PAIN (Tenderness at injection site) and VACCINATION SITE PAIN (Mild injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
16 year old male presented with chest pain, chest X-Ray normal, elevated troponin >20 ng/mL, and EKG  with diffuse ST segment changes. Admitted to cardiac ICU for work up. Primary diagnosis acute  myocarditis with pericardial involvement. During hospital course, only infectious source identified is  rhino/entero virus. Past history of Covid-19 infection as well as vaccination (Pfizer x3).  Due to literature finding myopericarditis as a possible adverse effect in this patient population from  mRNA vaccines (16 year old male), it is reasonable to report this hospitalization.
Within 24 hours I began to experience joint pain.  It became so painful that I was not able to zip and button or hold a pencil/type.  This extreme pain lasted for about a week and then began to fade over the course of a month.  The joint pain is gone except for my left hand, where it still remains.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX. Concomitant products included Atorvastatin and Paroxetine. On 27th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient's husband. The patient received the SHINGRIX vaccine last Friday in the left deltoid and experienced pain in her left arm within a few hours after receiving the vaccine. The patient had denied permission to contact their physician.
12/8/21-40-year-old male Covid vaccinated 3 days history of loss of smell when he eats nonproductive cough not short of breath body ache and lower extremities no previous Covid CPAP with history of sleep apnea
Grandmother reported that pt had a sore on forehead and lip on day of vaccination, 3/8/06. He became very irritable that evening and the next day. She brought him to see me on 3/10. He had several flat lesion and raised lesions on forehead, inside mouth and on feet. She took him to PCP who confirmed that child had chicken pox.
Donor noticed multiple red raised areas on shoulder,arm and wrist area. Increased itching. Area are raised and hard to touch. Denies any other s/s. Dr @ med ops notified. Informed he can take BENADRYL for itching. If rash get worse see your HCP.
Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.
Soreness in muscle, remained sore on a daily basis with it being the most painful first thing in the morning and at night.  3 weeks after shoot it still hurts if not more than before.  Hurts to lift arm and other reaching type movements.
Headache, body aches, skin sensitivity around 8:30pm. Chills and worse headache around 4:00am on 4/2/21.
shots were nearly killing him; COPD; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and chronic obstructive pulmonary disease. On an unknown date, the outcome of the near death experience and chronic obstructive pulmonary disease were unknown.   The reporter considered the near death experience and chronic obstructive pulmonary disease to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The case was reported by patient's son. The age at vaccination was not reported. The patient was working in a hospital so the shots were mandatory. He now had an exemption from his physician because the shots were nearly killing him.. The case had been linked with US2020214862, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020214862:same reporter
A few hours after my 2nd shot I got dizzy then a headache. My arm hurt too, quite a bit. The next morning I woke up with a fever of 101.5 and kept that fever for 2 more days. I felt weak, dizzy, but the physical pain was the worst. My head was pounding, my neck, back, and legs all hurt. That passed after a day except the headache. 3 days later I still have a low fever, headache, but mostly dizziness. I've never been seriously ill in my life. Ive never been sick enough to get antibiotics prescribed. I eat healthy, don't drink or smoke. This vaccine floored me though. Like getting run over by a truck.
12 hours after receiving the vaccination I was speaking to my husband and my neck and face started to uncontrollably move and spasm. This was painful and concerning. It got violent and much worse over; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient started to receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number en2613) on 23Mar2021 11:30 at single dose in right arm for COVID-19 immunisation. Medical history included Covid-19, asthma, gastroparesis, surgeries, gastric pacemaker, allergies to Penicillin, soya. Concomitant medications included dicyclomine, sucralfate, famotidine, and ondansetron. The patient previously received cefalexin monohydrate (KEFLEX) and Amoxicillin and had drug allergy. The patient previously received first dose of BNT162B2 (Lot number: en6202) on 02Mar2021 11:30AM in right arm. 12 hours after receiving the vaccination the patient was speaking to her husband and her neck and face started to uncontrollably move and spasm. This was painful and concerning. It got violent and much worse over the next few minutes, She could not control the movements. She called emergency responders and got an ambulance to the hospital. She was given muscle relaxers and sent home. Over the next two days it got worse and more painful so she went to the ER hospital again and they did a CT and blood work and said it was dystonia. She was given ativan and it stopped the convulsions. Again she was sent home. The dystonia continued to happen all day every day. She had returned to the ER one more time and needed medical intervention to control the awful, life changing adverse reaction. This was a horrible experience. She was completely devastated. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had no COVID tested post vaccination. The outcome of convulsions was resolved. The outcome of other events was not resolved.
Donor received vaccination in his right arm and two hours later he noticed blisters on his left hand knuckles (ring and middle finger) and a blister on his left forearm.
Pt experienced a red rash on the side of his face on top of his head, and swelling in his eye. Pt reported to hospital 5/25/12 due to the involvement of his eye. Pt was discharged on antiviral & pain med.
acute left arm pain, swelling, numbness and tingling in the little finger and ring finger 01/31/2011 noted symptoms of weakness in the left arm
The day after the shot, she got a rash on her right arm, which spread to right trunk and right thigh and buttock.  I saw her July 5. Although it was fading, it was still there. I saw her again Aug 2, 2022. The rash was still producing new patches that were flaring up, lasting about a week or two and then fading again.
Knot coded like a wheel 48 h post shot-involve most of arm-L arm put on Keflex.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 months old male patient who received a 0.5 ml dose of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. No concomitant vaccinations were given. On 07-Nov-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6375NA and expiry date: 30-Jun-2019) (dose in series, route of administration was not reported) in left vastus lateralis. It was a case of actual medication error due to overdose. It was unknown if the patient had any 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. List of documents held by sender: none.
pt presented to ED with SOB; positive test for COVID; placed on BiPAP; worsened respiratory requirement; intubated; developed right LE DVT; developed mild GI bleeding; severe septic shock; multiple vasopressors given; shock improved, then a reoccurrence of shock; worsening renal function; started on CRRT; progressively declined; comfort care established; pt died in the hospital
Female patient age 44, comes to the clinic after 2 days of getting second vaccine Pfizer. Reports 24 hours later she got nauseated, vomit, myalgia. We explained the effects expected to get after getting vaccinated. The effect of concern for the patient are angiodema in the ears and urticaria in bilateral extremities. She was treated with Benadryl by mouth and it was recommended if the symptoms did not improve or if they worsened, she should visit her primary doctor.
Patient came to office on 4/7/17 with C/O skin rash. Patient displayed typical chicken pox rash on his trunk and upper chest. No systemic features. Developed three weeks after VARIVAX vaccine.
A strange painful lump emerged prominently from my abdomen suddenly on March 12.  It is hard and fixed.  I don't know if it is related to the shot or not, but I have NEVER experienced anything like this before.   as I fill out this report it hasn't changed
I have had shoulder surgery in October, my doctor has assured me that My shoulder is healing fine, and this has nothing to do with my surgery. On 12-16-2021, I received the injection at 1:05 pm. At 4:30pm I started experiencing pain and muscle spasm in my shoulders. I was in pain at work, I took a prednisone. I got off at 5:10 pm. I had to take a bus to my car, but on I could not drive, I called my husband. I got to my home at 1:20 pm. The pain in my arm and shoulders were worsening. My Husband had to pick me up, from my car the pain was all over like labor cramps. When I went home I took 800 Ibuprofen. The pain is in my triceps, bicep, scapula, pectoral muscle. The spasms are significant and go on from time to time. I went to the doctors and she put me on anti-inflammatory and muscle relaxers. I take prednisone 40 mg. for 5 days. Through the weekend the pain was horrible and went to work and went to occupational medicine and saw a doctor at work the determined it would be best for me to go to the hospital. I received a MRI's that determined I had a adverse inflammatory response from receiving  the vaccine. I am still being treated for the spasms. The hospital had me see Dr. and he saw a budging disck in my spine on 5-6 and 6-7. He getting my shot. prescribed a a spinal epidural. I am experiencing now muscle weakness. I cannot grasp well, or hold my hand to my head. None of this was like this until that afternoon.
5 ml dose administered insted of 0.5 ml; Arm was sore for 2-3 days; This is a spontaneous case, initially received from pharmacist via Agency (reference number: SEQ19-03332) on 26 -Sep-2019, concerning a 56-year-old male patient.   The patient's relevant medical history included artificial knee joint on Dec-2017.   The patient's concomitant medications included Celebrex azitamide (celecoxib) for an unknown indication.  On 26-Sep-2019, pharmacist thought that the vaccine was diluted version.  On 26-Sep-2019, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 259815 and expiration date: Jun-2020] (explicitly coded as 'Accidental overdose') for influenza prophylaxis instead of 0.5 ml.  On an unknown date in 2019, after vaccination, the patient's arm was sore for 2-3 days and resolved after third day.  The case was assessed as non-serious and the reporter did not provide causality assessment.  Follow-up received from other health professional on 08-Oct-2019: Special case with no adverse event removed from general tab. It was confirmed that patient received Flucelvax Quadrivalent vaccine. The outcome of the event of accidental overdose was changed from not reported to resolved. Event of painful arm was added. Narrative was amended accordingly.  Follow-up received from other health professional on 30-Oct-2019 via Agency (reference number: SEQ19-04918) : The outcome of the event painful arm was changed from not resolved to resolved. Narrative was amended accordingly.; Sender's Comments: Reportedly, accidental overdose occurred with the suspect product Flucelvax (QIV). The patient experienced pain in extremity, on an unspecified day after vaccination. Chronology needs more clarification. For the event pain in extremity, causal role of the suspect product is assessed as possibly related. Accidental overdose is assessed as not related per company conventions.
Burning and swelling of left upper arm at injection site.  ROM affected.  When I lift or move my arm in certain ways, I get a shooting pain in my arm that continues to burn.  THIS CONTINUES ONE MONTH AFTER VACCINATION.  I know she administered it wrong--too deep and damaged my nerve.    I've had zero problems with vaccinations in my lifetime!
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On 12th May 2018, the outcome of the fever was recovered/resolved. The reporter considered the fever to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine in the left deltoid. The patient experienced high fever and her cheeks, neck and forehead were hot after the vaccination and the issue resolved 10 to 12 hours.
Caller received the 1st dose of the Moderna vaccine on 04May2021, but hasn't been able to; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller received the 1st dose of the Moderna vaccine on 04May2021, but hasn't been able to) 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.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller received the 1st dose of the Moderna vaccine on 04May2021, but hasn't been able to). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller received the 1st dose of the Moderna vaccine on 04May2021, but hasn't been able to) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Headache, Myalgia, Fever, NauseaVomiting, T 99.6, chills
Patient with myelodysplasia seen in cancer center and given flu shot. Went home and began to develop a fever up to 102 F around 1600.  Took APAP at home to no effect, temp next AM was 103.8. Presented to clinic and was hypoxic with 82% sat on RA. Slightly confused and nauseated. Admitted to CCU with neutropenic sepsis. Patient also complained of myalgias.
not receiving 2nd dose in time; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose in time) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049c21a) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 24-Jul-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 PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose in time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose in time) had resolved.            No treatment information was reported.
vaccine BUD 10/11/2022, expiration date from mfg date 09/30/2022
TERRIBLE EXPERIENCE; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced terrible experience. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible experience was not reported. This report was non-serious.