chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On 01-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 (lot was reported as K007824; expiration date: 05-NOV-2015) (dose and route were not provided). On an unknown date in October 2014, the patient experienced swelling of the arm where PNEUMOVAX 23 was administered. The patient sought medical attention on an unspecified date at the office of unspecified physician and was prescribed KEFLEX and Clindamycin. The outcome of swelling of the arm where PNEUMOVAX 23 was administered was unknown. This is one of several reports from the same source. Additional information has been requested.
Day 1 tired. Day 2 - 6 horrible GI symptoms(gas, bloating, diarrhea, acid reflux) Day 8- hives Day 9 bad pain in breast. Ariola starts peeling. Intense pain in butt, hip, knee, shin, & feet. These symptoms have not stopped. Pain keeps me up at night. Also feel somewhat weak! Still experiencing symptoms!
Parsonage-Turner syndrome: Pain and weakness in the right arm due to brachial plexus inflammation.
Vaccine was mixed with sterile diluent instead of the provided Saline Diluent. This was discovered the next business day when an extra bottle of Saline Diluent was found. There were no adverse reactions or complaints reported. This adverse event was immediately reported to Sanofi Pasteur upon discovery.
Patient received H1N1 vaccine, intramuscular injection in his right deltoid at 10:45 AM. While watching his sibling receive his vaccine, at 10:50 AM, patient complained of feeling like he was "going to pass out". Became pale, diaphoretic and became sycnopal. Patient was lowered to chair by nursing staff. 5 second loss of consciousness. Symptomes resolved spontaneously. Vital signs post event: BP: 98/58, pulse 68. Observed patient for 20 minutes. Skin returned to pink, warm and dry. Speech and gait normal. Provided with 12 ounces of fluids, po. Left the school accompanied by father without assistance.
Redness, small lump and heat at the injection site.  Fatigue for several days post vac.
mild sore throat; This is a spontaneous report from a contactable Consumer or other non-HCP (patient) communicated to a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced mild sore throat on an unspecified date. It was reported that the patient was due to get the second dose on an unspecified date (tomorrow), but currently experiencing a mild sore throat. The patient outcome of the event was unknown at the time of this report.  Information about the Lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
feel itching all over the body; had one quarter size rash on left leg; Feel tired; Warm (99.5 F); This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 05Apr2021 at 16:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021, one to two hours after the first dose, the patient felt tired and warm and could not even open eyes. On the same day body temperature was 99.5 Fahrenheit. On 07Apr2021 at 21:00, at night, the patient felt itching all over the body and had one quarter size rash on left leg. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events felt tired and warm (99.5 F), could not even open eyes, felt itching all over the body and had one quarter size rash on left leg was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Rash all over body, red small bumps with red lines. Pt. not itchy. Dr ordered BENADRYL.
I have not had a period since January 2021 before I had my first vaccine 2/11/2021.  My last period was 1/12/2021 threw 1/16/2021.  I went to my  OB dr about this  and he did blood tests to make sure I?m not going three early menopause and all my hormone levels were normal.  And I am not pregnant and I had my tubes tied several years ago I also have pin point red blood spots on my chest and face since the vaccine. The dr wasn?t sure what they were.
At approximately 6:00 pm on 1/24/09 He was unable to lift his right arm due to severe pain.  Pain then moved to left shoulder then both knees began to ache.  States he then started to go "crazy yelling & screaming due to hurting so much"  At 11:30 he went to bed woke x2 in a "puddle of water."  States he next "woke up in a hotel on 1/29/09 unaware of how he got there.  He returned to his home @ 6pm 1/29/09. Right shoulder continues to ache.  States he has no memory of driving to place but his vehicle was in parking lot of hotel.
6-5-2019 Student came to clinic and asked if he could take to the nurse He said he got his 1st Hep b on 5-7 Tues .   He said he also had blood titers and a health Screen that night.  He had just got over a bout with the flu but was feeling ok that night.  He said about 2 days after the shot he started having some numbness in his feet and abdominal area.   He went to the Dr. But they cannot figure out the cause. He just wanted to let us know in case we had ever heard of something like that.  He thought it might be also from the flu .   I sent him a message today with all the info about his shot ( lot number ECT).  In case he should need that.  He said he is feeling much better this week and the numbness in his abdomen is gone and he only has a little in his feet now.
feeling sick; aches and pains; low grade fever; aches and pains, soreness at the injection site; headache; exhausted; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling sick), MYALGIA (aches and pains), PYREXIA (low grade fever), INJECTION SITE PAIN (aches and pains, soreness at the injection site) and HEADACHE (headache) in a 50-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032472) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Pfizer (1st dose) on 07-Apr-2021, Pfizer (2nd dose) on 28-Apr-2021, Pfizer (Booster) on 01-Jan-2022 and Moderna bivalent on 09-Nov-2022. Past adverse reactions to the above products included No adverse event with Moderna bivalent, Pfizer, Pfizer and Pfizer.    On 18-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling sick), MYALGIA (aches and pains), PYREXIA (low grade fever), INJECTION SITE PAIN (aches and pains, soreness at the injection site), HEADACHE (headache) and FATIGUE (exhausted). At the time of the report, MALAISE (feeling sick), PYREXIA (low grade fever), INJECTION SITE PAIN (aches and pains, soreness at the injection site), HEADACHE (headache) and FATIGUE (exhausted) had not resolved and MYALGIA (aches and pains) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided.  The patient was still feeling sick. Patient stated the reactions were not severe. The patient was very achy and exhausted all the time. The reactions got started about 12 hours after the shot on Wednesday night.
Severe muscle and joint pain, sharp shooting pain from back of shoulder to hand, weakness, muscle loss.
hurt both times; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain (1st dose received on nknown date in 2019 which hurts refer case US2021AMR024825).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was reported. The age group at vaccination was not reported was captured as an adult as per vaccination. The patient stated, the shot hurt. The reporter did consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR024825:Same reporter
Roughly 5 minutes after vaccine administration, patient experienced dizziness while waiting in the store for monitoring. The patient stated she had a headache, fuzzy headed, weird taste, dry mouth, tingly head, felt like she was going to pass out, blurred vision, and all around felt strange. Emergency services were called and took over care once arrived.
3 weeks after first shot (05/05/21) woke up  at 2:30 am with chest pressure, high heart rate, and left side pulsating feeling, and weakness on my left arm and leg. Called emergency and was taken to ER.  Had similar episode while in ER at 5am. CT of lungs and heart found nothing. D-dimer slightly elevated on blood test. ECG showed nothing. Was discharged.  Primary doctor did tests for viruses and enzymes. Found nothing. Cardiologist scheduled a stress test and echocardiogram. Passed out on stress test after 8 minutes. Still waiting for an echocardiogram on 18th of June. Neurologist scheduled EEG, MRI of the neck. Still waiting for them. Was in ER (06/02/21) a week after my second shot (05/27/21), with continuous left arm and leg weakness (I was limping). MRI of the brain showed nothing. Got discharged.
From initial information received on 08/11/04 from a physician regarding an adverse event occurring in the USA, it was reported that a two month old female patient received an ACTHIB vaccination, lot number and rout and site of administration were not reported, "about one month ago" (exact date was not reported). An unspecified time later, the patient's mother stated that the child cried fro several hours, developed redness at the injection site and experienced a low grade fever of 100 degrees Fahrenheit. The patient recovered from these events. From additional information received on 09/21/04 from the initial reporter, the patient's date of birth was provided. The patient received a first dose of ACTHIB, lot number UA797AB (French lot number W0795), administered intra-muscularly in the left thigh and a first does of Daptacel, lot number C1663AA, administered intra muscularly in the right thigh on 07/14/04. No other information was provided at this time. No further information is anticipated, this case is considered closed.
pt recvd vax & w/in 30mins post vax pt exp chest pain,diff breathing,& was nauseated;sx resolved w/o treatment;
Pt had red, raised rash x 2 days with c/o pruritis. Came to office D/T lack of improvement with OTC ointment.
May 26, 2021 afternoon started feeling a bit nauseous, sweats, upset stomach, similar flu  symptoms as first days of Covid from last year.  Later in evening around 7pm chills and  aches (especially back got worse) By around 9:30pm I was fine.  March 27, woke up in morning and was good  March 28, right arm (injection site) was a little sore and noticed slight swelling and warm to the touch in that area. Also my underarm pit (injection arm) felt sore and  swollen.  Soreness extended to breast area (near underarm) March 30, underarm soreness almost all gone. Injection site soreness gone just still a bit warm to the touch
post herpetic neuralgia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 77-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about April 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for shingles and post herpetic neuralgia. The outcome of shingles and post herpetic neuralgia was not reported. The reporter considered shingles and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Soreness around the injection area/it's the injection area but the pain goes towards the back of arm towards my shoulder; Soreness around the injection area/it's the injection area but the pain goes towards the back of arm towards my shoulder; soreness around the injection area/it's the injection area but the pain goes towards the back of arm towards my shoulder; Hard to sleep; It's an unpleasant dull ache/still in pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Jul2021 (Lot number: EW0180) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Trintellix for Anxiety, notes: 10 mg once a day. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 16Jul2021, outcome "not recovered" and all described as "Soreness around the injection area/it's the injection area but the pain goes towards the back of arm towards my shoulder"; ARTHRALGIA (non-serious) with onset 16Jul2021, outcome "not recovered", described as "soreness around the injection area/it's the injection area but the pain goes towards the back of arm towards my shoulder"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "Hard to sleep"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "It's an unpleasant dull ache/still in pain". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, arthralgia, insomnia, pain.  Additional information: Consumer stated that he did not receive any prior vaccinations (within four weeks). The patient was taking Trintellix sporadic actually, this is down to his last  No follow-up attempts are possible. No further information is expected.
Pt stated she ate and was feeling well. She received HPV, MENACTRA, and Tdap. After the vaccines she stated she felt well. Denied dizziness, lighthead or any other symptom. She stood up and nurse and her father escorted her to waiting room so she could wait 15 min. Pt stated she was lighthead, dizzy, ringing in ear, visual disturbances. She was guided to ground. Her blood pressure was 88/56. She was pale, diaphoretic. She was given cool rag and fan. She was given a cool drink of water. At 2:37 vision got better. At 2:37 she was guided to an exam table to lay down. She ate and was cooled off at 2:45. Blood pressure was 116/76. Her only complaints were a headache. At 3:00 she denied any symptoms. At 3:07 her father stated that since she was feeling better, he was going to take her home.
PT C/O LEFT ARM ITCHING AND HIVES TO INJECTION SITE.  MILD SWELLING 1.5 CM.  PT. DENIED ANY OTHER SYMPTOMS. BENEDRYL 25 MG WAS ADMINISTERED PO AND PT WAS MONITORED FOR 30 MINUTES.  PT CALLED FOR SOMEONE TO DRIVE HER HOME AFTER RECEIVING BENEDRYL AND STATED A REDUCTION IN ITCHING SENSATION PRIOR TO LEAVING.
LEFT ARM FROM SITE OF INJECTION DOWN TO HAND IS VERY RED; 3 BUMPS AROUND SITE OF INJECTION; PATIENT DESCRIBED FEELING AS HOT AND CLAIMS ARM IS VERY SORE
Patient was seen in ER on 7/8/2023 for seizure. Per mother, patient had episodic seizure witness by mother that lasted approximately 1 minute. She sat down to eat popsicle then slumped over. Mildly fatigued after seizure.
Extreme pain at time of injection and loss of use. Multiple MD visits needed, orthopedic Doctor and Physical therapy.....ongoing.
This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked cases include A0809349A, A0809358A through A0809362.
Patient admitted for Acute disseminated encephalomyelitis.   1/29/08 Case closed w/medical records that accompanied report which reveal that patient experienced sore throat, congestion & persistent cough when seen 10/8/07.  Treated symptomatically & improved initially.  Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener & resolved with change.  Then received multiple vax on 10/16/07.  Returned to clinic 10/19/07 w/worsening cough, fever, sore throat & nasal discharge.  Tx symptomatically & improved.  On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine & falling asleep on his feet.  Taken to ER & transferred to higher level of care.  Temp in ER 103.2.  Had LP in ER which showed CSF WBC 2240 w/82% polys.  Admitted 10/26-11/5/2007 in ICU.  Was stiff, unresponsive to stimuli, wringing his hands & shaking.  Tx w/IV antibiotics, antivirals & steroids & placed in isolation.  ID & neuro consults done.  Gradually improved & was d/c to home w/ID & Neuro outpatient f/u.  ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory & concentration problems.  Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognitive function.  Referred for neuropsych & congnitive rehab.  As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue & some difficulty w/memory & concentration. FINAL DX: ADEM.
Severe hives on face, neck, trunk, back, arms, legs starting 24 hrs after injection (10/18/2021), went to urgent care and received steroid shot, steroid dosage pack, prescription antihistamine, prescription itch cream at 48 after injection (10/19/2021) due to severity
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 5:44 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 5:44 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications on use were not provided.  Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on 16 Nov 2021. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No treatment information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
24/7 arthritis; This case was reported by a consumer via media and described the occurrence of arthritis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced arthritis (serious criteria GSK medically significant). On an unknown date, the outcome of the arthritis was not recovered/not resolved.   The reporter considered the arthritis to be possibly related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was reported. The patient reported that the Shingrix triggered unbelievable 24 by 7 arthritis. The patient stated he/she would give anything to go back in time and not take that 2nd dose. The follow-up would not possible as no contact details were available.