chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came home and went to sleep. He ended up sleeping for 3 days. he only got out of bed to get something to drink & use the restroom. I forced him to get out of bed on 6/19/2021. It took him 45 minutes to get dressed with help after a bath. He was very disoriented. On 6/20/2021, he seemed mor oriented & felt better. I attributed it to 3 days without eating anf finally getting some nutrition in his body. On 6/21/22, he tried cutting the grass with our zero turn mower and fell twice trying to get on the mower (he is very familiar with mower: normally services it and cuts our grass weekly in the summer). Early on the morning of 6/22/21 (05:00), he awakened & stumbled on the way to the bathroom, nearly falling. After using the bathroom, he tried to go to the kitchen to get a drink of water. He could not find the bedroom door or the light switch (we have lived in this house for over 10 years). I told him not to move for fear he would fall. When I turned on the bedroom light, he had closed the bedroom door & was standing in front of it. He was very confused & disoriented. I opened the door for him. He made it to the kitchen but when he got back to the bedroom, he fell & hit his head. I decided it was time for me to just get up and watch him. I put him to bed & dressed his superficial head wounds. I then went about my morning, getting ready for work. He seemed to do better once I had him drink a protein shake. I went on to work. He made it to an ophthalmologist appointment that morning. Around 10:30 am, I received a phone call from the ophthalmologist. Patient was talking about a dog in the office that was not there! Since we live in a small town, office staff drove patient to the local emergency department for evaluation. I met him there, Lab work (which included CBC, CMP, ESR, urinalysis & CSF studies) were pretty much normal with a few abnormalities, but nothing to explain his confusion, loss of equilibrium, and hallucinations. He also had a CT of head w/o contrast, which was normal and MRI of head w/o contrast (normal). When the CSF studies were normal, he had a CT of chest/abdomen/pelvis w/o contrast (normal). Even though he has been doing better, since receiving his second Covid vaccine 6/15/21, I have noticed he is more forgetful and does not remember when we have had certain conversations. Obviously, he will not be receiving any booster vaccines. Lab Results of 6/22/21: CBC: WBC 5.1, H/H 19.7/40.7, PLTS 185, MCV 84, MCH 28.6, MCHC 34, EDW 14.7; DIFFERENTIAL: Neuto 44, Bands 22, Lymph, 32 and Eosin 2. CMP: Na 136; K 4.9, Cl 103, Bicarb 25, BUN 33, Creat 1.6, glucose 105; anion gap 12.9; Osmolality 279.6, albumin 2.6, Globulin 4.6, Alk Phos 86, Asp Amiontansferase 23, ALT, 31, Bili 0.5, Ca 8.7; Lactic acid 1.5; Procalcitonin 0.165; PT/PTT 14.7/30.2; INR 1.08; U/A: Color dark brown; Sp grav 1.030, pH 6.5, protein 14, glucose negative, ketones trace, Urobilinogen 1.0, RBC 0.3, WBC 0.3, leuk esterase negative, nitrite positive, epithelial cells occasional, bacteria negative, casts negative; CSF: glucose 54, protein 70, WBC none, RBC 2800
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00561558).  This case involves a patient (unknown demographics) who received an expired 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5611BA and expiry date: 03-Apr-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 13-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included NA (sodium).  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
patient became very diaphoretic in the observation area, her head went back, eyes closed, extremities became very rigid and patient appeared to have lost consciousness for a brief moment.  RN was present at side of patient, patient was hypotensive, vitals checked BP 71/48 and pulse 54.  Patient states she felt like she went to sleep, started to feel better several minutes later.  EMS was contacted to evaluate and transport patient to ED.
Full body, red, warm, itchy, rash worse over face/neck on left side that began 45-60 minutes after the vaccine was given. Hives to left side of neck, torso and arm that were itchy.  2 doses of 50mg benadryl administered at home; reaction subsided by 10:00 am following morning. Intense joint pain occurred after rash subsided and lasted approximately 4 hours. Itchiness on left arm and neck remained until 36 hours after vaccination.
sick; head ache; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced headache, general body pain and sickness. On an unknown date, the outcome of the headache and general body pain were recovered/resolved and the outcome of the sickness was unknown.   It was unknown if the reporter considered the headache, general body pain and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced body aches and a headache for 2 days. The patient asked did anyone feel sick after getting the shot. The follow-up would not possible as no contact details were available.
Full body rash that itches and burns.  Covers face, neck, chest, abdomen, back, arms and legs
Pt has had moderate muscle pain requiring treatment daily with acetaminophen at sight of injection for 10 days after injection
Increasing erythema, warmth, tenderness and pain, R arm flexor area-site of vaccination. Treated with warm compresses, Levaquin then rec'd IV Ancef in hospital. The hosptial discharge summary received on 2/19/04 states diagnosis of cellulitis.
Started a week after injection as egg-shape and size, swelling, red, hot, itching. Progressed to larger area each day but more like a red oval ring - larger and larger in diameter but less swollen, still hot and itchy. Today circles entire upper arm, more red on the perimeter. Took antihistamine last two days and less itchy
Started having vertigo symptoms within 24 hours of the shot.  Still having them today.  Otherwise feel fine -- no sinus or ear issues, no cold, no fever.  But feeling lightheaded and/or dizzy when I look up, bend down, etc.  Will likely go to doctor if continues for another day or two.  Noticed several other reporting vertigo onset within 24 hours of flu shot on several online blog sites, so thought I would report.
Worsening Injection site pain starting around 9pm, any movement of arm causes pain, but unable to lift arm to shoulder height due to pain.  Also started feeling unwell around that time.  Unable to sleep, tossing and turning all night and the few times I did fall asleep I had very disturbing dreams which is unusual for me.  Still feeling unwell the next morning, like I?d had a cold for a week and had started to get better, but still not 100% better.
After day one I was extremely sick to the point where I could not move. During the month after my vaccination I started having severe chest pain and was recently diagnosed with PAC (premature atrial contractions) which cause syncope at random times.
Still dose not feel great this morning; Fellt sick all the day; Exactly like when she gets the flu; Remained in bed all day long; Felt nauseous; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Fellt sick all the day), INFLUENZA LIKE ILLNESS (Exactly like when she gets the flu), BED REST (Remained in bed all day long), NAUSEA (Felt nauseous) and PYREXIA (Slight fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced ILLNESS (Fellt sick all the day), INFLUENZA LIKE ILLNESS (Exactly like when she gets the flu), BED REST (Remained in bed all day long), NAUSEA (Felt nauseous) and PYREXIA (Slight fever). On 04-Apr-2021, the patient experienced MALAISE (Still dose not feel great this morning). At the time of the report, ILLNESS (Fellt sick all the day), INFLUENZA LIKE ILLNESS (Exactly like when she gets the flu), BED REST (Remained in bed all day long), NAUSEA (Felt nauseous), PYREXIA (Slight fever) and MALAISE (Still dose not feel great this morning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not given.   No treatment information was not given.
pt recvd vax & w/in 45 mins exp a rash all over body, hives, & nausea; tx Atarax; still has rash 24 hrs p/inject; pt was on Bactrim therapy for UTI & RPH reports that rash looked like a sulfa react;
Breathing was still not back up where it should be so the patient was on oxygen all the time instead of being on at night; arm's still a little bit sore; This is a spontaneous report from a Pfizer. A contactable consumer (patient) reported that a 63-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via unspecified route of administration on 12May2021 as single dose for COVID-19 immunization; misoprostol, diclofenac sodium (ARTHROTEC), via unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The relevant medical history and concomitant medications were not reported. The patient just had Pfizer Vaccine, the first Pfizer vaccine on Wednesday because that's what the patient wanted. That's what the patient was trying to get before got COVID and ended up in the hospital, it was last month. On 14May2021, breathing was still not back up where it should be so the patient was on oxygen all the time instead of being on at night. It was just temporary. Patient later stated that arm's still a little bit sore but other then that the patient hadn't had any side effects with the vaccine. The patient was just happy and had a mild case. Action taken for misoprostol, diclofenac sodium was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Developed blepharitis in both eyes, but particularly evident in right eye, which blistered along edge of eyelid and turned dark purple.  Reaction started within 2 hours after vaccine was administered, became most intense within 24 hours, and started to recede after 48 hours.  Treated with increased prednisolone eye drops (3 times a day instead of once a day), topical triamcinolone, advil (oral), and hot compresses.  Five days later there is still some swelling of both eyelids, but condition is much improved.
Pt was swimming and started to cough (felt swallowed water) and upon getting out of water - collapsed and lost consciousness for a few seconds
The FLULAVAL vial was empty and was discarded after the injection. The patient called the pharmacy the day after the injection and complained of a headache. The headache was not severe and he did go to work on Monday. The pharmacist phoned the patient at 6:00PM Monday and the patient said the headache was gone but that he felt weak on and off throughout the day. The pharmacist phoned the patient Tuesday evening and the patient stated that he felt as if he had the flu.
5:00am- ichy palms of hands 2:00pm- ichy/hives developed on upper part of body, especially arms and torso Benadril taken at 4 pm on 11/09 Hives returned, another Benadril taken at 9 pm, hives returned and took Benadril at 3 am on 11/10.  Saw Doctor at 11am on 11/10 and received a shot for the hives.
Client alerted mother that he felt strange. Mother alerted staff sating this is how he typically lets her know when his blood sugar is low. Provided carbohydrate snack. Client reported feeling resolved after two minutes from eating snack. Reported feeling 'fine' when left clinic site at 0935.
Got MMR injection, came into office on 1/9/03 ? measles. Increased temperature on 1/7/03 up to 102. Next day 1/8/03 got spots(rash) all over.
mild headache, chills (for a couple of hours the day after the vaccine was given), bruise at the injection site.
Unspecific adverse event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unspecific adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Unspecific adverse event). At the time of the report, VACCINATION COMPLICATION (Unspecific adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Non-significant follow up appended
10-15 minute onset of sudden lethargy. Very difficult to arouse patient with sternal rubs. 15 minutes later patient is arousable and crying. Still showing signs of lethargy.
Information has been received from a 78 year old male with bronchitis and no drug reaction/allergies who in November 2008, was vaccinated with a dose of ZOSTAVAX (Merck) and in November 2010, was vaccinated with a dose of "pneumonia vaccine" (manufacturer unknown) (duration and dose not reported) and a dose of "flu vaccine" (manufacturer unknown) (duration and dose not reported). There was no concomitant medication. On 11-MAR-2011, the patient went to the emergency room and he was hospitalized for a fever of 102.5F and complaints of feeling jittery. Antibiotics were given for the events. "Blood cultures" was performed and the result was unknown. He was hospitalized from 11-MAR-2011 to 13-MAR-2011, and he was not fully recovered and he still had a hoarse voice. Consumer mentioned that he received an unspecified number of doses of LEVAQUIN (manufacturer unspecified and dose unspecified) during his hospitalization on 11-MAR-2011 to 13-MAR-2011, and he experienced swelling in his legs and a 10 pound weight gain. Consumer mentioned that the leg swelling had resolved and that he had lost the 10 pounds that he had gained. Additional information is not expected.
Received Pfizer vaccines on 4/21, 5/12, 9/21/21 Tested positive for COVID by PCR on 12/16/21 admitted to a local hospital/clinic on 12/16/21 for management of COVID 19 infection and SOB.  Underlying myelofibrosis.
He got the vaccine, 15 minutes later he got very fatigued, could not walk in his house and could barely make it to the bed and had to lie down.  He had headache, nausea, disoriented.  Then he went to bed, woke up at 9:00 AM and had a seizure, which he has had in the past but it had been over a year.  He rested after the seizure and knew what to do and it took 2-3 days to recover from that due to the weakness in the legs, disoriented.   He has gotten stronger and is pretty much back to his normal self.  He has not had any additional seizures since then.   He had his FU physical today and she is aware of the seizure and told them to report the incident.
Began one week ago with red bumps on face spreading to torso-most with scabs at this app't.
On Monday Jun 10th I received my second shot of the shingles vaccine. I felt fine all day Monday. That night I woke up in a feverish sweat and crazy dreams. I drank some water, put another blanket on the bed and was able to go back to sleep. Tuesday I woke up at 7:30 AM and took some Advil as I felt achy. I went downstairs for some coffee and sat in a chair. I quickly broke out into a full body sweat from head to toe. I was dripping wet and my partner said I was drewling. I was light headed and didn't feel like walking back up stairs to bed. I asked for towels for the floor, laid on them and got covered in another towel as I was cold. I took my temperature and it was 100.7°. It seems like I was there for about 20-30 minutes and the sweating stopped. I then fell alseep for about an hour. When I woke up I felt better and ate a little breakfast. Then went back updtairs to bed. I spent most of the day in bed, sleeping, drinking water and taking Advil. For most of the day I had a low grade fever and off and on would have a headache and feel achy. This morning, Wednesday June 12th I don't have a fever and feel back to normal.
Generalized weakness, dizziness, nausea, muscle aches. Treatment: Rest.
About 10 hr after receiving vaccine, developed alternating sensation of fever & chills, some leg aching, & all "hair follicles hurt". No rash. 24-28 hr after vaccine feeling much better.
Extreme fatigue, dizziness, hot flashes, chills,  Low level nausea but constant, sore throat, sore skin, (skin hurts-this is one of my very typical fibromyalgia symptoms). Symptoms lasting at least four days as it continues through today, Sunday, April 11.
Body aches, fever, chills, muscle pain, headache, nausseau, fatigue,
The pt experienced red whelp like areas on legs, arms and trunk. No blisters. Whelps vary in size from 1-2 cm. The child is active and alert.
pt recvd MMR/DTP vax 1AUG83 & 25SEP83 pt devel OM, febrile sz, t100.2 R, irritable, seizure activity, lethargy,behavioral & cognitive problems; rapid breathing, autistic features, viral encephalitis, behavior distractible;
Patient received ZOSTAVAX 7-29-08.  Discovered small red pustules on left shoulder blade the next day - reported to pharmacy 8-4-08.  More red spots appeared 8-5-08.  Gave Benadryl and referred her to her family doctor.
Suspected vaccination failure; Still get em; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that he/she had the Shingles shot twice and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.            No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up received included no new information.
Resident passed away unexpectedly on 01/19/21 after developing acute hypoxic respiratory failure on morning of 01/19/21.  She was transferred to hospital via EMS  where she was intubated, coded, and ultimately expired with uncertain underlying cause, potentially ACS.
Patient's mother reported to up on 11/10/15 that patient's arm where injection was given had a "knot" and was going numb when she laid down". Call to pt on 11/12/15 pt states this began on 11/4/15, lasted one week, then got better.
pt recvd vax 25MAY94 & amoxicillin for sinusitis developed rash & fever did not resolve once amoxicillin stopped; not seen by MD but reported to us;
Developed warmth, redness,  mild tenderness and firmness in the  R arm injection site skin and subcutaneous tissues on 1/24, 9 days after injection.   It was not raised and no fluctuance was present.  As of today, 1/26, it has improved spontaneously, but not completely resolved.  [also noted mild tenderness on 1/16 at injection site, but this resolved by day 2, 1/17.  ]
Shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 77-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 15-OCT-2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles resulting from his use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Experienced flu like symptoms for 2 days from receiving Prevnar 13 and flu together; This is a spontaneous report from a contactable Pharmacist, via a sales representative, who reported similar events for three patients. This is the first of three reports. This Pharmacist reported for a patient that: A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), at single dose and influenza vaccine (FLU) both via an unspecified route of administration on the same unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms for 2 days on an unspecified date with outcome of recovered.    No follow-up attempts are possible. No further information is expected, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019438282 same reporter, same product, same event, and different patient;US-PFIZER INC-2019438281 same reporter, same product, same event, and different patient