chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.     This case was linked to MOD-2022-501575 (Patient Link).
Moderna COVID-19 Vaccine: Symptoms after vaccination: Intense pain to my affected arm started around 5-6:00pm the day I received the vaccine. A little while after that I noted terrible body aches and intense chills. I took Meloxicam and Tylenol for the pain to my arm and the body aches. This helped a little.  I ended up going to bed at 7:00pm (same date) due to not feeling well. The chills were pretty intense going up and down my spine and I could not get comfortable in bed or sleep because I was freezing and aching all over.   I am not sure if I had a fever at the time because I felt so weak and chilled that I couldn't get out of bed but my eyes felt like they were burning. My husband said I was sweating and my skin was burning hot despite the fact that I felt extremely cold. I developed a headache around midnight that lasted until the afternoon the day after my vaccination. I took more tylenol , meloxicam, and benadryl for the pain/headache and I took a mid morning nap. I felt better and more myself by about 4:00pm the next day.  I did not need to receive any medical attention for these symptoms.
No additional adverse effects reported.; A nurse states that on 07/14/2020 a patient was administered an improperly stored dose of MMRII; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies was not provided.  On 14-JUL-2020, the patient was administered an improperly stored dose (product storage error) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: rha), lot number S022754 and expiration date 22-JUL-2021 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).  The vaccine was stored at a temperature of 52.2 F (Fahrenheit), for a timeframe of 45 minutes, with no previous temperature excursion. The call was due to a digital data logger.  No adverse events were reported.
Firm, subcutaneous swelling at injection site left lateral thigh. Treatment: Ice, Benadryl 3ml, PO, Q 6 hours. Follow up 8/25/00. 8/30/00 Condition improving.
Shaking; Can not move right arm over head; Body aches; Chills; Headache; Fever of 102; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 29Apr2021 at 10:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 21:00, the patient experienced fever of 102 (unspecified units), body aches, chills, shaking uncontrollably, headache, cannot move right arm over her head. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 102 (unspecified units), body aches, chills, shaking uncontrollably, headache, cannot move right arm over her head were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At 3am I woke up with: Chills Fever Headache Body aches  Throughout the day the symptoms persisted and included: Brain fog Dryness / dehydration Dizziness
Systemic: Fainting / Unresponsive-Severe, Additional Details: LOW BLOOD PRESSURE, RAPID DECREASE IN HEART RATE
Flu shot 10/16/13 arm swelled red and hot from shoulder to elbow.
Light headed, mild confusion, rapid breathing difficulty driving; Light headed, mild confusion, rapid breathing difficulty driving; Light headed, mild confusion, rapid breathing difficulty driving; Light headed, mild confusion, rapid breathing difficulty driving; This is a spontaneous report from a contactable physician (patient). A 35-year-old male patient received 1st dose of bnt162b2, lot number: El0140, via an unspecified route of administration in the left arm on 19Dec2020 16:30 at a single dose for COVID-19 immunization at the hospital. There were no medical history. The patient has no known allergies. The patient has no concomitant medications reported. The patient experienced light headed, mild confusion, rapid breathing and difficulty driving on 19Dec2020, started 5-10 minutes after injection that lasted approximately an hour. Outcome of the events was recovered in Dec2020; no treatment was given for the events. The events was reported as non-serious.
pt received vaccine at 1100 am went outside to smoke during 15 min observation period. at approx 1105 pt complained" her insides were itching like crazy" pt came back inside for observation.  Pt stated itching was getting worse offered po  benadryl, pt stated she couldnt take po benadryl.  at 1110 called for ambulance and administered 25 mg im diphenhydramine. pt vitals 10268 hr 100 pulse ox 97 on room air. pt no visable rash nor apparent respiratory distress. no difficulty breathing, nor impaired speech. ambulance arrived and observed pt declined transport and left ama
Patient received the vaccine (FLUARIX QUAD 2016-2017) intramuscularly from pharmacy on 8/20/2016 and came back complaining of a sore arm almost a month after on 9/18/2016. There was no sign of swelling or redness.
Horrible arm pain, chills, fatigue, fever, joint pain, headache, everything smells like burning metal, hair, or farts (no joke), ligament pain, muscle aches, chest tightness and pain
Information has been received from a health professional concerning a female who during the week of 31-MAR-2008 was vaccinated with the first dose of GARDASIL (lot# not reported).  Concomitant therapy included vaccination with the first dose of MENACTRA.  After receiving both vaccinations the patient immediately fainted and hit her head as she fell.  Per the reporter, she came to right away.  The patient was observed in the office and later sent home.  There is no additional information at this time.  Additional information has been requested.
After first dose: one week after vaccine Arm became red, swollen, warm, itchy for one week  After second dose: next day arm became red, swollen, warm and itchy. Next day woke up with a headache, joint pain, chills, nausea, weakness, and fatigue lasted for one day. Headache and nausea lasted two days.
Pt developed swelling at injection site that increased over 24 hours to her upper arm down to her elbow.  Area became firm and painful.  Symptom resolved with ice to area.
Approx 2 hrs p/DTP/OPV, pt became cyanotic & had difficulty breathing; Pt had no lung congestion or inject site rxn; 1 hr later, pt was asymptomatic;
Woke up feeling nauseous/diarrhea at 1 am on Wednesday (approx. 60 hours after injection). Side note- on Tuesday (day after injection), I donated blood. Not sure if this is relevant. After waking up nauseous, I experience extreme shortness of breath and full body chills for roughly 30 seconds to 1 minute. I walked about 10 steps to wake up my partner and fainted instead. I woke up to him calling my name, and almost immediately threw up. Afterwards, I felt okay, only tired and a little weak. I was able to go back to sleep and woke the next day with no lingering side effects. I would say the entire episode lasted roughly 5 minutes.
My right armpit lymph node swelled up to about the size of an egg. It was tender to the touch and uncomfortable. The soreness began in the evening, and when i woke up in three morning it wad worse and the swelling was very noticeable.  I took naproxen for an unrelated pain and there discomfort has subsided. The swelling though, now many hours later, still remains.
Information obtained form Mom 02/12/2006, vaccine given at 1:30pm, later that afternoon had terrible headache, nausea that evening, patient admits to her mom that she did have a sore throat before she received the vaccine. 02/13/2006 went to school that morning, saw DR that after noon, fever 99, aches and pains in her back and spine, negative influenza test, ordered Levaquin and Lortab, patient is lethargic, sleepy, 02/14/2006 7pm went to hospital ER for itchy rash on neck and face, given Toradol and Compazine, rash resolved during ER visit. 02/15/2006 sleepy all day, at 8pm, eyes cross, tongue sticking out and she can't talk, called 911 and taken to Medical center, given Benadryl and jaw loosened. MD told mom it was dystonia or locked jaw. MD stopped Levaquin and Lortab and ordered Amoxicillin and Tylenol. 02/16/2006 had MRI of head and thinks blood cultures done, will be seeing DR for follow up, nausea comes and goes, headache is continuous ranges from a 5 to a 8, very sleepy doesn't wake up unless someone wakes her, MD instructed MOM to wake her up every 2 hours.
Side effects started around 10:30pm  the evening of the vaccination. Was awaken from sleep to my body feeling like a burn victim (not like my body was hot, but literally burned) from the top of my neck to the end of my ankles. Extreme nausea and fever reached 101. Those were the worst symptoms but also had horrible muscle and joint pain that didn't experience with the first shot, chills and shaking and body aches.
Pt describes, injection site as pea-sized white spot with brown discoloration around it. Not sore or painful
Comprehensive metabolic panel performed with low RBC, high mean RBC and high Iron levels.  Indications of anemia and increased symptoms of Hypothyroidism despite treatment with levothyroxine 150mcg 6 days/week
Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors (PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did no occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 90 yo and admitted on 2/10/21 for SOB and a fall resulting in a femur fracture. Patient was on Eliquis and has h/o CABG x5, dementia, bradycardia s/p pacemaker. Patient was discharged to a rehab facility where his condition declined ultimately resulting in transfer to inpatient hospice. He eventually required care in ICU where he eventually deceased.
This is not so serious but I started with horrible belching ,  25 to 30 times a day , every day and it?s continued till now . A week of Pepcid isn?t helping nor is eliminating  coffee. It was just today I realized there might be a connection with the vaccine since that?s when it started.
Low back and upper butt pain started on and continues. Diagnosed with shingles on 12-28-10 - taking 1000 mg. Valacyclovir.
On 2/15/21 received first dose of Moderna COVID-19 vaccine. Received Pfizer COVID19 as second dose.
Patient called to report a bump in his armpit on the same arm he received his vaccine on. Patient reports pain only when he presses on the bump, but no issues other than that. RPH told patient to self monitor and call back if symptoms worsen.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8730), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Negative, notes: testing negative on Day 9 (13May2022); (17May2022) Positive, notes: I had recurring Covid symptoms on Day 13 (17May2022). Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Patient had recurring Covid symptoms on Day 13 (17May2022) - congestion and a sore throat and tested positive with an at home antigen test after testing negative on Day 9 (13May2022). No Known allergies.
COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK570), via an unspecified route of administration in the left upper arm on 21Dec2020 at a single dose for COVID-19 immunization.  Medical history was none and there were no concomitant medications.  The patient stated that she felt yucky afterwards on 23Dec2020, experienced shortness of breath on exertion and coughing on 26Dec2020; chills, dizziness, headache, muscle pain, body aches, fever on 28Dec2020; loss of taste, loss of smell and COVID-19 pneumonia on 07Jan2021.  All the events were reported as being medically significant.  The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 29Dec2020.  Therapeutic measures were taken as a result of COVID-19 pneumonia and included: started on bronchodilator, cough elixir, steroids and azithromycin (ZITHROMAX).  The outcome of muscle pain, body aches and COVID-19 pneumonia was recovering and of loss of taste and loss of smell was not recovered.  The causality of the suspect vaccine to the events was reported as related.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Vaccines given 6/17/08.  Slight swelling and warmth of right upper arm.  No drainage.  Advised TYLENOL, and cool compress.
Tingling and pin pricks in hands, neck and feet; having dizziness; Felt like might fall asleep; did not feel well; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 (Lot number: 30130BA, Expiration Date: Nov2021) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 08Oct2021, outcome "recovering", described as "Tingling and pin pricks in hands, neck and feet"; DIZZINESS (non-serious) with onset 08Oct2021, outcome "recovering", described as "having dizziness"; SOMNOLENCE (non-serious) with onset 08Oct2021, outcome "recovering", described as "Felt like might fall asleep"; MALAISE (non-serious) with onset 08Oct2021, outcome "recovering", described as "did not feel well".  Additional Information: Relatedness of drug to reaction(s)/event(s) Reaction assessed: Tingling and pin pricks in hands, neck and feet   Source of assessment: Primary Source Reporter    Method of assessment: Global Introspection Drug result: Related    Relatedness of drug to reaction(s)/event(s) Reaction assessed: having dizziness and did not feel well   Source of assessment: Primary Source Reporter   Method of assessment: Global Introspection   Drug result: Related    Relatedness of drug to reaction(s)/event(s) Reaction assessed: Felt like might fall asleep   Source of assessment: Primary Source Reporter   Method of assessment: Global Introspection   Drug result: Related    Pfizer Covid Vaccine: Tingling and pin pricks in hands, neck and feet - Related. Pfizer Covid Vaccine: having dizziness and did not feel well - Related. Pfizer Covid Vaccine: Felt like might fall asleep - Related  No follow-up attempts are possible. No further information is expected.
Guillain Barre with 30 day hospitalization. Diagnosed with lumbar puncture and CSF findings. Treated with IVIG x5 doses. Inpatient and outpatient rehabilitation.
Case number PHEH2013US004936, is an initial spontaneous report received from a pharmacist on 26 Feb 2013: This case refers to a female patient of unspecified age. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: not reported), subcutaneously on 24 Feb 2013. No adverse reaction reported following this administration error.
Patient received vaccine 6/27 at 10:30 am. Came to pharmacy 6/28 around 10 am to talk to us about the reaction she was having to her vaccine. She presented with a red and swollen left deltoid approximately 5 inches in diameter. She said she had pain and believed that the vaccine had caused a flare in her fibromyalgia. Later that afternoon, around 3 pm, we were told that she was taken by ambulance to the hospital. I called today to check on her, two days after receiving her vaccine, and she said that she passed out and believes that the vaccine caused a flare-up of her tachycardia as well. She received pain medication from the hospital and has been using ice on her arm and is doing somewhat better.
Admission Date: 11/12/2022 Discharge Date: Nov 20, 2022 COVID positive 11/12/2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] Acute respiratory failure, unspecified whether with hypoxia or hypercapnia [J96.00] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: 73 y/o male wheelchair-bound nursing home resident who has a history of dementia, morbid obesity, DM-1, HTN and GERD. He presented to the  ED 11/12 via EMS after being found hypoxic by staff with O2 sats in the 80-84% range along with decreased mental status. Initial workup revealed positive COVID PCR, leukocytosis and CTA which was negative for PE and showed lower RUL and bilateral lower lobe consolidation. He was initially placed BIPAP with inability to tolerate and changed to NC/NRB with stability in o2 saturations. His stay was complicated with recurrent hypoxia due to removing his oxygen in a delirious state. He was put on soft wrist restraints in discussion with his family. He remained agitated stating that he wants to die. Pulmonology was consulted due to severe bibasilar PNA and started on empiric rocephin/azithromycin with IV solumedrol. He was placed on endotool with expectation of hyperglycemia secondary to steroids. Palliative care was consulted due to his critical status with patient expressing wishes of comfort care. He was delerious in making these statements but does have baseline dementia. Family was engaged and agreed to a trial of aggressive care. ICU was consulted for precedex gtt which helped with his agitation. He complained of chest pain and stat ekg showed NSR  and flat troponins. He remained on telemetry without incidence. His IV steroids were weaned and o2 weaned. Restraints were discontinued and precedex gtt discontinued as the patient calmed down. IV haldol PRN utilized to stabilize agitation associated with illness and dementia. On 11/14/22 he was weaned off bipap and NC/NRB and did well on NC alone.His steroids were weaned further and he will complete a 5 day course of antibiotics for complicated PNA. Pulmonology signed off.  He was transferred out of intensive care unit.   He finished 5 day course of remdesivir and will finish steroids post discharge by 11/23.  Patient did have episodes of bradycardia, unclear etiology, possibilities include Precedex drip but no ongoing Toprol and possibly also having OSA pathophysiology.  Toprol was discontinued, his heart rates remained in 60s and 70s, replaced by losartan which she was on prior.  Ultimately was transitioned off EndoTool switched to 2 injectables.  His COVID isolation would end on 11/23 he was discharged back to LTC and 11/20
103 degree and unconsolable irritability approximately 2 hours post PEDIARIX and PREVNAR administration. Treated with ibuprofen. No local reaction.
Red/large welt, about the size of a baseball, was hot to touch with itching/discomfort.
Tinnitus, might be left ear only, and left ear feels like it's being heated.  Did not see a physician since nothing can be done.
apx 30-60 min after vaccine, developed fine, dry, rough, blanchable, papular rash upon trunk, face, and extermities  does not seem pruritic no other symptoms involved given diphenhydramine in clinic plan: scheduled antihistamine now, follow-up with allergist as planned (already scheduled for time before vax #2 would be due), given epi-pen and go to ER for difficulty breathing/swallowing, facial/lip swelling, vomiting (already has epipen)
After the shot, I was feeling off around 8 PM on 4/16/21. I couldn't get up to use the bathroom later on. I fainted around 6 AM and fell on my ribcage. I fainted again and went back to bed for an hour. I woke up and fainted again. I tried to get up later on and fainted yet again. I took an extra dose of my pills for my condition. I had to go get an IV of phosphorus, potassium and magnesium. About a week later I started to feel better. It took a few visits for the IV treatment.