chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna  shot,  2nd  dose.   evening of injection developed Pain all thru  my bones, which lasted  thru next day.  At 9:30 next  am became nauseated.   My head got tight and I made it to BR and felt blood drain from my head, very pale unable to see, everything went white and lowered myself to floor.  Was very weak.  I then vomited.  Tried getting up and same thing happened,  Everything went completely  white and vomited again.   Lied on floor till i was able to crawl to recliner.   Rested in recliner all day and drank water for several hrs.   Finally felt better by that night.
day p/vax pt exp muscle joint pain, h/a, fever, 100.1-100.9, chills, & back pain.
The patient went to bed in her usual state of health around 930 or 10 PM on 11/20.  She woke up 11/21 with slurred speech.  She was unable to get out of bed.  EMS mediately activated and noticed right-sided facial droop and right upper extremity weakness.  In the ED she also has dizziness, headache, nausea, and vomiting.  Vomiting is induced by movement.  She endorses generalized body tingles, but not necessarily paresthesias.  She has chronic unchanged constipation, last bowel movement yesterday.  She denies chest pain, shortness of breath, diarrhea, melena, hematochezia, dysuria.
Roughly 30 mins (10:30am) after I received my 2nd Pfizer vaccine shot, I was about 5 mins from my home and began to feel tingling/numbing in my mouth and tongue. I got in my house and told my wife I was not feeling right and started to notice a dizziness coming on. I was to call the pharmacy to find out what I should do, but noticed my heart rate was up, I looked at my Apple watch monitor and my BPM was 164. I felt flush and told my wife to call 911. Ambulance arrived and took my vitals and ( I do not recall the blood pressure, but it was high for me) when they put me into the ambulance I began to shake uncontrollably and then began to sweat profusely. They took me to the emergency room, but did not administer any drugs. The Dr. came in and said he did not think it was related to the vaccine, but my personal Dr. agreed with me based on my medical history that it had to be related to the vaccine. My resting heart rate (I monitor this daily) is between 45 - 60 and my last blood pressure reading at my yearly physical on April 2nd, 2021 was 100/70.
0810: Pt complained of itchy throat, eyes and she complained of "foggy" chest as described by the pt.
Client phoned; C/o face swelling; trouble breathing; dizziness and weakness. 911 phoned for client home address; client refused medical care/ambulance service.
Chills; Headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 09:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. 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. Concomitant medication were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 19Feb2021 at 09:00 as a single dose for COVID-19 immunisation. On 13Mar2021 at 18:00, the patient experienced chills, headaches, and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, headaches, and body aches were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
I started developing a hive like rash at the injection site about a week after receiving the second Moderna covid shot. It is itchy and has spread down my L arm, and left chest and now my right arm and hand .
Patient received 3 vaccines on 10/4/21. Received Shingrix in right arm and both Pneumovax 23 and Flublok in left arm. (PPSV23 lower and to right, Flublock upper and to left from ppsv23 separated by at least 1 inch.) Patient called today 10/7/21 stating the following reaction in left arm. Patient had pain in arm which has been improving. Very sore where patient really unable to use at beginning. She says pain has been an ache but now more of a throb.  She checked arm yesterday and noticed a rash. Says rash is spreading, larger area today. covers top half circumference of her arm, (180 degree circumference.)  Width is about 3 inches (top to bottom). She says the area is warm to the touch. No itching. When I asked her if the area was swollen she said she thinks so. She has been taking tylenol and ibuprofen which she says has not been helping much, She has been icing the area and says she was putting hydrocortisone cream on the area. Patient states no fever.
Female patient received the portion only of Shingrix / diluent portion only; Female patient received the portion only of Shingrix / diluent portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 34SD3, expiry date 15th November 2022) for prophylaxis.   On 19th May 2021, the patient received Shingrix. On 19th May 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the portion only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
This spontaneous report was received from two Licensed Practical Nurse (LPN) referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unspecified date in January 2018, after 09-JAN-2018 (which had been previously reported as "between 03-JAN-2018 and 09-JAN-2018"), the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot number M036057 (also reported as "N036057"), expiration date 18-MAY-2019, (strength, dose, dose number and administration routes were not provided) for prophylaxis. The vaccine was exposure to a temperature excursion; the data logger registered a temperature of 48 Fahrenheit (F) for 1 hour and 45 minutes. The previous temperature excursion registered was 35 F for 3 hour. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA003362.
pt recv vax 12SEP95 & 1JAN98 pt exp 50-60 vesicular lesions which were initially all red bumps & a fever;to MD 6JAN98;
I developed sudden onset generalized severe abdominal pain with bloating. I followed a full liquid diet and saw my provider on day 3 of the pain. Lab work was done as well as a stat CT scan of the abdomen. I remained on liquids only for approximately 6 days and the pain eventually lessened each day and then subsided.
Received both Moderna vaccines (#1 on 3/26/21, #2 on 4/23/21) and tested positive for COVID-19 by PCR on 5/21/21.  Patient was asymptomatic, testing obtained on admission to hospital for management of Diabetic ketoacidosis.
Patient reported feeling itching all over her body, her gums were swollen, her skin on her neck got darker a day after the shot was administered and she used cortisone cream and otc Benadryl pills for the symptoms. Patient also mentioned that she has had a similar reaction to the flu vaccine receive several years prior.
This spontaneous report as received from a patient's wife refers to a 75 year old male patient with no pertinent medical history and no drug reactions/allergies. In approximately 2013, reported as 'four to five years ago', the patient was vaccinated with a dose of ZOSTAVAX, dose, route and lot # not reported. Concomitant therapies included sterile diluent. On 24-JUN-2017, the patient had a slight rash and on 25-JUN-2017 the rash was more pronounced. The patient was diagnosed with shingles on 26-JUN-2017. There were no lab tests done. An unspecified treatment was given for the patient. The outcome of shingles was unknown. The relatedness between event and suspect therapy was not reported. Additional information is not expected as the reporter declined to provide demographics for her husband or his physician.
Mom called and stated that there were red whelts down arm in 6-7 areas around deltoid; pt exhibited itchy and burning; back tingling x1 hour; mom gave Benadryl x3d; no streakiness ; upper arm swelled-noticeably larger than other arm
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 14-JUN-2013, the patient was vaccinated with a dose of MMR II (Lot # reported as H014978, expiration date 09-AUG-2014) and a dose of VARIVAX (Merck) (Lot # reported as H019449, expiration date 15-OCT-2014) that were exposed to unknown temperatures during a 4 hour power outage. The nurse reported that after additional excursion information was provided and evaluated, VARIVAX (Merck) was supported for 3 months and MMR II was supported until date of expiration. No adverse symptoms were reported. Additional information has been requested.
Fever, chills, muscle aches, and joint pain within 12 hours of receiving injection.  I was already receiving treatment for SI joint pain prior to receiving the vaccination and this aggravated the joint.  Approximately 48 hours after receiving injection, I experienced a sudden onset of Tinnitus.  It has now been 10.5 weeks and the Tinnitus has not subsided or changed in intensity.
"Ache" "sore" pain upper right arm upon "movement over head or lifting." Onset after vaccine administered on 10/10/13 per patient. Patient says Tylenol and heat has helped some. Pain continues to this date. (Info received from girlfriend.) Pain still off/on since Oct 2013.
Cellulitis on (R) arm. Measuring 21 x 24 cm. No fever. Warmth, erythema, edema & pain are present.
Body aches; Severe headache; Chills; Sweating; When breaking a fever after taking tylenol but when Tylenol wore off, "I"  would spike 103 fever.; Exhausted/slept most all day.; Slept most all day but choppy sleep because could not get comfortable due to body aches.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 28Apr2021 at 12:15(at the age of 43-years-old) as a single dose for COVID-19 immunisation. The medical history included bipolar, depression and anxiety. 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 COVID-19 vaccine. The concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), lithium (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient also had taken morphine (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 29Apr2021 at 02:30, the patient experienced body aches, severe headache, chills, sweating when breaking a fever after taking tylenol, but when tylenol wore off, the patient's fever would spike to 103 and exhausted. The patient slept most all the day but it was a choppy sleep because she could not get comfortable due to body aches. On the same day, the patient underwent body temperature test and the result was found to be 103 (units unspecified). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever which included treatment with paracetamol (TYLENOL). The patient did not receive any treatment for the events body aches, severe headache, chills, sweating, exhausted and slept most all the day but it was a choppy sleep. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, severe headache, chills, sweating, fever, exhausted and slept most all the day but was a choppy sleep were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Shortness of breath, red and swollen eyes, rash on neck and chest, hypotension, tachycardia, chest pain. Developed in evening after receiving vaccine at approximately 1pm. Treated in ER for possible allergic reaction to flu vaccine. 1st flu shot employee had ever received.
Patient became very pale, they crumpled to the ground.  about 2 minutes after vaccine. They did not loose consciousness.  ems was called, patient was laid down and feet were elevated and and ice pack was applied to forehead. Their color returned within a minute or two and they seemed fine once ems arrived. They refused trip to ER and went home.
PATIENT RECEIVED PFIZER COVID VACCINE ON  Dose 1 date: 12/21/2020 AND Dose 2 date:  01/11/2021. PATIENT TESTED POSITIVE TO COVID ON 8/23/21
Received expired dose of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) 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 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.
Night of shot 4 mo in Oct 06 pt experienced an involuntary spasm of his left arm. He experienced several more spasms in the next week. In FEB 07 he experienced two more arm spasms (once right, once left). On March 22, 2007 he experienced a seizure and was hospitalized for three days. Currently is developmentally delayed and on seizure anti-meds.  VAERS report with hx. written by mother attached.  4 mon. shots given 10/25/2006.  That pm mother reports  child had a L arm spasm, from elbow to fist with fist clenched, lasting ~10 sec.  Several more similar incidents over the next week.  No spasms again until 6 month vax given on 1/23/2007.  One L arm spasm and one R arm spasm occured 2/26/2007.  Flu vax given 3/5/07.  On 3/21/07 mother noticed increased drooling and that infant was "floppy".  He later had a full body spasm/convulsion involving all 4 extremities. Infant was limp after episode.  He was taken to ER and was staring to the right for the 30" ride. Child also began night terrors and high pitched screeching following 4 mon. shots per mom.  Mother reports loss of verbalizations and rolling over.  Seen by Ped. Neuro.  Awaiting reports.  07/02/2007 MR received from 8/2006 through 6/2007. First several visits are for normal 2, 4 and 6 mon. well baby checks  with normal growth and development noted. Visit 27 March 2007 in F/U for hospitalization for status epilepticus.  First seizure however has hx of unilateral hand spasms at age 4 months.  Neuro exam showed dysfunctional tone. Developmental Peds consult 4 April 2007 with DX: Seizure Disorder.  Global Developmental Delay. R/O metabolic disorder. R/O Cerebral Palsy. Neuro consult 22 april with DX Seizure Disorder.  Delayed milestones.  Hemiflaccidity of left side.  Hemiflaccidity of right side. Opthalmology consult 13 April 2007 showed no opthalmic manifestations of metabolic disease. Peds Neuro consult 26 April 2007 remarkable for lack of visual responsiveness, no social smiling. Motor hypotonia of the head, trunk, and neck with normal strength.  Impression:  Hx of focal seizures and global developmental delays, possibility of Autistic Spectrum Disorder. 2 more grand mal seizures in May 2007.  1/15/2010 Chronic diarrhea/GI issues, high mercury levels, severe developmental delay, epiliepsy, autism, failure to thrive and hypotinia.
Patient presented to the ED and was subsequently hospitalized for bilateral lower leg cellulitis, Severe sepsis with acute organ dysfunction,- hyperlactatemia within 6 weeks of receiving COVID vaccination.
Pt recv vax on 10/27/98; on 10/28/98 pt exp red, swollen, warm vax site w/ firmness; pt imp 11/3/98
Bruise at the injection site on his arm; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 28Feb2021 14:00 (Lot Number: EN6198; Expiration Date: Jun2021) (at the age of 79-years-old) as dose 1, single for covid-19 immunisation. Medical history included heart condition. The patient had no family medical history. No additional vaccines administered on same date of suspect vaccine. Concomitant medications included PLAVIX taken for heart condition, start and stop date were not reported. Patient had no prior vaccinations within 4 weeks of Covid-19 vaccine. No relevant testes were performed. On 02Mar2021 morning, when the patient got up, he noticed a real good size bruise at the injection site on his arm. It wasn't bothering him physically. On the day of reporting, when he woke up, the bruise was bigger than the day before. The bruise was not causing any great pain, but it was noticeable. The patient stated could be because of a medication, as he was on a blood thinner. The patient asked if it doesn't bother him yet, does he really need to go to a doctor. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender might have received PNEUMOVAX23 (lot # unspecified) dose, frequency and location unspecified, which were stored improperly on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant via Pfizer, Inc (ref # US17-019244) and refers to a currently 85-year-old patient of unknown gender. No information about the patient's concurrent conditions or concomitant medications was provided. The patient was vaccinated in 2006, with a dose of PREVNAR 7. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported). The reporter also inquired when they could administer PREVNAR 13. Additional information is not expected as no contact details were provided.
administered a dose of MENACTRA that was mixed with the lyophilized component of MENVEO with no reported adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 16 years old male patient who was administered a dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] that was mixed with the lyophilized component of meningococcal vaccine A/C/Y/W CONJ (CRM197) [Menveo] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) for Immunisation.  On 14-Sep-2023, the patient received a standard dose 1 of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] Solution for injection at a dose of 0.5 ml total (lot number, strength, expiry date-  not reported) via intramuscular route in the left deltoid for Immunization that was mixed with the lyophilized component of meningococcal vaccine A/C/Y/W CONJ (CRM197) not produced by Sanofi Pasteur (lot number, strength, expiry date, dosage-  not reported) with no reported adverse event (product preparation error) (latency-same day). Information on the batch number was requested.  Reportedly, Caller reporting a patient was administered a dose of MENACTRA that was mixed with the lyophilized component of MENVEO. Caller asking if the dose is valid. Caller reporting she would also call GSK to see if they have any data. Menveo was given on 15-JUL-2019.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
shingles in the right eye; This is a spontaneous report from a contactable consumer reported for her husband (patient). A 67-year-old male patient received second dose bnt162b2 (BNT162B2, Lot Number: EN6204; Expiration Date: 30Jun2021) administered in left arm on 27Mar2021 10:00 as single dose for covid-19 immunisation. None medical history neither concomitant medication. None Prior Vaccinations within 4 weeks. Patient received first BNT162B2 (Lot#: EN6202, Expire date: 30Jun2021) dose on 06Mar2021 in left arm. Everything seem to be fine then 2 weeks or maybe 2 and half weeks after the second dose (but also reported begins on "14Apr2021"), he ended up with shingles in the right eye. Consumer was not sure if it is something to do with the immune system. She did search the net regarding adverse reaction and it said there are cases of shingles in another country. 6 women in a second country, whose ages and location of shingles varied. Some of these were after the first shot and some were after the second. The event was not recovered.  No Follow-up attempts are needed. No further information is expected.
L deltoid swelling and pain after administration of pneumococcal vaccination. TYLENOL #3 and cephalexin given.