chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Neck Stiffness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: Pt received Moderna Booster 0.25 ml at 6:52 PM. Just before 7 PM, pt called RPh over & fainted while sitting in chair & being held up by RPh for <30 seconds. When she came to, she complained of tingling in arms, stiff neck, & weakness. RPh stayed with pt until husband came to pick her up 30 minutes later. Had no symptoms at the time & returned to pharmacy on 12/3 stating no other symptoms occured since administration & did not visit MD for any issues.
No reported ADRS- however upon processing the vaccine the next day- insurance rejected with a missing invalid birthday and upon contacting prescriber confirmed that parents falsified birth date on the form to be 2016 instead of 2017- making the child only 4.
constant headache; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (constant headache) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (constant headache) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of 1 dosage form; FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Adverse event, at a dose of 1 dosage form and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR) for Adverse event, at a dose of 1 dosage form. At the time of the report, HEADACHE (constant headache) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided.   Reporter did not allow further contact
Post vax, the client denied adverse symptoms. About 1 hour after leaving the clinic, she states she developed a "severe generalized rash" and went to her PMD.
The patient recieved an H1N1 IM injection. The patient fainted approximately 1 minute after the vaccine was given. His sister caught him. We carefully layed him on the floor. We called 911 immediately. The patient was unconscious for approximately 30 seconds. When the pt came to he said he was ok. The paramedics arrived in 3 minutes and took the pt to the ER. The patient returned later and is ok.
Ringing in ears head cold  feel.  Throbbing and slight pain in ear. Mainly left ear. Have contacted nurse and tele doctor and I am taking antibiotics now. About 4 days now.
Burning sensation in neck for 24 hours tapered slowly.; Back pain.; Sore armpits for 1 week; Tender breast for 1 week; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25Apr2021 at 14:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included bell's palsy on left side 2 years ago and the patient was still dealing with synkinesis. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 14:45, the patient experienced burning sensation in neck for 24 hours tapered slowly, back pain, sore armpits and tender breast for 1 week. The clinical outcome of the events burning sensation in neck for 24 hours tapered slowly, back pain, sore armpits and tender breast for 1 week was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had asthma. HPV shots (9/23/06, 11/24/06, 7/5/07).  1/07 tired, chills, dizzy, stomach ache, sick for one week saw doctor. Addtional appts for body ache, dizzy, vomitting, no energy through 2/07.  3/07 exhausted, sore throat, body aches, sinus. 5/07 chronic fatigue & referred to specialist.  7/26/07 specialist diagnosed fibromyalgia. 9/06 - 2/08 had 13 medical appts. 3/08 passed out in shower, possibly from medication, emergency room treatment.  Through 7/08, multiple specialist appts for treatment and pain management.  08/21/2008 MR received from PCP. Seen 11/24/06 for HPV#2.  Asymptomatic at that time. Frequent OVs beginning 2/9/07 with c/o feeling sick x 1 week-dizzy, H/A, belly pain, tired, chills-hot and cold, nausea, vomited x 2. PE (+) for exudate on tonsils, swollen lymph nodes in neck. Assessment:  Fatigue. Seen again 2/15, 2/21, 2/27 for same sx.  Assessment:  Chronic Fatigue, Achiness. Myositis. OV 3/22/07 with c/o sore throat.  Hyperreflexia noted on exam. Assessment:  Healing myositis, r/o Guillain Barre. H/A, Tiredness. Pharyngitis. Seen 5/9 now dx CFS 2' to post-viral. R/O Fibromyalgia/COD. WCC 7/5/07 with HPV#3. Seen 3/18/08 in f/u to ER for passing out in shower with head trauma/chipped teeth. 4 episodes that day. Lacerations to chin, knee, head. Dx: Syncope. F/u 3/20/08 feeling exhausted, sore w/ H/A. 5/6/08 Dx: Croup, Pharyngitis. 7/3/08 WCC Dx:  Fibromyalgia.  11/13/08 Consultant records received from Rheum. First seen in June 2007 and dx with fibromyalgia.  OV 2/13/08 with report of worsening sx of malaise, fatigue, difficulty sleeping and H/A. PE (+) for joint pain, back pain, myalgias, neck pain, morning stiffness.  Seeing Pain Mgmt and psych for CBT. Seen 4/17/08 in f/u for drop seizure, preceded by nausea and followed by amnesia of event, ?2' to Elavil. Reports muscle pain and daily occipitoparietal band-like H/A. OV 7/30/08 with improving sx. 1/26/2010 Headaches, body pain, physical weakness, loss of stamina. These symptoms are ongoing and have resulted in patient making many life changing actions.
Left arm edema a week after the vaccine, with induration and erythema, he was treated on 6/9/21 with Augmentin 875/125mg BID x 7days, then she started to have  erythematous painful nodules in the arms, legs and abdomen, multiple joint pain, generalized weakness and suggestive fever.
S:The pt walked in, C/O tongue numbness    O: Appearance: alert, well appearing, and in no distress and oriented to person, place, and time.    A: The patient received 1st Covid-19 Moderna Vaccine at 1526, at 1550 c/o mild numbness to tongue 2-3/10, 1615 c/o lips numbness and tingling,     P: VS taken, BP elevated, stated took BP rx in AM but does not know what he took. 1610 walked pt over to nurse clinic triage area, 1615 report given to  RN.  1617 Benadryl 50mg IM RD administered.     Electronically signed by:  RN 3/31/2021 4:36 PM    (R.N.), R.N.    Start Time 3/31/2021  4:48 PM      Filed at 3/31/2021  5:33 PM  Status: Addendum      male who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction:  #1 Covid-19 Moderna Vaccine in series administered.  o Action(s) taken:  See SOAP note below o Allergy to COVID-19 vaccine documented in Allergies activity:  o Patient advised to discuss second dose considerations with a clinician    (M.D.), M.D.    Start Time 3/31/2021  5:14 PM      Filed at 3/31/2021  5:20 PM  Status: Sign when Signing Visit    Patient requested chart be copied to primary care physician.    Chart reviewed and nursing notes noted. Patient had mild tingling sensation to tongue and lips after covid vaccine.  Agree with assessment and treatment by RN and nursing staff. Patient was much improved and stable at time of discharge. His wife will drive them home.  Dr advice allergy-- ok for patient to receive second vaccine but recommend monitoring 30 minutes post vaccine.    I did notice his blood pressure was mildly elevated. Nurse, please schedule patient for bp10. Thank you.
Administered only the diluent; Administered only the diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA677A, expiry date 30th March 2024) for prophylaxis.   On 2nd November 2022, the patient received the 1st dose of Menveo. On 2nd November 2022, unknown after receiving Menveo, 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 Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The reporter consented to follow-up by email. Additional supportive information: The patient was vaccinated with only the diluent of Menveo, which led to
2 days unable to communicate; words disorganized (OK now); pain in body later head;
Information has been received from a pharmacist who stated that a physician's office called her and asked if shingles can be caused by zoster vaccine live (Oka/Merck). She thinks a patient is involved, but was not entirely sure. Additional information has been requested.
This spontaneous report as received from a patient's mother refers to a 12 year old healthy female patient and was identified during social media monitoring. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL injection (strength, route, dose, frequency and indication not provided). No concomitant medication was reported. On an unknown date, the patient died. The outcome of the event was fatal. The causality assessment was provided as related (reported as GARDASIL suspected). Product quality complaint was not reported. Additional information has been requested.
Hot to touch; Redness; Swelling; Rash the size of a bullseye; Soreness in arm; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hot to touch), ERYTHEMA (Redness), PAIN IN EXTREMITY (Soreness in arm), SWELLING (Swelling) and RASH (Rash the size of a bullseye) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032220A) 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 historical condition was reported).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm). On 05-Feb-2021, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling) and RASH (Rash the size of a bullseye). On 08-Feb-2021, the patient experienced INJECTION SITE WARMTH (Hot to touch). On 31-Jan-2021, HEADACHE (Headache) and FATIGUE (Tiredness) had resolved. On 07-Feb-2021, ERYTHEMA (Redness) outcome was unknown, SWELLING (Swelling) and RASH (Rash the size of a bullseye) had resolved. At the time of the report, INJECTION SITE WARMTH (Hot to touch) and PAIN IN EXTREMITY (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-090348, US-MODERNATX, INC.-MOD-2021-090495, US-MODERNATX, INC.-MOD-2021-090656 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090495: US-MODERNATX, INC.-MOD-2021-090348:Crosslinked Case
PATIENCE INDICATES THAT THE VACCINE CAUSES DAMAGE TO THE NERVES, THAT SHE WAS HOSPITALIZED BY THE SECONDARY EFFECTS OF THIS VACCINE
Mom put child down for nap. Mom heard child playing and went in to check on her, Mom states that when she picked child up she was burning up. She took her Temp it was 103.2, Mom said they told her this was normal after shots and just give her tylenol. Mom states after back home child fever back up to 105 eyes rolled back and child had apparent seizure activity. Mom called ER they told her this was normal. Mom continued motrin and tylenol rotating each. Dr called next day. Mom states as child she had reaction to MMR. Mom states child was on Amoxil but she stopped it until after shots given.
9 AM got vaccine afternoon rash swollen arm. Pt states had a swollen red arm after vaccine given and a fine (on arm) red rash the afternoon after vaccine given today still slight swelling & redness not certain from vaccine but timing is right.
Itchy rash all over lower body, reported by patient only. Neither parent nor physician was shown the rash.
Resident had a seizure on 01/30/2021 at approximately 3:15PM.
Day after receiving second dose of moderna covid vaccine patient had syncopal episode and presented to urgent care.  Patient was admitted to floor for less than 24hours for observation and was discharged.
injected only half of the dose (0.25) with no reported adverse event; Initial information received on 19-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 2 years and 4 months old child patient (10 kg) who experienced injected only half of the dose (0.25) with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received only 0.25(half dose) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE injection (strength, frequency was unknown, lot U7196AB and expiry date was unknown) via intramuscular route in Left leg for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "injected only half of the dose (0.25) with no reported adverse event" (incorrect dose administered) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported"Our child is 2 years and 4 months old (but weight only 10kg). Doctor tried to inject Menactra (series U7196AB) into the left leg (intramuscularly), but child unexpectedly moved. Doctor injected only half of the dose (0.25). Please advise, what should we do in this situation? Doctor suggests: enter another half dose (0.25) after 2 weeks. And then give a second dose after 3-6 months. Please, we need your advice."  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (injected only half of the dose (0.25) with no reported adverse event).  At time of reporting, the outcome was Unknown for the event injected only half of the dose (0.25) with no reported adverse event.
This is a spontaneous report obtained from a contactable consumer. A 19 year-old female patient received on 03MAR2015, TRUMENBA intramuscular on left arm, single dose. No other vaccines were received. Relevant medical history was unknown. Concomitant medications included oral MICROGESTIN, 1/20 tables) once a daily, for birth control and fluticasone (nasal spray) as needed used to relieve stuffy (caused by an allergy). On 05MAR2015, the patient experienced lightheadedness, fatigue, dizziness, feeling of warmth, sweating, nausea, irritation of eyes, and headache. On an unspecified date, the patient was feeling like she was going to faint. No hospitalization was required. The patient was recovering from the event, nausea. Clinical outcome of the event "felt faint" was unknown; while clinical outcome of the other events was reported as not recovered.  Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
Nine (9) days after receiving the vaccine I noticed a very red rash on my left arm. The rash was located approximately 3" down from the injection site. The rash ran in a slight diagonal direction and measured approx. 3" x 2" , along with a slight spreading beyond. The rash was slightly swollen and was warm to the touch.  It was slightly achy but not painful. Over the course of several days (12)  the rash has been diminishing.
Extraordinary pain in left arm/injection site but also in shoulder rotator cuff, same pain in right shoulder and right elbow rendering both arms immobile. Any slight touch or movement created a deep burning and ripping sensation. Lasted a full 72hrs
Pt states that he experienced fever for a few days post vaccination as well as cramping/pain at the site of injection that is still ongoing today (10/18/2010), 2 months later. Pt also states that he feels that there is a lump that developed at the injection site after he received the vaccine.
Mild arm pain (expected) for a couple days post-injection, but now, on day 9, I developed a raised rash (about size of baseball in diameter) around injection site, as well as dull pain in entire arm and seemingly dull (but deep) pain in my right armpit near lymph node area.
Shortness of breath Couldn?t breath Stomach upset- diarrhea uncontrolled for 1 week Extreme fatigue Confusion Assisted living facility gave nebulizer and then called ambulance at 6pm- approx 4 hours after vaccination.
Mom noticed redness to the area 2/23/13, improved 2/24/13 & appears worse today (2/25/13). No fever no firming, good level of activity. 2; 4 cm diameter areas of erythema on lateral aspect of (L) thigh & anterior thigh.
Severe body aches, chills, sore throat, coughing, runny and stuffed nose, back pain, nausea.
my left arm it is just a little swollen; my right arm and my forearm, like my veins through like kind of bruising up my forearm; vein is like pop up kind of bruising in my right arm; my right arm and my forearm, like my veins through like kind of bruising up my forearm; vein is like pop up kind of bruising in my right arm/vein is pushing out of my arm; This is a spontaneous report from a contactable consumer, the patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, UPC number and NDC number was unknown), via an unspecified route of administration, administered in left arm on 11Jun2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the vaccine today in the left arm, it was just a little swollen but in the right arm and forearm, it seemed like the veins through like kind of bruising up the forearm, that's never happened ever. Patient did not know if it was serious. Patient need to go and get checked out because the vein was like 'pop up' kind of bruising in my right arm. Patient's vein was pushing out of the arm. Patient had very deep vein, which patient meant that was my skin, and thought they had like an emergency. The outcome of all the events was unknown.  Follow-up attempts are possible. Information on Lot/Batch number has been requested.
pt recv vax & exp staring spells, shortly p/vax;EEG abnormal, lt central sz activity subsequent dx learning disorder fine motor skill problem;
On 12/13/02 about noon, while breast feeding, patient had 30 seconds of generalized shaking per mom. No associated fever; no post-ictal or other adverse symptoms afterwards. Normal vital; exam in clinic at 14:15.
Sore, can't move arm, red, swollen and hot to the touch, rock hard on the vaccine site about an inch
Patient reported epi-pen level allergy to penicillin in pre-vaccine questions, given 25mg Benadryl po 15 min BEFORE vaccine administerd 12:05pm - Moderna dose#1 given, asked to stay in pharmacy for a minimu on 30 min to monitor for any reaction 12:15pm - patient reported itchy throat 12:38pm - patient reported itchiness gone and feeling fine, patient left pharmacy 1:10pm - patient called pharmacy from home to report "tingling on tongue", patient breathing easily without obstruction, pharmacist advised patient to take another 25mg Benadryl PO and to call 911 if any sign of breathing difficulty or compromised airway occurred 1:29pm - pharmacy called patient to check in, patient reported feeling same and that she had retrieved her epi-pen tohave close by just in case 1:46pm - pharmacy called patient to check in, patient reported benadryl was working and the tingling feeling on tongue was d=fading, airways open and no issues breathing 2:04pm - pharmacy called patient, she was feeling better, no new s/s 2:40pm - pharmacy called patient, she was lseepy from Beandryl but feeling otherwise fine 3:45pm - pharmacy called patient, no tingling on tongue, slight tingling in throat but feelng good overall 4/1/21, 9:12am - pharmacy called patient to see how night went, patient felt normal, slept well and no further issues
Father called parent to report diarrhea-8 stools in 15 hours fussiness.
chronic on-and-off swelling and itching at both injection sites, persisting 2+ years after vaccine doses administered
We have some past expiration administrations that have surfaced; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced). On 08-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-392126 (Patient Link).
I started off by having chills body fatigue flu like symptoms no appetite. Within a few days I took a home test and it was positive and then I went to a urgent care and they came out to my car and did my test. The results came back positive, and they didn't offer any treatment. I was told to isolate for 7 days, and I tested again and was positive. Which they said was normal and wait 48 hours and test again I did and was negative.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. The physician reported same adverse event for different patients. This is third of the three reports. A patient (age, ethnicity and gender unknown) received PREVNAR 13 single dose, on an unspecified date. Relevant medical history and concomitant medications were unknown. It was reported that the patient experienced stinging during injecting PREVNAR 13. Therapeutic measures taken in response to the event were unknown. Clinical outcome of event was unknown at time of this report. Follow-up (26Nov2013): Follow-up attempts completed. No further information expected.
Intense swelling of entire arm, limited range of arm motion.  Intense swelling lasted roughly 1 month.  Veins still swollen under skin and limited swelling still occuring now, 4+ months after vaccination.