chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is 13 mo old girl transferred from ED on 06/26/10 to ER/PICU with positive blood culture and suspicion of sepsis. one week prior to her admission patient started to have subjective fever which was followed by petechial rash which her mother noticed first on the back of her ear bilaterally and progressed to her trunk and extremity. She has her 1 yr immunization 2 day prior to the onset of fever. Started to have loose stool 3 days prior to admission. On 06/24/10 she was seen at the  ED and was sent home with AUGMENTIN with Dx of Acute otitis media after the did labs including blood culture. Culture grew Gm positive cocci in chains. Parents get called and patient given 2 boluses of NS , and ROCEPHIN and transferred by medflight. She recived another NS bolus in ED and CBC was done and showed 4k with 65% segs. LP was done csf analysis showed 1 WBC, 145 RBC, with normal gulcose and protein. She was started with ceftrixone and vancomycin for possible meningiococcal meningitis and strep and Doxycycline for possible RMSF. CSF culture NGTD and negative for enterovirus PCR. Blood culture from 06/27 NGTD. She was febrile on the first day of hospital stay with 38.3 and then remained afebrile. ID consult done while she was in PICU and recommended EBV panel, Rickettsia IGM and IGG, Ehrlichia IGG and IGM - (EBV consistent with early infection; others are still pending at discharge). HIV serology was done and is negative. FA6 negative. In the mean time the culture from OSH growed 3 different spp namely alpha hemolytic streptococcus, coags negative staph and multiple spp of strep which were felt to be contaminant by Dr of ID. The vancomycin was stopped. ROCEPHIN stopped. She received approx 5 days of IV doxycline to cover for Rocky mountain spotted fever. She is being discharged home on oral doxycycline for an additional 2 days. Blood culture for enterovirus pending.  Peds ID felt her rash/symptoms may be adverse reaction to the measles vaccine. Measels IGM pending. Peds ID did not feel it was acute measles infection since that tends to occur weeks after exposure but that her symptoms may be due to adverse reaction to the vaccine. She felt the rash distribution and characteristics along with history of 1 yr immunizations 2 days prior to the onset of her fever/symptoms.
Brief "shiver" like episodes associated with grunting occurred frequently for approx 1 wk beginning the day after the vaccines. Hib administered on 8-13-08. No LOC, no other sxs. Does not seem to bother child.
pt recv vax & nausea, chills, fever, h/a, sweats, exhaustion;gen achiness;stomach cont to growl & rumble;
The morning after I got the shot (Wed), I had a sinus headache which got worse throughout the day. As the day progressed I had body aches, was exhausted, got congested and coughed from time to time. I worked every day during the week with this. And later that night, I got severe chills for about 4 hours. I lost my appetite and had to urinate frequently. My headache got worse and my arm was red, itchy, painful and hot to the touch. I felt like I had the flu or maybe even Covid. I woke up every 2 hours during the night with the headache and having to urinate. Finally around 3 AM I decided to take 2 Ibuprophen and the headache was gone when I woke up (Thurs) at 5:30 AM. On Thurs, I was still tired at work, arm was sore and no appetite. But no matter how much water I drank, I hardly urinated. I was still very tired but cough & congestion was just about gone. By Friday I felt a lot better. But my arm is still sore today (Sunday.)
Information has been received from a physician concerning a 71 year old female with no medical history who, on an unknown date, was vaccinated intramuscularly in the left deltoid with a second dose of Pneumovax 23 (Lot# 651320/1008P).  Concomitant therapy included a dose of Zostavax (MSD) (Lot # 652936/0981F) subcutaneously in the right arm, atenolol, hydrochlorothiazide (manufacturer unknown) and CELEBREX.  On 27-OCT-2006 the patient experienced swelling, redness and aching that extended 3/4 of the arm and systemic fatigue.  Subsequently, the patient recovered gradually over the next week.  Additional information is not expected.
it was rpt a pt who was vax w/2nd dose of varivax &  lab tests revealed negative varicella antibody titers.
Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist stated she had a patient that was there for the second dose of the Pfizer COVID vaccine. The pharmacist stated the patient received the first dose of the vaccine on 31Mar2021 and then she tested positive for COVID-19 on 15Apr2021 and had symptoms. The pharmacist stated the patient tested negative for COVID-19 yesterday (15May2021). Outcome of the events was unknown.   Information on the Batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Muscles of facial expression on L side of face were dropping. Could not smile, close eye, furrow eyebrow, raise eyebrow, frown, kissing with lips. DX: Bell's Palsy at ER. Muscles of facial expression slight return at 1 month. Treatment: corticosteriod injection 11 am 1/17/13, prednisone 10 mg 2x/day 10 days started 1/17/13.
Information has been received from a physician concerning a 7 month old female, with no medical history, who was vaccinated with an oral first, second, and third dose of Rotateq, on 19-SEP-2006, 20-NOV-2006, and 16-JAN-2007, respectively. There was no concomitant medication. On 20-FEB-2007, the patient developed intussusception and was admitted to the hospital the morning of 21-FEB-2007. The patient was given an air enema three times before the condition responded. It was reported that the patient would be released from the hospital on 22-FEB-2007. At the time of the report the patient was recovering. No product quality complaint was involved. No other information was provided. The patient's experience was considered to be an other important medical event, immediately life-threatening, and disabling by the reporter. Additional information has been requested.
Patient was fully vaccinated. he PUI says that the only symptom that he has had was a cough. The PUI is currently in the hospital but it is not covid related. Patient died due to COVID-19 on 8/30/2021.
On 6JUN92 c/o severe pain in both groin areas; started taking APAP p/vax was given on 5JUN92; switched to ASA on 6JUN92 PM; ASA did relieve pain; sx disappeared on 8JUN92;
Fever; Headache; Chills; Chest pain; Muscle pain; Site injection pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 17Apr2021 at 09:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 27Mar2021 at 16:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 21:00, the patient experienced fever, headache, chills, chest pain, muscle pain and site injection pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of fever, headache, chills, chest pain, muscle pain and site injection pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
swelling of face and throat; swelling of face and throat; bad rash all over body; numbness on her face; allergic reaction from her nose down to her chin; tongue still feels heavy; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer (patient) reported for herself.   A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0202, Expiry date: unknown) via an unspecified route of administration in Arm Left on 27Jun2021 14:45 (at the age of 57-years-old) as single dose for covid-19 immunization. Medical history included patient was diagnosed about 10 or 20 years ago for thyroid nodules from an unspecified start date and ongoing. Family medical history includes: Father has high cholesterol, no cancer in her family. Her dad has thyroid conditions. Patient didn't have any other vaccine prior to vaccination (within 4 week) and no adverse event prior vaccination. Concomitant medication included thyroid (ARMOUR THYROID) taken 0.25 one tablet daily for thyroid nodule. Sign of severe allergic reaction include swelling of face and throat, bad rash all over body. Upon follow up on 29Jun2021 patient reported that on 27Jun2021 15:20 patient experienced allergic reaction from her nose down to her chin, her face was numb like she had Novocain. And when patient woke up in morning and recovered (28Jun2021) from numbness in her face but tongue still feels heavy. Patient states she had COVID, and it was not severe and felt like it was not enough to put a vaccine in her body. She felt like with delta strain it may be more severe than the other strain. Patient feel like she was pressured to have it, took it for piece of mind. Patient received treatment for allergic reaction and numbness. The outcome of the event allergic reaction from her nose down to her chin, her face was numb like she had Novocain recovered on 28Jun2021 and tongue still feels heavy unknown.   Referred to HCP for further clinical recommendations.
Pain at the site of Injection; Feeling unwell; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3247) via an unspecified route of administration in the left arm on 18Feb2021 at 09:15 and the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via an unspecified route of administration in left arm on 27Jan2021 at 10:30 as a single dose for COVID-19 immunization. The patient medical history included mild seasonal allergies. The patient not had COVID prior vaccination. The patient had no known allergies. Concomitant medication received in two weeks was included loratadine (CLARITINE). The patient did not receive any other vaccine in four weeks. On 18Feb2021 at 20:30, patient experienced Pain at the site of Injection and feeling unwell. The patient was not tested COVID post vaccination. Therapeutic measures were taken as a result of events and included treatment with Tylenol. The outcome of the events is recovering.
pt devel immed red splotches around vaccine site-up shoulder & arm;also devel mild swelling lt arm-pt was treated in office;oral DPH, prelone & epi;
There was a miscommunication between the pharmacist and the nurse and the shot did not get reconstituted so patient was injected with 0.3mL of the concentrated stock solution which probably ended up being about 4-5 doses worth. She complained of a sore arm the next day and said it was moderate pain (4/10). This was the only adverse event that was reported by the patient we followed up with her on 4/14/21 and she said she had fully recovered.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed. No concomitant medicines were reported No treatment medicines were reported
I eventually (30Jun2021) contracted symptomatic Covid (testing + for Covid on 02Jul2021); I eventually (30Jun2021) contracted symptomatic Covid (testing + for Covid on 02Jul2021); This is a spontaneous report from a contactable consumer (patient).     A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot number was not reported, expiration date not provided) at age of 57 years old as a single dose, 2nd dose via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot number was not reported, expiration date not provided) at age of 57 years old as a single dose for covid-19 immunisation.  Medical history included systemic Lupus, prior CVA, seizure disorder, osteoporosis and known allergies: Yes. The patient eventually (30Jun2021) contracted symptomatic covid (testing + for covid on 02Jul2021) on 02Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 02Jul2021.  The outcome of the events was not recovered. The patient received Regeneron Covid Antibody cocktail as treatment. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The report was reported as serous for being disabling/incapacitating.   Information on the lot/batch number has been requested.
achy; feels just blah; breathing was quick and fast(kind of like panting); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), RESPIRATION ABNORMAL (breathing was quick and fast(kind of like panting)) and FEELING ABNORMAL (feels just blah) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced RESPIRATION ABNORMAL (breathing was quick and fast(kind of like panting)). On 16-Apr-2021, the patient experienced PAIN (achy) and FEELING ABNORMAL (feels just blah). At the time of the report, PAIN (achy) and FEELING ABNORMAL (feels just blah) outcome was unknown and RESPIRATION ABNORMAL (breathing was quick and fast(kind of like panting)) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) increased.         She is having difficulty completing forms and attaching the forms to provided email received from Safety it was reported in the follow up. Treatment medicines were not reported. Action taken with mRNA-1273 in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20 May 2021 and contains non  significant information
Caller stated very minimal soreness approx 2 days after rcvding the vaccine, more of a discomfort around the injection site but otherwise felt okay. Caller stated on Friday morning on 3/26/2021 he felt fatigue, tired, and muscle ache in his arms and legs. He took Ibuprofen on Sunday evening 3/28/2021, felt better the next morning but still felt very fatigue. Caller also stated he tests positive for COVID-19 on 3/31/2021, and as of today his throat feels scratchy and itchy, and still feeling fatigue.  4/5-Patient symptoms have resolved, awaiting to take second vaccine in the upcoming week.
The day after the vaccine there was localized erythema and edema, pain and tenderness in the left upper arm as well as left neck pain.  Four days after the vaccine there was inability to fully close the left eye and raise the left side of the lips.  Patient was diagnosed with Bell Palsy the next day and started on a Medrol Dose-Pak and acyclovir.
I have been having uncontrollable muscle twitching and believe my ulnar nerve has been effected from the flu shot. I wake up with numbness in my feet, hands, and pinky fingers that I have never experienced before. I went to a neurologist and my nerves and muscles are functioning promptly . They believe the flu shot I received could be the cause of my distress. I have had to miss work multiple days because the pain is so intense. I was a perfectly normal and healthy person until this flu shot. I haven't had a flu shot in years and never intend on getting one again.
Pt. Reported swimmers ear, sweating, and felt faint approximate three minutes in observation. Vitals were taken. Bp 112/74, temp 97.6.  Pt was cleared.
Pt. Felt sudden onset of chest palpations and flushed skin several minutes after receiving vaccine.  No evidence of hives , shortness of breath, or any other allergic reaction found.  Pt. was placed on the cardiac monitor showing a normal sinus rhythm, BP was hypertensive.  Pt. stated she was seeing her Dr. for her hypertension and started to feel better after several minutes of observation.  BP started to come down and pt. refused transport to hospital via ambulance.  Pt. was advised to contact her primary Dr. about the event and she agreed.  Pt. was accompanied by her husband and walked out of the clinic under her own power.  JDG301797
pain down left arm and into the armpit/chest  swelling in left supraclavicular area going on 7 days
pt recv booster dose in NOV93 & failed to seroconvert; No further info was available since the pt was lost to f/u;
H/a, ears ringing, stomach upset, anxious. EMS  evaluated. Stayed longer and felt better went home
This is a spontaneous report from a contactable pharmacist via non-clinical-study program. A 68-year-old female patient received first dose of PREVNAR 13 (lot. J67648), intramuscular on left upper arm on 03Feb2015 at 0.5 single. The patient had a low thyroid, and it was unknown if she took thyroid medication. The patient went to the pharmacist to get a shot and stated that she had reactions to PREVNAR 13, described as follows: she had a welt/raised area, which was red and 3 inches long and 2 inches wide, she started to feel really bad, threw up 6 times and she ached all over. The pharmacist said she didn't see the welt, but there was a lump; it was a pink area and it felt like a knot, but she wasn't sure if the knot was there before. The events throwing up and aching all over only lasted about 24 hours. The outcome of welts was recovered and the outcome of the other events was not recovered. In reporter's opinion, the throwing up and body aches were just a coincidence: she said there was a virus going around and she's been seeing people who have been throwing up and having aches and it was not from the shot. Reporter thought the patient had a localized reaction from the shot but she thought the patient had something else, stating "it seemed like a little more than she saw, but nothing major". The patient got a different shot (unspecified) from reporter and didn't have the reaction.
pain at the injection site; pain on her left armpit; soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (pain on her left armpit), VACCINATION SITE PAIN (soreness in the injection site) and VACCINATION SITE PAIN (pain at the injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FAMOTIDINE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness in the injection site). On 05-Apr-2021, the patient experienced AXILLARY PAIN (pain on her left armpit). On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 02-Apr-2021, VACCINATION SITE PAIN (soreness in the injection site) had resolved. At the time of the report, AXILLARY PAIN (pain on her left armpit) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the injection site), AXILLARY PAIN (pain on her left armpit) and VACCINATION SITE PAIN (pain at the injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Loratadine pills, Diclofenac sodium gel, Birth control pill, FAMOTIDINE and Oxymetazoline nasal spray for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness in the injection site). On 05-Apr-2021, the patient experienced AXILLARY PAIN (pain on her left armpit). On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 02-Apr-2021, VACCINATION SITE PAIN (soreness in the injection site) had resolved. At the time of the report, AXILLARY PAIN (pain on her left armpit) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
fever of 105 w/in 24hrs p/shot; taken to ER;no other sxs x/fussiness; all other illness r/o; pt was given inj & fever med as stated by MOC
Expired vaccine was given . No adverse effects were observed in client before leaving clinic at around 10:45 am 5/15/2019. Expected side effects from vaccine were given to Mom and explained on VIS. Instructed Mom to contact MD if anything else out of ordinary occurred. GLaxo SMith Kline contacted about expired vaccine given.