chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Yesterday at 1030 patient  received his second dose of Menactra at his 16 year WCC.  1.5 hours later developed chills, shaking, 10 episodes NBNB emesis, "room spinning sensation",  difficulty with balance.  Returned to office, physical exam: pale/yellow skin coloring, clammy/cool skin, nystagmus of eyes, worse with lateral EOM, unable to balance well without support. Blood glucose 97, VS stable, afebrile.  Unable to obtain UA or urine drug screen from patient.  Zofran given in office. Sent to ED,  physical exam: notable nystagmus on right lateral gaze, somewhat unsteady with toe and heel gait but not ataxic. Dx with vertigo vs. labyrinthitis. Given IVF, zofran and PO meclizine. After treatment patient felt significantly better, discharged home, follow up with PCP.   Of note, patient was up until 2am the night before playing video games at friends house.  Only had a cookie for breakfast, nothing to drink all morning. Denies alcohol, marijuana or drug use.
4cm swelling with redness, warmth, itching, and tenderness at injection site.
A redness at the injection site; It is raised at the injection site; it is itchy at the injection site; Feeling hot; A spontaneous report was received from a consumer concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vaccination site erythema, vaccination site pruritus ans vaccination site swelling.   The patient's medical history was not provided. No relevant concomitant medications were provided.  On 23 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route in right hip for prophylaxis of COVID-19 infection.  On the next day 24 Jan 2021 patient developed  a redness at the injection site, it was raised and  itchy .  No treatment details were reported.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s), redness at the injection site, it was raised and  itchy were considered as not recovered.  Based on MSA comment, Feeling hot coded as Vaccination site warmth
This spontaneous report as received from a medical assistant refers to a 30 year old female patient with no pertinent medical history or allergies. On 06-MAY-2013 the patient was vaccinated with the first dose of PROQUAD (merck), (lot number H015781, expiration date 24-FEB-2014), (anatomical location unspecified), dose 0.5 ml via subcutaneous. The patient also received ADACEL and FLUZONE on 06-MAY-2013. There were no concomitant medications. On 06-MAY-2013 the patient was administered of PROQUAD (merck) (instead of her first dose of M-M-R II). On an unspecified date between 06-MAY-2013 and 09-MAY-2013, the patient developed strep throat, the patient returned to the physician's office on 09-MAY-2013 and penicillin (manufacturer unknown) was prescribed. Lab diagnostics studies were not performed. The outcome of strep throat was unknown. Additional information has been requested.
TIA; I felt really lousy; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), dose 2 at the age of 73-year-old, via an unspecified route of administration on 26Feb2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure (don't have really high blood pressure but the doctor has her on blood pressure medicine, have no diabetes or whatever, and had allergies. Concomitant medication included amlodipine besylate 5 mg, taken every morning. She takes most of her medicines in the morning and had taken that stuff at about 5 o'clock or so early in the morning. The patient was previously vaccinated with the first dose of BNT162B2 on 05Feb2021 at the age of 73-year-old and hand no problem. The patient stated that when she had the first COVID vaccination she had no problem and then Friday she went to get the second one, it was 3 weeks later, when she had first one she stated that she had allergies, so they had her wait 15 minutes, no problem. When she went for the second one, thankfully someone drove her that was outside the 'game court' location. When they gave it they said, she pull up and will let her know after she pull up and will decide if she has to wait 15 minutes or 30 minutes and they asked her if she had allergies, and she said yes, they said pull over here and she has to wait 30 minutes and all she know was, it's probably 2 minutes from the time she got the vaccine until she got to the place to wait. She would say 15 minutes after she got it on 26Feb2021, she felt really lousy and told her friend, they 'said' she was having a Trans Ischemic Attack (TIA), and took me to the hospital and everything. An ambulance was called on 26Feb2021 at around 8 o'clock that morning, right after she had the vaccine and carried her straight in the hospital. She was discharged the next day 27Feb2021 at about 7 PM. The patient had a CT scan of her brain, MRI of her brain, and then cardial, something with reference to her heart, she forgot, all with unknown results. The body weight right now was about 150 pounds. The outcome of the events was unknown.
Leg pain and some foot pain, appears to exaggerate pain that was present and now wakes me up.
Information has been received from a physician concerning a 21 year old female who was vaccinated with a 0.5 mL first dose of GARDASIL. Subsequently the patient experienced headache, nausea and arm numbness (injection arm). The patient did not mention it to the physician until she came back to receive her second dose of GARDASIL, by that time she was already recovered. The physician did not administered the second dose at that time and wanted to check first if that would be safe because of the previous reaction. No laboratories studies performed. Additional information has been requested.
Speech garbled, client  complained of tongue swelling. Client was given EPi Avi Q injection. Following injection client self amdministered PO Benadryl. Then taken by EMS  to ER.
Very gradually got stiffness in shoulders and hips. Had trouble end of golf season to pick ball up from ground. Slowly got worse until July 2016: diagnosis PMR and September 2016 diagnosis GCA.
At approx. 1300 CNA reported resident was in the bathroom holding onto the door and the bar in bathroom crouching over and she needed assistance getting resident into w/c. Resident was diaphoretic at the time and weak. BP 96/56, pulse 120, respirations 20, temp 98.3, O2 96% RA. No c/o pain, he did c/o weakness to his left leg with walking. Resident said he walked from his bed to the bathroom independent. Res. did have the 2nd dose of the Covid vaccine on 1/14/22. Gave order to send resident to ED for eval at 1325. EMS called at 1357, EMS left with resident at 1419.
Patient husband came in and said pt complained left arm pain. Also spoke about a rash in adbomen/ribs on 11/03/14 - Advised patient to go to Emergency Room. Patient husband came back and said arm is still hurting but never went to see MD. 11/17/14 vaccine give 10/20/14 when pt 64. Before vaccine given, patient complained of arm pain.
Day of vaccine: Fever, extreme fatigue, headache,  muscle soreness, lameness of left arm (injection site).  symptoms subsided after ~24hours.  one week post vaccine:  neck ache, subsided after a week.  Sharp pain/radiating heat feeling in left arm at injection site, subsided after a few hours.  Pain/cramping in right lower abdomen/stomach, subsided within 24 hours.    two weeks post vaccine:  slight pain and swelling in right foot.  Many of these are symptoms I experience leading up to and during menstruation as well, which occurred in the week after vaccine.
Patient given undiluted Pfizer COVID-19 vaccine for ages 5-11. The patient received a 0.2mL dose, however, this was not diluted.
Narrative:  97yo male with Past Medical Hx: htn psoriasis bhp gerd barretts syndrome 1995 - cauterization of lesions by EGD - at medical facility. spinal stenosis - lumbar 4-5; 3-4; GERD cts benign polyps aortic stenosis died on 08/09/2021. Pt with no information or notes regarding pt's death nor any recent medical notes. Pt had received covid vaccinations on 1/11/21 and 2/8/2021. Likely pt's death is not related to vaccines given pt's advanced age.
she was so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FE3594) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (hospitalization, medically significant), outcome "unknown", described as "she was so sick". The event "she was so sick" was evaluated at the emergency room visit.  Clinical Course: Patient was 113 Pounds. Consumer reported that she was sick for first 2 days after her first dose and she was sick for 6 days after her third dose.Consumer stated, that she was in emergency room for 6 hours because of blood pressure which was out of control.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 10:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 10:33 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.75. No concomitant medications were reported. Batch number 041L20A administered on 11-Jan-2021 underwent temperature excursion with temperature range of 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
pt recvd vax 9NOV93 & 10NOV93 devel a rash; No further details were provided;
Pt given DTaP right deltoid 9/15/04. Presents with parent to clinic 9/17/04 , diagnosed with localized cellulitis at DTaP injection site. Treated with Amoxicillin 200 mg po TID x 10 days.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Developed itching with throat swelling & vomiting. Resolved with 2 doses BENADRYL.
Severe fever, drenching night sweats, itchy skin on and around neck all started Sunday night and were unbearable Monday morning. Drenching night sweats and itchy neck continued the night of Monday, April 12. Night sweats subsided Tuesday, April  13, Itching has turned into rash on neck.
Information has been received from an office manager concerning a male with NKDA or pertinent medical history, who on 03-JUL-2008 was vaccinated with the first dose of ROTATEQ (lot # 660600/0281X). The patient received the second dose of ROTATEQ on 05-SEP-2008 (lot #661034/0470X). Suspect therapy included hepatitis B vaccine (MSD) given at the second visit. Concomitant therapy included (PREVNAR), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine inactivated (Vero) (IPOL) and Hib conj vaccine (CRM197) (HIBTITER). About 5 days after vaccination with the first dose of ROTATEQ, the patient developed a head to toe rash that resembled contact dermatitis. The rash resolved in 2 weeks without treatment. The patient developed the same AE after dose 2 but it has not yet resolved but he has been started on steroids. The patient sought medical attention, seen in office after second vaccination. No laboratory tests were performed. No product quality complaint involved. Additional information has been requested.
c/o swelling, pain and "heat " to left upper arm, sts "heat" is improving Patient advised to see PCP or ER for any new or worsening of symptoms, sts is improving
The patient believed to be 18 by the person who administered the vaccination; therefore a Moderna dose given at the request of the patient and patient's parent. It was discovered immediately after administration the patient will not be 18 until May.
Patient developed vomiting, diarhea within 12 hours. Seen in ED.   Developed cough/congestion in 24°, seen in ED.   Seen by PCP on day #5, recovered.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a child patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be related to BOOSTRIX. Additional details were provided as follows: The age at the time of vaccination was not reported. Few patients got whooping cough from the vaccine. This case is linked with US2017GSK129330, reported by same reporter.
4 days later, severe headache for 24 hours and legs felt heavy and weak for 24 hours.
Fever, UrticariaPruritus fatigue Narrative:  Other Relevant History:
light-headed, c/o heaviness, some tightness 15min later;c/o itching all over;5-6cm erythema @ inj site immed p/inj;pt given DPH, rested few min;went home to sleep;has stated no allergic to eggs;
Arm pain. Migraine and dry mouth however a little over a week after I lost taste everything has a tinge of metal except salty foods and pickles. At the same time lost sense of smell but can still smell strong  strong odors
No adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. No information regarding patient's gender, concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. On 04-SEP-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # S002874, expiration date 29-JAN-2021, for prophylaxis (exact dose, route of administration and injection site were not provided). The vaccine was reconstituted with properly stored sterile diluent. The vaccine was exposed to a temperature from 6 to 14 degrees Fahrenheit (F) for 50 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of several reports from the same reporter; Sender's Comments:  US-009507513-1909USA005231: US-009507513-1909USA005078: US-009507513-1909USA005124: US-009507513-1909USA005119: US-009507513-1909USA005129: US-009507513-1909USA005134: US-009507513-1909USA005139: US-009507513-1909USA005220: US-009507513-1909USA005231: US-009507513-1909USA005365: US-009507513-1909USA005375: US-009507513-1909USA005424: US-009507513-1909USA005468:
This spontaneous report as received from a doctor pharmacist refers to a 61 years old female patient with allergy to sulfas, who on 27-SEP-2012 was vaccinated with ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included XANAX, atropine sulfate, LOMOTIL, nortriptyline, ESTRACE and NASONEX. The pharmacist reported that the patient developed numbness and tingling on her ipsilateral arm and leg after receiving ZOSTAVAX. No treatment information was reported. The patient sought medical attention, she contacted the pharmacist. At the time of the report, the patient had not recovered from numbness and tingling. The relatedness for numbness and tingling was unknown for ZOSTAVAX. Additional information has been requested.
Cellulitis x 4 days at left deltoid site of Varivax and Hep A given 3/27/2006. Itchy, tender, hot to touch, occurred 10 days after vaccination.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
reported  started to feel dizzy after receiving vaccine.  Thought it was nerves, tried to walk to chair for monitoring. Observed by clinic staff fainted on way to chair.  Medical Doctor who was vaccinating on premises responded to incident immediately and patient came too right away.   Patient is reporting butt feels sore, head and shoulders are fine.  Place where shot was given feels sore.
death Narrative:  patient did not receive active care at the clinic since 2017 no evidence of COVID positive diagnosis in past no known hospitalizations no acute ADRS following vaccination no death note or autopsy in record no other ADRS documented in record
Got shingles as a result of vaccine.  Diagnosed with on 9-11-09.  Received VALTREX 1GM- 21 Pills on 9-11-09.
Immediately after injection the patient became pale and his lips turned blue. He was made to lay down with his knees elevated. He was give a lollipop and recovered fully within 5 minutes.
Mom called on 8/25/2008. On 8/23/2008 am pt. had fever 100.1, swollen sore arm that was warm to touch.
Patient came to health dept on 11/12/15 and received MMR in right subcutaneous. MOC stated she wanted to only do one vaccine at a time. Child then seen at primary MD provider on 11/13/15 and received HBV, HAV, Dtap and IPV. The site of vaccination was not indicated on IZ record. Child began having symptoms on 11/15/15 of pain and swelling on upper left arm. On 11/16/16, child awoke with full hives/blisters. MOC took child to PCP, was prescribed Benadryl and Prednisone. MOC took child to ER to get second opinion. She stated she was told that it was a vaccine reaction, but MOC could not remember which vaccine they stated could have been the cause. Patient was prescribed Benadryl and Prednisone. Mother discontinued medication on 11/18/15 with the result that the rash recurred, looking like "mosquito bites". Mother then began administering medication again. Child did not have a fever at any time during these events.
She says it's an aching, constant pain as if someone is punching you in the arm./Arm pain/(Arm pain) So bad I can't even sleep in my bed; The pain is in left arm from shoulder to elbow and into back.; My wife has severe arm pain where she got the shot. It really hurts her bad.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She says it's an aching, constant pain as if someone is punching you in the arm./Arm pain/(Arm pain) So bad I can't even sleep in my bed), VACCINATION SITE PAIN (My wife has severe arm pain where she got the shot. It really hurts her bad.) and ARTHRALGIA (The pain is in left arm from shoulder to elbow and into back.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (My wife has severe arm pain where she got the shot. It really hurts her bad.). On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (She says it's an aching, constant pain as if someone is punching you in the arm./Arm pain/(Arm pain) So bad I can't even sleep in my bed) and ARTHRALGIA (The pain is in left arm from shoulder to elbow and into back.). At the time of the report, PAIN IN EXTREMITY (She says it's an aching, constant pain as if someone is punching you in the arm./Arm pain/(Arm pain) So bad I can't even sleep in my bed), VACCINATION SITE PAIN (My wife has severe arm pain where she got the shot. It really hurts her bad.) and ARTHRALGIA (The pain is in left arm from shoulder to elbow and into back.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The consumer is taking ibuprofen, Tylenol, and has applied Bengay as advised by their HCP to try to alleviate the symptoms. On 11-Apr-2021, the patient experienced second episode of arm pain and she could barely raise her arm and was barely better by Monday (12-Apr-2021). She can't even sleep on her bed due to the pain.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up information includes therapy details were added. Event (Pain in extremity) verbatim and outcome was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt w/ allergies to shrimp.  Pt w/hx of fainting when getting vaccinated.  Pt c/o blurry vision, dizziness.  BP 94/49, HR 60, RR 18.  Pt A&Ox4. VS Stable. Cleared to go home by NP.  Recommended pt to get second dose while lying down.  Pt stable and released from the vaccination site.