chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a laboratory technician concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VARIVAX (lot #: M005972 with expiration date: 02-FEB-2017) (dose, strenght, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 6°F but less than 14°F for 15 minutes (no digital data logger involved) without any previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006906:
pt recvd vax 28APR92 & exp hives; pt seen by MD told not to worry but no visit on med record;
Could not sleep; Does not feel right; Received second dose 8 weeks after the first one; Headache; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), MALAISE (Does not feel right), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 weeks after the first one), HEADACHE (Headache) and PYREXIA (Slight fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Could not sleep), MALAISE (Does not feel right), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 weeks after the first one), HEADACHE (Headache) and PYREXIA (Slight fever). At the time of the report, INSOMNIA (Could not sleep), MALAISE (Does not feel right), HEADACHE (Headache) and PYREXIA (Slight fever) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 weeks after the first one) had resolved.            No concomitant medications reported. Treatment information not reported.
Cellulitis of upper Left Arm--Measured about 20cm in length and 18cm round--Given Septra antibiotic for 7 days--Patient did not return for follow up appointment and did not answer or return any phone calls when message was left on home phone.
By 6pm the day of the shot I had a fever of 100.4. The highest fever I recorded over the weekend was 101.4. Cold sweats, weakness, loss of appetite.  It is now 1/10/2022, 7:50 AM and my fever is still 100.6
KINRIX given on 10/11/10 during well child exam in (L) thigh in PM. Developed 8 cm x 17 cm area of erythema/induration 2 days later. Treated with TYL/MOTRIN and ice. No systemic s/s.
LEFT SIDE OF BODY COMPLETELY NUMB, TINGLING, BURNING SENSATION.  LEFT UPPER ARM TO FINGERTIPS WERE LIKE THIS FOR ABOUT 3 MONTHS AND THEN IT WENT AWAY.  I STILL HAVE THIS BURNING AND AWFUL PAIN IN MY LOWER LEFT CALF WHICH ALSO RADIATES TO THE SHIN.  I CANNOT SLEEP AT NIGHT BECAUSE OF THE INTOLERABLE PAIN. I WAKE UP EVERY MORNING, SAYING I WANT TO JUST CUT MY LEG OFF, THATS HOW UNBEARABLE THIS HAS BEEN SINCE JANUARY.  I CANNOT TAKE THE PAIN AND SLEEPLESS NIGHTS ANYMORE!  PLEASE HELP!!!
Pt recvd 2 doses of Engerix-B & 14AUG92 the day p/recvd 2nd dose of vax pt devel rash;
Skin surface redness/pain to touch Large red raised rash (no bumps) stretching across left shoulder blade covering more than 1/4 of back Low-grade fever 99.2 Fatigue
Swelling and redness within hours of injection. Circumferential 10x15 cm region near injection site.
I had a lot of pressure on the left side of my chest. I stopped doing my resistance training and laid on the mat and it went away. I went to the doctor, and he did an EKG, and it didn't show anything. All my vitals were normal. They also did a test that showed increased pulmonary vascularity. They did Troponin test, and those results were high. Everything else was normal. I have to go in for a follow up Monday to do a stress test and then an Echo test Wednesday. I was advised not to do any vigorous exercises.
running nose, throat irritation from Friday 8OCT95 till 10OCT95 never had temp
No noted reaction  on 10/04 0655 I saw employee getting on elevator and asked how she did with the booster  "just a sore arm is all"  Employee signed up for Covid Pfizer  Booster vaccination- had Moderna vaccines x 2 doses . She sent me an text on 10/06 that " she she received moderna dose originally and received a phizer dose for booster. I just received an email that states they are not supposed to be given together.   I asked her why she signed up for the Pfizer booster if she knew she received Moderna " I wanted the booster so just signed up, im breastfeeding, had children and work in the ER"
Soreness at injection site; fatigue; headache; body aches; This is a spontaneous report from a contactable consumer (patient herself).  A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 09:00 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE (age at vaccination was 22 years old) for covid-19 immunisation at a Workplace clinic. The patient medical history was not reported. Concomitant medication(s) included birth control, loratadine, ibuprofen and paracetamol (TYLENOL), all taken for an unspecified indication, start and stop dates were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 at 09:00 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE. No other vaccine was administered to the patient in four weeks. She was not tested for covid prior to vaccination and post vaccination. On 17Feb2021, at 07:00 hrs, the patient experienced soreness at injection site, fatigue, headache and body aches. No treatment was received by the patient. At the time of this report, the outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 25-SEP-2014 the patient was vaccinated with improperly stored VARIVAX (Merck) (dose and lot # not reported). No adverse effects reported. Additional information has been requested.
Started running fever at around 1am, took Advil(ibuprofen) fever went away around 3am, returned at 730am. Taking Tylenol now. Fever, chills,  and body aches.
Patient reports day after, soreness in arm, neck pain  fever (although when went to see md-md confirmed no fever), sick. Patient also did come into the pharmacy to pick up an antiviral on 10-15-17 to treat something seen in the walk in-  so what ever they may be treating may be the cause.
MOC REPORTS THAT CHILD HAD A TEMPERATURE OF 101.3, DIZZINES, SENSITIVITY TO LEFT ARM.  MOTHER GAVE TYLENOL EVERY 4 HOURS AND COOL BATH.
CHILLS; FEVER (A LITTLE TEMPERATURE); LIGHTHEADED/ DIZZY; SLEEPY; FELL AGAINST THE WALL; SORE ARM; TIRED; This spontaneous report received from a patient via company representative on 10-NOV-2021 concerned a 52 years old female. The patient's height, and weight were not reported. The patient's past medical history included: previous fall, and concurrent conditions included: epilepsy, and shoulder dislocation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021 (one day after vaccination), the patient had a sore arm and felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the events of sore arm and felt tired was not reported. Additionally the patient received non-company suspect vaccine included: bnt 162 ( form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 04-NOV-2021 14:15 for prophylactic vaccination as booster dose. On 04-NOV-2021, the patient experienced lightheaded/ dizzy and fell against a wall and was also feeling sluggish/tired and sleepy. On 05-NOV-2021, the patient experienced chills and fever (a little temperature). Laboratory data included: Body temperature (NR: not provided).  The action taken with bnt 162 was not applicable. The patient was recovering from chills, and fever (a little temperature), and the outcome for the events of tired, lightheaded/dizzy, sleepy and fell against a wall was not reported. This report was non-serious.
I have not regained all the feeling in my left arm. I can feel all sensations on the top of my arm only. If I touch the under part of my arm all the sensation is not their, and it is gradually getting worse. The numb sensation or lack of feeling has started to travel up my arm and to my left hand.
Right ear itching; Ear burning; Skin started to crack; It was the weirdest thing; Ear burning and very hot; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer reported for herself that: A female patient of an unspecified age received first dose of BNT162B2 (PFIZER COVID 19 VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history included autoimmune disorder from an unknown date and unknown if ongoing Verbatim: auto-immune disorder. The patient's concomitant medications were not reported. The patient experienced right ear itching, ear burning, skin started to crack, it was the weirdest thing, ear burning and very hot on an unspecified date. NDC number of COVID vaccine was not provided. It was unknown that reporter was a Healthcare Professional or the prescribing HCP. No medical questions addressed by this program forwarded/referred to Medical Information. Query was raised to confirm the correct CEP ID and correct CEP id was provided. The outcome for all the events was recovered except for the event ear burning and very hot it was unknown.  Information on the lot/batch number has been requested.
Information has been received from a physician concerning a patient who on unspecified dates in the past was vaccinated with two doses of VARIVAX (Merck). Subsequently, the patient developed varicella. At the time of the report, the patient's outcome was unknown. No further information is available.
Pts. stated he received the Flu shot to high in his arm, and now he can not raise his right arm above his elbow. The Pt came into the pharmacy on 10/22/2018 after receiving the vaccination on 09/25/2018 to report the event to us.
Pregnancy history: 27 weeks at time of injection, history of a significant subchorionic hematoma at 12.5 weeks, vaginal bleeding at that time. Two more episodes of light spotting (dark in color) over the next week and a half. Then no more vaginal bleeding. Growth ultrasound showed no concerns other than healing SCH, nothing indicated for follow up or concern.  Date of delivery: 4/7/21. No birth weight yet, still pregnant. Baby was measuring at 25th percentile for weight at 20 week ultrasound.  Adverse events: strong, shooting pains felt in area of cervix extending upward. Irregular (every hour or half hour) increasing in frequency (around 6:00 I had four within ten minutes). Throughout the day after getting my vaccine I purposefully stated physically low key. No exercise or long walking etc. At 6:00 when the pains came more frequently I stopped reading to my daughter and laid down, drank more water, electrolytes, took a topical progesterone 90mg vaginally, two more acetaminophen (had taken 2 of these 20 minutes after injection) and napped. Next morning uterus/cervix felt tender with some cramping especially when lifting and holding leg up (to put pant leg on). Did not go to work, laid down most of the day. By end of day feeling less tender.
p/vax given pt became limp, vomited, became pale w/grey lips, thready pulses, BP 76 systolic-taken to ER where did not improve w/in 5min;
o Altered mental status characterized by confusion likely due to dehydration in the setting of COVID-19 o Toxic metabolic encephalopathy secondary to above o Acute hypoxia secondary to COVID-19 pneumonia
Large area (5cmx7cm) of redness, blistery pimples overlying tender indurated soft tissue swelling at site of injection. Note: same thing happened last year, but milder.
Shot administered in arm at 9:15am CDT.  At 7:00 pm, noticed welts with redness and swelling on the back of both legs, slightly elevated temperature, and slightly altered state (she was clingy and whiny).  Administered 5cc benedryl at 7pm and again at 1am.  This morning she appears to be much better.  The redness is mostly gone, and she is acting much better.
11/23/16: seen in urgent care for bilateral ear pain and sore throat. Denied any other complaints. Strep test neg. Dx w pharyngitis.  12/5: seen in urgent care for numbness and tingling in hands and feet and weakness in all extremities x 3 days. Also c/o current HA. Exam: normal gross motor strength in all extremities. Gait unsteady. No patellar Achilles or UE reflexes. MD discussed w/ neurologist who recommended admission to hospital to r/o Guillain-Barre. Same day consult by Neurology: presents w/ tingling sensation x 1 week and difficulty walking x 5 days. Onset following febrile flu-like illness. Areflexic in bilateral upper and lower extremities. Plan for LP, nerve conduction studies and imaging. Same day LP performed. CSF cell count and protein WNL, culture neg. Per neurologist: "CSF results negative for Guillain-Barre". Suspect "some element of inflammatory polyradiculoneuropathy. The question is whether this is acute or subacute". MRI brain and C-spine WNL. Nerve conduction studies performed. "The findings although not consistent w a / Guillain-Barre like syndrome, cannot totally exclude that possibility and clinical correlation is required". 12/7: Per neurologist: continues to decline. Given lack of any other explanation, 5 days of IVIG treatment started per neurology based on clinical grounds. PT and OT initiated.  12/9: LE weakness significantly improved, much more ambulatory. 12/12: Minimal weakness, less unsteadiness, less numbness and tingling. Neurologist dx: "likely an acute /subacute progressive neuropathy very suggestive of a Guillain-Barre like syndrome". Pt recovered well. Discharged home w/ PT and OT. As of 12/27, cleared to drive by PT and neurologist. Continues to see PT and OT.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL9263), in left arm, on 14Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 14Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Mar2022 as dose 4 (booster), single (Lot number: EY0584) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received treatment of Paxlovid for COVID-19 from 11Jul2022 to 15Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was pale and had a difficulty breathing, warm to touch after 3-5 minutes after vaccine was given. spasms of legs, fingers curled up soon after as well. ems was called and took pulse and blood pressure. All appeared normal. patient refused to go to ER for further monitoring. she stood up with no problem. She will monitored at home.
shortness of breath which is been ongoing for the last several days.  His symptoms have progressively worsened over that time.  He was seen here in the ED 5 days ago and had a neb treatment for COPD, he had a positive D-dimer and negative CT angiogram of the chest for PE.  He was discharged home on Azithromycin and prednisone for AECOPD.  His symptoms unfortunately continued to worsen with increased cough and shortness of breath no fever, chills, sore throat, nausea, vomiting or diarrhea.  He came back to the ED today for evaluation since he was feeling worse.  Patient has a history of lung cancer on the right status post pneumonectomy in 2013.  On initial eval in the ED he was noted to have  bilateral rhonchi on the left greater than right and received neb treatments and Solu-Medrol 125 IV push.  His symptoms did improve somewhat.  ED staff checked a COVID 19, despite confirming his second Pfizer vaccine was received on 3/21/2021, and it came back positive.  Procalcitonin was negative.  He clearly has an exacerbation of his COPD but with the COVID 19 positivity, the ED staff was concerned with his comorbidities that his prognosis is poor in the face of progression of symptoms.  I was contacted and agreed to admit him for Remdesivir therapy, supplemental O2, dexamethasone and supportive care.
two year old patient inadvertently received a dose of Kinrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 07-OCT-2024) for prophylaxis.   On 14-AUG-2023, the patient received Kinrix. On 14-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: two year old patient inadvertently received a dose of Kinrix.). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 15-AUG-2023 The reporter reported that patient inadvertently received a dose of Kinrix. The reporter did consent to follow up. At the time of reporting, Kinrix was given to a 2 years old patient, which led to inappropriate age at vaccine administration.
Pt. received AFLURIA.  Minutes later she passed out in aisle of our store. She was very pale. Came back to rx and we gave her candy and H2O. She hadn't eaten since noon. Vaccine given at 8:10 pm. Passed out at 8:13 pm. Her BP and BS were normal. She was weak but better shortly after events.
8 hours after vaccine terrible chills, and cold, stomach ache 12 hours after vaccine had 104.7 temp. 24 hours still was dealing with 104.7 temp - showers and cold compress with tylenol would bring it down, but would spike back up 36 hours temp of 101
Patient checked in by RN al 1100, screening questions asked, patient stated no allergies and does not carry an epi pen. Patient states no previous reaction to the two Pfizer doses, states only had a sore arm. Patient vaccinated at 1105 by RN. Patient screening questions asked and verbalized hx of sulfa allergy, has anaphylactic reaction. 1106 patient proceeded to triage area in vehicle. RN asked screening questions to patient and patient declined having any previous reactions to Pfizer vaccines. Patient given instructions to wait for 15 minutes to make sure patient does not have any reactions and to honk if she needed any assistance. Patient honked horn at 1116, RN and Site Manager approached car, patient was visibly loosing consciousness, was pale, diaphoretic, and shaking. 1116 shaking time occurred for 20 seconds, timed by RN. 1117  called 911 for EMS services. RN at scene obtaining VS and assessing patient. 1117 sternal rub was preformed by RN. 1118 patient started to regain consciousness, remains pale and lethargic. 1118 VS BP:153/62 R:22 02:100 HR:99, denies pain. 1119 patient conscious alert and oriented x4. Patient states no previous hx of seizures, diabetes or other pertinent medical hx. Patient states hypothyroidism and takes Synthroid. Patient states phobia of injections and having past out previously from injections. 1121 BP: 121/70 P:78 O2:98% R:22 T: 98.4F, denies pain, patient alert and oriented x4, regaining color, patient aware of EMS en route, declining to go to ED but agreeable to be assessed. 1124 BP:129/71 HR 77 O2: 99% RR: 18, VSS. Patient remains alert and oriented x4, denies any difficulty breathing or pain. 1130 EMS on site, report given to EMS, EMS performs assessment of patient, patient offered to be transported to ED, patient declines and signed declination form. 1140 Site Manager strongly encouraged patient to wait and be observed for a longer period of time, patient declined and left via private vehicle.
15 hours after injection, sore arm developed, followed soon thereafter with nausea, low-grade fever and quite rigorous chills that persisted for about 4 hours.   After chills subsided, nausea, headache, myalgia, arthralgia, malaise, loss of appetite and abdominal tenderness began that persisted through the following day.  No loss of smell or taste.  No vomiting.  No shortness of breath.
received her first dose of the COVID-19/now testing positive; received her first dose of the COVID-19/now testing positive; This is a spontaneous report from a contactable other HCP.   A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date after vaccination, the patient was now testing positive for Covid-19 at the hospital she works at regularly. She was not sure what test she had done, i.e. antibody or virus. The outcome of events was unknown.   Information about batch/lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Diarrhea for 3 weeks, 4 times a day,  blowouts, very watery
Warm, itchy, swollen red lump on deltoid, below injection site.  -  Patient went to urgent care because her primary care doctor's office was closed at the time. She was advised to take Benadryl and apply hydrocortisone to the site of injury. No antibiotics were prescribed.
Moderna 5/10/21, 6/7/21, 9/16/21. Positive on 12/21/22
Client felt chilled fri evening about 7pm. Saturday had diarrhea and fever of 101. Also chills, sweating, stomache cramps and low back pain. All symptoms subsided in one day except fever of about 101 which persists today ( 10-28-05)
This spontaneous report as received from a nurse practitioner and refers to a patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 29-MAY-2009, the patient was vaccinated with improperly stored VARIVAX lot # 663710/0219Y dose number 2. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
vaccine received 4-9-2018 fever to 102 afternoon of 4-10-2018. Large local reaction, redness 3-4 cm. Slight swelling and pain. Fever up to 104 am of 2-11-2018.