chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; slept all day the day after dose; This is a spontaneous report from a contactable consumer. This consumer reported for a 73-Year-old female patient that who received bnt162b2 (BNT162B2) solution for injection, dose 2 (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 73-years-old) as dose 1 single for covid-19 immunisation. Medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Chills and slept all day the day after dose (but no fever), age: 73, date of birth: provided, slept all day the day after dose. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: numbness and tingling in hands
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 27Aug2021 (Lot number: FD8448) at the age of 38 years as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset Aug2021, outcome "recovering", described as "ringing in ears". Additional information: It was reported that, a couple of days probably 2-4 days after she developed ringing in her ears during the day. It was changing pitches. It would happen at night too. It gradually became less often. It was no longer during the day, but she still had it every night. When she would lie down the pitches would change. Now, when she wakes up in the middle of the night she can hear it. This has been four months now and the ringing was still occurring. It does happen less often, but the intensity hasn't changed. So it has improved some because it was less often, but it doesn't appear that was going to go away. She did not get the second vaccine because she was afraid of hearing loss because of this. She was trying to avoid the doctor. She has read it can cause hearing loss. She has also read there isn't much doctors can do for it. It was potentially long lasting. That was why she wants it reported so others will know. No history of all previous immunization. No additional vaccines administered on same date of the Pfizer Suspect. AE(s) not resulted to emergency room and physician office visit. No prior Vaccinations (within 4 weeks) to Covid vaccine. No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 6 month old female patient with asthma, hip dysplasia and no drug reactions/allergies, who on 17-DEC-2009 and 17-FEB-2010 was vaccinated with the first and second dose of PEDVAXHIB respectively. Concomitant therapy included albuterol. On 04-APR-2010 the patient was seen in the emergency room through 05-APR-2010. Blood cultures and spinal tap were performed at the emergency room, both were positive for Haemophilus. In the evening of 05-APR-2010, the patient was transferred to a hospital when was admitted to the pediatric intensive care unit. The physician did mention the child's father reported that his other daughter had meningitis that required a shunt to be placed. The timing as to when the patient's sibling had meningitis was unknown. At the time of the report the patient had not recovered. Follow up information was received via a telephone call, from a registered nurse who reported that on 17-DEC-2009, the patient was administered the first dose of PEDVAXHIB (lot # 657705/1438U). On 17-FEB-2010, the patient received the second dose of PEDVAXHIB (lot # 664098/1292Y). On the same day, the patient was vaccinated with the second dose of ROTATEQ (lot # 664688/1182Y). Concomitant vaccine included PEDIARIX (lot# AC21B19288). The registered nurse stated that the patient's discharge summary from the medical center included the following laboratory test results: Blood culture, positive for Haemophilus influenzae, Cerebrospinal fluid (CSF) results, positive for Haemophilus influenzae and Critical results: Gram-Negative Coccobacilli. The registered nurse stated that there was no diagnosis reflected in the Discharge summary. Additional information has been requested.
Tied & in bed by 6pm that same evening. Second day concussion, third day, throwing up, not feeling well at all. Called on call nurse twice in this 3 day period & they said to go to ER within an hour. She had an underlying UTI hospital said & her body was working ?overtime? with vaccine & UTI. Still was sick for another 2-3 weeks. Took to dr several times to check. Second vaccine - tired, body aches. Has slept much, much more since vaccine. Seems confused & just not THE SAME!  Went to hospital 6/3/21 by ambulance because she wasn?t feeling well - throwing up yellow bile, extremely clammy (sweating), confused, bp when ambulance got to her, 89/60. ER can every test - urine, blood, cat scan, stroke, heart attack. NOTHING. Came back all normal. A mystery. This is 5 months since first vaccine.
Information has been received from a physician concerning a 20 week old male who on 14-OCT-2008 was vaccinated with the first dose of ROTATEQ. The physician reported that there were no adverse symptoms noted. The patient sought medical attention in the office. A product quality complaint was not involved. Additional information has been requested.
Urticaria - tx: BENADRYL & po steroids cough & cold.
The patient wasa given the influenza vaccine in the left deltoid muscle upon admission.  The patient developed an inflammatory reaaction at the site.
Arthritic reactions. Have had my uric acid and blood checked for RA. My symtoms were/still are severe swelling and numbness in my extremities. Just above the wrists to tingling in my fingers with swelling and crippling and swelling and pain in my feet and toes. Swelling from my ankles to my toes. I've had exams, xrays, Dr visits, etc... I still can't open things, but swelling and what appears to be cycts in both hands from what might be ganglion cysts and crippling fingers. This is very frustrating and painful. It has taken almost 3 months and large doses of steroids, scary as I have CHF. I did NOT take my second shot as the reaction from the first shot to severe. The Orthopedic doctor said that he has.
Patient received J&J vaccine on 6/4/21. Admitted at Hospital for breakthrough COVID infection since 7/8/21. Completed remdesivir; currently on methylprednisolone BID and HFNC. PMH of RA being treated with hydroxychloroquine. Currently in ICU. BMI of 41.
About an hour after receiving my initial shot, started having a constant headache, nausea, and fatigue.  The nausea would vary in intensity but headache and feeling of fatigue remained no matter what I was doing. Attempted to go into office for work but could not concentrate due to headache & nausea. Had to telework. Went on planned trip 11/5/2021 but headache continued, was nauseous, and nearly fell asleep during event due to fatigue. Could not drive.  Nausea and headache intensified into migraine like levels on 11/8/2021.  Prescription migraine meds were not able to relieve symptoms. Attempted to go into work 11/9/2021 and 11/10/2021 but had to go home when overcome by nausea and headache. Additional migraine medications did not give relief. Symptoms were not improving so went to see doctor 11/11/2021. Flu and covid tests were negative. Was dehydrated so had to receive IV fluids and anti nausea medications.  Dr said to increase fluids and rest.  Dr did notice mild constipation in xray and suggested Miralax.  I cannot take Miralax because it causes me intense nausea, headache, and stomach pain. She suggested magnesium citrate instead.  Nausea and headache have continued although they are more mild. Still feel fatigued, tire easily.
Moderna Bivalent Booster 0.25mcg was given, patient was to receive 0.5mcg. Wrong dose given.
Burning and severe itching in genital area.  Used 180mb Benadryl.  PCP is prescribing  a ingested medication and genital cream application.
Approximately 10 minutes post vaccination patient complained of feeling light headed, patient felt clamy and cold. Pt also complained of blurry vision and dizziness . BP taken 80/52 leaft arm sitting HR 92. Unable to obtain O2 sat at that time. Medical triage called.
Inflammation of lining of heart and lungs. Sinus tach, abnormal ekg. Liver levels elevated
This spontaneous report was received from a nurse regarding an approximately 66 year old male patient. There was no information on pertinent medical history and drug reactions or allergies. On 21-AUG-2014, the patient was vaccinated with PNEUMOVAX 23 Product lot # J015868, Expiry date: 25-FEB-2015, dose 1.5 ml (milliliter), intramuscularly in the right arm (reported as right delt). The nurse stated that she inadvertently drew up 1.5 ml of PNEUMOVAX 23 from multi dose vial and administrated to patient on 21-AUG-2014. No adverse effects reported at this time. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Pain lasting more than 48 hours after vaccination. I examined the patient to see where the vaccination was given. It is possible that the vaccination was given too high on the arm and was injected too close to the acromion. I advised patient that if symptoms do not resolve after 5-7 days then consult with PCP.
Area hot swollen and firm to touch per pt and mother-red on arm after vaccination went to camp and noted area on arm. Came to clinic and seen by provider given script for CEPHALEXIN, LORADINE, Ibuprofen.
Within 24 hours of dose, patient experienced headache (which lasted several days and was not relieved by any ibuprofen or APAP), fever, chills, body aches, "stiffness", mouth swelling, vomiting, raised and red at injection site for approximately 2 weeks; Within "a few hours" of second dose, she had headache, fever/chills, body aches, sore joints and muscles, raised and red at injection site, she claims after the second dose the symptoms only lasted a few days.
Patient reports shoulder pain and decreased range of motion the next day after vaccine administration.  Patient was seen by urgent care 1 week later and had an x-ray done which was negative.  MRI done in December 2021 which found mild bone marrow  edema at the humeral head.  Patient was treated with steroids and physical therapy.
Flu vaccine admin 3-1-13 Rt delt per new hire protocol. Evening following vac. admin pt began feeling tired, developed chills, Rt arm increasing painful, red, swollen over weekend. Temp 101. plus Sun. 3/3/13. Three irregular, red, swollen, tender patches Rt upper arm.
hip fracture; atrial fib; could not communicate; everything the patient's wife touched he said "ouch"; rigors or chills; he was limp; loss the use of his legs; convulsion; Still not eating and confused; Still not eating and confused; This is a spontaneous report from a contactable consumer (patient's wife) medical information team.  A male patient of an unspecified age (reported as 90, no units provided) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 24Feb2021 at a single dose for COVID-19 immunisation. Medical history included dialysis receiving dialysis 3x/week; and walker (walking aid user). Concomitant medications were not reported. The patient received his second Pfizer vaccine dose on 24Feb2021. When the patient came home Thursday morning (25Feb2021) from dialysis, he was limp, loss the use of his legs, could not communicate, everything the patient's wife touched he said "ouch". They had to push the patient around on his walker. Her son was helping the patient in the bathroom and he called out and thought the patient was having a convulsion, although she thought it may be rigors or chills. The patient was brought back to the recliner and took his vital signs and he was in atrial fib. The MD was called and medicated him. On Friday (26Feb2021), he was not doing so well, his nephrologist was called and was told to watch him for another day. The patient was admitted to the hospital on Saturday (27Feb2021). The patient was still not eating and confused and he has been diagnosed with a hip fracture. The patient's wife wanted to know if other people had these kinds of side effects. The patient has not recovered from "still not eating and confused". The outcome of the remaining events was unknown.
It was flu-like symptoms for me. I had more congestion, sneezing and sore throat. It lasted about a day.
11-year old child was administered first dose of Pfizer, at time of vaccine administration and after monitoring the patient was not in acute distress.
Swelling and redness at site of injection (R) deltoid; "Zoster-like" rash on left upper back area, itching and B/L eye irritation.
Patient present to ED with vomiting and diarrhea. She was initially suspected to have gastroeneteritis but then began to have bilious emesis and bloody stools in the ED. She was diagnosed via KUB and ultrasound with an intussusception. It was reduced with an air enema.
Patient was given a flu vaccine. After 5 min. she returned to the pharmacy, in her mom's arms looking pale and not feeling well. 911 was called and mom sat with patient in her arms until paramedics arrived and took over 5 min. later. Pt was given oxygen and began feeling better. Walked out of pharmacy on own 10 min later.
This spontaneous report was received from a nurse practitioner and refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-SEP-2018, the patient was vaccinated with an expired dose of ROTATEQ lot # N000175, expiration date 20-SEP-2018, orally (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
pt devel redness rt thigh & rt side on trunk; 3-4 hrs p/inject; also had inconsolable crying lasting 2 1/2 hrs; redness dec p/15 hrs;
Headache, Myalgia, Fever, Rash, inj site pain/discomfort/swelling/itchy; fever, chills, headache, myalgia, fatigue x5 days Narrative:
Pt recvd Engerix-B on 26SEP91 & 28OCT91 & pt exp no adverse events following the first vax but the day following 2nd vax 29OCT91 pt devel dizziness; pt treated in ER w/Antivert; dizziness resolved by 3NOV91;
(R) leg at site of injection on day after vaccines with erythema, then child with fever. 2 d later in clinic with temp 101 and erythema, swelling about 8cm and then with central ecchymosis about 4 cm.
Pt became non-responsive, very dizzy and vision disturbances, never passed out, sat pt on floor, 911 responded took vitals, pt was escorted home by mother.
Redness of injection site (about 1.5 inches radius). Headache. Dizziness. Soreness of arm.
Narrative:  73yo male died at home in hospice care on 1/1/22 from lung cancer. Pt had received covid vaccines on 3/26/21 & 4/29/21. This death is not related to the covid vaccines.
FLU-LIKE SYMPTOMS; FEELING SICK; FATIGUE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol drinker, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy (anaphylactic reaction) when treated with macrogol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the patient experienced flu-like symptoms. On 12-MAR-2021, the patient experienced feeling sick. On 12-MAR-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, feeling sick, and fatigue on 15-MAR-2021. This report was non-serious.
The patient complained of pain at the injection site; MMR II was administered via the intramuscular route; This spontaneous report as received from a pharmacist refers to a 71-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot number and expiration date were not provided), diluted in sterile diluent (DILUENT MRK INJ) (dose, lot number and expiration date were not provided), intramuscularly, for prophylaxis. On an unknown date, the patient complained of pain at the injection site. The outcome of injection site pain was unknown.  The relatedness between the event of injection site pain and suspect therapies was not provided.
On Saturday 3/20 I experienced the usual symptoms that were noted. On Monday 3/22 I began to get very dizzy with a heart rate of 150bpm. My blood pressure went up to 210/138 which is extremely abnormal for me. I began to tremor uncontrollably. I thought it was an anxiety attack so I took my Xanax. .50mg. That did not work at all. I experienced nausea and stomach pain. I called 911 and was taken to the hospital where after 4 hours I started feeling better. Tuesday I continued to have tremors. Wednesday the rapid heart rate, stomach pain, and nausea returned. The rest of the week did not get any better. On Saturday 3/27 I slept all day long which again is not normal for me at all. At this point we are 1 full week into the vaccine administration. On Sunday 3/28 I bagan to have the same feeling as the prior Tuesday. Sweating, couldn't breath, heart rate hit 170 this time. BP was the same, tremors, stomach pain, nausea, dizzyness, and this time my Carbon Dioxide level dropped to 24. This morning 3/29 I woke up with extreme tremors. No dizzyness.
No AE; administration of expired vaccine; This spontaneous report was received from a medical assistant and refers to an 18-year-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-NOV-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #T013724, expiration date: 21-APR-2022, therapy type rHA, administered for prophylaxis (strength and route of administration were not provided) (expired product administered).  No additional adverse event was reported.
I had a headache and a sore arm after the injection for one day.   A week later I developed a rash with swelling and heat on my left arm around the vaccine injection site.  It took six days for the reaction to resolve.  Local allergic reaction reported to allergist.
Redness at injection site about the size of an orange, site is hot, itchy, and hard knot present.
Patient reported 102 degrees fever starting the day of vaccination that lasted about 3 days and resolved on its own.  Reported red knot at injection site starting the day of vaccination, still ongoing but getting better. Patient reported rash on upper lip that extends up to his nostrils that started 2 days after vaccination. Patient received treatment from dermatologist. Dermatologist told patient she believed rash was caused by vaccine and prescribed treatment. Patient reported rash is getting better with treatment and starting to dry up.
8:46: Rt deltoid started  itching, 25 mg Benadryl PO Given, Then pt left to go to work did not continue observation
Mother noted 1/2 dollar sized lump on 01/24/2004.  Sore when touched no fever.  Today red area size of orange, not sore to touch, no fever.  Prescribed Tylenol every 4 hours on 01/24-01/25, no today.
Rash began 19JAN, red raised, itching, tiny bumps; has continued & worsened through 23JAN92; started on legs & is spreading; No rash or itching around inject site;
pt developed a lump / itchy rash on her abdomen day after administration. fatigue, low grade fever. treatment has been rest and OTC hydrocortisone cream for the itching.
This spontaneous report was received from a nurse via physician regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reaction and allergies were unknown. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ (strength, dose, frequency, route not reported) lot # R016791 and expiry date 16-APR-2020 for prophylaxis. The vaccine underwent temperature excursion of 47 degree Fahrenheit (F) /9 degree Celsius (52F) for 3 hours and 25 minutes. Previously no temperature excursion was reported. The call was due to digital data logger. No adverse symptoms reported (no adverse event). Product quality complaint was not involved.
Shortly after the injection the patient lost consciousness and fell off the chair hitting the right side of her head. She woke up after a few seconds and became incontinent. Mother reported that she has this problem when she gets an injection, however Pt has never had a reaction before. Pt stated that she feels fine and mother stated that she did not want any further medical attention.
This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient experienced Myalgia after receiving SHINGRIX vaccine. The health care professional reported that the patient did not want to receive the second dose of SHINGRIX due to adverse effects from first dose. This question was sent in to health care professional by the patient. The health care professional did not receive any patient, vaccine or adverse event details except the adverse event myalgia. The patient wanted to know effectiveness of only one dose of SHINGRIX.
pain in the arm; fatigue; muscle pain, calf and arms; Cramping/burning in calves; Cramping/burning in calves; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unknown date, at single dose, for covid-19 immunisation. The patient medical history included hypothyroid. Concomitant medication was not reported. On an unknown date, next day after vaccination patient experienced pain in the arm, two days after on friday afternoon patient had fatigue muscle pain in calf and arms which came and went off and on and had cramping/burning in calves. Treating with Motrin. Reached out to health care professinal, asked if need to get the second dose. The outcome of all the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arm ache started almost immediately after injection. Was more severe 3 hours later. Headache and muscle aches with stiffness started 12 hours later.