chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick, in bed/ in the bed for 5 or 6 days, kind of nasty), PAIN (after all the vaccines she was in pain) and BLOOD PRESSURE INCREASED (180/ something big blood pressure) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 012220A) for COVID-19 prophylaxis. Concurrent medical conditions included Thyroid disorder NOS (Thyroid), Night terrors, Dry eyes, Anxiety, Pollen allergy (outdoor allergies pollen) and Allergy to plants (Pine trees). Concomitant products included CETIRIZINE for Allergy NOS, SERTRALINE for Anxiety, CICLOSPORIN (RESTASIS) for Dry eyes, LEVOTHYROXINE, ALIROCUMAB (PRALUENT), EZETIMIBE, METOPROLOL SUCCINATE, CLONAZEPAM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (Sick, in bed/ in the bed for 5 or 6 days, kind of nasty), PAIN (after all the vaccines she was in pain) and BLOOD PRESSURE INCREASED (180/ something big blood pressure). The patient was treated with APIXABAN (ELIQUIS) at a dose of 5 milligram twice a day. At the time of the report, ILLNESS (Sick, in bed/ in the bed for 5 or 6 days, kind of nasty), PAIN (after all the vaccines she was in pain) and BLOOD PRESSURE INCREASED (180/ something big blood pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 180/something big blood pressure. Concomitant medication included Fish gel pills and centrum vitamins everyday. This case was linked to MOD-2022-629219, MOD-2022-629244 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2022: Live follow up received contains non-significant information.
19 hrs post vaccination there are red, itchy bumps on body trunk, right arm that appear to be getting worse (more red, bigger bump, round) at 21 hr post vaccination. There are approximately 15 red bumps.
Patient received expired COVID vaccine that expired on 2/12/2022. The patient had no adverse symptoms reported at time of injection.
Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed.  I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS  Still having very achy joints all over my body. Diarrhea, sweats/chills
I woke up that night around 2 am, sicker than a dog. I was hot, had a headache, pain and redness at the site of injection, muscle aches and extreme fatigue. I missed work the day after. I returned to work the following Thursday. I still had a fever, but it wasn't high enough for me to stay home. Four days later, I had a horrible headache and facial pain. I thought I had a sinus infection, but via a tele visit, my doctor told me it was a side effect of the vaccine since I was still within my 7-10 days. I just took it easy the rest of the day and I was fine from then on.
9 days post injection :  noticed mild itching of slightly red, swollen patch at injection site, approximately 1.5" oval shape. Mild irritation continues.....
The patient was given the second dose of Pfizer 12 days after the first dose instead of 21 days later. The pharmacist inadvertently read the first dose date on the vaccine card as 8/2/21 instead of 8/12/21. It was later discovered when imputing the information in database that the first date was 08/12/21. The patient is feeling okay and no side effects reported on 8/24/21 or 08/25/21.
Epigastric pain, gastroesophageal reflux disease, Hiatal hernia
Information has been received from a pediatrician via medical records concerning a male baby who was born to a 17 year old mother with mild intermittent asthma. On 10-AUG-2009 the mother was vaccinated with the first doses of GARDASIL (Lot # 662300/0100Y). On 09-MAR-2010, 37.6 weeks from LMP the mother delivered a normal, healthy male baby weighing 7 pounds, the mother delivered a normal, healthy male baby weighing 7 pounds, length 19.5 inches, apgar score 9.9, head circumference 13. The mother had no complication and no infections or illnesses during pregnancy. The mother had no complication during labor/delivery. On 19-MAR-2010, the baby was brought to the pediatrician's office. It was reported that the baby weighing 7.9 pounds, length 20 inches, head circumference 14, body temperature 99.1 degree F. The baby was fed every 2-3 hours and he had been spitting up. The baby was diagnosed with mild GERD. On 14-APR-2010, the baby had a one month follow-up visit. It was reported that baby weighing 9.13 pounds, length 21 5/8 inches, head circumference 14 3/4, body temperature 97.8 degree F. The baby ate well, still spitted but not much. It was reported that the baby's left eye had been crusted ever since birth, spitting up a lot. The mother put child back on SIMILAC advance because ENFAMIL AR was causing constipation. On 21-APR-2010, the baby was brought to th pediatrician's office. The baby had cough symptoms, and stuff nose with body temperature 99.2 degree F. It was reported that the baby ate well, weighing 9.5 pounds. The baby was diagnosed with upper respiratory infection (URI). On 03-MAY-2010, the baby was brought to the pediatrician's office. The baby was weighted 11.7 pounds, body temperature was 98.8 degree F. It was reported that the baby cried for 2 days non stop and he had balls swollen. The baby was diagnosed with hydrocele, GERD and ?small hernia. On 19-MAY-2010, the baby was brought to the pediatrician's office. The baby was weighted 12.8 pounds, body temperature was 98.4 degree F. It was reported that the baby had left eye swollen, and can't open left eye in the morning. The baby was diagnosed with conjunctivitis. Left eye had been crusted ever since birth, hydrocele and ?small hernia were considered to be congenital anomalies. No further information is available. All available medical records will be provided upon request.
back as appearing to have zits and potentially shingles./shingles; left side of back became very itchy; in pain; sweat; freezing; fever; Weak; Ill; Tired; sore Arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 1st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st October 2020, 1 hr after receiving Shingrix, the patient experienced pain in arm. On 2nd October 2020, the patient experienced unwell, tiredness, fever and weakness. On 3rd October 2020, the patient experienced sweating and feeling cold. On 21st October 2020, the patient experienced shingles, pruritus and pain. The patient was treated with dermatologicals nos (Lotion) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, weakness, pruritus and pain were not recovered/not resolved and the outcome of the pain in arm, unwell, tiredness, sweating, fever and feeling cold were recovered/resolved.   It was unknown if the reporter considered the shingles, pain in arm, unwell, tiredness, sweating, fever, weakness, feeling cold, pruritus and pain to be related to Shingrix.  Additional information was provided as follows: The reporter states that have no known allergy to medications and having chickenpox as a child. The patient received the 1st dose of Shingrix and experienced sore arm an hour after vaccination and lasted for one week. The patient felt ill, weak and tired and that night developing a fever, sweat and was freezing, which was recovered recovered till the time of reporting all symptoms On 21st October 2020, the reporter stated that the left side of back became very itchy. The patient asked his wife to rub lotion on his back and his wife described his back as appearing to have zits and potentially shingles. The patient visited physician office on 22nd October 2020 and the patient was diagnosed with shingles. The patient was prescribed for antiviral medication for shingles. The patient complains of being in pain. The reporter consented to follow up.
8 days after my shot, my arm near the injection spot started to itch and turn red.  A red oval formed about 3 inches long and 2 inches wide.  It lasted about 3 days.
not feeling too bad; lower back pain/minor lower back pain; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (not feeling too bad) and BACK PAIN (lower back pain/minor lower back pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling too bad) and BACK PAIN (lower back pain/minor lower back pain). At the time of the report, MALAISE (not feeling too bad) and BACK PAIN (lower back pain/minor lower back pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.
Patient didn't bring vaccine card to 2nd dose appointment. Pharmacist asked him if it was 28 days and due for 2nd dose and patient said yes. Patient falsified information. When we typed up the vaccine information we discovered we already had a profile for him and noticed that the 1st dose was given at a different store of ours on 04/21//21 (15 days prior).  We called patient and asked how he got an appointment at our store at 15 days.  He told us his wife scheduled it.  He did not follow procedure of clicking the link to select Moderna vaccine and have our scheduler app book appt at original store on day 28.  He was under the impression he had waited the correct duration of time when we spoke to him on follow up.
Swollen glands in neck area and swollen glands under tongue. Itching of the roof of my mouth.
urticaria/itching 2 days p/vax administration; pt was treated w/Hydroxyzine & reaction improved;
After what I remember to be the 2nd round of my vaccine, I had developed extremely severe uterine cramping at random moments and endless bleeding that caused me to have to go on an IUD in order to try to manage my bleeding and the pain.   Additionally, my left arm had a sharp shooting pain down it and is still sensitive nearly 2 years later. There was an intense pain caused by it for an extraordinarily long time. I began to watch a superficial clot slowly move down my arm about a year and a half later, as well.
-4 year well check 2 days ago (6/17), received Kinrix (RD) and Proquad (LD) -R arm has been painful- now red, swollen and warm -No fevers  Skin: RUE with large area of erythema surrounding deltoid injection site, mild edema present   Physical findings demonstrated by parent/patient: area is warm, tender and mildly indurated per mom  Start Keflex. -Call for lack of improvement, spreading/streaking redness, worsening pain/swelling, or new fevers.
My left arm pit started hurting to the touch and when lifting and moving arm.  My arm pit is swollen and when pushing/feeling it when inspecting, it was very painful.  I felt little tiny nodules.  I sometimes take ibuprofen.   The pain is still ongoing.
Client had chest tightness and Shakiness 2 minutes after vaccine given..  Benadryl 25mg administered.  Client recovered to baseline within 30 minutes and released by physician to home
This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative.  A male patient received the fourth dose of PREVNAR on an unknown date.  Relevant medical history, drug history and concomitant medications or vaccines were unknown.  Vaccines taken within the last four weeks were unknown.  On an unspecified date, the patient developed staphylococcal pneumonia disease.  It was unknown if the patient was hospitalized.  In Nov2010, the patient died.  The cause of death was staphylococcal pneumonia disease.  At the time of the report, it was unknown if an autopsy was performed.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR.
This spontaneous report was received from a pharmacist and refers to a 68 year old female patient. The patient's concurrent condition include bipolar disorder, gastroesophageal reflux disease, hyperlipidemia and hypothyroidism and her medical history included bronchitis. The patient had not any drug reaction or allergies. On 22-APR-2016, the patient was vaccinated with ZOSTAVAX (lot # L039126, expiry date 18-JAN-2017 (dose, route and frequency  were not reported.); and laos with BOOSTRIX. Concomitant therapies included RISPERDAL and LAMICTAl. On the same date, since the patient received the vaccination, she experienced extreme fatigue and she "could not get out of bed". The patient visited the pharmacy, regarding the adverse events. No treatment was given an no laboratory studies were performed. No product quality complaint (PQC) was involved. At the time of reporting, the outcome of fatigue and movement disorder was reported as not recovered. The reporter did not provide a causality assessment between the events and the suspect vaccines. Additional information has been requested.
Delirious thinking; So uncomfortable couldn't sleep; Delirious thinking, loss of appetite; Loss 5 lbs after the vaccination; Headache; A spontaneous report was received from a consumer concerning a 71-year-old,male patient, who received Moderna's covid-19 vaccine(mRNA-1273) and experienced headache, couldn't sleep, delirious thinking , loss of appetite and loss of weight.   The patient's medical history included COVID-19 infection from 07 Jan 2021- 20 Jan 2021. No relevant concomitant medications were mentioned.  On 01 Feb 2021, the patient received mRNA-1273 (Batch number not provided)  in the left arm for prophylaxis of COVID-19 infection.   After the vaccination, side effects were 36 hours of headache, couldn't sleep, delirious thinking, loss of appetite for solid foods,only drank liquids, lost 5 lbs after the vaccination.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.  Outcome of the events, headache, couldn't sleep, delirious thinking, loss of appetite and loss of weight, were considered as recovered/resolved.; Reporter'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.
Patient has a bump at the injection site that has a white head with a dark red ring around the base. The patient also reports arm soreness.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Additional Details: Patient had not eaten prior to vaccine. She felt faint and naueous following her vaccine.  She vomited x 1.
Information has been received from a registered nurse concerning a 39 year old white female with no history of prior drug reactions or allergies, who was vaccinated at 13:15 on 30 JAN 2007, intramuscularly into the left deltoid with a first dose of RECOMBIVAX HB (Lot # 654018/0904F). There was no reported illness at the time of vaccination. On 30-JAN-2007 at 13:45, about one half post-vaccination, the patient broke out in hives on the left arm, but not at the injection site. At the time of reporting the patient was not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Received DTaP, IPV, Hep B/HIB left thigh. Developed a cellulitis.  Nurse follow up on 07/20/04 states: "Fever, pain, drainage at injection site, erythema, induration."
Varicella Information has been received from a health professional concerning a 36 month old female who on 09-OCT-2003 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# "C1063M"). There was no concomitant medication. It was reported that on 26-SEP-2005 the patient experienced a breakthrough case of varicella of 50 lesions or less. It was reported that the patient was recovering. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Receive vaccine at approximately 0855 at off site location. Waited 15 minutes in post vaccination waiting area and left clinic. He drove to medical  office at 0920 to report "throat swelling" on the left side that started 10 minutes post vaccination that progressed to bilateral. He reported difficulty swallowing. No respiratory distress. EMS called and he left per EMS at 0928. Attempts to contact later in the day on 3/18 not successful
PATIENT HAD A 12-13 SECOND PAUSE ON HER LOOP RECORDER AND WEAKNESS
Client reported feeling flushed shortly after being vaccinated.  Described itchy "red blotches", hives on face and chest.  Client with hx of Lupus and multiple allergies to various medications.  Client stated hives resolved after taking Benedryl.  Client with no other symptoms or complaints at this time.
Pfizer pediatric vaccine was not diluted and the dose of 0.2ml was administered to the patient.
Pain in arm lasting 5 days. Swelling in lymph nodes on the right side of my body, neck, under arm, groin lasting 6 days. Rash on stomach and left thigh still present. Whole body fatigue still present. Chest pain on and off still present.
11/13/2022 in the morning I had a sore throat, congestion, yellow drainage. I felt worse in the evening, no improvement overnight. 11/14 I went to urgent care, there they tested for Strep, Flu, and COVID-19. All negative. Prescribed an antibiotic and decongestant. 11/15 Aches and fatigue began with all the other symptoms. I fell asleep at 04:30 PM. 11/16 took an at home COVID-19 test and was positive. Reached out to my doctor that day. Doctor prescribed antibody treatment and ordered phenotype test. I tested positive on a PCR COVID-19 test. 11/16 took the antibody treatment with bebtelovimab antibodies. Fever spiked at 100. 11/18 I felt much better after. Symptoms tapered off with a slight cough, slight headache, and some fatigue now.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL on 21-DEC-2006, with the second dose on 07-MAR-2008, with the third dose on 07-JUN-2012 and with the fourth dose on 28-AUG-2012, respectively (doses, routes, lot numbers were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. Additional information has been requested.
When I went to go to sleep, I laid down as usual, but I couldn't relax. My legs felt tingly. I only slept 1 hour the entire night. Legs kept feeling like there was vibration under the skin on both legs (beginning at the hips & moving down) all night. I would get up, walk around, but the instant I would try to relax it would begin. Also, I developed muscle twitching. I could actually visually see tiny muscles jumping at various places all over my legs. ALL NIGHT (still occurring 10/18/04 - & some on my body).  Next day, felt tired, slight stomach upset. Muscles felt weak. By 10/16 night I was exhausted and slept but felt the tingling as I fell asleep.  Felt slight tingling all day when at rest. 10/17/04 Sunday - felt the tingling when at rest. Now my upper body (arms) felt weak and began to experience a slight vibrating feeling and weakness. Some tingling and twitching continued as I went to sleep tonight.  Today 10/18/04 I still feel an odd sensation over my body and some muscle twitching. Other symptoms included deep leg pain & knee pain or stiffness that began Saturday afternoon - helped w/ Ibuprofen. Buzzing, tingling throughout body. Kept me awake several nights. Then it became sporadic buzzing, tingling, pinching and worst of all constant fasciculation and parethesia. Continued symptoms to present. Symptoms occur 24 hrs a day! Some days better, some worse than others. DR has recommend that I do not get an influenza vaccine next year.
pt recv vax & exp fever,chills,nausea,h/a & low back pain;@ time of report pt had not recovered;No further details were provided;
p/vax pt devel flushing of face; difficulty breathing; tightness of muscles of face; spots before eyes; resolved p/several minutes; no tx
Pharmacist called to report that a 3rd dose of GARDASIL 9 was missed. HCP reports that the missed dose occurred on Jan. 4th, 2021, but has no information available for when the 1st or 2nd dose was delivered. HCP has limited demographics on the patien; This spontaneous report was received from a pharmacist referring to a 42-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported).         On 04-JAN-2021, the patient missed the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). There was no information available for when the 1st or 2nd dose were delivered
got shot /ended up getting shingles\ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shot and still ended up getting shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Fever. Severe joint pain and stiffness ankles, knees, wrists, blurry vision, headache lasted 24-36 hours. No medical treatment sought.