chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/10/06 Mom noticed rash on left thigh from waist. Rash looked yellow and had pus in it. Mom noticed child scratching rash - swelling and pain noticed in area. Mom noticed fever 8/11/06. Child was taken to ER room 8/10/06.
Patient stated that 3-4 days after getting the flu shot she experiences pain at the injection site. The patient also stated that within a couple days of the pain, the site developed a small blister which then left a scar. She said she was not in pain but just experienced mild discomfort. She did not seek medical attention. She just used bacitracin and soap and water to keep clean.
Fever up to 102.1; Chills/shivering; Malaise; Nausea; Dizziness; This is a spontaneous report from a contactable nurse (patient). A 32-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EK4176, expiry date not reported), intramuscular on 18Jan2021 13:15 at a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported.  The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient had first dose of COVID-19 vaccine BNT162B2 (Brand: Pfizer, Lot number: EH9899, expiry date not reported) on 30Dec2020 04:00 PM, intramuscular in the left arm. There was no other vaccine in four weeks. On 19Jan2021 12:00 AM, patient experienced fever up to 102.1 treated with Tylenol, chills, shivering, malaise, nausea, and dizziness. No treatment received in response to the events chills/shivering, malaise, nausea, and dizziness.  The patient was not tested for COVID post vaccination. The patient recovered on an unspecified date in Jan2021 from the events fever up to 102.1, chills/shivering, malaise, nausea, and dizziness.
(L) thigh - 10 cm diam red induration. Non-tender (-) fluctuance. Temp- 99.3 Cephalaxin prescribed due to initial temp 100.7 on presentation.
PT SAID ARM WAS SWOLLEN AND PAINFUL FROM SHOULDER TO ELBOW. HE WENT TO HIS PRIMARY DOCTOR NEXT MORNING AND THEY TOLD HIM TO WATCH FOR SIGNS OF INFECTION, TAKE TYLENOL AS NEEDED, AND TO REPORT TO PHARMACY SO THEY COULD REPORT.
Severe apneic and bradycardic episodes. Total of 10, requiring stimulation and 2-3 bag and mask and also increasing flow and fio2 to 2LPM and fio2 to 40%. Did CBC and Blood Culture.
30-45 minutes after flu vaccine administered broke out with rash/hives. Mother contacted husband who returned to home. Child with HR 148, irritable, T 97.2. Benadryl 0.14cc (50mg/cc) given IM RT. Symptoms resolved within 1 hour. MD at ER informed of reaction and treatment.
A non-serious spontaneous report of FLUMIST given to a pregnant female has been received from a Registered Nurse concerning a 26-year-old female. Medical history included asthma, smoking, bipolar disorder and allergies to codeine and aspirin. Obstetrical history included eight previous pregnancies (four full-term deliveries, three spontaneous abortions and one delivery of twins at 24 weeks, the twins died shortly after birth). The patient continued to smoke throughout this pregnancy. Concomitant therapy included albuterol and prenatal vitamins. The father's medical history included "borderline" retardation/was "slightly retarded'> On 02-Oct-2008, the patient received FLUMIST at a county health department. When filling out her paperwork to receive FLUMIST, she indicated that she was not pregnant. The patient's obstetrician/gynecologist contacted the reporting nurse to indicate that the patient was pregnant. Gestation at the time of exposure was 13 weeks. Last menstrual period was 13-Jun-2008 and the patient's estimated date of delivery was 24-Mar-2009. On 26-Mar-2009, the patient gave birth to a normal baby boy (eight pounds, one ounce; 19.25 inches) via vaginal birth at 40+ weeks gestation. Apgar scores at one minute was nine and at five minutes was nine. The patient had no complications during her pregnancy and no complications with the delivery. There were no adverse events reported. Additional information received on 11-Dec-2008 was incorporated into the narrative and included patient demographics, vaccine information, medical history, concomitant medications and pregnancy information. Additional information received on 21-Apr-2009 and incorporated into the narrative included the outcome of the pregnancy and the labor and delivery summary.
Fever of 100.4, chills, achy.   My fever lasted for 34 hours.  Still feel weak, achy and tired.  I took tylenol every 6 hours.
Ocular migrane, tingling in left arm, chills, nausea, exhaustion, headache for two days, diarrhea.
I received the high dose flu vaccine by injection in my upper left arm close to my shoulder. I received the pneumonia vaccine by injection in my upper right arm close to my right shoulder. Both injections were administered by a pharmacist. Several hours after the vaccinations, my upper arms started to hurt. The pain became so excruciating that I was unable to undress or dress myself, my shoulders were frozen. The pain persisted for 48 hours. There was no redness but my muscles pained on any movement.
prescribed to get a Tdap dose on this day but was in error given the Fluzone Quadrivalent with no AE; Consumer was prescribed to get a Tdap dose on this day but was in error given the Fluzone Quadrivalent and that this will make the second dose of flu vaccine in this flu season with no AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist  via Call Center.  This case involves a 63 year old female patient who was prescribed to get a TDAP dose on but was in error given the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UT7096KA expiration date 30-Jun-2021) and that this will make the second dose of flu vaccine in this flu season (wrong product administered and extra dose administered).  Medical history, medical treatments, concomitant medications and family history were not provided.  It was a potential medication error due to wrong product administered and extra dose administered.  The patient previously had Fluarix vaccination and asked for another flu shot so they gave her INFLUENZA QUADRIVAL A-B VACCINE, wanted to know if there are any adverse effects to doing so.   No relevant laboratory tests were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
16 April about 1330 received SHINGRIX. 19th of April my scalp became very tender. So much so, that I called my Doctor to get it checked out. My Doctor didn't have clinic so I saw another Doctor. No rash was present at this time, but he gave me a Rx for Prednisone, (he called it Occipital neuralgia). I took the series of pills for 6 days and was going to call the Doctor because I felt a painful rash on my scalp and nothing eased the pain. I took a pill for pain I had (4 years ago). I helped by made me a little lightheaded, I twisted my ankle and my husband took me to the ER. They looked at my head and diagnosed shingles. They gave me an RX for ten day and said to see my family Dr. when I was finished with them. He looked at my scalp and said to take 800mg MOTRIN three times a day. Not much he could say. I had crusted sores across my head and I still can't lay my head down on the right side. Today is May 26th and I still have at least 3 clusters of scabs. I found "TERRASIL" on line and use it on the rash at least three times a day. (It's for Shingles skincare). It does ease the pain and itching. No allergies except TEGRETOL, which I took about 10 years ago. I had a routine check up with my family doctor on the 12th of April. That's when he gave me the script for SHINGRIX which I got around to getting the following Monday. No illness prior to the shot. At hospital medication ordered; Acyclovir 800 mg and a RX for the next 10 days, then follow up with family Doctor. This paper with all the other documents says it all. The scabs have gone however, the scalp pain continues. Vaccination given by the Pharmacist, I don't know anything about the actual injection except it was given in my Rt arm. Which is also the side of my head that was affected with the pain and rash.
On 08/18/2005 at 9PM mom found baby with body shaking, stiff, crying loudly.
After half an hour after i had left the pharmacy after the first dose of Covid Pfizer vaccine, Hamza(12 yrs) started clutching his neck saying its on fire, tears were coming from his eyes and he started choking and coughing. He barely managed to say that his throat felt like something burning hot was pouring down. I immediately gave him cold water to drink. He drank and continued to drink in small sips for the next hour and was feeling normal in an hour. He had not eaten or drank anything after his vaccine. He had also had lunch at 3 pm, a full 2 hours before the vaccine.
Per telephone and triage nurse, left deltoid red with medium swelling. No warmth. Afebrile but slightly itchy. Advised to give Benadryl and to follow up in office if no improvement.
Swollen arm pit, puffy, achy, not red or warm. Noticed about 36hrs after that had ache under arm pit. Visually swollen. Took naproxen helped with pain but not swelling.
pt states bloody noses began 2 days later-required follow up in hospital and has developed second bloody nose since
altered taste; altered sense of smell; slight left arm soreness; slight headache; This is a spontaneous report from a contactable consumer (patient).  A 75-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283 and expiration date not provided), via an unspecified route of administration left arm first dose on 08Jan2021 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. It was reported that patient got the first shot of the Pfizer Covid 19 vaccine last Friday 08Jan2021. Stated that she had normal slight arm soreness and slight headache on Saturday 09Jan2021. Stated that she woke up this morning 11Jan2021 and had altered taste and sense of smell. Stated that she has not heard of this as reaction to the shot. Stated that she feels fine. Stated that she put on perfume that was old and fixed grits with cheese which she could barely taste. Stated that she tried other things and noticed that she has altered sense of taste and smell. The patient did not received treatments for the events. The outcome of the events slight left arm soreness and slight headache was recovered on 09Jan2021 and not recovered for the other events.
Developed a rash that now looks like a burn; Rah on the arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rah on the arm) and RASH (Developed a rash that now looks like a burn) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), GABAPENTIN and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Rah on the arm). On 19-Mar-2021, the patient experienced RASH (Developed a rash that now looks like a burn). At the time of the report, RASH (Rah on the arm) and RASH (Developed a rash that now looks like a burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was provided.
After receiving the first COVID-19 vaccine dose I have experienced severe joints pain and joints stiffness. Also, for a week I had excessive tiredness. More concerning is the postmenopausal bleeding. After 15 months of menopause I started bleeding, having a full period cycle with all the PMS symptoms. The period continued for the next two months.
By 7pm after vaccine symptoms started:  Fever Tmax-100.8, chills, body aches, elevated BP:160/90 norm for Pt is 120/60 Taken Tylenol 650mg on 3/7/21 but fever returned today Hx of HTN but per Pt controlled (on medication for mgmt)
2nd booster - today I had a cluster of six cold sore blisters on upper lip. Applied OTC Abreva.
Skin was red; Hot pink look on skin/photo sensitivity to sun; A spontaneous report was received from a 64-year-old female patient concerning herself who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced photosensitivity to sun/ Photosensitivity reaction with hot pink look on the skin and skin was red/ Erythema.   The patient's medical history was not provided. Concomitant medications included 2 Ibuprofens and 2 Motrin prior to vaccine administration  On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J202A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021 after receiving the vaccine, the patient was sitting out in the sun and had complaints of photosensitivity to sun with a hot pink look on the skin. She tested this again on 09 Jan 2021 and noticed her skin was red. Patient states she can normally sit out in the sun without burning. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, experienced photosensitivity to sun with hot pink look on the skin and skin was red, were considered resolved on 10 Jan 2021.; 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.
after receiving the vaccines, pt felt hot and dizzy. symptoms started about 10 mins later.
Very red and swollen arm warm to the touch with redness extending down to elbow.  Cellulitis diagnosed in Emergency Room.  Keflex 500 mg given 4 x day.
Patient developed an itchy red rash on torso, back, arms legs and top of feet, while at home. Patient took 75mg of Benadryl that evening  went to bed. Upon awaken in the morning (12/03/15) much improved   with slight raised red bumps. Patient denied respiratory symptoms or  distress, no nausea or vomiting. Patient came to urgent care on 12/03/15 for evaluation of his  symptoms. Patient give Rx for Epipen  and Tdap was added to his allergies list on his records.
throwing up; white as a ghost; wasn't feeling good; This is a spontaneous report from a contactable consumer (Mother of patient).  A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0196 and expiration date: not reported), via an unspecified route of administration, on Right Arm, on 12Jun2021 in the afternoon (at the age of 12-year-old), as DOSE 1, SINGLE for covid-19 immunization at . The patient had no medical history and there were no concomitant medications. There were no other previous immunizations. No other vaccines administered on same date. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. There were no adverse events following prior vaccinations. Reporter stated that, the patient has an elderly grandmother and patient wanted to go see her and every time they go see her, they have to get tested for COVID. On 22Jun2021 patient experienced, throwing up. The patient went and got the milk and came back and wasn't feeling good, she was as a ghost on 22Jun2021. The reporter stated that patient is okay now, at the time of reporting, and wanted to know if it was normal after taking the shot, if it was a side effect from the shot or not. No test was taken. The outcome of the events was recovered on 22Jun2021.
Patient presented to emergency department on 11/23/2021 for generalized fatigue, shortness of breath, loss of appetite, fever, chills, and nausea. She tested positive for COVID-19 infection at a previous emergency room visit on 11/19/2021 and was given ivermectin. She was given monoclonal antibodies on 11/23/2021. She later became hypoxic and was started on supplemental oxygen. She was admitted for further management and was treated is dexamethasone and remdesivir. Her symptoms improved and was weaned off oxygen. She was discharged home on 11/26/2021.
Light case of shingles; Sore arm; Flu-like symptoms; a rash (under her left breast; a rash (under her left breast) that was painful, itchy; Tiredness / Fatigue; Headache; Nausea; Abdominal pain; Body aches / a rash that was painful; itchiness all over (mainly back and head)\Itch burning; a rash that was burning; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bronchitis. Concomitant products included calamine lotion (Calamine) and topical antibiotic (nos) (Antibiotic Ointment (Trade Name Unknown)).   On 22nd September 2020, the patient received the 1st dose of Shingrix. On 23rd September 2020, 1 days after receiving Shingrix, the patient experienced shingles, pain in arm, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain, generalized pruritus and burning sensation. On an unknown date, the outcome of the shingles, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain and generalized pruritus were recovering/resolving and the outcome of the pain in arm was recovered/resolved and the outcome of the burning sensation was unknown.   It was unknown if the reporter considered the shingles, pain in arm, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain, generalized pruritus and burning sensation to be related to Shingrix.  Additional details were provided as follows:  The patient experienced light case of shingles. The patient has been healthy most of her life and has only really been sick twice in her life. The day after receiving the vaccine, the patient experienced a sore arm (but nothing around the injection site) for a few days, flu-like symptoms, a rash (under her left breast) that was painful, itchy, and burning; tiredness, fatigue, headache, nausea, abdominal pain, body aches, and itchiness all over (mainly back and head).  The rash has gotten better and was clearing up. The patient was feeling much better compared to a week before reporting.  The patient might have contracted the shingles from her sister who recently recovered from it.  Not all information was available. The reporter did not consent to follow-up.
On an unknown date, in Feb2021 / Mar2021, the 65 year old female patient was vaccinated with the COVID-19 from Pfizer (lot/batch# unknown) (two doses 4 weeks apart).  Medical history included: depression, skin cancer (removed; Concomitant medications include unspecified depression medications.  On 11Aug2021, the patient had a fever of 102 degree Fahrenheit and felt really chilly. On 12Aug2021, the patient's son went to buy COVID-19 test, came home, took the COVID-19 test and it came out positive. The patient had a fever, sore throat, nasal drainage, felt lousy, (described as nasty flu like symptoms) and was quarantining her bedroom away from the family. On 13Aug2021, the patient still felt sick with the same symptoms with frequent naps. On 15Aug2021, she was feeling better, taking zinc and orange juice,  but still quarantining in her bedroom and nervous about going back to work (in person) at the University.  On 15Aug2021, she reported that her 29 year old vaccinated (by Pfizer) son now has COVID-19 and a separate report will be completed in VAERs.  The reporter (Registered Nurse) assessed the causality of lack of effect, COVID-19 vaccine failure, and all adverse reactions as absolutely related to the COVID-19 Pfizer vaccine.
Patient suddenly fell out of the chair 10 minutes after getting vaccinated and her bridge of the nose hit the concrete. Patient had tonic clonic movements for 5 seconds and regained consciousness immediately, was breathing spontaneously and had a pulse. Patient reported feeling dizzy prior to falling and anxiety over getting vaccinated. Patient was taken to a cot to lay on for 15 more minutes. Patient reported feeling better after laying down. Mother of the patient stated that there is a family history of epilepsy. Informed mother to bring patient to her primary care provider for follow up.
unusual visual disturbance/ see a circle in the center of vision/ jagged line that he could see with eyes open and closed; eye doctor made a diagnosis of ocular migraine; unusual visual disturbance/ see a circle in the center of vision/ jagged line that he could see with eyes open and closed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISUAL IMPAIRMENT (unusual visual disturbance/ see a circle in the center of vision/ jagged line that he could see with eyes open and closed), MIGRAINE WITH AURA (eye doctor made a diagnosis of ocular migraine) and VITREOUS FLOATERS (unusual visual disturbance/ see a circle in the center of vision/ jagged line that he could see with eyes open and closed) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (unusual visual disturbance/ see a circle in the center of vision/ jagged line that he could see with eyes open and closed), MIGRAINE WITH AURA (eye doctor made a diagnosis of ocular migraine) and VITREOUS FLOATERS (unusual visual disturbance/ see a circle in the center of vision/ jagged line that he could see with eyes open and closed). At the time of the report, VISUAL IMPAIRMENT (unusual visual disturbance/ see a circle in the center of vision/ jagged line that he could see with eyes open and closed), MIGRAINE WITH AURA (eye doctor made a diagnosis of ocular migraine) and VITREOUS FLOATERS (unusual visual disturbance/ see a circle in the center of vision/ jagged line that he could see with eyes open and closed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.