chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 78-year-old female who on 29-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient was given varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No adverse events were reported. The nurse did not feel this was product confusion. A product quality complaint was involved. Additional information has been requested. Follow-up information was received on 10-SEP-2007. Follow-up information was received via a telephone call with a registered nurse who stated that a prescription was written for varicella virus vaccine live (Oka/Merck) for shingles. The pharmacist filled the prescription with varicella vaccine live (Oka/Merck) and then the nurse administered the vaccine. It was reported that the patient had not experienced any untoward effects. The nurse also stated that the patient is considering have the zoster vaccine live (Oka/Merck). No further information is expected.
Little sore arm at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore arm at the injection site.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Little sore arm at the injection site.). At the time of the report, VACCINATION SITE PAIN (Little sore arm at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded. The reported event is consistent with the known safety profile of the vaccine.
Information has been received from a nurse practitioner concerning a 26 year old female with no pertinent medical history and no drug allergies, who on 04-MAY-2009 was vaccinated with her first "standard" dose of GARDASIL (IM, lot # 1702X), and received her second dose on 29-JUN-2009 (IM, lot # 1702X). There was no concomitant medication. On 29-JUN-2009 the patient experienced dizziness, lightheadedness and shortness of breath after the second vaccination. The symptom lasted for approximately one hour. There were no labs and diagnostic tests performed. The patient did not seek for medical attention. The patient had recovered on 29-JUN-2009. Follow up information has been received from a nurse practitioner indicating that on 14-SEP-2009 the 25 year old female patient who was seen for her AE stated that she had dizziness, lightheadedness and shortness of breath for 1 hour after the second vaccination on 29-JUN-2009. Then the patient returned to work. The patient did not seek medical care. The patient recovered with spontaneous resolution. There was no illness at the time of vaccination. No further information is available.
A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 31-year-old male. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose (0.1ml) of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
8 days after 1st Moderna vaccine redness circled injection site approx 1.25in diameter appeared around 12pm 5/15.  Approx 3.5 hours later got sudden, severe headache followed by nausea.  Vomited 1x 1 hour later. After resting felt better..  could feel heat radiating in my arm around the injection site without touching it around 6:30pm 5/15/20. Noticed severe swelling around the injection site, approx 5in diameter.
Approximately 4 minuets after receiving Pfizer vaccine, client reported itching on bilateral arms and back. No redness on affected areas noted. 25 mg  of Benadryl given by mouth. Blood pressure 130/84.  Client discharged home after a 30 minuet observation period accompanied by her husband. Client instructed to go to activate emergency response for difficulty breathing. Also, avoid driving day of incidence.  Client verbalized understanding of teaching.
pt recvd vax 23MAY92 & 1JUN92 devel a fever; On 3JUN92 1AM & 130AM devel seizures that lasted for 1-3 minutes; EEG & CBC were nl;
He woke up yesterday morning and he was very cranky and had a high fever. We gave him Motrin and I called the pediatrician and we got in for early afternoon. I brought him in and the Motrin had brought his fever down. She examined him and checked him for an ear infection and his throat. She noted that his throat looked a little sore and they took a nasal swab, but it came back invalid. Since he?s not in day care or anything, I didn?t plan to get him retested. Today he?s feeling a lot better. We kept up the Motrin over the night and we let that wear off and he?s doing better. He did wake up one time last night though when the Motrin wore off. At this point, his temperature seems to be normal.
RespDepression, HYPERtension, Chest Pain, swollen eye lids Narrative:
In June 2021, 2 months after 2nd dose shot (April 2021), experienced sudden vision changes and migraines. (Had severe general malaise and racing heart beat after first dose in March 2021).  Upon investigation, it was determined that I had a macular hole and detached retina in my left eye. I was diagnosed with a CHIRPE (don't remember if it was my left or right eye) 14 years earlier in 2007, however it had been stable ever since as verified at my yearly optometry and ophthalmologist appts.
Chills, fever, sweats, headache, body aches, vomiting all night.
Severe (R) arm pain. Limiting activities including combing hair, cooking. Treated with steroids and pain meds. Has an appointment with an orthopedic doctor wk of 1/26/15.
Two hours after receiving the vaccine he became lethargic and he had fever. He became very weak to the point that he could not walk. His heart rate was increased. He had a high fever, blurry vision, nausea and vomiting. We went into the doctor the next day and he sent us back home. Sunday we went to the emergency room.  They did a sonogram and found that he was suffering from something burst into his stomach. He had to have surgery because they thought it was appendicitis, but it was not. He did receive an appendectomy.
Child started running fever evening of 6-6-11. Was taken to ER on 6-7-11 at 7:45AM. Mom reports fever was 105 degrees F when they left house, was 102.7 F at ER. Was given MOTRIN, TYLENOL PRN. Mom reports child had 103 degrees F this morning 6-8-11, but has been normal since.
Treated in ED for COVID with Regeneron antibodies. Vaccinated in April 2021.
Patient was given intramuscular shot too low on the arm (not in the deltoid muscle).
Extremely high fever developed 10 days post vaccination. Temperature of 104.5. Fever subsided the next day.  After fever, has been unusually fussy and is having trouble sleeping at night. This is still occurring 3 days after fever. Frequently waking (4-6 times per night), crying, and stretching our legs. He seems to be experiencing discomfort in his legs.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 10-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 996 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
+ erythema with minimal edema to left arm. Swelling is noncircumferential, close to capsule.
Patient came in on 9/24/22 to request Shingrix vaccine. While investigating his history we found that he not only received two doses in 2019, he also received two doses of the vaccine in 2020. The patient stated that he thought it was a yearly vaccine. Explained to the patient that he already received the necessary course and is not eligible for further vaccination.
2 days after second dose, I had Intense menstruation: cramping and bleeding that lasted longer and felt more intense than I have ever experienced. After one day of light flow, I had 2 days of heavy flow, where I always have one. I hardly ever have cramping, if I do, it is once or twice, followed by bleeding. In this case, I had cramping throughout two days, and the second day, the cramping took a long time to lead to bleeding, and the bleeding was like nothing I have had. Had headache, where I usually do not have one, several times. Then I had 6 days of light flow, totaling 9 days of bleeding, Had a lot of Dizziness (have history of anemia, so wondered if it was this, but I had it more often than usual).
He has been experiencing pain; Sensitivity on the right side of his gums; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown. Expiration date: Unknown) via unspecified route of administration on an unknown date at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. He received the Pfizer Covid-19 vaccine last Thursday or Friday of last week and a day or two after he has been experiencing pain and sensitivity on the right side of his gums, which is the same side where they administered the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-JUL-2015, the patient was vaccinated with ZOSTAVAX (dose, route and lot number or batch number unspecified). No concomitant medication was reported. On 07-JUL-2015, the patient developed pruritus, warmth and a large area of redness at the injection site after receiving ZOSTAVAX. The patient sought medical attention - saw pharmacist in the pharmacy. The patient was treated with TYLENOL and ice pack was applied to the affected area. Lab tests were reported as unspecified. The outcome of injection site pruritus, warmth and redness was not recovered. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
Vaccine amount is .25 mL and comes in single dose vial with overfill. Nurse did not notice that there was overfill and gave slightly more than 0.25 ml (about 0.3ml) . Provider was notified and decided that since it was an insignificant amount of extra vaccine, the parent did not need to be notified.
Pt admitted on 10/26/2021: 48-year-old female presents with multiple seizures today.  Patient has a history of glioblastoma multiforme.  She had her initial resection at our facility 2 years ago.  She most recently has been followed.  She has a follow-up appointment scheduled with them for 6 days from now.  However the patient states that mid last week she lost her taste and smell.  She presented to a walk-in clinic 3 days ago and reports that she had a positive antigen test for COVID.  She has not had any fever.  No cough.  No shortness of breath.  She is unaware of what her exposure might have been. She does work in a daycare but in an area away from children.  The patient states that she was
A non-serious, spontaneous report of fever, headache, and nasal congestion has been received from a registered nurse concerning a 17-year-old male patient, subsequent to H1N1 Vaccine. The patient's medical history included sore throat at the time he received H1N1 Vaccine. Concomitant medications were not provided. The patient received H1N1 Vaccine on 20-Oct-2009. On 21-Oct-2009, the patient developed a fever, headache, and nasal congestion and was sent home from school. The event outcomes were not reported.
Covid monitoring documentation. PT admitted 12/18/21 documented to have positive covid. PT received 1st dose Janssen 5/10/21 Lot 204A21A.
Flucelvax received 9/29/21 afternoon Sore arm started 9/30/21 morning before getting covid booster Pfizer Covid booster received 9/30/21 11am from a different source (hospital) in other (right) arm Noticed Induration 1.5 inch diameter around flu vaccine injection site, red, swollen, very painful to touch,  slightly itchy , some pain with arm movement 9/30/21 evening Increase in pain and swelling of left deltoid slightly 10/1/21 morning Tylenol 600mg taken 10/1/21 afternoon
Initial report received from a consumer on 28 August 2013. A 22-year-old female patient had received an intramuscular dose 1 of MENACTRA vaccine (lot number- U4585AB, expiry date- 10/26/2014, anatomical site of administration was not reported) on 27 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was not reported and the estimated date of delivery was 17 January 2014. The patient had no risk factors (e.g.: alcohol, tobacco or recreational drugs). Patient's medical history, concomitant medications and treatment for infertility were not reported. Complementary tests were not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: none.
localize swelling of rt leg; warm approx 4cm x 5cm; non-raised; no itching; no fever;
Information has been received from a nurse concerning a teenage patient who was vaccinated with a second dose of varicella virus live (Oka/Merck). On approximately 16-FEB-2007, the patient experienced a reaction at the injection site". The nurse reported that the area felt hot and had redness and swelling. There was no product quality complaint. The patient's status was not reported. Additional information will be provided if available.
flushing on upper torso and face, hives on lips, tingling of tongue, throat itching , bloating and gas approximately 35 to 40 minutes after injection. Self dosed with Benadryl, alerted my physician
Generalized macular rash after 15 minutes. No SOB, wheezing. Noted partial  improvement of rash after dose of Benadryl 50 mg
Following the first vaccine I experienced 2 side effects.  Side effect #1 was extreme arthritic type pain extending throughout the left side of my body. The pain persisted throughout and following the second shot spread through my right side as well. The arthritic type pain persisted for 6 months finally subsiding in September with both hands returning being the last to return to normal.  Side effect #2 was extreme skin sensitivity to the sun. I have not been sunburned in probably 15 years. However 3 days after receiving the first shot, I was literally burned to the point of blisters after approximately 15 minutes in the sun doin normal yard activities. I found it strange, but assumed it must be related. After the blistering healed, I received my second shot. Knowing what happened the previous time, I heavily applied 100 spf prior to going outdoors. I received the same result as the previous time, but slightly less blistering. I spoke to my dermatologist about it approximately two weeks later at a visit.  They had not heard of any vaccine associations regarding this side effect but stated they were constantly hearing about new ones. By June I could agin be in the sun for short periods without blistering, but would get very blotchy red skin patches  all over any exposed area. Similar to the arthritic pain, by September the skin sensitivity had diminished as well and I could again resume normal outdoor activities.
On 7/7/2022 patient received her first COVID-19 vaccine at 4:43 pm. One hour later mom said patient started having tachycardia. Her heart was beating faster than normal. This lasted until 10 pm. Patient did not receive treatment. Mom just gave her water.
on 2/16/2021 by 2pm, extreme pain Left arm including knuckles + fingers, neck, shoulders. By 4pm same day, headache, nausea, extreme fatigue, no temp at this time. That evening same symptoms and during night. on 2/17/2021 all the same and at night    99.2 temp. (shortnessofbreath both days)
Reports he went to pharmacy, reports having a "senior flu vaccine" reports hives began that day.
I experienced chest pains for 3 days - left side, heart area. They were not severe enough for me to go to the hospital and would subside. There were about 3 episodes in a given day. I was concerned but not panicked about it. Then, after 3 days they stopped. The only other side effect I had was a very sore arm the day after receiving the vaccine.
My shoulder got swollen hurts a lot and can't sleep at night because my left arm hurts a lot and still does at this time.
This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Lot number: ER0113) via an unspecified route at arm right on 17Apr2021 in the afternoon (around 15:30) (reported as this past Saturday) as a single dose for covid-19 immunisation and diphenhydramine (Lot Number: P122793 and Expiry Date: NOV2023) for two black spots under the site and that part was swollen too, it itches. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8730) via an unspecified route at arm right on 27Mar2021 in the afternoon (around 14:00) as a single dose for covid-19 immunisation with no adverse effects. On Apr2021, patient had experienced the site under where she got it was swollen and hard and it hurt. she put ice on it for the swelling. Patient reported that it started as just one spot which turned black and then she had little black spots everywhere under the spot where the vaccine went in. She had two spots and then those spots turned black and then she has tiny spots like polka dots over her arms and when she woke up next day, she had two black spots under the site and that part was swollen too. She took 2 allergy Diphenhydramine HCl 25 mg antihistamine that morning. They are oozing and she has the little black spots on her left and her right arm, but she had the vaccine in her right arm (further stated that the black spots that are oozing and it was kind of hard under it and under the site. The spots were blacker and more discolored). Patient stated that it itches and that's why she took allergy Diphenhydramine HCl 25 mg antihistamine but that made her drowsy. Patient felt like throat was kind of dry and was feeling hot and had COVID-19 test resulted in everything okay, she didn't have COVID. Patient right deltoid and right below it, maybe 3 fingerbreadths below on the left and right side bilaterally she had blotches that appeared, and they looked red. Next day they looked more like a burn kind, when a darker person gets burned by an iron then the spot gets darker in nature. One of the spots has like a vesicle that was fluid filled kind of like a blister and it was weeping. Overnight this went from blotched to burn-like marks with one vesicles that was oozing and then there are spots dispersed through her body. On her right arm, left arm, and on her right leg as well it was like black spots. Patient does not require to visit emergency room or physician office for the events. Outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
5 min after the injection pt began to feel very warm, became diaphoretic, and nauseous. Pt advised to lay down and a cool compress was applied to her forehead. Pt was given a freezie pop and she began to feel better within minutes. Pt stayed in office for another 15 min. Pushed fluids when pt got home. That night pt dev a fever. Pt was seen in office 1/21/16 dx with sinusitis and pharyngitis and placed on abx.
Home schooled child took vaccines and started public school the next day. 3 days later had uncontrollable shaking and crying. Went home 3x in one week. Mom called us and referred to behavioral. Told anxiety. No meds given. Still having crying. Pulled from school. Told to see MD and behavioral and call back with future outcome.
Superficial Thrombophlebitis of right leg, severe abdominal pain with no found explanation as to why, insomnia, dizziness, heart racing at night with neck:head discomfort
Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FC3181) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes". Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Patient took a took a Naproxen pill.  Follow-up attempts are completed. No further information is expected.
101 fever for 2 days.  Temperature lower with Tylenol. Decreased appetite for 3 days. Cried when moved for 2 days. Rash on face and chest developed 2 days after shots.
Small bruises in both arms. Disappears after 2 weeks and then i get them; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EN6208) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Upper respiratory tract infection" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; MONTELUCAST; BREO ELLIPTA. The following information was reported: CONTUSION (non-serious) with onset 10Apr2021 08:00, outcome "not recovered", described as "Small bruises in both arms. Disappears after 2 weeks and then i get them". The event "small bruises in both arms. disappears after 2 weeks and then i get them" was evaluated at the physician office visit. Therapeutic measures were taken as a result of contusion.  Additional Information: Facility type vaccine reported as other. Patient had not taken any other vaccine in four weeks. Other medications in two weeks provided as losartan, montelucast, breo. Adverse event reported as small bruises in both arms. Disappears after 2 weeks and then patient get them. Adverse event treatment was blood work. No covid prior vaccination. And patient covid tested and result is negative.  No follow-up attempts are possible. No further information is expected.
pt recv vax 15SEP95 & seen in office 1AUG95 w/full case varicella-over entire body;
Possible Guillain-Barre Syndrome. Ascending sensory and motor symptoms and deficits with hyporeflexia and areflexia. Rx includes IVIG 400mg/kg/day x 5 days (3/23/21 - 3/27/21)  No significant  improvement. Followed by plasma exchanges every other day x 5 treatments.
Mild URI on day of immunizations decreased appetite, irritable. ER days after shots. Saramine for 6-12 hours. Temp 102.4.