chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On day of vaccine, pt developed temp of 101.5. He was irritable and refused to eat. There was a lump at the injection site which was also red and warm to touch. Below injection site there was a red rash. The fever responded to Tylenol. On 5/22/01 the rash looked worse and MD prescribed Tylenol per phone call. Pt. continued with low grade fever and had diarrhea x 4. On 5/23/01 pt. still had a low grade fever and lump remained at site but rash was fading, had nor further diarrhea, and was less irritable.
I had the Booster shot for PREVNAR 13 yesterday. My left arm/shoulder is very swollen and the pain kept me from sleeping last night. It's still very painful very warm to hot and it hurts just to touch my skin anywhere on my shoulder. The Pharmacist did the injection. I've never had a reaction to any injection before and I've been having them since the polio vaccine was prevalent. It Hurts. I'm 73.
Fatigue, whole body aches, tenderness at injection site. Onset within 12 hours, duration approximately 36 hours. Treated with rest, fluids, and Aleve (1 dose, 24 hours after injection). All symptoms resolved within 48 hours.
little knot on the backside, like a big area; fever in it; a little red; back of the neck is sore and hurting; still has the knot, which is swollen and sore; It is swollen and itchy / which is swollen and sore; knot was itchy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (little knot on the backside, like a big area), SKIN WARM (fever in it), ERYTHEMA (a little red), NECK PAIN (back of the neck is sore and hurting) and BACK PAIN (still has the knot, which is swollen and sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 052B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Diabetes.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced SKIN MASS (little knot on the backside, like a big area), SKIN WARM (fever in it), ERYTHEMA (a little red), NECK PAIN (back of the neck is sore and hurting), BACK PAIN (still has the knot, which is swollen and sore), SWELLING (It is swollen and itchy / which is swollen and sore) and PRURITUS (knot was itchy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN MASS (little knot on the backside, like a big area), BACK PAIN (still has the knot, which is swollen and sore) and SWELLING (It is swollen and itchy / which is swollen and sore) had not resolved and SKIN WARM (fever in it), ERYTHEMA (a little red), NECK PAIN (back of the neck is sore and hurting) and PRURITUS (knot was itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient had several medication but did not have the list.
Initial and follow up information has been received from a physician concerning a 10 year old male who on 14-FEB-2008, at 14:45, was vaccinated into the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 659730/1781U). On 15-FEB-2008, the patient developed redness and swelling at the injection site (also reported as red swollen large area) as well as a low grade fever.  At the time of reporting it was noted that the patient had recovered (date unspecified) from the redness and swelling at the injection site. The outcome of the low grade fever was not reported. Unspecified medical attention was sought. There was no product quality complaint. This is one of several reports from the same source. Additional information is not expected.
I broke up in hives when I got the vaccine at about 11:45 am and then I went to urgent care the very first time and they recommended taking an antihistamine, and I had Allegra at home, and if I was having any swelling on the tongue throat or difficulty breathing to come in but I never had. The hives started in my arm and worked its way to my abdomen and I took Allegra and probably by 3 pm or so it had mostly gone away. Then, subsequently I had hives come up again three more times on different days.
pt stated he had fear of needles prior to administration.  after 5 mins of observation in a chair, patient shouted he was about to pass out. pt was braced for safety and remained unconscious in a chair for 2 minutes.  EMS was called and was on scene within 4 minutes of incident.  pt consulted EMS for medical assessment and was determined nothing else was wrong and he was good to leave if he felt better.  pt refused to be transported for further assessment.  pt drank apple juice and water and continued to recover in the pharmacy for 30 minutes prior to leaving.
Information has been received from a physician concerning a 4 year old male who in 2000 was "vaccinated at 12 months" of age with a SC dose of varicella virus vaccine live 0.5mL. On approximately 08/06/03, "a few days ago", the pt presented to the doctor's office with "50 lesions which started on the lower half of his body, but spread to other parts". Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Chills; Feeling unwell; Fatigue; Headache; Fast heartbeat; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in right arm on 19Aug2021 09:15 (at the age of 74-years-old) as dose 2, single for covid-19 immunization at pharmacy or drug Store. The patient medical history included atrial fibrillation (Other medical history: Afib). Concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in right arm on 29Jul2021 04:45 PM (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. The patient does not have any allergies. No other vaccine was received within four weeks. Other medications were received in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 19Aug2021 07:45 PM the patient experienced chills, feeling unwell, fatique, tiredness, headache, fast heartbeat, arm pain. The patient underwent lab tests and procedures which included fast heartbeat (heart rate): fast on 19Aug2021. No treatment was received for adverse event. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Bad case of hives head to toe. Took two doses of BENADRYL and it did not work. Awoke on 1/24 and hives were gone but now I have diarrhea and feel like I could throw up.
After receiving the vaccines, the mother started home with the child and noticed that he was wheezing and starting to swell up. The pt was taken to the ER.  Diagnosed with allergic reaction
Starting around 09/16/2021, I developed a fever x 3 days, body aches, abdominal pain, nausea, coughing and "the works". The joint pain was very intense. The arthritis in my knee flared up after this event. I received the monoclonal antibodies possibly on 09/20/2021 and then ended up being put on the Z-PAK and prednisone. I had missed work when I was sick.
lumps all over my body/breaking out all over; lumps all over my body/breaking out all over; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that patient getting side effect from this thing, breaking out all over. It was also reported that started getting lumps all over body. When probed if consumer have some medical information about the same, patient stated, "Yes. The outcome for the event was reported as unknown at the time of this report.   Information about lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Mother reported that 2 hours after given the vaccine, he started screaming and cried for unknown period of time. He had two "jet black" pudding consistency stools. One that day and one the next day.
Immediate shoulder pain. Found unconscious on floor 12 hrs after injection. Taken to hospital with resulting 3 day stay. Currently under MD care for unresolved shoulder pain.
Initial report received on 24 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initial not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3917AA received on 04 April 2012, lot number C3945BA received on 01 June 2012 and lot number C4049AA received on 16 August 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 29 November 2012, approximately three months after the last dose. On 29 November 2012, the subject developed a cough and paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 04 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 05 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 13 December 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
left side of face started swelling and painful to touch. Both side are swollen now but left way worse than right.; left side of face started swelling and painful to touch. Both side are swollen now but left way worse than right.; Left ear feels plugged and ringing in ears.; Senses of Taste is greatly effected; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm right on 27Mar2021 at 11:00(at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included gluten sensitivity, allergic to formaldehyde and preservatives. Concomitant medications were not reported. The patient previously took Erythromycin on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 the patient experienced left ear feels plugged and ringing in ears and senses of taste is greatly effected. On 02Apr2021 the patient experienced left side of face started swelling and painful to touch. Both sides are swollen now but left way worse than right. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event left side of face started swelling, painful to touch, left ear feels plugged and ringing in ears and senses of taste is greatly effected were not recovered.   No follow-up attempts are needed. No further information is expected.
Felt a rush of clarity in thinking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Felt a rush of clarity in thinking".  Additional information: It was reported that, as a retired researcher but still active scientifically the patient wanted to notify them regarding the patient's COVID-19 2nd shot. Stated that, the patient thought at first was imagining the effect, however after speaking with several pathologists and friends, the patient had seen a pattern. Stated that, on or about day 5 after the 2nd dose, they all had felt a rush of clarity in thinking. Stated that, during the past year there has been like a covid fog (whether depression or not) but out of nowhere their thinking both clearer and sharper has evolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache lasting the first 10 hours after shots. Next 2 days flu like chills and weakness and extreme fatigue causing hours of deep sleep. Following day extreme fatigue causing hours of sleep. My ability to conduct normal daily routine was definitely impaired for at least 3 days following my shots. I am writing this report on Friday late afternoon following vaccinations on Tuesday late afternoon.
mom called 350PM on Friday 30JUN95 & stated pt had hives badly; mom spoke w/pediatrician;
Thursday, November 18, 2021 my son was eating pizza (from a restaurant where he has eaten for last 6 years), peas, and carrots.  He suddenly started to not feel well have difficulty breathing. 911 was called. He was transported by ambulance to the hospital and then his condition deteriorated and he was transferred to another medical facility. He was intubated, in ICU for a day and then moved to a regular room for 3 days....where he had a second reaction to some chicken fingers. There were no know allergens in any of the foods. And, skin test for new allergens, the pizza and the chicken fingers were all negative.
Had 4 strokes/My girlfriend took me to the hospital to find out I suffered 4 strokes. 2 were 2 weeks old.; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; Didn't feel well for 2 weeks; the next day didn't know anything,  couldn't speak, shaking, weakness; the next day didn't know anything,  couldn't speak, shaking, weakness; the next day didn't know anything, couldn't speak, shaking, weakness.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received bnt162b2 (Pfizer, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in arm left on 01May2021 as dose 1, single for covid-19 immunization. Other medical history was none before the covid shot, was healthy and now he lost his business and no income. Not known allergies. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. The patient experienced had 4 strokes/my girlfriend took me to the hospital to find out i suffered 4 strokes. 2 were 2 weeks old, few hours after 1st shot severe headache and vomiting/didn't feel well for 2 weeks till i got the severe vomiting and headache again, didn't feel well for 2 weeks, the next day didn't know anything, couldn't speak, shaking, weakness all on 01May2021. The events were serious per hospitalization, disability. The patient was hospitalized for these events. Had 4 strokes, few hours after 1st shot severe headache and vomiting. Didn't think too much about it since they said 50 + men don't get reactions. Didn't feel well for 2 weeks till he got the severe vomiting and headache again, and the next day didn't know anything, couldn't speak, shaking, weakness. His girlfriend took him to the hospital to find out he suffered 4 strokes. 2 were 2 weeks old. Backing it up till 01May2021 when he has the first covid shot. Therapeutic measures were taken as a result of events (Treatment for strokes). The adverse event result in doctor or other healthcare professional office/clinic visit and a visit to Emergency room/department or urgent care. Duration of Hospitalization was 5 days. Hospitalization was not Prolonged. Facility where the most recent COVID-19 vaccine was administered was hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was resolved with sequelae.
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: had COVID five different times. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "covid". The patient has had the vaccine and been hospitalized for COVID. Patient was sick again with Covid right now. Every time got a booster patient got sicker and the problems got worse and more immediate.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Extreme spinal pain for the last 10 days. Nausea and chill's intermittently. The back pain was so severe that I ended up in emergency Room today.
Information has been received from a certified nurse midwife concerning an 18 year old female with asthma and no known drug reactions/allergies, who on 11-JAN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5 mL, IM, and on 11-MAR-2008 with the second dose. Concomitant therapy included DEPO-PROVERA and an unspecified inhaler. On 12-MAR-2008, the patient was diagnosed with Coxsackie virus. The patient was evaluated and treated, by her unspecified primary care physician, with folic acid, thiamine, and unspecified steroids. The first course of treatment was completed after one month. On an unknown date, the patient experienced a recurrence of the lesions and a second course of the same treatment was prescribed. The patient sought medical attention by a phone call. The patient's Coxsackie virus persisted. Additional information has been requested. Follow up information was received from a licensed practical nurse concerning a 17 year old female who on 11-MAR-2008 was vaccinated with a second dose of HPV (lot # 0152X) intramuscularly into the left upper deltoid. On 12-MAR-2008 the patient developed ulcers in mouth, severe swelling and pain. The patient was treated by a different physician. At the time of reporting the outcome of the patient was unknown. It was not specified if there was an illness as the time of vaccination. Ulcers in mouth, sever swelling and pain resulted in persistent or significant disability/incapacity, prolonged hospitalization and required emergency room/doctor visit. Follow up information was received from a nurse who confirmed that lot number of first dose of HPV given on 11-JAN-2008 was 655327/1287U. There were no problems after the first dose. The patient had not been seen in their office since the second dose was given on 11-MAR-2008. Patient present outcome was unknown since she was treated by her primary care physician. Additional information has been requested.
Onset of pruritic papules approx 15 day post vaccination with SPV. Few papulovesicles, 2-4 mm in size, on the dorsal hands overlying the (R) 2nd and 3 MCP's, few also about PIP of (R) hand; fewer similar appearing lesions are also scattered in a similar distribution about the (L) hand.
Got COVID shot about 10am Friday and started to feel sick about 6pm. Tiredness, headache, muscle pain, fever, nausea. Rough night and still had symptoms all day Sat 1/23/21. By Sunday morning only headache remained, mild compared to day before. Now Monday, and still have light headache and tired.
pt recv vax; mom began red in urine & BM;to take pt to er immed; MD felt rxn due to MMR since had DTP w/ no rxn;vax affected stomach ? causing it to bleed;
Around 12hrs of first injection, I began to feel very cold.  Left arm was very painful to move. Hands and feet felt like ice. I was shivering. Fever of 102. Could not sleep. I was up at 3am feeling like I was going to vomit and I couldn?t get warm. Whole body aches. Couldn?t go in to work the next morning. I had a terrible headache. Slept all day. Went to bed in the evening and woke again at 3am shivering uncontrollably. Hands have continued to stay cold. No appetite as well.
Initial report received 14 August 2007 from a health care professional. A male newborn baby had received a prophylactic dose of Fluzone transplacentally through maternal exposure during his second trimester of pregnancy on 26 December 2006. The baby was born and presented with jaundice at birth which resolved within 2-3 days requiring no treatment. The baby had cyanosis at birth which resolved within 2 hours after birth. Shortly after birth, the baby started having difficulties breathing, he was diagnosis with pulmonary hypertension and intubated for 24 hours. Baby was admitted to the NICU for four days for pulmonary hypertension. The pulmonary hypertension resolved within 24 hours; however resolved within 24 hours; however the baby was breathing normally and no longer required supplemental oxygen. He was given prophylactic antibiotics for one week and all laboratory results were normal, he was not positive for any infection. The baby was monitored for five additional days and released from the hospital on 26 May 2007. Per the reporter, the baby's mother "had a c-section after diagnosis of oligohydramnics on 18 May 2007, her AFI was 2. Her date of conception had been reported as 25 August 2006 with an estimated delivery date of 18 May 2006". Maternal exposures reported during pregnancy included alcohol, passive smoke, caffeine, and mold "in office". During her third trimester, from 08 March 2007 until 04 May 2007, she experienced "bronchitis/cold" symptoms which had been treated with antibiotics from 01 April 2007 to 04 May 2007. An ultrasound had been performed on 02 May 2007 which revealed "low amniotic fluid". This case is linked to the mother's case 2007-02829 (Oligohydramnios).
Patient had influenza vaccine administered in right deltoid on 10/25/10. On 10/26/10 at 9PM, patient describes appearance of induration on right forearm characterized by tingling sensation and itching.  On 10/27/10, three other indurations developed on the right upper arm, with similar tingling/itching sensation. A fifth induration developed on the left wrist characterized by itching.  Patient notified the provider by telephone on 10/29/10.