chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever spikes up to 102; Crushing headaches; Soreness at injection site; Soreness radiating through shoulder and underarm; Extreme fatigue; Significant body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 01Apr2021 at 09:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021, the patient experienced fever which spiked up to 102 (unspecified units), crushing headaches, soreness at injection site and radiating through shoulder and underarm, extreme fatigue and significant body aches; all these occurred post second dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (ADVIL). The clinical outcome of the events fever up to 102 (unspecified units), crushing headaches, soreness at injection site and radiating through shoulder and underarm, extreme fatigue and significant body aches were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
HIB was given that was incorrectly mixed with sterile water instead of the normal saline which is provided.  No adverse effect was noted.  MD notified patient's parent to have child re-immunizied.
We administered vaccine and within seconds she tried to get up and felt faint. She passed out for a second and then came so. Her mom caught her and put her back in the chair. Patient said she felt fine right away and I told her to put her feet up and drink water, which she did. We had her sit for an addition 15 minutes just  in case, and she felt fine that whole time. I called the patient's mom later on that day and she said that she still felt fine. The patient mentioned at the time of vaccination that this has happened before with vaccines.
Diarrhea, started about 5 hours after shot, mild, only had it for about 2 hours.
Swollen glands - posterior cervical. Diffuse macular papular rash. Diarrhea x2 days.
I started feeling bad and coughing, could not catch my breath and breathing was very hard. I called my primary care doctor and was unable to get in for an appointment she recommended that I go to the local urgent care. I went in as soon as I could, I saw an DO we discussed my symptoms. She ordered an x-ray of my chest; I was then prescribed prednisone that barely helped. I had to call her back and discuss my lingering symptoms. She recommended that I use my inhaler more often and called in an antibiotic. I am feeling better, but I am just hurting from my chronic conditions.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ 2 milliliter, once, orally, lot # R021216, expiration date 25-APR-2020 (reported as "25-MAY-2020) for prophylaxis. The vaccine was exposed to a highest temperature above 47°F (50°F) for 2 hours. There was a previous temperature excursion, where the lowest temperature was below 36°F/2°C (33.4°F) for 12 hours, and the highest temperature was above 47°F/9°C (50°F) for 12 hours. It was reported that digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA006849.
Received H1N1 vaccine in (#2 H1N1 this season) and developed urticaria with swelling of UPT (no resp. distress)-resolved with BENADRYL.
Initial and follow-up information has been received from a Medical Assistant refers to a patient of unknown age and gender, medical history and concurrent conditions were not reported, who on 01-MAY-2015 was vaccinated with a dose of GARDASIL lot # K006960 (route and dose were not provided) that was exposed to temperatures outside of the recommended range during an unknown number of hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter.
First dose. Pt fainted, father states pt fainted two times on the drive to clinic. Pt recently admitted to assisted living for syncope..pt remains awake after episode oriented to person place and time paramedics here to evaluate.
I started getting sinus pressure up in my forehead and in between my eyes and nose. It started happening on 06/19/2021, I started getting serious headaches. It went on for a couple of days. I got a COVID test, which was negative. It was very uncomfortable. I got some stuff from the pharmacy. It would help a little bit. After 2 weeks I went to see my doctor at the VA. They gave me some medications and it kind of went away a month and a half later. I have not had any problems since it went away.
Redness was noted at injection site of Left upper arm posterior where both MMR and Varicella vaccinations were given SQ.  Patient c/o severe redness and swelling and itching by evening time. Posterior section was so swollen she could not place arm next to her body. She was concerned and worried and came to the clinic but we were closed on the weekend. When patient presented today at 11am the swelling was gone but the site was still quite red and pt still complained of itching at the site. No doctor was seen over the weekend and no topical cream to combat the itching was used.
Flushing, macular rash/warm. BP 127/74 (pulse 91), O2 sat 95%. Erythematous rash on chest, lungs clear. Given Benadryl 25 mg PO.
Verbal order to administer Adacel, last tetanus documented on office visit form as 6-20-06.  Visited with mom, mom stated that last time pt had shots was in kindergarten.  Vaccine administered, pt education given.  Pt left office.  Went to document vaccination, and noticed that Adacel was charted as a history immunization in computer.  Not charted in IRIS at all. Informed Dr. of event.  Tried to contact mom to inform of above event, not available, msg left for her to call office for instructions.  Will make sure mom informed of signs to watch for and how to proceed.
Right eye turned blood red; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's father) that:  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date the patient's right eye turned blood red. The outcome for the reported event was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
My 20-year-old son received his first Moderna shot on March 16, 2021, at his college health clinic with no obvious side effects. He received the second Moderna shot at the same location on April 13, 2021. On the morning of April 14, 2021, he began running a high fever with repetitive vomiting and stomach cramping. He did not immediately seek medical attention because he had been told of side effects of the vaccine. When it was no longer tolerable, he reported to the local ER where it was later discovered he had a 4 mm kidney stone, which he passed two days later. We were told that the kidney stone would likely have begun forming about 31 days earlier, which would approximately coincide with his first COVID injection. There is no family history on either side of any kidney stones in the family. While my son's lifestyle may introduce some risk factors for kidney stones, I felt it was reasonable to report it as potentially relating to the vaccine.
6 hr p/vax pt devel hives on chest & neck w/severe itching; mom called family MD who ordered DPH; hives disappeared p/1st dose; 2nd dose given 4 hr later; pt slept during noc but woke up w/hives on neck again @ 23 hr p/vax;
pt recv vax 28AUG95 & 16MAY97 pt devel chickenpox & presented to MD;
Shingles after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles after first shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced HERPES ZOSTER (Shingles after first shot). The patient was treated with VALGANCICLOVIR for Shingles, at a dose of 10 day treatment. At the time of the report, HERPES ZOSTER (Shingles after first shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
A report was received from a healthcare professional on 04/09/2001, concerning a 14 year old male patient who experienced mid-epigastric pain on 03/01/2001 after receiving the Fluvirin vaccine on the same day. On 03/02/2001, the patient experienced epigastric pain.  The symptoms eventually resolved on an unknown date without further complications. There was insufficient information to determine the causality assessment of the reporter. Cross reference with PJP-2001-00267 and PHP-2001-00271.
ptn fussy on 9FEB95 w/o explanation on 11FEB95 had 5-6min generalized tonic-clonic sz  w/lt eye deviation, postictal mild & brief; onset of fever, day p/sz;
Extreme lethargy/tiredness, sleep all day, muscle aches, headache, fever, sore arm
Patient came in 24 hours later, area was puffy, redness the size of a 1/2 dollar.  Warm to the touch.  Tender around area.
3 days after vaccination - had stiff neck, fever and itching around drog. 04/01/03 - 5 times elevated temperature 104 degrees.  04/02/03 - stiff neck, dizziness, light-headed - CP and L arm pain, flu-like.  5 times temp (had Tomopol IM and Rx for po pain meds).
After receiving the shingles and flu shots I felt very flu like aches. Developed a fever of 100.3 sore, red, hot, hard bump at injection site and a very bad headache. Fever lasted until mid morning, still have mild headache and arm is still red, hot, sore, and hard bump 24 hrs after injection.
Covid breakthrough, first vaccine 3/30/21. Patient admitted 1/8/22 with worsening generalized weakness.  Patient WC bound with history of DM, HTN, Obesity, Afib, GERD, PUD, OSA, arthritis and non healing left leg wound.  Patient also came to hospital for possible rehab placement.
patient stated that he had fainted once during an immunization , but has had others in past and has been fine, I told him to stay for the 15 min post immunization event and monitored him. about 10 mins later he said he was seeing black spots and asked if he could lie down, I said that was fine, 911 was called and an EMT took over, patient never actually passed out, it seemed that he was dizzy . followed up with patient later that day, he stated he was feeling fine.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "57 YO female with past medical history significant for R breast high grade ductal carcinoma in situ (ER+, PR+) s/p partial mastectomy (2011) followed by radiation and chemo, chemo induced anemia, left bracheocephalic dvt (on Xarelto), hepatic flexure colon cancer s/p right colectomy, with recurrent malignant neoplasm of the colon with mets to the lungs, adrenals,  and lymph nodes who presented to SJ ED on 1/12 with complaints of intermittent abdominal pain that began 2 weeks ago. 3-4 days ago she began having nausea and non-bloody vomiting and decreased po intake. She reports that her abdominal pain continued to progress and became persistent driving her to come to the ED. The patient reports compliance with her medications, but she has been holding her rivaroxaban (xarelto) for 1.5 weeks in anticipation for a dental procedure. Her last chemo was 12/21/2022 as per Dr. notes.    On presentation she was tachycardic. Work up revealed SBO on CT abdomen/pelvis likely secondary to cancer vs adhesions from previous surgery. CXR shows L basilar consolidation and right suprahilar soft tissue mass. Lesions have increased in size since previous imagining in early December.    Patient also tested positive for COVID but has been asymptomatic respiratory wise. She is fully vaccinated and boosted. She does endorse being around a lot of family and friends over the holidays.    Labs revealed an AKI, leukocytosis, thrombocytosis and anemia. Procal and magnesium was elevated. She was given 2L of NS, zofran,  and fentanyl. General surgery was consulted, NGT was placed to LIS. Patient will be admitted to medicine service in anticipation for possible surgery in the near future. Dr. has been contacted by our team.    Of note in the ED she became very tachy cardiac via monitor, however, repeat EKG was reassuring."
lip swelling; tongue swelling; This is a spontaneous report from a contactable pharmacist via Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported) via an unspecified route of administration on an unspecified date, as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after 3 weeks of vaccination, the patient experienced lip swelling and tongue swelling. The outcome of the events was unknown at time of report. The reporter didn't think that was part of the vaccine since it had been 3 weeks, but he wanted to make sure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, cough, headaches  Netti pot  Loratadine 10 mg daily   OTC Sudafed    Tylenol    Plenty of rest / fluids
About 5-10 minutes after the patient received the vaccine, she lost consciousness and fell off her chair. She regained consciousness and I had her lay on the ground on her back. Her blood pressure was 88/69, heart rate was 86 and she was sweating a lot. EMS came and took her blood pressure again and it was 110/80. She went to the hospital for further observation and they did an EKG and said everything was normal, and now she is feeling okay.
Patient is an ICU nurse who experienced acute demyelination within the central nervous system within one week of vaccination for influenza. MRI brain: focal areas of T2 signal around frontal horns and atria of lateral ventricles and (L) cerebellum with at least 1 enhancing lesion. MRI cervical spine: multiple demyelinating lesions with cord expansion. MRI thoracic spine: multiple demyelinating lesions.
muscle pain activated by motion at injection site starting 8 hrs after injection and subsiding 22 hrs after injection
After receiving the vaccine,  the patient waited for 30 minutes in front of the pharmacy. After 30 minutes the patient walked up to the pharmacy's counseling window and told me that she was experiencing sore throat and her tongue was swollen. I immediately, call for the store's management to head to the pharmacy and administer 10 mL of benadryl to the patient orally. Explained to the patient that both her and I will be sitting down for another 30 minutes to make sure the symptoms don't progress. After 25 minutes the patient said her symptoms were getting better. I followed up with her the next day and she said she feels much better.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Soreness in arm at injection site immediately after injection. Awakened at 1:30 am approx. 12 hours after injection with chills and fever of 100.1 degrees. Also felt very sore in arms and legs and weak. Fever broke about 6:00 a.m. so far has not returned but I still feel achy and weak and arm is still sore.
Staring spells with limb stiffening. Possible seizure activity. Followup/diagnostic testing ordered.
While working with the  Department of Health it was determined that our vaccines were out of the temperature recommendations for a brief period of time before vaccination.
Initial unsolicited report received from a pharmacist on 10 July 2015. A 19-year-old male patient, whose concomitant medications were not reported, had received an intramuscular a dose of TYPHIM VI (batch number- K0330-1, expiration date 18 July 2015) in right deltoid on 10 July 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. On 10 July 2015; few minutes after vaccination, the patient became light headed and he felt very hot. The patient sat in a patient area for a while and began to feel better. Laboratory investigations were reported as none and corrective treatments were not reported. At the time of this report; the patient was recovered from the events. Documents held by sender: none.
Dose received from vial opend> 12h; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose received from vial opend> 12h) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis (RA). Previously administered products included for Product used for unknown indication: Janssen COVID-19 Vaccine on 04-Oct-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 Vaccine. Concurrent medical conditions included Penicillin allergy, Hypothyroidism, Hyperlipidaemia NOS, Hypertension and Alzheimer's disease (ALZ). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, TICAGRELOR (BRILINTA), DULOXETINE HYDROCHLORIDE (CYMBALTA) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.    On 10-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose received from vial opend> 12h). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose received from vial opend> 12h) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported. No adverse event outcomes were noted. It was reported that dose of the vaccine was given greater than 12 hrs after the vial puncture.  Patient had Janssen   This case was linked to MOD-2021-416295 (Patient Link).
Abrupt diarrhea and cramping occuring one week after vaccination. Lasted 1-1/2 days. Self-care, took ibuprofin for pain. Sinus trouble for one week, following two days after vaccination.
Mild rash starting, followed by irritability and worsening of rash. High fever began 1/19/2011 and continued. Inconsolable crying and exhaustion.
Second bivalent dose was administered when it wasn't recommended yet by CDC guidelines. Patient didn't have any adverse reactions
10 hrs p/vax pt's extremities became stiff, & started drooling, head dropped, not responsive for 3-4 mins;
24 hours following injection, experienced chills; 24 hours following injection, experienced some fatigue.; Booster / Dose received : 3; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 50125BA) via an unspecified route of administration in the left arm on 30Sep2021 at 02:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes (II) and known allergy to penicillin.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to COVID vaccine. Concomitant medication included influenza vaccine inact sag 3v (FLUAD) for an unknown indication in the left arm on 23Sep2021. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 19Feb2021 at 10:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 29Jan2021 at 11:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. On 01Oct2021 at 14:00, 24 hours following injection, the patient experienced chills and some fatigue. This persisted for about 4 hours. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 24 hours following injection, chills and some fatigue was resolved on 01Oct2021 at 18:00.  Amendment: This follow-up report is being submitted to amend previously reported information: to update vaccination facility information and adverse event off label use was removed since the booster dose was administered after 22-Sep-2021 and off label use checkbox was unchecked in product notes accordingly.
Can't sleep due to itching; Very itchy rash; Full body rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Full body rash), RASH PRURITIC (very itchy rash) and SLEEP DISORDER (can't sleep due to itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (Full body rash), RASH PRURITIC (very itchy rash) and SLEEP DISORDER (can't sleep due to itching). At the time of the report, RASH (Full body rash), RASH PRURITIC (very itchy rash) and SLEEP DISORDER (can't sleep due to itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included antihistamine and an ointment.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUN-2021 contains updated reporter information.