chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upper body area and feels cold; Mini 30-60 minute episodes like a hot flash; Fever; chills/still experiencing chills for more than a month; Received her second dose one week late; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received her second dose one week late), FEELING COLD (Upper body area and feels cold), HOT FLUSH (Mini 30-60 minute episodes like a hot flash), PYREXIA (Fever) and CHILLS (chills/still experiencing chills for more than a month) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 025A21A) for COVID-19 vaccination.     Concomitant products included CICLOSPORIN (RESTASIS) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Received her second dose one week late). On 10-Apr-2021, the patient experienced FEELING COLD (Upper body area and feels cold), HOT FLUSH (Mini 30-60 minute episodes like a hot flash), PYREXIA (Fever) and CHILLS (chills/still experiencing chills for more than a month). On 07-Apr-2021, OFF LABEL USE (Received her second dose one week late) had resolved. At the time of the report, FEELING COLD (Upper body area and feels cold), HOT FLUSH (Mini 30-60 minute episodes like a hot flash), PYREXIA (Fever) and CHILLS (chills/still experiencing chills for more than a month) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information reported included heat pads.   This case was linked to MOD-2021-062367 (Patient Link).
Blood clot developed in the upper arm from arm pit to elbow. This was the  same arm as injection site . Clot developed within 4 days. Diagnosed as DVT of axillary vein, acute.
Developed fever around 3am, woke at 8am and my skin was extremely sensitive (hurt) to touch, including clothing, water (shower), drying off with towel. Became faint and light headed, had to lie down a few times over the course of 2 hours. Took Tylenol rapid release, felt better within 1.5 -2 hours.
Severe Aches in back neck hips, Severe headache, High fever, Lassitude.
Myalgia. Methylprednisolone, Famotidine, Diphenhydramine.
Recd vax 8AUG91 & exp h/a; 12AUG91 had one sz in AM & passed out; Had 2nd sz in PM & went to ER; EKG showed nonspecific T-wave abnormality; anemia was rx'd w/Fe PO; p/ d/c pos Lyme titer of 1.3 & c/o severe lethergy & instability see WORM..
site of injection is in pain; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (site of injection is in pain) and PYREXIA (fever) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (site of injection is in pain) and PYREXIA (fever). At the time of the report, VACCINATION SITE PAIN (site of injection is in pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment details were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: TCR - Patient declined for further follow-up
Case number PHEH2015US026842, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 31 year old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 19 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Pt recvd 2 doses of Engerix-B & between 22JUN & 24JUN mom reports rash behind ear, fever & poor eating; tx APAP;
Treatment of COVID-19; Treatment of COVID-19; Moderna, Date: 23Oct2021/ Pfizer, Date: 02Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Lot number: 037K20A), in left arm, on 23Feb2021 as dose 2, single (Lot number: 002A21A), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: 047C21A), in left arm and on 06Jun2023 as dose 6 (booster), single (Lot number: 065H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "H pylori (recovered)" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Apr2022, outcome "not recovered", described as "Moderna, Date: 23Oct2021/ Pfizer, Date: 02Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Jun2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2023) Positive, notes: tested positive; (25Jul2023) Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
PATIENT LIED ABOUT AGE AND RECEIVED VACCINE AT 17 YEARS OLD. AGE WAS CAUGHT 10 MINUTES AFTER ADMINISTRATION
positive tested for COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive tested for COVID-19) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FISH OIL and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced COVID-19 (positive tested for COVID-19). The patient was treated with AZITHROMYCIN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and VITAMINS NOS at a dose of 1 dosage form. At the time of the report, COVID-19 (positive tested for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
My son had a sleep walking incident at around 11:00 PM the same night that he received the vaccine that was dangerous and disturbing (and a little funny). He has no prior history of sleep walking. He woke me up at 11:30 PM to tell me he had made breakfast for me. He was highly excited and anxious for me to come and have my breakfast. I could smell toast. When I got up all the lights were on in the kitchen and dining room. There was a plate on the dining room table with toast that had a pile of peas and syrup on top. There was also a bowl with oatmeal, raisins, hot sauce, butterscotch ice cream topping, a hardboiled egg cracked in half with the shell still on on top of the oatmeal along with his karate mouth guard. Condiment jars and bottles were scattered around the table. In the kitchen he had combined, milk, Sprite, Root beer and Rice Vinegar in a tall glass. The Kitchen smelled strongly of the rice vinegar. All of the containers were scattered on the kitchen counter. He was extremely excited for me to eat the breakfast and seemed drunk. I thanked him and told him he could go back to bed and tucked him in. As I left the room, he asked me if I loved the breakfast.  When I cleaned up, I found a glue stick in the oatmeal bowl he'd prepared for me. It occurred to me that this must be related to the vaccine he'd received that day.  When I went online I found some disturbing references to sleep disorders related to Gardasil 9. We've been watching him for further sleep walking incidents and he hasn't had any, but I'm extremely hesitant to give him the booster shots.
Pharmacist mixed a pediatric vial of Pfizer Covid instead of the adult version. Patient received a pediatric vaccine. Pharmacist on duty called Pfizer and pharmacy was informed to call patient and have them return for a full dose of the adult version as soon as possible. The patient returned on 12/07/2021 and received the correct dose. Patient had no issues.
Pt given PNEUMOVAX & FLUVIRUI in same arm at same time b/c pt s/p mastectomy and no lymph nodes in right arm.  Pt experienced 3" X 3" in flamed rash which was very painful and feels "hard" to the touch.  Tingling radiates down left arm to fingers, comes and goes with position.
Initial report received from a health care professional on 28 October 2013. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number UH898AD), via intramuscular (IM), (site of vaccination were not reported), on 28 October 2013. On 28 October 2013, patient received vaccine during her pregnancy. Patient did not experience adverse event. Documents held by sender: none.
redness & swelling @ inj site of DTAP (lt thigh)-almost 50% of medial thigh area;Keflex & DPH & cold compress;
A FEW HOURS FOLLOWING INJECTION, NOTICE SORENESS. AT THE END OF THE EVENING, PT COULD HARDLY LIFT ARM. THE NEXT MORNING AFTER THE VACCINE THE PATIENTS ARM WAS RED AND SWOLLEN AROUND ENTIRE DELTOID AND TRICEP AND WARM. THIS INFLAMMATION AND WEAKNESS IS STILL THERE AND STARTING TO GO DOWN AROUND DAY 3. PATIENT HAS APPLIED COLD COMPRESS AND TAKEN IBUPROFEN FOR INFLAMMATION AND PAIN. PT HAS NEVER EXPERIENCED SUCH A SEVERE REACTION OR INFLAMMATION FROM A VACCINE BEFORE.
Two months after receiving my second dose of the Pfizer COVID19 vaccine, I suffered a stroke.  Symptoms included vision loss, complete left-side paralysis, loss of cognition, and loss of consciousness.  Within ~15 minutes of the event, I was transported by ambulance to the nearest hospital and provided care.  Within 3 hours of the event, I received tPA (Tissue Plasminogen Activator), and recovered fully.
No adverse effects immediately after the vaccination. Very sore arm at night. The following morning and afternoon fatigue, muscle aches and mild headache. Arm continues to be mildly sore, but a large area at the injection site is red, swollen and bumpy, like a rash, with no itchiness. About a four inch irregular area. Still very tired with mild muscle aches at 7pm.
(RA) SC area 2 days later arm very red & swollen, from shoulder down to elbow on (RA).
Donor reports of weakness about an hour after shot and felt Nausea, vomiting, and feverish for 24 hours. Donor  reports of taking Tylenol and Ibuprofen and a good night of rest and felt back to her normal self.
All side effects subsequent to2nd Moderna vaccination shot exhaustion headache chills (temp not taken) Above lasted <48 hrs Itchy, burning  vaccination site- continues  5 days post vaccination
Pain and soreness in arm through afternoon on 2/12 after getting vaccine. I started to get a small lump on my arm. That evening I had bad chills through the night and next morning. I took tylenol and got a low fever on 2/13. Lump was red and grew all day. Had low fever all day, increased to 101.6 in afternoon despite the Tylenol. Fatigue, headaches, and body aches. 2/14 I felt better in the morning. Headaches and fatigue still. Large red lump/swelling on arm (around 3 inches wide) at site of vaccination, arm still sore and painful to touch.
started 11 pm same date. severe chills , couldn't begin to get warm. Wanting to sleep all the time. It lasted till 9 pm 01/28/2021
Flu shot L/ pneumonia R-became red and swollen, tender to touch, hot to touch. had gotten pneumonia maybe two year ago. No SOB. Tx with Medrol dose pack/Cephalexin 500 bid. Pt called 11/20/02 re: adverse reaction. Add: when pt asked Re: notifying clinic re: adverse reaction. She stated "I thought it would pass."
Pt had neck jerking once on 10/13/2009 and another neck jerking on 10/14/2009.  Pt denied c/o pain, weakness, or other s/s
Mom called on 2/4/22 saying Pt's arm had swelling and rash around vaccine injection site. Pt did not complain of any pain, just that arm was itchy.  Pt was seen in clinic on 2/4/22 and was told to take Benadryl to help with swelling and itchiness.  Border was also drawn around swelling and mom was told to call if swelling or redness gets larger. Ice was also suggested as a treatment.
My pregnancy was completely normal. Every test was normal. On 4/4/21 when I was 31 weeks pregnant my son?s heart stopped unexpectedly. He was stillborn on 4/5/21. The cause is unknown. My due date was 6/6/21. My son weighed 4 lbs, 1 ounce which was normal.
I had a runny nose and a sore throat for quite a while. I tested myself for COVID-19 and was negative. My symptoms got worse, and I developed body aches and headaches. I tested again and it was positive. It lasted for 11 days. I tested four more times and was positive each time. I finally tested negative on 01/02/2023. I had a tele visit with my doctor the day before I tested positive. I had the appointment because I had red eyes. They were not irritated, but just red. She prescribed something for my eyes, but I did not require any treatment for the COVID-19.
Missed the Recommended interval inter doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the Recommended interval inter doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-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 PRODUCT DOSE OMISSION ISSUE (Missed the Recommended interval inter doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the Recommended interval inter doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported. No concomitant medication was reported.
Booster Dose given too soon. 1st dose administered 7/30/2021 2nd dose administered 8/20/2021
He has developed a rash macular rash, that gradually grew in size over a period of 1 week. No pain, no numbness. Has some itching.
Left ear moderate to severe tinnitus, occurs 1-2 days post vax and continues up to 2 weeks. Left knee pain and periodic right leg joint pain.
2 Hours aFter receiving vaccine while at school Patient started to Feel weak along with nasal congestion and sneezing. The Following morning patient was so weak she could not get out of bed. Unable to stand up and move her arms. For part oF That morning. Pt was able to get up towarD The end of The morning but still Had to sit down a lot due to Feeling weak.
Patchy hairloss, eventual complete baldness and loss of eyebrows and eyelashes.  Contracted an auto-immune disease
Patient did not get 2nd dose on monday 12Apr2021; Had a fast heart beat that lasted; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Had a fast heart beat that lasted) and INTENTIONAL PRODUCT USE ISSUE (Patient did not get 2nd dose on monday 12Apr2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PALPITATIONS (Had a fast heart beat that lasted). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient did not get 2nd dose on monday 12Apr2021). At the time of the report, PALPITATIONS (Had a fast heart beat that lasted) had not resolved and INTENTIONAL PRODUCT USE ISSUE (Patient did not get 2nd dose on monday 12Apr2021) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.
Diluent administration only; Diluent administration only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 377A4, expiry date 17th February 2024) for prophylaxis.   On 28th February 2023, the patient received Shingrix. On 28th February 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: A reporter called in to report the administration of the diluent of Shingrix to a patient without reconstitution of lyophilized component. The Shingrix maladministration of the AS01B adjuvant only. The reporter asked how to proceed with the patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Information Tab: A reporter called to report the administration of the diluent of Shingrix to a patient without reconstitution of lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient complained of numbness and tingling sensation in mouth and later complained of tongue swelling. Patient was observed, vital signs taken, given H20, O2 6L, and epinephrine.  Patient then transported to Emergency Department.
t104 ax, persistent crying inconsolable for 4 hrs; could not be comforted;
reported sx started 1/5/21 at 7 am noticed injection site was red, itchy, warm, and hard.  took photos.   took benedryl at night before med.  no change over course of day, size circle 1/5 inches.   1/6/21 states itch has decreased, still red and hard and now a circle around it making total size 3 inches and 'most of upper arm'.  Suggested applying ice, calling PCP and sending photos from both days.  If PCP cannot see to go to urgent care or ED for evaluation and evaluation about getting vaccine injection #2
24 hours after the immunization was given the child had a high pitched scream for 48 hours then it resolved.
Information has been received from a nurse practitioner concerning a 22 year old female with pertinent medical history and drug reaction/allergies not reported who on an unspecified date was vaccinated with the initial dose of Gardasil injection. Concomitant medication was not reported. In December 2006 ( a few weeks ago), the patient fainted after Gardasil was administered. The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.
THE PATIENT SLUMPED OVER IN THE CHAIR AFTER THE SHOT WAS GIVEN AND WAS UNRESPONSIVE FOR ABOUT 5 SECONDS (AT 4.35PM). HE RECOVERED IMMEDIATELY AND SAID HE MUST HAVE FALLEN ASLEEP. HE THEN BROKE OUT IN A SWEAT, I GAVE HIM WATER, TURNED ON A TABLE FAN AND TOOK HIS BP- INITIAL READING AT 4.38 WAS 87/37/36  I SAT WITH HIM FOR 30 MINUTES AND TOOK HIS BP EVERY 10 MINUTES- 4.50PM -124/75/46, 5PM-124/78/50, 5.11PM 113/78/48. PT SAID THIS WAS HIS NORMAL READING. PT INSISTED THROUGHOUT THAT HE WAS OK AND COULD GO HOME. HE SAID THIS HAS HAPPENED TO HIM A FEW TIMES BEFORE WHEN HIS BLOOD IS BEING DRAWN BUT FIRST TIME WITH A VACCINE. HE LEFT AT 5.16PM AND WE WALKED HIM TO HIS CAR. I CALLED HIM AT 8.48PM SAME DAY 8/3/21 TO CHECK ON HIM, HE SAID HE MADE IT HOME OK AND IS FEELING OK. I ADVISED HIM TO GET AN MD AS HE HAS NONE NOW AND TO CALL ED IF HE DOES NOT FEEL OK AGAIN.
Hard, swelling lump at site of injection, very itchy and tender , red in color and hot to touch
Patient came in from out of state requesting 2nd dose of Twinrix and Shingrix. Vaccines were given. While entering admnistration information. pharmacist realized it had not been 2 months since first Shingrix dose. Spoke to representative from GSK on 01/17/2020 3:00p and based on CDC recommendations, it has been at least 4 weeks since first dose, so it does not have to be repeated. No adverse events/side effects have been reported.
This spontaneous report was received from a medical assistance and refers to patient of unknown age and gander. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 13-NOV-2017, the patient was vaccinated with 1 dose of improperly stored ROTATEQ, orally, lot # N009962, expiration date 15-NOV-2018, for prophylaxis. The vaccine underwent a temperature excursion between 47 to 77 Fahrenheit degrees for 20 minutes. No previous excursions were reported. Digital data logger was involved in recording the excursion. No adverse effects were reported.
Pt. had minor swelling of his upper arm and redness. It started the day after he received the injection and the swelling lessened but the redness is the same.