chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cold; reaction to Covid shots; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) and IMMUNISATION REACTION (reaction to Covid shots) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Pneumonia (Double pneumonia), Cervical cancer, Loss of memory, Pain in spine, Thrombus and Hysterectomy. Concurrent medical conditions included Relapsing-remitting multiple sclerosis, Osteoporosis, Bursitis, Migraine and Atrial fibrillation. Concomitant products included OCRELIZUMAB (OCREVUS), IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA), APIXABAN (ELIQUIS), ONDANSETRON (ZOFRAN [ONDANSETRON]), BUTORPHANOL TARTRATE, DIAZEPAM, MIRTAZAPINE, TIZANIDINE, METOPROLOL, POTASSIUM, VITAMIN C [ASCORBIC ACID], CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3), OXYCODONE and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold) and IMMUNISATION REACTION (reaction to Covid shots). At the time of the report, NASOPHARYNGITIS (cold) and IMMUNISATION REACTION (reaction to Covid shots) outcome was unknown.            It was reported that the patient had a "reaction to Covid shots". The patient further clarified that after she received the Moderna Covid vaccine she was always cold, even if it was 90 degrees outside, she has a sweatshirt on. The patient reported that she was not permitted by her doctor to receive the Covid booster because of the reaction.  Treatment information was not provided.
Migraine  High blood pressure  Bruises  Blood clot  Dizziness  Nauseous  Fatigue  Itching  Chills Muscle aches
At this point, it isn't actually an adverse event. came to the pharmacy to receive his second Shingrix dose and my nurse accidentally gave him a Pfizer Covid-19 dose instead.  had already completed his Pfizer Covid-19 vaccine series about 3 weeks ago. I have notified his prescriber and they said they will monitor the situation.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (subcutaneous, 0.5 ml, once). No adverse effects were reported. Additional information has been requested.
Redness/swelling to left thigh Friday night.  to ER on Saturday, continued red/swollen.  Rx for Amoxi illan.  Childrens Advil, ice pack to effected area.
From July 14 to July 20, 2021 intense mid back pain, low back pain. Does not improve with medication or relaxing creams. It does not go away, it was not there before getting the Covid-19 vaccine.
Covid exposure on 3/3/2021.   3/9/2021  received first Pfizer vac.  Within an hour was nauseated with pressure pain across the top of her stomach "under her ribs" and nausea.  3/10/2021 dev fever, weakness, and cough.   Covid test 3/12/2021 neg.   Eval in walk in clinic.  Diag allergies.  Rx oral steroid and Amoxicillin.   A couple of days later, symptoms still continued.  Eval in her physician's office 3/18/2021.  Given steroid injection and antibiotic changed to Azithromycin.   3/19/2021  felt worse with pain/pressure under ribs and upper abd.  eval in ER.   O2 sat 87 improved to 93 with oxygen.  Labs, chest xray, and CT scan obtained.  Covid test neg.   Admitted to hosp with diag of bilat pneumonia.  Discharged on 3/22/2921 with steroids to take over next 5 days.   She continues to have mild cough and pressure under her lower ribs.  F/u appt scheduled with her physician.   Was advised by her physician  her pneumonia might be a reaction to the vaccine.
The following day after receiving my first vaccination my right arm had numbness and tingling down to my fingertips, redness at injection site, and a nodule the size have a golf ball.  On the second day after receiving vaccine I continued to have the numbness and tingling down my arm, the redness had spread to over half of my right arm, and I started to have headaches and nausea for the next two weeks.
Mother states his site of injection red and size of egg. Complained of itching all over arm and right side of face.  No other rash.  Mother has been giving Benadryl 25mg 2 times a day along with Ibuprofen til today, 10/20/2014. Redness gone today but injection site still slightly swollen. Mother inquiring if he should go to school.  Instructed he should be able and if any other S & Sx occur to check with Clinic or ER if severe. Reinforced information of other adverse reactions.
Pt recvd vax 24SEP92 & exp tingling in legs; pt recvd 2nd dose of vax & did not report and noted problems;
For about a month after the vaccine, I had severe vertigo to where I didn't feel safe driving a car and was unable to work.  I had to see a physical therapist that specialized in treating vertigo and used their techniques to train myself out of the severe vertigo.
This spontaneous report as received from healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2015, the unspecified number of patients were administered unspecified doses of improperly stored GARDASIL (lot # K006124 and expiry date: 02-FEB-2017). No adverse effects were reported. No product quality complaint (PQC) was reported GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Neck stiffness that started 3-5 min after vaccine. Improving, but saw Dr. today for muscle spasm.
Tightness or pain in jaw and ear on left side like I ate something sour and have a headache near my ear
Four hours post vax, the pt developed a fever, chills, and tightness in his throat/chest. Because of his preexisting cardiac problems, he went to the ER. He was advised to rest, drink plenty of fluids, and take some Tylenol.
Within 12 hours of receiving vaccine patient experienced swelling and redness in left side of face. Resulted in sinus infection. Skin red and blistered on forehead.
lost his sense of smell and taste; Muscles in arm aching; Sense of smell comes and goes similiar to when he had Covid; This spontaneous case was reported by a non-health professional and describes the occurrence of ANOSMIA (Sense of smell comes and goes similiar to when he had Covid), AGEUSIA (lost his sense of smell and taste) and MYALGIA (Muscles in arm aching) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced ANOSMIA (Sense of smell comes and goes similiar to when he had Covid) and MYALGIA (Muscles in arm aching). On an unknown date, the patient experienced AGEUSIA (lost his sense of smell and taste). At the time of the report, ANOSMIA (Sense of smell comes and goes similiar to when he had Covid) and MYALGIA (Muscles in arm aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 16-SEP-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M009768 with expiration date at 23-FEB-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
received the 2nd dose 20 days after the 1st one; A spontaneous report was received from a health care professional, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient received the 2nd dose 20 days after the 1st one.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that the patient received their second dose 20 days after receiving their first vaccination.   Action taken with study drug was not applicable as the subject had already received both scheduled doses  The outcome of the event, the patient received the 2nd dose 20 days after the 1st one was resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273 (lot# unknown) with no associated AEs reported after the second dose.
Sore at injection site for 3 days; extremely tired for 7 days, hungry but food did not settle well on stomach for 7 days, incontinent of stool  twice on 2nd day;  very itchy, tiny raised blebs on chest, started 2nd or 3rd day, got progressively worse so on 4th day I took Benadryl daily, 25 Mg., oral, some days twice, tiredness got better after starting Benadryl.  Itchy rash continues and it is day 7 today.
Tightness in chest, shortness of breath, feel the need to take heavy deep breaths because tightness. Infrequent but sometimes painful palpitations and fluttering in chest. Increased anxiety and stress since first symptoms. Mornings and evenings significantly worse. Pain/pressure on lower left of chest in the front.
Very cold and difficult to warm up starting in early morning  hours through afternoon,  very tired, head felt too heavy to lift, no appetite throughout day. vomited in the morning
Pt with cellulitis of right thigh 2"x1" redness ? Able Started on Ceftin po bid x 7 days.
The employee reported to the Observer RN for skin redness from neck to chest and down to body/trunk; also "feel throat tightness".  She was taken to Emergency Room for further evaluation.
pt made multiple initial appointments at both pfizer and moderna sites. he went to moderna site for first injection and then to pfizer site for his second, he received a mixed series , no AE's were noted while on site . he was counseled on the vaccine series administration protocol
sore leg after covid and flu vaccinations; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An 8-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore leg after covid and flu vaccinations". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Friday 1:30pm - shot administered, Friday ~5:30 - feeling of being in a haze/mental fog, fatigue, warm and sweaty. no fever, Saturday ~630am - woke up from a headache and body aches. Saturday ~730am - curled up in a ball, in bed, uncomfortable to move due to body aches.  pounding headache. Saturday 10:30am - chilly.  took a shower. Couldnt get the water warm enough which was very odd.  took 800mg advil. Did nothing for headache or body aches. spent the rest of the morning/afternoon in bed. Saturday 3:30pm - headache subsides, body aches still present but beginning to subside. Saturday ~630pm - headache starting to come back, only have muscle aches in my legs. Shoulder more sore than it had been since the shot. Sunday morning - swollen lump at injection site. sore, tender.  headache. no body aches to speak of. Sunday ~10am - out for a walk with the dogs, got nauseous and fatigued.  no other adverse events to note.   Sunday evening - started feeling dizzy/slightly nauseous again when I'm up and moving around. Dizziness continued to Monday. Arm still has swollen lump and sore.
acute colitis, neck stiffness, n/v, diarrhea, h/a, back pain, eye irritation, pain w/urination, retina adhered to cornea, knee popped & filled w/fluid, muscle & joint pain, vision rt eye blurred;bed rest until 27SEP
12 hours after vaccine woke up with fever (100.3 F), chills, body ache, headache.
Received second dose Moderna vaccine on Monday 1/25/21 at approx 0730.  On Tuesday 1/26, woke up with fever of 101.1, body aches, and redness/swelling at injection site on R arm--approx 1 inch diameter.  Treated fever with Motrin and fever was reduced.  On Wednesday 1/27, woke up with increased redness/swelling to R arm, 2-3 inches across up, 2 inches up arm.  Area red, hot, swollen, with increased tenderness.  No fever noted on 1/27.  Contacted employee wellness and occ health.  On Thursday 1/28, redness and swelling decreased, tenderness still present.  Large bruise noted to area.
Patient began to feel cold and clammy, and lose color in his skin.  He temporarily lost consciousness for about 2 minutes.  I monitored his pulse and respiration and he began to feel better after about 5 minutes.  He remained seated for 10 more minutes and left under his own power.
Swelling redness in arm 8days after shot swelling is the size of a fist.
I had a mild asthmatic reaction. I took my inhaler when I got home and felt better.  Since receiving the vaccine, my menstrual cycle has gone from 28-34 to 44-76 days. We are trying to get pregnant and we are unable to tell when I am ovulating. I have never had an issue with missing my period in my entire life and this is completely out of the ordinary for me and it started after I was vaccinated. We are going to have to go to a fertility doctor because of the irregularity of my period and the prolonged time between periods.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N001528 with expiry date: 13-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Swollen left upper lip; took Claritin in on 10th with some relief. Saw provider at  health center on 5/10 in am. "Achy, fatigued" by 11 am; patient states this would be r/t sleep deprivation.
I had a brain bleed on 08/07/2021. I was diagnosed at a small hospital. They flew me to another larger advanced hospital and I received care. I received some therapy and flew back to home. I am continuing therapy since I had experienced stroke-like symptoms. I also had loss of appetite and stuttering.
Severe pain in joints; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203) via an unspecified route of administration in the right arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included arthritis on an unknown date. Concomitant medications were not reported. The patient previously received sulfa drugs (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced sulfonamide allergy, codeine (MANUFACTURER UNKNOWN) and morphine (MANUFACTURER UNKNOWN) both for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9809) via an unspecified route of administration in the right arm on 02Feb2021 at 13:00 as a single dose for COVID-19 immunisation. On 05Mar2021, since the patient got the second dose the patient had severe pain in her joints. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with prednisolone (MANUFACTURER UNKNOWN) from an unknown date in 2021 and without relief. This pain had lasted 3 months. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain in joints was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
JYNNEOS vaccination error no wheal Patient revaccinated 0.5 SQ
Pt recv vax on 1/11/99; on same day pt exp crying w/ difficulty to console & fever (99.8-100.3)
A healthcare professional reported that a 37 year old female inadvertently received 0.1 cc of Pnu-Imune 23 intradermally on 4/27/00. A half hour later, the pt developed an injection site reaction characterized by redness and swelling.
Pain in the legs and shoulders that affected the muscles and patient states that she could not walk. Patient had also been to the gym the day before. She did not receive anything at the urgent care to treat the pain. Fever with a temperature of about 101 degrees Fahrenheit.
ITCHING, REDNESS, AND SWELLING APPROXIMATELY 1 INCH BELOW INJECTION SITE
About 2 hours after vaccine administration, child complained of severe "shooting" pains in L neck, L arm and B legs. Tender on all those areas. Next morning with vomiting, T101, sore throat and small rash at injection site.
Myalgia, ARM PAIN, FATIGUE, MUSCLE ACHES Narrative:
Pt received ZOSTAVAX and pneumococcal vaccine 11/21/22. Dr called 11/22/11 - stating she developed redness, swelling, pain at the left lower arm with sling  hx fever = 100.0 - 99.0.
after the vaccine when my menstrual  cycle began it was very heavy the blood flow was nothing I have ever  seen I have never experienced anything like it . I was overwhelmed by  the constant change I had to do to keep up.   I did keep my family on the loop incase something drastic was to happen. the same week on the 25th  of october 2021 I went to the doctor to see if there is anything wrong
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, dose and route were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
About 10:30pm on 2-27-2021 patient became short of breath and ended up with O2 Saturation of low 70%. This was explained to our staff when she returned for her second dose. it was discussed and decided not to receive second dose. 3 day in the hostipal.
ELEVATED LIVER ENZYMES; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the subject experienced elevated liver enzymes. On MAR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Elevated liver enzymes (NR: not provided) Liver enzymes elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and elevated liver enzymes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210403235.
Starting the night after vaccination, had a rapid heartbeat, sweating, and anxiety that I have never experienced before. I did not sleep at all for about 7 days. After day 3 of no sleep, I sought treatment for the issue. I was prescribed Ambien to try to help me sleep. It did not help at all. Day 4 of no sleep I went to the ER where they ran blood tests and performed an EKG. All tests were normal. Day 7 of no sleep I was admitted to a behavioral health inpatient facility to help me sleep. I finally was able to sleep with the help of an antipsychotic drug. I was there for 4 days and then discharged. I left with a script for Remeron to help me sleep. Some days I have slept well and others not so much.
pt recv vax 11JUL95 & pt devel a puffy, crusty rash from chin to ankles which was noted to be possible atypical measles;rash left unsightly blotches all over pt body;maculopapular eruption devel
Information has been received from a pharmacist referring to a patient of unknown age. Concurrent conditions and medical history of the patient were not reported. On 02-APR-2016 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot# K009107, expiration date 21-JAN-2016) (dose and route unspecified). Other suspect and concomitant therapies were not reported. The reporter stated the PNEUMOVAX23 did not have any previous temperature excursions. No adverse symptoms reported. Additional information has been requested.
heart palpitation, shortness of breath (did not require hospitalization, pain on right side of chest and arm. Felt like I had to take a deep breath every 15 minutes for about five-seven days. Heart palpitations were mostly on 4/18/21
Adverse events: muscles aches, chest pains, nauseau, dizziness and headaches  Treatment: hospitalization, prescribed colchicine upon release Outcome: 2 month follow-up appointment signaled nothing note-worthy; on and off chest pain since the event