chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported that she had chest pain, malaise, and back pain with the Moderna vaccine on 3/3/21 per provider NP.
Missed the appointment of Moderna COVID-19 vaccine/ missed the appointment for the second shot; Not feeling well; Redness from the shot; Felt like a baseball bat hit my shoulder/ I felt weird, a lot of pain; Shoulder was cramping up/ arm was cramping; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Shoulder was cramping up/ arm was cramping), PRODUCT DOSE OMISSION ISSUE (Missed the appointment of Moderna COVID-19 vaccine/ missed the appointment for the second shot), MALAISE (Not feeling well), VACCINATION SITE ERYTHEMA (Redness from the shot) and VACCINATION SITE PAIN (Felt like a baseball bat hit my shoulder/ I felt weird, a lot of pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced MUSCLE SPASMS (Shoulder was cramping up/ arm was cramping), VACCINATION SITE ERYTHEMA (Redness from the shot) and VACCINATION SITE PAIN (Felt like a baseball bat hit my shoulder/ I felt weird, a lot of pain). On 05-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the appointment of Moderna COVID-19 vaccine/ missed the appointment for the second shot) and MALAISE (Not feeling well). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 800 mg three times a day. At the time of the report, MUSCLE SPASMS (Shoulder was cramping up/ arm was cramping), MALAISE (Not feeling well), VACCINATION SITE ERYTHEMA (Redness from the shot) and VACCINATION SITE PAIN (Felt like a baseball bat hit my shoulder/ I felt weird, a lot of pain) had resolved and PRODUCT DOSE OMISSION ISSUE (Missed the appointment of Moderna COVID-19 vaccine/ missed the appointment for the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken by the patient included multiple medications to treat Lupus.  Treatment activities included some pain medications.
paraesthesia; Body wide intense itchiness; tickle in throat; Hives in flushes over arms,trunk,face and upper legs; some sensation of tightening; increased mucous production; several weeks late on 2nd dose; closed up 2nd dose appointments for all the health care providers without notice; dry itchy eyes; dry itchy eyes; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (paraesthesia), PRURITUS (Body wide intense itchiness), OROPHARYNGEAL DISCOMFORT (tickle in throat), URTICARIA (Hives in flushes over arms,trunk,face and upper legs) and THROAT TIGHTNESS (some sensation of tightening) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CETIRIZINE for an unknown indication.    Concurrent medical conditions included Paraesthesia generalised (Without known cause which flares during some viral infections or intense heat/ UV exposure. It is usually at a low fuzzy feeling but intensifies to pin-pricks when viral sickness.) since 2010.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and CETIRIZINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced PARAESTHESIA (paraesthesia), PRURITUS (Body wide intense itchiness), OROPHARYNGEAL DISCOMFORT (tickle in throat), URTICARIA (Hives in flushes over arms,trunk,face and upper legs), THROAT TIGHTNESS (some sensation of tightening), SECRETION DISCHARGE (increased mucous production), EYE PRURITUS (dry itchy eyes), DRY EYE (dry itchy eyes), PRODUCT ADMINISTRATION INTERRUPTED (several weeks late on 2nd dose) and PRODUCT AVAILABILITY ISSUE (closed up 2nd dose appointments for all the health care providers without notice). At the time of the report, PARAESTHESIA (paraesthesia), PRURITUS (Body wide intense itchiness), OROPHARYNGEAL DISCOMFORT (tickle in throat), URTICARIA (Hives in flushes over arms,trunk,face and upper legs), THROAT TIGHTNESS (some sensation of tightening) and SECRETION DISCHARGE (increased mucous production) outcome was unknown and EYE PRURITUS (dry itchy eyes), DRY EYE (dry itchy eyes), PRODUCT ADMINISTRATION INTERRUPTED (several weeks late on 2nd dose) and PRODUCT AVAILABILITY ISSUE (closed up 2nd dose appointments for all the health care providers without notice) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported No treatment information was provided Action taken with mRNA-1273 in response to the event was not applicable. Patient took cetirizine prior to vaccination with standby epinephrine. A second dose of cetirizine was taken at onset.   This case was linked to MOD-2021-004774 (Patient Link).
Cried all day after shot, inconsollable, fever. Is refusing any food or drunk by mouth for 2 weeks (oral aversion).
Pt was inadvertently given Pfizer for their second dose when they were supposed to get Moderna.
Rash developed within 2-3 days after vaccine starting at injection site, spread to chest, back, arms, axillae
Right knee pain developed 2 weeks after covid vaccine. Patient had total knee replacement in that joint in 6/2023. Subsequent testing by orthopedic surgeon (including CRP, ESR, synovial fluid analysis) negative.
Headache  Nausea Chills/ low grade fever Aches Weakness Stomach ache
Systemic: Unknown, patient found deceased at home evening after receiving vaccine.-Severe, Additional Details: called pharmacy inquiring about vaccine for patient. She received her COVID vaccine on 4/6/21 and later that evening was found at home deceased. Called to gather information on the patient/vaccine. Caregiver stated that the patient did not have a PCP, therefore they do not have much medical history on her. There were no notes on adverse reaction during post-vaccine observation. It is unknown at this time if vaccine played any role.
whelps,SOB,swelling of joints w/pain,muscle pain in feet,hands & knees;seen @ hosp given DPH;seen again 24JUN94 started on Pred & tetracycline x 4 days;sx resolved;14JUL94 devel peculiar rxn of tightness in jaw,stinging in face & mouth
This spontaneous report was received from a 58 years old female patient concerning herself. The patient reported that on 24-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot no. not reported0 instead of a first dose of VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. The patient mentioned her titers were low for varicella and she needed the varicella vaccine for entrance to nursing school clinical. The patient mentioned her arm was sore after receiving ZOSTAVAX. The patient did not seek medical attention. At the time of the report, the patient was recovering from her arm swore. The relatedness for the events were unknown for ZOSTAVAX. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunization; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 01Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given as anti-viral treatment for covid-19 from 22Jun22 to 27Jun22. Other medication given in 2 weeks: Wellbutrin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Slight blurry vision in left eye. Vaccination received in left arm. Intermittent slight blurry vision in left eye for following weeks.
Got COVID; Got COVID; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 (lot number: EL3247), dose 1, single and on 18Feb2021 (lot number: EL3247), dose 2, single; both via an unspecified route of administration at the age of 29-year-old for COVID-19 immunisation. The patient's medical history was not reported and there were no concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22Oct2021, the patient got COVID. The patient underwent lab tests and procedures which included (nasal swab) test: positive on 23Oct2021. No treatment was received for the event. The event was reported as serious (medically significant). The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.
Non-stop leg cramping in the right leg starting from 10 days after the second Pfizer vaccine & still continuing a month later. I went for blood work from my doctor & an ultrasound of both legs from the hospital. Both showed nothing wrong. They suggested lowering my dose of Topiramate from 50 to 25 mg.. this did not help, I am still in severe pain.
Left leg pain and swelling, very pronounced as compared with right leg which did not appear to be swollen.  Patient attempted to schedule with primary doctor, but was not able to set up an appointment.  Patient went instead to an urgent care where she was instructed to immediately proceed to local hospital ER.  Several tests were performed, but patient was not treated.  Instructed to follow-up with Primary Care Physician.
Developed a shingles; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The reporter reported this case for her aunt. The age at vaccination was not reported. The reporter reported that the patient paid for shingles shot and developed shingles after few days later. The reporter reported that the patient never got a refund. The reporter reported that chances are if you don't get the shot, you probably won't get them. This case is linked to the case US2021AMR172883, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR172883:Same reporter
pt recv vax & devel inconsolable crying x 10-11hr; rx observation/reassessment;
02/18/2021 - I woke up and my eye ball was swollen and painful. It felt like something was stuck in my eye that I couldn't get out.
at 2:00 am she had a fever it was 101 degrees,  had chills, had fever through the rest of the day it was 102 degrees Clogged milk / infection of the milk  got prescribed antibitiocs
Patient is a 34 y.o. female who was seen at COVID Vaccine Clinic today for her  dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Moderna vaccination in the left deltoid muscle.   During her waiting period after the injection, the patient began to experience dizziness / lighheaded.  She denied syncope, N/V, visual changes, headaches.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to shortness of breath, swelling of the throat, Difficulty breathing, chest pains. Patient did not experience any of these symptoms   She is 18 weeks pregnant. No complications with pregnancy.
Received a call from patient on 8/20/21 at 1145h; patient stated that she received Pfizer vaccine at 12PM on 08/18/2021 and stayed in the office for 30 minutes without event. While driving home, client states she started experiencing throat swelling and her ears felt like they were closing up so she took a benadryl. She states she got really hot. She stopped at ER and they noted nothing in her throat, client states labs were normal, and they looked up an ingredient of Pfizer and informed client that there was a cross-reactivity to one of the ingredients and her sulfa allergy. The ER administered solumedrol and pepcid. They prescribed prednisone 20mg, take three pills, x5days.
Initial unsolicited report received from Physician on 23 September 2016. This case involves a 77- years-old female patient who was vaccinated with a dose of vaccine Fluzone HD (batch number-UI664AA, expiration date-06 April 2017, dose in series, dose and route were not reported) in "L" on 22 September 2016. Patient's Illness at time of vaccination was denied and pre-existing physician diagnosed allergies, birth defects, medical conditions were denied (any relevant pre-existing conditions). Concomitant medications were reported as none. On 23 September 2016, one day following the vaccination, the patient developed large erythematous patch measuring 4 cm diameter, itchiness (c/o), no warmth and no fever. Relevant laboratory data was not reported. Corrective treatment included Kenalog and Benadryl. On an unknown date outcome of event was reported as recovered. List of documents held by sender: none.
Vaccine was administered 10/05/22 - received a notice on 10/13/22 that this particular lot from Pfizer was short dated and in actuality expired on 9/30 and should not have been used past that date. At the time the vaccine was given it was not believed to be expired. Patient has had no reactions or issues with the vaccine.
Sat a few moments after shot started getting dizzy pharmacist took BP and it kept going up. Felt like she couldn't talk and felt like pressure in her head. Vision got blurry  and a few days later she had throbbing in legs
INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021, and dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-SEP-2021, the patient experienced inappropriate schedule of vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate schedule of vaccine administration and off label use was not reported. This report was non-serious.
Sore arm after injection. 12 hours later had headache overnight. Next day headache almost gone but returned following AM. 24 hours after injection (L) side of neck felt stiff and mild difficulty swallowing. 11/15/12 - pt getting better - arm still sore and neck less stiff feeling.
I had typical moderate soreness at injection site.  On Tuesday morning severe pain started in the shoulder.  Contacted Dr on 9/21 and was instructed by nursing staff to ice and take Tylenol every 4-6 hours.  Pain has not subsided.  Follow-up appointment scheduled with Dr. on 9/23.
Received the shot at 11 am and had felt fine all day.  Arm was sore a vaccine  site but that's it    Then around 10 pm I started to get chills. Within 10 minutes of this I felt violently ill.  The chills amd shaking were intense.  I began vometing and had severe intestinal issues.  This attack came on fierce and lasted until 4 am.    I was sweating and shaking at the same time and for at lease 6 hours.    My body felt tired and drained.    I never expected to be so sick.   The following day  my symptons had began to go away for the most part,  headache and  feeling drained continued for a few more hours.
soreness developed within 2 hours  .  Muscle spasms developed shortly after a.c. well as a frozen shoulder and severe pain.  Called pharmacist around 3:00 and suggested ibuprofen as a ice.  24 hours and sleepiness painful night spasms are less but frozen shoulder. Pain persists.
My son had tested positive for COVID two weeks ago, 08/13/2021, and right after receiving my third dose, I tested positive.
No additional adverse effect reported; Patient received improperly stored VAQTA; This spontaneous report was received from a medical assistant, referring to a 3-year-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 11-NOV-2019, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5 (units not reported), lot # S009562, expiration date on 05-MAY-2019 (anatomical location, route of administration and dose were not reported) which was improperly stored. The Hepatitis A Vaccine, inactivated (VAQTA) vaccine underwent temperature excursions above 47°F (52.09 °F) for 1.39 hours. The previous temperature excursions were above 47°F (64.83 °F) for 13.35 hours. This call was by the digital data logger. There were no additional adverse effects reported.
Body aches, felt cold, night sweats, headaches, Started 1/09/21, resolved by 1/10/21
Shoulder pain where shot was administered, arm still, hard to move.  Took some Aleve and symptoms have lessened.
Extreme fatigue; lethargic; cannot wake up, in deep sleeps often; low energy; frequent headaches; body aches; weakness; stomach problems; nausea; cramps; cannot eat at times; low appetite; neck pain; muscle weakness; brain fog; she has not had blood tests to determine what state her physical health is in. I also read in reports that is vaccine causes infertility, she has not had testing to determine her state of what her fertility is in.
Pt vaccinated with DTP/OPV 5 days later developed lump oral antibiotic treatment given leg required incision & drainage and grew Group A Beta Streptococcus
The first evening after the vaccine, I had strong shaking (the "chills").  In the morning I first took my temperature and had 101.6 fever which lasted all day.  My arm was extremely sore at the vaccination site and whenever raising my arm and lasted over three days.  I was nauseated all day and slightly nauseated the next day.  my fever subsided the next day to 99.6-100.  I had a slight headache.
Bad headache. Joint and muscle pains. Fever of 102. The headache is unbearable.
As soon as I was injected it hurt real bad whole needle was in arm and burned as I was being injected,I then felt lightheaded dizzy weak I asked her and didnt answer told me to sit down and w as it 15 minutes then leave next few days arm felt real sore could barely lift and was tired with headache for 3 days I called my dr,and he said sounds like I was injected incorrectly because of the pain and burning immediately while being injected.I'm now ok.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). On unspecified dates the patients were vaccinated with unspecified number of doses of PNEUMOVAX 23 (Lot # and dose not reported), intramuscular, which had been improperly stored. No adverse effects were reported. Additional information has been requested.
While waiting 30 mins after vaccine administration, 10 mins into waiting period, patient was in waiting room felt dizzy & started sweating. While Walking him to an examine room, pt stated that he lost vision, everything went black, within a few seconds, the vision returned he said. When we walked into the exam room, he felt like he was going to pass out, and started to fall. He was caught before falling by myself & his mother and sat on the floor. BP at that time was 90/52, HR 52, O2 100%.  911 called, rechecked, normal Blood sugar per paramedic, sitting BP around the same, after standing him up, BP drops to 65/32, pt began to feel dizzy & loss of vision again. Pt transported to ER via EMS, mom with him
Patient contacted after vaccination and told he received a 2.5 mL dose, not 0.5 mL dose of Tdap vaccine on 12/14/2006. Syncopal episode, fever, cough caused him to be seen at the emergency department.  Manufacturer contacted- no documented cases of infection from receiving higher doses than 0.5 mL. Vaccine is inactive, so unlikely to have caused the current infection, but wanted to submit this, as patient received 5 times the regular dose, then presented with symptoms 2 weeks later.
left arm under the injection site is  warm; left arm under the injection site is red; left arm under the injection site is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (left arm under the injection site is  warm), VACCINATION SITE ERYTHEMA (left arm under the injection site is red) and VACCINATION SITE PRURITUS (left arm under the injection site is itchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. (0 or U)17F21A, 026A21A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW), ATENOLOL, MULTIVITAMIN [VITAMINS NOS], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ATORVASTATIN, MAGNESIUM and FAMOTIDINE (PEPCID AC) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced VACCINATION SITE WARMTH (left arm under the injection site is  warm), VACCINATION SITE ERYTHEMA (left arm under the injection site is red) and VACCINATION SITE PRURITUS (left arm under the injection site is itchy). At the time of the report, VACCINATION SITE WARMTH (left arm under the injection site is  warm), VACCINATION SITE ERYTHEMA (left arm under the injection site is red) and VACCINATION SITE PRURITUS (left arm under the injection site is itchy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported.
patient felt  numbness or tingling in left arm, numbness around mouth going up to nose area
R Facial droop, photophobia, to st ER. CT negative, diagnosed Bell's Palsy. Valtrex & Predinsone. L x2 cornea abrasion.
8-9-06 muscle soreness (left deltoid) 8-10 and 8-11-06 diarrhea, site warm to touch-arm, shoulder and neck achy and sore, tiredness, temperature 99.3.  8-12-06 same as 8/10 and 8/11/06 plus heart beat fast and irregular for short time.
Flublok is recommended for 18years and older. Pt is 13 years old. No adverse side effects at this time. Discussed with MD. Pt and mother are aware to look for s/s of reaction.
Breakthrough case admission after two vaccines  Moderna 3/29/21 Lot# 002B21A;  Moderna 4/26/21 Lot# 048B21A