chrisvoncsefalvay/vaers-outcomes huggingface dataset:
light headed; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Lot number: Er8727) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaemia" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline", notes: Known allergies: Doxycycline. The following information was reported: DIZZINESS (non-serious), outcome "recovering", described as "light headed"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "sore arm". Therapeutic measures were taken as a result of dizziness, pain in extremity.  No follow-up attempts are possible. No further information is expected.
1st dose administered on 27Jul2021; 2nd dose administered on 04Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 27Jul2021; 2nd dose administered on 04Aug2021) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 04C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 27Jul2021; 2nd dose administered on 04Aug2021). On 04-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 27Jul2021; 2nd dose administered on 04Aug2021) had resolved.            Concomitant product information was not provided. Treatment information was not provided.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: Pt reported golf ball sized lump on arm at injection site after receiving vaccine as well as some redness and mild pain around injection site initially.Vaccine was given in March as pt's booster, problem is ongoing as of July. Lump on arm is visible and palpable, pain has subsided.
Immediately after tetnis shot(6/8/07 in ER) a large, red, hot, round bump was on my arm.  Within 35 hrs it had grown to the size of a soft ball and was very painful.  I was burning and chills, felt sick, heart pounding, dizzy, and was in severe pain. 2nd trip to ER (6/10/07)was diagnosed with Cellulitis at site of injection. 6/21/07-records received for DOS 6/8/07 and 6/10/07 -received updated tetanus after an abrasion to her right foot. Seen in ER 2 days later for complaint of pain at right biceps where she received injection. PMH significant for asthma, DeQuervain's tenosynovitis in right hand. PE swelling at injection site, difficulty moving arm. Large area of cellulities.Allergic to Cipro, Reglan. Patient was not admitted. 02/02/2010 There is still pain and swelling at shot site. Patient still on Beta-blockers (Inderol LA) for heart realted PVC's as reaction to shot.
Normal exam at 2 months of age, given 2 months shots 05/09/2005.  Family noticed baby developed poor muscles over the next 2 weeks.
Immediate headache and fatigue that went away after 36 hours.   Complete loss of smell and most of taste that is still impacting me (I can only taste and smell fruits) which really stink(no pun intended). But seriously, what can we do to get it back.
Stomach pain a little bit; Feel very cold; Muscle pain; Have pain where  the injection was put in; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain a little bit), FEELING COLD (Feel very cold), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Have pain where  the injection was put in) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-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 ABDOMINAL PAIN UPPER (Stomach pain a little bit), FEELING COLD (Feel very cold), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Have pain where  the injection was put in). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain a little bit), FEELING COLD (Feel very cold), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Have pain where  the injection was put in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment medication was reported
irregular heart rhythm; Heart palpitations; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203 and expiration date not provided), via an unspecified route of administration, on 06Apr2021 15:30 (at the age of 43-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included allergies to penicillin. No other medical history. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 06Apr2021, the patient experienced heart palpations and irregular heart rhythm. Events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. No treatment received for events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
15OCT93 t103, aching, hypersensitivity & chest pain went to hosp 15OCT93; CXR, infection;
@ 1 hour post vaccination, Lethargic, in am , @ 12 hours General bodyache + fatigue "didn't feel well, Self-adm aspirin. Went to work developed chills, At 6 pm, 6/11/02 went to ER Temp 103, Fluids admini,x-ray + labs done. DIC home with Vicodyn 12/12/02 called Imm clinic, Patient at work. Temp 99.8, Remains  tired with general muscle pain, taking Ibuprofen at work.
Patient  age 16 was administered Janssen (J&J) vaccine.  Age limit for Janssen is 18.
Consumer received first covax on 10Feb and they scheduled the second covax for 30Mar; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she received first covax on 10Feb and they scheduled the second covax for 30Mar. She is asking if this is wrong because her facts sheet says 21 days for the Pfizer covax. She has not called be-fore, read FB. Due to 13 callers ahead of us. Will fax to Pfizer DSU from Covax US Support. CEP 159558 for AE. Outcome of the event unknown.  Information on the lot/ batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Waiting to pay bill my daughter passes out on floor. Passed out she did not hit her head. Had some shots.  V/S at 10:00 AM 94/53 - pulse 51 - pt denies any pain or hitting herself when passes out, states "feels fine>" 10:10 V/S 94/60 - pulse 51 - pt discharged home with mom with no distress noted.
Hives and rash on left side of body started 3 hours after vaccine. Given Benedryl and Tylenol and majority of the rash went away after approximately one hour. Vaccine was given in the left arm.
After 8-10min of vaccination I felt the entire right arm heavy, and with a tingling sensation. The lower right hand side of my neck, right check and lip felt slightly numb with tingling sensations. The side effects lasted approximately 15-20min.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for patient.  Treatment medications were not reported. This case contains information for patient 18 out of 25 described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
Left arm muscle pain; Chills; Fever; Weakness; Fatigue; Joint pain in left knee; Headache; Neck and upper back ache; Neck and upper back ache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: L:er8734E:7/21) via an unspecified route of administration in the left arm on 20Apr2021 at 16:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient has no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and vitamins; for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: L:er8735E:7/21) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 16:15 as a single dose for COVID-19 immunisation. On 21Apr2021 at 04:00, the patient experienced left arm muscle pain, weakness, chills, fever, fatigue, joint pain in left knee, headache, neck and upper back ache. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event left arm muscle pain, weakness, chills, fever, fatigue, joint pain in left knee, headache, neck and upper back ache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
#1 2/15/21 Pfizer - lump under arm 2-3 days, right side back pain - took muscle relaxer and aleve for 2 days, better, #2 3/8/21 - lump under arm, palpitations 3/9/21 lasting 1 1/2 days, left side swelling on back 3/15/21, went across lower back, by 3/17/21 back pain worse and felt like couldn't breathe due to back muscle spasms went to ED, sore but better today 3/18/21
increased postnasal drip; had a fever of 100.7 orally; bodyaches; headache; chills; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient (not pregnant) received the second dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 09Jan2021 09:30 at single dose in right arm for COVID-19 immunization. Medical history included asthma, hypertension/ Blood pressure, acid reflux, food allergies, Known allergies: tree nuts, peanut, shell fish, Penicillin, Erythromycin, IVP dye, Rocephin. The patient's concomitant medications in two weeks included Blood pressure, acid reflux. The patient previously took the first dose of bnt162b2 on 19Dec2020 for COVID-19 immunization and experienced Sore arm. No other-vaccine-in-four weeks. Second dose on 09Jan2021 within 17 hours had a fever of 100.7 orally, body aches, headache, chills and increased postnasal drip on 10Jan2021 02:30. No treatment received. No covid-prior-vaccination and no covid tested post vaccination. The outcome of the events was recovering.
Patient reports pain at injection site that isn't better after 2 weeks. Pain is not worse but not getting better, and sore to move and lie on that arm. Pain is dull and achy, but not sharp in nature. Spoke with patient again on 12/21/17 and patient reports pain is much improved and is experiencing only minimal tenderness/pain.
This case was considered medically important. Information regarding Prevnar was received from a consumer regarding her son who experienced autism. The patient received a dose on an unspecified date. Relevant medical history was not provided. The indication for Prevnar was immunization. The product was administered on an unspecified date. The dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The mother reported that her son is autistic. No additional information was available at the time of this report.
I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 4/17/2023 ACUTE ST ELEVATION MI, UNSPECIFIED    DIABETES REMOTE MONITORING I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 4/15/2023 ACUTE ST ELEVATION MI, UNSPECIFIED    DIABETES REMOTE MONITORING
No additional adverse effect reported; underwent a temperature excursion that took place on 8/13/2021 were administered; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 16-AUG-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (dose and vaccine scheme was not reported; lot number 1707590 has been verified to be valid, expiration date reported and established as 23-MAR-2022) taken orally for prophylaxis.   The vaccine was exposed to a temperature excursion of below 36 degrees Fahrenheit (32.9°F) during a time frame of 90 hours. There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003185:
The patient stated that he experienced nausea, tense/ anxiety, muscle spasms of his hands and feet (lasted about 2 days) and insomnia. He said the other symptoms lasted about 3 days. The patient did got to the doctor. They did not prescribe anything for his reaction.
OXYGEN SATURATION IN 70'S, "EVERY INTERACTION LISTED FOR THE VACCINE".
Patient returned to office after had left and went to get dessert where she became pale and laid down in the parking lot while waiting to get into car and then again when got into car seat she slumped down. No seizure activity. No fevers. Mom states she looked pale and did not seem upset.  She got home and pt wanted to lay down on couch. Mom then brought her back here and she is acting completely normal and color is little better.
MODERNA COVID #3 VACCINE GIVEN 10/28/21, LOT #076C21A; pt had a positive COVID test at Dialysis on 2/7/22; 2/8/22 pt brought to ED with increasing SOB; hypoxic; O2 supplementation; Remdesivir and Decadron; worsening respiratory status requiring BiPAP; pt was made a DNR; pt became unresponsive on dialysis and hypotensive; transitioned to comfort measures; pt expired in the hospital
Fridge door opened for long Max/Low temperature reached: 46.6F Duration-2 minutes with no adverse event; ipol given after the temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235015, 2023SA235023, 2023SA235246, 2023SA235694, 2023SA236046 and 2023SA234814.  This case involves a 6 years old male patient to whom ipol given after the temperature excursion with no reported adverse and fridge door opened for long max/low temperature reached: 46.6f duration-2 minutes with no adverse event and event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine), hepatitis A vaccine (Hepatitis A) and COVID-19 vaccine for Prophylactic vaccination.  On 27-Jul-2023, the patient received 0.5 ml (dose 6) of suspect IPV (VERO), Suspension for injection lot W1A191M, expiry date: 16-Feb-2025 via subcutaneous route in the left thigh for immunization (strength: unknown), given after the temperature excursion with no reported adverse event (poor quality product administered) (latency same day).  On an unknown date the fridge door opened for long max/low temperature reached: 46.6f duration-2 minutes with no adverse event (product storage error) (unknown latency).  This situation is due to human error.  Action taken: not applicable  Outcome was Unknown for the events poor quality product administered and product storage error  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Severe headache, loss of appetite, chills, pain in hips and upper legs, severe soreness in arm, confusion
Hives head to toe, swollen leg with 4 inch diameter of red lacy rash.
Experienced skin irritation, rash, hives across body in multiple locations. Further irritated and causing skin "markings" when scratched. Went to ER when allergic reaction became significant enough to lead to chest pain and trouble breathing.  Was given steroids and antihistamine to initially get it under control.  Diagnosed with Dermatographic Uriticaria (i.e. "skin-writing) by a allergist weeks after the initial skin irritation / hives and prescribed a daily antihistamine (Allegra) to control daily allergic reactions.
26JUN91 mom states pt had no inc temp; Reddened area approx 2x2 on lt arm appeared the day of immun to cont to be visible for 8 days;
BODY ACHE; VOMITING 2 1/2 DAYS; UNEXPECTED THERAPEUTIC BENEFIT; HEADACHE; This spontaneous report received from a consumer concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included appetite lost, weight lost, and exhausted, and concurrent conditions included anxiety, bad mood, and bad cramps. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced body ache. On 2021, the subject experienced vomiting 2 1/2 days. On 2021, the subject experienced unexpected therapeutic benefit. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, body ache, and vomiting 2 1/2 days, and the outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Joint pain. I do not remember how many days after the second injection it started but I reported the new onset joint pain in real time to the v safe system. Pain has gradually progressed over months. I was diagnosed with RA this week.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown, born on date reported as "17205"). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. On or about 03-JAN-2013, the patient was administered ZOSTAVAX by a physician (lot# and route unknown).  On or about 26-DEC-2016, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Patient received a pfizer covid vaccine and flucelvax immunization, approximately 2 minutes after patient stated he did not feel well. He appeared pale and while trying to take a pulse he seemed to lose consciousness and went limp. While attempting to move him to the floor he began to convulse and went stiff. While this was happening, his face went flush and he began to make noises. Once on the floor he yelled one time and came to, asked if he screamed. We kept him on the ground until paramedics arrived and took over.
Pain, redness, swelling injection site x 5 days. Muscle pain Headache Fever 100.5  Shivering  NO GI symptoms. Symptoms started about14 hours post injection and lasted 30 hours
Raised rash on face; Raised rash on face and injection site; flushed feeling face; chills; Body aches; brain fog/ overall not up to feeling like myself; This is a spontaneous report from a contactable nurse reported for herself. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the right arm on 22Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing and cerebrovascular accident from an unknown date and unknown if ongoing. The patient previously took morphine and experienced drug hypersensitivity. On 23Jan2021 10:30, the patient experienced raised rash on face and injection site, flushed feeling face, chills, overall not up to feeling like myself, body aches and brain fog. No treatment was received for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.