chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VERY MILD REACTIONS; This spontaneous report received from a patient concerned multiple patients. No past medical history or concurrent conditions were reported. 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 Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced very mild reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very mild reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20211055553 and 20211055777.
The patient had a large red swollen area measuring 6 x 7.5 cm at the injection site.
legs hurt so bad she cant walk; PAIN; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs hurt so bad she cant walk) and PAIN (PAIN) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (legs hurt so bad she cant walk) and PAIN (PAIN). At the time of the report, PAIN IN EXTREMITY (legs hurt so bad she cant walk) and PAIN (PAIN) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included non-specific diabetic medications. The patient thinks that the side effects were due to other medicines and she has reported to the other company.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: AE outcome, 2nd dose fine, no further follow up needed, other medical history updated
Fay of vaccine sore arm, headache. Three days later, felt like I was going to throw up and poop at the same time. I was dizzy on the toilet, when I tried to leave the bathroom I fainted in the hallway. I had a racing heart and sweating. Then I began to have chills and pain inside my bones particularly my hips, legs and knees. Back pain too. Slight headache. This started at 9:30 pm 4/24/21, went to sleep, just nauseous. Middle of the night is when I woke up feeling like I was going to throw up and poop. I fainted at this time as well. In bed the rest of the night with pain in bones, tired, headache until about dinner time on 4/25/21.
I was very tired and I experienced Chills like I've never felt before and I had a high fever. After I was admitted in the hospital I was diagnosed with cellulitis.
With vaccines 2-5 patient had considerable body aches/significant body aches for 18-24 hours/onset about 12 hours after the injections; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (With vaccines 2-5 patient had considerable body aches/significant body aches for 18-24 hours/onset about 12 hours after the injections) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A, 002B21A, 033F21A and 005M21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: flu shot on 07-Sep-2022, shingles (2nd shingles vaccine) and shingles (2nd shingles vaccine). Past adverse reactions to the above products included Myalgia with shingles; No adverse event with flu shot; and Shivering with shingles. Concurrent medical conditions included Drug allergy (Sudafed (tachycardia)). Concomitant products included NADOLOL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced MYALGIA (With vaccines 2-5 patient had considerable body aches/significant body aches for 18-24 hours/onset about 12 hours after the injections). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (With vaccines 2-5 patient had considerable body aches/significant body aches for 18-24 hours/onset about 12 hours after the injections) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: First night fever was 103.5.   On 07-Sep-2022, the patient received fifth dose of Moderna bivalent (unknown route) .5 milliliter with Lot number as AS7144B.  The event does not cause the patient to seek medical care.  Patient states that with the 2nd through 5th doses of the Moderna COVID-19 vaccine but no other symptoms.  Patient had yet to test positive for COVID despite patient exposure to husband.  It was reported just seems like a strange coincidence that patient husband contracted COVID exactly 1 month and 2 days post these last two vaccines. Would love to know why the virus is successful in bypassing the vaccine in patient husband body and so far not in patient.   This case was linked to MOD-2022-658148 (Patient Link).
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 04-APR-2016, the patient was vaccinated with an improperly stored dose of MMR II 0.5 ml injection, lot# L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Hive-like rash; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 30Mar2021 at 14:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included finasteride (MANAFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 09Mar2021 at 11:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 02Apr2021 the patient experienced hive-like rash that started on his both biceps and both upper thighs and then spread to underneath both arm pits and lower legs. The patient did not receive any treatment for the event. The clinical outcome of the event urticarial rash was unknown.  No follow-up attempts are needed. No further information is expected.
Redness on backs of hands progressing to bumps on the head near hairline. On 03/06/2002 took Benadryl which didn't help. On 03/07/2002, hands swollen, 03/08/2002 nickle size blotches on wrists, on 03/10/2002 swelling down, 03/13/2002 bumps on back of head itching, on 03//14/2002 MD ordered doxepin and allegen. At midnight hives all over body and in throat, went to ER started on methylprednisone. on 03/15/2002 morning, symptoms resolving.
extreme headache/arm discomfort, high fever (102) that lasted 24 hours. headache/dizzy spells/naseau that lasted 4 days
This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with doses of PNEUMOVAX (lot number and expiration dates not reported) for prophylaxis, which were improperly stored at >46°F but < 77°F for 15 minutes. No adverse effects were reported. There were no previous temperature excursions and call was done because of a data logger. No further information was provided. This is one of 5 reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA009556: US-009507513-1701USA009569: US-009507513-1701USA009570: US-009507513-1701USA009571.
Patient states she developed  a stutter 24 hrs after 2nd dose of vaccine. Pt has had stutter for the past 3 months
pt previously in local Medical Center with c/o worsening SOB, fatigue, weakness; dx with positive COVID test; hypoxemic respiratory failure; on NRB; transferred for higher level of care to local Regional Medical Center; started on Remdesivir, Baricitinib, Dexamethasone, ABX; status worsened requiring intubation with mechanical ventilation; positive for MRSA; CT showed right lower lobe PE; worsening kidney status; started on CRRT; worsening gas exchange and respiratory status; family decided to transition to comfort care; pt extubated and dialysis stopped; pt passed away in the hospital
Pt. rcv'd vaccine at 12:15 pm. Called at 15:10 pm to report "hives". Pt. had spoken with MD's office & stated "was going to take Benadryl" per MD's advice. Pt. denies diffifulty breathing or hoarseness.
About 14 hours  after receiving the vaccine, I developed chills and felt feverish (do not own a thermometer so was unable to check temp). Throughout the night, I had chills and moderate muscle/joint pain. The following day, I had chills, muscle aches, joint pain, and a headache. I took some Tylenol and the symptoms lessened significantly. The following day (48 hrs after receiving the vaccine), I felt completely back to normal.
Broke out in hives a few days after the vaccine/ Been suffering from the hives for over 2 months
pt recv vax 14NOV96 & immed p/vax pt devel an arthus type rxn local to inj site;4DEC96 area was still red, pt c/o pain lifting & the turning of elbow or wrist;16DEC96 pt called PMD & said that pain @ the inj site persisted;inc swelling
Employee started experiencing symptoms of slurred speech and periods of zoning out on 10/21/2021. She saw her physician on 10/27/2021 believing she was experiencing symptoms of an underlying condition. The employee and physician were not suspecting the vaccine as the cause at that time. On 06/09/2022 the employees physician determined the Vaccine as the cause. The employee has not experienced any symptoms since 11/17/2021.
Patient stated that Friday evening she fainted and hit her face on her counter.  She then slept all day Saturday 10/5 and Sunday after brunch noticed a "12x4 inch" localized swelling/rash on her arm that reportedly did not respond to ice or Tylenol.  She then called her PCP who recommended she go to the hospital.  She states she was diagnosed with cellulitis, given 2 doses of vancomycin IV and was discharged this morning with a prescription for cephalexin.
felt weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt weak). At the time of the report, ASTHENIA (felt weak) had resolved.            No relevant concomitant medications were reported.   She got weak after the booster shot, she does not know the side effects she had but knows it is after the Moderna shot. She only knows she felt weak for several hours and then was fine.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
SATURDAY MORNING SORENESS TO INJECTION SITE, FATIGUE, AND BODY CHILLS SATURDAY NIGHT PATIENT PAIN TO LEFT UNDER ARM , TENDER TO TOUCH , ENLARGEMENT AND SWELLING TO LEFT AXILLIA LYMPH NODE.
Mom called about 1 hr after Flumist was given. Patient's bottom lip was slightly swollen along with a swollen right ear. Noticed he had 7-8 welts/hives on face and neck. Mom gave BENADRYL and symptoms resolved. Leg pain later that afternoon and MOTRIN was given. By the next day patient was fine.
Patient became light headed after receiving vaccine. Patient states same happens with bloodwork and injections. Patient sat in chair leaning over with cold pack on neck. Patient was able to sit up and felt better after 10 minutes.
I became symptomatic on July 09. I sensed fatigue. I was very tired and went to bed at 3:00 PM on this date. A few days later, a family member revealed that he had tested positive for COVID -19 so on that Thursday I went to get tested and was positive. I called my doctor to let her know on that Friday. She did not prescribe Paxlovid. Since I had developed a cough and a runny nose along with fatigue, the doctor prescribed  Benzonatate. The medication has helped me. I am at about 90% recovery.  I was retested yesterday and was negative. I am still experiencing a little cough and fatigue.
Shingles. Left side of face. Left of eye. Less than 3 weeks after 1st Pfizer vaccine. Not sure if related but wanted to report just in case. Taking antibiotics. And other than that I'm feeling fine.
Information has been received from a physician concerning a male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed mild breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. It was reported that the pt's sister (WAES0506USA03340) had a similar experienced after vaccination with varicella virus vaccine live. Additional information has been requested.
Fatigue; malaise; confusion; headaches; body ached; Vaccine administered at inappropriate site / dose vaccine location=Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in leg left, administration date 24Apr2021 11:00 (Lot number: EW0122) at the age of 17 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy: Sulfa" (unspecified if ongoing), notes: Known allergy: Sulfa. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev_dose_vaccine_location=Left leg},, {prev_dose_product=COVID 19,, prev_dose_brand=Pfizer ,, prev_dose_brand_unknown=False,, prev_dose_lot_number=Ew0150,, prev_dose_lot_unknown=False,, prev_dose_administration_date=01A, pr2021,, prev_dose_administration_time=04:00, PM, prev_dose_dose_number=1,, prev_dose_vaccine_location=Left leg}]), administration date: 01Apr2021, when the patient was 17 years old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 24Apr2021, outcome "unknown", described as "Vaccine administered at inappropriate site / dose vaccine location=Left leg"; FATIGUE (non-serious) with onset 05Dec2021, outcome "unknown", described as "Fatigue"; MALAISE (non-serious) with onset 05Dec2021, outcome "unknown", described as "malaise"; CONFUSIONAL STATE (non-serious) with onset 05Dec2021, outcome "unknown", described as "confusion"; HEADACHE (non-serious) with onset 05Dec2021, outcome "unknown", described as "headaches"; PAIN (non-serious) with onset 05Dec2021, outcome "unknown", described as "body ached". Therapeutic measures were not taken as a result of product administered at inappropriate site, fatigue, malaise, confusional state, headache, pain.   Additional information: On 17Dec2021 at 02:00 pm, patient received Dose 3 (Lot number: FH8028) on right arm. Prior or post vaccination patient did not have COVID-19.  No follow-up attempts are possible. No further information is expected.
Chest pain, dyspnea, rhinitis, asthma; Epi given;
pt recv vax 25JUL94 & devel vomiting; 26JUL94 pt devel bruising, redness & sl swelling @ inj site;
Fever, shakes, muscle soreness, loss of appetite, long term constipation, chills
Pt. states 7-8 hours after receiving vaccine she started feeling dizzy and her equilibrium was off and she had staggering. Pt. states she had dry heaves and on 05/09/2021 at 2-3am heart started racing. Pt. states she also had area on her back itching. Pt. states she thought about calling 911, but she did not and the heart racing quit. Pt. states she did not sleep during the night and she then was very tired and slept from Sunday morning until 5pm on Monday 05/10/2021. Pt. states she still has been extremely sleepy and tired. Pt. describes symptom like "narcolepsy". Pt. has not been to see a healthcare provider about her symptoms. Pt. states no difficulty breathing. Pt. did have left arm soreness
Pt reported dizziness and nausea. BP borderline low 90/50s resolved with repeat reading 113/70. Sx likely secondary to vasovagal response. Pt was observed in car for 30 minutes
After going to bed, had headache, shivering, fever and stomach pain. I took some TYLENOL and the shivering and fever subsided. The headache remained for a couple of days. Arm was sore for 6 days.
It was reported that by the patient that she , a 49 year old female patient, received a Fluzone SV '01-'02 vaccination on 12/03/ at 1:50 pm. Within 24 hours after vaccination the patient developed a metal taste in her mouth. Reportedly, the symptoms have resolved and the patient recovered from this experience.
Local redness at injection site forming wheal later swollen lymph node (axillary), patient felt feverish (didn't take temp.). All symptoms started next day 2/8. Patient was advised to apply BENADRYL gel on inj. site.
developed serum sickness with arthralgias, urticaria, and angioedema of eyes and lips, high CRP during hospitalization (CRP = 7.9).  Received Gardasil on 7/6/07, 5 days before her symptoms began.  Hospitalization lasted 5 days for refractory pain from arthralgias.  Did not have fever.  Urticaria were refractory and lasted for several days after her hospitalization.  Of potential confouding interest, she had also recently received keflex (finished a few days prior to when her symptoms began) 8/16/07-records received for DOS-8/9/07-clinic visit after hospitalization for uticaria, angioedema and pain secondary to arthralgias. 7/11/07-began having mild arthralgias in hands and feet followed by urticarial rash head to toe and angioedema of her eyes and lips. Sensation of throat swelling. Two days later after steroid treatment admitted to hospital with worsening arthralgias for pain control.  Impression chronic idiopathic urticaria with angioedema.  8/22/07records received for DOS 7/13/07-7/17/07-DC DX: Allergic reaction. Episode 3 days ago of urticaria, extreme arthralgias accompanied by angioedema of face lip and tongue. Generalized itching was severe and generalized rash.
- Patient was given Covid-19 Bivalent (grey top) Vaccine which was beyond the usage date of 01/11/2023, lot #GJ6738. Patient has been notified. No adverse effects reported. Reports filed. -  ?Pulled a report of all administered vaccines by lot number and verified those that were administered past the BUD.  - Pulled all vaccines in fridge and placed a ?Do Not Use? sign on them while we completed investigation - Sat with each MA within the clinic going over the following: o Training on administration workflows to include ? entering vaccine information into System prior to administering vaccine, always having a team check which includes verification of vaccine, verification of patients age, timeframe between vaccines, BUD, dosage o BUD versus expiration date versus puncture expiration o Dosage of maroon top, orange top and gray top for monovalent and bivalent o The difference between monovalent and bivalent o Storage instructions o Workflow associated with what to do when clinic receives the vaccine o Training on lot manager and immunization system reconciliation o Training on how to enter information into System when a provider places an order versus immunization clinic - Reached out to Pfizer who is recommending all patients who received an expired vaccine get re-vaccinated due to unknown efficacy - Clinic will reach out to all patients letting them know about the situation and offer to have them come into the clinic free of charge for re-vaccination or to a sister clinic if they prefer?
Patient's father told clinical staff that child was 18. Patient inadvertently received the Janssen vaccine instead of the Pfizer vaccine. The birthdate was verified prior to the injection being given. No adverse symptoms are noted.  Phone message has been left for the parent to call our office to notify them of the error. The call has not been returned yet.
4 days after 2nd vaccine the patient develope an itchy rash on both collar bone. The next day it had spread to his back and abdomen. within 2 week his entire body was cover and it began to shed scales off his entire body. A biopsy was preformed at the dermatologist and it as determine A Drug Reaction. It cause Erythrodermic Psoriasis to develop, LIFE THREATENING.  His skin as shed and peeled off multiple times. He was hospitalized June 5, 2021. He as been in the hospital for 87 day. He has been on Life support (10days). He kidneys , lungs and heart have all been attacked and complete paralysis to the right side. He is currently fighting for his life. He was told today he will die. The damage the reaction has done to his lungs is  too much to overcome.
They gave 24 doses from this lot that expired on 8Oct2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave 24 doses from this lot that expired on 8Oct2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave 24 doses from this lot that expired on 8Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They gave 24 doses from this lot that expired on 8Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Information has been received from a doctor of pharmacy concerning a 71 year old female patient with a history of high blood pressure and penicillin allergy, who on 10-JUN-2010, was vaccinated with a 0.65ml SQ dose of ZOSTAVAX (Merck) (Lot#: 665515/1373Y). The pharmacist mentioned that the patient had redness at the injection site for 1 week; the redness area itched at times and felt hot. It was confirmed there was no rash. The patient visited the pharmacist. At the time of the report the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.