chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (dose received 5 days after it expired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 058F21A) for COVID-19 immunization. No medical history reported. On Feb 11, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 11, 2022, patient experienced administered expired product (dose received 5 days after it expired). At the time of the report, administered expired product (dose received 5 days after it expired) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
I received my vaccine on 04/27/2022. Next morning I started feeling chill and flu like symptoms with muscle soreness and loss of appetite. Feelings lasted 3-4 days with soreness from the injection site. Felt fine until 06/11/2022. Woke up from nap with a minor cough and sore throat. On the 06/12/2022 I started to get a horrible persistent cough that was a cloudy phlegm. I tested positive for COVID-19 on 06/12/2022. I reached out to my doctor and was prescribed TESSALON PERLES. By 06/16/2022 the cough was starting to subside and was clear and 06/17/2022 the cough had improved with occasional cough with phlegm.
This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8844) via an unspecified route of administration in the left arm on 15Nov2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. 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 COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 21Jan2021 at 12:00 (at the age of 39-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 11Feb2021 at 12:00 (at the age of 39-years-old); both as single dose for COVID-19 immunisation. On 16Nov2021 at 06:00, the patient experienced headache, high level of fatigue, muscle and joint pains, injection site soreness, low grade fever, chills and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, high level of fatigue, muscle and joint pains, injection site soreness, low grade fever, chills and nausea was resolving at the time of this report.
feels like a ghost and feels disconnected from the body and described the his symptoms as; had brain fog; tinnitus (ringing in the ear).; The patient was driving and passed high feeling; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (The patient was driving and passed high feeling), FEELING ABNORMAL (had brain fog), DISSOCIATION (feels like a ghost and feels disconnected from the body and described the his symptoms as) and TINNITUS (tinnitus (ringing in the ear).) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Post-traumatic stress disorder (Takes Anxiety medications for sleep).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced EUPHORIC MOOD (The patient was driving and passed high feeling). On 25-Mar-2021, the patient experienced TINNITUS (tinnitus (ringing in the ear).). On 29-Mar-2021, the patient experienced FEELING ABNORMAL (had brain fog). On an unknown date, the patient experienced DISSOCIATION (feels like a ghost and feels disconnected from the body and described the his symptoms as). At the time of the report, EUPHORIC MOOD (The patient was driving and passed high feeling), FEELING ABNORMAL (had brain fog), DISSOCIATION (feels like a ghost and feels disconnected from the body and described the his symptoms as) and TINNITUS (tinnitus (ringing in the ear).) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Symptoms: Patient reported that he had experienced COVID like symptoms post vaccination.
INFANT IN BED WITH PARENTS AT TIME OF DEATH.  6/30/08 Autopsy report states COD as SID, pt found unresponsive in bed w/parents.
10 days after first vaccine, experienced deep thoracic pain with increased in severity  over the course of 3 days to pain and numbness in the upper/middle back (T1-9).  The symptoms of numbness wrapped around to the chest and abdomen, right triceps, and 4th and 5th digits.  I lost abdominal wall, triceps strength.  Pain was incredibly intense in the upper/middle back to the point that I was unable to tolerate lying in bed in any position resulted in needing to sit upright in a chair to dose on and off throughout the night.  On average, I slept 2-3 hours per night for 3 weeks.  I am now able to sleep propped up in bed most nights otherwise I am up and sleep in a chair currently. I have seen a Chiropractor, Physiatrist, and was seen in an Emergency Department (untenable night pain required Morphine to ease the pain for 4 hours).  I have had x-rays of the neck and torso.  I have had MRI of the c-spine and t-spine - all diagnostic tests were normal and did not explain the incredible nerve pain and numbness.  I am currently on Gabapentin every 8 hours and Hydrocodone prn up to every 6 hours.
Lost Energy; Arms feel like he is carrying extra weight.; I feel weight on my shoulders; Aches on one side of the body, on the other side of his body, the left side, like elbow; Just a little pain where the injection went in on right arm in the shoulder; Also has some tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021513868 (Pfizer).  A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05May2021 (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus", start date: 2015 (ongoing), notes: States his readings have been below 7. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 05May2021, outcome "not recovered", described as "Aches on one side of the body, on the other side of his body, the left side, like elbow"; VACCINATION SITE PAIN (non-serious) with onset 05May2021, outcome "not recovered", described as "Just a little pain where the injection went in on right arm in the shoulder"; FATIGUE (non-serious) with onset 05May2021, outcome "not recovered", described as "Also has some tiredness"; ASTHENIA (non-serious) with onset 06May2021, outcome "unknown", described as "Lost Energy"; LIMB DISCOMFORT (non-serious) with onset 06May2021, outcome "not recovered", described as "Arms feel like he is carrying extra weight."; FEELING ABNORMAL (non-serious) with onset 06May2021, outcome "unknown", described as "I feel weight on my shoulders".  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Drinking Fluids and Aleve for Pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A pharmacist reported that an unidentified patient received Flu Shield (influenza virus vaccine, trivalent, types A&B)(formula year not identified). Eight weeks post immunization, the patient developed brachial neuritis and subsequently recovered. No additional information was available as of the date of this report.
Pain radiating up to neck, from upper arm and numbness in arm - persisted through 06/08/07 when patient telephoned.
Case number PHEH2012US007397 is a spontaneous report initially received from a nurse on 30 Mar 2012 with a follow-up received on 20 Apr 2012: This report refers to an 11-years old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10130/ X10130 and expiry date: 01 Feb 2013) intramuscularly and with GARDASIL vaccine (other manufacturer, batch number: unspecified) on 20 Mar 2012. It was reported that he became shaky after getting the shots and experienced a near fainting episode on 20 Mar 2012. The final outcome of the events was reported as complete recovery of the patient on 20 Mar 2012. No additional information was available. Follow-up received from the nurse on 20 Apr 2012: Updated events, onset date and outcome.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077895 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077895:Cross-linked with second dose
2-22   6PM extremely sore left arm 2-22    9PM could not move left arm up but about 8" 2-23    10AM-12PM   Flushed  hot to touch cheeks-normal temperature 2-24     9AM  rash on left underarm....had scratched during the night  & arm sore to touch in that area 2-25     9AM  rash had subsided but arm still sore to touch
a patient received a 2nd late dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: a patient received a 2nd late dose of Twinrix). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 6 Jul 2023: A health care professional reported that a patient received a 2nd late dose of Twinrix, The patient consented to follow up. The patient received 2nd late dose of Twinrix which led to drug dose administration interval too long. This case has been linked with case US2023092918 reported by same reporter.; Sender's Comments:  US-GSK-US2023092918:Same reporter
Severe chest pains. Started at 9:00a, lasting until 7:30-8:00p. Pain came in waves, high pain waves followed by aches.
Headache was excruciating. Felt dizzy and foggy and tired.  Symptoms lasted 2 full days. 3rd day was still foggy but headache finally gone.
Redness, swelling and burning 7 days after 1st vaccine injection & itching and burning on 9th day....still very swollen!
fully vaxed 3/29/2021; admitted to Hospital 08/29/2021. Case attempted 2x with no answer. Unknown PMH or course of illness or reasons for admit
Walked to my neighbors house and fell on the sidewalk.  Had my second shot in the morning.  Can?t figure out why it happened.
Moderna Monovalent 0.25 mL was administered as booster dose instead of Moderna Bivalent 0.5 mL. Pt. tolerated well, there was no adverse reaction at time of vaccination and after. Once error was caught by RN Manager - pt. was contacted and made aware of the above.
Swollen limph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen limph nodes) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen limph nodes). At the time of the report, LYMPHADENOPATHY (Swollen limph nodes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
This spontaneous case was reported by a pharmacist and describes the occurrence of ARTHRITIS (Arthritic reaction), VACCINATION SITE REACTION (Arm reaction, a muscular reaction) and SWELLING (Some sort of swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-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 ARTHRITIS (Arthritic reaction), VACCINATION SITE REACTION (Arm reaction, a muscular reaction) and SWELLING (Some sort of swelling). At the time of the report, ARTHRITIS (Arthritic reaction), VACCINATION SITE REACTION (Arm reaction, a muscular reaction) and SWELLING (Some sort of swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Company comment: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected non serious event/AESI of Arthritis after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course, medical assessment and treatment provided. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. This case was linked to MOD-2022-455761 (Patient Link). Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected non serious event/AESI of Arthritis after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course, medical assessment and treatment provided. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Swelling, redness and pain in joints. First started in right wrist. Moved randomly throughout joints in my body. I was diagnosed with Rheumatoid arthritis by a specialist on April 20, 2021.
This spontaneous report was received from a registered nurse via a company representative, regarding to her two sons of unknown age. The patients medical history, drug reactions or allergies were not provided. Approximately in 2014 (reported as approximately one year ago), the patients received their first dose of GARDASIL (dose, route, lot number and expiration date were not provided). Approximately in 2015 (reported as recently), the boys received a dose of GARDASIL 9 (dose, route, lot number and expiration date were not provided). No adverse effects reported. At the time of the report, the patients outcome was unknown. Additional information has been requested.
The evening of 10/15, I experienced arm pain and had a migraine. The next morning, I was fatigued, had a sore arm, feeling of tightness in the chest, whole body aches, and nausea that was severe enough that I was unable to eat all day. All these symptoms continued throughout the day, and in the afternoon (about 24 hours after being vaccinated), I began to vomit. Though I felt better after, the nausea persisted for the rest of the evening.
Pt received 2nd dose of Moderna too early.   On 03/12/2021 when health dept nurse learned of the error, the patient was called to assess for any problems and to determine if the doses were given too early.  RN  said the patient was hard to understand and a poor historian.  Pt could not give names of caregivers.  RN  had EMS go by to provide a welfare check. EMS reported pt was at baseline health status.  EMS staff spoke with nephew who reported pt has only had one vaccine.  On 03/15/2021, RN  received calls from step daughter-in-law and Nephew, both advising pt did get both vaccines. Per family, the patient?s vaccine appointments were not communicated well between the family caregivers.  One caretaker thought the 2/24/2021 trip to health dept was just to register and the second trip on 03/05/2021 was when the actual vaccine was to be given.  Registration forms were completed at each visit, with both showing no previous vaccine administered.  Pt and family report no side effects after the 1st vaccine, the nephew did report noticing that the patient was lethargic and weak 3 d after the 2nd vaccine. Family was advised the patient does not need another dose of COVID vaccine at this time, 2 dose series complete.
RECEIVED SHOT AT 7:37PM; EXPERIENCED SHORTNESS OF BREATH AND SWELLING WITH 3+ PITTING EDEMA THAT EXTENDED FROM ABDOMEN TO FEET. FOLLOWED UP WITH PULMONOLOGIST AND CARDIOLOGIST TO RULE OUT HEART DISEASE. CARDIOLOGIST PRESCRIBED DIURETIC THAT HAS HELPED MINIMALLY BUT PATIENT IS STILL EXPERIENCING SWELLING PERIODICALLY SINCE VACCINATION. PATIENT INFORMED ME THAT THEY WERE POSITIVE COVID-19 IN FEBRUARY 2021.
I have not had a period due to my Mirena, 2 days after my second injection I received a heavy period.
Moderna COVID-19 Vaccine EUA - Diarrhea , nausea, headache, chills, fever, 100.5,  flush face, very sore arm at site of injection
Pt called on 7/16/2021 stated that they received the vaccination on 7/11/21 in their left arm.  On Wednesday 7/14/21 they started having a tingling in their right hand.  Upon calling their Dr they where instructed to call the pharmacy were the received the vaccine.
This spontaneous report as received from a pharmacist refers to a 11 year old female patient, the daughter of the co worker (pharmacist). Patient's medical history was not reported. On 18-MAR-2014 the patient was vaccinated with GARDASIL (dose and frequency unknown). Patient's concomitant medications were unknown. On 18-MAR-2014 the patient experienced a seizure (medically significant), lost consciousness (medically significant) and tonic clonic movements (medically significant) after receiving GARDASIL. It was reported that the girl recovered within an hour of receiving the dose at her physician's office, but the girl was sitting on her mother's lap when she received the dose. The girl's mother reported that she demonstrated tonic-clonic movements for an unspecified brief period of time after she received the dose, and the mother lowered her daughter to the floor after she lost consciousness. The reporter states that soon after the girl was lowered to the floor, she regained consciousness. The girl was fully recovered within an hour, and she had no residual effects. The outcome the events were reported as recovered/resolved. The reporters causality assessment were not provided. Additional information has been requested.
1. 2 lesions on labia - lidocaine jelly, ACYCLOVIR 200 mg/ 2tsp TID 5cc TID. 2. Fever 100.2. 3. Coughing for 3 days. 4. Colitis x 3+ days. 5. Pharyngitis. 6. Eyes sticky. 7. Pains in hands and feet. Nystatin suspension 1 tsp swish and swollen qid x 2 wks. 7. Pains in feet and fingers - arthralgias - referral. 8. Epitaxis. 9. Headaches. 10. Fatigue home from school 3-13 -> 3/23 then half days. 11. Decreased appetite. 12. Lungs diffuse scattered rhonchi - z pack rheumatologist.  5/21/09 Medical records received DOS 4/7/09. FINAL DIAGNOSIS: Post viral syndrome. Post vaccination: Small healing lesions in corners of mouth and buccal mucosa. Previous viral illness with conjunctivitis, oral and genital sores. low grade fevers, and, marked fatigue.
First injection on 2-15-19 of shingrix Pt only had sore arm.  Pt felt this was normal.  Second shot on 5-17-19 Pt experienced that night fever of 101.3 degrees and pain.  2 days later a red band appeared on outer portion of arm below the injection site about 3 inches wide.  severe itching was experienced for 2-3 weeks at this red band location.  Pt tried OTC products to stop the itching and nothing worked.
Bee sting on sole of foot morning of getting her second Pfizer dose. She then had a "spider bite" on her abdomen the next day. About 3 days later she developed an itching, lacy, red rash on dorsum of foot and sought care at an urgent care. She was given cephalexin for the spider bite and prednisone 40 for the bee sting. She had never had a reaction to bee stings before and no history of any anaphylaxis. She then came to see me, and I noted the rash with a red rash also over her left second toe with no signs of arterial occlusion or neurologic symptoms.  She had no symptoms or known Covid exposure and the community positivity rate was 1%. We decided to try a high potency topical corticosteroid for the itching on her foot and use the prednisone if symptoms worsened or go to the ER if severe. The next morning, (7 days post vaccination) she reported lightheadedness, increased pruritus of her foot and went to an urgent care where she started systemic prednisone and had a negative Covid nasopharyngeal swab.  She then recovered without complications.
COVID-19; COVID-19; Moderna, Dose Number: 4 / Pfizer, Dose Number: 1, 2, 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 28Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Sep2022 as dose 4 (booster), single (Lot number: A57163B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022, outcome "unknown", described as "Moderna, Dose Number: 4 / Pfizer, Dose Number: 1, 2, 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Apr2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.