chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     The patient's past medical history included Eczema since an unknown date. Concomitant products included DUPILUMAB (DUPIXENT) for Eczema.  On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced PAIN IN EXTREMITY (Soreness on the arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not  provided.   This case was linked to MOD-2021-302087 (Patient Link).
Adverse event: Vaccine was administered 3 weeks after beyond use date and is less effective. Treatment: Pt returning to our office for additional vaccine based on Pfizer recommendations.
Patient received 15 month immunizations including DTaP and developed sputerficial cellulitis around injection site (right thigh).
pt recv vax; approx 5 days later, pt suffered a petit mal convuls; following wk, had 2 more & was sent to the Hosp for an EEG & blood tests;
First day I was unable to work due to severe headache. BP went crazy. I was having palpitations.  I also experienced headache, nausea, diarrhea and fever. I continue to have  tingling in my face. I called employee health, and they told me to isolate. Because they were trying to rule out if it was COVID, but test was negative.
Patient's mother contacted the writer and reported that patient had nausea and vomiting that started the night after he received his flu shot.
Bruising still visible at injection site. Itching began early morning of 8th day. Itching increased, red blotches circling bruise formed throughout the day. Small welts/bumps in some part of the redness.
Narrative:  99yo male with symptoms of dementia, chronic cellulitis and frequent falls requiring 24/7 supervision and care by family. Family called to notify medical facility pt had passed away at home on 5/13/2021. Pt had received both covid vaccines on 2/6/21 & 4/19/21. Pt was in palliative care medical care. Appears death is not related to vaccinations given. .
Approximately 14 hours after vaccination, developed chills, bodyaches, sweats . duration approximately 7 hours.
Event occurred while getting my Moderna Booster for covid19. the pharmacist injected the booster into my left arm, when he removed the needle, blood spurted from my arm, onto the floor and down my arm. The pharmacist acted very surprised at the event and recalled that it had never happened to him before in many years of administering shots.
Nausea, vomiting for 4 days, then felt better by 5/18. Was given Japanese Encephalitis Vaccine on 5/18 as she failed to give history of illness at the travel appointment. Then worse again.
Patient had a profound reaction to COVID vaccine. Experienced numbness in hands, Raynauds phenomenon, nausea, continued vomiting from 5p-12am. Temperature went from 98.6F at 330pm, 98.3F at 6pm, 102.9F at 830pm, 98.3F at 1000pm
Patient called the day after injection, 3/10/12, and stated she had rash on face & neck that was red & itching continuously. Advised the patient to take BENADRYL and keep a close eye on rash. Advised that if symptoms didn't improve to see a doctor. Followed up on 3/11/12. Symptoms had improved, no itching, still slightly red.
warm to the touch at the injection site; itchy at the injection site; red knot at the injection site; Arm soreness; pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE PAIN (pain at the site of the injection) and VACCINATION SITE ERYTHEMA (red knot at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PAIN (pain at the site of the injection). On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red knot at the injection site). At the time of the report, PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE PAIN (pain at the site of the injection) and VACCINATION SITE ERYTHEMA (red knot at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment taken and symptoms have subsided.
Patient was scheduled to receive dose #2 of the primary series and was instead given the bivalent booster vaccine dose. Patient was given a second bivalent booster dose per director of nurse consulting to equal primary dose.
Flucelvax given to person under 18, not currently approved for lower than 18.
Hives; swollen lymph nodes; burning skin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 11:30 (Lot number: EN6202) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal Asthma or Allergy" (unspecified if ongoing); "Seasonal Asthma or Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 24Feb2021 13:00, outcome "not recovered", described as "Hives"; LYMPHADENOPATHY (non-serious) with onset 24Feb2021 13:00, outcome "not recovered", described as "swollen lymph nodes"; SKIN BURNING SENSATION (non-serious) with onset 24Feb2021 13:00, outcome "not recovered", described as "burning skin". The events "hives", "swollen lymph nodes" and "burning skin" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, lymphadenopathy, skin burning sensation.  Additional information: Patient received dose 2 of Pfizer- BioNTech on 17Mar2021 at 12:30 PM in left arm with lot number  ER2613.Facility type vaccine: Hospital. Patient did not had other vaccines in 4 weeks. Patient did not received other medications in 2 weeks.AE treatment: Steroidal cream.Patient did not had Covid prior vaccination. Patient did not had allergies.  No follow-up attempts are possible. No further information is expected.
Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood pressure 193/94; shakiness; This is a spontaneous report from a contactable consumer (patient) reported for that a 73-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) , via an unspecified route of administration on 30Jan2021 14:30 at single dose at right arm for covid-19 immunisation.  Medical history included blood pressure.  Concomitant medication included pantoprazole, metoprolol, atorvastatin, metformin. The patient previously took Cefdinir and experienced allergy.  The patient experienced dizziness with very high blood pressure 193/94, also shakiness, major headache on 30Jan2021 16:30. Adverse event result doctor or other healthcare professional office/clinic visit. The patient had EKG. Therapeutic measures were taken as a result of events included unspecified medication. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
Gave vaccination, child said "ow", second later his eyes rolled to back of head, body shook and rolled off his chair to ground & fell unconscious for couple seconds then woke up!
FELT LIKE THE FLU; BAD RESULT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced felt like the flu, and bad result. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like the flu and bad result was not reported. This report was non-serious.
Colitis; Blood in the diarrhea; Felt so sick; Rash in her stomach; Abdominal pain; Diarrhea; A spontaneous report was received from a consumer concerning herself, a 59 years old female patient who experienced colitis, abdominal pain, diarrhea, blood in diarrhea/hematochezia, sick/malaise and rash in her stomach/rash.    The patient's medical history included current conditions such as diabetes, asthma, reflux, dry eyes, osteoporosis.  Products known to have been used by the patient, within two weeks prior to the event, included cholesterol medication, blood thinner for heart attacks, asthma medication, medicines for reflux, dry eyes medicines, osteoporosis medicine shot every 6 months and liraglutide.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 014M20A) on 03-Mar-2021 intramuscularly in left arm for prophylaxis of COVID-19 infection.    On the same day of vaccination, the dose of liraglutide was increased. On Saturday, March 06, patient experienced abdominal pain and diarrhea. On Tuesday 09 Mar 2021, Liraglutide was stopped because patient experienced rashes in the stomach. On Wednesday 10-March 2021, patient experienced blood in diarrhea and was very sick and was hospitalized for one day for Colitis and was given medication. She is feeling better now and has colonoscopy on 09 Mar 2021.    Treatment information was unknown.    Action taken with mRNA-1273 in response to the events was unknown.  The event(s), abdominal pain, diarrhea, blood in diarrhea/hematochezia, sick/malaise, rash in her stomach/rash were considered were unknown. The event colitis was considered recovering.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
I am a cancer free of 8 years, had a double mastectomy no other surgeries or any medication. I took the 1st vaccine(9am) 9/28/21 on a Tuesday, a few days later early Saturday morning while I was sleeping I had heavy legs, I could not move my legs for about 10mins . later the same morning when I got out of the shower around 9am, it felt as if someone was stabbing me in my upper body right side in my back, and no it was not gas,that lasted for about 3-5 mins.   I took the 2nd vaccine 10/29/21 (10am)my arm was sore body was aching and had a very weird headache (I never get headaches) I took tylenol  still get headaches.
lost 3 pounds; a little worried; helped with fatigue, depression; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (lost 3 pounds), ANXIETY (a little worried) and THERAPEUTIC RESPONSE UNEXPECTED (helped with fatigue, depression) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (lost 3 pounds), ANXIETY (a little worried) and THERAPEUTIC RESPONSE UNEXPECTED (helped with fatigue, depression). At the time of the report, WEIGHT DECREASED (lost 3 pounds), ANXIETY (a little worried) and THERAPEUTIC RESPONSE UNEXPECTED (helped with fatigue, depression) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-325352 (Patient Link).
Patient had a concerning drop in his hemoglobin level after receiving the 1st Moderna shot on 3/26/21.  He was suspicious at that time that it was due to the vaccine, nevertheless, he agreed to receive his 2nd dose on 4/22/21.  The following day his hemoglobin level dropped AGAIN an alarming amount (from 11.8 to 7.7) which resulted in hospitalization and blood transfusion.  The patient's platelets dropped extremely low and his graft for dialysis clotted, resulting in loss of the access and catheter placement.  After this, the patient became convinced that the vaccine was the cause of dropped hemoglobin level BOTH times.
no adverse event; Doses were administered after the 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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 EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD).    No concomitant medication was reported.  Doses were administered after the 30 day BUD between 08-JUN-2023 -15-JUN-2023. No treatment information was reported.  This case contains information for patient 1 out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-729912, US-MODERNATX, INC.-MOD-2023-729921, US-MODERNATX, INC.-MOD-2023-729922, US-MODERNATX, INC.-MOD-2023-729923, US-MODERNATX, INC.-MOD-2023-729924, US-MODERNATX, INC.-MOD-2023-729909 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729912:(Patient no- 3 out of 7) US-MODERNATX, INC.-MOD-2023-729921:(Patient no- 6 out of 7) US-MODERNATX, INC.-MOD-2023-729923:(Patient no-  4out of 7) US-MODERNATX, INC.-MOD-2023-729922:(Patient no-  7 out of 7) US-MODERNATX, INC.-MOD-2023-729924:(Patient no-5  out of 7) US-MODERNATX, INC.-MOD-2023-729909:(Patient no- 2 out of 7)
Temperature 99.5F, muscle pains lower back, mid back, neck (with spasms), fatigue.  Spasms were so bad, I was unable to swallow without pain.  16-Oct-2020 through 22-Oct-2020, unable to work.
Injection site pain; Fatigue; Headache; Muscle pain; Chills; Low grade fever; Joint pain; Mild swelling at the injection site; Nausea; Feeling warmness; This is a spontaneous report from a contactable consumer.  A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included middle ear infection. Concomitant medication included ciprofloxacin taken for Middle ear infection.  It was reported that patient got the first shot about 2 weeks ago and is still having side effects. He stated he knows it should only last a day or two and he asked what he should. When probed for symptoms experienced, consumer stated on an unspecified date he had injection site pain, fatigue, headache, muscle pain, chills, joint pain, low grade fever, mild swelling at the injection site, nausea, feeling warmness. Patient also stated, For the first couple days he took Acetaminophen they said not to take anything but Acetaminophen and since then he had been taking Ibuprofen. Outcome of the events was unknown.
patient had some pain when she got the injection and she has pain continuing after 5 days in the injection site sometines radiating to the sfoulder and sone times to the neck. No rash or swelling and injection site looks normal
Syncope, severe bradycardia followed by 20+ hours of chills, fatigue, weakness, body aches
covid vaccine breakthrough  dose 1  2/24/21 EN6202 dose 2  3/17/21 ER2613
3 days after vaccination client reports ongoing and increasing inflammatory response.  Size of swelling and redness reported to be silver dollar size.  This inflammatory response continues over the course of the following week.  Client states after about one week skin started to get bright red and the most superficial layer of skin began to slough off.  Client calls HD regarding his arm and HD invites client in to observe the reaction.  Client arrives to HD 9/15/22 and has a bright red spot at the site of vaccination, smaller than a dime, with less sever erythema surrounding.   No treatment sought by client.  HD will see client for his 2nd dose of Jynneos on Monday 9-26-22 and observe for any new changes.
Immediately after injection with flu vaccine, pt had episode of hives/urticarial rash, concentrated on thighs and upper arms, some on face.
Red, itchy; burning rash to both arms (fore) & hands while driving onset day after receiving ZOSTAVAX; rash relieved with cold compress; also has occurred after spray insecticide & lotions; patient thinks vaccine altered.
Red and swollen skin surrounding injection site. Injection site was noticeable, with 2 rings around the site. Lighter red color closest to site then redder color ring surrounding first ring. Redness was very large, a little larger than a baseball.
Caller states that she was talking to one of her friends regarding her reaction and he told her that when he googled, he saw that women were experiencing this reaction more than others; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Caller states that she was talking to one of her friends regarding her reaction and he told her that when he googled, he saw that women were experiencing this reaction more than others) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller states that she was talking to one of her friends regarding her reaction and he told her that when he googled, he saw that women were experiencing this reaction more than others). At the time of the report, IMMUNISATION REACTION (Caller states that she was talking to one of her friends regarding her reaction and he told her that when he googled, he saw that women were experiencing this reaction more than others) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Monday - injection given. Tuesday/Wed. - Fatigue, Thurs - Erythematous macular rash, pruritus, edema hands/feet/knees. Tx - Allegra/Benadryl
Patient called after about 5 days complaining of redness, warmth, and irritation at the injection site. The patient was advised that per the medication information sheet that this immunization may have that effect lasting 7-10 days. Patient called back after 10 days from the immunization and was still complaining of redness at the injection site (golf ball size), irritation, and warmth. Followed up with the patient after 14 days and the patient states that the redness has decreased to a pea-sized amount and warmth is decreasing.
The first morning after the vaccine I awakened with a terrible headache and fever of 101.7 and chills. The second morning the lymph nodes in my left armpit were substantially swollen and the right side less swollen.
Fainted morning after 2nd Pfizer shot and needed 8 staples for gash on back of my head. Second day after shot I woke up with 102 fever and general malice.
Treatment of COVID-19; Treatment of COVID-19; 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0175), in left arm, on 12Nov2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 13Apr2022 as dose 3 (booster), single (Lot number: FK9895), in left arm and on 08Nov2022 as dose 5 (booster), single (Lot number: ER8737) at the age of 58 years for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation.  The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Heart" (unspecified if ongoing), notes: Heart; "Known allergies: Pickles" (unspecified if ongoing), notes: Known allergies: Pickles; "Known allergies: Bees" (unspecified if ongoing), notes: Known allergies: Bees. Concomitant medication(s) included: ALLERTEC [CETIRIZINE HYDROCHLORIDE], start date: Apr2017; CARVEDILOL, start date: Jan2006; CLOPIDOGREL AUROBINDO, start date: Jan2006; LAMOTRIGINE, start date: Jan2004; ROSUVASTATIN, start date: Jan2018. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient received concomitantly multivitamin from Jan2017. No treatment received for the event. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Have had joint pains in differing parts of my body since I have had the Lymerix vacine shots. At first it was diagnosed as possible Arthritis starting. Now every time I mention a pain it gets attributed to Arthritis.