chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got sick (after 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick (after 2nd dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick (after 2nd dose)). At the time of the report, ILLNESS (Got sick (after 2nd dose)) outcome was unknown.            No concomitant drugs were reported. Treatment medication were not reported .   This case was linked to MOD-2021-381023, MOD-2021-381140 (Patient Link).
Allergic rxn, large confluent erythematous urticarial lesion with swelling.
have a headache; am feeling tired; general malaise; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on an unknown date, refer case US2020AMR047463).   In February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced headache, tiredness and malaise. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, tiredness and malaise were unknown.   It was unknown if the reporter considered the headache, tiredness and malaise to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had vaccine about a month before the time of reporting and felt tired, had a headache and general malaise. Someone told the patient that this could be long lasting side effects of the Shingles vaccine. The patient wanted to know if that was possible. This case had been linked with case US2020AMR047463, reported for same patient.
welts (size of a quarter) on rt side of face w/redness 1 1/2hr later rt side welts & then lt side got welts;next day lt arm still has red areas on face;no fever, no difficulty breathing;playing & happy;
Patient received MENACTRA, HPV and FLUZONE on 1/6/16. Approx. 13 hrs later awoke at 4:30 am to vomit x 5, felt abdominal discomfort, chills and headache. Felt short of breath at time of vomiting. On exam had 3mm injection site redness/tenderness/swelling at site of MENACTRA.
I received my vaccine on 1/19/21 and had no immediate reaction, but did notice yesterday 1/27/21 that i have an area of inflammation right under my injection site. i am not able to tell if there is any redness or discoloration because i have a tattoo in the are with conflicting color. the are is roughly between the size of a quarter and a fifty cent piece. I font have any itching or pain and there doesn't seem to be any change between yesterday and today.I called my doctor's office and was told to monitor it for any changes.
Narrative:  On 9/22/21 patient's family contacted SW for help with pt due to pt requiring more care then family could provide at home. Patient is a 89 yr. old. Patient is followed medically at the clinic and has a diagnosis h/o cad, htn, PAF, hyperlipidemia, stable pulmonary nodules, phtn on chest ct, thyroid nodules, RA, (B) carotid stenosis, TAA, AAA, benign (R) adrenal adenoma, (B) hip pain, (R) knee djd, gerd/esophagitis/esophageal stricture (s/p dilatation)/gastriti, chronic constipation, diverticulosis, h/o tubulovillous/tubular adenoma/hyperplastic colon polyps, iron def anemia, bph/nocturia, (L) renal cyst, depression, dermatitis and rhinitis. On 9/26/21 pt passed away. No information provided regarding circumstances of pt's death. Pt had received covid vaccine on 1/12 & 2/9. Likely this death is not related to covid vaccines given patient's advanced age, comorbidities, and long length of time between date of vaccines and date of death.
In Mar2021, the patient experienced COVID; In Mar2021, the patient experienced COVID; This is a solicited report received from contactable reporters (Consumer or other non-HCP). The reporter is the patient. Other Case identifiers: 22K-163-4359071-00.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1157153), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2021, outcome "unknown" and all described as "In Mar2021, the patient experienced COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2021) experienced COVID, notes: In Mar2021, the patient experienced COVID. The action taken for upadacitinib was unknown. Clinical course: Solicited report from (name country) by a consumer of a 64-year-old female with events of non-serious FELT LIKE GAINING WEIGHT FROM RINVOQ/HAD NOT FIGURED OUT WHEN TO STOP EATING THROUGHOUT THE DAY, WEIGHT LOSS and COVID with RINVOQ (UPADACITINIB). There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of "in mar2021, the patient experienced covid" with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for the events of COVID was not provided with respect to RINVOQ (UPADACITINIB).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and vaccination failure.
Few minutes after having the second moderna shot. PT started to get severe swelling, redness and itching at the shoulder injection site.  this was followed by pt having swelling in the back of the throat and  trouble breathing.   This occued at the Clinic.  She was given  sub cutaneous epinepnephirne. She was trasported to my hospital emergency room where additional benadryl,  pepic and prednisone.    She was observed in the emergency room and discarged home. to follow up her doctor.
Went to dr bc I wasn?t sleeping bc I thought my allergies/asthma was acting up. Wheezing not sleeping . They did on normal pulse rate was very high did ekg and was sent to hospital.  Was determined I have Afib.
Breakthrough case admission after three vaccines Moderna 3/4/21 Lot# 029A21A;  Moderna 4/1/21 Lot# 028A21A;  Pfizer 12/15/21 Lot# FE3594
This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling of upper arm in a child subject of unspecified gender who was vaccinated with combined KINRIX. In February 2009 the subject received 1st dose of KINRIX in an unknown arm. At an unspecified time after vaccination with KINRIX, the subject experienced swelling of upper arm (the arm where the KINRIX was given). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. It was reported that 5 subjects in the age range of 4 to 6 years received KINRIX within the last week developed swelling in the arm where the KINRIX was given. No specific details were known at the time of reporting. Linked cases include A0770472A, A0770473A, A0770474A and A0770475A.
Reports mild right knee pain and swelling  following vaccination. Took Benadryl at ~7 PM d/t hives and swelling on lower legs bilaterally and face. Next morning symptoms were resolved except for mild pain and swelling in right knee that had surgery on in 2016.
On 1/11/00, the pt received her first IM dose of Lymerix. On 1/12/00 AM the pt developed hives on her face with itching and swelling. Applying baking soda to her face decreased the itching and the swelling.  The most recent information received on on 1/12/00 reports the condition of the pt is improving.
Soreness/dull pain at injection site (left arm) on day of vaccine (Saturday 3/20), soreness continued on Sunday and Monday (3/21 and 3/22) and then started to subside.  Almost no soreness  on Tuesday and Wednesday (3/23 and 3/24).  Thursday evening (3/25) it started to feel sore/painful again and has continued through Friday (3/26), six days after vaccine injection.  Discomfort is about the same level as the day after getting the vaccine.
Itchy, painful, swollen and bruised area of injection.  Area of injection looks like a bee sting on top of a swollen bruise.  Shoulder is very sore. Side effects are tolerable for an adult, only reporting because the side effects may not be so tolerable for a child.
Pt recvd 2 doses of Engerix-B & devel an upper respiratory infection & was treated w/Amoxicillin 29OCT92 blood work revealed Thrombocytopenia; hospitalized for 1 day;
The center of the rash patches began blistering in the centers; Left arm had large blotches; The rash was red with raised patches about 1 1/2 inches across; The rash was red with raised patches about 1 1/2 inches across; Intense Rash (hive like) on left arm; Extremely sore left shoulder; Stiff neck; Her left forearm was still sore and weakened; Her left forearm was still sore and weakened; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0162, expiry date: unknown) via an unspecified route of administration, administered in left arm on 10Apr2021 08:35 (age at vaccination 62-years-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient has no known allergies. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via an unspecified route of administration, left arm on 20Mar2021 09:30 AM (age at vaccination 62-years-old and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. On 09May2021 05:00 PM, the patient experienced intense rash (hive like) on left arm, extremely sore left shoulder, stiff neck. The patient experienced stiff neck and extremely sore left shoulder started on 09May2021 5 PM. By 14May2021, her left arm hand had large blotches. The rash was red with raised patches about 1 1/2 inches across. On 15May2021, the centre of the rash patches began blistering in the centres. Rash disappeared within a couple weeks. Her left forearm was still sore and weakened on an unknown date in 2021. The patient was not diagnosed with COVID-19 prior to vaccination and since the day of vaccination, she has not tested for COVID-19. The patient had COVID test on 07Nov2020 and the result was negative. The patient visited clinic for consulting Doctor/other healthcare professional. The patient received treatment for the events experienced intense rash (hive like) on left arm, extremely sore left shoulder, stiff neck and had alignment to reduce neck pain. The patient had chiropractic treatment for the events. The outcome of the event rash on left arm was recovered on an unknown date in May2021, shoulder soreness, left forearm was still sore and weakened and stiff neck was not recovered, outcome of other events was unknown. These events were reported as non-serious.  Follow-up attempts are completed. No further information was expected
Swelling at injection site... overall aching pain in right arm... chills... headache... nausea
Pt. states that after receiving the J&J dose 06/18/2021, started experiencing symptoms 06/21/2021, visited Walk-in Clinic 06/28/2021 with severe dizziness, sinus (antibiotics), 06/29/2021 presenting with Migraine. 07/04/2021 ER visit presenting weakness, dizziness, nauseous, and loss of appetite. 07/13/2921 ER Cat Scan
Patient reported having Shingles 4 days after the covid-19 vaccine.  She saw an MD after she started experiencing the vesicles and itching/pain.  Patient states she still is having symptoms today (5/25/21).  The MD did not know if it was related to the vaccine.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer and concerned a male of unspecified age. The patient's height, and weight were not reported. 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, and batch number: 207A21A expiry: UNKNOWN) dose, start therapy date were not reported, with frequency time 1 total for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient was transmitted to displaced specialty unit (DSU) for Covid-19 infection after receiving the vaccine. The patient's Covid-19 infection resulted in suspected clinical vaccination failure. He was not doing good. On an unspecified date, the patient was hospitalized. Number of days hospitalized and discharged date were not provided. They wanted to know if the patient could take Pfizer Covid vaccine series. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event of suspected Covid-19 infection and suspected clinical vaccination failure not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000198444.; Sender's Comments: V0: 20211037891-Covid-19 vaccine ad26.cov2.s-suspected Covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211037891-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I received my vaccine on 12/28 and 7 days after I developed a swollen lymph node in my left clavicle area.  It was painful and would get bigger and smaller over the next 10 days.  On 1/14/21, I developed several more swollen painful lymph nodes on the left side of my neck and clavicle area. On 1/16 I noted a red welt starting on the back of my neck.  On 1/17 the welt became hot and a rash developed.  I contacted my doctor and he placed me on valtrex since it appeared to be a shingles rash.  This is my 3rd time getting shingles, so I?m aware of it?s appearance.  Today the rash feels better after being on Valtrex for 3 days but the lymph nodes are very painful and swollen.  I was scheduled for my second vaccine on 1/25/21, but I am concerned about the side effects since the second dose appears to have more.  I finish with the valtrex 1/24.
10 days after vaccine developed fever 0f 101-102. Swollen glands at neck - achey joints.
pt recv vax 22MAY96 & 24MAY96 pt devel an itchy rash @ the inj site described as indurated 3 circular, red & warm @ the inj site;
fatigue, muscle aches (arms, hands, back), indigestion, diarrhea, almost complete loss of smell and taste.  Occurred after first series of 2 and finally resolved after 9 months.  then had booster dose adn sx all returned again.
Swollen Tongue,  Shortness of Breath, Aches, Dizziness
This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Skin disorder/SPOTS ON ELBOWS), PSORIASIS (CHRONIC PLAQUE PSORIASIS FLARE UP) and VACCINATION SITE PAIN (Vaccination site pain/ sore arm) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Plaque psoriasis. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced SKIN DISORDER (Skin disorder/SPOTS ON ELBOWS), PSORIASIS (CHRONIC PLAQUE PSORIASIS FLARE UP) and VACCINATION SITE PAIN (Vaccination site pain/ sore arm). At the time of the report, SKIN DISORDER (Skin disorder/SPOTS ON ELBOWS) and VACCINATION SITE PAIN (Vaccination site pain/ sore arm) outcome was unknown and PSORIASIS (CHRONIC PLAQUE PSORIASIS FLARE UP) had not resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant and treatment medications were reported.
Client came the vaccination table requesting a booster COVID vaccine. PHN, looked client up in database, 1 COVID Moderna vaccine full dose documented on 1/19/2022 from Pharmacy. PHN asked client how many doses he had received already, client confirmed received "one Moderna" and stated lost his record of it. Client reports rashes after taking P.O. penicillin as a child. Client denies any chronic medical conditions, not immunocompromised, takes ibuprofen as needed for pain. PHN, completed COVID vaccine screening and education  of side effects for 2nd dose Moderna. PHN, administered 0.5 ml COVID Moderna vaccine lot # 054A22A to client in the left arm at 9:30 am today. After administration client stated had "3 doses of Moderna" and showed PHN, digital record of vaccines received. The record showed one Moderna received on 5.18.2021 and another Moderna dose received on 6.16.2021. PHN texted Dr. at 10:50 am and reported what happened. Per Dr., "no (medication) error occurred based on the situation", but confirmed to file a VAERS. PHN, telephone called Dr. and he confirmed to transcribe all 4 vaccines onto COVID white card, and list the 4th dose as a booster, even though it is a full dose. PHN, telephoned, agent at 10:20 am and requested to change data to a booster. Agent changed dose to first booster, as no other option was available due to client's age. PHN, emailed agents with client's historical record from another state to add into database.
Body has been itchy, on feet and sole, palms and hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Body has been itchy, on feet and sole, palms and hands) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 012M20A and 029L20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, IRBESARTAN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRURITUS (Body has been itchy, on feet and sole, palms and hands). The patient was treated with PREDNISONE for Itch, at a dose of 3 pills for 3 days, 2 pills for 3 days, and 1 pill for 2 days. At the time of the report, PRURITUS (Body has been itchy, on feet and sole, palms and hands) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After patient body has been itchy, on feet and sole, palms and hands the patient took prednisone 3 pills, the itch stops. For 6 days, there was no itch. On Day 6, which was at the time of report, the patient took 2 pills (last day of 2 pills), and at night the itch started again.
he had a negative reaction to Shingrix1st shot/he had a flu-like reaction; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza like illness (Verbatim: he had a negative reaction to Shingrix1st shot/he had a flu-like reaction). The outcome of the influenza like illness was resolved.   It was unknown if the reporter considered the influenza like illness to be related to Shingrix.     It was unknown if the company considered the influenza like illness to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-MAY-2023 and 01-JUN-2023 The reporter was the patient who had stated that, he had got the 1st shot 4 years ago.  No second shot received. The reporter had asked if he should get a new series.  He was advised he would receive a letter from safety. He stated that the reason he did not received Shingrix second shot was that he had a negative reaction to Shingrix first shot.  He indicated that he had a flu-like reaction. (The event was resolved).  No further details were provided. The reporter consented to follow-up.
fever as high as 104 with chills, sweats, aches, bad headache, sleeplessness for 36 hours,  Next 36 hrs: hot/cold sweats, headache, vertigo.  Nasty rash on arm of injection sight.
Information has been received from a health professional concerning an 87 yr old Caucasian male with diabetes neuropathy, non insulin dependent diabetes mellitus, aspirin allergy and hypertension who on 20Mar06 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot651320/1008P), IM, in the right arm. There was no concomitant medication. There was no illness at the time of vaccination. One day after injection the pt developed soreness at the site of injection. An exam revealed erythema and induration and tenderness consistent with cellulitis. The pt was treated with cefdinir (Omnicef), 300mg, BID x 10 days. The pt was also given an IV. It was noted that the pt had no adverse reaction following his first dose of pneumococcal 23v polysaccharide in 1999. The reporter considered the pt's experience to be other medical event (OMIC). Additional information is not expected.
24 hours after receiving Afluria experienced symptoms of peripheral neurtits   Tinglin pain and cramps in bilat lower extremities which felt like"ants crawling up legs"
Experienced dizziness after being observed for vaccine. . Did eat breakfast and drank water.  Decreased after drinking water, having some apple juice and laying down.  BP 146/89 sitting, 136/96 standing.  No dizziness on standing.   Observed for 30 minutes.