chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 57 year old female consumer with a history of osteopenia and no drug reactions/allergies, who on 11-OCT-2007 was vaccinated SC in the  abdomen with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included alendronate sodium (+) cholecalciferol (MDS), tablet (duration, dose and indication nor reported). Other concomitant therapy included Requip (manufacturer unknown). On 12-OCT-2007, the patient developed a red circle and itchiness at injection site. The patient was concerned that the effectiveness of the vaccine would have been compromised because the vaccine was not administered in the deltoid region of the upper arm as recommended. The patient was considering suing her physician for the latter reason. There were no lab diagnostics studies performed. Medical attention was not sought. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 11/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Arm where vaccine shot was given turned bright red the size of a half dollar. Still have red spot by is now getting lighter (this is now 6 days later).
On the morning after the second vaccine I woke with swelling of my left eye,face, neck and under arm/breast area on the left side  .By the afternoon all swelling was gone except under the arm. It is uncomfortable to put my arm close to my body and to lay on that side today. It is still sore and swollen today.
1) Swelling and erythema 4 cm x 3 cm of left deltoid. Pain after 5 days. Ibuprofen and ice.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 91 year old female of unspecified race and ethnicity. Initial information was processed along with the additional information received on 06-OCT-2021 and 07-OCT-2021. 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, and batch number:1805029 expiry: unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient did not have antibodies (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) no antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000196498 and 90000196262.; Sender's Comments: V0: 20211012353-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine 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
Significant cold sore outbreak on oral mucosa of the upper lip.  This outbreak was in the absence of EVER having a cold sore in the past.  This was the only time the HSV had ever been experienced and it hasn?t happened since the outbreak that occurred after the second vaccination.
PATIENT CAME TO OUR PHARMACY  4/26/23 AND REPORTED THAT RED ITCHY SPOTS(HIVES)  FOUND ON HER CHEST ,NECK, BOTH ARMS AND SHOULDERS (PER PT, NONE FOUND BELOW THE CHEST).  IT STARTED A DAY AFTER HER SHOT.  PHARMACIST ON DUTY RECOMMENDED HER TO TAKE DIPHENHYDRAMINE 25 MG 1-2 TABLETS  BY MOUTH EVERY 4-6 HOURS AS NEEDED FOR HIVES.
x 2 days, red, swollem hot to touch and pain in the arm pit. On-call nurse evaluated and instructed her to seek appt w/PCM.
In Dec 2021 I experienced shortness of breath and went to my PCP in January and he did an EKG and didn't like the way it look. He sent me to a Cardiologist, and since then I've been to numerous doctors. Recently Sept 19th I had a heart procedure (stent was put in one of my arteries, cleaning out of another artery and still have 2 blocked arteries) and now I'm recuperating.
Increased migraine headache; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (Increased migraine headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Migraine headache (Migraine headache).   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In May 2021, the patient experienced MIGRAINE (Increased migraine headache). At the time of the report, MIGRAINE (Increased migraine headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.  No treatment medication details was reported.
Starting the day after vaccination, patient states her arm was red and warm to the touch from her shoulder down to her elbow. Stated redness is a side effect of the vaccine but she states it was not just around the injection site but rather her entire upper arm.
Myalgia, Fever, chills, HSV-1 outbreak, anxiety, fatigue, insomnia Narrative: Per nursing report: "Employee presents today [8/23] with c/o adverse events from her Covid-19 2nd dose of Moderna on 8/18/2021, that evening she started feeling body aches, fever, chills, on Saturday morning 8/21/2021 she began have lesions on her lips, she has self-treated with abreva. Employee states she has a history of HSV-1, but wanted to report adverse events. She has 2 lesions on on the bottom lip on the right and one top lip on the left. Employee states she has enough Abreva for topical use. Prescribed Acyclovie 400mg BID x 7 days."  Further nurse note from  09/10/21: "Employee called today with complaints of anxiety and not being able to sleep, employee states symptoms are not relieved with medications, state that symptoms of fatgue,exhaltion and feeling tired) has been getting worse x1 week,sleeping for 1hr out of a 24hr peroid.Employee has appointment with her PCP 9/15/2021. Employee is to call with findings and recommendations after her appointment."
pt diagnosed positive for COVID 19 on 8/13/21; to ED on 8/15 with increasing SOB; hypoxic with O2 sats 70%; on BiPAP; Hx of lung CA, currently not taking chemotherapy or radiation; treated with dexamethasone, tocilizumab, remdesivir, therapeutic anticoagulation; DNR; TPN; became septic with increasing weakness; made comfort care; inpatient hospice; pt died in hospice
8JAN92 pt felt warm; 9JAN92 sitter called mom @ work pt pale, shaking & breathing irregularly; felt hot (this was 10AM); 1030 seen by MD t102.6 ax MD dx ear infect; 10JAN92 mom states still low fever, emesis x2; not active self;dec appetite
Mom noticed 02/4/10 Left arm red puff sore and mom called to the office 2/5/10.
8/10/2004-was seen in our office fussy, more than normal, shaking head, no fever, local reaction, ? Cellulitis. Started Duricef. Left thigh. +induration and erythema Left thigh. Episodes of shaking head for a few seconds.
This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 44-year-old female patient who received BOOSTRIX (batch number 7Y29Z, expiry date 17th August 2019). Concomitant products included vitamin D. On 29th August 2017, the patient received BOOSTRIX (intramuscular) .5 ml. In August 2017, less than a week after receiving BOOSTRIX, the patient experienced lymphadenopathy cervical. On 30th August 2017, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling and lymphadenopathy cervical were not recovered/not resolved. The reporter considered the injection site swelling to be possibly related to BOOSTRIX. It was unknown if the reporter considered the lymphadenopathy cervical to be related to BOOSTRIX. Additional details were provided as follows: The case was reported by a medical assistant. The patient experienced injection site swelling at the right arm where the injection had been given. The swollen lymph node was on the right side of the neck. On 31st August 2017, the patient was seen at the physician's office for injection site swelling and swollen lymph node on the right side of the neck. On 29th September 2017, the patient was at the office to see the physician because both symptoms had not yet resolved and remaining unchanged. The reporter gave permission to be contacted by global clinical safety and pharmacovigilance (GCSP) with any further related questions.
I did not have an adverse event to the vaccine but I got, COVID-19 about 3 months after getting the vaccine during the time I had COVID-19 I also got hives.
Side effects; Breathing problem; Massive body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Side effects), DYSPNOEA (Breathing problem), PAIN (Massive body aches) and PYREXIA (Fever) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Side effects), DYSPNOEA (Breathing problem), PAIN (Massive body aches) and PYREXIA (Fever). At the time of the report, ADVERSE DRUG REACTION (Side effects) outcome was unknown and DYSPNOEA (Breathing problem), PAIN (Massive body aches) and PYREXIA (Fever) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Pain is specified as body aches.  Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up information received on 07-MAY-2021, Events fever, breathing problem, massive body aches were added
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves two-year old male patient who received a 0.5 mL dose of FLUZONE QUADRIVALENT (batch number UT6301JA, expiry date 30 June 2018) intramuscular  in right thigh on 04 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to overdose as patient under 3 years of age, reports he was "just three days shy of his 3rd birthday" and was administered FLUZONE QUADRIVALENT 0.5mL. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Developed symptoms of COVID on 6/24/21, cough, shortness of breath, sore throat, myalgias, and a fever.
Patient presented with a fever of 38.2 on the evening of 10/6 She developed flu like symptoms (cough/congestion) on 10/8  On 10/14 she had vomit with bile and was referred to Medical Center ER. she had a large vomit and acted hungry afterwards. The vomit was clear, then yellow/light green.  In the ED and there she was examined, received IV fluids, blood tests (results not available) and two swabs (one for Covid was negative and second swab unclear what it was for.) ED sent her home after ~3 hours. No urine tested.  On 10/16 she presented in my office pale, lethargic and with significant weight loss. Her stool was green, having been yellow prior to 10/6. She was immediately referred to  hospital where she was admitted from the ER for IV fluids.
Initially w/burning, red, irritated eyes.  Later in day had leg cramps.  On 4/14/07 neck began to pull backwards and could hardly move legs and arms.  Employee did not seek treatment, nor notify IC & EH until 4/17/07
nausea and general malaise occuring evening and next morning after vaccines requiring patient to stay in bed
hives; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6198), intramuscular, administered in left arm on 27Feb2021 11:00 as single dose for COVID-19 immunisation. Medical history included ongoing interstitial cystitis diagnosed 1.5yrs prior, ongoing idiopathic chronic pancreatitis diagnosed 2.5yrs ago, depression and heartburn. Ongoing concomitant medications included ibuprofen (ADVIL) taken for interstitial cystitis, bupropion hcl for depression, omeprazole (PRILOSEC) taken for heartburn, biotin and multivitamin gummies. The patient received first dose of bnt162b2 on 06Feb2021 for COVID-19 immunisation and experienced broke out in hives from her hands to the arches of her feet, and it was progressive. On 02Mar2021, 11:30, the patient experienced hives 3days after vaccine. Treatment for the event included 2 Benadryl 50 minutes apart. It was reported that benadryl was required for second dose to resolve, take Zyrtec before and after second dose prevented a second outbreak. (Also: no caffeine, Alcohol, exercise, and stress). The event was considered as important medical event. The patient had no other prior vaccination (within 4 weeks). Outcome of event was recovered on an unspecified date. The reporter considered the product had a casual effect to the adverse event.
This spontaneous report as received from a certified medical assistant refers to an approximately 64 year old  patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown date in 2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose, was not reported ) (lot # reported as N037669, expiration date 09-MAY-2018) , intramuscularly for prophylaxis. No adverse effects were reported. Lot number N037669 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent).
some swelling going on under both of his arms; glands are swollen on both sides, but it is mostly on the side he got the shot on, which is his right side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 13Mar2021 12:30 (Lot number: EN6207) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing). Vaccination history included: Bnt162b2 (Lot number: EN6198 intramuscularly in right arm at 12:30 as dose 1, single), administration date: 20Feb2021, when the patient was 65 years old, for COVID-19 immunisation, reaction(s): "right arm was a little sore", "his right arm was warm at the site of the shot", "felt kind of blah". The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 14Mar2021, outcome "recovering", described as "some swelling going on under both of his arms"; LYMPHADENOPATHY (non-serious) with onset 14Mar2021, outcome "recovering", described as "glands are swollen on both sides, but it is mostly on the side he got the shot on, which is his right side". The events "some swelling going on under both of his arms" and "glands are swollen on both sides, but it is mostly on the side he got the shot on, which is his right side" were evaluated at the physician office visit.  Additional information: It was reported that events has improved since Sunday and he was hoping it goes away.  No follow-up attempts are possible. No further information is expected.
Chest is closing; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest is closing) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer since 2016.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST DISCOMFORT (Chest is closing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Chest is closing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Metrol Dose Pack .
2nd Vaccine at noon on 4/20/21.  At approx 9:00 pm, hands and wrists became painful.  Woke up at 1:00 with typical flu-like symptoms, fever, body aches, etc for about 16 hours.   After that, pain in hands/wrists never went away, became worst over time.  Then right hip, left knee, arms, became painful.  Over next few months, left arm and both hands went numb every night.   To date, hand/wrist are crippling each morning, along with joint pain.  Hands and wrists are painful through out the day.
10 minutes after pt received vaccines she reported feeling "sick" & "light-headed".  She put head down & elevated her feet.  BP 80/40 pulse 64.  Vomited at 3pm.  Felt better then & BP went back up to 90/60 at 310pm.  Pulse 64.  Wanted to leave by 320pm.  Mother was with her.  She reports patient reacts this way when she is anxious.
CIDP; Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy; This literature case was received on 18-Oct-2021 and concerned an elderly, male patient who was 87-year-old at the time of the reporting.   The patient's concurrent conditions and concomitant medications were not provided.  On an unknown date in 2017, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). Thyroid function tests, haemoglobin A1c, serum protein electrophoresis, syphilis and lyme titers were unremarkable. The patient had incomplete resolution of symptoms with a course of five plasma exchange treatments.  On an unspecified date in 2017, one month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP), for which he received ongoing plasmapheresis, on every two weeks basis.  At the time of this literature report, the patient was recovering from the events of GBS/AIDP and CIDP, with symptom improvement but not normalization.  The authors did not provide causality assessment.  Company comment: An elderly patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). One month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP). Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship. Brighton Collaboration criteria could not be assessed due to insufficient information about diagnostic findings.; Sender's Comments: An elderly patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). One month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP). Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship. Brighton Collaboration criteria could not be assessed due to insufficient information about diagnostic findings.
Presented to ED w/ c/o involunatary movements since night before presentation; admitted for AKI and acute urinary retention; +COVID w/ acute resp failure tx with oxygen support via NC, Vit C, zinc & steroids; pt weaned to RA prior to DC.
pt. developed hives to the Lt. arm & redness to the chest.  Medics present.  Pt. denies any difficulty swallowing &/or other S/S.  Administered Benadryl 50mg PO at 1635.  pt. waiting as vaccination site an additional 15 mins to be monitored (45mins total).  pt. having someone else drive her home  BP: 127/78.  HR: 79, RR:16.
Sharp muscle pain and tremors. Heart fluttering palpitations and now having to take heart medication
Administration lower than the deltoid muscle (she thinks); A spontaneous report was received from a nurse concerning a 41-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) administration lower than the deltoid muscle (Vaccine administered at inappropriate site).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 26 Jan 2021, prior to the onset of the event administration lower than the deltoid muscle, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 038K20A) in the right arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient had her second dose of the vaccine on her right arm and she thinks the placement of vaccination was incorrect, lower than the deltoid muscle.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event administration lower than the deltoid muscle was considered recovered.; Reporter's Comments: This report refers to a case of Vaccine administered at inappropriate site for mRNA-1273 (lot/batch: 038K20A) with no associated AEs.
dizzy, lightheaded, legs "feel heavy," EMS evaluated, pt. refused transport.