chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID VAccine Breakthrough CAse  Pfizer Dose 1 2/21/21 (EN6200) Pfizer Dose 2 3/15/21 (EN6207) COVID Positive 11/27/21  12/5/21: The patient is a 68-year-old male with a past medical history of CAD status post PCI, type 2 diabetes mellitus, hypertension, and hyperlipidemia presented to ED with complaints of shortness of breath.  He tested positive 8 days ago for COVID-19.  He was experiencing fatigue, body aches and chills prior to being tested.  He has been fully vaccinated against COVID-19 but has not received his booster.  His wife and daughter are currently positive for COVID-19 as well.  He did receive monoclonal antibody infusions 5 days ago on outpatient basis.  He continues to experience fever, body aches and worsening shortness of breath at rest and with activity.  He has had a normal appetite with no nausea, vomiting or diarrhea.  He reports normal oral intake.  No loss of taste or smell.   On arrival to ED the patient was febrile 101.2, tachycardic 128 and requiring 2 L of oxygen to maintain oxygen saturations of 95%.  Laboratory findings were significant for AKI BUN 37 and creatinine 1.41.  Lactic acidosis 2.4.  Leukocytosis 19.06.  D-dimer 1.06.  CT chest no PE marked enlargement of thyroid gland with left thyroid lobe calcification consistent with goiter.  Extensive patchy bilateral pneumonia consistent with atypical viral pneumonia.  Zithromax and ceftriaxone were initiated in ED. Patient received Decadron 10 mg IV.  IV fluid resuscitation was given with NS 0.9% 1 L bolus.  12/7/21: 68-year-old man who presented to the emergency department with worsening shortness of breath following diagnosis of COVID-19 infection 8 days prior status post monoclonal antibody infusion.  He was hypoxic requiring initiation of supplemental oxygen.  Twelve lead EKG revealed atrial fibrillation which is of apparent new onset.  He was admitted to the hospitalist Service, started on antiviral therapy with IV remdesivir, Decadron and empiric antibiotic therapy.  Eliquis was initiated for therapeutic anticoagulation, beta-blocker was continued for rate control.  Clinical response was favorable with progressive improvement in oxygen requirements.  Oxygen walk for home determination done on the day of discharge revealed that he did not meet criteria for home oxygen.  Has been discharged in stable medical condition to continue outpatient follow-up.
administered to a 4 months old pt; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 21-Nov-2022 Reporter's comment: The reporter did not had any patient demographics or vaccine details (date of administration, lot, expiry  date).  The reporter consented to follow-up via postal. Additional supportive information: The patient received Flulaval at inappropriate age, which led to inappropriate age at vaccine administration.
Pt c/o mild SOB and palpitations 8 minutes after receiving her first dose of the vaccine. She noted that her medical hx is GERD for which she takes pantoprazole and HSV for which she takes acyclovir. She reported NKA. She was assessed and monitored by NP, EMT and Paramedic. Initial BP - 141/91, HR- 110, O2 sat 99% on RA, ST w/o ectopy on monitor on RA. Repeated BP- 136/78, HR -96. She was instructed on relaxation techniques, given H2O and granola bar. She kept and monitored until she felt better and call friend to drive her home. Her only complaint when she left was that she felt tired. She was given the Vaccination information sheet, reinforced instructions on SE/ADRs to call 911 and go to ED as well as follow up with her PCP. She verbalized understanding and willingness to comply. She left site in no acute distress, awake, alert, oriented to person, place, time and situation.
I started feeling like a runny nose on Wednesday. It got worse on Thursday And on Friday it got worse I started feeling like I was running a fever and flu like symptoms. I took an at home test and went to see my doctor to get Pavloxid. Urgent care was worried about my heart and they sent me to ER they monitored me on a EKG for a couple hours. I don't think they found anything and they sent me home. They did take XRAY of my chest and thought that i could have pneumonia but I didn't have any symptoms and they thought they say something so they started me on antibiotics that i took the next 5 days. I was feeling better on Monday. And I feel fine.
I began having shoulder pain on my left side. I work a desk job, and it has been hard to raise or use my left arm. It is sore and itchy sometimes. The shoulder is barely working now. My doctor ordered some x-rays. I have been taking Motrin for the pain. After receiving the vaccine, it makes my migraines happen more frequently.
Tenderness left upper arm. Ibuprofen  600 mg every 8 hours PRN x 5 days.
This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: (141003). A 76-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Xeljanz xr for arthritis. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "Patient reports arthritis symptoms flared up following covid vaccinations"; ARTHRALGIA (non-serious), outcome "unknown", described as "joints achy, shoulders the worst". Additional information: patient stated she was on Xeljanz XR a couple years ago; did not recall date started or how long taken. Patient stated therapy was changed; reason not stated. Patient reported arthritis symptoms flared up following covid vaccinations: joints achy, shoulders the worst. MD decided to re-start Xeljanz XR.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Swollen lymph node and pain in the left arm pit; Swollen lymph node and pain in the left arm pit; Chills; Fatigue; Booster; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received third booster dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via intramuscular route of administration in the left arm on 06Oct2021 at 13:00 (at the age of 30-year-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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via intramuscular route of administration in the left arm on 14Jan2021 at 10:00 (at the age of 30-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via intramuscular route of administration in the left arm on 04Feb2021 at 10:00 (at the age of 30-year-old); both as a single dose for COVID-19 immunisation. On 07Oct2021, for the third dose, the patient experienced swollen lymph node and pain in the left arm pit (same side as injection). This was not experienced during the first or second injection. Additional adverse events included body chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node and pain in the left arm pit, body chills and fatigue was resolving at the time of report.
Diagnosed with UTI Sat 12/19/2020 at Urgent Care Monday 12/21/2020 returned to urgent care for fever, flank pain, no relief from urinary symptoms, later went to Hospital for treatment Today 12/23/2020 have severe body pain, extreme fatigue, still having urinary symptoms; unable to do daily activities such as grooming and dressing without assistance
Narrative:  84yo male HBPC pt with Past Medical History: Loose stools (SCT 398032003) Malnutrition (SCT 2492009) Hyperlipidemia (SCT 55822004) Benign Prostatic Hypertrophy Without Outflow Obstruction (SCT 254902007) Constipation (SCT 14760008) Disorder of vitamin B12 (SCT 386067009) History of cervical spine surgery (SCT 4Hip fracture (SCT 263225007) Myoclonus (SCT 17450006) Hyperparathyroidism due to renal insufficiency (SCT 19034001) IH - Inguinal hernia (SCT 396232000) Metabolic bone disease (SCT 50279003) Vitamin D deficiency (SCT 34713006) Anxiety disorder (SCT 197480006) Osteoarthritis (SCT 396275006) Degeneration of intervertebral disc (SCT 77547008) Conduction disorder of the heart (SCT 44Chronic kidney disease stage 5 (SCT 433146000) Raised antinuclear antibody (SCT 4445510Angiokeratoma of skin (SCT 254788004) Chronic low back pain (SCT 278860009) Seborrheic dermatitis of scalp (SCT 156329007) Bradycardia (SCT 48867003) Peripheral vascular disease (SCT 400047006) Primary degenerative dementia of the AlzAnemia co-occurrent and due to chronic kidney disease (SCT 707323002) Hypertension (SCT 38341003) Active problem list reviewed Had requested hospice services on 9/9/21. Pt had recently started dialysis. On 9/14/2021 pt died at home. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
SOB, cough, Sats at 70% on RA. Acute resp failure w/hypoxia, COVID Pneumonia, Treatment - O2 @ 2L, abx, vit C&D, zinc, Remdisivir, decadron. O2 titrated down toRA at dc.. home with abx, dexamethasone and zinc
Chills Fever up to 101.8 Body aches lack of appetite fatigue Injection site - swollen, tender, hot, red, and itchy large (grew to 3") lesion
Redness about 3/4 the size of the patient's palm on the patient's left arm around injections site. No other symptoms besides soreness in arm (which is to be expected from this vaccine).
no additional AE reported; expired dose of VARIVAX was administered to a patient on 11JUL2022; X expired on 30JUN2022 and did experience a temperature excursion on 1APR2022.; This spontaneous report was received from the Office Manager and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-JUL-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #T022312, expiration date: 30-JUN-2022, administered for prophylaxis (dose number, strength, an anatomical location and route of administration were not provided). The vaccine experienced a temperature excursion on 1-APR-2022 (product storage error), and additionally did expire on 30-JUN-2022 (expired product administered). No other adverse event reported.
Itching Head to toe. Headache. Rash. Patient took Benadryl and reported rash and itching subsided.  Feeling malaise on 08/16/15.  Thinks she may be sweating due to vaccine but works around ovens.
About 4 hours after receiving the vaccine I felt pain in my chest, like it my heart was being squeezed. I felt no other symptoms. When I woke up the next morning it went away so I thought it was a reaction to the vaccine. I did not see a doctor.
less than 21 days administration of 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 21 days administration of 2nd dose) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 002F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 21 days administration of 2nd dose). On 04-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 21 days administration of 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the dose 12 days early. Scheduled dose was supposed to be on the 15th.  No concomitant product was provided by the reporter. No treatment medication was provided.
Pfizer bivalent booster(GK1657)  was ordered as dose #3. Original pfizer vaccine was given instead (GD1857). Mom was notified of vaccine event and advised to monitor for any adverse effects and call back with further questions.
pt recvd vax & devel fever up to 101; rash noted; diffuse erythematous face trunk, spreading to extremities; maculopapular rash;
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 20-NOV-2017, the patient was vaccinated with the first dose RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 20-FEB-2018, the patient would like to receive the second dose of RECOMBIVAX HB.
Information has been received from a 66 year old female who in 1995 was vaccinated with the 1st and 2nd dose of Hep-B vaccine recombinant and subsequently, she experienced a burning sensation in the groin. It was reported "the skin never broke, but it was like the shingles". The pt also experienced a "yeast and sugar imbalance" that was returning to normal at the time of the report. She also experienced a tightness while running that took her breath away. She also received the 3rd dose in 1996. No further information is available.
Tongue swelled.  I was able to take Benedryl every 4 hours for the next 24 hours.  Headache, tired, and sore arm.
COVID arm; Itchy; Huge welt; Painful; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Huge welt), VACCINATION SITE PAIN (Painful) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEBREX) and GABAPENTIN for an unknown indication.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Huge welt), VACCINATION SITE PAIN (Painful) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 25-Jul-2021 at a dose of UNK dosage form. At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Huge welt), VACCINATION SITE PAIN (Painful) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
LOCALIZED SWELLING, ERYTHEMA, PRURITIS AT SITE OF INJECTION LEFT DELTOID.
I received a Hep-B vaccine and after arriving home, I experienced and developed a rash along with right arm soreness and weakness. I treated it with Benadryl 50mg X 2-8 hours apart.
Client reported "burning in chest that radiated towards left shoulder" that started approx. 15 mins. after receiving 2nd dose of Pfizer. Declined EMS offer, Vital signs WNL. Client stated "feeling much better" at 11:37am Client observed for total of 45 mins. and stated "feeling fine" at 11:58am. Was advised to follow-up with cardiologist. Client left site unassisted, with a steady, accompanied by her daughter.
Initially flushed face and weakness, 2 weeks later, tachycardia, hypertension, anxiety, drowsiness, weakness.
Itchy erythematous rash began on bilateral thighs at site of vaccine administration the morning following administration. Spread to arms/ belly 2 days following vaccine administration. Also with tactile fever x1-2 days following vaccine administration, as expected.
Immunizations given 04/10 and parents took him to ER that evening with swelling and redness in left deltoid.  Given Keflex and Benadryl.
Previously noticed tics and twitches after Dtap#1&2. Dtap#1 was given by doctor before recommended age without full informed consent to parents. It was administered at 4 weeks adjusted age to premature baby. Neurological regression after 3rd shot. Seizures and developmental regression. Also onset lymphadenopathy diagnosed.
I experienced a delayed hypersensitivity reaction at the injection site. On Sunday evening (1/31/21) I noticed a few petechiae at the injection site (~10) but had no other symptoms. On Monday morning (02/01/21) I woke up with a large wheal at the injection site that measured 7cm by 6cm. The area was red, warm and incredibly itchy and uncomfortable. Vital signs were measured and were normal. No treatment was administered, although I may take benedryl later. *Note- no one asked about signs of anaphyalxis etc. when I called saying I was having an allergic reaction. You should add this to the  voicemail because it took 2 hours to speak with a person and this could be incredibly dangerous/deadly in other cases.
Information has been received from a physician concerning a 10 year old female who was vaccinated with VARIVAX (Merck), and broke out with a case of chickenpox after being exposed to a peer. It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
On 4/29/2022, I got my second Moderna COVID-19 booster and a flu shot. On 5/2/2022, I took a home antigen test and got a positive result. On 5/3/2022, I woke up and felt like I was getting chest congestion. I had a productive cough and coughed up some phlegm. I called my PA, and he prescribed me PAXLOVID, which I began taking that day. I had just the congestion, cough, and a bit of a chill for the rest of the day. On the morning of 5/4/2022, I woke with a productive cough. By that evening, the cough was pretty much gone, though. I had fatigue for a few days. I then finished my isolation and then returned to my normal life afterwards. I have been dealing with fatigue for the past couple of years, but it became even more pronounced in September 2022. I don't blame the vaccine or the COVID-19. I have osteoarthritis, psoriatic arthritis, and arteriosclerosis, so I think it may tie in with those conditions.
5 days later reports extreme dizziness/fatigue. No other symptoms noted. Reviewed severe side effects and what to do including calling 911, call doctor.
Severe full body rash starting at neck and continuing to toes; This is a spontaneous report received from a contactable consumer, the patient. A 81-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Feb2021 (at the age of 81-years-old), as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration on 02Mar2021 at 11:30 (at the age of 81-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications were not reported. The patient had not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced severe full body rash starting at neck and continued to toes. Therapeutic measures were taken as a result of severe rash and included treatment with prednisone. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome for the event severe rash was not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Red, swollen & warm arm at vaccinations site on 3/15/2021  Vaccine was given to me 3/6/2021
Initial and follow-up information has been received from a registered nurse and a physician concerning a 57 year old white female patient with chronic obstructive pulmonary disease, reactive airway disease, hypertension, hyperlipidemia, pneumoconiosis and allergies to penicillin, erythromycin, prochlorperazine, and oxycodone (+) aspirin who at 03:50 on 29-JUN-2005 was vaccinated IM in the right deltoid with a first 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 649692/0371P). Concomitant therapy included antimicrobial (unspecified) aspirin, rosuvastatin calcium (Crestor), hydrochlorothiazide (manufacturer unknown), amlodipine besylate (+) benazepril hydrochloride (Lotrel), flunisolide (Nasarel) and tiotropim bromide (Spiriva). Subsequently, on 29-JUN-2005 the patient developed cellulitis around the injection site (right arm). The patient sought unspecified medical attention and was treated with unspecified oral antibiotics. The patient recovered on an unspecified date. There was no product quality complaint. Injection site cellulitis was considered to be an other important medical event (OMIC). Additional information is not expected.
Pt experienced body aches, stiffness, severe headache, fever and pain in area of liver. Symptoms lasted two weeks with pain in area of liver continuing.
Pt came in to get an influenza vaccine and reported that she had what she thought was a localized case of shingles at the injection site and stated it was a painful rash which lasted approx. 2 days.
My left shoulder hurts if I raise/move my left arm up to and above my shoulder line.