chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via Company Representative refers to a 60 year old female patient. Medical history and concurrent conditions were not reported. On 02-AUG-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous in the right arm, lot # K000330, expiration date 06-MAR-2015 (dose and strength were not reported) for prevention of shingles. Secondary and concomitant therapies were not reported. Pharmacist reported that on 05-AUG-2014, the patient presented after receiving ZOSTAVAX vaccine with a very red, swollen and itchy patch on her right arm. This was the same arm and location where the ZOSTAVAX vaccine was administered. The pharmacist suggested that patient could use MOTRIN and CLARITIN to relieve the reaction. The outcome of the events was reported as recovering. The pharmacist suggested to the patient to show her reaction to her physician for an evaluation. The patient had an follow up visit on 06-AUG-2014 with her primary care physician. Additional information has been requested.
Right anterior thigh 2 1/2 x 4 cm patch warm raised painful. Left anterior thigh 4 x 7cm raised erythemic painful patch.
Pt was scheduled for the 2nd shot exactly 28 days out from the 1st vaccine. However, pt showed up 14 days later and received the vaccine in 14 days instead of 28 days. This mistake was found out coincidentally today for the shot that was given yesterday. Pt was attempted to be reached throughout the day, but could not be reached.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 09:00 (Lot number: 30155BA) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0179, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 18May2021, when the patient was 19 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 27Apr2021, when the patient was 19 years old, for Covid-19 Immunization.The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 09:00, outcome "unknown", described as "Dose number:3"; VACCINATION SITE PAIN (non-serious) with onset 05Jan2022 18:00, outcome "recovered" (Jan2022), described as "injection site pain"; FATIGUE (non-serious) with onset 05Jan2022 18:00, outcome "recovered" (Jan2022), described as "fatigue"; CHILLS (non-serious) with onset 05Jan2022 18:00, outcome "recovered" (Jan2022), described as "chill". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills.No follow-up attempts are possible. No further information is expected.
Swollen lymph nodes, pressure on ear drums, I saw the physicians assistant at the Clinic. Recommended taking 800 mg every 6 hours for the next 3-4 days.
Arm swelled up the day after I received my second shot. This never happened with my first shot. I had a huge red bump that covered a large portion around the injection site. It?s itchy, swollen, red, puffy. I took pictures of my arm in case.
Presented with Shingles on Jan 11/2021. Had a rash on the ribs. Right side, burning sensation on the rib area, both sides and the feeling that my clothes were made of sand paper. I was prescribed acyclovir tablets. 1g every 8 hours for a week.  After that shingles progressed and over the next week I developed more discomfort at wearing clothes, the rash moved to my back. I also had numbing sensation in the area and the feeling of warm tickling worms crawling over the area. Finally I started experiencing a lot of pain in the area. All of this caused me to miss about a week and a half of work. I was given gabapentin for the pain, but it messed with my equilibrium a lot so now I am taking lírica 150mg every 8 hours. The rash is almost gone as are most of the other symptoms except for the pain and occasional discomfort to clothes. I am also on lidocaine cream to help that.
Mild axillary lymphadenopathy on left side ( same side as the site of administration) starting on day 9 progressing to mild lymphangitis by day 11 extending to mid arm.  Resolved by day 20 without any treatment
About 5 minutes after vaccines given, felt dizzy and nauseous while being observed in waiting room. BP 95/62 PR 72. Given orange juice and sweet salty nut bar. Gradually improved. Subsequent BP 100/60. PR 76. Released after 1 hour observation. Alert, ambulatory, in no distress. Had not eaten breakfast.
12 hrs p/vax, began to run high fever; did not respond to APAP initially;
no reaction to the vaccination, but patient was hospitalized for COVID on 9/5/2021. ED provider note 9/5/2021: Clinical impression.  Patient presents with cough, fever, tachycardia and hypoxia with symptoms concerning for COVID-19 pneumonitis.  Pursue diagnostic studies including laboratory studies for septic work-up, chest x-ray.  These were largely unremarkable however his COVID-19 test is, in fact, positive.  While he does not have medical conditions putting him at risk for disease progression he is elderly.  In view of these factors patient shall be admitted to the hospital treated with supplemental oxygen and dexamethasone and observed for disease progression with plan for appropriate intervention as indicated.  Inpatient provider note 9/9/2021: o Plan  A/P: 88 YOM w/ T-cell LGL leukemia not being actively treated, fully vaccinated for COVID, presented with cough, subjective fever, weakness and found to be +COVID w/ hypoxia.   1. ID: afebrile, nl WBC, decreasing CRP - sx start 8/29, +test 9/5, CXR unremarkable - cont remdesivir/dexamethasone - no indication for abx - contact/airborne precautions - recommend 3rd COVID shot once recovered  2. Pulm: mild hypoxia - stable - ambulatory challenge today - cont tessalon prn, encourage IS  3. CV: sinus bradycardia - asx, normotensive - TSH normal - monitor on telemetry  4. Heme: mild anemia w/ macrocytosis - stable - B12/folate normal  5. FEN/Renal: nl lytes and renal fx - regular diet, SLIV  Proph: lovenox Dispo: possible dc home with O2 FULL CODE - confirmed w/ pt today
developed petechiae (1/19) with platelet count down to 4,000 on admission (1/21) given IVIG, later received oral dexamethasone for  platelet count <20,000 but still being followed up as platelet count may still drop  3/14/08 Reviewed hospital medical records of 1/21-1/23/2008. FINAL DX:Idiopathic thrombocytopenic purpura, bilateral otitis media & RSV bronchiolitis. Records reveal patient experienced fever, nasal congestion, wheezing x 1 week.  Seen at urgent care & dx w/croup.  Tx but no improvement & then petechiae/bruising, poor appetite, continued fever.  Seen by PCP, dx w/otitis media & labs done which revealed plts 4000.  Tx w/IVIG, IV antibiotics
soreness at the injection site; headaches and dizziness; headaches and dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (headaches and dizziness), HEADACHE (headaches and dizziness) and VACCINATION SITE PAIN (soreness at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045a21a) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE and VENLAFAXINE for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (headaches and dizziness) and HEADACHE (headaches and dizziness). On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, DIZZINESS (headaches and dizziness), HEADACHE (headaches and dizziness) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. Concomitant medication include- iron supplement, vitamins
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During June of 2012, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUN-2016, the patient was treated by a physician (at an unspecified medical facility/office) for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
TESTED FOR COVID  10-17-22.  TRANSFERRED FROM NURSING HOE TO ER WITH SHORTNESS OF BREATH.  GIVEN ZOSYN AND DEXAMETHASONE, GFR WAS 18 AND REMDESIVIR NOT RECOMMENDED DUE TO KIDNEY FUNCTION.  HIGH FLOW OXYGEN AT 10 LITERS NASAL CANNULA AND NON REBREATHER, ZOSYN LATER SWITCHED TO ROCEPHIN hoSPICE CONSULT WAS MADE AND HE WAS TRANSFERRED TO HOSPICE
strong immune response with generalized body aches, pain, headache and heart palpitations upon waking up the morning after booster shot of Moderna.  self checked pulse and missed beats noted. feeling unwell with persistent missed beats on pulse checks for several days.
"side effects were manageable."; headache; slight fever; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT ("side effects were manageable."), HEADACHE (headache), PYREXIA (slight fever) and VACCINATION SITE REACTION (Covid arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced ADVERSE EVENT ("side effects were manageable."), HEADACHE (headache), PYREXIA (slight fever) and VACCINATION SITE REACTION (Covid arm). On 27-Mar-2021, ADVERSE EVENT ("side effects were manageable."), PYREXIA (slight fever) and VACCINATION SITE REACTION (Covid arm) outcome was unknown and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-090370 (Patient Link).
unsafe syringes shipped to us; right hand palmer 1mm puncture wound base of the 4th finger, Left hand palmer 1mm puncture wound base of the 5fth finger; medical assistant was cut on both hands today by glass when taking a prefilled syringe of Vaxneuvance; medical assistant was cut on both hands today by glass when taking a prefilled syringe of Vaxneuvance; 3 broken syringes found when employee was removing from tray after initially opening sealed carton/shattered barrel, broken plunger side of syringe; This spontaneous report has been received from an administrator form provider's office and refers to a patient (medical assistant) of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 20-JAN-2023, the medical assistant was cut on both hands by glass when taking a prefilled syringe of pneumococcal 15v conj vaccine (CRM197) (VAXNUEVANCE) (lot # W021510 confirmed to be valid with expiration date 08-OCT-2023) from the original, unopened package carton (injury associated with device). The reporter stated that 3 broken syringes were found when employee was removing from tray after initially opening sealed carton (shattered barrel, broken plunger side of syringe) (syringe issue). The syringe tip cap was attached properly prior to use, the syringe tray was intact and undamaged on receipt, the cellophane covering the syringe tray was intact and completely sealed, and the syringe carton was not damaged prior to use. The medical assistant was sent out for treatment and at time of last call, was at urgent care but had not been seen yet. Broken syringes were not administered to any patient. The outcome of the events was not reported.  The causality assessment between the events and the suspect vaccine was not provided.  Follow up information was received from the clinic administrator on 10-FEB-2023. The patient was female. It was reported that the patient had the injury due to the unsafe syringes shipped to them (Product quality issue). The patient experienced right hand palmer 1mm puncture wound base of the 4th finger, left hand palmer 1mm puncture wound base of the 5fth finger, and left middle finger proximal palmar 2mm laceration (Limb injury). She had been referred to physical therapy for multiple appointments, would need a follow-up with her provider. She was working at the moment, but was not able to perform her essential job functions. She had 1 week where she was not able to work and continued to need time off for her appointments. The outcome of the event was not reported. No causality assessment was provided.   This case was previously considered non-valid, but became valid upon receiving follow up information.
I had the shot Saturday afternoon. Mid Sunday morning , I started feeling bad, I thought it was allergies. Started to get worse as the morning went on. My masseter muscle in my right jaw started tensing and spasming. That continued all day. I was running a fever between 101.4 to 102.5. My face in my lower jaw was swollen. -I thought I might have the mumps or tray us but I e been vaccinated for those. I generally felt awful. I had a knot at the Injection site snd soreness that lasted a week. In the past I never had discomfort during injection, until this time, this one hurt.  This all lasted for about 24 hours.
2 days after injection, b/l thigh pain. Walked with limp, resolved 7-10-14. Black and blue areas (R) thigh, warm to touch.
Patient administered vaccine after the manufacture's date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) in a 62-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown. The expired date is reported as 07Apr2022. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received with non significant information: reporter's address updated.
The patient is not experiencing any additional adverse symptoms.; The patient is a two-year old female who was administered GARDASIL 9 on 02/25/2020; This spontaneous report has been received from a consumer (the patient's grandmother), referring to a 2 years old female patient. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.    On 25-FEB-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 injection; strength, frequency, lot# and expiration date were unknown) intramuscularly for prophylaxis (product administered to patient of inappropriate age). The patient was not experiencing any additional adverse symptoms (no adverse event).
After 5-10 min following vaccination pt began to exhibit itching of the neck and slight SOB
No adverse effects; a patient was administered an improperly stored ROTATEQ.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 23-AUG-2019, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot# S010702 with expiration date 16-JAN-2021; dose, frequency, route of administration were not reported) for prophylaxis (Product storage error). The temperature and time frame were unknown (late shipment). Information of previous temperature excursion was not provided. No adverse effects were reported. Data logger was not involved.
Information has been received from a physician concerning a male who "ten years ago", in 1995, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Subsequently, "ten years ago" in 1995, the patient developed respiratory problems. The patient recovered "ten years ago." Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
She arrives with medics after receiving Benadryl and an albuterol breathing treatment.  This improved her wheeze.  Upon my evaluation she is stable but begins to cough.  She has moderate posterior pharyngeal irritation as well.  She has been monitored.  Chest x-ray is reassuring.  The present do not think labs are necessary.  She is been advised to monitor her symptoms at home and return for any concerns.  I recommended Benadryl as well as short course of prednisone.  She has received prednisone here and advised her to take prednisone tomorrow and then discuss additional doses with her primary doctor control
the bottoms of my feet feels like I'm walking on needles; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (the bottoms of my feet feels like I'm walking on needles) in a 66-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Aug 2022: I had Covid) in August 2022. Concurrent medical conditions included Diabetes.    On 10-Oct-2022, 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. On an unknown date, the patient experienced LIMB DISCOMFORT (the bottoms of my feet feels like I'm walking on needles). At the time of the report, LIMB DISCOMFORT (the bottoms of my feet feels like I'm walking on needles) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. No treatment medicine were reported.
2 Potential adverse Reactions: 1- "8-day Covid arm": 8 days after vaccination, this arm became red, swollen at injection site almost down to elbow and had hives; @ 3-4 inch area of redness; Called PCP- took benadryl; resolved; PCP had not heard of "Covid arm at this time" 2-6 days after injection: 1/23/21: experienced chest pressure;/pain radiating to jaw; went to ER; diagnosed with severe HTN (@ 210/100); given EKG, Stress test, CXR/ cardiac blood work; all normal; released
INCORRECT PRODUCT STORAGE; PATIENT RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional 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: 1822809 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 05-MAR-2022, the patient experienced patient received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649704, 20220649370, 20220650014, 20220649804, 20220649045, 20220650111, 20220649417, 20220649137, 20220649421, 20220649488, 20220649626, 20220649803, 20220649915, 20220650185 and 20220650933.
I developed severe hip and lower back pain the 2nd day after the 2nd dose - I have seen a few chiropractors without relief.  After I received the 3rd booster shot on Oct 1st, the next day,  I had severe hip and lower back pain even worst than the previous shot.  I couldn't bend, or sit without difficulty (excruciating pain).  In addition, I experienced severe chills, face ache and sharp stabbing pains in my arms and legs.  I also had abdominal pain, soreness at the site (not severe) and a fever of 100.0.  At the time of the 3rd shot I was trying to cope with the pains, still not being quite sure that this was the source.  However I'm not convinced that this is the source of my hip and back pain and it's not even worst.
lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine administered.  about 1 hour later had wheezing and chest tightness  lasting about 4 hours
swelling; redness; This is a spontaneous report from a contactable pharmacist received via regulatory authority. A non-pregnant 68-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included vitamin D3 taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On unspecified dates, the patient experienced swelling and redness for 9 days. The patient recovered from the reported events on unspecified dates.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.