chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 4:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 50.20 for dose administered on 03-APR-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion 03-APR-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-MAR-2021 and beyond use date for the vial was reported 29-APR-2021. Product moved to clinic 03-APR-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
patient reported red, swollen and itchy local reaction near the injection site that started 5 days after vaccination. Lasted until 03/27/21, patient self treated with diphenhydramine.
since the injection my left upper arm and shoulder have had a muscle pain or cramp. The odd thing is my wife has had the same problem, we both received the same product in the left arm. I have been doing exercises and stretches and can work the pain down but this is still staying with us.
Patient is a 12 year old girl. She was given the Pfizer 5-11 yr old dose.
Chills,muscle aches, general aching all over,pain to touch, tiredness x 3 days.  Ibuprofen 600mg QID -but didn?t seem to help much. Symptoms mostly subsiding on day 2 but general body aches still present on day 3
Presented to ED with one-week history of abdominal pain and new episode of hematochezia, diagnosed with extensive venous thrombosis of abdomen. CT showed complete thrombosis/occlusion of portal venous system, superior mesenteric venous system, superior mesenteric veins and splenic vein. Received Pfizer vaccine booster 10 days PTA. Also on norethindrone-ethinyl estradiol-ferrous sulfate OCPs. Patient was admitted to hospital for further care/possible vascular intervention if decompensated. Required resection of 30% large intestine and 90% small intestine. Currently maintained on therapeutic enoxaparin.
Fully vaccinated with J&J, not boosted COVID infection breakthrough, asymptomatic with inpatient hospital admit
pt devel localized erythema, swelling (10cm diameter);devel fever, gen malaise, myalgia;pt had diabetes which went out of control during illness;required hosp for dehydration & BS control
11:03 Td given IM L deltoid; allergic reaction (anaphylactic shock). 11:05 50mg Benadryl PO. 11:10 EMS notified. 11:12 0.3 epi given L thigh. Pt was not seen in ER or doctor's office. Once EMS arrived at the school and established the patient's recovery, they did not feel it was necessary to transport him. Therefore no medical records.
about 4 days after vaccine administration patient developed rash behind right ear and periauricular area, persistent headache, scalp tender to the touch as if he had sunburn, seen 3/21/21 diagnosed with shingles prescribed valtrex rash resolved in about 3 days.  4/1/21 patient seen again continued headache, diminished hearing on right side, rash resolved. Audiologist referral placed meclizine prescription given.  4/12 seen again, dizziness, ringing in right ear, hearing loss, dizziness is not positional but emanating from the right side.  Lightheaded, woozy feeling, numbness/tingling, and sunburn-like feeling around right ear down neck.  Chiropractor performed epley maneuver no improvement, meclizine ineffective.  Now also describing "feels like water in ear".  4/15/21 Audiogram demonstrated sloping sensorineural hearing loss right ear with STS score of 76% and type A tympanogram, symptoms persisting urgent ENT referral sent.  4/28/21 seen by ENT Right ear with hearing loss and disequilibrium prednisone 60mg once daily in the morning prescribed, repeat audiogram 1 week, MRI with contrast ordered.  5/7/21 ENT completed course of prednisone hearing has significantly improved on right side still describing equilibrium, NOT acute episodic vertigo.  Audiogram SDS improved from 76% to 92% and SRT improved 30-10DB.  Physical therapy offered.  5/18//21 MRI performed impression: 1-no acute findings, no acute neuroma, no abnormal enhancement temporal bones eitherside. 2-several nonenhancing white matter T2 Flair hyprintensisties bilaterally 3-giant cisterna magna 4- generalized cortical atrophy 6/7/21 follow up with ENT still experiencing disequilibrium MRI does not show any significant pathology to account for hearing loss or disequilibrium.  7/7/21 follow up with PCP patient reports he is not feeling any better, symptoms of loss of balance and tinnitus continue although hearing in right ear largely improved.
This spontaneous report was received from a certified medical assistant via a company representative and refers to a 16 year old non-pregnant female patient, who was the primary reporter's daughter. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. In approximately October 2016 (reported as about 4 months ago), the patient was vaccinated with a dose of GARDASIL 9 (lot #, expiration date, site and dose were not reported; intramuscularly). On an unknown date, the patient experienced injection site redness, bumps and swelling. She received an unspecified treatment for the events. No lab diagnostic studies were performed.  The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported.  Additional information is not expected as no further information is available.
Patient received SHINGRIX vaccine in her left arm on 7/23/18. Patient came in on 7/25/18 and complained about redness on her left arm. I recommended that she try using OTC pain relievers or a cold compress to help with the symptoms and to follow up with her PCP if condition worsens. She was satisfied with this information.
Patient received Pfizer COVID vaccine on 12/29/20 (lot EL1284), 2/9/21 (lot EN6201), and 10/15/21 (lot FH8020). Patient lives on adult facility living. On 1/3/22, patient tested positive for COVID (exposure due to a big outbreak in the adult living facility). On 1/4/22, patient admitted to our inpatient unit with acute hypoxic respiratory failure secondary to COVID-19 pneumonia(breakthrough/reinfection) currently on high flow oxygen and acute encephalopathy, toxic metabolic/ delirium in the context of COVID-19.  As of today (1/6/22), patient is still admitted in our med/surg unit.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 11/12/2021. PATIENT FULLY VACCINATED ON 03/11/2021. PATIENT RECEIVED MONOCLONAL ANITBODY INFUSION ON 11/15/2021
Red bumps in different places in breast; Red bumps in different places in arm of injection; Itchy bumps; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (Red bumps in different places in breast), ERYTHEMA (Red bumps in different places in arm of injection) and PRURITUS (Itchy bumps) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high, Pain, Leg cramps and Sleep disorder. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), ATENOLOL and AMLODIPINE BESILATE, VALSARTAN (AMLORTAN) for Blood pressure high, METFORMIN for Diabetes, TIZANIDINE for Leg cramps, TRAMADOL and GABAPENTIN (GABAPEN) for Pain, TEGAFUR (RESURGE) for Sleep disorder, THYROID (ARMOUR THYROID), VITAMIN B COMPLEX, PROTEIN and MAGNESIUM for an unknown indication.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced BREAST MASS (Red bumps in different places in breast), ERYTHEMA (Red bumps in different places in arm of injection) and PRURITUS (Itchy bumps). At the time of the report, BREAST MASS (Red bumps in different places in breast), ERYTHEMA (Red bumps in different places in arm of injection) and PRURITUS (Itchy bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was unknown.
Each day, her temperature is going up and she had a temperature of 106; Each day, her temperature is going up and she had a temperature of 106; A spontaneous report was received from a consumer, who is a 73-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced each day her temperature is going up and she had a temperature of 106/ hyperpyrexia.  The patient's medication history was not reported. No relevant concomitant medications were reported.  On 11 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 044A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   Since an unspecified day in 2021, after receiving vaccine, the patient experienced each day her temperature is going up and she had a temperature of 106 (medically significant). Treatment included acetaminophen every 4 hours and her doctor told her to take ibuprofen as well.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Joint pain/muscle aches over entire body. Weakness/fatigue. Knees and hip continues to hurt.
Received Varicella vaccine 8/18/10. Diagnosed w/ chicken pox 8/20/10.
Dizziness - Started at 5:30am lasted 11hrs. I had to sit/laydown that entire time, moving around made it worse. Nausea -  lasted 4-5hrs. Chills - started at 4pm, temperature was 98.5. Hives - Started around 4pm 03/23/21 and are still cover half my body.
Arm was hurting; Back pain; Arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), BACK PAIN (Back pain) and FEELING HOT (Arm was warm) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Back pain.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting), BACK PAIN (Back pain) and FEELING HOT (Arm was warm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was hurting), BACK PAIN (Back pain) and FEELING HOT (Arm was warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rapid heartbeat that lingered for a couple of days. Cold symptoms (runny nose) started 4 days later (may be unrelated)
Coughing become worst again; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing become worst again) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity and Hay fever. Previously administered products included for Product used for unknown indication: Erythromycin (Erythromycin- Hives) in 1976 and Zanaflex (Erythromycin- Hives) in February 2021. Past adverse reactions to the above products included Hives with Erythromycin; and Passed out with Zanaflex. Concurrent medical conditions included Drug allergy (ZANAFLEX and Erythromycin), Clot blood since 06-Dec-2006, Cardiovascular disorder since December 2006 and High cholesterol since 1991. Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE and DOXAZOSIN for Blood pressure management, APIXABAN (ELIQUIS) for Clot blood, ATORVASTATIN for High cholesterol.   On 03-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced COUGH (Coughing become worst again). The patient was treated with AZITHROMYCIN at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, COUGH (Coughing become worst again) had not resolved.            Treatment details included Cough medicine.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-091736 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Events out come updated, medical history updated and concomitant drugs reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Developed itching, welts on Sun 11/23. Called FMD, took her own Prednisone 40mg PO, tapered to 20mg Mon 11/24 and Tues 11/25. (Not treated in ED).
Monday, May 3 developed lymph node on left collar bone, went to ER due to pain on Thurs May 6
Initial report received on 27 December 2008 from a physician. A 31-year-old pregnant female experienced oligohydramnios approximately 193 days after she received a first left deltoid intramuscular injection of ADACEL (lot number C2457AA) on 04 May 2006. At that time, the patient had medical history of moderate mitral regurgitation on echocardiogram in 2002, history of pregnancy induced hypertension (PIH), chronic hypertension the was well controlled with LISINOPRIL that was stopped prior to the current pregnancy, and exercise induced asthma. The patient had no drug use, alcohol use (ETOH) or use of tobacco. Regarding the current pregnancy, the date of patient's last menstrual period was on 15 February 2006 and her expected date of delivery was on 22 November 2006. The patient had a normal alpha feto protein test on 7 June 2006 and normal serology testing on 3 May 2006 with B+; antibody-neg, HIV-NR; Rub Immune; Syph IgG-NR; Gc/chlam, neg-neg; HBsAg-NR. Ultrasounds on 03 May 2006 revealed a single intrauterine pregnancy (IUP); on 23 June 2006 an ultrasound revealed normal anatomy; on 02 October 2006 an ultrasound revealed abnormal amniotic fluid index (AFI), at 6.4; normal growth; an ultrasound on 09 October 2006 revealed abnormal amniotic fluid index (AFI) at 7.8; an ultrasound on 16 October 2008 revealed abnormal amniotic fluid index (AFI) at 7.6; an ultrasound on 24 October 2006 normal AFI at 10.4; an ultrasound on 30 October 2006 revealed normal AFI at 9.4 and an ultrasound on 6 November 2006 revealed normal AFI; normal growth. An ultrasound on 13 November 2006 revealed an abnormal AFI on 2.1 and oligohydramnics. The following day the patient was treated with induction of labor and she delivered vaginally a single healthy female baby whose Apgar scores were eight at one minute, and nine at five minute. The baby was delivered at 38 plus six days/7 weeks and weighed 3 kilogram (3180g). The baby did not experience any congenital anomalies. The oligohydramnios was considered to be recovered at delivery. Documents held by sender: none. The reporter for this case is the same as in case numbers: 2008-04101, 2008-04102,2008-04103, 2008-04104, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04111, 2008-04112, 2008-04113, 2008-04114, 2008-04115, 2008-04116, 2008-00011.
lymph nodes removed; graft at hospital; This is a spontaneous report received from a contactable Consumer. A 72-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 2, single (Lot number: EP7533) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer", start date: Feb2021 (unspecified if ongoing); "first surgery to remove the skin cancer", start date: Apr2021, stop date: Apr2021, notes: 03Apr2021 or 04Apr2021 had first surgery to remove the skin cancer; "wheelchair" (unspecified if ongoing), notes: Durable medical equipment company brings wheelchair, nebulizer; "nebulizer" (unspecified if ongoing), notes: Durable medical equipment company brings wheelchair, nebulizer. The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Allergies: Bactrim"; Ativan, reaction(s): "Allergies: Ativan". Vaccination history included: BNT162b2 (Dose 1, Manufacturer: Pfizer , Lot number: EN6199), administration date: 15Mar2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "Skin cancer". The patient underwent graft at hospital on 20May2021 and lymph nodes removed on 22May2021 at medical center (name withheld). Patient was hospitalized on 20May2021. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300139170 same patient/drug/reporter, different dose and event.;US-PFIZER INC-202300293266 same patient/drug/reporter, different dose and event.;US-PFIZER INC-PV202300150867 same patient/drug/reporter, different dose and event.;
Patient c/o of painful cardiac palpitations, some SOB, lightheadedness and weakness (mod), which required her to sit and rest about 15 minutes.
Chills, achy all over body, tired, sore throat, feeling "sick" lasting until late night on 9/24/2016.  Next morning (9/24/2016) started cough, runny nose, sore throat. Today is 9/25/2016, still have coughing and severe running nose, nasal-congestion, tired and sore throat.
pt devel an inj site rxn characterized by soreness & redness;also devel chills & palpitations;pt has recovered;
I95.9 HYPOTENSION 7/21/2022 HYPONATREMIA I95.9 HYPOTENSION 7/21/2022 HYPONATREMIA I95.9 HYPOTENSION 7/21/2022 ASCITES I95.9 HYPOTENSION 7/21/2022 HYPONATREMIA
Mom reported red itchy rash all over arms, chest and legs within 1-2 hours after 12mo vaccines and flu vaccine.  Pt still has rash 1 wk later; responding to topical hydrocortisone.  Denies any resp, CV, GI, nasal, ocular sx concerning for anaphylaxis.  Pt has h/o atopic dermatitis.  Egg allergy consists of positive skin prick testing, with h/o vomiting and hives with scrambled eggs and hives with skin contact only of cake baked with eggs.
Contracted COVID 19 3 weeks after 4th dose (aka 2nd booster) and was told to report. Congestion, slight sore throat, fatigue. May 19, 2022-May 25, 2022
Severe neck pain for 2.5 days.  Hurt to swallow.  Inflammation of neck.  Could not turn head.  Impaired sleep.
Patient she was experiencing normal side effects - headache/tiredness until this morning. Patient stated she was having tingling, pink/redness and warmth on the left side of her face above her eye on her forehead to her cheek bone. Patient stated she has had issues with shingles on her face in the past. She was instructed by her doctor to start her VALTREX when she gets these signs. I did call GlaxoSmithKline. Spoke to RPh, she stated there is no contraindication for anti-virals listed but there is no data with anti-viral use. I called patient back to let her know there was no contraindication with VALTREX. I did call patient's PCP and left a message on the nurse's line.
Shoulder/arm pain one week after receiving injection. Pain was severe enough to wake me up at night and disturb sleep even after taking acetaminophen and applying a heating pad. Pain in shoulder increases with movement (shooting pain up to neck and down to elbow at times), but persists at a low level when still.  Pain level with movement makes it difficult to accomplish normal tasks (dressing, cleaning house, etc.) Pain level when still ranges from minor distraction (still able to accomplish remote desk work) but consistency/duration of pain is exhausting.    Iced shoulder on-and-off throughout day. Ice reduces pain somewhat (more effective than heat). No rash, itching, or redness on skin.
4-4-08 rash appeared, no fever, no runny nose per mother. 4-8-08 child seen in office, rash on face, trunk, back, and external genitalia-taking Benadryl. 4-9-08 child seen in office-rash is more pronounced all over including eyelids and ears-taking Benadryl and Orapred.
dyspnea on exertion, peaked on 12/31/20, now much improved but not completely resolved as of 1/4/21 Narrative:
Localized moderate redness/swelling noted 1 day after vaccination; resolving by following day.
Headache with little bump on the neck area (lymph node swollen); Headache with little bump on the neck area (lymph node swollen); Headache with little bump on the neck area/The bump was sore; This is a spontaneous report from a contactable consumer or other non healthcare. A 27-years-old non-pregnant female patient received first dose BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318), via an unspecified route of administration, administered in arm right on 16Feb2021 at 09:45 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient was not covid prior vaccination. On 17Feb2021 at 08:00 the patient experienced headache with little bump on the neck and lymph node swollen. The patient was vaccinated at the workplace clinic. It was reported that the patient had headache with little bump on the neck area (lymph node swollen) on the next day. The bump was sore. Headache and the little bump was gone by the third day of vaccination. Patient was not covid tested post vaccination. Patient did not received treatment for AE. Outcome of the event neck pain was unknown and the outcome of the other two events were recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.