chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is serious spontaneous case, initially received on 17-Nov-2017, from other non-health professional (consumer), concerning a 72-year-old, elderly, male patient. The patient's medical history included: cholesterol and high blood pressure (since an unspecified dates). The patient's concomitant medications included atorvastatin calcium for high cholesterol, BYSTOLIC for high blood pressure and hydrochlorothiazide for bladder (as reported). On 02-Dec-2016, the patient was administered with FLUVIRIN Thiomersal (route of administration: intramuscular, anatomical location: left arm and dose, batch number and expiry date: not reported). The reporter confirmed that the patient had no gastrointestinal infection or any other viral infections from Dec-2016. On an unspecified date in Dec-2016, after a week of vaccination, the patient got up but could not walk, had numbness and weakness in his ankles, feet and hands. He also started to experience tingling in hands and sickness. When he walked, he couldn't feel his feet. He did not know where he was going, so he had to pay attention. On 30-Jan-2017, the patient was hospitalized. On an unspecified date, cerebrospinal fluid (CSF) examination was performed, in which Guillain-Barre syndrome was diagnosed, complete blood count test was performed, results were not provided. The patient stayed in hospital for 10 weeks. The patient was treated with intravenous plasma, immunoglobulin and spinal fluids. He could walk with assistance (cane), which had not got over. On 07-Apr-2017, the patient was discharged from the hospital. At the time of this report, the patient had not yet recovered from the event Guillain-Barre syndrome. The reporter assessed the event as serious due to hospitalization and considered the causality of the event as related. Follow-up received on 14-Dec-2017: Indication of the concomitant drug Atorvastatin calcium was changed from cholesterol to high cholesterol. The event numbness of upper extremities was changed to numbness of extremities. Added new symptoms weakness of hands, tingling and malaise. The outcome of the events (hands weakness of, tingling feet/hands and sickness) was not recovered. The reporter confirmed that the patient had no gastrointestinal infection or any other viral infections from Dec-2017. The narrative was amended accordingly. Follow up report received from the reporter on 19-Jan-2018: The patient's relevant lab tests (cerebrospinal fluid [CSF] and complete blood  count test) were  added. The patient's concomitant drug (hydrochlorothiazide) was added. The narrative was amended accordingly.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medication included sterile diluent. On 12-FEB-2018 the patient was vaccinated with improperly stored one dose of PROQUAD injection (dose, frequency and route were not reported) (lot # N019248, expiry date 20-DEC-2018) for prophylaxis. No adverse event reported. Product quality issue was not involved. The outcome of events was not provided. The relationship between the events and PROQUAD was not provided. The vaccine was stored in temperature of -9 degree Celsius (C) to 8 degree C for 216 hours. There was previous temperature excursion reported -14 degree Celsius to -10 degree C for 1 hour. A digital data logger was involved.
Pt was given 3rd dose Pfizer as requested, no adverse reaction , but then found out patient is only 15 years old, not approved for booster covid  vaccine yet at this age
Vaccine administered:  1150hrs         Adverse Event:  1222hrs Pt complained of feeling dizzy and nauseous as she stood up to exit clinic.  Pt able to ambulate to chair and sit down.  Water given to pt.  Vital signs taken.  Monitored pt until symptoms resolved. Pt steady on feed upon standing after symptoms resolved.  Able to ambulate on own.  Released from clinic at 1245hrs.
Came into office limping. 2" round, red, warm, swollen area at injection site. Advised monitor size. Call if streaking, dischg or s/s infection.
headache, neck pain, throat pain, unable to take full breath while mouth closed due to tightness, pain and burning in lungs
Date and time of vaccination: (list both if they received both shots): 1/12/21 0830; 2/12/21 1500 Brand and lot of vaccine:  1st EL9262 ,  2nd EN9581 extreme fatigue, itching underarm of injection site, lightheadedness, poor appetite
llarge rash at the injection site; had bulk site; itchy at the injection site; lot of fatigue; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (llarge rash at the injection site), VACCINATION SITE SWELLING (had bulk site), VACCINATION SITE PRURITUS (itchy at the injection site), FATIGUE (lot of fatigue) and NAUSEA (nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis (severe osteoporosis) and Alpha thalassemia intermedia. Concomitant products included VITAMIN D3 and VITAMIN K2 [MENAQUINONE] for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE RASH (llarge rash at the injection site), VACCINATION SITE SWELLING (had bulk site), VACCINATION SITE PRURITUS (itchy at the injection site), FATIGUE (lot of fatigue) and NAUSEA (nausea). At the time of the report, VACCINATION SITE RASH (llarge rash at the injection site), VACCINATION SITE SWELLING (had bulk site), VACCINATION SITE PRURITUS (itchy at the injection site), FATIGUE (lot of fatigue) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-may-2021:Patient's height , weight , race and ethnic group was updated and concomitant medications were updated
2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to 1 patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 1 patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 55-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 1 patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 1 patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that the 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated. The total number of vials were 2. The vial was not initially stored in the refrigerator. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-582455, MOD-2022-582637, MOD-2022-582638, MOD-2022-582640, MOD-2022-582644 (Patient Link).
Patient had shallow breathing and mentioned pain with each breath, otherwise no other symptoms. Care team was in the room providing discharge assessment. Provider and patient verbally confirmed agreement to receive vaccine despite pain. Shortly afterwards, patient complained of shortness-of-breath but maintaining SATs and tachypneic, patient complained of not being able to feel upper extremities despite pressure on fingers. Non-rebreather was placed. Patient then became unconscious, sternal rubs were provided without response.  The code team was called and patient began to seize. Ativan was administered and patient was prepared for intubation. Patient was intubated on the floor and subsequently transferred to PICU (Pediatric Intensive Care Unit).
Fever = 101, left side of body is weak/sore, generalized weakness, lymph nodes swollen on left side only
Nausea; Chills; Muscle aches; Fatigue; Mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 02Mar2021 at 09:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), simvastatin (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN), all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received hydrocodone (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 10Feb2021 at 11:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 02Mar2021 at 11:00, the patient experienced nausea, chills, muscle aches, fatigue and mild headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, chills, muscle aches, fatigue and mild headache were recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Approximately 1 hour after injection I became exhausted with a headache and unable to drive. Then 1.5 hours after injection I began to vomit and had a stiff neck. Used ice packs on head and neck for 12 hours for pain. Body aches and injection site pain continued for 48 hours.
Inflammation increase; Immunization reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Immunization reaction) and INFLAMMATION (Inflammation increase) in a 38-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Inflammation.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second 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) pre-filled pen. In 2021, the patient experienced IMMUNISATION REACTION (Immunization reaction). On an unknown date, the patient experienced INFLAMMATION (Inflammation increase). At the time of the report, IMMUNISATION REACTION (Immunization reaction) had resolved and INFLAMMATION (Inflammation increase) had not resolved.            It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Concomitant medications details were not reported by the reporter.  The reporters causality for the event Immunization reaction and inflammation increase was not provided for HUMIRA (Adalimumab).  Treatment details were not reported by the reporter.
arm was barely sore; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The Patient medical history included knee pain for which he periodically gets a steroid injection, and he will eventually have surgery. He has a doctor appointment coming up and wonders if he can get the steroid injection in his knee. He has been referred all over the place looking for answers and no one can tell him. He was referred to Pfizer. The patient concomitant medications were not reported. The patient reported that his arm was barely sore after first Pfizer covid vaccine injection and after the second dose, his arm was sore for 24 hours and he got a little headache. The patient stated that he was on oral steroids and got the flu vaccine and he got sick as a dog. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt. rec'd  5 yr IMM. On 12/15/15 in office. Seen for s/s 'reaction' today. S/s -> edema, pruritis, erythema and c/o pain to site on lt upper arm. Tx with prn BENADRYL (10 ml) and ibuprofen (10 ml) q 6 hours, cool compresses prn and to return if s/s increase.
Congested nose; Runny clear liquid coming from nose like a faucet my nose; Sore Left Arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congested nose), RHINORRHOEA (Runny clear liquid coming from nose like a faucet my nose) and VACCINATION SITE PAIN (Sore Left Arm at the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007CZ4) for COVID-19 vaccination.     Concomitant products included DICLOFENAC (VOLTAREN [DICLOFENAC]) for Arthritis.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Left Arm at the injection site). On 13-May-2021, the patient experienced NASAL CONGESTION (Congested nose) and RHINORRHOEA (Runny clear liquid coming from nose like a faucet my nose). On 24-Apr-2021, VACCINATION SITE PAIN (Sore Left Arm at the injection site) had resolved. At the time of the report, NASAL CONGESTION (Congested nose) and RHINORRHOEA (Runny clear liquid coming from nose like a faucet my nose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   .  No treatment medication was provided.
Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weakness, & fatigue that had started 4/4/21 and diagnosed w/COVID-19 (4/10/21). She had just received 2nd vaccine (3/27/21), but had been exposed to COVID-19 the following day from a relative.  She was discharged w/dexamethasone and pulse oximeter.  Symptoms had continued to worsen and returned to ED where she was admitted for acute hypoxemic respiratory failure and tachycardia secondary to COVID pneumonia requiring steroids, remdesivir, oxygen, but unfortunately succumbed to her illness (4/18/21) given condition critical and prognosis poor.
Mini seizures; Body chills; A spontaneous report was received from a consumer, concerning herself, a 21-year-old female patient, who received Moderna's COVID-19 vaccine and experienced mini seizures and some chills.  The patient's medical history reported includes seizures. Concomitant product use was not provided by the reporter.  On 06-FEB-2021, prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for the prophylaxis of covid-19 infection.   On an unspecified date in Jan-2021, the patient received her first dose of vaccine and on 07-FEB-2021, a day after the second dose of vaccine, patient experienced some chills and mini seizures. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events, mini seizures and some chills were considered unknown at the time of this report.; Reporter's Comments: Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, however, patient's history of seizure is a confounding factor that may a possible contributory role. Further information has been requested.
I experienced pain in my left arm right after the shot. Also, both sides of my groin were already hurting at that point. I saw lumps on both sides of my groin that evening (lymph nodes were swollen). The pain was becoming more severe and I felt I would not be able to walk. I went to the ER and they told me to take Tylenol and ibuprofen. They did not do any tests at that time but they examined the legs to see if there was any injuries but didn't see anything of note. Fever continued for a few more days and I experienced a headache with nausea. I went to the ER on 12/25/2021 and they ran tests on me (noted below). I was hospitalized overnight (woke up with a fever), and they assumed it was likely another virus because they hadn't seen somebody react like that after the booster. I got some nausea medicine and I was told to follow up with my PCP if I didn't get better.
pt received mmr vaccine and left office approx 15 minutes after receiving vaccine. Once in parking lot and throughout drive home, mom noted new onset coughing and patient complaining that her throat felt like she had to cough all the time. When mom arrived home, she noted pt to have facial swelling and flushing, body rash and refusing to swallow her drink. Mom called our office where she was instructed to call 911 for transport to nearest er and give patient 18.75mg of Benadryl.  Mom refused ambulance and transported pt by car to nearest er.  According to mother pt was treated for allergic reaction and mother was told pt was allergic to MMR vaccine.
COVID POSITIVE>14 days post vaccine Narrative: COVID POSITIVE>14 days post vaccine
Pt developed a rash . Pt had a fever of 102F. Pt was seen in the ER and was treated with Benadryl. Fever disappeared the same evening.
Patient had itching of tongue, bronchospasm with excessive coughing, shortness of breath  and was given 50mg diphenhydramine and 0.3mg of epinephrine which helped her shortness of breath and coughing and was then assessed by local 911 paramedics and advised to go to ER
I have some kind efdecrs /I have more sintoms about 2 dosis of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have some kind efdecrs /I have more sintoms about 2 dosis of moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I have some kind efdecrs /I have more sintoms about 2 dosis of moderna vaccine). At the time of the report, VACCINATION COMPLICATION (I have some kind efdecrs /I have more sintoms about 2 dosis of moderna vaccine) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No treatment medications were provided. No concomitant medications information was reported.   This case was linked to MOD-2021-230040 (Patient Link).   Reporter did not allow further contact
4/26 (L) thigh red and swollen, Temp 102 (Ax). 4/27 OV (L) thigh redness/swelling, temp 103.5. 4/30 OV no temp, energy & appetite returned, modest amt induration to (L) thigh, no erythema or warmth.
Approximately 12-13 hours after injection, I experienced chills/shakes for approximately one hour.  Severe muscle and joint pain (mostly upper body).  Fatigue, minor headache, and severe malaise lasting for circa 15 hours after initial onset of the symptoms.  I have received many vaccines throughout my life and this was the most adverse reaction and discomfort I felt. nurses advised not/not to take pain killer and allow body, "to do it's thing."
This is a spontaneous report from a contactable HCP (physician). A 64-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL9267), via an unspecified route of administration, on Feb 10, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL3246), via an unspecified route of administration, on Jan 21, 2021, single dose, for COVID-19 immunization. On an unspecified date in Feb 2021 (after the second dose), patient had generalized joint pain for 12 hours. On an unspecified date in Jun 2021, patient experienced gout-type symptoms/gout-type of reaction in both big toe joints. Big toe joints are red and swollen. The patient developed gout-type symptoms that started a month ago, and affect both great toe joints per HCP. Because his big toe joints were red and swollen, he was treated with  colchicine, diclofenac, ibuprofen, steroid injections and local anesthetic injection (therapeutic measures). The patient was wondering if gout, idiopathic joint pain and swelling of the joints had been reported after the administration of the Pfizer COVID-19 vaccine. The patient was not an alcoholic. He does not consume large amounts of alcohol. He eats no red meat but has had this horrible reaction in the joints since the vaccination. The outcome of the generalized joint pain recovered on an unspecified date in Feb 2021; while the outcome of all the other events: unknown. Follow-up attempts completed. No further information expected.
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received PEDIARIX (batch number 4233K, expiry date 6th September 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. Six patients received PEDIARIX that was exposed to temperature of 30.4F Three lot numbers LK94M exp 05Sep2015 or 4233K exp 05Sep2016 or 43GM4 exp 30Aug2016.