chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA001261: Original Case : 1808USA001261.
Pt seen 1/30/17 for viral illness/URI. Afebrile at visit at 1949. HIB and PREVNAR and FLUZONE QUAD 0.5 ml administered at 2012. Maternal aunt called our office on 1/31/17 1152 reported child developed fever of 101.3 degrees F this am and suffered a prolonged seizure of > 15 min 911 called, on route to ER.
Patient was under age 18 and received the Moderna vaccine.  She did not have any reaction to the vaccine as far as we know.  Patients Mother was contacted to let her know that her child did receive the vaccine and was told if she had any concerning symptoms she was to take her child to the ER.
Vasovagal syncope.  patient fainted while walking towards clinic lobby.  patient was assessed by MD who cleared patient of any injury.  patient was allowed to lie down and drink water until he felt stable enough to stand and walk on his own.
pulmonary embolisms; blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "pulmonary embolisms"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clots".  Clinical course: Patient reported that your covid vaccine almost killed myself, my son and my daughter. All 3 of us developed blood clots (pulmonary embolisms) in the same time frame after getting the vaccine. We have all suffered life changing effects and have ongoing medical issues. And no we're not old and fat and out of shape. In fact, if it hadn't been for being somewhat in shape none of us would have lived through it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
by next day, had a sore and red strip across left arm 1.5 below the injection site.  Lasted about 3 days.  This morning, 3/8/21, when arose, had a red spot about silver dollar sized in area where strip had been earlier.  This spot is hot to the touch and firm to the touch.  Not particularly sore.  Will contact primary doc and send picture.
Janssen COVID-19 Vaccine EUA About 6 hours after receiving vaccine, sudden onset of fever to 101 degrees with chills.  About two hours after the fever began, extreme fatigue and muscle and joint pain, and left breast pain began (had the injection in my left arm).  The extreme fatigue lasted for about 9 hours, during which time I felt like I could barely walk or move in bed.  After the extreme fatigue passed, and for about 24 hours, I continued to experience moderate fatigue, joint and muscle pain, and headaches.  A bad headache has bothered me for about 36 hours since the extreme fatigue passed.  All symptoms are now clearing up (it is now about 42 hours post vaccination).
Patent is a 66 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EW6208 on 3/11/2021.  The patient experienced the following reaction(s) during the immediate of observation: 12:00p: Patient c/o "lightheadness and feeling flushed" during observation period. Patient was treated/managed as follows:   12:02p: Patient taken to treatment area. 12:05p: VS BP 140/90, HR 71, RR 18, O2 sat 97% on room air. Patient reports feeling better. 12:15p: VS BP 126/84, HR 75, RR 18, O2 sat 96% on room air. 12:22p: Patient escorted to car by husband and RN. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.
Looks like measles rash on his trunk below his abdominal/ Looks like measles rash on his shoulders/ Looks like measles rash on everywhere/ Measles like rash on his scalp/ Pin head bumps/ Rash around his ears; Very very itchy scalp; Doctor wonders if it is affecting his nerve; Rash around his ears; itchy scalp; This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (Looks like measles rash on his trunk below his abdominal/ Looks like measles rash on his shoulders/ Looks like measles rash on everywhere/ Measles like rash on his scalp/ Pin head bumps/ Rash around his ears), PRURITUS (Very very itchy scalp), NERVE INJURY (Doctor wonders if it is affecting his nerve), RASH (Rash around his ears) and PRURITUS in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-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 experienced RASH MORBILLIFORM (Looks like measles rash on his trunk below his abdominal/ Looks like measles rash on his shoulders/ Looks like measles rash on everywhere/ Measles like rash on his scalp/ Pin head bumps/ Rash around his ears), PRURITUS (Very very itchy scalp), NERVE INJURY (Doctor wonders if it is affecting his nerve), RASH (Rash around his ears) and PRURITUS. The patient was treated with FLUOCINONIDE (FLUOCINONIDE F) at a dose of 5 %; CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE E) at a dose of 5 %; HYDROXYZINE HCL at a dose of 10 mg; LORATADINE (CLARITINE S) at an unspecified dose and frequency; CLOBETASOL for Itchy scalp, at a dose of 5 %; TRIAMCINOLONE ACETONIDE at a dose of 10 mg and PREDNISONE at a dose of 20 mg. At the time of the report, RASH MORBILLIFORM (Looks like measles rash on his trunk below his abdominal/ Looks like measles rash on his shoulders/ Looks like measles rash on everywhere/ Measles like rash on his scalp/ Pin head bumps/ Rash around his ears), PRURITUS (Very very itchy scalp), NERVE INJURY (Doctor wonders if it is affecting his nerve), RASH (Rash around his ears) and PRURITUS outcome was unknown.            Concomitant medications were not provided.   This case was linked to MOD-2021-265811 (Patient Link).
After shots, symptoms was fear, restlessness, crying, staying to himself, staring at his hands as though he was in another world, had no sense of danger, he stop speaking in sentences and stared to stay one word than he started repeating what he heard. Also he had problem speaking ETC.
On 01/29/21 at 10:32 am patient complained of dizziness and seeing spots; VS: BP=154/108, HR= 79, RR= 20, O2 Sats RA= 97% while sitting in chair. At 10:38 am VS: BP=153/89, HR= 82, RR= 20, O2 Sats RA= 97%,.  At 10:42 am, VS: BP=157/89, HR= 79, RR= 20, O2 Sats RA= 99%.  At 10:47 am, patient on the phone with spouse still complaining of dizziness and seeing spots.; VS: BP=135/91, HR= 81, RR= 20, O2 Sats RA= 96%.  At 10:52 am VS: BP=133/95, HR= 84, RR= 18, O2 Sats RA= 98%.  At 10:57 am patient states she feels the same, VS: BP=135/95, HR= 87, RR= 18, O2 Sats RA= 98%.  At 11:02 am, VS: BP=142/94, HR= 82, RR= 20, O2 Sats RA= 97%.  At 11:07 am, patient states she is feeling better and still a little dizzy but can see better, VS: BP=139/90, HR= 78, RR= 20, O2 Sats RA= 97%.  At 11:12 am VS: BP=139/92, HR= 81, RR= 20, O2 Sats RA= 96%.  At 11:17 am patients states she is much better, vision is better, slight dizziness is still present but "I feel so much better," VS: BP=137/93, HR= 77, RR= 18, O2 Sats RA= 98%
Face redness; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Face redness), PYREXIA (Fever) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (Face redness), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 UNK. On 12-Mar-2021, ERYTHEMA (Face redness), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.            Upon internal review on 24-May-2021, the age was corrected to unknown.
His wife (me) had tested positive; His wife (me) had tested positive; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of unknown age received (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Aug Friday as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 01Sep2021 his COVID PCR test came back positive which was taken on Monday 30Aug2021. His wife had tested positive on Sun 29Aug. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on Sunday 29Aug2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101148635 different patient, same drug and event
Fell after the 1st dose of thre Moderna COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell after the 1st dose of thre Moderna COVID 19 vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Brain injury (Caregiver stated that her son is disabled with brain injury.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FALL (Fell after the 1st dose of thre Moderna COVID 19 vaccine). At the time of the report, FALL (Fell after the 1st dose of thre Moderna COVID 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   No treatment information was reported however the patient was recommended tetanus shot.
Migraine; Hives; patient received first dose on 05-Jun-2021 and second dose on 02-Aug-2021; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), URTICARIA (Hives) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 05-Jun-2021 and second dose on 02-Aug-2021) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Oct-2021, received third 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) 40 milligram. On 02-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 05-Jun-2021 and second dose on 02-Aug-2021). On an unknown date, the patient experienced MIGRAINE (Migraine) and URTICARIA (Hives). At the time of the report, MIGRAINE (Migraine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 05-Jun-2021 and second dose on 02-Aug-2021) outcome was unknown and URTICARIA (Hives) was resolving.            No concomitant medication were reported.It was unknown if patient was enrolled in a COVID-19 Vaccine trial. No treatment information were provided.
Site injection reaction, approximately 1" diameter, slightly raised and red.  Treated with acetaminophen; reaction has persisted from time indicated until time AE report is filed
1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left chest/breast pain, fatigue, stuffy nose.
This spontaneous report as received from other health professional (Medical Assistant) refers to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since January 2016 (Onset approximated to 2016), the patients were vaccinated with improperly stored doses of VAQTA (strength 24/0.5 units unspecified) injection (lot # K007791 with an expiry date 22-AUG-2016, lot# K019560 with an expiry date 02-JUN-2017, lot # L007559 with an expiry date 04-NOV-2016)(doses and frequencies unspecified) intramuscularly. No adverse effects were reported. It was reported that vaccines were not discontinued. This is one of the several reports received from the same reporter. Additional information has been requested.
Developed pain in neck and pack and sore at injection site. Having trouble with range of motion specifically reaching back with arm.
The patient returned to the pharmacy on 1/03/2011 stating that the arm in which she had received the flu vaccine (on 12/31/2010) was red, the area was swollen and felt hard and warm to the touch.
At 3 PM my mouth felt like it was going numb and I could taste novacain it lasted for about 2 hours and that night and the next few nights I would wake up from pain if I laid on that arm
5-10 minutes after shot felt warm and passed out on third day (3/11/21) extreme fatigue, diaria, vomiting
37 yo ad male c/o rash that started on forearms, then post head in the scalp and now in the buttocks.
both eyes are puffy underneath, both cheeks are red; both eyes are puffy underneath, both cheeks are red; A spontaneous report was received from a consumer concerning a -70 years old male patient who received Moderna's COVID-19 vaccine (Mrna-1273) and experienced events Periorbital swelling and erythema. The patients's medical history was provided and relevant concomitant medications were also reported. On 12Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 14Jan 2021, the patient experienced the events like both eyes puffy underneath and both cheeks appeared red.  The patient was on Brimonidine tartrate 1 drop both eyes TID, Dorzolamide HCl 1 drop both eyes TID, rhopressa one drop in both eyes at night before bed. The response provided was as follows: Redness of the cheeks and puffy eyes is not listed as a side effect however these may not be all the possible side effects of the Moderna COVID-19 Vaccine: Call the vaccination provider or your health care provider if you have any side effects that bother you or do not go away.  The reporter assessed the events as not related to the study drug.  Based on comment, repeated event line is delete
pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29th January 2022, the patient received the 2nd dose of Shingles vaccine. In January 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that he/she was going to get on and complain a little about the pain he/she experienced after the second shot a day before reporting. The reporter stated the pain other consumers had was much greater than his/her. This case has been linked to US2022AMR017852, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR017852:same reporter
Soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated with her first dose, she had nothing, just some soreness at the injection site. The patient further stated she got her vaccine, clarifies it was the second dose (Lot number: EL9265, Expiration date: May2021) on Friday, 02Feb2021, states she has redness (in left arm) at the injection site on 06Feb2021 and states it was swollen yesterday with a red rash around it, states it is not as swollen today. Patient stated yesterday she could feel the thickness of the bump at the site but today it is not as bad. Patient is wondering if this is something she should be concerned about, is it an allergic reaction. The outcome of the event was unknown.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient days after vial was initially punctured/ vaccine was given from a vial punctured more than 12 hours ago) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient days after vial was initially punctured/ vaccine was given from a vial punctured more than 12 hours ago). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient days after vial was initially punctured/ vaccine was given from a vial punctured more than 12 hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medications were not provided.Treatment medication was not provided. Medical assistant stated that a vaccine that was stored in the refrigerator between 4.1 C to 4.4 C, initially punctured at 9 am on 18AUG2021 was administered to a patient at 8:45 am on 20AUG2021. The vial was picked from the hospital which was 5 minutes away from the vaccination site. After this 5 minutes vial was put in the refrigerator on 17 Aug 2021. It was punctured on 18 Aug 2021 and dose was given on 20 Aug 2021. Vial had not suffered any temperature excursion and was had been less than 24 hours exposed to room temperature. Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Significant Follow-up received included dose 1 details, and patient's age.
Pt arm (R) began to appear red, swollen x today. 50mm x 63mm (R) arm SQ slightly sore some bruising.
Left arm around the vaccine shot site became extremely itchy and very red. The site expanded on the next day (Friday, the 22nd), and by Sat. it was swollen. Sunday the swelling subsided and the redness expanded around my arm. By Monday the redness had moved down my arm with the upper part clearing. Tuesday the new site had swelling, and today it is not swollen but continues to be red and a little itchy. It was my only reaction with no fever but a little tiredness. (not adverse event, but just reporting my reaction to vaccine...)
Headache, exhaustion, fever, and chills: Motrin and Tylenol every 4 to 6 hours better within 36 hours
Chills, muscle aches, joint pain, and fever up to 100.8 degrees F. Symptoms lasted for twelve hours then resolved.
MOTHER NOTICED (?) ARM SWOLLEN AND RED FROM ELBOW TO SHOULDER...TAKEN TO HOSPITAL.  PLACED ON CEPHALEXIN.
The patient stated that she had gotten her first dose of GARDASIL in 2012 and her second dose of GARDASIL in 2015; No AE symptoms were reported.; This spontaneous report was received from a female consumer of unknown age.   No information regarding the patient's pertinent medical history, drug reactions or allergies,  concomitant therapies was provided.  In 2012 the patient received the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (reported as "HPV 4" vaccination) 0.5 milliliters (ml), as prophylaxis. In 2015, she received the second 0.5 ml dose (inappropriate schedule of product administration) (vaccination scheme frequency, route, and anatomical location of vaccinations were not reported; lot numbers and expiration dates were unknown). No adverse event symptoms were reported.