chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after; Vomited; got really shaky; not able to drive; bad headache; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, formulation: solution for injection, Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 (17-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history reported as none. Concomitant medication(s) included fluoxetine hydrochloride (PROZAC) 40 mg once daily taken for an unspecified indication, start and stop date were not reported. On 30Jun2021, the patient experienced Vomited, got really shaky, not able to drive and bad headache. The patient received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after sars-cov-2 test positive on 05Jul2021. The reporter stated her daughter received the first dose and then ended up testing COVID positive. She received her first Pfizer Vaccine and she ended up with Covid positive, 5 days later. So, my question is with her second vaccine, do they recommend any way or not, should we, because she had the first one and became infected. She also had side effects from the first vaccine. Side effects: Pharmacist stated," I know she vomited, she got really shaky, really bad headache and she was not able to drive." Laboratory test: Pharmacist stated, "No lab but she tested COVID positive e on 05Jul2021 from 'PCR' (Not spelled) COVID test. The outcome of the events were unknown. The patient underwent lab tests and procedures which included PCR sars-cov-2 test: positive on 05Jul2021.  No follow-up attempts are possible. No further information is expected.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an elderly male patient of unspecified age. This refers 76 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
The same day of Zoster vaccine given, pt developed nausea and chills which resolved by nighttime. She awoke with no symptoms but after breakfast pt developed lower abdominal pain, copious emesis, and came to the doctor's office that day where she was found to be tachycardic at 120 in A Fib. Sent to the ER .
After day 9 post vaccine injection red rash that itches presented. Took benadryl, area has progressively gotten redder, hot and itching. Now cover entire bicep area of left upper arm.  Photo taken today for documentation Moderna 037 k or (IC) 2 or Z  o or 0 A  Lot number is hand written  so hard to tell exact lot number  Given 12/3/2020 at Medical Center
receding gums; pain; This is a spontaneous report from a contactable consumer (patient herself). A 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a 1st dose, single dose for COVID-19 immunisation. Age at vaccination was 82 years. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced receding gums and pain. Enquired that, the patient got the first dose of the Pfizer COVID 19 vaccine today. The patient have receding gums, can she take Tylenol or aspirin for the pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
fever to 105.6 on 23MAR98;seen in ER negative exam;mom reports fever 20MAR98 which resolved 21MAR then restarted late 22MAR98;also noted to have cough & wheeze on 22MAR98;
Situation:   Name of Reactive drug/vaccine: Covid Pfizer   Time of Immunization Administration: 14;50  Time of Reaction:  15:05  Subjective symptoms reported by patient: Complaints of dizziness  Objective symptoms/nursing  Assessment Diaphoretic  Anaphylaxis:    Immediate nursing interventions Placed in supine position. Cool compress to forehead,fluids offered.  BP taken.   104/68 supine  Repeated at 15:30 110/68 Skin warm and dry.  Was the Emergency Protocol for Anaphylaxis Initiated? no  Patient response to interventions and additional details:  Skin warm and dry. Left accompanied by co worker at 15:40   Background:   Allergies:  Allergies Allergen Reactions ? Aspirin Nausea And Vomiting ? Gluten Protein GI Distress ? Nuts (Other) Dizziness, Headache, Nausea And Vomiting and Respiratory Difficulty    PMH: social anxiety  Assessment: Influenza Vaccine Reaction. ***   Recommendation/Plan: Rest as needed
On 2/6/2022, 49 y/o F with DM, s/p renal transplant 10/2020, HTN p/w 1week of sore throat/rhinorrhea, several days of cough, and worsening SOB x 1d, found to have mild hypoxia 2/2 COVID. CXR w/ new streaky infiltrates BL bases and L mid lung. Admitted for treatment of hypoxia. Treated w/ remdesivir and dexamethasone.  At d/c to home on 2/10/22, no longer hypoxic at rest but drops to mid 80s with mild exertion, which resolves <30 sec at rest - ordered portable O2 for home.
Fever for one day (101 F), body aches, chills, mild productive cough, runny nose
At 12 hour mark- chills, fever, then sweats. Horrible injection site pain (couldn?t sleep on that side). Entire next day- fatigue, fogginess, muscle ache.
fainted/felt woozy after shot was given, patient laid down on bench in pharmacy, elevated legs and gave ice pack, patient came to and was ok, he was talking with us, we stayed with him the whole time and talked to him, we called his girlfriend and she came and picked him up, he stayed in the pharmacy about 45 mins, we advised girlfriend to monitor him the rest of the day and if symptoms/patient not feeling better, go to ER, patient stated that he felt better when he left
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium
Patient was given a expired (BUD) vaccination.  Patient was informed and advised to have another vaccination ASAP.
Narrative: Pt is a 77y.o. male who died on 02/10/2021 w/ h/o GERD, CKD5, hypothyroidism, T2DM, carcinoma of prostate, HTN, gout. Pt received Moderna Covid-19 Vaccination 1/2 on 01/15/2021. Pt died on 02/10/2021 at hospital. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
2ML OF VACCINE ADMINISTERED TO A PATIENT; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) 2 ml, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUN-2021, the subject experienced 2ml of vaccine administered to a subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 2ml of vaccine administered to a patient was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Patients arm was extremely sore immediately after vaccination and for a few days after. It seemed to improve somewhat, but recently pain has returned. Pain is so bad he has trouble using and lifting arm. No swelling, just pain.
8 days after initial shot, I developed firm and red and swollen spot at injection site. The next day I developed a small rash on my stomach. Overall feel itchy. But did not develop until well after my vaccine was first given.
Case number PHEH2013US019069, is an initial spontaneous report received from a pharmacist on 09 Sep 2013. This report refers to a 65 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: A 10042), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 05 Sep 2013. No adverse event was reported following this administration error.
Patient seen in clinic on 5/17/06 with varicella rash. No fever papule, vesicle, classical varicella rash.
Feeling ill after second dose of Pfizer vaccine; This is a spontaneous report from a contactable consumer. A female patient of unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.On 05Mar2021, it was reported that the patient needed to cancel class due to feeling ill after second dose of Pfizer vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event feeling ill after second dose of Pfizer vaccine was resolved an unknown date in Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
On 10/28 - Patient was walking to work from her car and became short of breath.  Patient then felt heart palpitations throughout the day.  The SOB, chest tightness, and palpitations happened all weekend according to the patient.  Patient then went to the ER on  the morning of 11/1/2021.
Patient was c/o redness, pain and swelling on left arm where Tdap injection was given. Patient was seen in ER and was given Keflex 1gm PO and was d/c with Keflex to take at home for 8 more days.
pt recv vax 23OCT95 & exp inj site pain which greatly hindered movement of that arm;also devel numbness in the fingers, which resolved p/1 day;pt cont to exp pain as of the date of this report
Pt describes 3 inch circumference of swelling. Site feels like it may be an allergic reaction.
A nurse reported that a male, inadvertently, received a triple dose of Typhoid Vaccince, USP, Heat Phenol Inactivated, on 6/4/99 and subsequently, developed an injection site reaction, characterized by redness and soreness which persisted as of 6/10/99. This is 1 of 2 pt's from this facility who experienced this event following receipt of Typhoid Vaccine, USP, Heat Phenol Inactivated, lot 4988014.
Extreme tiredness; headache beginning around 4pm.  Increasing fatigue and temperature into the evening. Stayed in bed. Temperature between 12 and 1 AM on that night/next morning rose to 102.7 F.   Feeling of distress, headache, fever abated but continued.  Felt barely able to move for several days. Extreme fatigue beyond normal has continued for many weeks.  Occasional piercing headaches continue.
Chills; General achiness; "blah" feeling; Required tylenol to be able to sleep; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 12:30 (Lot number: EN8735) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6208, administration time= 11:00 AM, Vaccine location: Left arm), administration date: 14Mar2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 05Apr2021 23:45, outcome "recovered" (2021), described as "Chills"; PAIN (non-serious) with onset 05Apr2021 23:45, outcome "recovered" (2021), described as "General achiness"; FEELING ABNORMAL (non-serious) with onset 05Apr2021 23:45, outcome "recovered" (2021), described as ""blah" feeling"; INSOMNIA (non-serious) with onset 05Apr2021 23:45, outcome "recovered" (2021), described as "Required tylenol to be able to sleep". Therapeutic measures were taken as a result of chills, pain, feeling abnormal, insomnia.  Additional information: The patient did not received any other vaccine in four weeks. The patient was treated with Tylenol for the events. No COVID prior vaccination and not tested for COVID post vaccination. No known allergies. The patient reported the adverse events at 10 PM Wednesday, 07Apr2021.  No follow-up attempts are possible. No further information is expected.
Pt had a positive COV ID test on 8/7/22 in SNF (AHC Paris in Paris, TN); c/o CP and SOB; CXR showed positive for infiltrates; treated with Zithromax and anti-viral lagevrio; pt found lifeless without VS, CPR started without success; pt passed away.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # L048848, expiration date: 09-AUG-2018, (dose number, route and anatomical location of administration were unknown). The temperature excursions reported were: 51.3 F for 40 minutes, and 50.2 F for 1 hour and 10 minutes. The temperature excursions were detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced terribly sick, lightheaded, bones felt like ice with four layers of clothes and a heating pad and three blankets, 104 F. fever for three days, terrible headache, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104 F. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terribly sick, 104 F. fever for three days, bones felt like ice with four layers of clothes and a heating pad and three blankets, terrible headache, nausea and lightheaded was not reported. This report was non-serious. This report was associated with product quality complaint 90000217062.
numb tip of tongue, numb, left side of face,  left eye pain, jaw pain . Start prednisone 20mg 3 tablets with food for 7 days
forgot to reconstitute the vaccine with a purple cap; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, 0.3ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown", described as "forgot to reconstitute the vaccine with a purple cap".  Additional information: The patient would like to report it, and apart from that, she would like to get advice on what else has to be monitored for in this case.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 09Apr2021 as dose 2, single (Lot number: ER8729) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Lot number: 939903), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Other medical history: cancer, Crohn's; "Crohn's" (unspecified if ongoing), notes: Other medical history: cancer, Crohn's; "Known allergies: mild laytex" (unspecified if ongoing), notes: Known allergies: neo/poly sporin; mild laytex. Concomitant medication(s) included: MESALAMINE. Past drug history included: Neo/poly sporin, reaction(s): "Known allergies: neo/poly sporin", notes: Known allergies: neo/poly sporin; mild laytex; Neo/poly sporin, reaction(s): "Known allergies: neo/poly sporin", notes: Known allergies: neo/poly sporin; mild laytex.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (05Jul2022) positive, notes: tested positive again four days after stopping Paxlovid. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient had Paxlovid from 26Jun2022 to 01Jul2022 for COVID 19 Treatment. Paxlovid rebound. Symptom returned and tested positive again four days after stopping Paxlovid. Patient also had treatment of Ipratropium Bromide.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200945085 Same patient/drug, different dose/events;
3/31/23 That morning I was on my way home from out of the town and had a sore throat. I woke up around 3:00am and felt really worse. I tested positive for COVID with an at home COVID test. I woke up and did a second test that was positive. I went to Urgent Care and was started on Paxlovid. I took the Paxlovid for 5 days. Two weeks later, I was still having a lot of chest congestion and sinus issues. I went to see my doctor and was put on an antibiotics and low dose prednisone. It took about 3 ½-4 weeks and finishing off the antibiotic to get better.
Information has been received from a pharmacist concerning a 53 year old female with allergies to erythromycin, tetracycline. Cephalexin (Keflex) and preservatives in eye ointments and a history of acoustic neuromomas of the brain with blindness in the right eye and deafness in the right ear who on 8/30/06 was vaccinated SC with a 0.65 ml dose of varicella zoster virus vaccine live (lot 652965/0622F). Concomitant therapy included estrogens, conjugated (Premarin). ON 9/2/06 the pt developed shingles on her arm and itching. No pain was noted. Unspecified medical attention was sought and the pt was treated with Valtrex. No lesions were remaining for VZV analysis. The pt had no history of shingles in the past, but a history of chickenpox as a child. Subsequently, the pt recovered from shingles. There was no product quality complaint involved. Additional information has been requested.
Vaccine given as part of well visit. Noted child scratching site with in 5 min of administration. Affirmed itching when asked ice applied. Md checked out and released after about 10 min of observation. No whelps, bumps or redness.
pt recv vax; 15 mins later began v; LOC x few sec;to hosp x 24 hr;fever of 100-101;MD not sure if sx related to vax or if it was viral;
administered a dose from a vial that was punctured and left at RT for 5 days; vial that was punctured and left at RT for 5 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial that was punctured and left at RT for 5 days) and PRODUCT STORAGE ERROR (vial that was punctured and left at RT for 5 days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A and 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022 at 5:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 27-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (vial that was punctured and left at RT for 5 days). On 01-Feb-2022 at 5:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial that was punctured and left at RT for 5 days). On 01-Feb-2022, PRODUCT STORAGE ERROR (vial that was punctured and left at RT for 5 days) had resolved. On 01-Feb-2022 at 5:15 PM, EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial that was punctured and left at RT for 5 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Date the vial was initially stored in the refrigerator- 27Jan22 Date(s) and time(S) vial was first punctured: 27Jan22 at 8.30am. Date(s) and time(s) of administration of vaccine: 01Feb22 between 2.30pm-4.30pm vial stored post puncture at room temperature. vial didn't undergone  any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2022: Follow-up received contains Significant information-Patient demographics- updated, Suspect drug details-route, body site and dosage regimen updated, Narrative updated: No adverse event occurred.
Mass confusion , lack of appetite, unsteadiness, extreme fatigue and malaise. This started exactly 1 week after his shot and has improved some but still lingers up to this date.  We don't know if there was permanent damage.
Abnormally large welt on delt muscle where injection occurred.  Very sore within few hours.  Large welt still there after 36 hours.