chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed symptoms and tested positive for COVID; This is a spontaneous report from a contactable nurse and consumer. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EL9264; expiration date: May2021), dose 1, via an unspecified route of administration, administered in left deltoid on 28Jan2021 08:00 (at the age of 61-year- old) as single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus diagnosed a couple years ago and total lung capacity decreased from asbestos scarring diagnosed about 15-20 years ago. Concomitant medication included metformin for type 2 diabetes mellitus. The patient received the first dose of the COVID-19 vaccine on 28Jan2021 08:00 AM. The patient developed symptoms on 29Jan2021 and tested positive for COVID on 01Feb2021. The patient mentioned that he has no idea what type of COVID-19 virus test was used when he tested positive. The patient received bamlanivimab (BAM) monoclonal antibody infusion therapy at 700 mg in 270 ml normal saline (lot number: D332489A; expiration date: 08Nov2021) in the infusion clinic of the hospital on 02Feb2021. It was reported that the hospital contacted the patient after he tested positive for the COVID-19 virus to let the patient know he was eligible for the BAM monoclonal antibody therapy based on his past medical history. The BAM therapy would have been physician ordered for the patient. The nurse reported that she looked at the information on the CDC's website for the COVID-19 vaccine, and the CDC website stated people who have the COVID-19 virus antibodies should wait 90 days before getting the COVID-19 vaccine. The nurse was wondering what is the company's guidance is on the patient getting his second COVID-19 vaccine dose, since patient had his first COVID-19 vaccine dose, and then tested positive for the COVID-19 virus, and then had the COVID-19 virus monoclonal antibody therapy. The nurse asked does the CDC's 90-day wait time apply to the patient's situation. The patient also wanted to know how he should go about getting the second dose, should he wait 90 days. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a female patient of unknown age, regarding herself. On May 2013 (reported as last week) the patient was vaccinated with a dose of ZOSTAVAX, (route, dose, site of administration, lot number and expiration date were not reported). In May 2013 (reported as last week), the patient skin irritation after taking ZOSTAVAX and the rash went from her upper arm to her elbow. She went to the local ER (Emergency Room). The doctor's there didn't provide her with any information. The patient asked to know why she developed the rash. The outcome of rash and skin irritation was not reported. The relatedness between rash went from her upper arm to her elbow and skin irritation was not reported. Additional information is not expected.
Received 1 ML dose instead of the recommended .5ML; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) received 1 ML dose instead of the recommended .5ML.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received his first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient received a 1 ml dose instead of recommended 0.5 ml. The patient hadn't had a reaction.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, received 1 ML dose instead of the recommended .5ML, was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a  male patient of unknown age. The patient's medical history is not provided. The patient experienced an unexpected event of inappropriate dose of vaccine administered (1ml instead of recommended 0.5ml).  The event occurred on 29 Dec 2020 during the administration of first dose of mRNA-1273. The patient did not have the reaction. The sponsor considered the event as not related to mRNA-1273.
My fingers don't feel like they have strength; weakness in the right arm and fingers, fingers feel extremely weak, fingers are not working right,; arm hurts when he lifts it straight up, arm flops around; wooziness; arm irritation, could not even write the case number down; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in the right arm and fingers, fingers feel extremely weak, fingers are not working right,), PAIN IN EXTREMITY (arm hurts when he lifts it straight up, arm flops around), DIZZINESS (wooziness), LIMB DISCOMFORT (arm irritation, could not even write the case number down) and ASTHENIA (My fingers don't feel like they have strength) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Aneurysm, Pacemaker syndrome, Heart disorder and Platelet rich plasma therapy (Platelet therapy for his right knee- 2 weeks before booster).    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the right arm and fingers, fingers feel extremely weak, fingers are not working right,), PAIN IN EXTREMITY (arm hurts when he lifts it straight up, arm flops around), DIZZINESS (wooziness) and LIMB DISCOMFORT (arm irritation, could not even write the case number down). On 30-Nov-2021, the patient experienced ASTHENIA (My fingers don't feel like they have strength). At the time of the report, MUSCULAR WEAKNESS (weakness in the right arm and fingers, fingers feel extremely weak, fingers are not working right,), PAIN IN EXTREMITY (arm hurts when he lifts it straight up, arm flops around), DIZZINESS (wooziness), LIMB DISCOMFORT (arm irritation, could not even write the case number down) and ASTHENIA (My fingers don't feel like they have strength) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Redness at injection site. Swelling to the area. Pain. Swelling in the lymph nodes.
weakness started 4JUL96 dx as transverse myelitis 6JUL96;
Well visit BP 98/59 prior to vaccines. Within 5-10 min of vaccine admin child c/o upper abd pain. Nurse first observed child in bathroom floor where mom had placed her. Child had apparent syncopal episode. Removed to exam room had episodes of tachycardia, hypotension and urticaria (onset 1255pm). 1223pm BP 81/53 P 126, 93/56 P 121, at 1230pm 46/61 P 111, at 1238pm 1 1/2 tsp Benadryl 1255pm 0.18mg epinephrine SQ 1pm. Transported by ambulance 1pm to hospital.  NURSE FOLLOW UP ON 06/08/04 STATES: ADD: HIVES, RASH. Discharge summary states somnolance. msv
Daily headache and left ear noise sensitivity and pain. Onset March 28, 2021. Not yet resolved.
elevated temp highest 104 w/rash & sore throat; diffuse maculopapular eruption;
5/22/15- Developed hives on right side upper body and trunk area. Cortisone 10 cream applied and oral Benadryl. Resolved in 2-3 days. Taking Tylenol every 4-6 hours for pain relief. 5/23/15- "Deep strong pain" in right shoulder area; top of shoulder into deltoid area. Did not notice any redness, swelling or bruising. Heat applied to shoulder area with heating pad, also used hot shower to relieve some discomfort. Reports that shoulder area very sensitive to pressure, could not wear bra strap. 5/30/15- Saw Chiropractor for adjustment. Slight improvement of symptoms. Continues to take Tylenol q 8-10 hours for pain relief. 6/1/15- Went to PCP. MD reports that slight redness in right deltoid area w/minimal swelling. Call to HD. Recommended to continue heat and Tylenol and if no improvement to seek care with PCP. 6/9/15- Continues to feel deep aching pain in right shoulder area. Continues to take Tylenol q 10 hours for pain relief.
she developed symptoms and tested positive; This is a spontaneous report received from a contactable consumer (patient's friend). A 54-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date (reported as a couple of weeks ago) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient developed symptoms and tested positive for COVID. He enquired if my friend would have the 2nd dose on later than 21 days, will it have the same effectiveness. she already completed her isolation and showed no symptoms at all. He wants to confirm if the patient can now have the 2nd dose on the scheduled appointment which is 21 days after since her primary care physician advised her to wait until she completely recovered and have the 2nd dose in between 21 and 42 days. The pharmacist told her that she can have the 2nd dose on the scheduled appointment which is 21 days. He says she scheduled the vaccine, and a major medical center are saying to wait the 90 days before the vaccine, she was not sure if she should get the second dose to start over. The outcome of the event was recovered.  Information on lot/ batch number has been requested.
This case was reported by a physician and described the occurrence of rectal bleeding in an infant male subject of unspecified age who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced rectal bleeding. The physician was not sure if it was due to the vaccine. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The subject also experienced rectal bleeding after the second dose of ROTARIX. Please see case A0782027A.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (606 doses given after expiration date) and product storage error (vaccine kept in refrigerator Sep 22, 2021; expiration date was Oct 3, 2021 and administered Nov 18, 2021) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 043B21A) for COVID-19 immunization. No medical history reported. On Nov 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 18, 2021, patient administered expired product (606 doses given after expiration date) and experienced product storage error (vaccine kept in refrigerator Sep 22, 2021; expiration date was Oct 3, 2021 and administered Nov 18, 2021). At the time of the report, administered expired product (606 doses given after expiration date) and product storage error (vaccine kept in refrigerator Sep 22, 2021; expiration date was Oct 3, 2021 and administered Nov 18, 2021) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Vaccine placed in refrigerator on Sep 22, 2021. Vial did not undergo temperature excursion. No adverse event reported.
anaphylaxis, shock-like state that occurred w/in 30min of vax;pt responded to 02 & epi;no local rxn;
PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: pacemaker. The patient previously received with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included rivaroxaban (Xarelto) 20 mg at night. On an unspecified date, the patient experienced pain (dose number in series 2). It was reported that sister of patient suggested to take Tylenol to aid from pain. But the label showed warning about taking blood thinning medication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain was not reported. This report was non-serious.
My husband was the one who was vaccinated by the Pfizer vaccine. I am currently nursing our 16 month old and had not had a period since I became Pregnant with her. One week after my husband received his second vaccine my period is back! I attribute this to the vaccine.
Arm was swollen to size of "3 tennis balls" according to patient. He went to to the ER that evening appox 8-10 hrs after receiving vaccine.
Pt received flu vaccine in office and mom states hours later pt's arm swelled up to a baseball size and red.
I had 3 little red spots on right arm; headache; chills for a minute; felt sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (felt sluggish), RASH MACULAR (I had 3 little red spots on right arm), HEADACHE (headache) and CHILLS (chills for a minute) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 624M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included FLECAINIDE, CARVEDILOL, LOSARTAN, AZATHIOPRINE, CLONIDINE, RIVAROXABAN (XARELTO), FAMOTIDINE (PEPCID AC) and PROBIOTICS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced SLUGGISHNESS (felt sluggish), HEADACHE (headache) and CHILLS (chills for a minute). On 26-Feb-2021, the patient experienced RASH MACULAR (I had 3 little red spots on right arm). At the time of the report, SLUGGISHNESS (felt sluggish), RASH MACULAR (I had 3 little red spots on right arm), HEADACHE (headache) and CHILLS (chills for a minute) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided..   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: TCR document received. No new information.
patient was dizzy, lightheaded after covid vaccine. we laid her down with a pillow and mat, raised her feet, and put an ice pack on her chest. BP 108/60 70
Severe hot flashes / chills off + on for about 4 wks. 2nd Booster; Just hot flashes had been reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history, drug reactions, allergies and concomitant medications were unknown. On 25-JAN-2016, the patient was vaccinated with the second dose of ZOSTAVAX lot # L028285, expiry date 28-COT-2016 (dose and route of administration were not reported). The pharmacist mentioned that about 9 months earlier, approximately in April 2015, the patient had been administered the first dose somewhere else (dose, route of administration and lot number were not reported). No adverse effects were reported. Additional information has been requested.
Case number PHEH2012US025704 is an initial spontaneous report received from a nurse on 31 Dec 2012: This report refers to a 36-year-old female patient. She was given only the CYW-135 liquid component of MENVEO vaccine (batch number: X11032) intramuscularly on 23 Dec 2012, instead of being reconstituted with Men A. No other adverse reaction was reported.
The patient received dose from vials beyond 30-day use by date; The patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vials beyond 30-day use by date) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
pt recvd vax 8NOV93 & exp prutitus, erythema, soreness & swelling @ inject site; pt had 2 inch wide reddened, swollen, itchy area @ inject site; MD advised DPH, APAP, & warm compresses to area;
Lightheaded, dizzy, nauseous, and heart palpitations about 5 minutes after getting vaccine. Laid supine for 30 minutes with blood pressure continuously taken.  BP 188/93
pt recv vax 15OCT96 & was hosp on 20OCT96 w/sx of numbness of the fingers & face & loss of coordination;pt condition dx as GBS but etiology from the flu had been r/o;pt stated that it is from a resp viral infect had 1-2wk prior to GBS
The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 27Jan2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse and from a contactable medical assistant via Pfizer Sales Representative. This medical assistant reported similar events on five patients. This is the first of five reports. A 84 year-old female patient of unspecified ethnicity received PREVNAR 13 (lot number 177780, expiry date 01Jan2017, NDC number: 0005-1971-02), via an unspecified route of administration, on the arm, on 19Aug2015, at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The patient experienced cellulitis on 26Aug2015. She received a course of antibiotics to treat the event and she was recovering from the event as of 31Aug2015.
Area of injection red, swollen, and hot. On second day, 7/31/14, area of redness spread, still swollen and very hot. Went to doctor 7/31/14 and he diagnosed cellulitis and prescribed antibiotics. Doctor said could have damaged my lungs and heart if not treated.
Shallow breathing, lips blue spots at each corner of the lower lip (cyanosis) appeared, and dizziness.
Pt. c/o experiencing light head immediately after receiving vaccine.  Pt. seen and assessed by EMT.  VS are:  BP 129/79, O2 97, HR 92.  Pt. states that she had experienced headache after the first dose.  MD was made aware and pt. cleared to take second dose.  Within 20 mins. of observation client verbalized a decrease in symptom and as cleared to go home by EMT.
Swollen area at site painful with touch, headache. Pt treated with Bextra 10 mg tab PO BID #15 tabs given.
Pt stated severe pain in right upper arm, right arm at injection site warm to touch 6 days post vaccination.
No adverse event. Patient received incorrect vaccine. Patient received 6 months-5 years dose of moderna vaccine when he should have received 6-11 year old supply of vaccine instead
Pt. developed rash, warm to touch, bruise, redness near site of injection.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 20-OCT-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, albumin status HSA, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports received from the same reporter. Additional information is not expected as no further follow-up is required.
Received Gardasil vaccine 10/10/07. Developed shoulder pain one week later that has persisted.
Patient did not receive 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The patient was in accelerated schedule for Twinrix and missed the second dose at 7 days and wanted to know how to proceed. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix ,which led to incomplete course of vaccination.
Onset several days after vaccination of  chills, feeling unwell, headache, dizziness. Symptoms continued. Evaluated on 5 August by MD for fever and headache. Brought to ER. Admitted to hospital
Irritability, low grade fever, rash, erythema multiforme. Target lesions. Concentric macules trunk and extremities.
Information has been received from a registered nurse (R.N.) concerning a 60 days old male infant with a history of premature baby 33 weeks who on 04-APR-2011 was vaccinated with the first dose of ROTATEQ (lot# 669072/1270Z, dose not reported). The patient spit up the dose within 30 seconds of receipt. The patient sought medical attention. At the time of reporting, the patient had recovered. Follow up information has been received from a physician concerning the child with no illness at time of vaccination who on 04-APR-2011 at 12:00, was vaccinated with ROTATEQ and threw up the vaccine at 12:00 PM. Physicians were called to see if the dose was needed to repeat. The physician did not repeat it. The patient was 100% fine and recovered after he threw up. No ER visit was request. Additional information is not expected.
Pt recvd Engerix-B on 9JUL91 & 8AUG91 & w/in 12-14 hrs of receiving each dose exp sudden onset of h/a, fever, diarrhea & a mild rash on trunk;