chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Allergy NOS and Depression. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy NOS, SERTRALINE and BUPROPION for Antidepressant therapy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) for Asthma.    On 04-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 04-May-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received a third dose of the Moderna COVID-19 vaccine on 04May2021 instead of a desired shingles vaccination.  Per the pharmacy intern, no symptoms were reported by the patient.   This case was linked to MOD-2021-104036, MOD-2021-103961 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Lot number and expiration date of third dose provided.
injection site pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that the patient experienced severe pain in his arm after vaccination. Additional information was not provided. The reporter did not consent to follow up.
vomiting; tiredness; severe headache; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm from at 00:00 on 06Jan2021 at single dose for COVID-19 immunization. Medical history included depression and anxiety. Concomitant medication included bupropion, vortioxetine hydrobromide (TRINTELLIX). The patient experienced tiredness, severe headache, nausea, vomiting at 08:00 AM on 06Jan2021. It lasted about 36 hours total. The events were reported as non-serious. The patient did not receive any treatment from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on 07Jan2021.  Information on the Lot/batch number has been requested.
1/17/2010 SLIGHT FEVER; 1/18-1/19 NAUSEA, DIZZINESS, SWOLLEN LYMPH NODES & SHIVERING-VISIT TO EMERGENCY ROOM; 1/20 SICK HALL, SAME SYMPTOMS BUT SLIGHT FEVER - PUT ON QUARTERS; 1/21 UNCONTROLLABLE MUSCLE CONVULSIONS IN BODY CORE - EMERGENCY ROOM-CONTINUE ON QUARTERS - CONTINUES TO CURRENT DAY - PRESCRIBED VALIUM AND BENADRYL - WHEN ON VALIUM CONTROLLABLE TEMORS - WHEN NOT ON VALIUM FULL BODY UNCONTROLLABLE TREMORS RETURN
Within 18-20 hrs after given DTP, Pt woke up /w truncal & facial hives,no fever, & no side effects usually noted from DTP vax.  The hives contined in varying amts for 72 hrs.  No changes were made to pt's environment or foods prior to hives
I was Breastfeeding when I received the covid 19 vaccine; I was Breastfeeding when I received the covid 19 vaccine; I was Breastfeeding when I received the covid 19 vaccine. After the first dose I noticed my milk decreasing within a 24hour period. After the second dose my milk was depleted completely within a 24; I was Breastfeeding when I received the covid 19 vaccine. After the first dose I noticed my milk decreasing within a 24hour period. After the second dose my milk was depleted completely within a 24; This is a spontaneous report from a contactable consumer (Patient). A 24-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 23Apr2021 15:00 (at the age of 24-years-old) (Batch/Lot Number: EW0172) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included glaucoma, aphakic, allergy of latex and mild mold/fungal allergy from an unknown date and unknown if ongoing. Concomitant medications included latanoprost (LATANOPROST, eyedrops) and dorzolamide hydrochloride/timolol maleate (COSOPT) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (Lot number: ER8730, Vaccine location: Left arm) on 30Mar2021 03:00 PM for covid 19 immunization and had reaction noticed my milk decreasing within a 24hour period. The patient was breastfeeding when she received the covid 19 vaccine. She was pumping 10-16oz in a session. After the first dose she noticed her milk decreasing within a 24hour period. By the next day she was only producing 3 or 4 oz in a single session. She struggled over the next few weeks to get her milk supply up to 6oz. After the second dose her milk was depleted completely within a 24-hour period. The patient was not pregnant. The patient had treatment by lactation consultation, the patient had no covid prior vaccination and patient had no covid test post vaccination. Outcome of the events I was Breastfeeding when I received the covid 19 vaccine was unknown and outcome of other events was not recovered.
1 of 3 pts exp rxn following vax from same lot of vax; pt exp a large inj site rxn & a fever;pt had recvd pneumococcal vax in 1986;unk if pt had any high risk underlying conditions which would warrant re-immunization
Patient is a 53 y.o. male with history of alpha-1 antitrypsin deficiency with secondary liver failure on liver transplant list who tested positive for COVID-19 around 6 days prior to admission on 1/4/22 and is not complaining of any cough or respiratory complaints.  Patient came into the emergency room because of worsening lightheadedness and fatigue.  In the ER the patient was found to be hypotensive with no clinical evidence to suspect any pneumonia with no hypoxemia, and the patient has no infiltrate on his chest x-ray.  He did have some cardiomegaly, he did have a prior echocardiogram that showed evidence of mitral valve regurgitation and pulmonary hypertension.  Denies any regular steroid use but did have previous steroids in the past Denies any lung involvement with the alpha-1 antitrypsin deficiency Denies any history of tobacco abuse Denies any productive cough or even sore throat or low-grade fever He did have some retrosternal chest burn. No altered mental status Patient noted that his blood was melena like over the last 2 days, he is not aware of any problem with esophageal varices or problem with gastric or duodenal ulcers or any prior history of GI bleed. The fatigue was worse with any slight activity and so was the lightheadedness, was relieved by laying back. Patient had to be started on IV pressors His hemoglobin was low but not that far off from his baseline but given the hypotension he was given orders for IV transfusion with red blood cells He did have some coagulopathy due to his chronic liver disease No diarrhea the ER but has had digital rectal exam showed positive Hemoccult on the stool.
pt recv vax 19OCT95 & w/in 15-20 min of vax pt devel urticaria @ the inj site;this is 1 of 3 patients @ this site who exp the above rxn;no other details known as of the date of this report
Severe Dizziness felt fuzzy. Like twirled in circles, and could not get balance, even lying down. Headache in left side of head, sore throat on left side of neck.  Injection site in left arm extremely sore, swollen by 3pm Temperature went up from 97.6 normal temp to 99.5 by 3 pm. Mild chills. Extremely sore arm by 3pm. Most symptoms but sore arm gone by 6am 5.15.2021. Mildly dizzy 5.15.2021 if moved head too fast. Felt tired.
Large local reaction. Treatment = symptomatic care with ibuprofen and cetirizine. Outcome yet to be determined.
Left arm extremely sore at vaccine site for nearly 2 weeks. Within 2 weeks my hair started falling out at top center of my head.   I didn't realize how bad it was until I went for my monthly hair cut on March 31st when my hair dresser brought to my attention that I had become bald there in quite a large area.  I always had a full head of hair previous to this vaccination!  I was so alarmed I immediately made an appointment with my doctor for the next morning.  The doctor couldn't find any reason for the balding.  The doctor told me there was no reported balding effects of the vaccine that he could find.
At time of injection, i felt a small discomfort immediately in my left forearm (side of injection).   In the 3 weeks since vaccination, I have had intermittent discomfort and tingling in my left forearm/hand.
Patient is a 3 year old male who had a seizure of 3 minutes on 10-25-06 PM. This progressed to cyanosis and no respirations. Mother gave 2 rescue breaths and then did not find the carotid pulse. She initiated CPR times 2 minutes. EMS arrived and found pulse and now breathing but posticial. Transported to Hospital and admitted overnight. DC DX: for 10/25-10/26/06 Febrile Seizure HX of febrile seizures times three in the past. Normal EEG 7/05. Previously followed by neurologist. URI symptoms for up to one week prior to seizure.  EEG pending CXR: normal chest  EKG normal Labs WNL with AST 45.
Case number PHEH2013US017529 is an initial spontaneous report from the pharmacist received on 15 AUG 2013. This report refers to a 25-year-old male patient. His medical history was not reported. On 14 AUG 2013, the patient was accidentally vaccinated with only MenCYW-135 liquid component of Menveo (batch number: M11077) via intramuscular route and did not receive Men A lyophilized conjugate. No adverse event reported following the medication error. No other information was available.
Flu shot was given on 10/20/08 on Pt Left arm. He developed a dime size redness the next day he has 10x12 cm red urticarial rash on his arm today
The patient presented to Medical Center on 02/04/2022 with c/o SOB.  The patient uses home O2 at 4 Liters.  On arrival at ED, oxygen saturation was in the 80s.  The patient was placed on a nonrebreather.  CT showed multifocal PNA in both lungs, and improved infiltrates of the soft tissue encasing bilateral structures of the pulmonary artery.  The patient was admitted to Med Surg floor.  The patient then tested positive for Covid-19 and was treated with Covid-19 protocol.  The patient's condition declined and he was transferred to the ICU and intubated.  The patient developed multiorgan failure and septic shock.  The patients condition did not improve with aggressive interventions including pressor support and antibiotic therapy.  The family transitioned patient to comfort measures.  The patient expired on 02/22/2022.
Case number PHHY2011US43334 is an initial spontaneous report received from a nurse on 19 May 2011. This report refers to a 14 year old female patient. She was given only the CYW-135 liquid component MENVEO (batch number 090701) intramuscularly on 13 May 2011. No other adverse reaction was reported.
On 12/3/01 PM, the pt attended Influenza Clinic and received Flu Shield vaccine. She developed sweling and discomfort. She was seen by her personal physician. She was treated and discharged to home. She did not respond to writer's request to be contacted to provide follow-up information.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Dilaudid, reaction(s): "known allergies Dilaudid", notes: known allergies Dilaudid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (received treatment for COVID-19 with Paxlovid on 15Feb2023 to 20Feb2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a 60 year old female of unspecified race and ethnicity. 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: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that on 15-MAR-2021, the patient was in the hospital with an other blood clot and had to be given 2 units of blood. The number of hospitalization days were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20211110749-COVID-19 VACCINE AD26.COV2.S-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
lot # FL2757 with manufacturer's expiration date of Sept 30, 22. Information has been received from the manufacturer indicating that stability and efficacy data supports the use of this product through Oct.19, 2022. Per guidelines: doses administered between Oct 1 - Oct 19
3 days of severe crying 24 hrs per day-starting 2 hrs p/inject
On January 25, 10 days after receiving 1 st shot developed a mild rash/hives on both arms. Today it is January 28 and I am seeing rash on my cheek bones.  Red areas still present on my arms and still itchy.  I am taking Allegra which relieves the itch and fades red areas.
Confusion, slight incoordination, fatigue, headache started 3 hours after receiving MMR & TD vaccines on 11/18/2013.
Complained of bad headache immediately after receiving the vaccine and felt hot. she was observed for a longer period and released from the vaccine  clinic. Rt arm was sore for 4-5 days and went away. on 1/12/2021 she was unable to sleep on her right side because of pain. complains of redness, pain and increased warmth, stiffness of right arm. On exam afebrile, pain 6/10 on an analog scale. 3x 3 annular macular rash, erythematous, with tenderness on palpation with increased warmth. ROM full. Prescribed Augmentin 875/125 x 7 days.
pt started feeling nauseous, dizzy, gagging and blurry vision within 5 minutes of administration.  Healthcare provider assessed patient and advised ER.  Clinic staff escorted patient to the ER.
severe rash on face, throat, eyes, and right arm; Rash doesnt have bumps just red and itching; Rash doesnt have bumps just red and itching; Rash with peeling skin; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of RASH (severe rash on face, throat, eyes, and right arm), RASH ERYTHEMATOUS (Rash doesnt have bumps just red and itching), RASH PRURITIC (Rash doesnt have bumps just red and itching) and SKIN EXFOLIATION (Rash with peeling skin) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011421A and 041LZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, SUMATRIPTAN SUCCINATE (IMITREX DF), METOPROLOL, AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-May-2021, the patient experienced RASH (severe rash on face, throat, eyes, and right arm) and SKIN EXFOLIATION (Rash with peeling skin). 08-May-2021, the patient experienced RASH ERYTHEMATOUS (Rash doesnt have bumps just red and itching) and RASH PRURITIC (Rash doesnt have bumps just red and itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (severe rash on face, throat, eyes, and right arm), RASH ERYTHEMATOUS (Rash doesnt have bumps just red and itching), RASH PRURITIC (Rash doesnt have bumps just red and itching) and SKIN EXFOLIATION (Rash with peeling skin) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-116551 (Patient Link).
pt broke out w/vesicular rash on 5FEB99 lasted 5 days;little over 50 pox all over body;no fever;given APAP 1x;no meds given;chickenpox dx;
Swollen red arm approximately 5 inches from injection site.  Vaccine stored too cold.  This was a reduced shot.
I started having heart palpitations that that started soft, and by the end of November hurt enough that I couldn't ignore them.made appt with doc..11/29/21. Set me up for blood work- that came out good, then heart monitor which confirmed PVCs.  By mid December, 2021, they started to subside and are now gone.  Back to my normal activities.  NEVER had issues like this before.
Headache, Myalgia, Fever, chills Narrative:  Other Relevant History:
Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremities started stinging, nose running & feeling feverish. My ears started ringing too & got vertigo. Also I started having trouble breathing with a slight ache/pain in my lungs. A noticible itch started in my nose & a tickle in my throat and I had extreme muscle pain, especially in extremities affected by previous carpal tunnel injuries & sciatica. Tuesday afternoon all symptoms were worsening so I used Zicam Gel swabs in my nose, made chicken garlic soup & tea with honey & went to bed. It took 3 days for the sinus, headache & respiratory symptoms to resolve. The neuropathy (skin stinging) pain in my arms, hands & lower legs persists and is very painful.
Client developed a large blotchy red rash on her upper chest, upper right arm immediately after receiving VZV, no S.O.B Epinephrine 0.3 mg Auto-Injector SC STAT R thigh. Fire rescue arrived @ 10:20 AM. Paramedics team recommended client's parents to observe the child and see the child's private doctor.
Severe pain on upper shoulder deltoid area, lost mobility and could not sleep on left arm. Could not raise arm above my head. I felt it was warm. It's now over 3 weeks and pain is extreme shoulder makes popping sounds and loud clicks.
Woke up 7/11/14 achy and fever. Decreased ROM (L) arm. Erythema, swelling and tenderness 7/12/14.
PATIENT RECEIVED 2 VACCINES IN LEFT ARM AROUND 415PM 10/7/19. PATIENT WIFE REPORTS PATIENT BEGAN FEELING FEVERED AND HAD EXCESSIVE REDNESS AND SORENESS AS WELL AS LIMITED MOBILITY IN LEFT ARM AROUND 12PM 10/8/19.
Awakened at 2:00 am with low grade fever and muscle and bone aches. (ankle, knees, hip joints, back) Experienced low grade fever and chills occasionally for3 days following injection. Today is day 4 and I have no side effects.
teh patient received a first dose of Menactra on 10 Oct 2019 and then on 12 Oct 2019 inadvertently, no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old female patient who received a 0.5 ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6208AB via intramuscular route in the left deltoid 10-Oct-2019 and again received a 0.5 ml dose of the same on 12-Oct-2019, inadvertently.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) on 10-Oct-2019; HPV VACCINE (HPV VACCINE) on 10-Oct-2019; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) on 12-Oct-2019.  It was a case of actual medication error due to extra dose administered.  At the time of reporting, the patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Guillain-Barre Syndrome - 1st seen here 2/4/09 - Hospitalization and long rehab stay - Still symptomatic 10/5/09.  12/03/09 and 12/08/09 MR and DC summary received for DOS 02/13/09  02/20/09 Final DX: Guillain Barre syndrome, hyponatremia  Pt presented with abdominal and back pain, parasthesias, bilateral weakness, diplopia, hyponatremia, unstable gait, and frontal headache. On neurological examination: ophthalmoparesis, absent reflexes, UE ataxia, sensory loss. Pt diagnosed with GBS. Tx: normal saline, IVIG. Pt with SIADH.   Pt's sensation and strength improved. Pt discharged home.  12/07/09 MR received for DOS 02/21/09  02/25/09. DX: Acute inflammatory demyelinating polyneuropathy, s/p IVIG. Pt in rehab hospital. Neurological exam: cranial nerve deficits on L side; muscle strength 3/5 proximally in BLE and 4/5 distall; DTRs absent; dysesthetic in trunk and extremities. Pt has atypical GBS. Pt discharged home.
Patient felt warm and was sweating profusely later the evening on the day of vaccination. 1 week later patient started experiencing muscle spasm initially starting at the lower legs, progressively walking upwards to the upper thigh.  And this time patient also developed a new left-sided facial droop, with facial muscle weakness.  He was evaluated at the ED 2 weeks after his Covid vaccine.  CT head, CT angio was unremarkable.  However MRI showed some mild diffuse cerebral atrophy.  On neuro exam There Is Mild Left-Sided Facial Droop, unable to raise left side eye, unable to puff out his cheeks.  There is also stocking glove distribution of decreased sensitivity to vibration, temperature, light touch.  At this time th
Right upper arm very firm, hot, and red.  Reddened area is 115 mm lengthwise and 100 mm wide.  Patient able to move arm and states it does not hurt.  Area swollen to about 2 times the size of the other arm.  Advised to give Motrin and Benadryl dose and to call back if worsening