chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unable to get pregnant; Having irregular periods; This is a spontaneous report received from non-contactable reporter (other non HCP). The reporter is the patient.  A female patient received BNT162b2 (Pfizer-BioNTech COVID-19), 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: INFERTILITY (medically significant), outcome "unknown", described as "unable to get pregnant"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "Having irregular periods". Caller states that the patient in the doctor's office told the caller that she has been having irregular periods and is unable to get pregnant. The patient believed this was from the Pfizer Covid Vaccine. History and Investigations: Caller is not aware of any other medications, medical conditions, labs, testing, or treatments related to these events for the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
experienced an increase in my Parkinson's tremor; had reactions like I have when I have seasonal allergy symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSONIAN REST TREMOR (experienced an increase in my Parkinson's tremor) and VACCINATION COMPLICATION (had reactions like I have when I have seasonal allergy symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044821A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Parkinsonian-like tremor and Immunocompromised.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PARKINSONIAN REST TREMOR (experienced an increase in my Parkinson's tremor) and VACCINATION COMPLICATION (had reactions like I have when I have seasonal allergy symptoms). At the time of the report, PARKINSONIAN REST TREMOR (experienced an increase in my Parkinson's tremor) and VACCINATION COMPLICATION (had reactions like I have when I have seasonal allergy symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-355938, MOD-2021-355986 (Patient Link).
Pt rec Zostavax Wed 6/19/13. On Monday 6/24/13 pt noticed a 2 inch swollen area at the injection site. It disappeared 2 days later. Spoke with pt. 7/19/13 and pt has felt fine and not experienced any other adverse reactions since.
"Tingling sensation in left elbow.   Feels like I've been laying on it.  Event started approximately 5 minutes after injection and is getting better now."
On 5/6/2021 @ 1:44PM Vaccination team inadvertently administered patient the 2nd dose of Pfizer vaccine 0.3 mL (Lot # EW0175) IM, left deltoid; earlier then the  manufacture's requirements. The patient 2nd dose was administered seven days after the patient had received his 1st dose Pfizer vaccination on 4/29/2021. Patient has s/s of adverse reactions and there were no treatments administered.  The patient was contacted for a follow up 5/10/2021 patient has no complaints of illness.  Patient was contacted for follow up on 6/4/2021, he has no complaints of illness.
red in the shot area; inflamed/It had spread a little bit, like five inches across and five inches down the injection site; sore/it hurts to the touch in the shot area; itchy to the touch in the shot area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red in the shot area), VACCINATION SITE INFLAMMATION (inflamed/It had spread a little bit, like five inches across and five inches down the injection site), VACCINATION SITE PAIN (sore/it hurts to the touch in the shot area) and VACCINATION SITE PRURITUS (itchy to the touch in the shot area) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:None.  Previously administered products included for Product used for unknown indication: Flu vaccine (2 weeks ago). Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 04-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Dec-2022, the patient experienced VACCINATION SITE ERYTHEMA (red in the shot area), VACCINATION SITE INFLAMMATION (inflamed/It had spread a little bit, like five inches across and five inches down the injection site), VACCINATION SITE PAIN (sore/it hurts to the touch in the shot area) and VACCINATION SITE PRURITUS (itchy to the touch in the shot area). At the time of the report, VACCINATION SITE ERYTHEMA (red in the shot area), VACCINATION SITE INFLAMMATION (inflamed/It had spread a little bit, like five inches across and five inches down the injection site), VACCINATION SITE PAIN (sore/it hurts to the touch in the shot area) and VACCINATION SITE PRURITUS (itchy to the touch in the shot area) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received Moderna dose 1 and dose 2 (unknown lot numbers and administration dates). It had spread a little bit, like five inches across and five inches down the injection site. Now it seems to be stable but did not be 100 percent sure, patient was not sure if it was recovering or not. Treatment medications were not reported.
I woke up with racing heart (over 120 bpm). Had not subsided several hours later. Went to Urgent Care. Received bag of fluids. Heart rate returned to normal. After 3 or 4 days I lost sense of taste for a month after. Sense of taste has returned. I received a COVID antibody test. I tested 2416.
Patient called into PCP office reporting red rash surrounding her mouth, extending to her chin and down her neck. Patient also described throat as "scratchy".
Chills, fever, general malaise, headache, fatigue, ?electric-like? shots all over head
curious side effects; This spontaneous case was reported by a consumer and describes the occurrence of vaccination complication in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (curious side effects). At the time of the report, VACCINATION COMPLICATION (curious side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Pt received yellow fever 8-16-11. She called in 8-17-11 to report the evening of 8-16-11 she became tired, then dizzy, ended up unconscious and started seizing. She was taken by ambulance to hospital for further work-up, and has recovered since.
COVID vaccine breakthrough case. Moderna 2/19/21 023M20A, 3/19/21 002B21A and boosted 11/23/21 067F21A
Pt devel facial erythema approx 48 hrs p/recvd flu vax; this adverse event has previously been reported to the USP;
Tingling & itching sensation to rt facial about 10-11 hrs after flu vaccine. The next morning, pt noted swelling & itching to whole face, arms & legs with body aches, more swelling noted to Rt facial. Pt was given 12 days prednisone taper.
headache; Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine.; could be sinuses; Dizziness; Sweating; lymph nodes swollen; she tends to get hot flashes, she is currently going through menopause; This is a spontaneous report from a contactable consumer, the patient. A 48 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EL3248 ), intramuscular in the left arm on 15Jan2021 at 06:34 as a single dose, for COVID-19 immunization. The vaccination was administered at a Hospital Facility.  Patient contact her doctor who told her, she absolutely needed the COVID-19 vaccine. Medical history included ovarian cancer 2014 (stage 3B and 3C), lymphoedema 2015, (lymphedema after aggressive chemo/ told she would always have lymphedema), and menopause from an unknown date and ongoing (tends to get hot flashes). There were no concomitant medications. On 15Jan2021 (around noon), the patient experienced Lymph nodes swollen/her lymph nodes in her throat were swelling up, dizziness, and  sweating. Patient explains she tends to get hot flashes, she is currently going through menopause. However, she ran to the store and she was really sweating heavily and felt dizziness and  just ended up going home. She felt it was better to be at home if she was having a reaction.  By Saturday, 16Jan2021, she woke up and felt fine. The swelling of her lymph nodes in her throat went away. The dizziness and sweating went away. On 19Jan2021 (Tuesday Evening)  the patient experienced Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine. Also states it could be sinuses. She didn't know if this could be related to the COVID-19 vaccine and a reaction to it or her sinuses.  On Jan2021 patient experienced Hot flashes.  No other vaccines were given within 4 weeks.  The clinical outcome of Dizziness, Sweating was recovered on 16Jan2021, the outcome of Headache/migraine was not recovered, and the outcome of  lymph nodes swollen, hot flashes and sinuses were unknown.
a patient was administered with an expired dose of daptacel, no AE; Initial information received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 months old male patient (also reported as 18 months) who was vaccinated with a 0.5 mL dose of expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], (fourth dose in series, lot C5366AA, expiry date: 07-Feb-2020) via intramuscular route in the thigh on 11-Feb-2020, for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Information has been received from a registered nurse concerning a 68 year old patient who on 17-FEB-2011 was vaccinated with a dose of VARIVAX (Merck) (lot number 666854/0163Z) instead of ZOSTAVAX (Merck) due to a human error. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
pt recv vax 4OCT96 & 15min p/vax pt devel paleness & diaphoresis;pt also devel an inc BP;vital signs remained stable;pt had no resp sx, rash, or diff breathing;pt was placed in trendelenburg & vital signs were monitored every 15min;
Patient received vaccine and had an allergic reaction 5 minutes post administration.  Itching, redness and hives and was given Benadryl 50 mg.  Vital signs stable.
Swollen lymph node above left collar bone, fatigue, headaches, nausea.
Patient tested positive for covid at urgent care then presented to ED on 9/29/21 with fatigue, chills, and cough. Patient is fully vaccinated. Patient was properly treated for covid and was discharged on 10/9/21.
Pt had seizure after administration of vaccine. Hands were twitching per mom. Pt felt dizzy. Pt is alert and oriented X3. VS WNL.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 3/26/21 and 4/23/21. Brought to ED 3/15/22 by EMS after being found to be unresponsive at home. EMS noted to be in VFib arrest placed on Lucas device. Shocked x5, amiodarone bolus of 300 mg followed by 150 mg, magnesium 2 gram, epi x4 given in field and intubated. Converted from VFib to PEA and finally NSR in ED. EKG shows LBBB, cath. lab activated, no HX of CAD. Cath lab showed clean coronaries. Admitted to ICU for STEMI, acute respiratory failure 2/2 cardiac arrest. Initial Covid test 3/15/22 neg. In ED, Labs shows K 2.8, Mg 4.1 after 2 gr infusion, ALk phos 154, AST 542, ALT 469, troponin 0.253, lac acid 7.2, ABG pH 7.21, PCo2 47,Po2 212 on the vent.  UA clear, CXR shows airspace opacities throughout upper lobes and increased interstitial markings bilateral consistent with pulmonary edema vs multifocal pneumonia. Repeat Covid test 3/18/22 positive. Steroids changed from hydrocortisone to solumedrol. Course c/b cardiogenic shock and heart failure. Head CT 3/27/22 global encephalopathy noted, suspected anoxic injury. Palliative care and hospice care followed. Expired on 03/31/2022. Treated with doxycycline and Zosyn.
39 days after the 2nd Pfizer shot I had numbness in my left calf and foot.  One weak after that I lost most feeling in my legs ( I can move both but cannot walk unassisted with them not giving out.  Went to the ER and had an MRI which said minor L3 L4 narrowing  but no herniated disc.
Joint aches  Dry mouth  Soar throat  Bump under armpits (right side) Back pain  Shivering  Tiredness  Hedache
FLUBLOK was administered to 14 years old patient with no adverse event; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case from  other health professional.  This case is linked to case 2021SA002575 (Same reporter).  This case involves a 14 year old male patient who was administered with a 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot number: UJ509AA, expiry date:10-May-2021) via intramuscular route at the right deltoid for prophylactic vaccination on 30-Dec-2020 (Product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration (latency-same day).   Reporter stated that FLUBLOK had been administered to 11 pediatric patients and would like to know if patients were covered for influenza vaccination for the season.  At the time of reporting, no adverse event reported (reported as none).  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
pt felt feverish;also devel h/a & a cough w/some chest congestion;19APR98 still feverish, h/a, chest congestion worsened;20APR98 T102 to ER;pt adm to hosp 21APR98 w/dehydration;dx bronchitis w/directives to r/o pneumonia, PCP, TB
a slight headache; fever; slight nausea; felt like COVID; irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a slight headache), PYREXIA (fever), NAUSEA (slight nausea), SUSPECTED COVID-19 (felt like COVID) and HEART RATE IRREGULAR (irregular heartbeat) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concomitant products included PRAVASTATIN for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (a slight headache), PYREXIA (fever), NAUSEA (slight nausea), SUSPECTED COVID-19 (felt like Covid) and HEART RATE IRREGULAR (irregular heartbeat). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of UNK dosage form. On 30-Mar-2021, HEADACHE (a slight headache), PYREXIA (fever), NAUSEA (slight nausea), SUSPECTED COVID-19 (felt like Covid) and HEART RATE IRREGULAR (irregular heartbeat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Experienced an episode of Bell's Palsy / facial and eye droop / Initially thought she was having a stroke; Had hearing loss; Eye droop on her lower eye lid; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), hearing loss (serious criteria GSK medically significant) and ptosis. On an unknown date, the outcome of the bell's palsy and hearing loss were not recovered/not resolved and the outcome of the ptosis was unknown.   It was unknown if the reporter considered the bell's palsy, hearing loss and ptosis to be related to Shingrix.  Additional information was received as follows: This case was reported from the daughter of the patient. The patient received the first dose of Shingrix and within a week or a week and a half she experienced an episode of Bell's Palsy.  She had hearing loss which was worse with facial and eye droop on her lower eye lid.  Her physician did an eye lift.  The lower eye lid occurred slowly and they initially thought she was having a stroke. The reporter consented to follow up.
I had a sore throat, fatigue, no appetite ,and fogging. I tested positive for COVID-19 at home. I called my doctor and she prescribed me Paxlovid. I felt like I got more sick taking the medication. I very nauseous, it made everything taste really bad ,and a horrible taste in my mouth.
COVID 19 Treatment; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer" (unspecified if ongoing); "asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 29Aug2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Aug2022) Negative, notes: Covid positive after testing negative; (29Aug2022) Positive, notes: Covid positive after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: The patient had taken paxlovid treatment from 19Aug2022 to 24Aug2022 for the treatment of covid-19. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left deltoid swelling, bruising, warm at site, rash over all of body. Small bumps began day after Td given 5/21/07. Patient seen by Dr, PMD seen 5/22/07. Given antibiotics requested Td due to cut to right lower leg.
Patient received dose 1 of the Pfizer COVID vaccine (lot EW0150, exp 7/2021) at 11:30am. Patient reported feeling dizzy to EMT at 11:40am. EMT notified PHN. Vital signs at 1140: blood pressure 110/70, pulse 92, O2 97%, respirations 18. No medical conditions. Allergies to penicillin and codeine. Medication includes diet pill called Accion, given by doctor. Patient reports she had a diet shake for breakfast. PHN offered patient Benadryl, patient declined. At 1150, patient reported feeling better. PHN advised patient to contact provider and when to call 911. Vital signs at 1153: blood pressure 116/80, O2 95%, pulse 98, respirations 16. Vital signs at 1208: blood pressure 112/72, O2 95%, pulse 87, respirations 18. Patient reported feeling better, only dizzy when looking down. PHN asked patient to try standing. Patient attempted but felt increasingly dizzy, asked to sit back down by PHN. PHN called 911 at 1209. At 1215 EMS assumed care, patient left at 1225 by ambulance to hospital.
Fever, fatigue, no appetite, chills, on 5/5/21 and 5/6/21.  Rash developed under left armpit same arm as injection site 5/7 to 5/10.  Right calf started to hurt on 5/12 and was diagnosed with a blood clot in right calf on 5/14.  Chest felt heavy hard to breathe on 5/15 and went to ER.  Bloodwork and EKG came back fine.
Whelps & measle-like rash over most of body (legs, chest, arms, hips) with itching started 11-18-11, has cleared some since, may go to the dr in the morning.
Patient received high-dose flu shot on 8/10/18. Experienced pain in shoulder since shot was given. Patient feels shot was given too high in shoulder due to the presence of a tattoo on the right arm where shot was given. Sought medical treatment from MD, MD diagnosed patient with Bursitis. Patient had to receive steroid shot in shoulder due to this.
This spontaneous report was received from a physician via field representative refers to a 66 year old male patient. The medical history of the patient was unknown. On an unknown date in October-2012, (reported as in beginning of October-2012 on an unspecified date), the patient was vaccinated with ZOSTAVAX vial, subcutaneously for shingles preventions (lot number, expiry date, dose and route unspecified). The concomitant medications were not reported. On 18-OCT-2012, the patient experienced shingles. The outcome and causality was not provided. The physician stated that patient as on 12-NOV-2013, had shingles again. The outcome of shingles as of 12-NOV-2013 was not recovered. The causality was not provided. No product quality complain was involved. Additional information has been requested.
Pt reported dizziness/vertigo beginning one hour post her vaccine and it is progressively getting worse over the past 13 days.  Her pcp prescribed a scopolamine patch which is making the symptoms more bearable.
24 hrs post vax pt had severe swelling on forearm (erythema, rash from elbow to wrist-not raised); myalgias & arthralgias; mild flareup of asthma; seen in ER 16SEP93; seen by MD 22SEP; pt still had 4x4 cm erythema @ site, but no swelling;
Tinnitus bilateral began within 25 minutes of administration and has been ongoing since the time of administration. Peripheral neuropathy worsened within one hour of administration and has not resolved or subsided since administration.