chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tightness under left arm running through his chest and throat; Anxiety; Patient was prescribed Zoloft, Duloxetine and Celexa but could not tolerate it; felt like lymph node reacting; tightness under left arm running through his chest and throat; numbness in mouth and extremeties; numbness in extremeties; extreme brain fog; full blown panic attack; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (tightness under left arm running through his chest and throat), PANIC ATTACK (full blown panic attack), FEELING ABNORMAL (extreme brain fog), HYPOAESTHESIA ORAL (numbness in mouth and extremeties) and HYPOAESTHESIA (numbness in extremeties) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, LORAZEPAM for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PANIC ATTACK (full blown panic attack), FEELING ABNORMAL (extreme brain fog), HYPOAESTHESIA ORAL (numbness in mouth and extremeties) and HYPOAESTHESIA (numbness in extremeties). On an unknown date, the patient experienced THROAT TIGHTNESS (tightness under left arm running through his chest and throat), CHEST DISCOMFORT (tightness under left arm running through his chest and throat), DRUG INTOLERANCE (Patient was prescribed Zoloft, Duloxetine and Celexa but could not tolerate it), ANXIETY (Anxiety) and LYMPHADENOPATHY (felt like lymph node reacting). The patient was treated with SERTRALINE HYDROCHLORIDE (ZOLOFT) at an unspecified dose and frequency; DULOXETINE at an unspecified dose and frequency and CELECOXIB (CELEXA [CELECOXIB]) at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (tightness under left arm running through his chest and throat), PANIC ATTACK (full blown panic attack), FEELING ABNORMAL (extreme brain fog), HYPOAESTHESIA ORAL (numbness in mouth and extremeties), HYPOAESTHESIA (numbness in extremeties), CHEST DISCOMFORT (tightness under left arm running through his chest and throat), DRUG INTOLERANCE (Patient was prescribed Zoloft, Duloxetine and Celexa but could not tolerate it), ANXIETY (Anxiety) and LYMPHADENOPATHY (felt like lymph node reacting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-234546 (Patient Link).
Reports that within 30 min of injection, she became "pale, sweaty and felt goofy - not right." This lasted 5 hours. Also reports that her arm felt "pinched at the top, not allowing her to move it" this lasted 1 hours - no residual symptoms remain at this time.
I broke out in hives a couple of hours after my vaccine. It covered my arms, legs, feet, hands, and shoulder blade.
Approximately 1-5 seconds after receiving the immunization, the patient rested her forehead down and proceeded to lose consciousness. The patient slid from the chair and knocked her head on the floor. Our facility's protocol was initiated and 911 called. Since the patient was underage authorities spoke with her father/guardian who waved and ambulance/fire being dispatched.  Patient was given water and remained seated with reporter and father for ~30 minutes. Father then took the patient home after waving any other services being called with the understanding he needed to take her to the emergency department if her condition worsened or any vomiting/headache occurs.
Patient came in to get a flu vaccine and was accidently given a Moderna booster vaccine. Patient had previously received the Pfizer primary series and booster vaccine.
Pt cross vaccinated. First dose was Moderna , second dose Pfizer.  Syringe of Moderna set next to injecting RN who accidentally grabbed the wrong syringe.
Rash and itchiness in the back; Rash and itchiness in the back; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8729) via an unspecified route of administration, administered in left arm on 12Apr2021 at 09:15 (at the age of 29-year-old) as dose 1, single for covid-19 immunization. No medical history reported. Patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. On 13Apr2021 at 12:00 the patient experienced rash and itchiness in the back. The case was reported as non-serious. The patient was treated with Benadryl for the events. Outcome of the events were not resolved.  Follow-up attempts completed. No further information expected.
Swelling & redness over right arm on 4/21/04 (DTaP & MMR seen- 4/22/04 Cellulitis, Local reaction given on 4/21/04 #2) Prescription Keflex 250 mg three times daily for 1 day Motrin 1 tsp three times daily for 3 days.
This spontaneous report as received from a healthcare worker refers to a 77 year old male patient. No information regarding the patient's medical history or concurrent conditions was provided. On 04-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (strength reported as 19400 plaque-forming units (PFU), lot# reported as J008023, expiry date February 2016; dose and route of administration were not reported). There were no concomitant therapies reported. On 13-JUL-2015, the patient experienced shingles. The patient sought medical attention (office visit on an unspecified date). The reporter stated that the patient's physician requested a lot check to see if there were any problems with the ZOSTAVAX the patient received. There was no product quality complaint (PQC) involved. The outcome of the event was reported as not recovered. The relatedness between ZOSTAVAX and the event was not provided. Lot# J008023 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
normally she exercises but she don't have the energies; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (normally she exercises but she don't have the energies) and FATIGUE (extreme fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (normally she exercises but she don't have the energies) and FATIGUE (extreme fatigue). At the time of the report, ASTHENIA (normally she exercises but she don't have the energies) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Patient was not under any medication.   Since the shot patient had extreme fatigue. The patient was spending most of the day resting, had to force herself to do what she needs to do, since she works from home, she was super super fatigue, really bad. Her body felt like really heavy like a toner weight. The patient was making sure to drink more water, normally she exercises but she did not have the energies.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient experienced syncopal episode soon after vaccine administered. Patient was helped to the ground. Patient did not experience any loss of consciousness, or seizure, or confusion. Patient does not have history of recent trauma, or seizure history, or diabetes, or CAD, or cerebrovascular accident, or GI bleeding, or infection. No report or observation of wheezing, or trouble breathing, or swelling/hives of face or lips or mouth, or increased sweating. Patient fully recovered.
Patient had vaccine around 6:45 pm on 2/16/2010. Woke up 17th morning with tenderness at site of vaccine. There was no swelling or redness but it felt warm and hard to area.
This is a spontaneous report from a contactable Nurse received via a sales representative. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA, at 0.5 ml, single and the first dose of MENVEO, at 1DF single, both intramuscular on the same unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced fever, nausea, vomiting and dizziness all on an unspecified date (same date of vaccination) with outcome of recovered. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
14MAR97 rt deltoid inj site painful & red & pt c/o pain rt suprascapular region;site indurated size quarter;site probably infected;recv ATB, ice compress;
Diarrhea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant product use was reported.  The patient reported that following after receiving their Moderna Covid-19 vaccine, the patient experienced diarrhea and headache.  No treatment information was provided.
CHILLS; LINGERING HEADACHE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and lingering headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and lingering headache was not reported. This report was non-serious.
On an unspecified date, the pt received her 1st dose of Lymerix. Subsequently, she reported arthralgias. As of 4/9/01, the outcome of the adverse event is unknown. Additional information has been requested.
- Nauseous -sat by garage door to get air.- Patient claims,  "she always gets nauseous and its not related to the vaccine" Patient stated she has severe ptsd and anxiety. BP 176/98; HR 91; RR 18; 02sat 98%-   second time BP190/99 and HR 90??..nausea improved but BP Elevated?.increased anxiety.  patient declined ems
This spontaneous report was received from a pharmacist regarding to an elderly male patient. The patient's concurrent conditions, historical conditions, past drugs and concomitant drugs were unknown. On an unknown date in 2018 (reported as within the past few months) the patient was vaccinated with PNEUMOVAX 23 injection (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date in 2018 the patient experienced an infection at the injection site (injection site infection) which the reporter was learned weeks later and reported on reporting day (07-DEC-2018). The patient sought medical attention (contacted pharmacist). The patient was fine then. The outcome of injection site infection was reported as recovered. The causality of event was not reported. This is one of the two reports received from the same reporter.
Pt received 1st dose COVID vaccine on 2/24/21. When she returned for 2nd dose on 3/17/21, reported that she had "fatigue for 3 days afterward, but also worked long hours those 3 days". Reported "swollen glands in throat and neck" on the 3rd day "that lasted about 8 hours". Reported "she could breathe fine through nose" and denied any other difficulties breathing. Stated her grandson "said she didn't sound right when she was sleeping" but pt denied any difficulty breathing or sleeping. Denied any rash, itching, or other s/s allergic ran/anaphylaxis. Did not seek medical care.
Left arm got swollen; Left arm got red; General fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm got swollen), VACCINATION SITE ERYTHEMA (Left arm got red) and FATIGUE (General fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Left arm got red) and FATIGUE (General fatigue). On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Left arm got swollen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (Left arm got swollen), VACCINATION SITE ERYTHEMA (Left arm got red) and FATIGUE (General fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication provided was Dietary Supplements.
Sore left arm near vaccination site, beginning 12/4/09 around 7:00 AM.  Fatigue.  Noticed redness and warmth on left arm near injection site on 12/5/09 around 8:00 AM.  Redness and warmth is still present 6 hours later while I am reporting this.  Fatigue persists.
Had throat swelling 4 wks earlier with MMR vaccine. Did not attribute but now with MMR #2 vaccine developing hives. Was still taking ZYRTEC daily after last episode so Rxn is much less dramatic than before. (Arms only).
cardiomyopathy; This is a literature report.  A 22-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: CARDIOMYOPATHY (medically significant) with onset 2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Brain natriuretic peptide: 2,187; Catheterisation cardiac: no significant CAD; PCWP 13; PAP 42/19 (28 mmHg); mild pHTN; Echocardiogram: LVEF 15%; moderately reduced RV function;, notes: LV, RV, and left atrial dilatation; elevated LVEDP; LVEF 3033%., notes: Repeat TTE in 1 month:; Magnetic resonance imaging heart: moderate to severely dilated LV; no LGA; Red blood cell sedimentation rate: 10; Troponin: < 0.03. Therapeutic measures were taken as a result of cardiomyopathy.; Sender's Comments: The causal association between the event Cardiomyopathy and the suspect drug BNT162b2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recv vax & immed devel a 4cm x 4cm area of erythema 1/4 cm high @ the inj site; tx w/DPH & cold packs
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 62 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated at a clinic for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Pt recv vax on 8/3/98;on 8/9/98 pt exp vax site pain x 2 wk;pain in right shoulder&hips;diff sleeping;stiff joints;muscle pain   dx=tendonitis,bursitis;tx=rest,physical therapy,Naprosyn, Dexamethasone,Prednisone,Darvocet cont....
pt recv vax 5JAN96 & 12JAN96, chicken pox lesions began to appear;the pox are widespread but relatively few;some of the pox have crusted over but the pt cont to get new ones 6wk pos vax;
Joint pain, chest pain started when I woke up this morning.  Slight pain/twinges in my chest, left side at my heart.  No shortness of breath yet, so waiting to see if it subsides or continues to get worse.  The pain is getting more severe now and more frequent.  No arm pain or numbness yet.  I called pharmacist and advised if I experience those or it gets worse to go seek medical care.
Lymphadenopathy - left supraclavicular. Painful, onset approx 36 hours post vaccine. Arm soreness almost completely resolved at this time
Onset of painful lump (L) side of neck 1 day after vaccine. No injury or other lumps determined to be enlarged lymph node which resolved w/out onset of any other sx.
Patient called on 10-11-11 1:16pm c/o wheezing, coughing, SOB post Flu injection - advised to call 911 or ER.
Dizziness started about 30 minutes after receiving the vaccination. It does come and go.
I feel sick; Left arm injections site hurts a lot; Fever of 100.4F; headache; chills; A spontaneous report was received from a health care professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events of headache, chills, fever of 100.4 degrees fahrenheit, left arm injection site hurts a lot, and I feel sick.  The patient's medical history, as provided by the reporter, included COVID. No concomitant medications were reported.  On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22 Dec 2020, soon after vaccine administration, the patient experienced the events headache, chills, fever of 100.4 degrees fahrenheit, left arm injection site pain, and felt sick. Treatment for the events included, paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, headache, chills, fever of 100.4 degrees fahrenheit, left arm injection site hurts a lot and I feel sick were considered not resolved.  The reporter assessed events, headache, chills, fever of 100.4 degrees fahrenheit, left arm injection site hurts a lot and I feel sick as related to the study drug.; Reporter's Comments: This case concerns a female patient with a medical history of COVID-19 who received their first of two planned doses of mRNA-1273 (Lot 011J20A), and who experienced the listed events of Injection site pain, Pyrexia, Headache, and Chills, and the unlisted event of Malaise.  The events were considered possibly related to the vaccine due to the temporal relationship and the known safety profile.
This case was reported by a healthcare professional and described the occurrence of not responded to therapy in 14-year-old (approximately) female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On unspecified dates (many years ago in 1998) the subject received 3rd dose, 2nd and 1st dose of ENGERIX B. A recent blood test showed no immunity, the subject had not responded to therapy. No additional information was provided.
persistent shrill crying for over 1 hr w/some color changes to grayish, pale skin color- transient;
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4325228-00 (RA). A 25 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 24 years as dose 2, single for Covid-19 immunisation; Risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Route of Admin: Intramuscular), administration date: 01Mar2021, when the patient was 24 years old, for Covid-19 Immunization. The following information was reported: APPENDICITIS PERFORATED (prolonged hospitalization, medically significant) with onset 01Jan2022, outcome "recovering", described as "Ruptured appendix". The patient prolonged hospitalization for appendicitis perforated (start date: Jan2022). The action taken for Risankizumab was unknown. Therapeutic measures were taken as a result of appendicitis perforated. Clinical course: Patient was hospitalized for a ruptured appendix at the end of Jan2022, a week after they received COVID booster. They had to remove appendix. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of RUPTURED APPENDIX with SKYRIZI (RISANKIZUMAB) was a reasonable possibility. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.