chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Could hardly move it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MOBILITY DECREASED (Could hardly move it) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and MOBILITY DECREASED (Could hardly move it). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MOBILITY DECREASED (Could hardly move it) outcome was unknown. Not Provided          The concomitant medications were not provided.  The treatment information was not provided.   The patient reported that her Chronic obstructive pulmonary disease got better after two shots of vaccine.She said she used nebulizer four times a day and that has went down to three times a day.  Oxygen level is up from 95 to 97. She said coughing got less, mucus not as bad, and has more energy.She said she had two COVID tests done on 6Feb, and 27Feb because she was getting cataract surgery on 10Feb and 3Mar. She said the benefits of the second shot have lessened a bit but not much. Breathing is easier and sleeping got better.   This case was linked to MOD21-066512 (E2B Linked Report).
PFIZER COVID #3 VACCINE GIVEN 8/23/21, LOT # FC3184; pt admitted to hospital on 2/7/22 and dx with AHRF secondary to multilobe pneumonia from COVID virus, bacterial infection, PE; Airvos at 90% support; ABX, remdesivir, steroids, heparin drip, Vitamins C, D and zince; multiorgan failure; suffered cardiopulmonary arrest with ACLS protocol followed; passed away in the hospital
Was exposed to a positive COVID person. On 4/4 PT reported to the emergency department with cough, sore throat, fatigue, sinus congestion. Tested positive for COVID on 4/4. Chest x-ray done, diagnosed with pneumonia on oral azithromycin.  On 4/7 PT returned to the Emergency department via ambulance - she was hypoxic, weaker and more short of breath - O2 sats in the 70s. Received blood on 4/5 as well as monoclonal antibodies.  Troponin elevated at 0.409, EKG showed inverted T-waves.. Patient transfered to Hospital.
Information has been received from a consumer, a mother, concerning her 10 month old son who on 10-APR-2007 (at 2 months) was vaccinated with a first dose of Hib conj vaccine (OMPC) (lot#656136/0077U). There was no concomitant medication. The mother reported that her son had several health issues since receiving the Hib conj vaccine (OMPC). On 10-APR-2007 he developed swelling, fever of 103, rash and behavioral issues (crying, irritability, eating things). The baby received a second and third dose of Hib conj vaccine (OMPC) on 01-JUN-2007 (Lot# 654679/1126F) and 27-AUG-2007, (Lot# 654678/1125F) respectively. The mother reported that her son had a blood tests done (no results). At the time of the report he was no recovered. Additional information has been requested. 02/18/09 This is in follow-up to report(s) previously submitted on 2/18/2008. Information has been received from a mother concerning her 10 month old son, and follow up information has been received from a registered nurse concerning the male patient who on 10-APR-2007 (at 2 months) was vaccinated in the left leg with a first dose of Hib conj vaccine (OMPC) (Lot# 654678/1125F) and in the right leg with a first dose of PREVENAR (Lot# B47742B). The mother reported that her son had several health issues since receiving the Hib conj vaccine (OMPC). On 10-APR-2007 he developed swelling, fever of 103, rash and behavorial issues (crying, irritability, eating things). The baby was vaccinated in the left leg with a second dose and third dose of Hib conj vaccine (OMPC) on 01-JUN-2007 (Lot# 654679/1126F) and 27-AUG-2007, (Lot#656136/0077U) respectively. The mother reported that her son had blood tests done (no results). At the time of the report he was not recovered. Follow up information from a registered nurse indicated that on 24-APR-2007, the patient developed a lump on his right leg where PREVENAR was administered. On an unspecified date, the patient recovered from lump on right leg. Additional information is not expected.
Flu like symptoms: aches, nausea, fever, chills, fatigue .  Lasted about 24 hours.
Had covid booster and flu shot at work and 4 hours later began to have progressive fatigue, chills, confusion, dysarthria, echolalia, dyskinesia, emesis and was taken to the ER. In the ER she was found to be hypotensive and febrile to 39.2 with tachycardia. Her psychiatric symptoms resolved with lorazepam, toradol and acetaminophen. She was admitted for ongoing care as she remained hypotensive requiring norepinephrine.   With remote teratoma 2015 s/p resection and no e/o recurrence I wonder if her COVID (and/or influenza) vaccinations reactivated a senescent paraneoplastic syndrome. Her prodromal headache, fever and dysautonomia have now been complicated by two prolonged episodes of anxiety, agitation, psychosis, dyskinesias, diminished language output and echolalia which are concerning for an encephalitis like picture. Her dramatic improvement after high dose lorazepam with complete normalization of neuropsychiatric symptoms but not all autonomic symptoms is puzzling. Her symptoms are not typical for anxiety attacks. She was responsive enough during the episodes to argue strongly against generalized seizures. CT abd/pelvis did not show recurrent mass. Procalcitonin negative, arguing against systemic bacterial infection/sepsis. Her symptoms are too delayed to attribute to anaphylaxis to vaccinations.
Itchy rash; swollen and redness at the injection site; swollen and redness at the injection site; This is a spontaneous report from a non-contactable consumer (the patient). A non-pregnant 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm Left on 13Mar2021 at 10:00 AM, at the  age of 70 years, (Lot Number: EN6206) as a single dose for COVID-19 vaccination. Medical history included atrial fibrillation, high cholesterol. Prior to the vaccination, the patient was diagnosed with COVID-19 Concomitant medication taken within two weeks of vaccination included apixaban (ELIQUIS), diltiazem, atorvastatin (ATORVASTATINE). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm (Lot Number EL3246) in the left arm on 20Feb2021 at 10:15 AM as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 09:00 AM the patient experienced itchy rash, swollen and redness at the injection site. The patient had a physician office visit for events. Therapeutic measures were taken as a result of itchy rash, swollen and redness at the injection site and included Allegra 180mg and Hydrocortisone cream. The clinical outcome of the events itchy rash, swollen and redness at the injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Pins and needles feeling in hands after the second shot. It got worse and spread to all over my body by Wednesday; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 at 12:30 (at the age of 26-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE) and melatonin (MANUFACTURER UNKNOWN) and unspecified multivitamin; all for unknown indications from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 15:30 (at the age of 26-year-old), as a single dose for COVID-19 immunisation. On 19Apr2021, after the second shot, the patient experienced pins and needles feeling in hands. It got worse and spread to all over her body by wednesday and was gone by sunday. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pins and needles was resolved on an 25Apr2021, by Sunday.   No follow-up attempts are needed. No further information is expected.
None. The pfizer covid 19 was administered after the beyond use by date after being in the refrigerator for more than 10 weeks.
expired dose of Menactra was given to patient/no AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 years old female patient who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number U6219BA, dosing details 0.5 ml and dosage interval: once) route and site of administration not reported on 14-Jul-2020 for prophylactic vaccination which was already expired on 16-Jun-2020 (Expired product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.    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.
I woke up in the middle night with chills and I was unable to breathe. I was taken to a clinic. I was diagnosed with pneumonia on the middle lobe of the right side of my lung. I was given  Azithromycin. I was transferred to a hospital and I was hospitalized for 2 days.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 12-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient is a 75-year-old female with past medical history significant for hypertension and CHF who is presenting today for evaluation for cough and shortness of breath.  Patient was tested positive for COVID 19 2 days before presentation.  Patient came into the emergency department for further evaluation based on direction by her PCP.  Patient says that she has a nonproductive cough, occasional shortness of breath.  No significant medical history.  Patient denies any fevers, chills, nausea, vomiting, diarrhea.
On 04/21 left knee pain, outside/back of knee 04/23 - left side tingling , went to urgent care and then referred to ED due to concern about stroke. Sent home after leg scan - was told it was normal and referred to neurologist 04/29 - back to ED, admitted overnight, scan from 04/23 showed blood clot behind the knee. Also diagnosed by neuro with TIA  Also stated she had swelling, redness, and headaches for 4-5 days after vaccine
Left brachial plexus neuropathy (mostly sensory) with pain and numbness starting 2 days, post vax; weakness secondary to pain. Symptoms from left trapezius muscle to fingers. Improving. Referred to a neurologist who started Neurontin.
Mucosal cyst-inner lip; This spontaneous case was reported by a pharmacist and describes the occurrence of SALIVARY GLAND MUCOCOELE (Mucosal cyst-inner lip) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unk and 01Sm20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 18-Feb-2021, the patient experienced SALIVARY GLAND MUCOCOELE (Mucosal cyst-inner lip). At the time of the report, SALIVARY GLAND MUCOCOELE (Mucosal cyst-inner lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No lab data was provided. Treatment information was reported as the patient consulted HCP consulted via telemedicine and doctor prescribed Rx Keflex antibiotics.
Approximately 10 minutes after vaccination during post vaccination observation in lobby, patient's mother called for help and stated, "I think he's having a seizure." Patient appeared alert and oriented, seizure not observed by medical staff. Per mother, patient had a seizure at 4 months old where "he started shaking and went limp, and that's what happened today." Pt diaphoretic but otherwise well-appearing. Alert and oriented X3. Pt provided with juice and crackers; states he did not eat or drink very much on the day of vaccination. VS at 1451: O2 97%; HR 57bpm; RR 16; BP 127/83. VS at 1455: O2 95%; HR 68bpm; RR 18; BP 120/88. VS at 1500: O2 95%; HR 66bpm; RR 16; BP 110/77. After eating and drinking, pt reported feeling better. Patient offered option for EMS to be called; declined EMS. Advised to follow-up with primary care provider; verbalized understanding. Patient remained in observation for about 20 more minutes and left with parents.
Pain and redness at injection site. Prolonged redness lasting 12+ days. Area of 7 cm in diameter. Had primary care doctor examine. Recommended use of Aleve and ice for 2nd dose as well as injection in other arm.
given Flublok Quadrivalent in error with no adverse event; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist at call center (reference number: US-SANOFI-00334383).  This case involved a 14-year-old female patient who was given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] in error with no adverse event (Wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 27-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: UJ445AA, expiry date: 17-Mar-2021) in error with no adverse event (Wrong product administered) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered(latency same day).  At the time of reporting, the patient had no 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 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.
Leukocytoclastic Vasculitis Flare ups lasted 1 week. Prednisone 20 MG for 4 weeks
10 days p/vax started having joint pain, aches & pain lasted 3-4mo p/pain dissipated has devel superficial veins (blue)-concentrated on legs & arms;
The syringe or the plunger broke mid-dose. At least 2 large drops ran down my arm while the needle was still in my arm. It was reported that more than half the dose went in. However, I'm not a small person and wondered if it'd be better to "slightly overdose" me than "slightly underdose" me? Or if/when boosters are needed, should I get one sooner?
PERIPHERAL NEUROPATHY ACUTE RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE 2/16/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for two patients. This is 2nd of two reports. An elderly patient of an unspecified gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for pneumonia. The patient medical history and concomitant medications were not reported. The patient had the pneumonia shots and 5 months later the patient died from pneumonia. Before got the shot the patient was as healthy as could be. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018378783 different patient, same product/event; Reported Cause(s) of Death: 5 months later they both died from pneumonia; 5 months later they both died from pneumonia.
Initial unsolicited report received from a consumer (patient's husband) on 03 Nov 2016. This case involves a 70-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series, were not reported) intramuscularly in left deltoid on 01 Nov 2016. Reporter denied illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as brain aneurysm 1988 and 2003. Concomitant medications were not reported. On 01 Nov 2016, same day following the vaccination, the patient had developed headache, weakness, difficulty walking (felt "totally week" and could "hardly walk") and blotchy appearance to skin. On an unknown date, the patient went to hospital for evaluation. Patient required emergency room or doctor visit. It was reported that ED physician could not determine cause of symptoms and patient was discharged to home. The patient previously vaccinated with FLUZONE HD in 2015. The patient's laboratory data included Blood work, urinalysis and CT scan of head, results were normal. The patient's corrective treatment was not reported. On 01 Nov 2016, the patient recovered from blotchy appearance (duration 6-8 hours). On 03 Nov 2016, the patient recovering from other events (outcome was also reported as unknown). List of documents held by sender: none.
Information has been received from a nurse referring to a 83 year old female patient with allergies to codeine, DEMEROL and LORTAB. There was no pertinent medical history. On 21-MAY-2015 the patient was vaccinated with PNEUMOVAX23, (dose and strength were not reported) (Lot number K023328, expire date 23-JUN-2016), intramuscularly in the upper left deltoid. There was no concomitant medication. After being administered the PNEUMOVAX23, the patient experienced severe stomach pain that radiated to her lower lumbar region upon standing and leaving the examining room. The patient was assisted back to the examining room and provided an ice pack for her back pain. Also, she was given two TYLENOL tablets (dose was unspecified). The patient was observed for 10 minutes and was able to get up without any further pain or discomfort and leave the physician's office. On 21-MAY-2015, the outcome of stomach pain and lower lumbar region pain was reported as recovered. The patient sought medical attention. At the time of reporting, the causality was not reported. Additional information has been requested.
Shoulder pain after influenza vaccination provided at my employer. Initially very painful and limited ROM. This lasted at least a couple impacting my ability to work and exercise. Pain and limited ROM lasted for about 9 months.
10 x 7 cm swelling, redness, tender to touch.  Warm to touch, limping.  Effusion left knee present no limitation of movement of joint.
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Information about pertinent medical history, concomitant medication and concurrent condition was not provided. On 24-FEB-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot# M041686, expiration date: 20-MAY-2018, dose and route unknown) for prophylaxis. The doses of vaccine were improperly stored at the temperature above 46 Fahrenheit (F) and below 77 F for 45 minutes. Data logger was involved. No previous temperature excursion was involved. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
After the initial 3 days of post injection recovery, started feeling that my lung capacity was sub-normal when walking. Stated running a low grade fever. ON about Feb 24, symptoms included chills, fever reaching 101.  Ran several tests at the clinic, and finally got admitted in hospital for more tests on March 04, released on March 05
Information has been received from a physician concerning a 4 yr old male who was vaccinated at approx 12 months of age with a dose of varicella virus vaccine live. At four years of age the child developed a case of chickenpox. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Spoke to Staff on 8/8 to discuss error. Per Staff member, the child and mother arrived to her work station and she struck up a conversation with the parent. Staff member stated she remembered thinking the child was tall for his age when she confirmed name and birthdate. Staff member stated all the vaccines were labeled appropriately and in their appropriate basket. She administered the vaccine and when she was filling out the vaccine card, that is when she realized she made the administration error. She stated she remembered grabbing a vaccine from the basket and going through the notions of administering the vaccine but it did not fully process that she gave the wrong dose until afterwards. She stated as soon as she realized what she did, she got up and notified the site lead. She notified another clinician and they pulled the parent into a private room and informed her of the mistake. Staff member stated the parent was understanding and appreciative. I let Staff member know of the process on the back end- We contacted parent after error via phone and will follow up for five days.
This spontaneous report as received from a pharmacist refers to a 58 year old female patient with phenol allergy. In approximately September 2005 ("8 years ago") the patient was vaccinated with PNEUMOVAX23, 23 injection, (lot #, expiration date, dose, route unspecified). In approximately September 2005 ("8 years ago") the patient has an allergic reaction, but not anaphylaxis, after received a dose of PNEUMOVAX23. The reporter thought it was due to the phenol in the vaccine. The event outcome was reported as recovered on an unknown date. Additional information has been requested.