chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  MOderna vaccine in March 2021,pt reported angioedema of lips and ears, sore throat started 24 hours later and pt still have ear, mouth, sore throat reaction." unclear if patient sought or received treatment for adverse reaction. No additional information available regarding ADR
Client reports immediately following vaccine administration that she had pain at injection site and then later in the day significant swelling and redness at injection site.  She went to the ER at local hospital and reports that the ER physician said that injection had gone in an artery and client reports she was prescribed prednisone for this.  The client had come to the Health Department the following noon to report the incident to the secretary but refused to speak to a nurse during her visit.  This writer phoned the client to discuss the adverse event which from her explaination appears to be redness and pain at the injection site.  It is explained to client that about half of people who get PPSV vaccine will have some redness and swelling at the site.  She reports that the site is better now and denies any bleeding at the site after injection or any bruising at the site (left deltoid).
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. No treatment medication were reported.  It was reported that the Patient had no adverse reaction other than a sore arm for Dose 1.   This case was linked to MOD-2022-439259, MOD-2022-439515 (Patient Link).
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30,75 hours and 59.4 for 4,5 hours) doses of ROTATEQ (orally, lot # M006111 with expiration date 18-NOV-2017 or lot # M019707 with expiration date 25-OCT-2017; dose was not reported). No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested.
A 68 year old male patient with transitional cell carcinoma of the bladder was given 3 instillations of Tice BCG (last treatment on 17MAY2004) and developed a febrile episode and a systemic reaction to TICE BCG. The patient's fever was measured at 102.5-103 degrees Fahrenheit. Tice BCG treatments were stopped and the patient treated with anti-TB drugs. Rifampin and INH.
Achy left arm, tenderness in left armpit, pins & needles feeling in left hand, discomfort extends to left chest & shoulder blade
Very sore arm; ramped up ringing in ears; increase of parathesia tingling lower legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Jan2022 03:15 (Lot number: FC3209) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "I might have rheumatoid arthritis" (unspecified if ongoing); "Lupus" (unspecified if ongoing); "lyme disease" (unspecified if ongoing); "vector bacterial infections" (unspecified if ongoing); "allergy to antibiotics" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Sick". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FC3183, Location of injection: Arm Right), administration date: 22Aug2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0198, Location of injection: Arm Right), administration date: 02Aug2021, when the patient was 64 years old, for Covid-19 Immunization, reaction(s): "Paraesthesia", "vaccination site swelling", "headaches", "feeeling dizzy", "developed neuropathy", "most alarming was swelling of supraclaivicular lymph nodes", "General unwell feeling". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Jan2022 15:45, outcome "recovering", described as "Very sore arm"; TINNITUS (non-serious) with onset 17Jan2022 15:45, outcome "recovering", described as "ramped up ringing in ears"; PARAESTHESIA (non-serious) with onset 17Jan2022 15:45, outcome "recovering", described as "increase of parathesia tingling lower legs". Therapeutic measures were not taken as a result of pain in extremity, tinnitus, paraesthesia.  No follow-up attempts are possible. No further information is expected.
I vomited within 30 minutes and then again later in the day.  I hadn't eaten breakfast, they didn't ask or mention that it was required.
Daughter woke me up at 4:45AM and said that her upper lip felt funny. In my sleep state I thought she said her lip was bloody. I told her to put some vasaline on it and go back to bed. When I went to her room at 6:45 to get her up from school, she was up and her upper lip was swollen 2-3 times its normal size. She said it was also tingling. I immediately gave her some ice to put on it and a Benadryl. I called the doctor's answering service, a nurse called me back, and then she put it through to the doctor on call. She took Benadryl throughout the day and by the evening, her upper lip was 90% better. She is claiming her lip is still a little tingly(?)today.
Lymph swelling in armpits, chest and around right arm including neck and back causing chest tightness after laying in bed all night. Took Tylenol and stayed upright and swelling and tightness went down. Occurred morning of 11/1/21.
Patient experienced vasovagal reaction and fainted at vaccination table but was caught by RN. EMS evaluated patient; patient vomited; EMS administered cold compress to back of patient's neck. EMS took vitals and monitored her for 30+ minutes and she was able to leave.  Patient said she has had this reaction before for bloodwork.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient's medical history was not reported and there were no drug reactions/allergies. However, concomitant therapies included an unspecified monthly medication for an unspecified "bone" disorder. On 29-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX with lot number M035692 and expiration date of 07-NOV-2017 (strength, dose, route of administration and anatomical location were unknown) for immunization (prophylaxis). On the same date, the patient experienced headache. Moreover, it was reported that on 30-JAN-2017, the patient experienced swelling, redness and warmth around the injection site. The patient did not seek medical attention and there were no laboratory diagnostics studies performed as well as no treatment was given for the adverse event. No product quality complaint was involved. At the time of reporting, the patient was not recovered from the events. The causality between ZOSTAVAX and the events was not provided. Additional information has been requested.
Patient experienced redness, inflammation, pain and hot to the touch at site of injection. Patient sought treatment 5 days after receiving immunization and was prescribed KEFLEX and Prednisone. Patient 1 month out is completely recovered and does not have any of the above signs of redness, inflammation, pain or warmth to the touch at site of injection.
During mass Flu Clinic for adults and children I gave "FLUARIX" to a child, meant for adults 18 years and older by mistake. No known adverse events.  Follow-up - No adverse events occurred.
I've been tired, dizzy and have had a headache since receiving the covid vaccine. I'm lethargic and have no energy. Initially upon returning home from receiving the vaccine, I felt dizzy and had chills. My face has been red and flushed on and off since the shot.  I felt fine before receiving the vaccine. I'm more than afraid to receive the second shot.
Vaginal hemorrhage 5 days after 2nd Pfizer dose on 1/16/21.  Very heavy menstruation on 1/21/21 with large clots one week prior to anticipated cycle date. Prior to event, menstrual cycle regular at 29 days and lasted 7 days from date on onset. After event, cycle shortened and then became irregular. Second menses after 2nd Pfizer began at  23 days 2/12/21, next cycle at 24 days 3/7/21 , next  34 days on 4/9/21, next to 22 days 4/30/21, next to 14 days 5/12/21.
Redness, warmth in area 5 cm diam medial upper arm, but not surrounding injection site (deltoid) coincides with arm in which PNEUMOVAX was given.
pt recv vax 14SEP95 & 2JUL97 pt devel chickenpox;pt recovered;
Swelling/itchy the next day on the right side like the "egg side" and blue black afterward. But per pt has no fever, only pain, not feel any different.
Moderna COVID-19 Vaccine EUA Itchy red rash on upper arm below injection site, appearing 7 days after injection. Now day 11, it contunes to spread.
Redness, swelling, hot to the touch. Redness extends to underside of left arm. Went to Dr. got steroids and antibiotics.
36hr of lethargy; headache; running nose; extreme weakness; muscle / joint pain and cramps; muscle / joint pain and cramps; muscle / joint pain and cramps; muscle / joint pain and cramps; lack of apatite; chills; low grade fever; loss of taste and smell; loss of taste and smell; nausea; lymphadenopathy; dry sore throat; increased heart rate; This is a spontaneous report from a contactable other hcp (patient). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via intramuscular, administered in Arm Right on 11Mar2021 10:00 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hyperlipidaemia from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing, insomnia from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, drug hypersensitivity (amoxicillin) from an unknown date and unknown if ongoing known allergy, covid-19 from an unknown date and unknown if ongoing; If covid prior vaccination: yes. Concomitant medications included trazodone taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; sitagliptin taken for an unspecified indication, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported; glipizide taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported; loratadine taken for an unspecified indication, start and stop date were not reported; fluticasone taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 22:00, the patient experienced 36hr of lethargy, headache, running nose, extreme weakness, muscle / joint pain and cramps, lack of appetite, chills, low grade fever, loss of taste and smell, nausea, lymphadenopathy, dry sore throat, increased heart rate. No treatment was taken as a result of events. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Starting 24 hours after the vaccine, I developed a low grade fever and loud, whistling tinnitus in both ears. The elevated temperature abated after 1 day, but this tinnitus is still present over a month later. It has reduced in volume by about 2/3, but it has not gone away. I have NOT had this kind of tinnitus before the vaccination. Also starting at the same time as the fever was diarrhea and fatigue. The diarrhea lasted for 2 weeks then stopped, the fatigue lasted 17 days then stopped.
This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 15-OCT-2017, the patient received vaccination with first dose of PNEUMOVAX 23, one dose for prophylaxis (route, lot # and expiry date unknown). On 15-OCT-2018, the patient was vaccinated with second dose of PNEUMOVAX 23, one dose from lot # N023651, expiry date: 20-MAY-2019. No adverse effects were reported. Product quality complaint was not involved.
Patient reports red, hot, swollen area starting the day after PNEUMOVAX 23 was administered. It grew to the size of her upper arm. No pain associated with reaction. Resolved in 4 days.
Weakness, frequent falls, Unable to ambulate independently, altered mental status, unable to transfer and participate in most ADL's
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (2-3 months old patient, gender unknown) who received only DTAP and IPV portion of PENTACEL.(Suspension for injection) without ACTHIB portion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE, PNEUMOCOCCAL VACCINE and HEPATITIS B VACCINE. On 29-Nov-2018, the patient received a single 0.5 ml dose of suspect PENTACEL lot number not reported via intramuscular route in the leg (side unknown). It was a case of actual medication error due to it did not have 0.4NaCl saline solution to reconstitute the vaccine. Patient experienced 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 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. Documents held by sender: none.
1 Hour after injections, raised, red area around injection sites. Advised to apply cool compresses, and administor 1 tsp oral Benadryl every 6 hours as needed. Followup with phone call the day after injections were given, parent stated child had raised, red areas on front and back of legs, and arms. Advised parent to take child to Emergency Room for evaluation. Parent called 2 hours after advisment to report that Benadryl was given again and that child would not need to go to Emergency Room because raised, red areas on body were decreasing.
rashes face, back, and chest.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 11Feb2021 at 12:00 PM as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 11Feb2021 at 12:00 PM the patient experienced rashes face, back, and chest. The clinical outcome of the event was unknown.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Huge lump at injection site; Lots of arm pain; Fever; Headache; Chills; Major body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE MASS (Huge lump at injection site), PAIN IN EXTREMITY (Lots of arm pain), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE MASS (Huge lump at injection site), PAIN IN EXTREMITY (Lots of arm pain), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Major body aches). At the time of the report, VACCINATION SITE MASS (Huge lump at injection site), PAIN IN EXTREMITY (Lots of arm pain), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Major body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
COVID+ one week PTA, arrived with increasing SOB, admitted for COVID pna. Fully vaccinated Aug 2021. Steroids, Vit-c, zinc, O2, anticoag, lasix, actemra. Progressed to Airvo, then Bipap, then vent support 10/6. Condition declined to renal failure. Pt made comfort care and passed away after withdrawal 10/16.
Patient describes developing large local reaction manifested by erythema and edema from the elbow to the top of the scapula within 24 hours after vaccination with anthrax #4 administered subcutaneously on 11 May 2004. No associated neurovascular compromise or other systemic symptoms. Symptoms resolved within one week with supportive care to include ice and TYLENOL. No further sequelae. Patient has subsequently tolerated 5 additional anthrax vaccines with no adverse events.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, an unspecified number of improperly stored doses of GARDASIL (lot number K010215, expiration date 5-MAY-2017, dose and route were unknown) might had administered to the patients. No adverse effects were reported. The excursion temperature was 31 F with duration of 16 hours and 30 minutes. The call was due to a date logger. There was no previous excursion. This is one of several reports from the same reporter. Additional information has been requested.
A few hours after dose 2, weakness, fatigue, arm soreness. A few hours after dose 2, chills through the night which prohibited sleep, fatigue and soreness that lasted into the afternoon, about 24 hours after does 2 was administered.
pt recv vax 31DEC96 & devel zoster 9AUG97;
Pneumonia; ended up with CDIFF; symptoms like parkinson's disease; feeling bad kinda like after a flu shot; fatigued; cold; Upper respiratory infection; flu like symptoms; She got mono due to low immune system; She was diagnosed with POTS; Now has chronic nerve damage; a really bad tremor to her hand; Can hardly walk; her health "continues to decline"; This spontaneous report has been received from a consumer referring to a great-niece of her friend of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, route of administration, lot number, and expiration date were not reported).   The reporter stated that her friend s great-niece could "hardly walk" since an unspecified date and that she had the same exact symptoms as her daughter after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), the onset of the events not reported.  Reporter's daughter symptoms included: Pneumonia, ended up with CDIFF (C.difficile colitis), symptoms like Parkinson's disease, feeling bad kinda like after a flu shot, fatigued, cold, upper respiratory infection, flu-like symptoms, got mono due to low immune system, was diagnosed with POTS, Now has chronic nerve damage,  a really bad tremor to her hand, her health "continues to decline" (disease progression).  At the time of the report, the patient's outcome of aforementioned events was unknown.  The causal relationship between the aforementioned event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)  was not reported.  Upon internal review, the events of Pneumonia, ended up with CDIFF (C.difficile colitis)and symptoms like Parkinson's disease were considered to be medically significant.  This is one of several reports received from the same reporter.  This is an amended report.  This .safety report report was previously submitted with the incorrect number: US-009507513-2010USA011617. This safety report submission is to provide the correct number: US-009507513-2011USA010344.; Sender's Comments:  US-009507513-2010USA011617: US-009507513-2011USA010224:
Pt recd series of Engerix-B vaxs (1cc/IM rt deltoid) 17SEP90, 19OCT90, & 28MAR91; Pt had needle stick 11MAR91 & had Hepatitis B Ag test done since series was incomplete; 13JUN91 f/u HBsAb test was neg; 20JUN91 recd 4th dose vax (1cc);
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 31-AUG-2017 the patient was vaccinated with PROQUAD lot # N008826 for prophylaxis. Other suspect therapies included VARIVAX. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On 31-AUG-2017, 1 day after onset of therapy the patient experienced overdose. On an unknown date the patient experienced no adverse event. The outcome of overdose and no adverse event is unknown. The reporter considered overdose to be not related to PROQUAD and VARIVAX. The reporter considered no adverse event to be not related to VARIVAX and PROQUAD. {Additional information has been requested. / Additional information is not expected.}
This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of GARDASIL 9 with the following lot numbers and expiration dates: L043213/28-AUG-2017, M009378/23-APR-2018, M024261/30-JUL-2018, M032650/31-MAR-2019, M042853/17-JUL-2019 and M043731/22-JUN-2019 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) (47 °F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) (9°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1708USA013008: US-009507513-1708USA013009: US-009507513-1708USA013010: US-009507513-1708USA013011: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-1708USA013006: US-009507513-1708USA013005: US-009507513-1707USA005187.