chrisvoncsefalvay/vaers-outcomes huggingface dataset:
atopic dermatitis; This is a spontaneous report based on the information received by Pfizer from  Laboratorie (Case number: GL-090321-21301). A contactable 36-year-old female consumer (patient) reported. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 15Mar2021 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took tacrolimus for dermatitis atopic. No other vaccines, illnesses, or dental procedures in the last 6-12 months. Patient was injected with a total of 1 ml of what she believes to be Restylane Kysse (Lot and exp Unknown) to tear troughs and upper and lower lips on 20Apr2021. She reported that she developed swelling under her right eye one day in Aug-2021 and the next day she woke up with swelling to both upper and lower eyelids and upper and lower lips, she reported they were very inflamed. She saw the HCP who administered certisone injections to both eyes and lips and prescribed her with a 5-day course of oral prednisone, swelling resolved. After finishing the oral prednisone, the swelling returned (02Sep2021). She contacted the HCP by phone and sent him photos of the swelling and he prescribed her lisinopril 5 mg daily and advised she take cetirizine dihydrochloride and fexofenadine. She reported that she is reluctant to take the lisinopril because its for high blood pressure. Event has not resolved, still has swelling and inflammation both eyes and upper and lower lips. The patient was diagnosed with atopic dermatitis around the eyes 6 weeks prior to injections, she was treated with Tacrolimus ointment which she had stopped about 2 weeks prior to injections. No other medical history, allergies, or medications. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
The pt experienced intermittant pain in the left elbow. The pain began the following morning. Pain continued through today (approximately 2 months post). Localized pain, (comes and goes) aggravated by lack of motion.
Pt recvd vax & began experiencing diarrhea, muscle aches, weakness on 15JUL92 while traveling in Nigeria; tx self w/anti-diarrheal med;
Headache, body aches, fatigue, malaise, chills starting about 12-18 hours after. Symptomatic relief with Tylenol 500 mg PO q6h helpful. Symptoms were self-limited by 48 hours post-vaccination.
Patient said have redness on bicep area. Patient said tender to touch and warm. Advised patient to check with her doctor. Doctor prescribed her an antibiotic just in case of a bacterial infection. Patient did not report any issues since.
This spontaneous report as received from registered nurse refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX on unspecific date. The patient developed a sterile abscess after being administered ZOSTAVAX. The pharmacy has a Registered Nurse (RN) that came in to administer the vaccines. The patient's physician informed the pharmacy of this event and questioned the administration of the vaccine. It was unknown whether the patient sought medical attention. The outcome of event was unknown. Additional information has been requested.
1st dose /August 4, 2019.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 4th August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive the 2 nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
I took the 1st dose of Moderna COVID primary series/. But unfortunately, it turned out 2nd dose of Moderna COVID primary series is not available; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (I took the 1st dose of Moderna COVID primary series/. But unfortunately, it turned out 2nd dose of Moderna COVID primary series is not available) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (I took the 1st dose of Moderna COVID primary series/. But unfortunately, it turned out 2nd dose of Moderna COVID primary series is not available) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (I took the 1st dose of Moderna COVID primary series/. But unfortunately, it turned out 2nd dose of Moderna COVID primary series is not available) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (I took the 1st dose of Moderna COVID primary series/. But unfortunately, it turned out 2nd dose of Moderna COVID primary series is not available).    Concomitant medications were not reported.  Patient took the 1st dose of Moderna COVID primary series in mid-March. For the administration of 2nd dose of Moderna COVID primary series is not available.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2023: Live follow up received is non significant.
Approx 1 hr p/inject exp acute swelling of lt ankle; 24 hrs p/inject acute swelling & pain of lt knee; 48 hrs later acute swelling & pain rt knee; again on 13JUL91 lt knee;
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 02 Apr 2021 that they had power outage and vials were in Freezer and Refrigerator where temperature dropped to : Frozen Vaccine 47Minutes  minus 13.79 C Refrigerator 59 Minutes 12 C No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments:  MOD21-068620:crosslinked
Patient reports 4 days after receiving Tdap vaccine she began to break out in hives. She has required several office/ER visits. No reported changes in other habits - no new exposures other than vaccine still has episodic urticaria 6 1/2 months later.
AE: felt like patient was going to pass out Tx: no medication was given. water resolved the symptoms Outcome: Patient was discharged to POV/Home.
After 12 hours, extreme fatigue, headache,tinnitus, chills then joint and muscle pain I took Aleve and was able to sleep off and on during the night. The following morning still had headache and fever.  I could not eat breakfast.  I took a two-hour nap during the afternoon.  Symptoms dissipated slowly by evening.
Patient presented with superficial red bumps that did not previously recall on left inner thigh. Patient encouraged to stay further after drinking 16 fluid ounces of water, Patient stated he was okay to drive.
Initial report was received on 08/24/2005 from a healthcare professional.  A five year old male child received an injection of Daptacel in the left arm, and Ipol route and site not reported, on 08/20/2005.  One day later the patient developed length of arm swelling and redness.  The area was also hot to the touch.  The patient was seen by a physician on 08/23/2005 and was treated with Benadryl and Tylenol.  The patient recovered from these events.
vomiting, fever 104, h/a & loss of appetite; APAP was given w/no results; pt taken to hosp; 7AUG92 seen by MD for URI & cough & congestion & felt vax was not cause of illness;
Immediate itching, tingling, "crawling" sensation in arm. Vertigo increasing for 4 hours, nausea, vomiting for 2 days, confusion, vertigo.
Patient experienced extreme fatigue, weakness, nausea and vomiting, felt like she had a fever, chills, migraine, and malaise.
Pt was given 2nd dose of Moderna vaccine 7 days post first dose  (8/16/21 and 8/23/21). She reported  nausea, chills, "feeling terrible" after 2nd dose. Went to Dr 9/14/21 after continuing to have nausea, loss of appetite, wt loss of 5 pounds.  Now reporting dizziness, tremors in hand, vomiting.
Patient developed swelling , warmth, redness and pain 5 days after the initial injection.
The DTaP we gave this pt was expired on 5/11/23, and we gave the vaccine on 5/15/23 by accident.
Information has been received from a registered pharmacist concerning a 62 year old female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). The pharmacist reported that the patient "may have developed shingles after receiving ZOSTAVAX (Merck)". The outcome of the patient was not reported. It was unknown if the patient sought medical attention. No further information is available.
w/in 24 hrs post vax, pt exp systemic urticaria; pt has no prior hx of reactions to other flu shots; treated w/Medrol pack; urticaria still persisting 5 months p/vax;
Headaches, vomiting, fever to 101.9 F beginning few hours post vaccination.
Morning after vaccine, woke up with left jaw pain, which worsened in discomfort & pain over the next 5 days. Seen by dentist on 1/27/21, diagnosed with jam, gum, tooth infection. Treated with antibiotics.
her tinnitus is getting worst; felt little bit tired; had a fever that was really bad; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (her tinnitus is getting worst), FATIGUE (felt little bit tired) and PYREXIA (had a fever that was really bad) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (her tinnitus is getting worst), FATIGUE (felt little bit tired) and PYREXIA (had a fever that was really bad). At the time of the report, TINNITUS (her tinnitus is getting worst), FATIGUE (felt little bit tired) and PYREXIA (had a fever that was really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included estrogen combipatch.  Treatment medication was not provided.   This case was linked to MOD-2021-283142 (Patient Link).
Pericarditis characterized by chest tightness, difficulty breathing, rapid heart rate, and severe chest pain.
1 week after injection I woke up with severely swollen lymph nodes in neck, swollen throat and could barely swallow. Right arm at site of injection 1 week prior was acutely hard, elevated, red, warm and tender to touch.  I immediately took a benadryl and 5 mg predniosne tablet, water, elevated position to rest. Swelling of lymph nodes in neck improved and gradually resolved 3-4 days later. Right arm redness and size of affected area doubled over the next two days, but then started improving. Resolved in about 8 days.
Initial information was received from a consumer concerning her daughter who on 08-JUL-2008, was vaccinated with the first dose of GARDASIL. On 23-SEP-2008, the patient was vaccinated with the second dose of GARDASIL. The mother reported that her daughter received her second dose of GARDASIL due to being on antibiotics. The mother did not wish to document the experience. No farther information is available.
Patient had swelling of eyelids & erythema with slight wheeze.  Decadon 4 mg subcutaneous w/ given.  Benadryl 12.5 mg x1 was given.  Wheezing stopped after 5 min.  All symptoms resolved after half an hour.
Within 2-3 minutes of injection, intense itching and burning sensation at site. Ice applied immediately. Within 1.5 hr throat constricted, lasting approximately 7-8 minutes. Hematoma at injection site 2 days after injection. Lip swelling day of injection.
Information has been received from a 22 year old female patient with yeast hypersensitivity, no drug/reactions allergies who on 23-JAN-2009 was vaccinated with a 0.5 mL dose of GARDASIL vaccine. Concomitant therapy included hormonal contraceptives (unspecified). "Eight hours after receiving the GARDASIL vaccine", the patient experienced a rash on her legs. The patient sought unspecified medical attention. There were no laboratory or diagnostic tests performed. At the time of reporting, the patient was recovering. Additional information has been requested.
I LEFT THE VACCINE FACILITY AND I ONLY GOT ABOUT A MILE AWAY & I STARTED FEELING THIS BURNING & TIGHTNESS IN MY CHEST WHEN I WOULD BREATHE SO I FOUND A PLACE TO SIT DOWN AND I HAD SHORTNESS OF BREATH SO I CONTINUED WALKING THEN WHEN I GOT HOME I WOKE UP IN THE MIDDLE OF THE NIGHT & BOTH OF MY LEGS FELT LIKE THEY WERE FREEZING COLD SO I TURNED ON MY ELECTRIC BLANKET & IT TOOK ABOUT 2 HRS BEFORE THEY FELT WARM I WAS LAID UP IN BED FOR THE NEXT 36 HRS & I JUST RESTED & SLEPT I HAD A HEADACHE FOR MOST OF THE TIME & WAS VERY NAUSEOUS.I CALLED MY DR THE NEXT DAY & WAS TOLD TO MAKE APPT & HE REFERRED ME TO AN ALLERGIST.
Quarter size hives or rash above butt, center, near tail bone; Quarter size hives or rash above butt, center, near tail bone; Joint pain; Tenderness; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer survivor and it was stage 1 both breast and had double mastectomy in 2015. The patient's health checks on an unknown date with doctors and primary care were all good. The patient had no allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included anastrozole (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), 1 a day 50+ (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 24Mar2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, after several hours of her vaccinations, the patient experienced joint pain and tenderness which went away by next day. On 16Apr2021 at 15:00, around 48 hours after second dose of vaccine, the patient experienced quarter size hives or rash above her butt, center and near tail bone. There were also small bumps not with puss. It did not itch unless she itches it. The patient applied coconut oil on it. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events quarter size hives or rash above butt, center and near tail bone was resolving. The clinical outcome of the events joint pain and tenderness was resolved on an unknown date Apr2021.  No follow-up attempts are required; No further information is expected
9-18-16AM Rt eye swollen below eye, at eye with conjunctival hemorrhage, that spread through the day. 9-9-16 - LD - hard, red, hot were it was given, felt feverish - 9-8-16  9-9-16 TYLENOL was taken.
shrill cry for > 3 hrs steady local swelling & pain LLT; t103; dad states choking episode & limpness p/crying; inflammation @ the site of inject; crying
little numb; left eye droops; lesions appeared on the left side of her face, scalp and left eye; lesions appeared on the left side of her face, scalp and left eye; severe headache/ head tenderness; burning presented on the left side of her head; area was tender and stretched from the face to the back of her head / tenderness on the base of her head; couldn't lay on her back; stretched from the face to the back; itchy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax.   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 1st November 2020, 10 days after receiving Shingrix, the patient experienced headache, burning sensation, pain localized, mobility decreased and tenderness. On 6th November 2020, the patient experienced shingles and skin lesion. In November 2020, the patient experienced itchy skin. On an unknown date, the patient experienced numbness and eye discomfort. On an unknown date, the outcome of the shingles and skin lesion were unknown and the outcome of the itchy skin was recovering/resolving and the outcome of the numbness, eye discomfort, pain localized, mobility decreased and tenderness were not recovered/not resolved and the outcome of the headache and burning sensation were recovered/resolved.   It was unknown if the reporter considered the shingles, skin lesion, itchy skin, numbness, headache, burning sensation, eye discomfort, pain localized, mobility decreased and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. In the evening of 1st November 2020, the patient had severe headache and burning presented on the left side of her head. By 6th November 2020, lesions appeared on the left side of her face, scalp and left eye, the reporter stated that, the lesions were shingles lesions.The area was tender and stretched from the face to the back of her head. The patient could not lay on her back because of the tenderness on the base of her head. The area where the lesions presented was still a little numb and itchy. The patient's left eye droops a bit. The reporter consented to follow up.
Symptoms included, body aches, fevers, chills, fatigue, nausea, cough, diarrhea. Required to get the flu vaccination every year. With each vaccine I have worsening adverse reactions, sending me to seek emergency medical attention  in the emergency room.
Hospitalized 9/20/2021; COVID-19 positive 9/20/2021;  fully vaccinated a 60 y.o. female who presents today intubated, tested positive for COVID. According to information obtained from EMS, patient was vaccinated for COVID but started having symptoms last Wednesday.Shje was intubated yesterday. Husband is also COVID positive. ROS limited due to limited hospital record. ASSESSMENT / PLAN: 60 year old female with PMHx significant of but not limited to  of hypertension, COPD presented while intubated AHRF 2/2 COVID ARDS; COVID Pneumonia: Patient was COVID vaccinated in May,developed symptoms( dyspnea) 09/16, intubated 09/19 for worsening hypoxia, previous chest X-Ray indicative of ARDS.Bedside bronchoscopy did not show any mucous plugging. On VC with FiO2 100% ,PEEP 20,TV 360,plateau of 28.Unable to get hold of tocilizumab. Continue decadron 6 mg daily for 10 days. S/p loading dose of remidesivir, will continue maintenance dose. No proneing now, PF ratio 228 Continue lung protective ventilation with low TV Follow up ABGs every 4 hours Follow up blood and sputum culture Holding antibiotics, low suspicion for bacterial pneumonia  Note from 9/26/2021: a 60 y.o. female with a past medical history of significant for hypertension, chronic obstructive pulmonary disease who presented from an outside hospital with ARDS secondary to COVID-19 pneumonia requiring intubation and sedation as well as shock requiring pressors.  Assessment/Plan:  Acute hypoxic respiratory failure secondary to COVID 19 pneumonia COVID ARDS Patient vaccinated in May, develops symptoms 9/16, intubated outside hospital 9/19 for worsening hypoxia.  Recent chest x-ray indicative of COVID ARDS.  Bedside bronchoscopy revealed no mucus plugging.  Currently on volume control PEEP of 18, FiO2 of 55, tidal volume 300.  Plan Decadron 6 mg daily for 10 days -day 5 of 10 Remdesivir discontinued due to AKI P/F improving - maintain FiO2 with goal p/F of >160 Blood cx NGTD CXR 9/26/2021: No significant change. Appliances are in stable, satisfactory position. Normal cardiac size. Mild diffuse coarse bilateral interstitial infiltrates. Mild atelectasis left base.
pt recv vax; within 24 hr p/ vax, exp vomiting; sx persist;
This spontaneous report was received from a registered nurse refers to a female acquaintance of unknown age who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that she "heard" that on an unknown date, the female got shingles post vaccination. No treatment information was reported. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for patient got shingles post vaccination was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a woman in the physician's office concerning a 7 yr old female with no medical history, who on 19May00 was vaccinated SC in the right leg with a first dose of varicella virus vaccine live (lot reported as 18705). There was no concomitant medication. On 23Jan06 the pt was diagnosed with varicella. It was noted that the skin over her face, forehead, arms, legs, chest, back and head had vesicular eruptions with blisters. At the time of this report there was no outcome noted. It was also reported that the pt's sibling experienced an adverse event following vaccination (WAES0602USA00521). Additional information has been requested.