chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reported Symptoms:  10033556:PALPITATION;  10038678:RESPIRATORY DEPRESSION; 10040047:SEPSIS;  10043088:TACHYPNEA;  10084380:COVID-19 PNEUMONIA; Narrative:  Patient has received two Pfizer COVID 19 Vaccines (Jan/Feb 2021). The patient presented to the ED on 5 Nov 2022 with fever, chills, cough, and shortness of breath.  The patient was admitted to the hospital with sepsis, covid pneumonia, respiratory failure, and afib.  The patient was treated with remdesivir and dexamethasone.  The patient was discharged on 9 November 2022 in stable condition.  Reported per EUA. Other Relevant HX:  Other: COVID Pneumonia, sepsis
Pt experienced chest pains, numbness in right arm, swelling under right arm and above collar bone; neck pains (muscular) on right side of neck, rashy feeling under arm and above collar bone; bruised feeling under skin above collar bone. Symptoms lingered for about 6 days. Chest pains still lingering as of 08/29/2000.
24NOV spiked a fever p/vax dx MMR rxn;24NOV 4PM febrile sz seen in Er started then on amoxicilin for LOM;APAP & motrin together to control fever;
shoulder pain (possible injection injury), been taking ibuprofen OTC but given medrol dose pack today.
Patient had a fever of 102 with tonic-clonic movements of hands, eye rolling and was post-ictal. Taken to hospital by ambulance. Diagnosed febrile seizure.
Developed a red spot and itching for several days on the right arm that was injected with polio and yellow fever vaccines.
This spontaneous report was received from the registered nurse refers to a 1 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medications included VAQTA. On 21-MAR-2018, the patient was vaccinated with M-M-R II (dose, units and frequency not reported) (lot # N020922 and expiration date: 01-AUG-2019) subcutaneously. On 18-JAN-2018, manufacturer received vaccine with Lot # N020922, from the time it was received it was stored properly in the refrigerator in temperatures between 2 to 8 C. On further review, on 03-APR-2018, it was determined that, the temperatures had been out of range that is greater than 8 C (product storage error). This issue has been notified to manufacturer and received information from global information medical scientist, dose would need to be repeated. A letter was sent to patient's parents to let them know about the situation and appointment has been made to revaccinate the patient.
Anaphylaxis w/ airway closing/angioedema - Treated with an EpiPen.
Breakthrough case admission after three vaccines Moderna 2/10/21 Lot$ 027L20a;  Moderna 3/10/21 Lot# 031L20A;  Moderna 3/31/22 Lot # 033K222A
Pt reported chills & 104 fever PM of inject lasting 2 days & sl fever 3rd day; Pt reported unable to open lt eyelid, weakness in lt extremeties & redness, knot, swelling lt upper arm, h/a;
Headache; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious), outcome "recovered", described as "Sore throat".  Additional information: Reporter's daughter was 12 and had a headache and sore throat 45 minutes after receiving the first shot of covid vaccine. Lasted a few hours and that was it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives on face, neck and chest, wheezing, dizzy, headache and confusion and pressure in head. Took 2 benadryl  and it took symptoms down. Next day had to do breathing treatment for wheezing but hives were gone. Also took Ibuprofen for headache and body ache.
Vaccinated with Pfizer vaccines in September 2021 x 2.  Symptom started on 12/29 - runny nose x few days.
Swelling of armpit lymph nodes; This is a spontaneous report from a contactable other health care professional. A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3247), via an unspecified route of administration from 18Jan2021 11:15 at SINGLE DOSE at left arm for covid-19 immunisation. Medical history included Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any vaccine within 4 weeks prior to the vaccine.  There were no concomitant medications. On 18Jan2021 23:00, the patient experienced Swelling of armpit lymph nodes that started 12 ish hours later and is still here a full 60 hours later. It was unknown if the patient receive treatment for the event. The outcome of the event was not recovered.
Patient reports sudden onset of severe nausea, sweating. C/o "not feeling well and feeling hot". Patient was assessed by onsite clinic EMS, vitals were taken and evaluated. Patient was monitored for 30 additional minutes. Patient's symptoms resolved, never vomitted. Patient disposition: went home and recovered feeling fine.
vesicular rash RUE, redness; rash also around mouth; area of inj mildly ecchymotic & petechial poss erythema multiforme;
PATIENT HAD NOT COMPLETED A PRIMARY SERIES AND WAS GIVEN PFIZER BIVALENT AS HIS SECOND DOSE. PATIENT HAD ONLY RECEIVED 1 PFIZER DOSE PREVIOUSLY.
No adverse side effects until 10:00 PM- chills began, fever until 2:30 AM, fever broke, then whole body aches with intense headache, high level of fatigue- with advil and mucinex- symptoms subsided- unknown if they will return once  medication wears off
DID NOT TAKE FOURTH DOSE; This spontaneous case report (PVX2019-1737) was received from a healthcare professional on 02-Jul-2019. It describes a female consumer who "did not take fourth dose" (PT: Incomplete course of vaccination), while being on Vivotif for an unknown indication.  Case report: The consumer took three doses of Vivotif but did not take the fourth dose. The last dose had been taken a week ago.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not take fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take fourth dose" was considered as not applicable.
3/30 Pt called, c/o erythema (L) upper arm at injection site, Sl. raised "welt" in appearance, "larger than half dollar" in size. No c/o discomfort, and decrease in size now.
Headache, Rash, Chills, body aches Narrative: Employee reports she took Motrin and used cold compress
I asked mom before HPV shot was given if patient ate breakfast and if he ever passed out before from an immunization. Mom reports that he did eat breakfast, and that he never passed out before. Patient was given shot in his left upper deltoid. I asked patient right after administration how he was feeling, he reported he was feeling good. I advised mom and patient that he needed to stay in the room for 15 minutes after he got that shot due to it making people not feel good, mom verbalized understanding. Left the door open just in case, and told patient if he started to not feel well that he could lay back in on the table, he verbalized understanding. 15 minutes later, patient walked out with his mom, to go to checkout, asked how patient was feeling and he said good. About 5 minutes afterwards patient was standing at check out and passed out. Employee was made aware, she came to check on patient.  Apple juice was given to patient. An ambulance was called, but was cancelled once doctors finished assessing patient. Patient was then taken to a room after he started coming to it and a 2nd set of vitals were taken. Patient states that he started feeling dizzy when he was standing out checkout and then passed out.
Starting about 6 days after vaccination, developed rash progressing down left leg. Was getting worse and painful so went to urgent care. Dx = shingles. Started valcyclovir 6/15/21.
Early April 2021, my mother said she was experiencing pins, needles, numbness and pain in right leg (mild in left leg), her hands, severe back pain, and extreme fatigue.  She soon lost the ability to hold items in her left hand.  On May 10th she was in extreme pain, barely able to walk or hold herself up, making her mostly immobile up to the present day.  She has experienced repeated intense "shock" sensations down her right leg, and localized areas of intense pain in different parts of her body such as the hip bone, wrists, collarbone, and left side of temple that come and go.  In recent weeks, she's lost function of two fingers on the right hand.  For the past several weeks, she's had an intense itchy scalp.
A 68-year-old female presented to ED with complaints of headache, body aches, congestion and  shortness of breath. Patient reported history of breast cancer and currently on chemo. Patient has fatigue and had a slight cough. Patient stated her biggest issue is her headache. Her head is pounding, she feels weak and fatigued. These symptoms started shortly after getting the COVID-19 booster on 1/18/2022.
Swelling, redness, slight warmth - inject site low for documented left deltoid. Symptomatic treatment.
Fully COVID vaccinated patient admitted to hospital through ED with dyspnea, fever, and tachycardia.  Started on O2, remdesivir (2 doses), decardron, antibiotics (potential UTI).  On day 2 of admission patients symptoms had improved.  Patient given option to return home or stay for continued observation, patient opted to return home.
This spontaneous report was received from a Medical Assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 24-OCT-2016, the patient was vaccinated with expired RECOMBIVAX HB lot # K026666/expiration date- 22-OCT-2016. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
SON REPORTED THAT PATIENT DIED 2 DAYS AFTER GETTING THE VACCINE
After the 2nd dose was very nauseous, upper shoulder,& neck pain, Lower back pain, tired, dizzy.  2 weeks after the 2nd dose I am extremely cold, nauseous, tired, confused, lower back pain, phlegm.
Received vaccine 1/6/2021; immediate redness and pain in injection site. Continued, along with itching, for 2-3 days, then was mostly gone except a warmth and slight discoloration (pink, not red). Began to feel fatigue within the next week. Then, around 1/17 or 18, the heat, pain, itching, and redness returned, along with a painful swelling on the left side  bottom of my mouth, and on the left side bottom of my tongue.  I'd been told someone I knew had pain as well, and was prescribed Benadryl, so I took the over-the-counter type as directed, and within the second dose (after 4 hours), the pain and swelling receded in my mouth and on my arm. Within a day, I had no more mouth pain, and the arm feels better, although it's still pink, itchy, and warm.
Excruciating pain up and down arm. Naproxen 500mg; Cyclobenzaprine 5mg; TYLENOL 1000mg; Hot/Cold pack on arm; limited activity using arm; splint usage; keep arm elevated.
Mom noticed a red area on patient's arm the morning of 7/21/15. Patient was examined at our clinic on 7/22/15. His (R) deltoid was warm to the touch and a red area was on his (R) deltoid (about 4.5 cm in diameter). Mom to ice the area to reduce swelling and give patient ibuprofen as needed for discomfort.
Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Additional Details: Pt's temp at time of vaccine was 99, dropped to 94-95 during acute distress. Pt had eaten breakfast but was doing manual labor before getting vaccinated. He was very hungry after he recovered from acute distress. BP had dropped significantly but did return to normal ~80/120 after recovering. All other sypmtoms resolved after several minutes except for injection site swelling
Rash on arm, 4 inches wide from injection site to elbow; soreness of the injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE RASH (Rash on arm, 4 inches wide from injection site to elbow) and VACCINATION SITE PAIN (soreness of the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash on arm, 4 inches wide from injection site to elbow) and VACCINATION SITE PAIN (soreness of the injection site). At the time of the report, VACCINATION SITE RASH (Rash on arm, 4 inches wide from injection site to elbow) and VACCINATION SITE PAIN (soreness of the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.
I only had a sore arm for a few days. I had a sty on my eye that was small and irritating but it got considerably worse after the shot. I went to see my primary care physician because it was very big, puffy swollen eye lid and felt like it was scratching my eye. It was very uncomfortable. He prescribed antibiotic eye drops, which I took for a week. He suggested I see an ophthalmologist. I saw Dr.  He said it was too small by then to cauterize it so he said to continue with the eye compress for another month and I still have it.
Felt feverish, fever blisters in and outside of nose and mouth, headache, swollen and sore right arm to elbow, severe word finding deficit. Word finding problems subsided in 90 minutes. Arm swollen for 2 weeks. Headache lasted one day. Fever blisters lasted 2 weeks.
patient described severe shaking, freezing and body becoming very sore beginning at 3am on 01/11/22. As of 9am 01/11/2022 patient  continuing to monitor for any further symptoms.
Patient who is Day +165 post transplant received an MMR vaccine at the patient's PCP on 11/30/22. The facility did not contact our site and patient's treating physician found out on 12/1/22 when the patient had her scheduled BMT follow-up. Treating physician contacted ID and immunology to discuss incident. Patient was given IVIG and titers were drawn on 12/1/22. This is a safety concern in terms of transplant and timing of post-transplant re-vaccinations per out institute's BMT. The drug abatacept also warns to contact physician prior to vaccinations. As of 12/5/22, patient has no symptoms and additional flow cytometry laboratory assessments were drawn to closely monitor the patient.
T 103.2 F 24 hrs post inject, irritable, lethargic (T 104F 21Apr91) had an episode @ midnight /w marked pallor, very shallow respiration. Local rxn /w induration, bruise /wout redness. Also DX /w oitis media.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild
itching; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching) and PAIN IN EXTREMITY (sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 13-Mar-2021, the patient experienced PRURITUS (itching) and PAIN IN EXTREMITY (sore arm). At the time of the report, PRURITUS (itching) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-017475 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-017475:crosslink
patient presented with TIA on 8/28  presented with acute infarct on 9/11 and is currently in rehab facility
Pt. developed fever, muscle ache, pain and redness at site of injection. Reported fever, muscle ache evening of administration.
(mild) fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE ((mild) fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FATIGUE ((mild) fatigue). At the time of the report, FATIGUE ((mild) fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported. No treatment information was provided.  The lot number of the first dose was either 0011321A or 001B21A (hard to read). The subject received the second dose and booster dose as well.   This case was linked to MOD-2021-395738, MOD-2021-395749 (Patient Link).
REDNESS AROUND INJECTION SITE. RASH- PERSISTED FOR 3 DAYS.
Patient became ill and tested PCR positive for Covid > 14 days after the completion of Pfizer vaccine series
22APR98 onset of varicella;mild case 20-30 pox noted @ ped office on 23APR98;papules noted on trunk, neck, face & extremities;
This spontaneous report as received from a healthcare professional as part of a marketing research program conducted by HRA, title PENUMOVAX23, and refers to an unspecified number of patients of unknown gender and unspecified age. The patient's medical history and concurrent conditions were not reported. The reporter stated that in the last 3 months she/he had heard or seen to give PREVNAR 13 she/he to adults of 50 age and older (inappropriate schedule of vaccine administered) and if above age 65, gave PREVNAR 13 (dose, lot #. expiration date and route were not reported) first and then PNEUMOVAX23 8 weeks later (dose, route, lot # and expiration date were not reported). (interchange of vaccine products). Also the reported had heard the new Advisory committee on immunization practices (ACIP) recommendation of give to all adults greater than 65 years old, PNEUMOVAX23 naive at age 65 year give PREVNAR 13 first, then PNEUMOVAX23 8 weeks later. At the time of the report, the outcome of the patients was unknown. The relatedness between the events and therapy with PNEUMOVAX23 was not reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. On 21-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # H012643 and expiry date: 30-MAR-2015). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
c/o stiff neck & pain in joints x 2 1/2 wks duration post inject;
pt recvd vax & exp onset of asthma sx; wife administered Epi which relieved the sx & took pt ER: pt also had fever & myalgia;
Tinnitus and hearing loss. Prednisone for 30 days, blood test and MRI. Symptoms still present.
Initial unsolicited report received from a Consumer (Patient's mother) on 16- Oct -2017. This case involves a 9-year-old female patient who was vaccinated with a single dose of INFLUENZA QUADRIVAL A-B VACCINE (FLU SHOT) (batch number: U5913BA, expiry date, dose, form, route and dose in series was not reported) via in the left arm on an unknown date. (Reported as Thursday at 4:00). Concomitant medications were not reported. On an unknown date, three hours following the vaccination, the patients had reaction where her arm (left) became increasingly red and swollen from her shoulder to her elbow. It was reported that on an unknown date on Saturday she could barely get her shirt on, and by Saturday the swelling had increased such that her elbow was not defined, and the swelling moved to her forearm. It was also red and itchy in her triceps area, but she had no hives and no other reaction anywhere else. Patient's mother treated her with IBUPROFEN (Motrin) after shot, because she said her arm hurt, then with DIPHENHYDRAMINE HYDROCHLORIDE (Benedryl) orally and topically Friday through Sunday. Lab data was not reported. Other corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
This case was reported by a physician and described the occurrence of bubbles under skin at site of injection in a 57-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 17 May 2013 at 15:00 the subject received 2nd dose of HAVRIX (1 ml, unknown, right arm) and experienced bubbles under skin at site of injection. The subject had a round bubble under the skin at injection site. The subject was noted to have small arms. At the time of reporting the event was unresolved. Follow up received from pharmacist (initial reporter) on 18 June 2013. Previously, the reporter was documented as a physician; however, on follow up, the reporter noted that they were a pharmacist. According to the pharmacist, on 18 May 2013 (described as "24 hours after shot") the subject experienced bubbles under the skin. The onset date was previously reported as 17 May 2013. The pharmacist documented that the adverse event had resolved. The pharmacist did not consider the event to be serious. According to the pharmacist, the event could have been associated with erroneous administration "subcutaneously rather than intramuscularly" and "side effect for patient." The pharmacist documented that the subject had received the vaccine before and had "no side effects from 1st set of immunizations." The immunization series was not discontinued. It was unknown if the series was delayed. The pharmacist noted that the subject "had not had final shot as of yet and patient will have physician do a titer test in 1 month and report to us if physician wants her to be reinjected."