chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 43 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER2613), on 20Apr2021 as dose 2, single (Lot number: ER8735) and on 20Oct2021 as dose 3 (boostre), single (Lot number: FF2590) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "Other medical history: peripheral venous insufficiency" (unspecified if ongoing), notes: Other medical history: peripheral venous insufficiency; "Other medical history: plantar fasciitis" (unspecified if ongoing), notes: Other medical history: plantar fasciitis; "Other medical history: dermatofibroma" (unspecified if ongoing), notes: Other medical history: dermatofibroma; "Known allergies: KNDA" (unspecified if ongoing), notes: Known allergies: KNDA. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (14Jan2023) Positive, notes: Rebound COVID 19 URI. positive PCR 14Jan2023; SARS-CoV-2 test: (unspecified date) Negative, notes: Negative rapid Ag on days 8; (unspecified date) Positive, notes: 10 Positive rapid Ag; (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid on 14Jan2023 to 19Jan2023.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
5 days after covid-19 pfizer vaccine was given she developed a fever with a mild rash on her extremities. Started treatment at that time for tick borne illness. Rash progressed to what appeared to be erythema multiforme, she had conjunctivitis as well as persistent fevers. Ended up being sent to ED on 12/31/21 for leukocytosis and thrombocytopenia in addition to malaise, myalgias, joint pains to get further lab work. Found to be hypotensive in the ED (was not in our office) and ended up in the PICU for treatment. Current working diagnosis is Kawasaki disease.
Mother reported "hive" on left cheek 1/2 hour, post vax. Hive on left leg and smaller hives later. Fever to 100.5F, fussy and "itchy". Fever up to 101.8F, the following day. No further problem.
Patient developed sores on lip approximately 3-4 days after receiving the vaccine.  She then developed sores on her nose as well as around here eyes 8 days after receiving the vaccine.
This is a spontaneous report obtained from a contactable physician. A patient of unspecified age, gender and ethnicity, on an unknown date, PREVNAR13 0.5 ml, single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced reddish rash. The event lasted about a week after injection of the vaccine. Follow-up (06MAR2015): Follow-up attempts completed. No further information expected.
Patient developed 20-25 lesions on his face, trunk and hands. Patient had 2 lesions in his mouth.
He accidently received Pfizer vaccine instead of Moderna. He is aware the series is complete
11/4/08 - Redness on left arm at injection site.  11/5/08 - Left arm from shoulder to elbow red, warm to touch.  Also, complaints of tiredness; no fever
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 25-FEB-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had two temperature excursions: 972 and 336 hours respectively. The lowest recorded temperatures was -3 (-3 Celsius). The highest recorded temperatures was 59 (15 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
2.14.22 When 7 minutes into my usual morning indoor cycling hour, I notice my heart rate was running 50-60 when normally it is 112 at that level of exertion. I stopped, laid down, felt lightheaded, slightly nauseated, slight cold sweat. I felt that very slow pulse and arrhythmias. I recovered enough to work from home. Through the day and evening I was weak, no appetite, and felt continuous arrhythmias and slow pulse. BP was 121/76. I took several tracing on my iPhone. iPhone read unable to provide reading but suggested AFib. I slept normally. Next morning, all back to normal with normal sinus rhythm on my iPhone. Nevertheless, I booked an appt. with my cardiologist.
Bell's palsy; The patient got first and second COVID shots, but he developed Bell's Palsy after the first one. He didn't realize it was caused by the vaccination,; This is a spontaneous report from a contactable consumer (Reporter's brother). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ,Batch/Lot number was not reported) via an unspecified route of administration (Shoulder, but not sure which one. Probably gave them all in the left shoulder) on an unspecified date (but before 09Feb202) as 2nd Dose, Single for COVID-19 immunization. The patient's Medical history included Bell's Palsy before, but it has been a long time ago. Reporter would say probably more than 6 or 7 years ago. Reporter is not aware of AEs following prior vaccinations,if his brother had and he normally doesn't take vaccines. Information on prior vaccinations within 4 weeks is not provided The patient's concomitant medications were not reported.  Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient got first and second COVID shots, but he developed Bell's Palsy after the first one. He didn't realize it was caused by the vaccination, so he got the second one or he never would have gotten the second one. Immediately after the 2nd dose of vaccination, the patient experienced Bell's Palsy which is ongoing and has stayed about the same on an unspecified date, but before 09Feb2021. The patient went to the ER and they treated him and sent him to the doctor there. Therapeutic measures were taken as a result of bell's palsy. The outcome for the events was not recovered.  Information about lot/batch has been requested.
ADMINISTRATION OF IMPROPERLY STORED VACCINE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced administration of improperly stored vaccine. On 01-JUN-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of improperly stored vaccine and out of specification product use was not reported. This report was non-serious.
Starting 02/15/2022, I came home and all of a sudden I got a headache, nasal congestion and felt extremely fatigued. I had no fever but it progressed more as time went on. I started developing pressure on my upper chest (making it hard to breath). I went to bed like normal but couldn't sleep. So, I took an OTC COVID test and that was normal. The next day, I was feeling the same, I took another COVID test (which was negative) and I canceled my rheumatologist f/u until I felt better. I called my PCP and they had me come in that day. My BP was elevated and my HR was higher than normal. Any exercise I did, getting on the table, would cause my HR to spike. I looked at my fitbit and my HR was moderately elevated. He thought that that was what was causing the pressure. So, he took a D-dimer test (for clots) and a PCR COVID test. Over time, it progressively improved and by 02/23/2022 I felt mostly normal.
Site: Redness at Injection Site-Severe, Additional Details: Husband notified pharmacy on 9/16/21 that patient had been hospitalized. She had redness and swelling over her whole right arm from shoulder down. Husband stated patient has Lupus. Vaccine questionnaire did not list any adverse reactions to vaccines in the past. Husband and patient were not availabe at time of this report for further details.
palpitation. PT brought in by EMS for nausea and chest tightness starting an hour after the J/J shot at 1000. States taking tylenol this am but nothing recent. Pain is described as intermittent tightness to the center of chest without radiation. States intermittent shortness of breath. PT speaks in full and complete sentences. MDM: 21-year-old male presents with constitutional symptoms after COVID vaccine reaction.. Stable on arrival, mildly febrile with moderate tachycardia and otherwise reassuring vitals.  Patient well-appearing on exam with no productive cough, hypoxia, abnormal lung sounds, or respiratory distress to suggest pneumonia. No urinary symptoms or abdominal pain to suggest UTI or other acute intraabdominal process. No AMS, neuro symptoms, meningismus, or rash to suggest meningitis/encephalitis. Non-toxic appearance; low concern for sepsis or severe bacterial infection. No dry mucous membranes or tachycardia to suggest clinically significant dehydration. No exam findings to suggest strep, epiglottitis, RPA/PTA, or AOM. EKG nonischemic with no dysrhythmia, sinus tachycardia evident.  Given Toradol, Zofran and IV fluid in the ER with improvement of symptoms and tachycardia. PO tolerant in ER. Plan for discharge with Tylenol/motrin PRN for fever/pain, and PCP follow-up.  Discussed findings with patient/caregiver. Plan for discharge as above. Patient/caregiver verbalized understanding and agreement with plan. All questions were answered to satisfaction of patient/caregiver. Written and verbal discharge instructions were given to the patient, including strict ER return precautions. Patient was discharged in stable condition.  Voice-recognition software was used in the documentation of this note and may contain minor grammatical errors/typos. CONSULTS: NA  DIAGNOSIS: Vaccine reaction  DISPOSITION: Discharge home      acute intraabdo
large swollen knot. Very hard, painful, and hot to touch. Also, very itchy.
Patient reported fever of 102 and muscle aches from her "ears to ankles" lasting approximately 24 hours following vaccination.
Patient contacted pharmacy stating that the injection site was inflamed. Patient did not have hives, redness, or fever. Swelling was localized to the injection site.
I got chills right after 30 min when I got home  the got so fatigued and was shivering and then my headache came and it won?t go away not even with anteceptamine the back  of my neck is also hurting which goes up to my head my headache is worse on the 3rd day and have to stop what Iam. Doing and lay down also feel very nauseous and feel like I have to throw up with very dry mouth
REDNESS, SWELLING, AND RASH AT INJECTION SITE. RADIATING THROUGHOUT UPPER ARM. RASH/REDNESS AND SWELLING ALL OVER UPPER ARM STILL ON 09-06-2014. PAIN PERSISTS. FEELS SMALL BUMPS AROUND SITE. MD SAW PATIENT 9-6-2014. PRESCRIBED KEFLEX 500MG.
Developed small area of erythema and swelling at injection site about 1-2 days after administration, treated with keflex for cellulitis by another provider, and symptoms resolved.
Patient first reported redness & swelling at injection site on 5-9-12 beginning previous day. Seen by Dr for worsening on 5-10-12. Left bicep & triceps area swollen & red & itchy - extended down below injection site. BENADRYL & Cortisone cream Rx'ed.
In July I had sore throat, joint pain, body ache, couldn't smell nor couldn't taste and hard time to breath.
strep throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (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: PHARYNGITIS STREPTOCOCCAL (non-serious) with onset 2021, outcome "unknown", described as "strep throat".  Additional information: It was reported that, patient got his 1st dose of the vaccine on 27Mar2021 and scheduled for the 2nd dose on 17Apr2021. He said he got Strep throat after getting the 1st dose of the vaccine and his doctor prescribed him an antibiotic. He said he hasn't started taking in the antibiotic yet and is still waiting for a call from the pharmacy where he will get the antibiotic. He wants to know if he can still take the 2nd dose of the vaccine even if he still has Strep throat.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I tested positive for Covid-19 on April 1, 2023. I experienced tiredness and a cough had very mild symptoms. I was prescribed PAXLOVID for my symptoms.
Large red lump appearing nine days after injection. It is itchy and painful and incredibly swollen.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. The vaccine was exposed from 32°F to 35°F for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643: Original Case: 1707USA006643.
Case number PHEH2015US020348, is an initial spontaneous report received from a health care professional on 08 Oct 2015. This report refers to a 24 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515601) multi dose vial (MDV) intramuscularly on an unknown date. On 02 Oct 2015, the patient developed hives on the thighs and abdomen. The event lasted for about 5 days and was clearing up at the time of reporting The outcome of the event was condition improving. Seriousness and causality of the event was not reported.
Information has been received from certified medical assistant concerning unspecified patients of unknown age and gender. On 16-JAN-2015 the patients were vaccinated with improperly stored RECOMBIVAX HB (lot number, dose and frequency were unknown). No adverse events was reported. Additional information has been requested.
Area just below the injection site became red, swollen, and warm a few hours after receiving the vaccine. The patient visited the pharmacy again 4 days later and she said it had improved tremendously. Her arm was still slightly red approximately 2-3 inches below the injection site.
Red circular shaped rash 2-3 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red circular shaped rash 2-3 inches wide) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AMLODIPINE, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), VITAMIN B NOS and ANASTROZOLE (ANASTRAZOLE DENK) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red circular shaped rash 2-3 inches wide). At the time of the report, RASH ERYTHEMATOUS (Red circular shaped rash 2-3 inches wide) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included allergy injections.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080025 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080025:crosslink - Second dose
Pfizer BioNTech Vaccine administered (patient also took paxlovid for covid-19 treatment after received BNT162b2).; Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2).; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 at 14:15 as dose 3 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "acquired hypothyroidism" (unspecified if ongoing); "borderline hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: CYTOMEL; SYNTHROID; PRAVASTATIN. Vaccination history included: Covid-19 vaccine (Dose 1 (manufacturer unknown)), for COVID-19 immunization; Covid-19 vaccine (Dose 2 (manufacturer unknown)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2).". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (02May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (03May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (04May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (05May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (06May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid anti-viral details product for covid 19 Treatment. The patient started treatment on 19Apr2022, and treatment stopped on 24Apr2022. The patient previously received a COVID-19 Vaccine. Patient had not known allergies. Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. After paxlovid course, patient had 4 negative rapid tests, and then 4 days after that he had a positive rapid test and have been strongly positive on rapids for 6 days in a row now. He had mild symptoms of cough, congestion, fatigue and muscle soreness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.
24 hours after receiving the 2nd dose of Moderna, Patient passed out and fell to the floor, unresponsive for about 10 minutes.
within 2 hours, incision sites from prior surgery began to itch, by morning they were red, swollen and open and infected.  in 12 hours had fever, chills, and diarrhea in 24 hours.  day 4 started having sore throat, sinus issues, exhaustion, ear ache, loss of appetite, felt like the flu, strep, momo, sinus and ear infection all at one time.  Lasted for 5 days and then fatigue lasted for 12 additional days.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 20-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Information has been received from a nurse concerning a male with attention deficit disorder who on 05-AUG-1999 was vaccinated with his first dose of VARIVAX (SQ, 0,5ml, lot number: 631065/0445J) and on 13-JAN-2009, the patient received his second dose of the vaccine (SQ, 0,5ml, lot number:).  Concomitant therapy included ADDERALL TABLETS (manufacturer unknown).  The nurse reported the patient developed chicken pox on 9-APR-2009.  The patient was examined in the office on 14-APR-2009 and a diagnosis of chicken pox was confirmed.  The patient presented with a heavy distribution of orangish papules on the chest, back, upper and lower extremities.  No treatment was advised.  The patient sought medical attention visited physician's office.  The outcome of the patient was unspecified.  This is one of several reports received from the same source.  Additional information has been requested.
Chills, fever, cold sweats, muscle tightness, inability to sleep, fatigue, legathargy, headache. These symptoms lasted from 12-36 hours. Acetomenophen was used to treat some of these symptoms. Bed rest and fluids helped alleviate symptoms.
Headache, NauseaVomiting, body aches, chills Narrative:
08/29/07 1115 Received phone call from client;s mother who stated "Patient has not been feeling well and we were wondering if it was from the vaccine he was given."  Mother stated patient complained of a headache on Monday and had a slight fever.  She took to the doctor and he stated it was a viral infection.  Mother stated today patient is off balance and complaining of right ear pain.  Encouraged mother to take patient to doctor and explain symptoms and that he received Hepatitis A vaccine on 08/22/07.