chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme exhaustion, shakes and freezing cold, splitting head aches- most terrible head ache I have ever had. Weak feeling,
low grade fever, flu-like sx & stiff neck that lasted 2 wks; these sx started 1 wk p/2nd Recombivax;
I am pregnant, and ever since receiving my first and second covid vaccines, my platelet counts have continuously dropped. They have never been abnormal prior to vaccination. The platelet levels measured during pregnancy are not at this point requiring any medical intervention , but it is still concerning to me that now at 34 weeks pregnant the levels are on a downward slope.
tested positive within 2-4 days of the vaccine; tested positive within 2-4 days of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the first of 2 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse had questions about patients that received the first dose of the COVID 19 vaccine. One patient tested positive within 2-4 days of the vaccine and this patient had a known exposure to a COVID positive person. The nurse wanted to know if this patient should receive the second dose. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of SARS-CoV-2 test positive and LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520414 Same reporter, drug, and events; different patients
30 MINUTES AFTER HEPATITIS B ADULT DOSE GIVEN, PT REPORTED FEELING DIZZY, DIAPHORETIC, AND "OUTSIDE OF BODY".  NO C/O FEVER, HIVES, OR LOSS OF CONSCIOUSNESS.  SELF RECOVERED IN FEW MINUTES.
Redness on arm, area warm to the touch. Growing area of redness, firm, size of a golf ball.
Patient was in the pharmacy to receive her second dose of shingrix. Pushed down on the plunger and medication did not expel once in the patient arm. Was in the upper left deltoid muscle, pushed down on the plunger but medication did not expel. patient stated it was a little painful so took out the syringe and the medication was not being injected. 0.5 ml still in the syringe. Patient thought maybe the shot was a little high but No bruising or swelling visible. Mixed a second shingrix shot, patient had no issues with the second vaccine. No particles in the syringe that were visible.  Patient stated the pain subsided, just normal pain associated with a shot with the second dose.
Shaking violently when  awoken, migraine, nausea, difficulty walking straight and fever
Inappropraite age at vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropraite age at vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropraite age at vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropraite age at vaccine) had resolved.
No adverse event; Patient received two Moderna bivalent Covid-19 vaccines; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received two Moderna bivalent Covid-19 vaccines) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 023H22A and AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Nov-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received two Moderna bivalent Covid-19 vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received two Moderna bivalent Covid-19 vaccines) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received two Moderna bivalent Covid-19 vaccines).    Concomitant medication was not provided.  The patient had no adverse reactions after both bivalent booster dose.  The patient received first Moderna primary series on 30-Apr-2021 lot number 004C21A. Patient received in the left arm. Patient reported no adverse reactions.  The patient received second Moderna COVID-19 vaccine primary series on 28-MAY-2021. Lot number 033B21A expiration date was not known. Patient received the dose in the left arm. Patient reported no Adverse Reactions.  Treatment information was not provided.
Heart palpitations, increased fatigue, shortness of breath, lightheaded ness. All of these symptoms have continued since the second shot and I am still experiencing them. I had a Holter monitor for 24 hours that showed no irregular heart rhythms, but am still experiencing heart palpitations that make me short of breath everyday. Some palpitations make me feel as though I am going to pass out.
Patient stated had pins and needles feeling and burning pain day after injection. Beginning three days after injection patient states he has a chicken pox like rash on neck and chest.
not feeling well; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (not feeling well) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well). At the time of the report, MALAISE (not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information provided.  Action taken with mRNA-1273 in response to the event was unknown
pt recvd vax 7nov94, devel cold, constant nasal drainage, chills, chest tightness; buzzing in ears;about 1 wk after inject; 28nov94 cont to feel "badly" w/ t of 99.3;
Day 1: approx 12 hrs after receiving shot, started feeling "out of sorts" and developed a headache. Overnight got feverish, chills, body aches. Day 2: continuation of fevers, chills, body aches, fatigue, loss of appetite, injection site pain and swelling - took TYLENOL and ADVIL all day. Day 3: same as Day 2, only less severe "flu like" symptoms, injection sight swelling = size of softball, very hard, hot and painful to touch, arm stiffness. Day 4: symptoms lessening, called doctor's office to report reaction. Day 5: no chills or fever, body aches almost gone, still tired and no appetite, injection sight same except swelling size = baseball. Day 6: flu-like symptoms gone, developed headache and sore, stiff neck, injection sight swelling size = golf ball, pain and stiffness subsided.
Minor syncope without head trauma: pt slumped in chair and the chief pharmacist (myself) was alerted. Pt was assisted to another room and laid on the floor until symptoms passed (roughly 15 minutes). Pt was monitored for an additional 30 minutes before leaving the vaccination site.
TOOK VIVOTIF WITH MINOCYCLINE; This spontaneous case report was received from a pharmacist (PVX2019-599) on 08-Mar-2019. It described a 17-year-old adolescent male consumer who "took Vivotif with minocycline". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis and oral minocycline for prevention of acne vulgaris.  It was reported that the consumer took first two doses of Vivotif while taking minocycline. The Vivotif doses were taken on 04-Mar-2019 and 06-Mar-2019, respectively.  The action taken with Vivotif and minocycline with respect to the event "took Vivotif with minocycline" was not applicable.  The clinical outcome of the event "took Vivotif with minocycline" was unknown.  Company's Comment: The causality of the event "took Vivotif with minocycline" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with minocycline" was considered as not applicable.
1212 - APPROXIMATELY 3 MINUTES AFTER RECEIVING VACCINATION, PATIENT BECAME FLUSHED AND C/O NUMBNESS & SWELLING OF MOUTH & TONGE.  STATES SAME REACTION SHE GETS FROM BEE STINGS.  SKIN COLL, MOIST, & FLUSHED.  FACE EXTREMELY FLUSHED WITH BEGINNING OF ANGIOEDEMA. 1215 EPIPEN ADMINISTERED INTO LEFT OUTER THIGH.  1217 - 911 CALLED.  1219 - VITAL SIGNS: BP 142/80, HR 94 RRR, RR 16, LUNGS CTA, DENIES SOB, DYSPNEA.  1221 - EMERGENCY PERSONNEL ARRIVED & PROVIDED EMERGENCY TREATMENT.  PT TRANSPORTED TO HOSPITAL VIA AMBULANCE.  11/25/08 Reviewed ER medical records of 11/8/2008. FINAL DX: acute allergic reaction Records reveal patient experienced SOB, redness & oropharyngeal swelling within 2 min of flu shot.  Tx w/epi & benadryl prior to arrival in ER.  Tx w/oral steroid & antacid.  Complete resolution of symptoms & d/c to home on continued steroid & antihistamine.
Initial and follow-up information has been received from a licensed nurse practitioner concerning a female patient who on an unknown date was vaccinated with the first dose of GARDASIL and now was complaining of vision problems. It was reported that the patient's mother called the office and told her daughter's physician that she experienced scarring of cornea after the first GARDASIL vaccination. The nurse practitioner stated that the patient was vaccinated with GARDASIL vaccine in her pediatrician office and not in her gynecologist's office. It is unknown if the patient received the second dose of GARDASIL vaccine. The final outcome was not reported. Additional information has been requested.
PT WAS BEING MONITORED FOR 15 MINUTUES, HE BECAME THIRSTY AND FAINTED/PASSED OUT AND HIT HIS HEAD. PARAMEDICS CALLED AND TAKEN TO HOSPITAL FOR EVALUATION/MONITORING
Diarrhea, Cold-like symptoms (coughing, dripping nose and a leaking left eye)
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Shingrix for prophylaxis. Concomitant products included Shingrix. On 28th August 2018, the patient received the 2nd dose of Shingrix. In August 2018, less than a week after receiving Shingrix, the patient experienced injection site pain, pain and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, pain and injection site erythema to be related to Shingrix. Additional information was received as follows: The patient experienced soreness at injection site, achy feeling and redness at injection site. For tolerance after the 1st dose of Shingrix, refer case US2018157105, reported by the same reporter. This case was also linked to US2018157107, reported by the same reporter.
Developed shingles around right eye. Symptoms began 4 days post-injection. I had received the Shingrix vaccine x 2 in 2018. I am currently treated by my PCP and ophthalmologist with valacyclovir and gabapentin.
Headache, Myalgia, Fever, site discomfort; headache, fatigue, sore throat, chills, muscle ache, chest tightness Narrative:  Day 1 - discomfort to inj site, headache, fatigue, chills, sore throat, chest tightness, muscle aches; Day 2 - discomfort to inj site, headache, chills, muscle aches
allergic reaction; cellulitis/arm had a rash and was hot it continued to grow until I was admitted to the hospital; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 25Feb2017 as dose number unknown, single (Lot number: R12276, Expiration Date: 01Feb2018) at the age of 50 years intramuscular, in left deltoid for immunisation; pneumococcal vaccine (PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE]), on 25Feb2017 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "SLL lymphoma", start date: 20Jan2017 (unspecified if ongoing), notes: diagnosed 20Jan2017, no treatments; "Immunocompromised" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CELLULITIS (hospitalization, intervention required) with onset 25Feb2017, outcome "recovered", described as "cellulitis/arm had a rash and was hot it continued to grow until I was admitted to the hospital"; HYPERSENSITIVITY (hospitalization, intervention required) with onset 2017, outcome "unknown", described as "allergic reaction". The patient was hospitalized for cellulitis (hospitalization duration: 2 day(s)). The events "cellulitis/arm had a rash and was hot it continued to grow until i was admitted to the hospital" required emergency room visit. Therapeutic measures were taken as a result of cellulitis.  Clinical course: The patient had cellulitis on 25Feb2017 and was admitted to the hospital due to the event. The patient received treatment and was fine now. The reported issue occurred after the use of the Pfizer product. The patient reported that soon after receiving vaccination, her arm had a rash and was hot and it continued to grow until she was admitted to the hospital. She was there 2 days. In 2017, the patient received oral antibiotics from her internist, had no relief at ER provided antibiotic shot in the tush, and next day she was admitted with IV antibiotics. She only had cellulitis after receiving pneumonia vaccination. She would like to know the ingredients to potentially rule out an allergic reaction. She thought she had an allergic reaction, as she ended up with cellulitis. The patient had no other products that were taken together with those indicated above.
Pain in her arms; Then all her Lymphedema disappeared for ever/the improvement on her hands and arms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in her arms) and THERAPEUTIC RESPONSE UNEXPECTED (Then all her Lymphedema disappeared for ever/the improvement on her hands and arms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 002A21A, 071F21A and 048L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Lymphedema (primary Lymphedema on both hands and middle of forearms for 40 years).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arms). In February 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Then all her Lymphedema disappeared for ever/the improvement on her hands and arms). At the time of the report, PAIN IN EXTREMITY (Pain in her arms) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (Then all her Lymphedema disappeared for ever/the improvement on her hands and arms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient was not enrolled in clinical trial.  Patient stated that she had a medical history of primary Lymphedema on both hands and middle of forearms for 40 years. However, 3 days after the first vaccine, on 06FEB2021, in the middle of the night, patient noticed some pain in her arms, then all her Lymphedema disappeared for ever. She stated that when she visited her doctor's office for her annual mammogram someone at the office also noticed the improvement on her hands and arms. She did share the vaccination site but mentioned that it may have been closed for good. Patient further reported that she had pictures of her hands and arms before vaccination and she can email them.   Patient received dose 5 of Bivalent Booster on 12OCT2022 (Lot: 060F22A) at a grocery store pharmacy.  Treatment medication information was not provided.
About 5-6 hours after the vaccine, my face developed raised, red bumps that severely itched.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), on 27Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.The patient had no known allergies. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid from 28Aug2023 to 01Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Malaise; After my second dose, high fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise) and PYREXIA (After my second dose, high fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and PYREXIA (After my second dose, high fever). At the time of the report, MALAISE (Malaise) outcome was unknown and PYREXIA (After my second dose, high fever) had resolved.            The concomitant medications were not reported. The treatment information was not provided.   This case was linked to MOD-2021-306174 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: follow up received on 8-SEP-2021 contains no new information
Fever from morning after vaccine (4/1) through 4/4.  Earliest temp check was 100.  Even with Tylenol, fever went up to 102.  By morning of 4/4 was back down to 100 and no fever 4/4 in the evening.  During time of the fever, I had body aches, chills and headaches.  The injection site in my arm was quite painful, but I felt so sick that it didn't really bother me.
Cellulitis Left thigh, red warm left thigh of almost all of anterior aspect with swelling.
received a dose of the Moderna COVID-19 Vaccine that expired on 25-JUL-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on 25-JUL-2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on 25-JUL-2021). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on 25-JUL-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided
Swelling of left upper arm around injection site, redness. Ice, diphenhydramine.
about ten minutes after the second dose, i got dizzy, felt like my heart was pounding out of my chest, hives around the injection site, and my tongue went numb. after the nurses checked my vitals, my blood pressure was elevated, i was tachycardic, so they administered oral Benadryl. after an hour of being closely monitored i was cleared to go. the next day, i was still really dizzy, nauseous, had body aches and bad headaches. that saturday, i went to the er at hospital for the same symptoms just worsening and now at this point my lymphnodes under my left armpit were very large. they proceeded to do blood work, gave me 2 liters of fluids, iv zofran and iv pepsid. the blood work had no signs of infection and was completely normal. the doctor then sent me home with zofran to help with the nausea and pepsid 2 times dailey to try to get the lymph node to come down. 1/27/21 i returned back to the er for chest pains and still dizzy, body aches, and headaches. all chest x-rays, blood work, and ekg were normal and they sent me home. still today 1/28/21 i am still very dixxy, have body aches, bad headaches, nauseous, have no appetite, short of breathe when walking short distances, and have swollen lymph nodes.