chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken with Paxlovid as a result of vaccination failure, covid-19.  Clinical information: The patient has taken treatment for covid-19 with paxlovid the treatment start date was 11Jul2022 and the treatment stop date was 17Jul2022. The patient took other medication product in 2 weeks are Topiramate, Spironolactone, Zantac, Amlodipine and Lexipro.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reports, "i broke my arm over a year ago, 2 hours after the shot, the arm felt like it was broken again in the same place it hurt so badly.  then about 10pm that night, i started in with bad chilling, muscle aches, joint pain, fever of 101.5.  my arm bruised at the injection site also.  the shaking was so bad it was difficult to walk"
no additional adverse events reported; patient was administered an expired vaccine today; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 29-OCT-2021, the patient was vaccinated with a dose of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) 1 dose, lot # S032826, expiration date 16-OCT-2021 (route of administration was not provided) for prophylaxis. No adverse events were reported.
07/25/2020  Around 2:00 AM she woke up with a fever of 102 or 103 degree and vomiting. She slept until around 9:00 in the morning and still had a fever. I gave her acetaminophen. Throughout that day I treated her fever with Tylenol. Her temperature peaked that afternoon at 104 degrees. Tylenol made her fever go down. She woke up several times during the night. Around 1230am, she was hallucinating and very confused saying things that did not make sense.  The next day she woke up around 7:30am. She also complained of neck pain. I gave her more Tylenol. I switched to Motrin around noon and that seemed to bring her fever down better. She went to her pediatrician's office that afternoon and was given a COVID test which was negative. Her doctor said everything looked good. Around 4 o'clock her fever went up to 104 again. Her fever does respond to Tylenol and Motrin. She woke up this morning at 03:30 and had a temperature of 105.5. I gave her Motrin, put a cool washcloth on her. When she woke up at 7:30am this morning her temperature was at 100.4 and she appears to feel better, but am not sure if she is just responding to the medication.
Pain, redness and swelling at the injection site; Pain, redness and swelling at the injection site; Pain, redness and swelling at the injection site; Muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Pain, redness and swelling at the injection site), VACCINATION SITE ERYTHEMA (Pain, redness and swelling at the injection site), VACCINATION SITE SWELLING (Pain, redness and swelling at the injection site) and MYALGIA (Muscle pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain, redness and swelling at the injection site), VACCINATION SITE ERYTHEMA (Pain, redness and swelling at the injection site), VACCINATION SITE SWELLING (Pain, redness and swelling at the injection site) and MYALGIA (Muscle pain). At the time of the report, VACCINATION SITE PAIN (Pain, redness and swelling at the injection site), VACCINATION SITE ERYTHEMA (Pain, redness and swelling at the injection site), VACCINATION SITE SWELLING (Pain, redness and swelling at the injection site) and MYALGIA (Muscle pain) outcome was unknown.        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.   No concomitant medications were provided.  No treatment information was mentioned.
Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: S/P PROSTATE CANCER, TAKES LUPON INJECTION EVERY 6 MONTHS AND IS NOT SURE IF THIS DATA HAS SOMETHING TO DO WITH HIS PROLONGED SYMPTOMS, NEXT DOSE OF LUPON DUE IN A COUPLE OF WEEKS FROM TODAY.
Didn't have allergies this season; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Didn't have allergies this season) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Didn't have allergies this season). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Didn't have allergies this season) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.
My 15yr old daughter received her 2nd GARDASIL vaccine on Monday 2/15/18. On Wednesday 2/7/18 she started to become dizzy, nauseas, and developed a headache. The nausea and vomiting has continued for 5 days. She also has a headache. She had had hot flashes and periods of dizziness over the past 5 days.
Patient was getting 2 vaccinations; 1 fluzone hd and 1 updated Pfizer booster. Flu was given on the left arm and Pfizer was on the right. At the begining of the vaccinations, patient reported that pharmacist picked up the Pfizer syringe and tossed the cap in the trash but realized he wanted to flu vaccine first so he recapped the needle using the cap that was previous tossed in the trash. Then he gave the patient the flu shot to the left arm. After that, he gave her the Pfizer on the right arm. That evening patient's right arm swelled and became red and she went to urgent care and received antibiotics.
Patient experienced fainting and fell to the floor .  She claimed to have a rapid heart beat but her blood pressure was 106/59 with a pulse of 69.  She felt dizzy for 40 minutes.  She stated she wanted fresh air and something to eat.  We offered bottled water and crackers.  She spit the crackers out stating she did not like the flavor.  We monitored her for over 45 minutes.  Assisted her to the restroom and monitored outside in the fresh air until she felt comfortable enough  to leave.   We recommended she contact her primary care physician for additional monitoring if the symptoms returned.  We called her at home 4 hours later and left a message inquiring how she was feeling.  No response.
pt recv vax 7NOV96 1030AM & 12noon gen itching started @ 6-7PM a trunk rash (reddened spotted) devel itching cont;3AM pt woke w/chills, shaking;8NOV96 rash persists & spreading to arms & thighs;MD ordered med;
VACCINE NOT ADMINISTERED IN DELTOID; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included heart disease, defibrillator, lupus, fatty liver, prediabetic, and high blood pressure, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 08:30, the subject experienced vaccine not administered in deltoid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine not administered in deltoid was not reported. This report was non-serious.  Version created to amend previously reported information on 11/MAR/2021. Upon review, the following information was amended: Company causality updated for event.
patient has some swollen, red knots that are thick and hard on her lower left arm (not at the sight of injection), itching on entire body, and patient has been breaking out in a cold sweat. patient was seen at dr office on saturday morning 9/14 and was given prednisone to treat the allergic reaction that she seemed to be having.
Patient reports that he had a stroke in September of 2021 and felt that it needed to be reported since he had the covid vaccine in March of 2021.
Flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 15-Dec-2020.  This case involves a patient of unknown demographics who got flu (Influenza ), while the patient received Influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date (unknown latency), the patient got flu (Influenza) every time when received influenza vaccine.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Two days later got really sick; Had flu like symptoms; She could barely talk; Her throat hurt; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was Unknown) via an unspecified route of administration on 12Jun2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She took the Pfizer shot for the 1st dose on 12Jun2021, two days later on 15Jun2021, the patient got really sick, her throat was hurt, she could barely talk and had flu like symptoms and was asking if this is normal and will it go away or should she go to her HCP. She was aware that Pfizer cannot give medical advice or treatment recommendations and was referred to her HCP. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Redness and tenderness to injection site. Also hot to touch. Patient given Augmentin 2 tabs PO BID for 7 days.
Severe chills; fever of 101F; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Severe chills), PYREXIA (fever of 101F), NAUSEA (Nausea) and HEADACHE (Headache) in a male patient of an unknown age 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 05-Feb-2021, the patient experienced CHILLS (Severe chills), PYREXIA (fever of 101F), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, CHILLS (Severe chills), PYREXIA (fever of 101F), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reported.
pt ran high fever 103 R x 3 days & high pitched cry x 3 days; pt was able to be comforted for 5-10mins @ a time;
Achey; Fever; Vomiting; Chills; Muscle aches and pains; Dizziness; Tiredness; Headache; Intense sweating; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9266) via an unknown route of administration in left arm on 04Mar2021 at 8:30 (at the age of 40 years) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6201) via an unknown route of administration in left arm on 12Feb2021 at 18:30 as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to penicillin, eggs, garlic and seasonal. Concomitant medications included Lexapro, Nuvaring, Collagen, turmeric and multivitamin (MANUFACTURER UNKNOWN) all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  On 04Mar2021 at 20:00 (within couple of hours) the patient experienced aches. About 14 hours after the second shot the patient had 101.9 (units and reference was not provided) fever with vomiting, chills, muscle aches and pains, dizziness, tiredness, headache and intense sweating. These lasted for about 48 hours. Since the vaccine the patient had lots of dizziness. Therapeutic measures included increase of Advil and Tylenol (dose unknown). The clinical outcome of the aches, fever, vomiting, chills, muscle pains, dizziness, tiredness, headache and sweating was recovered with sequelae on an unknown date.   No follow-up attempts are needed. No further information is expected.
51 yo F presented for wellness visit as first visit to clinic.  Allergy to sulfa (hives) documented.  First Shingrix vaccine was prescribed and given ~1200 2/7/22.  Patient developed unusual reaction to this vaccine which was described as diaphoresis and feeling hot about 1-2 minutes following the injection.  Patient then developed bilateral hand cramping with numbness/tingling of her hands and feet.  Patient's muscles in upper forearms and upper arms were relaxed but both hands flexed at the MTP joins.  Radial pulses @+ bilateral with symmetric sensation in hands and feet.  No other symptoms.  Symptoms began to resolve after ~15 minutes.  Allergy to Shingrix was added to patient's medical record. Per family member, patient has never had a reaction to a vaccination but has had these symptoms in the past.  Provided water, juice, ice packs, assisted with gentle opening of R hand. L hand able to relax on its own after ~5 minutes from vaccine administration, took longer for R hand to do so. Vitals re-checked and within normal limits.
High fever and Severe muscle aches. Started the evening of the injections and was completely gone the next morning
muscle pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After the first dose, on an unspecified date, the patient experienced muscle pain. The patient will go to the doctor because of her experience. The patient also had questions about how long the vaccine will protect her from the virus. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Huge bruise, swollen, lump at injection site, red streaks down arm, swollen wrist, pain, very tired.
throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: unknown) via an unspecified route of administration on the left deltoid, on 27Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetic for at least 15 years. There were no concomitant medications and no prior vaccinations within 4 weeks. On 28Jan2021, patient got a migraine and on 29Jan2021, the vomiting started which was so bad her throat was still sore. The migraine resolved as of the morning of 01Feb2021. The vomiting lasted 3-4 hours and resolved the same day (29Jan2021). It was done at a clinic at a local church. There were no treatment, she just waited it out and rehydrated. Outcome of the event throat was still sore was not recovered.
supracavicular fossa masses; This is a spontaneous report from a contactable consumer via a sales representative.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced supracavicular fossa masses on an unspecified date with outcome of unknown.    No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Joint Swelling; slightly light headedness; Brain fog; Slight headache; Joint Swelling and pain; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration on 09Mar2021 at 13:30 (at the age of 75 years) on right arm as a single dose for COVID-19 immunisation. Medical history included arthritis. The patient was allergic to shellfish and some antibiotics and she was not allergic to any other vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266) via an unspecified route of administration on 16Feb2021 at 13:30, on right arm as a single dose for COVID-19 immunisation. The patient did not receive any medication with in the 2 weeks of vaccination The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021, at 16:00, the patient slept for 12 hours and then she experienced slight headache, joint swelling and pain, brain fog, and slight light headed. It was reported that events continued even after 10 days after 2nd dose. No treatment received as a result of event. The clinical outcome of headache, joint swelling, joint pain and light headedness were not recovered.   No follow-up are attempts possible. No further information is expected.
Client received his first COVID19 Pfizer dose (Lot #EW0187 Exp:  08/31/21) on 06/15/21 at 1654.  Client was accompanied by a friend and after receiving the injection they were instructed by RN1 to sit in the observation room for 15 minutes.  At approximately 1710 client was sitting in a chair in the observation room and informed RN2 and EMT that he felt dizzy.  RN2 and EMT opened the zero-gravity chair for client to sit in and client was able to transfer himself into it.  EMT also gave client a bottle of water and he took a few sips.  Client reclined in the zero-gravity chair and EMT took his vitals at 1722 (BP:  160/104, HR:  102, O2Sat:  97).  RN2observed that client was alert and oriented to time, place, event & self and did not exhibit any cognitive impairment.  Client informed EMT and RN2 that he did not have any shortness of breath or trouble breathing.  Client also stated that he has a history of high blood pressure and fibromyalgia.  Additionally, client stated he was currently chewing nicotine gum because he had quit smoking two weeks prior.  EMT obtained vitals at 1731 (BP:  155/100, HR: 112, O2Sat: 97).  Client stated he was feeling a little better.  EMT took vitals at 1736 (BP:  151/102, HR: 109, O2Sat: 97).  Client stated he had eaten and drank plenty prior to getting vaccinated.  EMT took client?s vitals again (BP:  141/101, HR: 94, O2Sat: 97).  At 1755 client informed RN2 and EMT that he felt fine and was leaving.  EMT and RN2 observed client was using a walker and could stand just fine.  RN2 informed client that he should go to urgent care if he began to experience any dizziness and/or his blood pressure continued to exceed recommended guidelines. RN2 also recommended client monitor his blood pressure and seek medical attention if he began to experience any shortness of breath, trouble breathing, or chest pain.  Client and his friend then left the observation room.  EMT went to the Lead room at 1758 and informed Lead RN of the incident that just occurred with the client.  Lead RN reviewed details with EMT and determined that EMT and RN2 had not obtained a complete medical history on the client, determined what medications he was taking, and/or if he had any known allergies.  Lead RN immediately walked to the observation room with EMT and informed both he and RN2 of the proper protocol for follow if a client has a reaction to a vaccine.  Lead RN noted that while RN2 and EMT adequately monitored the client and documented their actions, they did not obtain all necessary information or notify a Lead or Co-Lead RN of the situation as it was occurring.  EMT and RN2 communicated that they now understand what the proper protocol is and will ensure that it is followed if future incidents occur.
Information has been received regarding a case in litigation from a lawyer and a 81-year-old patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-NOV-2014, the patient was administered the ZOSTAVAX by pharmacist at a pharmacy (lot number, dosage and route of administration not provided). In MARCH 2017, the patient was treated by a physician at an ophthalmology office for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves and economic losses. The outcome of the shingles was unknown. Additional information has been requested.