chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels really bad (worse than 1st dose); Tired; Muscle aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (received 1st dose in January 2023 and also experienced Covid, refer case US2023AMR046548).   On 26-MAR-2023 20:00, the patient received the 2nd dose of Shingrix (right arm). In MAR-2023, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: Feels really bad (worse than 1st dose)), tiredness (Verbatim: Tired) and muscle pain (Verbatim: Muscle aches). Rechallenge with Shingrix was positive. The outcome of the feeling bad, tiredness and muscle pain were unknown.   It was unknown if the reporter considered the feeling bad, tiredness and muscle pain to be related to Shingrix.     It was unknown if the company considered the feeling bad, tiredness and muscle pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR046548   Additional Information: GSK Receipt date:27-MAR-2023 The patient self-reported this case. Patient received 2nd dose of Shingrix around 8 PM, and she reported that she was feeling really bad, (worse than the 1st shot of Shingrix), was tired and had the muscle aches, she stated that muscle ache could be contributed to just having got back from the gym that morning. The patient did not have a lot for her 2nd dose, as she threw away the paperwork.  The reporter did not consent to follow-up.  The patient stated safety could follow up with her pharmacy if necessary.; Sender's Comments:  US-GSK-US2023AMR046548:Same reporter
it might be blood clot; I have a node on my left leg; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left in Oct2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination: 48-year-old). Medical history included asthma, ongoing Blood pressure high, allergies, headache. The concomitant medication included cetirizine for High blood pressure (as reported). No Prior vaccinations received Within 4 weeks. In Oct2021 the patient had a node on the left leg, it's like a 'bulb', it had never been there and you can find it, it had never been there, it might be blood clot. No treatment received for the event. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a 77 year old female patient concerning herself. The patient had no pertinent medical history or drug reactions/allergies. On 13-JUL-2015, the patient was vaccinated with ZOSTAVAX (dose, route, lot# and expiration date were not reported) in her arm. There was no concomitant medication. On 13-JUL-2015, the patient experienced "pain in her arm at the injection site when she moved her arm while using ZOSTAVAX". On unknown dates, the patient sought medical attention from an unspecified physician on two occasions. No lab diagnostics studies were performed and no treatment was given for the event. The patient reported that she was recovering and the pain in her arm still persisted when she moved her arm. Causality assessment was not reported. Additional information has been requested.
pt felt dizzy and vomited immediately after vaccine administered, no hives/itching or trouble breathing, no loss of consciousness, pt said this reaction happens after every vaccination they have ever had
Information has been received from a physician concerning a female who was vaccinated IM, 0.5 ml, with a dose of GARDASIL and then fainted. The patient sought unspecified medical attention. There were no laboratory studies performed. The patient had recovered immediately afterwards. Additional information has been requested.
3x5 inch area in SQ tissue on back of upper arm from below deltoid to elbow, firm, raised, red and very warm to touvh. Also tender to touch.
dizziness; mild headache that was light tightness around head; nausea; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (mild headache that was light tightness around head), NAUSEA (nausea) and MYALGIA (Muscle pain) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer surgery (Patient had a lung cancer surgery recently).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-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 DIZZINESS (dizziness), HEADACHE (mild headache that was light tightness around head), NAUSEA (nausea) and MYALGIA (Muscle pain). At the time of the report, DIZZINESS (dizziness), HEADACHE (mild headache that was light tightness around head), NAUSEA (nausea) and MYALGIA (Muscle pain) outcome was unknown.            Concomitant medications reported were Heart medication, Prostate medication, Tranquilizer (not specified). Treatment details included  Tylenol and an antihistamine taken prior to the vaccine (prophylactic).
Itchiness - arms, back, shoulders, face.  First aid squad called.  Patient refused to be transported to E.R. and signed release.
Fever 102; Fatigue; Headache; Dizziness; Weak; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Sep2021 at 16:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies (reported as none that the patient knew of). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Aug2021 at 16:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. On 18Sep2021 at 03:30 (reported as 12 hours after second shot), the patient experienced fever 102 (unspecified units), fatigue, headache, dizziness and was weak. On 19Sep2021 at 00:30, at hour 32, the fever remained at 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 102 (unspecified units), headache, fatigue, dizziness, and weak was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right boob is bigger than the other one, looks swollen; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Right boob is bigger than the other one, looks swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) and FENOFIBRATE.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced BREAST SWELLING (Right boob is bigger than the other one, looks swollen). At the time of the report, BREAST SWELLING (Right boob is bigger than the other one, looks swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Mammogram: unremarkable. unremarkable..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment was reported for the events.
I started getting a rash on my legs around 3/12/21, after getting the 2nd Moderna vaccine it becam severe, itchy, painful with swelling of my legs. I went to my doctor on 3/15/21 & 3/22/21 and the rash was diagnosed as vacuities (angiitis).  I took steroids for about 5 days and the rash began to resolve.  I had optic neuritis in my left eye a number of years ago.  Since then, I have had occasional visual/ocular migraines. On 3/29/21, I had the flashing lights, associated with a visual migraine, dizziness, slurred speechand an inability to focus. It felt as if my eyes were working independently. This resolved, blind spot in my left eye, after about 30 minutes.
This initial report was received from a consumer, as part of a marketing research and refers to a 2 currently adult female patients. The patients' concurrent conditions and medical history was not reported. There was no concomitant medication reported. On an unknown dates, the patients were vaccinated with GARDASIL (lot number, expiration date, dose, route of administration and anatomical location were not reported). On an unknown date, the patients experienced unspecified adverse events following the immunisation. The outcome of adverse event following immunisation was unknown. The causality assessment between the event and the suspect therapy was not reported. Additional information is not expected as the reporter did not consent for new follow-up attempts.
Failure to seroconvert for mumps antibodies / The titres were positive for measles and rubella, but not for mumps; a patient [...] received a dose of MMR II on an unknown date in the past / the patient is currently pregnant; This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.      On an unknown date (reported as in the past), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, subcutaneous (dose, lot number and expiration date were not provided) for prophylaxis (reported as vaccination). On an unknown date, the patient had the anti-mumps titres drawn. The titres were positive for measles and rubella, but not for mumps. On an unknown date, the patient became pregnant. The date of last menstrual period (LMP) and estimated date of delivery (EDD) were not provided. The pregnancy outcome was pending at the time of the report.   The patient consulted with the physician. No treatment was given. The patient did not experienced a cancer. The patient did not overdose.   The outcome of the event of mumps antibody test negative was reported as not recovered.  The relatedness between mumps antibody test negative and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Right hand swollen and itchy.  Blisters on right hand.  I have the same reaction to Penicillin.
arm hurt immediately; felt like foggy/as soon as I took the shot I knew i got something; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt immediately) and FEELING ABNORMAL (felt like foggy/as soon as I took the shot I knew i got something) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurt immediately) and FEELING ABNORMAL (felt like foggy/as soon as I took the shot I knew i got something). At the time of the report, PAIN IN EXTREMITY (arm hurt immediately) and FEELING ABNORMAL (felt like foggy/as soon as I took the shot I knew i got something) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided for first dose. List of concomitant medication were not given.   This case was linked to MOD-2021-235605 (Patient Link).
1st dose- He was tired a little bit; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported same event for two patients. This is the second of two reports.  An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. Medical history included diabetes from 2011 and ongoing (diagnosed about 10 years ago), cancer removed from his buttocks the beginning of the year (2021), within the last 5 to 6 months; had stent put in and surgery for a valve replacement at the beginning of the year (2021). The cancer on his buttocks was done by removal by the dermatologist, this was recent within the last 5 months when a spot was noticed. She thinks it was within the last 5 to 6 months. It was either a basal or a squamous and they didn't feel it was bad and they had removed it all. The patient is on a lot of medications because of his heart and he is post CA (clarified as meaning cancer), and he is diabetic but there is nothing that is out of the ordinary for him. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient was tired a little bit and the reporter thinks that it began that same day probably within an hour or two after they got the dose 1 of COVID vaccine in the afternoon. Her husband's tiredness didn't last as long as hers did. The reporter added that for patient's 1st dose, he didn't have any effects basically. The patient was reluctant to get the COVID vaccine at first but at their age they knew that they needed to be protected. They had the fear more out of the quickness on everything and how all at once they had the vaccine but not being a medical people, they listened to their doctors. The outcome of the event was recovered on 24Feb2021.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021595075 same drug/event, different patient
After Booster: 3 days joints felt like cement was in them  1 week later: Post Menopausal Bleeding
patient had vaccine on 4/17/2021. on 4/25 in evening started having hives over body and itching. in the morning full body was covered in hives rash, itching.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site, Site: Swelling at Injection Site-Mild
pt recv vax & pt devel chicken pox w/five to six lesions or less;nurse reported 3 patients;
low fever, chills, generally feeling bad and pain in upper left abdoman under rib that was similar to kidney stone, intermittent not constant, lasting all night and next day.
01/28/2009 pt report n&v, confussion,HA,lip swelling & numbness.  2/23/09 MR received for several OVs beginning 1/8/09. Seen prior to vaccine for viral URI and rash. Returned 1/28/09 with c/o swollen lips with numbness, nausea and headache.  At school became had H/A at R temple with R eye pain and slightly disoriented. Still slow to respond and confused in office, had difficulty following commands. Assessment:  H/A.  paresthesia. Nausea.  Confusion.  Sent for labs and CT.
Chills, profuse sweating at about 8:30,continuing overnight.  Aches, nausea 10pm. Racing heartbeat lasted over 24 hours. By morning vomiting, dizziness and weakness. Injection site swollen and raised -area about 6inches across. Hives up shoulder and down injected arm. 10/03/2014. Have developed a cough but that could be caused by vomiting.
does not feel right.; tightening of her throat; felt like she was choking; severe fatigue; muscle aches / described / felt like her legs were going to fall off; headaches; lethargy; sore throat progressively worsened; raspy voice; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2021 06:30, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, 12 hrs after receiving Shingrix, the patient experienced fatigue, myalgia of lower extremities, headache, lethargy, sore throat, hoarse voice and choking sensation. On an unknown date, the patient experienced feeling unwell and throat tightness. On an unknown date, the outcome of the fatigue, myalgia of lower extremities, headache, lethargy, sore throat, hoarse voice, feeling unwell, choking sensation and throat tightness were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, myalgia of lower extremities, headache, lethargy, sore throat, hoarse voice, feeling unwell, choking sensation and throat tightness to be related to Shingrix.  Additional details were reported as follows: The patient reported receiving her first dose of the Shingrix vaccine at 6:30PM. The patient stated that she does not feel right. The patient further described this feeling by describing her symptoms. She stated that on the next morning at 9:30AM, she started to have severe fatigue, muscle aches, headaches, lethargy, raspy voice, and a sore throat. She stated that her sore throat progressively worsened and she felt like she was choking on the evening of 8th April 2021 and had to drink water. She further described her sore throat by describing it as a tightening of her throat. She further described her muscle aches by stating that it felt like her legs were going to fall off. She states that the fatigue, muscle aches, headaches, lethargy, raspy voice, and sore throat was still present and not resolved. Patient declined to provide an address or fax number for herself. Patient was unable to provide an email address or fax number for her HCP as well as the dosage and lot number or expiration date for the first Shingrix dose she received. GRC rep did not obtain the phone number of the health care professional. The reporter consented to follow up.
Fatigue; Hot flashes; intense nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of HOT FLUSH (Hot flashes), NAUSEA (intense nausea) and FATIGUE (Fatigue) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Concurrent medical conditions included Migraine since 2008, Nausea and Allergy to antibiotic (maculopapular rash).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-Nov-2021, the patient experienced HOT FLUSH (Hot flashes) and NAUSEA (intense nausea). On 04-Nov-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with ONDANSETRON (oral) ongoing since an unknown date for Migraine, at a dose of 8 milligram as necessary. On 03-Nov-2021, HOT FLUSH (Hot flashes) and NAUSEA (intense nausea) had resolved. On 04-Nov-2021, FATIGUE (Fatigue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HOT FLUSH (Hot flashes), NAUSEA (intense nausea) and FATIGUE (Fatigue) to be related.    Three hours after the vaccine administration had intense nausea and hot flashes not associated with migraine. The patient took 8 mg ODT of Ondansetron  and symptoms resolved after 45 minutes. No other adverse experience were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2021: Follow up received on 07-Nov-2021. Updated patient demographics, medical history, dose 1 and dose 2 details, and event fatigue updated.
pt rcvd adult dose of COVID-19 Pfizer vaccine.  Pt was a little achy the 1st day but doing great per dad on day 2.
The night of the vaccine, got itchy hives on torso, legs, and swelling on lips and hands intermittently for 5 months afterward (until mid-Jan 2020). No previous history of this. Oral antihistamines controlled it.  Elected to skip 3rd in series.
Chest pain with left arm numbness for 10 min duration. BP 110/80, HR 63, O2 99% RA. ASA 325 given and 911 called
made me soooooo sick; Initial information received on 28-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer via social media via Digital Media.    This case involves Adult female patient (age unknown) who experienced made me soooooo sick (illness)while receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer batch number, expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.   an unknown date the patient experienced a non-serious made me soooooo sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"The flu shot made me soooooo sick. Won't be doing it again".  It is unknown if the patient experienced any additional symptoms/ events.   It is unknown if there were lab data results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the reported event was unknown.  There will be no information on the batch number for this case.
Patient had a vasovagal response and fainted a few minutes after her injection.  She was unconscious, not breathing for a few seconds as her head fell to her chest, but resumed breathing when we opened her airways.  Her body seized upon taking in air and 911 was called.  She regained consciousness before the paramedics arrived and her vitals were within normal limits when they checked her.  Pt went home on her own  with mom.
Patient had an immediate headache, chills, pounding heart, tachycardia. B/P was elevated at 150/94, HR of 124. Pulse ox was good at 100% on room air. Patient then became warm, started taking off blanket, patient felt like something was stuck in her throat and like it was harder to breathe. Said throat felt like it was closing. 911 called and 0.3 mg Epinephrine given. Patient transferred to local hospital
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. Between 05-MAR-2018 and 06-MAR-2018, the patient received a dose of improperly stored ROTATEQ (lot # N005617, expiry date: 03-OCT-2018) and LIQUID PEDVAXHIB (lot # N016991, expiry date: 07-MAR-2020) (product storage error). The temperature excursion ranged between 58.6 Fahrenheit (F) on an unknown date for a time frame of 4.5 hours. There was no previous temperature excursion. The call was not because of a data logger. No adverse effects were reported. Product quality complaint was not involved.