chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild headech; developed swollen arm; developed fever; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-May-2021. The most recent information was received on 19-Jul-2021 and was forwarded to Moderna on 19-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (developed swollen arm), PYREXIA (developed fever) and HEADACHE (mild headech) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced PERIPHERAL SWELLING (developed swollen arm) and PYREXIA (developed fever). On an unknown date, the patient experienced HEADACHE (mild headech). At the time of the report, PERIPHERAL SWELLING (developed swollen arm), PYREXIA (developed fever) and HEADACHE (mild headech) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up information received on 19-JUL-2021 contains significant information.New event headache added
pt recv vax;noticed some swelling around lt collar bone & tender to touch;pt wondered if rxn related to vax;sl tenderness;pt is going to see MD;
Patient received Bexerso, dose #2 in office today.  Patient left exam room and walked to front desk.  Patient noticed her feet feeling clammy and she was having difficulty seeing when she told her mom and her sister she was having trouble standing.  Patient sat in chair in waiting room and LPN called for help.  Patient pulse was 60 and she was pale and clammy.  MD came to assess patient.  Dstick was obtained per order and was 88.  Patient was able to stand and pivot to wheelchair and was brought back to patient room.  Patient BP was 78/58 upon arriving to patient room.  Patient laid down on exam table with legs elevated and drank sips of of water and ate an ice pop. Patient noticeably less pale and verbally stating she feels much closer to her normal self.  Patient drank full cup of water and BP was 88/64.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown gender and age. The patients' concurrent condition, medical history and concomitant therapy were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored VARIVAX (dose, route, lot# and expiration date unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. The vaccine was improperly stored at 15 to 46 degrees Fahrenheit for 1 hour and 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours 30 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 1 hour. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA010011: US-009507513-1708USA010012.
She might have had a tiny scratch in her throat a couple of days before onset of Fatigue/a tiny scratch or tickle in her throat; she may have gotten a little bit of her Rhinovirus; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in Arm Left on 11Jan2021 as (at the age of 41-years-old) as a single dose for covid-19 immunisation at hospital. The patient had no medical history. Concomitant medications included ongoing metoprolol 12.5 mg, once daily for an unspecified indication (Been on it for years never had any trouble). The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. There were no adverse events following prior vaccinations. No family medical history relevant to adverse event. It was reported that patient might had a tiny scratch in her throat a couple of days before onset of Fatigue; but it was very minor. Pertinent Details: Her daughter had a little runny nose, so she was tested and was positive for Rhinovirus; not COVID; caller assumed that she may have gotten a little bit of her Rhinovirus, but she did not even develop stuffy nose; just a tiny scratch or tickle in her throat. The patient underwent lab tests and procedures which included on 04Feb2021 Chest X- ray: showed nothing; full blood count (CBC): all normal and Basic Metabolic Panel-test, Result: normal; Mono: negative; tested for any respiratory illnesses in her nose: none, all normal. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Injection site pain mild, tiredness, headache, muscle pain, chills in overall body, cold feet and hands, feeling unwell, and diarrheas
Moderna vaccine was administered outside of facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------- J96.00 ACUTE RESPIRATORY FAILURE 4/10/2021 LEUKOCYTOSIS
Within 24 hours of shot, taken to hospital ER for hot red rash from chest (both front and back) to scalp.; very uncomfortable.; 2 weeks later back in ER with pins & needles sensation on entire right hand side of body including face and scalp; cold "icy/hot" feeling that it still primarily on the right side of body, but moves around the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101705887 (Pfizer).  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 16:00 (Lot number: FC3184) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Other medical history: Thyroid and adrenal issues." (Unspecified if ongoing); "Other medical history: Thyroid and adrenal issues." (Unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; HYDROCORTISONE; METFORMIN. Past drug history included: Penecillian, reaction(s): "Known allergies: penecillian", notes: Known allergies: penecillian. The following information was reported: RASH ERYTHEMATOUS (medically significant) with onset 30Oct2021 19:00, outcome "not recovered", described as "Within 24 hours of shot, taken to hospital ER for hot red rash from chest (both front and back) to scalp."; DISCOMFORT (medically significant) with onset 30Oct2021 19:00, outcome "not recovered", described as "very uncomfortable."; PARAESTHESIA (medically significant) with onset 30Oct2021 19:00, outcome "not recovered", described as "2 weeks later back in ER with pins & needles sensation on entire right hand side of body including face and scalp"; FEELING OF BODY TEMPERATURE CHANGE (medically significant) with onset 30Oct2021 19:00, outcome "not recovered", described as "cold "icy/hot" feeling that it still primarily on the right side of body, but moves around the body". The events "within 24 hours of shot, taken to hospital er for hot red rash from chest (both front and back) to scalp.", "very uncomfortable.", "2 weeks later back in er with pins & needles sensation on entire right hand side of body including face and scalp" and "cold "icy/hot" feeling that it still primarily on the right side of body, but moves around the body" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash erythematous, discomfort, paraesthesia, feeling of body temperature change with steroids and antihistamines.  Clinical course: Patient have had a daily reoccurring red hot rash, and now 7 days of pins/needles. Now working w/5 doctors to try to get some, answers. Nothing has stopped in 21 days or let up. 21 days of a rash and the past 7 with pins & needles; very uncomfortable. Patient was not received any other vaccine four weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination. Since vaccination patient not tested for covid-19.  Follow-up attempts are completed. No further information is expected.
Resident found with generalized tremors, BP 156/73, P 129, R 24, T 98.4 O2 sat 83% on room air, increased to 93% on 2 liters NC, vomiting clear emesis. Sent to ER at 09:10 AM 10/2/2014.
Fever, fatigue, achiness  This reaction started at 8PM and continued to worsen until 12PM. I continued to have a fever all night and throughout the next day until 10PM the following day. I took Tylenol every few hours, but still had a fever and body achiness. I am feeling better today but am still sick. I have stayed in bed and remained at home.
Prior titter / of 3.1 (as reported) received Engerix-B/ and / had same titer 3.1; Received Engerix-B on 21-Oct-2020, 19-Jan-2021 and 21-Jun-2021; Received Engerix-B on 21-Oct-2020, 19-Jan-2021 and 21-Jun-2021; This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Engerix B. On 19th January 2021, the patient received the 2nd dose of Engerix B. On 21st June 2021, the patient received the 3rd dose of Engerix B. On 19th January 2021, not applicable after receiving Engerix B and Engerix B, unknown after receiving Engerix B and not applicable after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too long. On 21st June 2021, the patient experienced drug dose administration interval too long. On 2nd August 2021, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased, drug dose administration interval too long and drug dose administration interval too long were unknown.  Additional details were provided as follows: The age at vaccination was not reported. Health care professional reported that the patient had a prior titer of anti hepatitis B titers of 3.1. The patient received Engerix B longer than the recommended interval, which led to lengthening of vaccine schedule. On 2nd August 2021, a blood sample was drawn and the patient had the same titer 3.1, which led to therapeutic response decreased. The reporter consented to follow up.
fatigue; headache; muscle pain; joint pain; chills; nausea and vomiting; fever starting about 12 hours post-vaccine and continuing for about 36 hours Took Tylenol Headache (250 mg acetominophen; 250 mg aspirin; 65 mg caffeine) at around 7:30 am on 11/16 and again at 7:30 pm 11/16
thin, high squealing & screaming, high fever, white skin & blue lips, unresponsive, blank staring eyes;
At 2:00am, I had severe pain on the right side of my head...very severe headache, face pain, ear pain, jaw pain that included my teeth being very sensitive.  Tylenol helped ease the pain.  It lasted 13 hours.  The following night, I had the same exact pains on the left side of my head that lasted 12 hours.  For 2 days after, I had a few twinges of pain on the left side of face, mostly below the ear, didn't last more than a couple minutes.
Wheel was not observed during administration.  Repeat dose administered.  Lot number, manufacturer, expiration date of the repeat dose is the same as the initial dose.
Legs were weak; Left arm hurt (where the application was made); Headache; Eyes hurting; Little dizzy; Tired; A lump under arm pit; Tingling left arm and chest; Difficulty to breathe (like anxiety, but it was not); Feel a pinch on back with some pain; Lump under arm pit hurting; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 at 20:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). The patient had no known allergies. Concomitant medications included ascorbic acid (VIT C), vitamin b nos (VITAMIN B), colecalciferol (VIT D3) and fish oil (OMEGA 3); all for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Apr2021 at 20:30 on the first day of vaccination, left arm hurt for the patient (where the application was made), then the patient experienced  headache, eyes were hurting, little dizzy and tired. On 24Apr2021 on second day of vaccination, his left arm hurt, he also felt dizzy, tired and legs were weak. In Apr2021 on third (25Apr2021), fourth(26Apr2021) and fifth day(27Apr2021) of vaccination the patient's  left arm hurt, legs were weak, a lump under his arm pit was hurting, he felt tingling in his left arm and chest and experienced difficulty to breathe (like anxiety, but it was not) and on sixth (28Apr2021) and seventh day (29Apr2021) of vaccination, the lump under his arm pit was hurting, he felt tingling in his left arm and chest, and found it difficult to breathe. The patient also , felt a pinch on his back. The tingling sensation was bothering him. It felt like when you applied a bengay (hot and cold, but with some pain). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events left arm hurt (where the application was made), headache, eyes hurting, little dizzy, tired, legs were weak, lumps under arm pit hurting, felt a pinch on back with some pain, tingling left arm, a lump under arm pit and chest and difficulty to breathe (like anxiety, but it was not) was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt received ZOSTAVAX shot during flu clinic on 9/16/10. On Sat (9/18) she called to say her arm was swollen, painful, hard & hot I said to apply ice and call back if not resolved. She went to Immed Care on Sun, 9/19/10 & Dr treated her w/AUGMENTIN. Pt went to see Dr (whom I apprised of event) early last Wed for follow-up.
10/17/15 Patient came in and stated about an hour after receiving the flu shot (Fluzone High-Dose), her arms kept twitching in a "palms facing up then palms facing down manner", shooting sensation up and down the spine, and difficulty breathing. Patient was unable to call for help due to the twitching. The symptoms ended about an hour after they started. She had a consultation with a physician (for an unrelated reason) and mentioned these symptoms. The MD thought it could be Guillain-Barre. The patient is following up with her Primary Care Physician this week. When asked if the patient was "feeling sick" or had an infection she stated that she thought she may have had a UTI the Monday before and that the MD was awaiting culture results.
PATIENT STARTED NOTICING PAIN IN LEFT  DELTOID MUSCLE THAT DID NOT SUBSIDE AFTER 3 DAYS. HAS TROUBLE LIFTING ARM OVERHEAD. IS CURRENTLY TAKING TYLENOL AS RECOMMENDED BY HER PRACTITIONER.
Approximately 3-4 minutes after receiving MENACTRA and GARDASIL-9, patient was sitting up on exam table and felt nausea, abd pain and blacked out followed by falling onto ground. She then became conscious. BP stable. Pt was lying down for approximately 10 minutes, wanted to sit up but 5 min later, felt dizzy again. After lying down again approximately 10-15 min, pt recovered and symptoms resolved.
On June 3, 2022, I woke up and I was very tired and was tired all day. The next day I had a sore throat and congested, and I had bad body aches. The body aches lasted about two days. I tested positive for COVID-19 on June 4th. On Sunday I began getting a cough and had a low-grade fever, nothing over 100.4. I was pregnant during this infection, so I was watching my temperature closely. Mid-week I lost my taste and smell. I had fatigue for two or three weeks. I lost my sense of taste and smell for about a month and half, as of today.
Pt had vaccine on Friday 1/22 and then had dermal filler on Monday 1/25.  Patient had previously had filler with no reaction and at this treatment has significant swelling and pain in treated area along with itching of treated area and throat  and tongue.
no adverse effects; an expired dose of VAQTA was given; This spontaneous report was received from a nurse concerning a 2-year-old male patient. There were no concomitant medications, pertinent medical history and drug reactions/allergies were reported.  On 27-MAR-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection 25/0.5 (units unknown), lot # R010368, expired date 25-MAR-2019 (dose and frequency were not reported), intramuscular in the right thigh for prophylaxis. The hepatitis a vaccine, inactivated (VAQTA) did not have any prior temperature excursions. No adverse effects reported.
I  GOT A STIFF NECK THAT EVENING THAT LED TO A SEVERE HEADACHE AND NAUSEA  WITH LITTLE ENERGY FOR  4 -5 DAYS
No adverse event; Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date).    No concomitant medication was reported.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant Follow-up received; Patient information and vaccinations details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
fever; chills; sore throat; cough; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 06:00 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included measles vaccine, mumps vaccine, rubella vaccine (MMR) taken for an unspecified indication, start and stop date were not reported; meningococcal vaccine (MENINGOCOCCAL VACCINE) taken for an unspecified indication, start and stop date were not reported.The patient previously took doxycycline and experienced drug hypersensitivity.The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not received 2 weeks other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On Feb2021 the patient experienced fever, chills, sore throat, cough. The patient underwent lab tests and procedures which included blood test: unknown result on 25Feb2021, chest x-ray: unknown result on 25Feb2021, sars-cov-2 test: negative on 12Feb2021.Therapeutic measures were taken as a result of fever, chills, sore throat, cough. Ae treatment included antibiotics/chest xrays/blood work. The outcome of event was not recovered.  Information about lot/Batch number has been requested.     ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021228456 similar report from same reporter
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: profused sweating and dizziness x1 minute-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt came back to pharmacy a couple of hours after the vaccination to report said symptoms, pt seemed very coherent and came back to normal functions when talking to him at the consultation window
I had 2 mini strokes. I was unable to walk for a few days and was dizzy. I was taken to the emergency room and admitted for 3 days.
patient felt dizzy and had to sit on the curbside by the time he got in the parking lot
Severe, persistent joint pain and aches in bones. Right arm specifically is weak, sore.
pt recv vax & devel macular rash;4d later devel fever & diarrhea;pt fussy & not sleeping well;viral synd poss 2ndary to vax;swelling of groin;tender firm lymph nodes;testicles enlarged & tender;dx post-vax mumps orchitis & inguinal lymphade
No further AE's reported; administration of improperly stored doses of ROTATEQ and PEDVAX HIB; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On an unknown date, both vaccines of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion. The temperature excursion was above 47 Fahrenheit degrees (47.5 Fahrenheit degrees) for 0 hours 20 minutes 0 seconds, above 47 Fahrenheit degrees (46.7 Fahrenheit degrees) for 0 hours 10 minutes 0 seconds and above 47 Fahrenheit degrees (47.1 Fahrenheit degrees) for 0 hours 20 minutes and 0 seconds. On 15-FEB-2022, the patient was vaccinated with the improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 ml one time, lot# 1742464, expiration date 20-SEP-2022; strength was not reported) orally and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (0.5 ml one time, lot# U024089, expiration date 27-OCT-2023; strength, route of administration and anatomical location were not reported), both for prophylaxis (product storage error). There was no previous temperature excursion. No further adverse event (AE) was reported.
Patient seen by primary provider for redness, swelling, warmth and pain. After receiving vaccine at convenient care.