chrisvoncsefalvay/vaers-outcomes huggingface dataset:
congestion and runny nose; congestion and runny nose; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients (herself and her husband). This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced congestion and runny nose on an unspecified date. The clinical outcome of congestion and runny nose  was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021042569 same drug/events/reporter, different patient
woke up not feeling well, injection site red & swellon, as day progrssed became sicker with flu like symptons, tired, achy,. developed low fever of 101. about 2pm, took 2 tylenol, at about 5 pm went to use bathroom started feeling dizzy, then fainted. after about 5 min  bp 107/53 pulse83. wen to bed, got up the next am felt much better, as day progressed felt fine
Patient received the varicella vaccine on 06/26/09 (2nd dose). On 06/28/09 the parent notified the office that patient developed a three inch welt at the injection site. Mother has been applying an ice pack to the area, and the swelling has lessened.
pt recv vax 30SEP97 & 28OCT97 exp malaise & lymphadenopathy;
FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) once a total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
Patient reported experiencing hives on body beginning 1-2 days after vaccination and continuing x 1 wk. Still has hives as of 11/16/11.
Information has been received from a physician referring to a 2 month old patient of unknown gender. The patient's pertinent medical history and concurrent condition were not reported. On 16-AUG-2015, the patient was vaccinated with PNEUMOVAX 23 (strength, lot#, expired date, dose and frequency were unknown). No adverse effect reported. Additional information has been requested.
Tingling sensation on both sides of his body; Sweated at night; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation on both sides of his body) and NIGHT SWEATS (Sweated at night) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PARAESTHESIA (Tingling sensation on both sides of his body) and NIGHT SWEATS (Sweated at night). On 25-Aug-2021, PARAESTHESIA (Tingling sensation on both sides of his body) and NIGHT SWEATS (Sweated at night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product includes High Blood Pressure medication. Treatment information was unknown.
Moderna COVID-19 Vaccine EUA.  Fever and head ache hit abruptly and strongly at 4:45 PM.  It was not long after that I vomited.  A short while later, a 2nd vomit and then a vomit during the early morning hours between 12:00 AM and 1:00AM.  Fever was significant until approximately 05:00 AM of April 1, 2021.  Fever subsided.  Lingering head ache lasted until approximately 2:00 PM on April 1, 2021.  Minor to no site soreness for this vaccine.  The first vaccine (012A21A) only consisted of site soreness for approximately 4 days following the vaccine.
This spontaneous report as received from an unknown reporter refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of incorrect storage GARDASIL (lot # J003727, Expiration date 07-NOV-2015) (dose and route unspecified). This is one of several reports from the same source (linked MARRS#: 1310USA014881, 1310USA014883, 1310USA014888, 1310USA014891, 1311USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311USA000012, 1310USA014858, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1310USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA105090, 1311USA000067, 1311USA000064, 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1311USA000053, 1310USA015101, 1310USA104850, 1311USA000075, 1310USA104895). Additional information is not expected.
Right after injection, the patient felt the pain on the injection site. Apparently, the injection went to the tendon area of the patient. She tried to resist the needle and probably  in the process, I might have hit the tendon. She was in so much pain that in the same evening she went to the emergency room. It was confirmed by the doctor that the tendon was hit. She was given Naproxen 500mg to take.
retinal aneurysm, loss of job, coughing spells, dizzy spells, blood sugar was very high/low(uncontrollable directly after shot), several emergency room visits,ENT specialist
Irritation at site, chills, fever, shivers, tightness in tendon of right hand, swollen lymph node under right arm. Pt diagnosed with cellulitis. Pt treated with Nafcillin.
I had started getting headaches. I never had headaches like this before. I had pain on my back side of my body. I had pain below my belly button. These symptoms have been going on for about month now.
One week post vax, the pt developed a "severe stiff neck" which resolved after 4-5 days. Following the 2nd dose, she developed a "frozen left shoulder". An MD visit was required and the physician recommended physical therapy. The "frozen shoulder resolved 5/00. The most recent information received on 6/22/00 reports the outcome of the event as resolved.
Covid vaccine was given 10/9/21. When this provider called patient for other reason (billing), her husband answered and he reported to me that his wife had a "stroke" 2 days after she received her 3rd dose of Covid vaccine and she is currently in SNF.
SEVERE SWELLING, REDNESS AND PAIN TO INJECTION SITE. PT WENT TO ER AND WAS TREATED WITH NAPROXEN AND TYLENOL. F/U AT THIS CLINIC ALSO ORDERED BETAMETHASONE CREAM AND INSTURCTED TO USE ALTERNATING HOT AND COLD COMPRESSES.
no adverse outcome, realized vaccine expired 4/16/22 and was given on 4/18/22, verified with Moderna that dose was valid and did not need repeating.
Hypotension, severe lethargy, dysphagia.   supportive treatment, BP has improved as of day of reporting, still lethargic, continued dysphagia
patient reported feeling lightheaded immediately following vaccine. She was advised to stay for an additional 15mins after the initial 15min observatory period and we would reassess. Stated she was still lightheaded and had stomach pain as well 30 mins after vaccination.  Rph on duty gave her a bottle of water and granola bar to settle her stomach. She tried standing up/walking and continued to feel dizzy. Patient had someone pick her up and drive her home. Rph checked on patient 30 minutes later as the pharmacy was closing and pt said she was laying down at home, did have 1 episode of vomiting and the dizziness/lightheadedness was better because she was laying down. While talking to patient on the phone she also stated she has had episodes of vertigo in the past so she was unsure if this was vaccine related or not, and also had some hesitancies about getting the Covid vaccine but ultimately did. Rph told patient she would submit a VAERS and follow up with patient tomorrow.
Received flu vaccine at around 0940-0945 on Thurs 11/20/14. Left to return to work area. About 15 min later began to experience itching in mouth, back of throat, eyes and ears. Called Employee Health and was directed to ER for supportive care. Was given P.O. BENADRYL with no effectiveness. Followed up with IV BENADRYL and symptom relief. Discharged after 2 1/2-3h ER visit. Off work x 1 day to cont oral BENADRYL treatment.
I developed a Pulsatile Tinnitus on my left ear. I had like a hard bit on my ear, I spoke to the doctor in a radiology department, they did a Pure-tone audiometry.
No additional AE information; a patient was inadvertently administered an expired dose of VAQTA; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 20-DEC-2019, the patient was inadvertently administered an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (strength, dose, route of administration and anatomical site of vaccination were not reported; lot number R025518, expiration date 15-NOV-2019) (expired product administered). There was no temperature excursion. No additional adverse event information was provided.
Worked ICU Mon, Tue, Wed ...hands painful each day by Wednesday unable to open IVF bags or spike medications to IVF bags. Lifting people in bed or making fist and pulling against gravity was extremely difficult. My hands where very weak and painful. I text PA from my unit about my concern. He suggested that I get my labs drawn - most specifically inflammation marks. I will follow up with my PCP again this month. My labs drawn 8/9/19,  8/12/19 I became bed confined for 3 days with severe muscle weakness and pain. Then went to Urgent Care for Strep throat, on antibiotics and missed 3 days work. Continue to have weakness and pain in my hands with daily activity.
C/o blurred vision, lightheaded, diaphoretic. Became rigid and syncopal episode occurred x 10-15 seconds. Pt was incontinent of urine.
pt recv vax 25JUL97 & to clinic w/ c/o dizziness, chills, n/v & h/a, palpitations;given NS, BP 66/29;adm to hosp given med;
Approximately 6 to 8 weeks after receiving my second Pfizer Covid-19 vaccine, I developed tinnitus and hearing loss in my left ear.
Flu like symptoms (nausea, vomiting, fever, headache, chills, lethargic) swelling, large red blotch, hematoma, itching. On 4/20/2018 Pharmacist suggested extra strength TYLENOL for headache and then on 4/21/2018 suggested hydrocortisone for itching. Helped some but not much. On 4/23/2018, saw primary who prescribed a 7 day course of 500 mg Cefuroxime for Cellulitis.
After receiving the vaccine in the morning, redness and soreness started in the same arm the dose was administered.  She tried Tylenol and Ibuprofen, but it kept getting worse.  After 2 days, she came back to the pharmacy to ask advice.  She had a red spot around the injection site that was about 4 inches in diameter with bruising.  Her arm was sore and slightly swollen.  She was referred to her Dr for consultation/examination.
Patient  was given a 5-11 age Pfizer COVID vaccine instead of the 12 plus.  Patient had no adverse reactions from given the wrong dose.
Chief complaint was muscle weakness and fatigue. I experienced double the amount of soreness at injection site. Just felt bad and not able to do the things I normally do on a daily bases. I did not take anything to elevate the discomfort. I sprained a knee during all this because of feeling weak.
Sudden onset of headache approx. 24 hours after administration, dizziness, mildly slurred speech/stuttering described by patient (not seen on exam), neck pain, eye pain. Also c/o palpitations.
This spontaneous report was received from a nurse, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored dose of PNEUMOVAX 23 lot # M040004 with expiration date on 20-MAY-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 33 Fahrenheit grades range for a time frame of 336 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.
9/26/22 That afternoon I had a drippy nose. Tested that evening negative for COVID. On 9/27/22 woke up with severe body aches, a bad headache, pain of 9/10, bad sinus pressure and a severe sore throat. I took another COVID test and it was positive. I contacted Clinic, where I work, they used a Clinic calculator for COVID. I had a score of 4. Any score of 3 or better is high risk. On 9/27/22 I had the Monoclonal Antibodies Therapy Infusion. The severe headache and body aches are now gone. I still have a severe sore throat and have not recovered.
tachycardic, site edema, shortness of breath,  dizzy, and felt like her throat was getting tight. She got one dose of epi and 50mg of oral benadryl
Bad headache; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 77-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration in right arm on 23Feb2021 at 14:00 (age at vaccination: 77-year-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 25Feb2021 at 16:00 the patient experienced bad headache and nausea. The patient was not pregnant at the time of vaccination. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Vaccine given as intramuscular dose rather than orally. Discussed with parents that a local injection response could be expected with swelling and irritation and possibly fever. Discussed that dose would not count towards completion of vaccine series.
Stuffy, runny nose. Fever 100.2 degree. Body aches. Headache. Fatigue.
COVID toes.  Discoloration of toes, pain, numbness, discomfort, cold
Information has been received from a medical assistant concerning a 69-year-old female with (no known allergies), has type II diabetes mellitus, hyperlipidaemia, hypertension and hypothyroidism who on 28-FEB-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 656606/0033U).  Concomitant therapy included CRESTOR, hydrochlorothiazide, minocycline, lisinopril, SYNTHROID, vitamin E, CAL-CITRATE, alprazolam and ACTOS.  On 06-Jul-2007 a dermatologist diagnosed the patient with a mild case of shingles.  She was prescribed FAMVIR for the shingles and ALEVE as needed for the pain.  No laboratory or diagnostic tests were performed.  The patient states that she is not in pain.  No outcome was reported.  No product quality complaint was involved.  Additional information has been requested.
Contacted by father after hours who left on voice mail a description of reaction on 4/25/06. Home visa made by public health nurse (vaccine administrator) on 4/26/06 AM. Pt inside with mother. R arm affected elbow to shoulder about 1 1/2 times normal; warm, hard, red, painful to touch with slightly blistered area. Physician informed. 4/26/06, Physician presented Zithromax. Physician to make home visit.
Received H1N1 injectable and seasonal flu injectable. Develop warm sensation in chest cavity approx 2 hrs after injection. 4 hrs later developed pain and paralysis in L side of neck. Unable to move neck. Denies pain/paralysis radiation to extremities. Applied heat. Paralysis resolved. C/O pain in neck.
A non-serious spontaneous report of FLUMIST administration to a pregnant female was received from a consumer concerning a 37-year-old female. The patient's medical history, obstetrical history and concomitant medications were not reported. On 17-Aug-2010, the patient received FLUMIST. The patient was eight weeks pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
about 3.5 hours after the injection i felt tired; 8 hours after the injection i started to get a headache; 10 hours after the injection, I had severe diarrhea, arms started going numb, cramping and tingling and my bottom lip and chin felt the same way. I then broke out in a cold sweat but I didn't have a fever. Those feeling went away about 10 minutes after they started. I still feel tired.
pt recv vax;12jul95 exp flu like sx,i.e aching & nausea;
Pain at injection site. Unable to lift arm. Arm made popping sound. 2/7/14 still having problems saw PCP had MRI.
This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age (reported as 85, unit of measurement unspecified) and ethnicity received PREVNAR 13 (solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date, single dose, for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient already had the vaccine (noted to be possibly PREVNAR 13). It was reported that the patient was well aware of side effects. On an unspecified date, it was reported that in face and the arm were so sore; she could barely move it (arm) for several days. The outcome of the events was unknown at time of report. No follow-up attempts are possible. No further information is expected.
3rd dose of Havrix given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 04-MAY-2023, the patient received the 3rd dose of Havrix. On 04-MAY-2023, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: 3rd dose of Havrix given). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 05-MAY-2023 The healthcare proportional asked for safety information regarding this situation. The reporter consented to follow up. The reporter stated that the patient received a third dose of Havrix, which led to extra dose administered.
The day after getting the Janssen injection my urine was smelly. Every time I peed it was very smelly.  6 weeks after the vaccine I mentioned it to my doctor and he wanted me to do a urine test.  I didn't have any other symptoms besides my urine smelling really BAD!!!
pt recv vax 30OCT96 & 31OCT pt woke covered w/hives per mom;mom took pt to MD who reported lt as hives;MD feels this is not a true rxn but MD wanted skin test done by next series of vax;MD reports rash over entire body;
patient inadvertently received 2 doses of fluzone high dose quadrivalent with no adverse event; Initial information was received on 28-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist. This case involves Elderly unknown gender patient who inadvertently received 2 doses of influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received inadvertently 2 dose of suspect influenza quadrival a-b high dose hv vaccine (lot, dose, formulation, strength, and expiry date: unknown) (extra dose administered) (latency same day) via unknown route in unknown administration site for prophylactic vaccination (immunization  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt c/o sore rt hip morning p/vax; approx 3PM same day, pt had h/a & fever of 102, site of DTAP was reddened & had red streak going out from it; mom gave client APAP & had no further c/o;
He felt very dizzy and extremely weak. He was afraid he could have fallen so he sat down for about 15 minutes till the feeling passed.
10/20/10 PM on going to bed, rolled over on arm where vaccine administered, too a bit swollen & too sore to lay on. 10/21/10 5:45PM left work w/severe chills; chills & fever that night, ferocious headache in forehead region (frontal lobe of brain), bottoms of feet hurt strongly, aches in hip & knee joints. 10/22/10 called out sick from work, stayed home & slept. I appear fully recovered as of today, 10/23/10.
patient had approximately 30 minutes of witnessed generalized tonic clonic seizure activity. Was found to have a rectal temperature of 103.5F at that time. Subsequently awoke from post-ictal state and was behaving normally with a normal neurologic exam. The ER record and H&P received on 2/9/04 states atypical febrile seizure.
Pain to area of injection x 3 weeks. Developed bursitis, reported weakness, inability to dress comfortable.
pt exp weakness, gait abn;speech reduced to a monotone monosyllable;ability to fight off illness compromised;CSF shows cystic dilation, perivascular space or less likely a focus of encephaloclastic lesion;dx mental disorder & hemiplegic;
No appetitie; Feeling very tired; Fever at 102; Muscle ache; Nnausea; Vomiting; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetitie), DIARRHOEA (Diarrhea), FATIGUE (Feeling very tired), NAUSEA (Nnausea) and VOMITING (Vomiting) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nnausea) and VOMITING (Vomiting). On 08-Aug-2021, the patient experienced DECREASED APPETITE (No appetitie), FATIGUE (Feeling very tired), PYREXIA (Fever at 102) and MYALGIA (Muscle ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (No appetitie), DIARRHOEA (Diarrhea), NAUSEA (Nnausea), VOMITING (Vomiting), PYREXIA (Fever at 102) and MYALGIA (Muscle ache) was resolving and FATIGUE (Feeling very tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, Body temperature: 102 (High) On the 2nd day, she had a fever at 102. On 08-Aug-2021, Heart rate: 130 (High) rapid heart rate at 130.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.