chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The reporter's husband received SHINGRIX on an unknown arm. The reporter also reported that, the patient experienced soreness in his arm which resolved after receiving the vaccine in 2 to 3 days. The patient had been unable to secure the 2nd dose due to availability of the product. The reporter consented to follow up.
Parent reports redness and swelling of arm day after immunizations. Child admitted to hospital on 06/17/2010 with redness and swelling of arm and shoulder. Diagnosed with cellulitis. Treated with IV antibiotics and MIVF. Patient discharged from hospital to home on 06/19/2010 with oral Clindamycin, oral Diphenhydramine, and oral acetaminophen. Seen by PCP 06/21/2010 - Improving, Swelling resolved, minimal erythema.
Hospitalized for COVID 19 infection normal chest xray. Extreme fatigue and weakness.   BOOSTER Pfizer,Inc LOT FC3184 R arm on 10/5/2021.
No other AE; Pt received a dose of Pneumovax 23 today (11-DEC-2020) and the expiration date was 28-NOV-2020.; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 11-DEC-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S006778,expiry date 28-NOV-2020,  1 dosage form for prophylaxis (strength, administration route and frequency were not provided). No additional adverse events or prior temperature excursions were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: s006778; expirationdate: 28-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Severe side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Severe side effects) in a female 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 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 ADVERSE EVENT (Severe side effects). At the time of the report, ADVERSE EVENT (Severe side effects) outcome was unknown.            Concomitant medications were not provided. Treatment details were not provided.
Lightheadedness, warm, dizzy, throat tightness, chest heaviness.  Developed numbness and tingling around her lips.    Developed some swelling of lips and felt throat was swollen.   Given Benadryl 50 mg IM x1.  Transferred to ED - observed.
Runny nose, slight sinus congestion, minor flu like symptoms. Gradually symptoms have gotten worse each week to date. See doctor 02/16/2010 (have now pneumonia symptoms (severe) chest pain, hearing loss, sinuses plugged up). Thinking about hosptial but will check with doctors first 2/16/2010.
lymphadenitis; puffy, large, red, swollen ymph node under his left armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENITIS (lymphadenitis) and LYMPHADENOPATHY (puffy, large, red, swollen ymph node under his left armpit) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, the patient experienced LYMPHADENITIS (lymphadenitis) and LYMPHADENOPATHY (puffy, large, red, swollen ymph node under his left armpit). At the time of the report, LYMPHADENITIS (lymphadenitis) and LYMPHADENOPATHY (puffy, large, red, swollen ymph node under his left armpit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant TCR follow up received included information about the outcome of the events and was updated. Reported verbatim for the event Swollen lymph nodes was updated as per the previous report.
Palpitation; Not fast heart rate just felt like it was constantly pounding hard; This is a spontaneous report received from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in right arm on 06Mar2021 at 09:00, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's past drug history included Vancomycin and Gentamycin; to which the patient developed allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 08:30, 9 days after the first dose, the patient experienced palpitations for 3 1/2 days morning to night. Not fast heart rate just felt like it was constantly pounding hard. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of palpitation and heart rate just felt like it was constantly pounding hard was recovering at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
12 mo vaccines done 11 days ago on 1/21 - got Varicella and PREVNAR on right side, MMR and Hep A on left noticed swelling 2 days ago, marked yesterday fever today at daycare. Extrem - indurated area 3x3 cm right outer thigh, erythema and sl. warmth at area, no fluctuance, NT to palp., no vesicles or papules at area.
Swollen lymph node in neck, legs are swollen, wave-like pain passes through patient's legs at night, pinning and needling feeling in different parts of the body, weakness, heaviness, numbness and stretching pain in thighs and legs, painful bruises in legs, pain in left side of jaw.
a red rash pinkish rash; Sore arm / It is very sore; Big knot on the arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a red rash pinkish rash), PAIN IN EXTREMITY (Sore arm / It is very sore) and VACCINATION SITE INDURATION (Big knot on the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced RASH ERYTHEMATOUS (a red rash pinkish rash), PAIN IN EXTREMITY (Sore arm / It is very sore) and VACCINATION SITE INDURATION (Big knot on the arm). At the time of the report, RASH ERYTHEMATOUS (a red rash pinkish rash), PAIN IN EXTREMITY (Sore arm / It is very sore) and VACCINATION SITE INDURATION (Big knot on the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication. Treatment information was not provided.
Information has been received from a health professional concerning a 4 month old patient who was vaccinated with a 2ml PO first dose of Rotateq. There was no adverse event. There was no product quality complaint involved. Additional information has been requested.
we both got our shots and I would hate to think how sick we would be.; Initial information received on 14-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender who experienced we both got our shots and i would hate to think how sick we would be after receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, dose, formulation, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "we both got our shots and i would hate to think how sick we would be (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
pt recv vax 10MAY96 1120AM&mom called MD to report that pt legs were purple w/blotches&purple around lips;pt sent to ER stat as per MD;no tx needed in Er
Information has been received from a health professional concerning a 12 month old female with ear problems and a history of rhinitis and no known allergies who on 02/08/2006 was vaccinated subcutaneously in the left leg with a 0.5ml dose of MMR and varicella vaccine live.  Concomitant therapy included amoxicillin, antipyrine, benzocaine, glycerin, and carbinoxamine maleate/pseudoephedrine HC.  The patient had right ear pain at the time of vaccination.  On 02/13/2006, 5 days post vaccination, the patient experienced a bumpy rash all over her trunk.  At another office visit on 02/15/2006 the patient had eating issues, sweating, not feeling well and fever.  The rash had spread from the trunk upward to the hairline.  The nurse reported that when she pushes the rash apart it blanches and returns.  At the time of the report the child is improving.  No product quality complaint was involved.  Additional information has been requested.
The injection site became noticeably warm to the touch on Oct 13, 2022. This continued on Oct 14, 2022 and I notified my PCP via my patient portal. Dr shared this should pass. By Monday, Oct 17, the warmth started to subside  and by Wed evening, Oct 19, 2022, the injection site was no longer warm to the touch.  The reaction for noticeably warm to the touch had not occurred on the previous three Pfizer covid-19 vaccines shots and it was a concern that I shared to my PCP and in the vsafe app.
A report has been received from a Health Professional concerning a 7 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 17-Sep-2012. The patient experienced TESTED POSITIVE FOR FLU A which started on 17-Jan-2013. The patient recovered from the event of TESTED POSITIVE FOR FLU A on an unspecified date. The report was considered to be non-serious.
Slightly itchy rosy rash on torso and back, discovered when awoke, nearly 2 days after injection
LEFT DELTOID WITH REDNESS, SWELLING OVER 2 INCH AREA.  DR  ADVISED TYLENOL OR MOTRIN AS DIRECTED.  IF CONDITION WORSENS GO TO EMERGENCY ROOM.
Both eyes itchy, tongue swollen and sore and white spots. Itched eyes, right eye infected, Antibiotic ordered. BENADRYL taken. Gets some reaction to strawberries.
Moderna vaccine given on 6/28/21, 1 days after Beyond Use Date expiration 6/27/21.
Patient was given FLUARIX to (R) deltoid on 2/20/19 and reported pain to the site 1 day after. On exam skin is moderately erythematous with moderate skin warmth to touch, moderate swelling at the site of vaccine administration.
Case number PHEH2012US013371 is an initial spontaneous report received from a nurse on 03 Jul 2012: This case refers to 19-years-old female patient. She was vaccinated with expired MENVEO (batch number: 100005) intramuscularly on 28 Jun 2012. No other adverse event was reported following this administration error.
Redness and swelling at the injection site and down her arm. Hot to the touch. Saw her chemotherapy physician today and she gave her a prescription for BACTRIM DS.
?Moderna COVID?19 Vaccine EUA    shot 3/19/21 1:30pm, woke up Saturday morning 9:00 am dizzy and still have dizziness. My face is also red.
symptomatic pertussis; not culture confirmed; had 3 doses of vax from same lot# in APR, JUN, AUG92; typical sx of pertussis for 5-6 wks, started mid MAY; no local contact case discovered; pt @ Disney World 10-14 days prior to onset of sx;
SWOLLEN GLAND ON MY ARMPIT,; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 11:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced swollen gland on her armpit. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event swollen gland on armpit was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
p/vax pt exp chickenpox w/a rash in excess of 300 lesions;
A legal complaint was received from an attorney alleging that a male child received series of Tripedia, ActHIB, Engerix B, and Acel-Imune vaccines as well as Hib-TITER vaccine from 8/4/98 through 5/2/00 and subsequently "sustained severe, devastating, and permanent, neurological injuries through mercury toxicity and associated neurological injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via IM injections of mercury" in the "thimerosal-containing vaccinations." According to the legal complaint, the child "was born a perfectly normal, healthy boy whose APGAR scores at birth were well within the normal range." It is alleged that at approximately between 24 and 36 months of age, the child "was neurologically devastated by the accumulations of mercury in his body, having been exposed via IM vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to inability to speak, unresponsive to his environment, and initial loss of language skills, motor skills and affect." According to the legal complaint, the child "suffered severe and permanent injuries" and "sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments."
Patient was given vaccination on 9/10/10 went to pharmacy on 10/11/10. Talked to pharmacist she called our store. Pt complaining of being tired, dizzy, cloudy vision, sore left arm. Pt. has not seen a doctor but will made an appointment. Numbness in (L) calf - stumbling. Pt not sure if related to flu shot.
Pt recv vax on 10/7/97; subsequently pt exp funny feeling, unable to hold head up, shaking, trouble walking, stiff neck, headache.
Oval shaped redness and swelling about two inches long, tender to touch, slightly warm. Started day 10 after vaccine received. Same symptoms I had that started day 2 and went away day 5.
On Monday 10/11/2021 I woke up with numbness on the left side of my body. It started at my forehead then it radiated down my body to my left knee. I was seen in the ER at a local hospital for that condition. I was admitted overnight. They were able to determine that I did not have a stroke. They don't have a diagnosis for it. They increased my daily aspirin intake from 81mg to 325 mg. They added 1 prescription for a period of 28 days to take the medication for Plavix. I have not had these symptoms ever since going to the ER that day.
Bell's palsy; because it could be a stroke; This is a spontaneous report from a contactable consumer.   A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EM9810), via an unspecified route of administration on the right arm on 19Feb2021 14:30 at single dose for COVID-19 immunisation.  The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 on 29Jan2021 for COVID-19 immunisation and experienced a sore shoulder. A few years ago he got 2 at the same time, he got a flu shot and a pneumonia shot on the same day. He felt really bad for part of a day. He felt unwell that was years ago. he does not have any brand name, manufacturer name or lot number expiration information to provide for these vaccines from years ago.  The patient experienced bell's palsy on 25Feb2021. There is a drooping eye, his eye didn't fully close but his lip wasn't right and the doctor said no because it could be a stroke ( unspecified date in Feb2021), go to the ER and that is where he was diagnosed was in the hospital ER. He was discharged home from the emergency room. The outcome of the event was not recovered.
wed, evening 3/10/2022 around 5 pm, got very tired  thur, afternoon around 3, severe nausea, took anti-nausea med friday,  woke feeling better, but got fatigued after cooking, breakfast
patient developed confusion and weakness that last longer than one week.  Weakness improved but she remained with a decline in her cognitive function
Temp of 105.2 beginning 30 minutes after shot and continuing for 4 hours.  Approximately 2 months later, exposed to a probable virus.  Symptoms similar to sinusitis with addition of constant coughing, severe fatigue, loss of appetite, aches, and headaches, but no fever.  Lasted 10 weeks with two rounds of antibiotics and steroids.  Once sinus and cough symptoms stopped, continued to have fatigue and headaches with additional severe shortness of breath, irregular heart beat, and irregular pulse. These conditions persist today.
Patient began to experience a slight headache immediately after vaccine administration. She was observed for 15 minutes, after observation she said she felt fine but still had a slight headache. She works with us here at Sams (front end) so she remained in the building for a while. I checked up on her at end of day and she said she felt a lot better and headache was gone.
migraines; arm of injection warm; arm of injection hard; arm of injection itchy; arm of injection red; Chills; tired; low grade temp 100.6F; slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines), VACCINATION SITE WARMTH (arm of injection warm), VACCINATION SITE INDURATION (arm of injection hard), VACCINATION SITE PRURITUS (arm of injection itchy) and VACCINATION SITE ERYTHEMA (arm of injection red) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included GERD. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 07-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced MIGRAINE (migraines), VACCINATION SITE WARMTH (arm of injection warm), VACCINATION SITE INDURATION (arm of injection hard), VACCINATION SITE PRURITUS (arm of injection itchy), VACCINATION SITE ERYTHEMA (arm of injection red), CHILLS (Chills), FATIGUE (tired), PYREXIA (low grade temp 100.6F) and NAUSEA (slight nausea). The patient was treated with ACETAMINOPHEN for Migraine, at an unspecified dose and frequency. On 09-May-2021, MIGRAINE (migraines), CHILLS (Chills), FATIGUE (tired), PYREXIA (low grade temp 100.6F) and NAUSEA (slight nausea) had resolved. At the time of the report, VACCINATION SITE WARMTH (arm of injection warm), VACCINATION SITE INDURATION (arm of injection hard), VACCINATION SITE PRURITUS (arm of injection itchy) and VACCINATION SITE ERYTHEMA (arm of injection red) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Body temperature: 100.6 (High) low grade temp 100.6F.         Concomitant included vitamins and two medications for GERD ( unspecified)
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient became unresponsive/faiting while sitting in the chair.
Had fatigue, headache and L arm pain on Day 1 and 2. No sxs on Day 2. Had shaking chills beginning evening of Day 3. Night of Day 4 and ongoing have been having feverish, sweating, and chills several times per night, which continue. Woke up on Day 7 (1/8/2021) with pain in L axilla, which continues. On Day 9, I had red, slightly itchy, rash at site of injection approx 6x5cm. Had neg rapid COVID test on Day 9 and PCR, which was negative as well. Saw my provider on Day 10 and requested labs to be checked (cbc, iron also checked as needed to follow up those incidentally). Requested an esr but provider did not think it was necessary but did encourage me to report to Health Department or Moderna but found this website instead. Please let me know if I need to notify anyone else.
Had the vaccine at 11am; started diarrhea within the hour.  Restless during the night and about 3am woke with diarrhea, nausea and having dry heaves, general feeling of malaise.  Symptoms continued to get worse and finally went to the emergency room about 9am the next morning.  I was given fluids for dehydration and Zofran for the nausea.  Lab work was performed as well as x-rays and a CT Scan.