chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on an unspecified date a 6 month old patient was administered the first dose of ROTATEQ; No adverse effects reported; This spontaneous report was received from a physician referring to a 6-month-old patient. The patient's pertinent medical history, concurrent condition, previous drug allergies or reactions, and concurrent condition were not reported.  On an unknown date , the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally, as prophylaxis (dose, concentration, lot number and expiration date were not reported) (inappropriate schedule of product administration). No adverse effects were reported.
This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown age and gender. On unknown dates, unspecified number of unspecified patients received improperly stored GARDASIL-9, (lot # L016428; 30-JUL-2017) at a temperature of 30 F for 24 hours. No previous temperature excursion was reported and the data logger was involved. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
I have a mosquito bite looking lump at the injection site that I did not have previously; my left armpit is very swollen; Rapid heart rate; Weak; Muscle tenderness; My lymph nodes also started to swell in my left under arm on this day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Sep2021 13:45 (Lot number: FF8841) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing). Concomitant medication(s) included: CONCERTA; SLYND; BACTRIM; MAGNESIUM OXIDE. Past drug history included: Azithromycin, reaction(s): "known allergies: Azithromycin"; Vancomycin, reaction(s): "known allergies: Vancomycin". Vaccination history included: Bnt162b2 (Dose 2, Batch number=EL3248, Administration date: 01Feb202, Administration time: 07:00 AM, Location: Left arm), administration date: 01Feb2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Batch: EL3248, Administration date: 12Jan2021,, Administration time=07:00 AM, location=Left arm), administration date: 12Jan2021, when the patient was 33 years old, for Covid-19 immunization; Diphtheria vaccination, reaction(s): "Known allergies: Diphtheria vaccination". The following information was reported: VACCINATION SITE MASS (non-serious), outcome "recovering", described as "I have a mosquito bite looking lump at the injection site that I did not have previously"; SWELLING (non-serious), outcome "recovering", described as "my left armpit is very swollen"; HEART RATE INCREASED (non-serious) with onset 02Oct2021, outcome "recovering", described as "Rapid heart rate"; ASTHENIA (non-serious) with onset 01Oct2021 06:00, outcome "recovering", described as "Weak"; MYALGIA (non-serious) with onset 01Oct2021 06:00, outcome "recovering", described as "Muscle tenderness"; LYMPHADENOPATHY (non-serious) with onset 01Oct2021 06:00, outcome "recovering", described as "My lymph nodes also started to swell in my left under arm on this day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass, swelling. Therapeutic measures were taken as a result of heart rate increased, asthenia, myalgia, lymphadenopathy.  Additional information: Patient was not received any other vaccine four weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. Ae treatment: I visited the Pfizer clinic  Follow-up attempts are completed. No further information is expected.
DEVELOPED RED, RAISED RASH BETWEEN EYEBROWS, THAT SPREAD TO FOREHEAD 10-12NOON.  DENIED ANY ITCHING.   EYE SWELLED THAT EVENING.  TOOK BENADRYL 50 MGS X 2 DAYS-- NOT EFFECTIVE.  WENT TO ER SUNDAY AM.  GIVEN PREDNISONE 10 MG X 5 DAYS, AND HYDROXYZINE HCL 25 MG 1-2 EVERY 4-6 HRS.  STATED THAT 24 HRS AFTER PREDNISONE, FELT MUCH BETTER.
Became dizzy within half hour. R eye Headache, threw up, R ear fullness, dizziness kept getting worse - vertigo, vomiting not able to walk. Vertigo looking up, neck pain, R eye impairment floaters, flashes, leg cramps, numbness/pain 4 & 5 fingers, right foot. Got worse ended up in hospital. Oct 3/4-6th. Sent to office for Vestibular PT. NM ENT. Nystagmus. Labrynthtis L ear BPPV Right, hearing loss L/ high frequency both ears, R ear fullness & pain, NM eye specialist-change prescription again nystagmus, ordered a vision field exam. See another neurologist this week. Not able to use the computer without getting sick vertigo keeps returning. Need cane to walk. Ambulation deficits, balance deficits, coordination/proprioception deficits enduranc deficits, pain limiting function, strength deficits transfer deficits, transition deficits, Vestibular deficits visual perceptual deficits, occular flutter, inability to fixate gaze on target. High risk for falls. Lost weight. Tremors - hands, R leg.
Within around 20 minutes after the shot. I had left the clinic and I felt a hot flushed feeling come over me from the neck up. My ears and neck and head felt like they were on fire. My throat felt tight but not closed off. My heart was racing. It calmed down about 30 minutes later. Throat still feels tight with excessive thick phlegm. I am now running a fever and have a cough with sore throat.  Heart is racing but I think that is from anxiety.
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old male patient who was vaccinated with vaccine reconstituted with sterile water, while he received vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE QUADRIVALENT; PREVNAR 13; and PEDIATRIX. On 22-Feb-2019, the patient received a 3rd dose of suspect 0.5 ml HIB (PRP/T) VACCINE (lot number: UI951AA and expiry date: 13-Jun-2020) (route and site of administration was not reported). It was a case of actual medication error due to inappropriate reconstitution technique. There were no side effects. 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 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. List of documents held by sender- none.
They suspect that the vaccine was not administered in deltoid; administered subcutaneously; red spot on arm/red area where injection was; This is a spontaneous report from a contactable other healthcare professional (pharmacy student) and pharmacist via a Pfizer-sponsored program  inbound call center. A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), subcutaneously on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The pharmacy student called to ask if 3rd dose is needed if the COVID 19 vaccine was administered subcutaneously. He also wanted to know the efficacy and absorption of the vaccine if it was administered subcutaneously. The patient came back to the clinic with red spot on arm. They suspect that the vaccine was not administered in deltoid. They reported that the patient got her first and second dose of Covid vaccine. She came back in after second dose with red area where injection was. It was stated that they suspect that they gave the injection too low. They were wondering if the patient needed a third dose and if so when. It was stated that it may not be fully be in the deltoid muscle. They wondered if this affected absorption and efficacy of the vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
No additional AEs reported; Caller reported expired GARDASIL 9 was administered; This spontaneous report was received from Pharmacist and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-MAY-2022, the patient was administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #S028738, expiration date: 03-APR-2022, administered for prophylaxis (strength, dosage, and anatomical location of administration were not provided). No additional adverse events (AEs) were reported. No other information provided
Patient stated she had a large amount of swelling and redness on arm a day or two after the vaccination. Today she presented with some redness and warmth, although she noted it has improved. No evidence of swelling.
Information has been received from a consumer concerning his 6 year old Caucasian son who prior to 1999 was vaccinated with the 2nd and 3rd dose of Hep-B. It was noted that the pt received the 1st dose of Hep-B (Engerix-B) prior to 1999. For the past 3 years, the reporter noticed an auditory process problem. Six months ago, the child was dx'd with auditory process disorder from a child study group at school. The father wanted to know if prior to 1999, Hep-B had thimerosal as a preservative. The pt sought unspecified medical attention. Additional information has been requested.
This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2015, as reported since 20-APR-2015, the patient was vaccinated with improperly stored VAQTA. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
C/o of chest pain lower left margin of the breast, pain with deep breath 1 hour after getting the vaccine. She denies injury, denies pain with  movement. Lungs are CTA and she was not in distress. I followed up this morning and she was feeling better.
face tingling, couldn't move, neck pain same side as the shot, fell over in bathroom and couldn't move, and constipation
Area of swelling (L) anterior thigh approximately 6" with redness & heat x 3 days, fever - Tx cool compress, ibuprofen.
Patient came to the ED with syncope episode.  Patient admitted to hospital for syncope and Covid and treated with remdesivir.
felt her whole body was on fire; nausea; 100.3°F fever; chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt her whole body was on fire), NAUSEA (nausea), PYREXIA (100.3°F fever), CHILLS (chills) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FEELING HOT (felt her whole body was on fire), NAUSEA (nausea), PYREXIA (100.3°F fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). On 18-Jan-2021, FEELING HOT (felt her whole body was on fire), NAUSEA (nausea), PYREXIA (100.3°F fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Pt complained of lightheadedness , itching which worsened and he became flushed. Progressed to generalized pruritis and redness.  BP 117/74, HR70 )2 95% Epi 0.3 IM and Paramedics notified, transported to hosptial
pt recvd vax; severe lymph gland swelling under arm,hardness, red area;
This spontaneous report as received from a licensed practical nurse refers to 23 patients of unknown age and gender. The patient were vaccinated with RECOMBIVAX HB (lot # 0294AE and expiry date was 06-SEP-2014, routed and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time, on 03-OCT-2012, 04-OCT-2012, 05-OCT-2012, 09-OCT-2012, 12-OCT-2012, 15-OCT-2012, 17-OCT-2012, 18-OCT-2012, 22-OCT-2012, 24-OCT-2012, 26-OCT-2012, 01-NOV-2012, 05-NOV-2012, 06-NOV-2012, 07-NOV-2012 and 08-NOV-2012. The patient were vaccinated with RECOMBIVAX HB (lot number 0420AE, expiry date was 02-NOV-20154, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time, On 13-nov-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of the several reports received from the same reporter (MARRS# 1212USA000913, 1212USA003709, 1212USA003710, 1212USA003711, 1212USA003712, 1212USA003713, 1212USA003714 and 1212USA004285). Additional information has been requested.
2/13 I only had fatigue and a headache. 2/14, I had fatgue, a headache, muscle ache, joint ache, and trouble breathing. It was bad enough, I only got up from bed to pee and it took all of my power to do so. I fell asleep afterwards. 2/15, I only have fatigue, muscle aches, and joint aches, but they're bad enough that I called off from work.
Pain in Arm, cannot move upward, downward, or sideways freely. Feeling like a lump in the muscle of that arm. Was fine after first dose, this only started after second dose was given. Has not gone to the Dr. but is scheduling an appointment
Vaccine taken 09/21/21; by 09/22/21 muscle weakness had begun in lower extremities; 09/23/21 lower extremity severe pain and weakness took over; had to leave work and come home to bed; pain was excruciating and legs couldn't be moved without pain; unable to walk without assistance; 09/24/21 was taken to the Hospital ER; stayed in ER 3 days waiting on a room, then flown out to Hospital; was thought that Gillian Barre from vaccine and treated with IVIG; treatments helped relieve pain and was able to move and walk some again. 10/04/21 - pain and weakness still there - trying to avoid another ER visit due to the hospitals being overcrowded; attempting neurologist appointment with no luck as I am still waiting on a return call.  Pain, numbness, weakness still happening; walking with crutches what little I can walk; unable to do things for self, have to have help.
She was uncomfortable in bed because of this; Delay of 3 days in her period; Next period suffer a change in flow (lower than usual); Fever of 38.4°C; Strong pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (She was uncomfortable in bed because of this), MENSTRUATION DELAYED (Delay of 3 days in her period), PAIN IN EXTREMITY (Strong pain in her arm), MENSTRUAL DISORDER (Next period suffer a change in flow (lower than usual)) and PYREXIA (Fever of 38.4°C) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jun-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 27-Jun-2021, the patient experienced PAIN IN EXTREMITY (Strong pain in her arm). On 28-Jun-2021, the patient experienced PYREXIA (Fever of 38.4°C). On an unknown date, the patient experienced DISCOMFORT (She was uncomfortable in bed because of this), MENSTRUATION DELAYED (Delay of 3 days in her period) and MENSTRUAL DISORDER (Next period suffer a change in flow (lower than usual)). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency. On 28-Jun-2021, PYREXIA (Fever of 38.4°C) had resolved. At the time of the report, DISCOMFORT (She was uncomfortable in bed because of this), MENSTRUATION DELAYED (Delay of 3 days in her period), PAIN IN EXTREMITY (Strong pain in her arm) and MENSTRUAL DISORDER (Next period suffer a change in flow (lower than usual)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, Body temperature: 38.4 (High) 38.4°C, 37.4°c (High) 37.4°C and 37°c (normal) 37°C.         Concomitant medication included birth control pills.  Patient reported that all symptoms faded in a couple of days as normal identified side effects.   This case was linked to MOD-2021-187591 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Outcome of event was updated to resolved and event of menstrual disorder added. lab data updated from initial source.
First of all, my arm was immediately very sore following the vaccine. The next morning, I woke up and fainted in the shower.  I was unconscious for 5 seconds.  Later on that day, I developed a fever and severe chills, and muscle cramps...and the soreness on my arm grew unbearable.  It was a challenge to even lift my arm at this point because the site of the injection was so painful.  At this point, I went to the Emergency Room, and they gave me fluids (iv) because my white blood count was high due to fighting an infection which they believed was cellulitis at the site of the vaccine in my arm.  So, I was given antibiotics to treat the infection.  I am on my first day of antibiotics now.
Infant crying for the evening, but slept at night and is crying again today since he awoke. Time 10:30AM. He is consolable, has not cried for 3 hours solid. But he is irritable.
Sweating; Threw up; Chills; Painful lump on right collar bone; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Painful lump on right collar bone), HYPERHIDROSIS (Sweating), VOMITING (Threw up) and CHILLS (Chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced MASS (Painful lump on right collar bone). On 23-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), VOMITING (Threw up) and CHILLS (Chills). At the time of the report, MASS (Painful lump on right collar bone), HYPERHIDROSIS (Sweating), VOMITING (Threw up) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
A very strong metallic taste in mouth; This is a spontaneous report received from a non-contactable consumer, the patient. A 50-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration in left arm on 17Mar2021 (at the age of 50-years-old) at 14:00 hours as a single dose for COVID-19 immunisation. Medical history was not reported. It was reported that the patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Concomitant medication was not reported. On 17Mar2021, at 14:00 hours, the patient experienced a very strong metallic taste in mouth (taste metallic). No treatment was given for adverse event. The clinical outcome of taste metallic was recovering.   No follow-up attempts are possible. No further information is expected.
Beginning several hours after the vaccine I developed flu like symptoms including low grade fever (100 degrees F) and body aches. over the next 3 days pain increased similar to fibromyalgia pain -all over body especially joints and bones. By day 4, I was no longer running a fever, but severe pain continued in lower back and base of skull and  neck for 3 more days, as well as residual nerve pain along the back of the left arm (where i received the vaccine). By day 7 I was feeling back to myself. on day 10 I developed hives on my back, and the following day I developed a rash on my waist, both shoulders , underarms and back. Today is day 12 - I continue to experience and itchy burning rash in those sites. I am treating at home with anti-itch cream per what I read online.
Pt vaccinated with Influenza c/o severe neck & throat pain spreaded down resulting in generalized weakness & arm numbness. Admitted to hosp w/proximal weakness & difficulty swollowing & paralysis. Probable GBS.
Pt. had a Bacillus abscess on his calf about 1 week after receiving vaccines.  Could there be any link to recalled vaccines.
Patient received high dose flu shot rather than a regular flu shot based on age.  No symptoms or poor outcomes reported.
Fever of 101.5; Injection site pain; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 08Apr2021 at 11:45 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 18Mar2021 at 11:45 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 08Apr2021 at 22:30, the patient experienced injection site pain, headache, chills. On 09Apr2021, next morning upon waking up the patient experienced a fever of 101.5. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events injection site pain, headache, chills and fever of 101.5 was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt was given DtaP instead of flu vaccine. No adverse Rxns were noted.