chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was his 3rd Shingrix vaccination (extra dose); 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 70-year-old male patient who received Herpes zoster (Shingrix) (batch number y77xy, expiry date 21-AUG-2024) for prophylaxis.   On 11-JUL-2023, the patient received the 3rd dose of Shingrix (left deltoid). On 11-JUL-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: was his 3rd Shingrix vaccination (extra dose)). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 11-JUL-2023 The reporter stated that she administered a Shingrix vaccination to a patient, in his left deltoid. She noted that this was his 3rd Shingrix vaccination (extra dose) when documenting vaccination in patient's chart. The reporter consented to follow up. The patient received 3rd Shingrix vaccination (extra dose), which led to extra dose administered.
anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the fifth of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis in Dec2020. Therapeutic measures were taken as a result of the event and included administration of epinephrine (MANUFACTURER UNKNOWN).  The clinical outcome of anaphylaxis was unknown.    No follow-up attempts are possible.  No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 15th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On 15th October 2018, the patient experienced tenderness, burning sensation, pruritus and pain in arm. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the tenderness, burning sensation and pruritus were not recovered/not resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site pain, tenderness, burning sensation, pruritus and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient reported that, 30 days after receiving SHINGRIX, experienced tenderness, burning feeling and itching under his left arm and the left side of his belt line. The patient planned to follow-up with his physician on 4th December 2018. The reporter gave consent to follow up.
The adverse event was more than normal tiredness, running a fever not above 101. Anything above 96 I have to go to the ER. I went to the ER where they did a covid test and all kinds of Blood panels due to my Chemo. They told me to go home and take tylenol and two days passed after I went home and I was back to normal.
Initial case was received from a healthcare professional on 14 October 2013. A 46-year-old female patient had received an intramuscular dose of FLUZONE TIV vaccine, batch number: UH906AF in the left arm (dose number was not reported) on 03 October 2013. Patients illness at time of vaccination and medical history was unknown. It was reported that the patient had received many doses of flu vaccine since 1998. On 08 October 2013, the patient developed itching and swelling at the vaccination site on left arm. Patient also had hives all over body and rash on her other arm. Corrective treatments were not reported and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the event. Documents held by sender: none
Currently (4/5/2022) admitted to hospice for a bladder tumor. Hospital admission within 6 weeks of receiving the COVID vaccine.
Woke up with sore shoulder where the shot was injected, heavy headache similar to a migraine, sore joints and muscles all over the body, chills, fever, tired
Some hours after I received my vaccine my arm became sore and red and swollen. Then I got a runny nose, sore throat, sore ears, chest congestion, and coughing. Sneezing. Felt tired, exhausted.
Approximately 1 hour after receiving pneumococcal vaccines (left deltoid) area became red and swollen and painful.  Tender to touch.  Swelling experienced from shoulder to elbow for 2 days.  Resolved on day 3.
Headache Fingers start to get numb,Upper left arm felt tight and swelling. Narrative:  Other Relevant History:
Approximately 5 minutes after DTaP infant developed bradycardia, hypotonia, pallor and apnea. Required positive pressure ventilation to resolve. Event lasted approximately 8 minutes.
Six days after receiving the vaccine, patient had 3 red rashes on upper left arm. The sizes are about 4"x2". Patient said they were itchy. Patient did not take any medication to treat them. Pharmacist called to check on patient 05/24/19 and the rashes are all gone.
Morning pain; pain in joints of hands and wrists/ sore arm; pain in joints of hands and wrists/ sore arm; pain in joints of hands and wrists/ sore arm; Finger joint swelled; Fatigue; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Apr2021 (Lot number: ER8736) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Waldenstrom's syndrome", start date: 2006 (ongoing), notes: Additional Information for Other Conditions: diagnosed in 2006, found in routine annual physical. The patient's concomitant medications were not reported. The following information was reported: PAIN (disability, medically significant) with onset 29Apr2021, outcome "recovering", described as "Morning pain"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 29Apr2021, outcome "recovering" and all described as "pain in joints of hands and wrists/sore arm"; FATIGUE (non-serious) with onset 28Apr2021, outcome "unknown", described as "Fatigue"; CHILLS (non-serious) with onset 28Apr2021, outcome "unknown", described as "Chills"; JOINT SWELLING (non-serious) with onset 29Apr2021, outcome "unknown", described as "Finger joint swelled". The events "morning pain", "pain in joints of hands and wrists", "pain in joints of hands and wrists" and "pain in joints of hands and wrists" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: no known core "condition however is stable". No lymphnodes and do not have any signs of condition worsening. Therapeutic measures were taken as a result of pain, arthralgia, pain in extremity, arthralgia (put on prednisone 15mg and within 3 days it started going away).
Painful upper arm around site of injection General body/muscle aches. Chills. Symptoms lasted about 36 hours. I took aspirin but relief was minimal.
Patient was given the 2nd dose too early (first dose 10/6/21, next dose eligible would be 10/23/21 but pt was given 2nd dose on 10/22/21 at 5:09PM)
Next day redness and swollen area about 1.5 inch around injection site; itchy and tissue about 2 inches below site become hard and painful. Today tissue is still "some what hard and painful" but resolving.
Per Patient's story, Patient got Hepatitis B injection on 3/19/06.  The day after, patient developed dizziness and came to back to clinic to see by me (physician) on 3/26 because of persistence.  Dizziness described as lightheaded.  Denies vertigo.  Vital signs stable.  Gross neurological exam normal.  Patient stated dizziness improving.  Called hotline and was told can persist up to 10 days and to f/u if no improvement.  Was sent home with supportive care only with follow up on 3/28/06 with Primary care physician.
Extreme fatigue on day 6-7; Slept 14 hours; Itchy raised rash on chest and arms starting approximately 4-5 days after vaccine; Extreme itching, it woke me up in the middle of the night; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration on 17Apr2021 at 14:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included history of cancer. The patient had known allergy to radiography dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included resveratrol (MANUFACTURER UNKNOWN), NMN and berberine (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. On 21Apr2021 at 03:00, approximately 4-5 days after vaccine, the patient experienced itchy raised rash on chest and arms. The patient had extreme itching, it woke her up in the middle of the night. On 23Apr2021, 6-7 day after vaccine, the patient experienced extreme fatigue and slept 14 hours. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy raised rash on chest and arms starting approximately 4-5 days after vaccine, extreme itching, it woke her up in the middle of the night, extreme fatigue on day 6-7 and slept 14 hours were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Myalgia, Diarrhea, NauseaVomiting, Tachycardia, FATIGUE, FACIAL NUMBNESS Narrative:
Saturday night: bad headache which started around 7pm and lasted the wholel night Sunday: headache persisted, then ended around noon.  Around noon became bloated and then by 5pm I had the runs and was using the bathroom for about 6 hours
Patient with known history of palpitations complaining of palpitations. After 45 minutes of observation, pulse went from 117 to 93 bpm. No other complaints.
This spontaneous report as received from a healthcare worker (office administrator) refers to a patient of unknown age and gender. It was reported that on 10-SEP-2013 the patient received the first dose of GARDASIL (dose 0.5 ml, lot number and expiration date not reported) intramuscular injection. On 11-NOV-2013 the patient received the second dose of GARDASIL (dose 0.5 ml, lot number and expiration date not reported) intramuscular injection. On 02-APR-2014 the patient received the third dose of GARDASIL (dose 0.5, lot number and expiration date not reported) intramuscular injection. On 15-OCT-2014, the patient received the fourth dose of GARDASIL (dose 0.5 ml, lot number and expiration date not reported) intramuscular injection. There was no concomitant medication reported. No adverse effects reported. Additional information is not expected due to no permission was given to be contacted.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Dosage, dose number, route of administration, lot # and expiration date were not reported). No concomitant therapies were reported. No adverse effects were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
11:00pm migraine headache, lasted for 11 hours.  Up all night bad chills and fever Arm was so painful, couldn?t move it Very tired
10/27/2004:  Swelling below elbow, pink, firm below elbow, above elbow tender - ice, continued Tylenol, Benadryl.  10/29/2004 Upper arm edema and edema 5 inches below elbow, warm, tender to touch, pink, inner forearm assessed by doctor.  11/02/2004 Anterior forearm clear, edema posterior forearm, erythema almost gone - clear less tender, finishing 2-pac.  Return to doctor as needed.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 82 and the cause of death listed was vascular dementia. His cognitive status was declining up until his death along with his behavior. Caregiver had difficulty caring for patient and hospice was discussed prior to his passing. Patient was malnourished and had COPD.
8x11 mm area of erythema w/out induration or tenderness. No adenopathy no fever.
Temperature above 101 for 24 hours - took Excedrin to reduce fever and aches - Followed by dizziness and nausea the following day
Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted five minutes after receving 2nd dose. Hx of fainting due to needles. Reported not eating or drinking prior. Fainted from the chair and broke small fragment of glasses. Did not injure his head. Interventions: bottle of orange juice and water, lifting legs and having him laydown/ sit up for 15 minutes. Walked him to car with his partner ensuring safety. First set of vital signs taken at 1800 (3pm): 96 degrees F, 55 bpm, 102/62, 14 RR. 1815 vitals: 66bpm, 16 RR, 96.8F, 118/84 BP.
I was very fatigued. Then, I had a sore throat, and bad cough. Then, I took a home COVID-19 test, negative result. The next day, I still was not feeling well. I still had the bad cough, sore throat, and fatigue. Then later that day, I lost my taste. After 4 days, my taste came back. I took a total of 4 COVID-19 tests, all negative.
Nauseous; Extremely fatigued; Chills/ Shaking; Temperature went up to 102.3 degrees F/ Felt like she was on fire; Felt super weak; Felt really bad for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extremely fatigued), CHILLS (Chills/ Shaking), PYREXIA (Temperature went up to 102.3 degrees F/ Felt like she was on fire), ASTHENIA (Felt super weak) and NAUSEA (Nauseous) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (Covid pneumonia in the history.) in March 2020.    On 16-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (Chills/ Shaking), PYREXIA (Temperature went up to 102.3 degrees F/ Felt like she was on fire), ASTHENIA (Felt super weak) and MALAISE (Felt really bad for 2 days). On 16-Jan-2021 at 1:00 PM, the patient experienced FATIGUE (Extremely fatigued). On 18-Jan-2021, the patient experienced NAUSEA (Nauseous). On 20-Jan-2021, FATIGUE (Extremely fatigued), CHILLS (Chills/ Shaking), PYREXIA (Temperature went up to 102.3 degrees F/ Felt like she was on fire), ASTHENIA (Felt super weak), NAUSEA (Nauseous) and MALAISE (Felt really bad for 2 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
soreness at the injection site; Cough; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer (patient) reported in response to the consumer follow-up letter sent in cross reference case, which included that. A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Deltoid Left on 21Jan2021 06:00 as a single dose for covid-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in Deltoid Left on 11Feb2021 as a single dose for covid-19 immunization. Medical history included diabetes mellitus from 2000 and ongoing, hypertension from 2000 and ongoing, blood cholesterol increased from 2000 and ongoing, transient ischaemic attack from 2006 and ongoing No lasting effect. The patient's concomitant medications were not reported. Time the vaccination was given: Jan2021 6:00 (24 hour clock). On an unspecified date in 2021, the patient experienced soreness at the injection site, cough. No adverse reaction noted at either vaccination other than slight soreness at the injection site. The patient was no admitted to hospital due to the event. No illness at the time of vaccination, no diagnostic tests/imaging needed. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
About 5 hours after the injection, the injection site was sore and the pain started going into my shoulder and to my neck. I applied an ice pack to my shoulder and neck for about 30 minutes and the pain went away.
local rxn w/induration-10cm diameter;DT given following laceration, cellulitis from auto accident;
FEVER OF 102, CHILLS, NAUSEA, LOSS OF APPETITE, DISTORTED VISION, TIRED.
On day 8 post-shot a large rash on the injection site area of the R arm appeared. Rash was raised, red, itchy, sore, and hot to the touch. It was about the size of the palm of my hand. This rash has expanded over the past week and now covers the majority of my upper right arm and wraps around the bicep area as well. In addition, I have noted increased and more intense tinnitus and few headaches. No fever noted.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 21-MAR-2014, the patient was inadvertently administered with a dose of MMR II (lot # 0497AE), 0.5 ml, subcutaneously that had expired on 07-MAR-2014. No adverse effects report. No PQC involved. Additional information is not expected.
Patient called in and stated that he has lost 40 lbs. since February. He is very fatigue and has amsobia . He also a stated  that he has server pain in his shoulders. He can barley use his hands and his right hand feels paralyzed.
Information has been received from a physician concerning a 15 month old male with no known history who on 16-FEB-2005 was vaccinated with a first of MMR II. On 11-AUG-2005 he was vaccinated IM with a second dose of MMR II (lot # 649241/0032R). It was reported that the child experienced 2 convulsions (1 febrile and 1 non febrile) several months after receiving his second dose of vaccine. The child experienced a febrile seizure on 01-JAN-2006 (previously reported as 01-FEB-2006). On 30-MAY-2006 the patient experienced a non febrile seizure. The child was seen by a neurologist and seems to be fine, but the physician feels his present status is uncertain. An EEG was done on an unknown date and results were not reported. The neurologist report was not available. Upon internal review, convulsions were considered to be other important medical events. Additional information has been requested.
Fully vaccinated patient admitted through ED for shortness of breath and productive cough, hypoxis 87%.  COVID positive with history of COVID vaccine.  Sent with home O2, previously not on oxygen.
High irregular heart beat; Body twitches; Eye twitches; Eyes runny; Severe fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYARRHYTHMIA (High irregular heart beat), MUSCLE CONTRACTIONS INVOLUNTARY (Body twitches), MYOKYMIA (Eye twitches), LACRIMATION INCREASED (Eyes runny) and FATIGUE (Severe fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced TACHYARRHYTHMIA (High irregular heart beat), MUSCLE CONTRACTIONS INVOLUNTARY (Body twitches), MYOKYMIA (Eye twitches), LACRIMATION INCREASED (Eyes runny) and FATIGUE (Severe fatigue). At the time of the report, TACHYARRHYTHMIA (High irregular heart beat), MUSCLE CONTRACTIONS INVOLUNTARY (Body twitches), MYOKYMIA (Eye twitches) and LACRIMATION INCREASED (Eyes runny) outcome was unknown and FATIGUE (Severe fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were  provided.
SORE ARM; WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pain in sciatica. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and weakness was not reported. This report was non-serious.
Shot (DTaP) given 07/08/02 with mom noticed red rash, No raised @ site of injection, On 07/10/02, Afebrile, No other symptoms, No swelling @ site, On 07/12/02, child w/out symptoms, No redness.
t104 starting 1/2 hr p/vax on 18OCT94 fever never below 100 even w/APAP & cool bath-fever lasted for 3 days-pt explained as drowsy During this episode
have the flu/Been sick for 2 weeks; Initial information received on 23-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case is linked to case 2022SA520933(CLUSTER).  This case involves an unknown age female patient who got the flu shot and experienced Flu and been sick for 2 weeks.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, strength, formulation, expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed Flu and been sick for 2 weeks (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is 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.; Sender's Comments:  SAD20221226000410: