chrisvoncsefalvay/vaers-outcomes huggingface dataset:
raised swelling and redness at the injection site after administration of Prevnar 13; raised swelling and redness at the injection site after administration of Prevnar 13; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced raised swelling and redness at the injection site after administration of Prevnar 13. Event took place after use of product. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Panuveitis.    The patient's past medical history included Knee arthroplasty. Concurrent medical conditions included Ankylosing spondylitis and Panuveitis.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In February 2022, the patient experienced INJECTION SITE PRURITUS (Injection site itching). At the time of the report, INJECTION SITE PRURITUS (Injection site itching) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Reportedly, the patient had knee replacement in last summer and had itching on injection site for couple of months.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter causality for an event KNEE ARTHROPLASTY with the Humira was no reasonable possibility and causality for an event INJECTION SITE PRURITUS with the Humira was reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2022: Live Significant Follow up information received, procedure KNEE REPLACEMENT was added and causality for event injection site itching was updated to related.
I had my Pfizer shots on 07Apr and 28Apr. My last period was 14Mar .; The last couple days I've been vomiting.; Every since my second shot I've been feeling light head and dizzy.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Apr2021 14:30 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (COVID vaccine details: COVID 19,, Brand: Pfizer,, Lot unknown: True,, Lot unknown reason: Other, Lot unknown reason other: Unknown, Administration time: 11:30 AM,, Dose number: 1, Vaccine location: Left arm), administration date: 07Apr2021, when the patient was 45 years old, for covid-19 immunisation, reaction(s): "My last period was 14Mar". The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 29Apr2021, outcome "not recovered", described as "I had my Pfizer shots on 07Apr and 28Apr. My last period was 14Mar ."; VOMITING (non-serious) with onset 29Apr2021, outcome "not recovered", described as "The last couple days I've been vomiting."; DIZZINESS (non-serious) with onset 29Apr2021, outcome "not recovered", described as "Every since my second shot I've been feeling light head and dizzy.". Therapeutic measures were not taken as a result of oligomenorrhoea, vomiting, dizziness.  Additional Information: No other vaccine in 4 weeks. Allergy meds, Anxiety meds in 2 weeks. No Covid prior vaccination and not tested for Covid since vaccination. No Known allergies.Other medications in two weeks: Allergy meds, Anxiety meds. Other medical history:  None that know of   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
AFTER ADMINISTRATION OF 1ST DOSE MODERNA, PATIENT FELT FLUSHED THEN SOB AND TACHYCARDIC. PT WAS MADE SUPINE AND PROMPTED TO TAKE SLOW DEAP BREATHS; BP CHECKED 180/90, RECHECKED 176/87, RECHECKED 139/80.  LAST BP CHECK 129/75. HR INITICLALLY 106 THEN NORMALIZED IN THE 80S.  O2 WAS CONSISTANTLY AT 100%. PATIENT WAS MONITORED FOR 30 MINS, WAS OFFERED TO BE TRANSPORTED TO ED.  PT DECIDED SHE WAS GOOD TO GO HOME.  NO OTHER SIGNIFICANT SYMPTOMS NOTED- NEGATIVE FOR SWELLING, RASH, HIVES.
pt recvd vax 26OCT95 @ 120PM noticed burise 645AM on rt temple, neck & back of head, c/o itching;denies SOB, diff swallowing; DPH given for itching/hives;seen by MD
Chills; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration on 24Mar2021 14:00 in left arm (at the age of vaccination 59-year-old), as a single dose for COVID-19 immunisation. Medical history includes hypothyroidism. The patient had no known allergies. Concomitant history includes Levothyroxine sodium (LEVOXYL) started on an unknown date for unknown indication. The past drug history includes that the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration to left arm on 3Mar2021 14:30 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 14:30, the patient had experienced chills, muscle pain. The patient did not receive any treatment for events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills and muscle pain was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
c/o of nausea & lightheadedness 10 minutes fafter receiving vaccine. Slowly fell to the floor & fainted. Did NOT hit head. LOC for about 10-20 seconds. Upon arousal, alert and oriented x3. BP 84/59m HR56, pale and diaphoretic. 911 called.  Repeat BP 103/65, HR 72. Ambulance arrived. Transported to ED.
Pain all over body; Headaches; Fever; Sweats; Chills; Broke out rash; This case was reported by a consumer via patient support programs and described the occurrence of general body pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2021, the patient received Shingrix. On 31st October 2021, less than a day after receiving Shingrix, the patient experienced general body pain, headache, fever, sweating, chills and rash. On an unknown date, the outcome of the general body pain, headache, fever, sweating, chills and rash were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, headache, fever, sweating, chills and rash to be related to Shingrix.  Additional details were reported as follows: This report was submitted via the online direct entry reporting system. The patient reported that, she received the Shingrix vaccine on Sunday evening and for the last four days she was experiencing pain all over body, headaches, fever, sweats & chills, and broke out rash. The patient other history was unknown The patient consented to follow up
About 12 hours after receiving the 2nd dose vaccine,  I woke up with severe chills. I felt very cold, dizzy, light headed, swelling at injection site, body aches and pain, headache and no fever.  I took Tylenol.  I slept most of the day and went to see my doctor the next day and I was having symptoms of tightness in my throat and my tongue was swelling. The doctor advise to  keep an eye on it.  The chills lasted a few hours after onset but  the aches and pain resolved after 3 days.
Began as a swollen lower lip on Monday 03/01/2021 and turned into mutiple blisters.  I originally contributed the blisters to sunburn because I had been in the sun a lot the previous three days but I've worked outside for years and I have never had my lip swell or had blisters on them in the past.  I have not been to a doctor at this point because the blisters appear to be healing so the blisters have not been diaganosed as being a covid vaccine reaction.
High fever started the night following vaccination - 2 days hallucinations per patient. Also redness and swelling around injection site which lasted 3 days.
warm to the touch (not hot); Itching around the area where she got the shot; large swelling around the area where she got the shot; Red around the area where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch (not hot)), VACCINATION SITE PRURITUS (Itching around the area where she got the shot), VACCINATION SITE SWELLING (large swelling around the area where she got the shot) and VACCINATION SITE ERYTHEMA (Red around the area where she got the shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch (not hot)), VACCINATION SITE PRURITUS (Itching around the area where she got the shot), VACCINATION SITE SWELLING (large swelling around the area where she got the shot) and VACCINATION SITE ERYTHEMA (Red around the area where she got the shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to the touch (not hot)), VACCINATION SITE PRURITUS (Itching around the area where she got the shot), VACCINATION SITE SWELLING (large swelling around the area where she got the shot) and VACCINATION SITE ERYTHEMA (Red around the area where she got the shot) outcome was unknown.            The patient reported that area where she got shot was the size of a quarter and then it ended up being the size of an orange. Concomitant medications included blood pressure and diabetic medicines.
2 hours post immunizations had 30-40 seconds of shaking of head and left arm. Eyes straight ahead (no X rolled back), no LOC. After event alert and playful. Afebrile. Exam in office 30 min after event was normal. No other events.
feels worse; Patient is freezing/hands and feet are ice; Fatigue/wants to lay down and take a nap under many blankets; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels worse), PERIPHERAL COLDNESS (Patient is freezing/hands and feet are ice), FATIGUE (Fatigue/wants to lay down and take a nap under many blankets) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feels worse), PERIPHERAL COLDNESS (Patient is freezing/hands and feet are ice), FATIGUE (Fatigue/wants to lay down and take a nap under many blankets) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feels worse), PERIPHERAL COLDNESS (Patient is freezing/hands and feet are ice), FATIGUE (Fatigue/wants to lay down and take a nap under many blankets) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Horrific pain in my left side. Trouble breathing. 100DGS fever lasting for multiple days. Winded upon standing. Inability to move from fetal position for 24 hours. Sweats & chills
I received my COVID vaccine on may 25 the next day i went for dialysis and had what they told me a seizure. So we stopped the treatment and continued it on Friday and literally 6 minutes into my treatment i went in to cardiac arrest. Was rushed to the hospital and they said my heart was not the problem and they don?t know what happened.  So i am assuming its the vaccine because I?ve been downing dialysis now for 3 month and never had a problem.
Pt fainted after receiving immunizations. Regained conscious right after. Monitored v/s in clinic for 1 hour. Alert and oriented x 3 and stable when discharged. No other s/s presented.
Onset 12-20-11 with clear blisters between buttocks. The night before (12-19-11) body was warm to touch (temp. 97.9). This AM (12-21-11) upon awakening, lesions on trunk, increasing during the day to feet, hands, and vesicles on tonsils. Rx: LORTAB ELIXIR, 500 mg 7.5 mg/15 ml - 3/4 tsp. po q 6 prn pain.
When dad came for PPD reading on 4/14/06, he mention that the left arm is slightly swollen and slightly warm. Seen by Dr on 4/14/06 and ordered ice pack to be applied and to take Benadryl 12.5 mg PO x06 hours.
Patient was inadvertently given a 0.5ml dose instead of a 0.25 dose
Did not get very ill.; Little achy; A little feverish but didn't run a fever; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Did not get very ill.), MYALGIA (Little achy) and PYREXIA (A little feverish but didn't run a fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Bedridden and Housebound. Concurrent medical conditions included Myalgic encephalomyelitis, Connective tissue disorder, Immunodeficiency, Immunoglobulin M decreased and Neuropathy peripheral. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Did not get very ill.), MYALGIA (Little achy) and PYREXIA (A little feverish but didn't run a fever). At the time of the report, ILLNESS (Did not get very ill.), MYALGIA (Little achy) and PYREXIA (A little feverish but didn't run a fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.   This case was linked to MOD-2021-380837 (Patient Link).
extreme chills; body was shaking; teeth chattering; muscles were seizing; freezing/she had to get in the bath she was so cold; soreness in in her arm; body aches; headache; tired; felt like she got hit by a truck last night, she felt terrible; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: ER8735, expiration date unknown) via an unspecified route of administration at left upper arm on 20Apr2021 at 11 am Mountain time at age of 51-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Patient previously received 1st dose of BNT162B2 on 30Mar2021 (Batch/lot number: ER8735) on left upper arm for COVID-19 Immunization. She didn't have any reactions with the first dose. There was no family medical history relevant to the events. Caller called about the Pfizer COVID vaccine second dose. She stated that last night on 20Apr2021 around 12 hours after receiving the 2nd dose she had extreme chills, her whole body was shaking, her teeth were chattering, muscles were seizing, and she was freezing. She stated that she had to get in the bath she was so cold. She stated getting the vaccine at 11 am mountain time. 12 hours after, later she was freezing, she had body aches, headaches, and she got scared, so she got up and read the pamphlet. She said that it was more than a little chilly, her whole body was shaking, teeth chattering, she stated it was bad. She did state that she felt okay today. Chills resolved this morning on 21Apr2021, probably about 1AM. She stated that she still had soreness in in her arm, was tired and she still had a headache. She stated that they were improved. She stated that she felt like she got hit by a truck last night, she felt terrible. She stated the body aches were still on going but they were improved. Patient didn't visit emergency room and physician office. Onset date of the events was 20Apr2021. Outcome of events extreme chills, "body was shaking", teeth chattering, "muscles were seizing", freezing was recovered on 21Apr2021, of events soreness in in her arm, body aches, headache, tired was recovering, of "felt like she got hit by a truck last night, she felt terrible" was unknown.  No follow-up attempts are possible; information about lot/batch number requested.
Headache, Myalgia, Fever,  MALAISE, CHILLS Narrative:
Pt developed fever of 104.5 with irritability. Patient still with temp of 102 48 hours after vaccine administered
Started spotting the day after vaccination and then full me starting 4 days later.  Was menstrating for 26 days. Had 2 sonograms and bloodwork and nothing appeared to be wrong.  Maybe an adverse reaction from the vaccine?
Body aches; Joint pain; Injection site pain; Nausea; Headache; Fatigue; Skin sensitivity (painful on touch); Skin sensitivity (painful on touch); This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 12Apr2021 at 18:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included tretinoin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 as a single dose for COVID-19 immunisation. On 13Apr2021 at 10:00, the patient experienced body aches, joint pain, injection site pain, nausea, headache, fatigue and skin sensitivity which was painful on touch. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of events body aches, joint pain, injection site pain, nausea, headache, fatigue and skin sensitivity which was painful on touch were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Moderna vaccine was administered outside of office - reported by patient ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------- G47.33 OBSTRUCTIVE SLEEP APNEA 9/9/2021 COVID-19 J96.00 ACUTE RESPIRATORY FAILURE 10/14/2021 COVID-19 R09.02 HYPOXIA 9/23/2021 COVID-19
fever; Chills; Sore arm; Next day woke up and threw up.; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jun2021 at 09:15(at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included aspergers disorder and adhd. Patient had no known allergies to food, medications or other products. The patient received unspecified other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 09:00(at the age of 12-years-old) as a single dose for COVID-19 immunisation. 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 06Jun2021 at 05:15, the patient woke up next day and threw up and had fever, chills and sore arm. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. On 06Jun2021, the patient body temperature was measured and the result was 101(units unspecified). The clinical outcome of the event woke up next day and threw up and had fever, chills and sore arm was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT STATED HE WAS FEELING REALLY HOT AND DIZZY. PATIENT WAS HOT TO TOUCH.  PATIENT THEN STATED HE WAS HAVING DIFFICULTY BREATHING.  I HAD HIM LAY DOWN AND ELEVATED HIS FEET.  KEPT TALKING TO HIM AND ASKED HIM IF HE FELT LIKE HIS BREATHING WAS GETTING WORSE AND HE SAID YES. I ASKED TO CALL 911 AND  I ADMINISTERED ONE DOSE OF AN EPI PEN INTO HIS RIGHT THIGH.  WITHIN 30 SECONDS I ASKED HIM HOW HE WAS FEELING AND HE SAID HE COULD BREATH BETTER, HIS SKIN STARTED FEELING COOLER TO THE TOUCH.   PARAMEDICS ARRIVED AND TOOK HIM ON TO THE EMERGENCY ROOM.
Rash on Rt arm near injection site; episodes of tachycardia; eyes itchy & red; started day after injections; continued - and gradually resolved by 4-14-08.
I have not had a menstrual cycle since November, 2020. The afternooon after the shot, I had mild cramping in my uterus and spotting, that lasted for about 12 hours.
On 1/10/22 patient did not receive COVID-19 Moderna booster as requested and was injected with empty syringe in error.  Patient was followed up with and received correct COVID-19 Moderna vaccine booster on date entered.
Would develop welts on arms and legs at unpredictable periods. Welts would spread throughout body. Had unpredictable swelling of lips that did not occur before vaccination of 4th Anthrax. Had 1st Anthrax on 3/21/99; 2nd on 4/3/99; 3rd on 4/17/99; 5th on 3/18/00 and vaccinations ceased due to health concerns.  Follow up:  Patient did not recover from adverse event.  Patient did not receive any more shots since reported event.