chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this, and they are not able to support the temperature excursions that occurred. As per CDC guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
Patient has reported a red, raised and itchy area on the underside of her arm.  This was the same arm of the injection but was on the underside of the arm and not near the injection site.  The area is about the size of 3 quarters.
22APR94 4-730PM cried & would not eat & then fell asleep & was awake 930PM; pt was up though the noc crying;
Patient receieved the vaccine at 3:39PM. Immediately stated he felt he may pass out. Provider and LPN responded at 3:40PM. Patient had loss of consciousness for about 15 seconds. Vital signs taken: BP: 105/65, Pulse: 100; Temp: 98.2F, Glucose 77. Repeated after 5 mins with BP 109/66. Pulse 71. Patient reported nausea and left in laying position until 1600 with frequent vital checks. At 4:00PM vitals were 112/76 for BP. Patient cleared to leave.
Awoke 08-06-2020 feeling like a bad flu.  Didn't feel like doing anything but had to work a short time.  By evening dragging, feeling really tough and with fever.  As I, awoke the next day better but needing time to regain strength.  Doesn't want to talk about a second shot.
Today is more than one week from the date of my first dose.  I notice an itching that may have started yesterday evening.  I looked at my arm and there is a light red blotchy area about 2 inches in diameter in the area of the injection site.  I searched the internet and read this has occurred in others.  I enrolled in V Safe but I believe I will not get any communication any longer as it stops six days after the vaccine.
Child complaint of soreness, swelling and hard lump at injection site on 11/20/14 at 3:15pm. Mother applied cool compresses, gave the child Tylenol and used "B&W" onitment which she described as an herbal blend they have used previously.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 51-year-old female patient who received SHINGRIX. On 14th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced pain, swelling and erythema. On an unknown date, the outcome of the pain, swelling and erythema were not recovered/not resolved. It was unknown if the reporter considered the pain, swelling and erythema to be related to SHINGRIX. Additional details were reported as follows: This case was reported by GlaxoSmithKline employee. The patient received SHINGRIX on right deltoid. The patient was reporter's wife. The Liaison reported that he was on the road traveling and 1st heard about his wife's experience on 16th May 2018. The patient had denied permission to contact their physician.
headaches and weakness on one side of the face  Was seen in the ER and was dx with Bell's Palsy and Ramsay Hunt Auricular Sundrome  treated with Famciclovir, Meloxicam, Tramadol and he is still having weakness and headaches after completing the medication. He came for 2nd vaccine today and we told him to consult with his physician about getting the 2nd dose at this time, due to his continued symptoms.
No other AE's reported; Customer reports administration of V ARlV AX and MMR II (stored in freezer) 19.3 F; This spontaneous report as received from a nurse and refers to a 12-month-old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medications provided. On 20-MAY-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, subcutaneously, lot # T027305, expiration date 12-AUG-2022 and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) 0.5 milliliter, subcutaneously, lot # S037497, expiration date 20-NOV-2021. Administered dose of vaccine experienced the temperature excursion of 19.3 degrees Fahrenheit for 1 hour 31 minutes. Data logger was involved. There were no previous excursions reported.
Low grade fever 99.1. Chills. Body aches. Headache. Fatigue. Lasted from at least 6:30am to 10:00pm.
ADVERSE EVENT NOS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adverse event nos. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious.
massive headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (massive headache) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (massive headache). At the time of the report, HEADACHE (massive headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (massive headache) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (massive headache). At the time of the report, HEADACHE (massive headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
later in the evening of the day of vaccination, pt noted redness, swelling, tenderness of the area around the injection site. the area had spread more the following morning. she also felt dizzy and hot the subsequent day VSS, cortisone cream and cold pack applied to the area. pt already takes daily allergy medication.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 30-MAR-2016, the patients were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiration date 02-MAR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Most concerning reaction was: on Wed., 3/10/21, at approx. 9:30am, I fainted. I had just had a couple bites of food then felt really warm and nauseous. I fainted at table, then my spouse didn't know when he came downstairs, he thought my head was just resting at the table. He asked if I wanted to walk to the couch to rest, and as he helped me do so, I fainted and he caught me and carried me to the couch. Recovered within 1 minute but my hearing was  fuzzy for a couple more minutes, sounded like static in my ears.  Other reactions were:  Standard ones I read could happen- Fever of 100.1 that lasted less than a day, chills, aches, warm feeling and fatigue.
Two weeks after the vaccine I started having high blood pressure and heart palpitations. Had an abnormal EKG. Echo was normal. Got put on a holter monitor. Had frequent PVC?s and a 6 beat run of v-tach. I am now taking a beta blocker. I don?t know if it?s related to the vaccine but the timing seems like something to consider.
My COVID-19 infection symptoms started on 01/2023 in the morning. I had fever, chills, body aches, and head cold. It felt like I had a stuffy head. I did 2 COVID-19 home tests on 01/30/2023 which were positive. I called my doctor on the same day and did a telehealth. I was prescribed Paxlovid for 5 days.
PAIN IN MY BELLY WITH AN INCREDIBLE AMOUNT OF GAS  EXTREME ITCHYNESS  WITH CONSTANT UNCOMFORTABLE, IRRITATING SENSATIONS THAT I NEEDED TO SCRATCH  IT HAS LAST SO FAR BUT AFTER TAKING BENADRYL THROUGHOUT THE DAY BUT STILL VERY ITCHY
I had the flu vaccination. Within 24 hours I had nauseau, vomiting, headache. These symptoms lasted 24 hours.
MOTHER STATED PATIENT STARTED RUNNING FEVER OF 103 DEGREES LAST PM AND HAVING HEADACHE.  CAME BY CLINIC TODAY (8/18/10) TO TELL ME HE STILL HAD HEADACHE AND 103 FEVER.  FAMILY DR CLOSED THIS PM.  WAS GOING TO ER.  NEVER CONTACTED CLINIC AGAIN.  PHONE NUMBER WAS NO LONGER WORKING WHEN NURSE CALLED TO FOLLOW-UP.  ASSUMED THAT HE RECOVERED.
Diffuse chicken pox outbreak all over body with pox on face, palms, groin, legs, arms.
abdominal pain; feeling bloated; This is a spontaneous report received from a contactable consumer (Patient, self-reported). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 other, via an unspecified route of administration, (Batch/Lot Number was not provided) as SINGLE DOSE for covid-19 immunisation. Medical history includes Chron's. Concomitant medications were not reported. It was reported that Patient had colonoscopy about 6-7 weeks prior to the Pfizer Covid vaccine. After receiving his first Pfizer Covid vaccine he experienced abdominal pain & feeling bloated. Caller went to the ED and had a CT scan which showed a larger amount of air in the abdominal area, that wasn't there during the colonoscopy. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
12 year old son was administered Pfizer vaccine on 5/13/21 then accidentally given the moderna on 6/3/21. Just noticed today. No reaction to either vaccine, but when I called the cdc hotline I was advised to make a report here.
hands were shaking really bad; felt tingling in arm and back; mouth was dry; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (hands were shaking really bad), PARAESTHESIA (felt tingling in arm and back), DRY MOUTH (mouth was dry) and DIZZINESS (dizziness) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced TREMOR (hands were shaking really bad), PARAESTHESIA (felt tingling in arm and back), DRY MOUTH (mouth was dry) and DIZZINESS (dizziness). On 16-Jan-2021, TREMOR (hands were shaking really bad), PARAESTHESIA (felt tingling in arm and back), DRY MOUTH (mouth was dry) and DIZZINESS (dizziness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .
Office visit 5/8/2008 with notes on visit stating: Noticeable pink/red circular patch on left arm, superior to left elbow, inferior to left deltoid. Patch is hot to palpation. Dr able to assess patch. Notes stated allergic reaction from PNEUMOVAX injection. Given on 5/05/08.
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, METOPROLOL, BUSPIRONE and LORAZEPAM for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) higher blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had scheduled there second dose on 4 Aug.  Treatment Lorazepam 0.5 mg. The patient usually took it twice a day. this time took a third one at midnight.
Extreme pain in the arm which was vaccinated upon injection which continued for a few weeks.  High  fever, malaise, weakness, below than normal temperature (95-96 degrees) all started the morning after vaccine.  Symptoms continued for a few weeks after.  Frequent recurring urinary tract infections which started a couple of weeks after vaccine and a kidney stone and Emergency Room Visit.  I still do not feel "myself".  Extreme fatigue, etc. (a feeling of  being "not well")
Information has been received from a licensed practical nurse concerning a 13 year old female with allergic rhinitis and AMOXIL and a history of reactive airways disease who on 27-JUN-2007 was vaccinated with the first dose of GARDASIL, the patient was vaccinated with the second dose GARDASIL (lot # 658556/1060U) 0.5 ml IM in the left deltoid. On 24-AUG-2007, the experienced pain and tenderness in her left arm. On 11-SEP-2007, the patient sought medical attention (office visit) and at that time she had decreased range of motion, tenderness and pain of the arm. There was no masses and no redness. At the time of reporting, the patient had not recovered. The patient was scheduled to have a MRI. Additional information has been requested.
Mom reported pt had severe headache starting 24-48hrs after injections. Said she would take child to physician but has no phone and did not respond to letters.
hives; itching; kept me awake; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (itching) and SLEEP DEFICIT (kept me awake) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Feb-2021, the patient experienced URTICARIA (hives), PRURITUS (itching) and SLEEP DEFICIT (kept me awake). At the time of the report, URTICARIA (hives), PRURITUS (itching) and SLEEP DEFICIT (kept me awake) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product or treatment was not provided by the reporter.  Patient reports events "lasted about ten hours on the night of February 6th and kept me awakeall night. It was on my chest, neck, and arms. It went away in 8-9 hours; gone next day"
Site: Itching at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild
Pt received 1st dose of Pfizer vaccine and few minutes later while in observation area, she said she's feeling very hot and sweaty. Rph asked pt to have a seat and drink water. Pt was also offered to lay down in counseling room if that will be more comfortable. Nurse from the Clinic also came over and pt went over to the Clinic to sit on a recliner. She walked herself to the room and was getting a relief upon sitting down and left after 30 minutes. Since pt did not check with nurse or rph before leaving, rph called pt to follow up and she said she's doing ok.
45 minutes after shot lips tingled and puffed up, roof of mouth became sore , a bit swollen and irritated ,periodic heart palpitations. I took liquid benedryl  and after 15-20 minutes symptoms subsided, so I did not use my EPI Pen.
I experienced fever, chills, headache, fatigue, muscle aches,  nausea, and pain at the injection site. Symptoms have lasted for 36 hours and are ongoing. Tylenol was used to treat symptoms.
Information has been received from a registered nurse concerning a 61 year old female (weight 171#, height 62") with no known drug allergies who on 13-OCT-2006 was vaccinated with Pneumovax 23 (lot #651401/0619F), 0.5 ml, IM in the left deltoid.  Concomitant medication included influenza virus vaccine (CHIRON).  Previous vaccination with Pneumovax 23 in 2002 without problems.  Previous two vaccinations with influenza virus vaccine without problems.  Subsequently on 13-OCT-2006 at 03:45 pm, the patient returned to the physician's office with warmth, swelling, pain at injection and induration at injection (upper L arm).  Upon examination it was noted that the patient had left upper arm 2+ non pitting edema, mild warmth, erythema and tenderness.  The patient was treated with prednisone 10 mg tapered dose starting with 5Qday 4, 3, 2, 1 #15 and acetaminophen and VICODIN, PRN #15.  Subsequently a few days later, the patient recovered from warmth, swelling, pain, erythema and induration at injection (upper L arm).  Follow-up information has been received.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Swollen lips; This is a spontaneous report from a contactable consumer or (patient). A 70-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN6201), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 14:30 as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 70 years). Medical history included chronic obstructive pulmonary disease from, hypertension, thyroidectomy, cardiac failure congestive, gastrooesophageal reflux disease , osteoporosis. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Concomitant medication(s) included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); amlodipine besylate (AMLODIPINE BESYLATE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); calcium carbonate, colecalciferol (CALCIUM 600 + D); carvedilol (CARVEDILOL); levothyroxine sodium (LEVOTHYROXIN); losartan (LOSARTAN); pantoprazole sodium (PANTOPRAZOLE SODIUM); rosuvastatin (ROSUVASTATIN); risedronate sodium (RISEDRONATE); tiotropium bromide (SPIRIVA). The patient previously took bnt162b2 for covid-19 immunization lot number=EL3247 date=30Jan20210 1:45 PM, vaccine Left arm, dose number 1, anoran and experienced drug hypersensitivity, bevespi aerosphere and experienced drug hypersensitivity. On 23Feb2021 patient experienced swollen lips. No treatment was received as a result of event. The outcome of event was recovering.   Follow-up attempts are completed. No further information is expected.
Rash/Hives - itching burning rash and small blistery bumps on face, neck, ankles and legs.  Started 11/24/2021  Ended about 12/27/2021
Hives all over body; nausea; joints and muscles aches; joints and muscles aches; headache; dizziness; dose received 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 10:45 (Lot number: FF8839) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BENADRYL. Vaccination history included: Bnt162b2 (Dose Number: 2, previous dose details, prev dos product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EP6955, prev dose lot unknown: False, prev dose administrator route: Intra muscular, prev dose administration date: 14Apr2021, prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 14Apr2021, when the patient was 53 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EP6955, prev dose lot unknown: False, prev dose administrator route: Intra muscular, prev dose administration date: 24Mar2021, prev dose dose number: 1, prev dose vaccine location: Left arm), administration date: 24Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 10:45, outcome "unknown", described as "dose received 3"; URTICARIA (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "Hives all over body"; NAUSEA (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "nausea"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 15Dec2021 23:30, outcome "unknown" and all described as "joints and muscles aches"; HEADACHE (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "headache"; DIZZINESS (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "dizziness". The events "hives all over body", "nausea", "joints and muscles aches", "joints and muscles aches", "headache" and "dizziness" were evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of urticaria, nausea, arthralgia, myalgia, headache, dizziness.  Additional information: Reportedly, no other vaccine were administered in four weeks. Known allergies were reported as none. The patient did not have covid prior vaccination. The patient was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.