chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"My" right arm is hot and red near "my" elbow; "My" right arm is hot and red near "my" elbow; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 07Oct2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. 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. The concomitant medications included fluoxetine hydrochloride (PROZAC), simvastatin (MANUFACTURER UNKNOWN), aciclovir (ACYCLOVIR), hydrocodone (MANUFACTURER UNKNOWN) and unspecified medications, all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 34-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 03Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient previously took morphine (MANUFACTURER UNKNOWN), pethidine hydrochloride (DEMEROL) and experienced allergy. On 08Oct2021, the patient's right arm was hot and red near her elbow. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether the patient received any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right arm was hot and red near elbow were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
5 days after vaccination started getting small red splotches on arm below the injection site.  In 3 days the pinkish/red area was 3 1/4" and 2 1/4" wide.  Surface itched and sore in the muscle.  Doctor's nurse advised to just watch it and if gets worse to call back.  After another 7 days it went away other than a very faint outline.
First vaccine was fine.  With second, was fine til about 28 hours later, started to feel fatigued, then low grade fever, body aches, chills, headache.  32 hours later, rash on arms, inner legs, belly.  Slept a lot.  Rash bumps went away over night, 40 hrs later had just red arms and body, light fever, headache, body / skin aches AND lymph node in neck , on injection side, swelled up and visible bump.  Took benedryl ... hope tomorrow is better.
COVID vaccine breakthrough case. Pfizer 2/1/21 EL9265, 2/22/21 EL9267, and  booster on 10/22/21 FF2590.
Pregnant and received first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received first dose) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovarian syndrome since 2019. Concomitant products included METFORMIN for Polycystic ovarian syndrome, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Dec-2020 and the estimated date of delivery was 30-Sep-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Caller reports multiple doses of VAXELIS administered since temperature excursion that occurred 16JUN2022. Names of vaccines involved VAXELIS; This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.
Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 24-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments:  US-009507513-1704USA014784:
On 9/22/21 I developed "covid arm" a large softball sized swollen, red, painful area on my right arm. This lasted about 5 days. On this day I also developed slight nausea. Over the next several days the nausea worsened after eating and I began ot have severe stomach pain on 9/24, 9/25, and 9/26. I was unable to eat or drink much due to the difficulties. On 9/26 I passed out. I went to urgent care where I was given fenergan and a GI cocktail and they tested my blood sugar and did an EKG with normal results and referred me to the emergency room to rule out a heart attach or internal bleeding. The ER gave me IV fluids, did bloodwork, an x-ray of my chest, and CT of my head and abdomen and referred me out.
Fever - 102.7 (lowest was 100.6 spiked to 102.7 several times in a 24 hour period); excruciating joint pain (scale 1-10 it was a solid 10 for 24 hours I wanted to die), bones felt like glass, fever prickles all over body, dizziness, slept 22/24 hours, chills, Chest pain and rash.
Redness, round hive, warm to touch, pain on 1/13 measuring 6.75x6.24cm
fever 105 R (fever started day of vax); convuls started 1AM next day; seen @ ER, IV & shots; adm x 4 days; sz again in FEB95 now on phenobarb;
imz was given 7hrs20mins after dilution.  pfizer was called about dilution expiration time was identified.
6/7: received vaccine 6/8: new fever 6/9: chest pain worse with laying flat, mid sternal, without radiation
moderate itching, redness and swelling occured at the injection site..topical steroid  applied
Cellulitis developed at site of injection which may have been a little too low. Treated with topical mupirocin and systemic amoxicillin/clavulanate for 5 days
Disabling body pain within 6 hours sustained to time of report, sustained fever 102  more than 48 hours. Did not think treatment was available
I had a fever of 102.8, sore throat and a cough. I felt overall miserable. I tested on October 13, 2022, and it was negative. I retested on October 15, 2022, and, I was positive. I went to the urgent care center near my home, and they did a nose swab that was positive as well. I was prescribed PAXLOVID and TESSALON PEARLS. My symptoms gradually started feeling better the next day. I flew home on Wednesday. I was still feeling crumby. By that Friday I was just tired, all my other symptoms had dissolved. It took at least an additional week to stop feeling tired.
Seizure like activity. Tingling, face, hands, legs. Syncopal episode. EMS called results in pt. to ER (local).
shortness of breath, brain fog, confusion, papular rash with pruritic presentation, fever chills, fatigue
very bad itching; hard lump; Initially swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very bad itching), SKIN MASS (hard lump) and VACCINATION SITE SWELLING (Initially swelling at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (very bad itching), SKIN MASS (hard lump) and VACCINATION SITE SWELLING (Initially swelling at injection site). At the time of the report, PRURITUS (very bad itching), SKIN MASS (hard lump) and VACCINATION SITE SWELLING (Initially swelling at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Elevated TSH (Thyroid hormone). detected with blood test two months after last vaccination. Blood test ordered due to several symptoms related to hypothyroidism.
Almost immediately after receiving the shot, I could taste a strong metalic taste in my mouth. My saliva increased. It made me feel very nauseous. About two hours later, my bottom lip started to swell and my mouth on the inside and outside  felt like it was on fire. About 4 hours later I felt very weak. After drinking tons of water, these symptoms  disapated. The next day, my mouth was better but not completely free of the bitter, bitter taste!
On 1/28 By 11am both arms from shoulders to wrist could hardly move,  needed to grab wrist with other hand to raise my hand.  this did not get any better till 1/29 I was able to raise my hand from wrist to elbow.  shoulder to elbow is still difficult and painful.  on 1/28 while taking my shower around 5pm i turned around to rinse my back off and got nausea and that lasted about an hour.  on 1/29 got up at 415am to plus in coffee and got nausea and dry heaves.   by 11am after having coffee, water and tea vomited 3 times (unable to keep and of it down)  tried ginger ale and sipped at 1 can and so far able to hold down,  FYI on 1/28 I was at the gym from 630am till 830am which I do monday thru friday did full workout 1hr strength 3.5miles on treadmill and core exercise came home entirely fine and this all started later in the morning.
Vaccine-induced equivalent of "COVID19 long-haul syndrome" with symptoms last >6 weeks: myalgias, arthralgias, muscle stiffness, muscle fasciculations, malaise, fatigue, low energy, difficulties with concentration and memory
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that the patient was in office to receive a third dose of GARDASIL (lot# and expiration date not provided) (dose: 0.5ml), intramuscularly and it had been approximately one year, since the patient had received the second dose of GARDASIL  (lot# and expiration date not provided) (dose not reported). No adverse effect was reported. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19. Reporter stating events as non serious. Patient did not have any known allergies.
tired; chills; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (tired) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired) and CHILLS (chills). At the time of the report, FATIGUE (tired) and CHILLS (chills) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-042806  (Linked Report).; Sender's Comments:  MOD-2021-042806:Sercond dose
I developed Tinnitus after my second Pfizer shot. I got my second shot on May 17th, 2021. After a month, it had a very mild sound but I ignored it as I did not even know ear could possibly make phantom noise. On Aug 20th, 2021 the ringing got very personal and louder. My ENT doctor checked my ear and did an audio hearing test. Both ways came, I'm completely normal. Now I'm living with ringing in my ears 24/7. I would really appreciate it if this ringing can be stopped if it was due to the covid vaccine. Over time it develops into muscle and neck pain in the back of my head. The ENT doctor   MD confirm that my tinnitus not due to ear problem, I'm completly normal.
Pt reports sharp intermittent pain in right posterior thigh on and off x 3 days, no other associated symptoms. Symptoms are improving gradually with time.  Exam remarkable for mild tenderness along right distal posterior thigh medial aspect Advised on supportive care for possible muscle strain CBC and Ddimer ordered due to history of Janssen Vaccine
My friend thought she was going to die after getting the PBCV and it went away in one day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "recovered", described as "My friend thought she was going to die after getting the PBCV and it went away in one day".  Clinical course: Reporter stated that her friend thought she was going to die after getting the PBCV and it went away in one day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a consumer concerning her 71-year-old male husband who on 29-NOV-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).  On 02-DEC-2007 (three days post vaccination) the patient experienced tingling in his right arm.  Approximately two more days later the patient developed blisters on his right arm which were diagnosed as shingles.  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  No further information is available.
felt lymph nodes enlarged under both arms, in groin and neck; fractured wrist in 2019 but the day after the vaccine the wrist now feels painful and numb; sensitive to light like it was when I had Covid 19; all my allergies seem worse since having the vaccine; does not have a 2nd vaccine scheduled; very weak; very tired; fever of 101 DF; Slept for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), FATIGUE (very tired), PYREXIA (fever of 101 DF), SOMNOLENCE (Slept for 3 days) and LYMPHADENOPATHY (felt lymph nodes enlarged under both arms, in groin and neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced ASTHENIA (very weak), FATIGUE (very tired), PYREXIA (fever of 101 DF), SOMNOLENCE (Slept for 3 days) and PRODUCT DOSE OMISSION ISSUE (does not have a 2nd vaccine scheduled). On 02-Mar-2021, the patient experienced LYMPHADENOPATHY (felt lymph nodes enlarged under both arms, in groin and neck), ARTHRALGIA (fractured wrist in 2019 but the day after the vaccine the wrist now feels painful and numb), PHOTOPHOBIA (sensitive to light like it was when I had Covid 19) and HYPERSENSITIVITY (all my allergies seem worse since having the vaccine). On 04-Mar-2021, ASTHENIA (very weak), FATIGUE (very tired), PYREXIA (fever of 101 DF) and SOMNOLENCE (Slept for 3 days) had resolved. On 16-Mar-2021, LYMPHADENOPATHY (felt lymph nodes enlarged under both arms, in groin and neck) had resolved. At the time of the report, ARTHRALGIA (fractured wrist in 2019 but the day after the vaccine the wrist now feels painful and numb), PHOTOPHOBIA (sensitive to light like it was when I had Covid 19), HYPERSENSITIVITY (all my allergies seem worse since having the vaccine) and PRODUCT DOSE OMISSION ISSUE (does not have a 2nd vaccine scheduled) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I started feeling sick to my stomach and felt like I had a fever. The next day I had cramps and diarrhea that bothered me. The following day I only had cramps. Then it all started to seem as though it was improving until I started having outbreaks, nausea, vomiting. Anytime I bent over I would get sick. Dr. prescribed sucralfate and antibiotics to try and calm my stomach. I was also prescribed doxycycline hyclate, mupirocin, sucralfate, fluconazole, doxycycline hyclate. I was diagnosed with HSV-2.
The caller was tired and she took a nap; hives on the arm that the got the vaccine; The hives are burning now; Pfizer booster vaccine; Got a headache a few hours after the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 14:30 (Lot number: FE3594, Expiration Date: 11Jan2022) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Verbatim: Hypothyroidism; "Depression" (unspecified if ongoing), notes: Verbatim: Depression. Concomitant medication(s) included: ZOLOFT; SYNTHROID. Vaccination history included: Bnt162b2 (First Dose, lot ER2613, AE(s) following prior vaccinations: None), administration date: 19Mar2021, when the patient was 43 years old, for COVID-19 Immunization, reaction(s): "None"; Bnt162b2 (Second Dose, lot EW0158, AE(s) following prior vaccinations: None), administration date: 12Apr2021, when the patient was 43 years old, for COVID-19 Immunization, reaction(s): "None". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 14:30, outcome "unknown", described as "Pfizer booster vaccine"; FATIGUE (non-serious) with onset 20Dec2021, outcome "not recovered", described as "The caller was tired and she took a nap"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered" (20Dec2021), described as "Got a headache a few hours after the booster"; VACCINATION SITE URTICARIA (non-serious) with onset 20Dec2021, outcome "not recovered", described as "hives on the arm that the got the vaccine"; BURNING SENSATION (non-serious) with onset 20Dec2021, outcome "not recovered", described as "The hives are burning now".  Additional Information: Additional vaccine administered on same date was reported as none. Prior vaccination within 4 weeks was reported as none. Family history relevant to adverse event and relevant tests was reported as none. The caller was tired and had the hives. The caller clarifies that her headache was through yesterday night but it was gone today. tired, hives on the arm that the got the vaccine was reported as worsened. The events did not cause Physician Office or Emergency Room visit.   No follow-up attempts are needed. No further information is expected.~
A non-serious, spontaneous report of vomiting has been received from a consumer concerning a six-year-old female patient, subsequent to receiving H1N1, Intranasal. The patient's medical history and concomitant medications were not reported. The patient received H1N1, Intranasal on 15-Oct-2009. On 02-Nov-2009, the patient experienced vomiting. The event outcome is unknown.
Administered vaccine at 11:50 am. By 11:55am, the patient reported feeling flushed and warm. No outward signs of either. This reportedly lasted until 12:05pm. The patient was kept for a total of 45 minutes for observation before release.
patient was given the incorrect dose. the 12+ formulation was used and mixed using 1.3ml diluent and 0.2ml dose was given to the patient. Patient received a higher  dose than she should have.
Patient began sweating and felt lightheaded.  Blood pressure was low 98/62.  Cold pack was placed on his forehead.  Patient started feeling better.  Vitals were taken again BP 110/78, O2 98%, Pulse 56.  Patient was cleared.
Swelling and raised welt about 5 X 4 inches in diameter on location of shot. Warm-to-touch.
Fever, extreme Body aches, headache, fatigue, list of appetite, skin tenderness
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-MAR-2016, the patient who was indicated for ZOSTAVAX (dose, route of administration, anatomical location, lot # and expiration date were not reported) inadvertently received a dose of (Oka/Merck0 VARIVAX lot # L011083, expiration date 01-APR-2017 (0.5 ml (also reported as unspecified dose), route of administration and anatomical location were not reported). The nurse stated that the patient "was fine". No adverse effects were reported. Additional information has been requested.