chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 32-year-old patient who on 18-APR-2008 was inadvertently vaccinated SQ with a first dose of zoster vaccine live (Oka/Merck) instead of with varicella virus vaccine live (MSD) at a public health department. It was reported this was not product confusion. There were no adverse events reported. Medical attention was sought, The patient contacted the office. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
DIFFUSE URTICARIAL RASH ONE HOUR AFTER ADMINISTRATION. PATIENT WAS GIVEN BENADRYL.
About three or four months ago I started breaking out in red bumps which turned out to be hives. The first time it happened I was sitting outside, and they started to pop up around my elbow and as I scratched it, it started to spread down my arm. I initially thought it was a spider bite or chiggers because they just kept popping up, and there was no head. I started to rule out my environment and foods. I tried BENADRYL but it just knocked me out. I finally went to see a doctor and she gave me hydroxyzine tablets. It helped at first but then the hives started come back. I've had them on my feet, my arms, even under my toenails, my neck, my face, everywhere. My doctor doesn't know where it's from either. It's usually in the middle of the night.
Red rash (COVID arm), warm to touch, pain started to appear on the 2nd day, and it's becoming bigger. Also, had headache and nausea started on the 2nd day. Period started 10 days early (on the 5/16/21). On the 4th day (5/17/21), blurred vision on my right eye started. Doctor prescribed hydroxyzine HCL for COVID arm, headache and blurred vision.
My menstrual period, which started on the day of my first dose of the Pfizer vaccine, was unusually painful and was accompanied by diarrhea.  A month later, my next period is once again more painful than usual. In a normal month, I would only experience 1?2 days of painful cramps that require Ibuprofen. However, I am now on my 4th day of painful cramps. I completely understand that there is a chance these aberrant periods are unrelated to the vaccine, but hearing about other women's experiences prompted me to report. I also experienced the normal side effects of the 2nd dose (obtained on 4/27/21 at the same pharmacy), including body aches, chills, and a mild fever starting ~12 h after the vaccine administration and ending by ~30 h post-vaccine. I also had a very sore left arm and sore swollen lymph nodes in my left armpit for 3?4 days following the administration of the second dose.
This spontaneous case was retrieved on 19-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1734662-1), reported by other healthcare professional and concerned a 65-year-old, female patient. The patient's relevant medical history was not reported. The patient's concomitant medications included simvastatin, levothyroxine and Vitamine D (colecalciferol), all used for an unreported indication. The patient had no known allergies. On 22-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular (IM), dose: 'one' as reported, anatomical location: left arm (LA) and indication: not reported). The batch number reported was 312832. On 23-Sep-2021, one day after receiving Fluad Quadrivalent, the patient experienced rash, swelling, burning sensation and pain on left arm that was three inches below the injection site. As reported, Tylenol (paracetamol) helped her to control the pain. On 24-Sep-2021, the patient reported symptoms. The patient was provided with Benadryl (diphenhydramine hydrochloride) and advised to start first dose of 50 mg, then to repeat if needed at a dose of 25 mg, every four to six hours (q4-6 hrs) and to apply some ice on the burning sensation areas. Few hours later, the patient was followed up and she stated her conditions had improved. On an unspecified date in Sep-2021, the patient recovered from events. The reporter did not provide a causality assessment. The case was assessed as non-serious. Company comment: A 65-year-old patient was vaccinated with Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient experienced rash, swelling, burning sensation and pain on left arm that was three inches below the injection site. The patient was provided with Benadryl and few hours later conditions had improved. Due to plausible temporal relationship and biological plausibility, causality is assessed as possibly related for all events; Sender's Comments: A 65-year-old patient was vaccinated with Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient experienced rash, swelling, burning sensation and pain on left arm that was three inches below the injection site. The patient was provided with Benadryl and few hours later conditions had improved. Due to plausible temporal relationship and biological plausibility, causality is assessed as possibly related for all events.
Sharp pain (8/10) radiating down arm accompanied by numbness in left hand.  Started on Saturday, 2/6, at the injection site and has progressively gotten worse since then.  Also having a constant headache starting on Saturday, 2/6.  HA started out as a 4/10 and has progressed to 6/10 on pain scale.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022).    Concomitant medications were not reported.  They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
Two days post vax pt developed a sore throat and became hoarse. Seven days post vax pt was diagnosed with hypothyroidism and was treated with Synthroid. Eight days post vax pts symptoms of hoarseness and sore throat worsened and she also felt fatigue and joint and muscle aches and stiffness. Pt had trouble focusing, face and neck felt swollen and she experienced a headache and dizziness. Pts legs and entire body felt twitchy and tingly and the top of her head felt numb and was buzzing. Ten days post vax the pt awakened feeling frozen in one position and had trouble unfolding arms and fingers. Pt also continued to experience stiffness and achiness.  Throughout the day joint and body aches continued and hoarseness worsened. Eleven days post vax pt was seen in the ER, her skin was flushed and she had red streaks on her face. Pt was treated with Prednisone and advised to see her regular physician. Pt then realized that she was having the same type of allergic reaction that she had had years ago to a Tetanus vax.
Lot of bruising; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jul-2021 and was forwarded to Moderna on 20-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Lot of bruising) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Lot of bruising). At the time of the report, CONTUSION (Lot of bruising) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: normal (normal) platelet count :1,50,000 and decreased (Low) platelet count :crashed to 105,000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
The left side of the patient's face, left side of neck, left leg, and left foot became numb. The patient's face and neck felt as if she she had gotten novocaine at the dentist.  The patient's neck was tender and lymph nodes swollen. The patient's whole body was sore and she had difficulty moving, along with leg swelling and retaining water in extremeties.  The patient had difficulty swallowing , mouth felt like it had a metallic taste, and the lungs felt like they were impacted and may start wheezing. The patient had to use her albuterol inahler more than normal to help with breathing. Symptoms lasted about a day and a half before starting to improve.
None- I am reporting because he was erroneously given PCV13 instead of the hepB vaccine which was ordered.
Patient had present to the pharmacy to receive his 2nd dose of the monovalent Pfizer Covid-19 vaccine 12yrs +, but was accidentally administered the Pfizer bivalent vaccine product 12yrs+. Error was not realized until patient had left the pharmacy, patient was contacted and notified of error, and he reported no adverse reaction or symptoms. Was notified to reach out to pharmacy or healthcare provider in the event of any symptoms or adverse reactions.
On 12/22/2020 between 2000-2100, while driving, I experienced a definite notice of sensation of absence of my heart beating between 6-10 times. At one point, I was able to safely pull over, but by that point my right radial pulse palpated was 60 bmp and strong. Prior to this time but after the vaccination, I had felt  instances of a similar lack of sensation but am not sure of the times, had paid little attention to the events ? presumably because they were very very short and, though not driving, I was never able to catch them/i.e. palpate my heart rate during the events.  On 12/23/2020 at 2005, I again sensed my heart wasn?t beating. I immediately attempted to palpate my right radial pulse and felt no pulse for at least 3 seconds (I was not watching a clock to time). After the 3 seconds, I could suddenly feel a strong right radial pulse, HR was 56 bpm (my pre-vaccine HR). I had not taken my evening dose of Propanolol.
stinging sensation on my legs, also had similar sensations on my torso and back; pain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727); via unspecified route of administration in the left arm on 20Mar2021 at 12:00(at the age 51-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergy to any medications, food, or other products. Concomitant medications included low dose of acetylsalicylic acid (ASPIRIN) and amitriptyline (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications. The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 13:15, approximately 24 hours after the vaccination, the patient experienced stinging sensation on her legs. This had repeated the following two days as well, all at random times during the day, but not after he go to bed. he also had similar sensations on my torso and back. There had been no visible signs at all. The sensations last from 10-60 minutes. The pain is similar, but slightly less than a fire ant bite. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of stinging sensation of legs, torso, back and pain was not recovered. No follow-up attempts are needed. No further information is expected.
was supposed to get the second dose yesterday 19Jan2021 but location is closed/  could get it up to the 26Jan2021; paralysis of the chin and half of the face; and around the mouth; This is a spontaneous report from a contactable consumer report for self. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 29Dec2021 20:00 PM for COVID-19 immunization. Medical history included ongoing severe migraines. None family history. There were no concomitant medications. No Prior Vaccinations within 4 weeks. After an hour she had paralysis of the chin and half of the face; and around the mouth. It only lasted a few minutes, like 10 minutes and then it went away, she was fully recovered. She did not got to a doctor or the ER. Adds she was supposed to get the second dose yesterday 19Jan2021 but she has to go to another location as that location is closed. They told her she could get it up to the 26Jan2021 and then it would be more problematic to get. The event outcome was recovered on 29Dec2020.  Information on the lot/batch number has been requested.
VACCINE EXPIRED PER SITE VISIT 8/12/22. SHIPPING LABEL HAS DATE OF 12/31/2069. NO ADVERSE REACTION NOTED.
This spontaneous report as received from a 49 year old female consumer refers to herself. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU by an unspecified pharmacist two weeks ago (product circular # uspi-v211-i-fro-1703r020) (dose, frequency, route, lot # and expiry date were not reported). On an unknown date the patient experienced redness but not swelling at the injection site for the first three days. At an unspecified date, the patient began to experience pain in her head, at the back of her neck "like when you sleep in a bad position". The pain is still being experienced at the time of this report. The patient has not sought medical attention for the pain. The outcome of the events were unknown. Causality assessment was not provided. No further information provided. No PQC filed. Additional information has been requested.
mom states on 31JAN97 pt woke up crying c/o not being able to move legs, progressive diff w/talking, walking;c/o pain & swelling in joints of feet, knees, hips, fingers & knuckles;sx inc until 11FEB97 & began to subside 17FEB97;4MAR97 to ER
She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.; She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson Vaccine (Dose 1) since 09-Mar-2021 and Johnson and Johnson Vaccine (Dose 2) on 30-Oct-2021. Past adverse reactions to the above products included Bruise with Johnson and Johnson Vaccine; and No adverse event with Johnson and Johnson Vaccine.    On 20-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.). At the time of the report, INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745104, US-MODERNATX, INC.-MOD-2023-745185 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745104:Master case for SPIKEVAX 2023-2024 PFS US-MODERNATX, INC.-MOD-2023-745185:Monovalent dose
sicker; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID VACCINE).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sicker). The outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via interactive digital media. The patient reported 1st dose makes one sicker than the covid vaccine. The follow-up would not possible as no contact details were available.
This spontaneous case, initially received from a pharmacist on 19-Oct-2018, concerns a 74-year-old, elderly, male patient. On 28-Sep-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250804 and expiry date: 30-Jun-2019]. On 18-Oct-2018, in the same season, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250799 (reported as 257099) and expiry date: 31-May-2019]. No adverse events were reported after administration of the vaccine. On an unspecified date, the patient made an emergency room visit. The reporter assessed this case as non-serious. This case was considered as lost to follow up as the reporter did not provide consent for follow-up.
For about 5 hours my body ached, my legs, knees, back, neck, shoulders ached and were in pain sitting, and stiff and in pain when standing. I took 3 x 200 mg  Ibuprofen at 5:30. By 10 p.m. My body aches had disappeared but I was extremely fatigued. I am feeling better now.
Was taken to UCC then sent to ER left leg swelling sec from shots MENACTRA. At left thigh anterior lateral surface. There is minimal redness and swelling about 4x5cm and non-tender, no pus; no bleeding.
Information has been received from a physician concerning a female who in September 2007, was vaccinated SC with a dose of Zostavax. Soon after vaccination the patient experienced respiratory distress. It was reported that the patient's face and arm was swollen. The physician did send the patient to the emergency room. It was not known if the patient was admitted to the hospital. Unspecified medical attention was sought. A product quality complaint was not involved. The patient's experiences were considered to be life-threatening and disabling by the reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist via a company representative and refers to a elderly male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date in 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were not provided) for prophylaxis. At the same time, the patient received also a dose of influenza virus vaccine (unspecified) (reported as "Flu vaccine") (dose, route, lot # and expiration date were not provided) for an unknown indication. The pharmacist stated that, on an unknown date in 2017 (reported as "next day"), the elderly patient got sick and was hospitalized. The pharmacist reported that, shortly after that, the patient passed away on an unknown date in 2017. The cause of date was not reported. It was unknown if autopsy was done. The outcome of malaise was not reported. The causality between the events and PNEUMOVAX 23 was not reported. Reported Cause(s) of Death: Pharmacist reported the "elderly man passed away shortly after".
I did not having any symptoms but I did tested positive for COVID-19 on Jan 25th.
24JAN95 rash chest, abd, back, extremities x 3 days;fever 101 on & off;
Developed fever 102.8, chills, muscle and joint pain, headache, fatigue within 12hrs of vaccine administration.  Fever, headache, body aches lasted close to 36 hours.  Fatigue last over 48hrs.   Site of vaccine administration was  painful and swollen and lasted 3 days.. OTC  Acetaminophen 1000mg q 4-6hrs taken after fever developed and stopped when became afebrile.   Cool compresses applied to administration site.   Day 3 post administration of vaccine feel back to baseline.
Erythema 80mm x 60mm toward posterior area, left deltoid. Skin looks scalded w/several (TNTC) blisters over lft deltoid area (vesicles). Redness & edematous area noted 10/27. Worsened yesterday after ice then heat. 11/8 arm is better now,