chrisvoncsefalvay/vaers-outcomes huggingface dataset:
came to her appt for the second moderna shot 3/14/21 and  (intern pharmacist) ask her how was her first shot she said was fine, he gave her the shot and in 5 min she started to have severe urticaria and edema on her left arm. Denied feeling shortness of breath or throat closing. I went to check on her and she told me last time she had to go to the hospital and they gave her diphenhydramine 50 mg /1 ml,  inject her on her right arm with the 1 ml and we watched her for 30 min she started to feel better and the Hives got better.  Checked with patient later in the evening said she felt better, didn't have shortness of breath.
RASH, DYSPNEA, CHEST PAIN, FEVER JOINT PAIN, CHILLS, FEVER.   TREATMENT: KENALOG, BENADRYL, PEPCID.
Information has been received from a licensed practical nurse concerning her daughter who, at the ages of 4 and 16, was vaccinated with the first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. It was noted that the daughter is now entering nursing school, and has had titers checked on her previous vaccinations. In approximately January 2006, the rubella titer was found to be negative. The outcome was reported as not recovered. There was no product quality complaint. No further information was available. Additional information has been requested.
Information has been received from a medical assistant referring to a 12 month old patient of unknown gender. On 13-FEB-2015, the patient was inadvertently administered one dose of VARIVAX (Merck) injection, (strength, lot number, expiry date, and dose were not reported), and one dose of PROQUAD injection, (strength, lot number, expiry date, and dose were not reported), subcutaneously, which was accidental overdose. No adverse effects reported. Additional information has been requested.
This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age (also reported as under 65 year-old). The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were unknown by reporter. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient received at the same time PNEUMOVAX 23 for the prevention of pneumococcal disease (strength, dose, route, Lot # and expiration date were not reported); ZOSTAVAX for the prevention of shingles (strength, dose, route, Lot # and expiration date were not reported) and an unspecified influenza virus vaccine (strength, dose, frequency, route, indication, Lot # and expiration date were not reported). On an unknown date, also reported as after receiving all the vaccines, the patient developed a localized site reaction that was warm to the touch (injection site warmth), painful (injection site pain), and had red streaks going from the site to the inside of the patient's arm (injection site erythema and injection site streaking). The patient visited the physician's office and received treatment for the adverse experiences. At the reporting time, the patient was recovered from injection site streaking, injection site erythema, injection site pain and injection site warmth. The causality assessment between the events and vaccination with ZOSTAVAX; PNEUMOVAX 23 and the unspecified influenza virus vaccine was not provided.
I woke up at 2am in morning after vaccination on prior day with extreme cold chills. After 2 hrs. of stacking blankets on me and putting a heating bad, my chills finally minimized. During this time, I also became nauseated and puked several times. after these events, I had a severe headache for most of the following day and a very sore arm.
On 3/25 two days after my vaccine, I had a sharp searing, burning pain in my tooth, right side of face and pressure in my right ear. I went to the dentist and after an exam, he referred me to have a root canal. The pain continued to worsen and eventually in May I had a root Canal when they had an opening. The pain only got worse and began to involve my eye, ear, tooth. Some days was hard to get out of bed. I went back and after an exam he decided to repeat the root canal. Again, it only made it worse. The pain was burning, shooting, pressure and affecting my eyelid. The dentist then proceeded to place a crown. Both the dentist and endondontist never saw any reason to require a root canal only based on exam.  My dentist referred me to a neurologist. I had a MRI, MRA, CTA, CT? all vessels look great and no impingement on my trigeminal nerve. My neurologist named it an atypical trigeminal neuralgia / nerve pain and we started trying different medications. None seemed to help or the side effects were too much.   In December, the pain slowly started to improve. I have not had a reoccurrence.
Severe migraine 48-72 hours. High fever 102-104 for 72 hours.  Fever 100-102 another 48 hours. Not relieved by OTC meds. Racing heart beat and tightness in chest. Difficulty taking deep breath.  Family members wanted me to go to ER
Petechial Rash Viral Upper Respiratory tract Infection Bruising Cough CBC Data consistent with Idiopathic Thrombocypenic Papura
1st dose 23Aug2022, 2nd 21Sep2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 21-SEP-2022, the patient received the 2nd dose of Shingrix. On 21-SEP-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 23Aug2022, 2nd 21Sep2022). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 8-Mar-2023 The vaccine administration facility was the same as primary reporter. The follow up by safety team accepted by health care professional. The reporter consented to follow-up. The patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
L supraclavicular lymph node swelling and discomfort. This did not happen after the first dose. After first dose I just had headache for about a day. After second dose I also had this swelling also on same side as injection. It started approximately the day after injection and lasted about 3 days. This time it started a little earlier, the evening of the injection, and this is day 2 after injection and it?s still uncomfortable and swollen. No other symptoms no issues at site of injection.
I have had a heavy period every other week with large quantities of clots and pain. Periods also last much longer. Currently on period, 7th day, and still no sign of stopping.
pt recvd vax & 1mo later pt presented to MD w/intermittent vesicular rashes consisting of 2 to 3 lesions;MD indicated that had occurred for 2 to 3 months;
Tongue swelling and protruding. Benadryl 50mg IM given. Also, Epi pen administered. 911 called. Patient transported to ER.
01/27/2021 at 1514 Particpant c/o of fast heart beat, possible difficulty breathing and hand tingling. Assessed & noted p - 109, O2 sat 97%, skin warm / clammy with no discoloration at left upper arm injection site. Allergies verified and noted as Sulfur, Levaquin and PCN. Participant remained sitting and encouraged to deep breathe. At 1518 B/P 153/100, HR 102, O2 sat 98% with continued c/o. EMS activated at 1518 and pt moved to monitoring area; declined lying down, sat in chair for care. Post move to chair O2 sat drop to 90% then returned to 96%, HR 111. 1522 Administered Benadryl 50 mg IM right upper arm with no resp distress / rash noted. At 1554 participant voiced feeling better already with arrival of EMS noted
Information has been received from a nurse practitioner concerning her father, a 69-year-old male who on 18-APR-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  The next day, on 19-APR-2008, the patient developed autoimmune pancreatitis and was hospitalized.  No other information was provided.  Additional information has been requested.
arm was sore; This is a spontaneous report based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (Reference ID: NVSC2020US319232_OS). A contactable consumer (patient) reported that an 83-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm was sore. The outcome of event was unknown.  Information on the lot/batch number has been requested.
dizziness; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and MYALGIA (body aches) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported
Redness/swelling noted with induration (L) deltoid area seen on 2/5/08 and was doing much better
6cm x 6cm area of erythema, warmth, tenderness in right anterior thigh. Slight ecchymosis 1.5 x 1.5 cm at injection site.
Pain in shoulder, bruised, red, rash, itch, swollen, hot at injection site and fever. Waiting for Doctor appointment. Note: the prior 3 covid shots only had pain at site if I put pressure on the site. This shot was not administered into the deltoid muscle, but close to 6 inches below.
Injection site redness, tenderness, and small amount of swelling... Currently reported at approx 76hrs post injection time.
Inflammation and pain in my elbow - started immediately after shot.  Inflammation and pain in my thumb joint causing trigger thumb
Strong pain in left arm and left upper chest. Rapid heartbeat. Mild pain 10 minutes after shot then increasing intensity. At 10-12 hours after shot unable to lift arm. At 24 hours post shot pain only present in arm. Difficulty lifting even a cell phone. At 32 hours post shot arm still tender but can lift objects. Heartbeat still elevated but not as fast as day 1. Another side effect is tiredness which began 24 hours after shot.
covid-19 after receiving Pfizer covid-19 vaccine; covid-19 after receiving Pfizer covid-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6202), in right arm, on 17Mar2021 as dose 2, single (Lot number: ER2613), in right arm, on 20Oct2021 as dose 3 (booster), single (Lot number: FF8841), in right arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid - hypothyroid" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "covid-19 after receiving Pfizer covid-19 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 20Jul2022 to 24Jul2022.  Clinical course: The patient received Probiotic on 20Jul2022.  No follow-up attempts are possible. No further information is expected.
Patient experienced diarrhea, fever, limited range of arm mobility, and a sore shoulder that "feels like it has been wrenched out of the socket". She states it is slowly getting better.
20 minutes p/immun felt faint that night felt like throat was closing; pt monitors blood pressure monitoring device seemed to go wild; heart beat was fast-160 beats a minutes; fibrillation;
Patient gives history of redness and tenderness at site of injections. Today reddened area is approx. 1"x2" at injection site of Tda and .5"x1" at MMR site. States left arm was painful from shoulder to wrist yesterday. Today moves arm freely and states "I have to move it around, I have things to do." Has used cool compresses, warm compresses and Advil. Today relates hx of Tda 2 years ago.
Neck was swollen; above ankle, my legs are real red, it's like everyday something new is happening; I had a burn on upper left arm; had a burn on upper left arm; I got a booster shot and got ten times too much; Six hours later, I could not move; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Neck was swollen), ERYTHEMA (above ankle, my legs are real red, it's like everyday something new is happening), HYPOKINESIA (Six hours later, I could not move), VACCINATION SITE PAIN (I had a burn on upper left arm) and SKIN BURNING SENSATION (had a burn on upper left arm) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A-E, 013A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2.5 ml. In November 2021, the patient experienced HYPOKINESIA (Six hours later, I could not move). On 17-Nov-2021, the patient experienced OVERDOSE (I got a booster shot and got ten times too much). On an unknown date, the patient experienced SWELLING (Neck was swollen), ERYTHEMA (above ankle, my legs are real red, it's like everyday something new is happening), VACCINATION SITE PAIN (I had a burn on upper left arm) and SKIN BURNING SENSATION (had a burn on upper left arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 17-Nov-2021, OVERDOSE (I got a booster shot and got ten times too much) had resolved. At the time of the report, SWELLING (Neck was swollen), ERYTHEMA (above ankle, my legs are real red, it's like everyday something new is happening), HYPOKINESIA (Six hours later, I could not move), VACCINATION SITE PAIN (I had a burn on upper left arm) and SKIN BURNING SENSATION (had a burn on upper left arm) outcome was unknown.            No  concomitant medications were provided.  Treatment medications include:Steroid Pill,Muscle Relaxer
Pt recv vax on 10/16/98; on 10/17/98 pt exp swollen & painful breasts
This is a spontaneous report from a contactable consumer. A Pfizer employee reported on behalf of his colleague's daughter. A female patient of unspecified age received PREVNAR 13 on 30Jul2012 in the late afternoon between 4-5 PM for routine immunization. The relevant medical history of the patient was unknown. Relevant concomitant medications included unspecified vaccines administered on 30Jul2012 for an unknown indication. After the patient received the PREVNAR 13 on 30Jul2012, she experienced pain at the site of injection. No relevant laboratory data was reported. Therapeutic measures taken in response to the injection site pain were unknown. The clinical outcome of the injection site pain was unknown. Follow-up (31AUG2012): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a other health professional refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M044399, as prophylaxis. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA006953.
they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided    This case was linked to MOD-2021-365274 (Patient Link).
Experiencing eye rolling; Head movements to the right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 17:00 (Lot number: Fk5618) at the age of 10 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing), notes: Other medical history: Autism. The patient did not have any other known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient did not have COVID-19 prior to vaccination. The following information was reported: EYE MOVEMENT DISORDER (medically significant) with onset 29Nov2021 14:00, outcome "not recovered", described as "Experiencing eye rolling"; DYSKINESIA (medically significant) with onset 29Nov2021 14:00, outcome "not recovered", described as "Head movements to the right". The events "experiencing eye rolling" and "head movements to the right" were evaluated at the physician office visit. Therapeutic measures were taken as a result of eye movement disorder, dyskinesia with unspecified medication. The patient was not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.
Pt experiencing numbness and tingling on left side of tongue, left lower lip, and left index finger.
I had head congestion, left ear blockage and pressure. I had head pain, runny nose, and thick mucus. I was coughing. I also had fatigue and body aches. I am still coughing a lot.
Approx < 2 hrs after HEP B vaccine, parents reported episode of head twitching.  Not seizure.  Brief, lasting seconds, alert.  No further episodes that day, then 3 add'l episode the next morning.
Pt called pharmacy complaining of sneezing, sore arm, headache, and a cold feeling day after receiving second SHINGRIX shot - pt concerned may be allergy to vaccine- advised pt to speak to primary doctor. These may be more common symptoms following vaccine administration. If allergy may see relief with BENADRYL or cold medicine for other symptoms. If persists or worsens follow up with physician.
2x3 cm erythema to left deltoid. mild tenderness and induration. Left should slightly reduced ROM. tenderness started day of vaccination. other symptoms started about 24 hours later, worsened about 40-48 hours after vaccincation.
Patient died on 7/8/2021 in personal care apartment.  Reportedly had COVID vaccine about 8 days prior to death.  No other symptoms in the time between vaccine and death.    He received a "COVID' vaccine but family has not provided whether it was Pfizer or Moderna.  This was his second dose
High blood pressure, harder to breathe.  The first two days after the shot I felt ill... sore throat, headache, achy... much more than I expected.
After the pharmacist administered the vaccine, she accidentally poked her left palm with the needle before the safety device was activated. It is unknown if skin was broken. There was no blood.
I received the vaccine on Friday the 23rd.  Since, I have had pain in my arm.  But I have also had a headache that comes back after I take Tylenol, pain in my upper back and neck, nausea, stomach ache, some dizziness, and faster than my normal heart beat.
This spontaneous report was received from a registered nurse refers to 15 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 27-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: L036301, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Pt given expired vaccine. Moderna contacted and recommended to repeat the dose. Patient contacted and asked to return to clinic
Case number PHEH2015US003141, is an initial spontaneous report received from a nurse on 10 FEB 2015. This report refers to a n 11 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 14 JAN 2015, MENVEO (batch number: M14071, expiry date: NOV 2015) was at 0.4 degree Celsius for 1 hour and 16 minutes and the patient received 0.5 ml intramuscular dose of this frozen vaccine with excursion on 30  JAN 2015. The vaccine had two more other excursion as follows: on 26 JAN 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 JAN 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.