chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate to severe pain immediately after injection that improved after 5 minutes; pain then gradually returned over the next 4 hrs. Beginning approximately 4-5 hours after vaccine, began having nausea, chills, tingling of entire body, myalgia & arthralgias, and fairly violent shaking that lasted for another 5-6hrs. Was completely unable to perform normal tasks or function, even after taking  ibuprofen & acetaminophen. Also developed a fever about 8h after vaccine that lasted 3-4 hours.   Still having mild arthralgias & fatigue 48h after vaccine
Constant cough, head and chest congestion night after getting inj. feels its a reaction to vaccine.
No problem with the vaccine but on July 5, I started getting symptoms.  On July 7 I tested positive with a home test.
Patient was nervous before shot was given Immediately after administration patient had an episode of syncope She lost conciousness but breathing was normal Patient was laid down horizontally and came by just before EMT arrived EMT  thought it might have been a panick attack
adult dose (20 mcg) of Engerix B was administered to a 19 year old; adult dose (20 mcg) of Engerix B was administered to a 19 year old; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number 5L27A, expiry date 11th February 2022) for prophylaxis.   On 24th February 2021, the patient received Engerix B adult (intramuscular) 20 µg. On 24th February 2021, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional information provided were as follows: The patient who was 19 years old, received 20 mcg of Engerix B adult, which led to overdose and adult product administered to child. The patient was transferred to medical information for further assistance. The health care professional's information was not provided. The reporter did not consented to follow-up.
At the time of vaccination, the patient expected to receive the Moderna vaccine for dose 1 of COVID-19 vaccination series. The technician administering the vaccine unknowingly mixed pre-filled syringes of both Pfizer (lot EN6201, exp 6/2021; diluent lot 401817, exp 9/22) and Moderna together in the same container to bring into the vaccination room.  The techinician believed she was providing the Moderna vaccine but unknowingly administered 3 total vaccinations before the mix-up was discovered, and 2 doses of Pfizer vaccine were unaccounted when discovered by the pharmacist on duty. All 3 patients within this time frame of 3 vaccinations given were notified that they potentially received the Pfizer vaccine, as there was no way to confirm with certainty using store camera footage which syringe had definitely been used on each patient.
Patient is 15 and received Flublok in 2020 with no adverse event reported; Initial information received on 27-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old male patient who received flublok in 2020 with no adverse event reported (off label use), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient's past vaccination includes FLUBLOK (not coded) which he received in 2019.   It was a case of actual medication error due to off label use.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on batch number will not be available.
Fluzone High Dose was given to 58 years old patient, No AE; Fluzone High Dose was given to 58 years old patient, No AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received other healthcare professional.  This case involves a 58 year old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot-UJ271AA,exp- 13-MAY-2020) via intramuscular route injection in the left deltoid on 21-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Got shingles two weeks after the first dose; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 at 16:00(at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease and shingles. Concomitant medications included alprazolam (MANUFACTURER UNKNOWN) and levothyroxine sodium(SYNTHOID), all from unknown date for unknown indication. The patient previously took erythromycin(MANUFACTURER UNKNOWN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in 2021 two weeks after the first dose, the patient experienced shingles. The patient reported that she already had shingles a few years ago so this was her second time getting them and it was not severe but a small patch on her stomach and back. The patient received treatment(unspecified medication) for the reported event. The adverse event  resulted in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the event shingles was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt c/o of swelling, pain and pain with movement, redness, and left sided armpit pain.
Shortness of breath, fatigue, sudden weakness in the legs, weirdness.. something I never felt since I was born.. just like a rocking chair feeling.
Shortness of breath, body aches, nodules on my legs creating severe pain, extreme tiredness, fever, rapid heart rate. This started Thursday 04/29/2021 seen at hospital on 04/30/2021 in which they prescribed me Cephalexin 500mg taken every 8 hours for 7 days they also prescribed me Ibuprofen 600mg taken every 6 hours as needed for pain and fever.
I had a fever of 102 for 2 days . I had a low grade fever with my other COVID-19 doses.
I was high in fever, I could not walk without my vision being blurry and dizzy. After the 2 does it took a week before my fever and symptoms  went away however before that happened I could not walk I was literally tied to my bed if I walked I would have to hold on to something my leg strength was gone.
I am a 28 year old female. I received the first does of the Pfizer vaccine on December 28,2020. The next morning I woke up with severe neck pain. I received the 2nd Pfizer dose on January 22, 2021. Two weeks after receiving this 2nd shot, my right shin from the knee to the ankle was numb. The numbness lasted for at least 4 or more weeks. I continue to have neck pain. Recommended I get a MRI because of the neck pain and leg numbness. I have not pursued the recommendation for a MRI study. Both are in very good/ excellent health.
This is spontaneous report from a contactable other healthcare professional who reported similar events for three patients and from a physician. This is the third of three reports. A 10-year-old female patient received TRUMENBA, (lot number L13514, expiration date Jul2016, NDC number 0005010010) on 07Oct2015 around 4:15 PM at 0.5 ml single dose intramuscular in the left deltoid. Relevant medical history and concomitant medications were not reported. No illness at time of vaccination. On 07Oct2015, the patient experienced localized erythema. The patient experienced in Oct2015 headache, loss of appetite, vomiting, inability to move the arm, edema and dizziness. The patient was not hospitalized. The outcome of the events was unknown. Follow up (08Oct2015): New information received from the same contactable Healthcare professional includes: patient and product details, additional event (localized erythema), onset date.
Injection site and itching; Injection site started swelling; injection site red; hives around injection site; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site and itching), VACCINATION SITE PAIN (Sore left arm), VACCINATION SITE SWELLING (Injection site started swelling), VACCINATION SITE ERYTHEMA (injection site red) and URTICARIA (hives around injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE (HCT) for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (Sore left arm). On 09-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site and itching), VACCINATION SITE SWELLING (Injection site started swelling), VACCINATION SITE ERYTHEMA (injection site red) and URTICARIA (hives around injection site). On 30-Dec-2020, VACCINATION SITE PAIN (Sore left arm) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site and itching), VACCINATION SITE SWELLING (Injection site started swelling), VACCINATION SITE ERYTHEMA (injection site red) and URTICARIA (hives around injection site) had resolved.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: NNI On 08-Jun-2021: Follow-up information received on 8 JUN 2021 contains information related to Event Tab, event outcome updated and product tab updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient received Pfizer dose #1 on 1-13-2022 without complications noted. However, vaccine was beyond the use-by date which was 01/09/2022.
At 5:00 am I walked from bedroom to bathroom.  I was unstable, legs felt weak, and needed to crab furniture, door to keep from falling over. The symptoms have not abated. At 8:00 am That same day I felt numbness in my feet, both of them. My husband drove me to the hospital approximately 25 minutes later. I checked into the ER. Since this time the symptoms I have included severe restless legs at all times of the day, continued inability to walk normally - instability, weakness in legs in particular the left leg. In addition, while still being checked into the hospital, 1 day later I have now developed numbness throughout my abdomen and lower back. I am not emptying my bladder, even though I'm using the restroom regularly. I am not able to feel urges to use the restroom either to urinate or defecate. It is as if the entire area is numb. At this time, I am still in the hospital and I am not able to walk without assistance, walker, people holding me.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 06-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
I was dizzy for the first 10 min after receiving the vaccine shot, and I had soreness on my arm for 2 days (pain scale = 6/7) with shooting pains if I lifted it at all.
PATIENT WAS GIVEN "HIGH DOSE" AND SHE IS NOT OVER 65.
Day 9 after first dose my arm has large - 5 inches long red itchy area
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On unknown dates since 16-NOV-2015, unspecified number of patients have been vaccinated with improperly stored PROQUAD (Merck) (reported lot# L032760, expiry date: 24-FEB-2017) (dose, frequency and route were not reported). It was reported that the vaccines were exposed to the temperature between -15C and -10C for 126 hours and 50 minutes, and between -10C and -6.1C for 12 hours. There were no previous temperature excursions. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested. This is one of several reports received from the same reporter.
I have developed a 'bruising' around the vaccination site and down my arm. It is generally red in color with darker margins. No pain or discomfort. Two distinct areas that are not connected.
T - 100.5, fussy.  Advised Tylenol, call if symptoms change.
Narrative: 22yF with a hx of bipolar disorder and PTSD who presented to the ED with hypersalivation and tongue swelling for the past 1.5 weeks. Pt reported receiving hep B vaccine 1.5 weeks ago and since that time has experienced hypersalivation and tongue swelling every night after taking latuda. Symptoms resolve after a period of hours (wakes up without symptoms). She reported some difficulty swallowing due to tongue swelling but no hives, stridor, difficulty breathing, or other signs of anaphylaxis. She expressed concern this was related to hep B vaccine, though symptoms have been consistently temporally associated with taking her pm lurasidone. Per chart review, dose was increased to 60mg July 3rd and from last psychiatry note 8/31/22 she was tolerating it well without side effects. She has been otherwise stable from a psychiatric perspective. her other medications include tylenol, famotidine prn for gerd, sronyx and medroxyprogesterone inj q3 months. No recent changes to these medications. On review of possible adverse reactions, does appear there have been cases of angioedema (<1%) and reports of tongue edema on postmarketing. Unclear whether this is related to lurasidone but given the high potential medical risk associated with tongue swelling and apparent association of her symptoms with lurasidone doses, would recommend stopping the mediation.  Symptoms: Symptoms: 1. Angioedema
Patient called to report that shoulder became swollen.  Swelling spread down the bicep and over to chest.  Arm was red.  Pain and discomfort.  These symptoms persisted for 3 days and have now subsided.   Now reports itchiness down the arm and using  an OTC anti-itch cream.
Fatigue, dizziness, nausea, vomiting, diarrhea, chest pain, shortness of breath
red rash and some swelling.  treated with Benadryl cream for at least a week.  She experiences some itchyness but not everyday.
Patient presents to the ED with SOB and increased oxygen requirements on 9/11/2021.  Of note, she has received 3 doses of the Moderna COVID vaccine with the third dose just administered on 9/1/2021.  She was admitted and received 5 days of remdesivir, 10 days of higher dose of steroids.  She did require heated high flow oxygen of 50L, but this was eventually weaned down to her baseline oxygen requirements of 3L.  Patient was discharged home after a 6 day hospital stay.
She called back and said she had pain in her arm and burning . She called her doctors and no one called her back. I advised her again to ice the site of injection and she has Benadryl  to take those, she will take her Famotidine dose she was prescribed and to call us back.  She called back later and was feeling better. I advised her to use Epi Pen she was prescribed if her symptoms become anaphylactic.  I called her later before end of my day to follow up on her, she was feeling better just a sore arm. She will take another dose of Benadryl and Famotidine before resting. She mentioned she thinks she has blurry vision or she just was tired.
Received first vaccine on Saturday at 11:00 am. Sunday had a sore arm. Took 1000mg Tylenol and felt better. Woke up Monday morning to a slight rash/hives on back of neck. Tuesday it seemed to be getting worse so I went to my primary Dr. He prescribed Clobetasol cream 0.5%. He also said to take 25mg benadryl every 6 hours. Wednesday morning rash spread to shoulders and both arms. Called Dr and he prescribed a taper of prednisone.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified day in May 2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unspecified day in November 2017, the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 07-MAY-2018, the patient was vaccinated with the third dose of GARDASIL 9 lot # N021572 with expiration date of 01-MAY-2020 (strength, dose, route and anatomical location were not provided) for prophylaxis (inappropriate schedule of drug administration).  No adverse effects were reported.
Patient began to experience a high pressure headache and vision disturbances.  Over the period of the following weeks, the condition worsened to the point that patient was unable to attend school.  Because of patient's deafness, anything related to her vision is especially concerning.  The headaches continued to get worse to the point of her crying in pain.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient received all the Shingles shots. After receiving Shingles vaccine, the patient got shingles twice. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Red area approx. 5 cm in diameter - warm to touch on (R) arm at injection site of MENACTRA. No pain, no fever.
injected part if kinda hardened; injected part if kinda hardened almost to swelling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injected part if kinda hardened) and VACCINATION SITE SWELLING (injected part if kinda hardened almost to swelling) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (injected part if kinda hardened) and VACCINATION SITE SWELLING (injected part if kinda hardened almost to swelling). At the time of the report, VACCINATION SITE INDURATION (injected part if kinda hardened) and VACCINATION SITE SWELLING (injected part if kinda hardened almost to swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Reporter did not allow further contact
Information has been received from a registered nurse concerning a female healthcare worker who on 22, June 1988,  22, July 1998, and 22, Dec 1988 was vaccinated with a first, second, and third dose of hepatitis B virus vaccine rHBsAg (yeast). There was no concomitant medication. It was noted that the patient had previously seroconverted. She had positive tests on 12, Apr 1999 and 07, Jul 2000. On approximately 28, June 2006, the patient had an indeterminate test for hepatitis B. It was noted that the patient also had a rapid HIV test (results not provided) The patient had not contacted hepatitis B or had any problems with the series. Unspecified medical attention was sought. A product quality complaint was not involved.