chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history and concurrent condition were not reported. On unknown dates, the patient was vaccinated with three pneumonia shots (manufacturer unknown) (strength, lot#, expired date, dose and frequency were unknown). The last shot was administered when the patient was in her mid-40s and the patient was 62 years at the reporting time. The reporter did not know if any or all of those three pneumonia shots were PNEUMOVAX 23, therefore, this AE was being filed for PNEUMOVAX 23. No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient seen 3/13/07 with 4cm area of erythema/warmth on L arm. Patient seen again 3/14/07 with 9.25cm area of erythema and warmth. No other symptoms. Pt seen 3/12/07 for fall with laceration on R ant tibia.
Low grade fever and 3 in X 3.5 in cellulitis at injection site. Keflex 500mg 3 times a day x 7 days prescribed by NP.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-APR-2016 the patient was vaccinated with an improperly stored dose of VAQTA 10Pk 25 U/0.5 mL (lot # L004439, expiration date 04-JUN-2017, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours. The lowest recorded temperature was 34 Celsius degree. The storage criteria of the vaccine and the type of excursion were refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient complains of left arm pain after boosrix injection.  Injection site reaction with decreased mobility.
Moderna COVID-19 Vaccine EUA  Injection site soreness - feels bruised but isn't bruised. No other symptoms.
Information has been received from a physician concerning a patient who was vaccinated with hepatitis A virus vaccine (manufacturer unspecified) and subsequently had negative titer results. No product quality complaint was involved. No additional information was provided. Additional information has been requested.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 28-SEP-2016, the patient was vaccinated with GARDASIL 9 (dose: 0.5 ml, lot and expiration date unspecified) (inappropriate schedule of drug administration). Reporting nurse mentioned that the patient received first and second dose of GARDASIL on 16-MAR-2016 and 23-MAY-2016, respectively. No adverse effects were reported. Additional information has been requested.
Developed mild left side parotitis days 3 - 6 post primary vaccinia vaccination. Totally resolved without treatment by day 7.
45 mins after vaccine administration, felt extremely hot and clammy and felt like she was going to pass out.  After that passed, she got very lightheaded and dizzy and weak.  B/P 114/75; Pulse 58/min; No fever.  Sent to ER where she received a liter of IV fluids, Zofran and Meclizine.  Labs drawn. Sent home; still felt dizzy & lightheaded.  Next day returned to work and felt OK, except for residual Headache. Two-Three days later, she noticed a "rug burn" type of rash on her forearms and some "red bumps" on her body that were maculopapular in appearance, not vesicular.  Also had generalized itching like she had been exposed to "fiberglass". Sent home with steroid "dose pack" to follow-up in 2 days.
I have psoriasis and it had been dormant for 8 months prior to the vaccine.  I don?t take any medication for psoriasis but I do have a salve to apply to dry spots.  After I received the vaccine, I?m having a bad flare up all down the middle of my back and on the back of my head.  I?ve had flare ups before but never this bad.  I don?t know if the vaccine has anything to do with the flare up but thought it might be something you?d want to know.  I didn?t go to the dermatologist because there?s not much they can do for me other than try another ointment.  I?m scheduled for my second dose on March 4th.
Tinnitus:   I have never experienced tinnitus before.  I was bedridden within 45 minutes of the second shot and began noticing a ringing in my ears the next morning.  The ringing has been continuous since the start, there has been no cessation.  It varies in intensity, sometimes barely noticeable,  sometimes it is hears above everything else.
26JUN92 pt recvd 1st dose of Engerix-B & 13JUL92 devel bell's palsy; inability to shut eye, rt sided weakness & numbness of tongue; sx started to subside by 26JUL & were better by 2AUG92;
This spontaneous report as received from a healthcare worker refers to a 11 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 26-AUG-2015, the patient was vaccinated with improperly stored dose of GARDASIL 9 (Lot#L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Severe headache woke me from sleep approx. 6 hrs later,  continued till the next day; Severe headache woke me from sleep approx. 6 hrs later,  continued till the next day; severe neck and back stiffness, just did not feel well; severe neck and back stiffness, just did not feel well; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received bnt162b2 (Pfizer Biontech COVID 19 vaccine), lot number: EJ1685, via an unspecified route of administration at the left arm on 20Dec2020 06:30 at a single for COVID-19 immunization. Prior to vaccination the patient was diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), carvedilol (COREG), ergocalciferol (VIT D), vitamin b complex (VIT B COMPLEX) and bupropion hydrochloride (WELLBUTRIN). On 20Dec2020, the patient experienced severe headache that woke her from sleep approximately 6 hours later and continued till the next day.  She started having severe neck and back stiffness and just did not feel well. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The events recovered on an unspecified date in Dec2020.
Patient was receiving second moderna covid vaccination when her tongue felt tingly and started to swell. She waiting 15 minutes and then brought the reaction up to the pharmacist. The pt was brought into the immunization room and monitored by. With no improvement 5ml of 12.5mg/5ml benadryl was given to the patient at 345pm. Patient bp and pulse was taken. Blood pressure was 154/94 which was typical for her and pulse was 69. Patient then started to complain of her throat feeling tight and having difficulty breathing. Pt had albuterol inhaler on her due to history of copd. She took two puffs of albuterol at 353pm. Patient had audible wheezing and was still having difficulty breathing. A 0.3mg epi pen was administered to her right thigh at 354pm. Code white was called and as we were calling 911 she adamantly refused medical attention and did not want the paramedics to come.  , a co manager came back to check on the pt and she was still refusing medical attention. Pt was continually monitored as her pcp was called. called the pt to urge her to go to the ER to be monitored but she again refused. At this time I had a pulse oximeter measuring her blood oxygen level which was at 96%. The patients symptoms were improving. The patient stated she did not have an epi pen at home so sent an epi pen script to the pharmacy which was filled and sold to the patient.  Pt was thoroughly counseled on the how to use the epi pen and was told by the dr and the pharmacist if she had to use the epi pen again she needed to head straight to the er. Patient was monitored from 3:20pm roughly the time of injection until around 4:50pm. Pt was contacted at 630pm to check up and she stated she was feeling much better and all symptoms had improved.
Onset 1 week after vaccination of polymyalgia, polyarthralgia affecting ability to stand from seating position. Denies any loss of work. Denies relieving modalities. Denies, CP, SOB N/V or other symptoms. Symptoms self-resolved 3 weeks after onset. No sequelae to date.
Based on additional information received on 27 APRIL 2015 this case is now medically confirmed.  Initial unsolicited report received from a non-healthcare professional (consumer) on 19 MARCH 2015. This case was linked to 2015SA036845 (same patient). A 72-year old female patient, whose medical history and concomitant mediations were not reported, had received a dose of influenza vaccine ,dose, dose number, batch number, expiry date and site of administration was not reported) via intramuscular route on 14 SEPTEMBER 2014. It was reported that the patient is not having any illness at the time of vaccination and recovering from back surgery. It was also reported that the patient does not know what influenza vaccine she received. Stated she had pain and swelling at the injection site right away. Swelling at the site is about the size of an egg. Shoulder pain is constant with she is doing an activity. Patient can move her arm up and down without pain. No information about prior exposure to vaccine was provided.  Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome was not recovered. Documents held by sender:  none. Follow-up information received from the physician on 27 APRIL 2015. IT was reported that the patient was injected in the right shoulder the other day and one month ago for biceps tendonitis.
Starting April 9, 2021, I have been having painful ovarian cramps. Feels like I am about to have my period, even though my periid ended April 7, 2021. I have not had any treatment for it and symptoms are ongoing
Information has been received from a health professional concerning now a five year old female who in September 1996 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that in May 2001, the pt was diagnosed with "a mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Information has been received from an allergist/ immunologist concerning a 7-9 year old male "sometime in mid-July 2008", on approximately 15-Jul-2008 was vaccinated with a dose of VARIVAX (Oka/Merck). "About two weeks" after vaccination, the patient developed a severe case of Zoster. The Zoster rash covered the back from shoulder blade. The patient was treated in the emergency room for the rash (date unspecified) and prescribed Augmentin and Prednisone for two weeks. The rash did not improve with treatment. No other symptoms or treatment available. HCP was interested in VZV anylasis by PCR and wanted to send viral isolates. At the time of this report, the event persisted. Follow up information was received which indicated that the patient was enrolled in the Varicella Zoster Virus Identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV or with the Oka/Merck vaccine VZV strain. On 10-Sep-2008 the specimen was taken from a vesicle lesion on the patient's back and sent to the laboratory on a piece of gauze. The result indicated that the sample was inadequate, negative for B-globin, no strain I.D. . VZV  DNA could not be amplified. The reporter stated, "piece of gauze soaked for many days". Additional information has been requested.
PATIENT HAD BEEN SHOPPING IN THE STORE AND WAS IN AND OUT OF CONSCIOUSNESS WHEN I WAS CALLED OVER FROM THE PHARMACY TO CHECK ON HIM. PT ALSO USES OXYGEN AT HOME AND DID NOT BRING WITH HIM. BLOOD SUGAR WAS HIGH (>220) AND PARAMETICS ARRIVED ON SCENE AND TOOK HIM INTO AMBULANCE TO BE EVALUATED. THEY WERE NOTIFIED THAT HE RECEIVED VACCINE APPROXIMATELY 1 HOUR BEFORE EVENT.
A non-serious spontaneous report of "administration of expired product" was received from a non healthcare professional concerning a 26-year-old male out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
itching on injection site; muscle pain; fatigue; "real dizziness"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching on injection site), MYALGIA (muscle pain), FATIGUE (fatigue) and DIZZINESS ("real dizziness") in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching on injection site), MYALGIA (muscle pain), FATIGUE (fatigue) and DIZZINESS ("real dizziness"). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (itching on injection site), MYALGIA (muscle pain), FATIGUE (fatigue) and DIZZINESS ("real dizziness") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       physician advised not to take second vaccine shot.
No adverse event; expired dose given/Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given/Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 03-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given/Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired dose given/Dose administered after 30-day Use By Date).    Concomitant medications details were not reported by the reporter. Vial did not undergo any temperature excursion.  Date the vial was initially stored in refrigerator was Unknown. Treatment details was not reported by the reporter.
A few hours after patient received vaccine, she experienced muscle aches in her neck and shoulders; nausea and vomiting.  Upper lip swelling.  Patient is treated with diphenhydramine and IV fluids.
Information has been received from a physician concerning a 17 year old male patient who on an unspecified date was vaccinated with a pediatric dose of VAQTA (Lot # and route not reported). The physician reported that despite vaccination, on an unknown date the patient still contracted Hepatitis A. At the time of the report, the outcome of the patient was not reported. The patient sought unspecified medical attention. Follow up information was received from the physician who reported that on 08-CT-2010 at 8:30 am, the patient was vaccinated intramuscularly into the right arm with the second dose of VAQTA (Lot # 666802/1684Y). The physician reported that the patient developed hemolytic anemia due to  Hepatitis A infection, which was confirmed by an Hep. A antibodies test, and Epstein-Barr virus infection. A blood test performed on 08-OCT-2010 showed: Red blood cell count 3.39, Blood hemoglobin test 10.2L, Whole blood hematocrit 29.1 M, ean platelet volume 8.9, Neutrophil count 26, Lymphocyte count 55 Reticulocyte count 6.4, Blood reticulocyte count 0.22, Glucose test 140, Plasma carbon dioxide test 31, Bilirubin test 3.1, Indirect plasma bilirubin test 2.8, LHD 2224, AST 49, ALK PHOS 95, ALT 61. Hepatitis A Antibody test- Reactive positive. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Patient presented to our clinic with redness, swelling, itching, and pain at the injection site. Vaccine was administered in different location (about 30 minutes from our location). Patient had rapid onset of symptoms (about 2 hours). Patient seen by provider, reaction outlined with marker and given ED precautions as well as Benadryl for itching and Tylenol for pain. Patient PCM also contacted via email.
Pain in arm at sight, then umusual sensation in fingers.  Headache 3 days.  Fever of 101 the afternoon of injection, cold chills, fatigue, inability to sleep.  Temperature the following morning was 93.  Developed rash/hives over entire body on the third night.  Mostly resolved after taking antihistamine.
On 03/12/2021 - my  body temp went very cold.  I started having the shakes.  I could not breathe. My throat started getting tight. I started getting anxiety. I had to lie down.  After lying down for  an hour and half I started recuperating. Still after that I had a fever. The part that concerned me was the breathing.  (The 2nd dose, nothing, a little sore in the arm, but that's it.) It took about 3 days, until I finally started feeling better and getting back to normal.  I called the doctor and they said not to worry, if it gets worse to go the the urgent care.  In 12/2021, I was put on a CPAP, because they say I am low on my oxygen level.  Note: After I received chemo in 12/2012, my body changed. I get a reaction to certain things, like food. I was able to eat shrimp before and now I can't. I also have a reaction to certain medicines.
Chills, increased nausea and heavy vomiting with 101-102 fever for 24 hours from onset (started 12 hours after vaccination).    Resolved with rest and tylenol by following morning.  Fatigue extended for the following day.  12 weeks pregnant at time of vaccine.
Describe Event, Problem, or Product Use Error: Moderna (SARS-COV-2 Vaccine, MRN )use for COVID-19 under Emergency Use Authorization (EUA): Patient was 17years11months when he was administered Moderna vaccine in error.
nasty (rare) side effect / Guillain-Barre syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient.  The age at vaccination was not reported. The patient got shingles shot 2 years ago and got a nasty (rare) side effect.  The patient experienced Guillen-barre syndrome.
her throat is swollen; her arm is a little sore; She has Watery Diarrhea/ really bad diarrhea; a little bit of nausea; This spontaneous case was reported by a patient and describes the occurrence of PHARYNGEAL SWELLING (her throat is swollen), PAIN IN EXTREMITY (her arm is a little sore), DIARRHOEA (She has Watery Diarrhea/ really bad diarrhea) and NAUSEA (a little bit of nausea) in a 48-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058628) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 31-Oct-2023, the patient experienced PHARYNGEAL SWELLING (her throat is swollen), PAIN IN EXTREMITY (her arm is a little sore), DIARRHOEA (She has Watery Diarrhea/ really bad diarrhea) and NAUSEA (a little bit of nausea). At the time of the report, PHARYNGEAL SWELLING (her throat is swollen) and PAIN IN EXTREMITY (her arm is a little sore) outcome was unknown and DIARRHOEA (She has Watery Diarrhea/ really bad diarrhea) and NAUSEA (a little bit of nausea) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No relevant concomitant medications were reported.  It was reported that patient's throat was swollen but she could still swallow food. She does not have sore throat. No treatment medication reported.   Reporter did not allow further contact
This case was reported by a healthcare professional and described the occurrence of pain in a 3-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline). The patient's mother stated that it was "normal" for her son to develop a fever following vaccination(s). The subject received no other vaccinations on 07 March 2007. On 07 March 2007 the subject received the first dose of Havrix (0.5 mL) administered intramuscularly, in the left arm. On 08 March 2007, within one day after vaccination with Havrix, the subject experienced unspecified pain, and became cold and clammy. On 09 March 2007, the events were resolved. In the reporter's opinion, the events were not related to treatment with Havrix.
C/O lightheadedness, hot/cold feeling, nasal congestion, sore throat. Temp 98.2 F. Pt stated may be coming down with a cold virus. Water offered, approx 8 oz taken. Left center to go home, still c/o sore throat and nasal congestion.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Slight headache). The patient was treated with ACETYLSALICYLIC ACID, DIPHENHYDRAMINE CITRATE, PARACETAMOL (EXCEDRIN PM HEADACHE) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-034973 (Patient Link).
Injection site hot to touch, swollen, hard lump the size of jawbreaker and 3 inch red spot.  Painful.