chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; patients received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Their concomitant therapies included properly stored sterile diluent.  On unknown dates in 2019 (reported as between 01-JUL-2019 and 02-AUG-2019), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R030612, expiration date 23-OCT-2020 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, lot # S002490, expiration 23-JUL-2020 (doses, routes, vaccination sites and concentration were not reported) for prophylaxis. The temperature was from -14°C to -10°C (-14.2 C) for 6 hours. Previous temperature excursion was from -14°C to -10°C (-14.2 C) for 30 minutes. Digital data logger was involved. No adverse events were reported.   This case was considered to be non-valid due to lack of patients' identifiers.  Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.  Follow-up information was received from the nurse on 27-AUG-2019 and refers to three 1-year-old patients. On an unknown dates in 2019 (reported as between 01-JUL-2019 and 12-AUG-2019), the patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot # S002490, expiration 23-JUL-2020. There was no reactions or problems with the patients. The freezer was defrosted on 08-AUG-2019 (reported as last Thursday). On 12-AUG-2019, the temperature was -14.9°C for 30 minutes. The clinic manager was checking into getting a lab grade/ vaccine grade freezer. Total hours of excursions was 6 hours and 30 minutes at -14°C.  This is one of 4 cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA010528: US-009507513-1908USA010527: US-009507513-1908USA010526:
itching to Head + chest, 2-3 severity in itching. Pt observed for 45 min. VSS. Advised pt to take Benadryl 25mg Q6 hrs. Pt 112/68 HR 60 Resp 16 Ox 92%. Xyzol 5 mg x1 dose.
3-8-17 None, mom states child fine. 3-20-17 Pt states baby is well, no issues.
Extreme swelling on vaccinated leg.  Red and hot to touch.  Pain in walking.  Irritability.  Given Benadryl and ibuprofen.
administered Engerix-B inadvertently; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 62-year-old female patient who received HBV (Engerix B) (batch number 90746, expiry date 7th September 2023) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Engerix B. On 1st September 2021, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The patient was administered the Engerix-B vaccine inadvertently, which led to wrong vaccine administered. The reporter consented to follow up. This case has been linked to US2021222751, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021222751:Same reporter
Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Flu vaccine.   Linked case(s) involving the same patient:US2023AMR034744   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter stated that arm a little sore with flu shot. Additional Supportive Information: The follow up would not possible as no contact details were available. The case had been linked to US2023AMR034744, reported by the same reporter, for a different product.; Sender's Comments:  US-GSK-US2023AMR034744:Same reporter
Pt presented to the ER with x5 days of dizziness, ataxia , and lightheadness.  Imaging studies showed and Acute left  Cerebellar Infarction. Patient was recommended for inpatient acute rehab upon discharge which he refused, patient discharged home with home health services.
Redness,rash nodule formation at injection site, pain/soreness, swelling in rt arm down to rt knee  Symptoms reported to have resolved 05/23/19
36 hours after receiving the 2nd Pfizer covid vaccine, my lips swelled up twice their size.  I had previously had lip fillers of restylane placed 1 year prior to vaccine.  I phoned my Aesthetician's office and she told me to try taking 2 antihistamines every day till swelling persists and if it got any worse, I could come in for a steroid shot.  I took 2 zyrtecs for 2 days and after 2 days the swelling had decreased significantly.   In addition, 12 hours after receiving the 2nd pfizer covid shot, I had fever, body aches, muscle pains throughout body, chills, fatigue, lethargy, stabbing pains in legs.  I stayed in bed for 36 hours straight and after 48 hours, I began to feel better.
On 12/11/2000 at 15:00 hours the patient awoke from her nap and had developed a swollen face, ecchymosis around the eyes and sleepiness. The patient was treated with Zyrtec. Subsequently, on 12/12/2000 the patient recovered. Additional information is not expected.
Information has been received from a physician concerning a 10 year 9 month old patient who, at the age of 2 years, was vaccinated with a 0.5ml subcutaneous dose of varicella virus vaccine live. It was reported that the patient developed a severe case of breakthrough chickenpox. The physician described the rash as lots of vesicles on the trunk, stomach and all over the body. The child also had a sore throat. The child came back to the office on 5/16/2005 and was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information as provided. Additional information has been requested.
Patient received Dtap, Influenza on 11/14/2018 and returned to the site with her left leg red with swelling noted around the injection site. Swelling is increasing after home interventions, ice and ointment.
Information has been received from a 60 year old male with a history of several episodes of shingles with post herpetic neuralgia over the past twenty years and no allergies who on 16-MAY-2011, was vaccinated subcutaneously into the left upper arm with 0.65 ml of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included simvastatin (manufacturer unknown) and lisinopril (manufacturer unknown) and six hours after he described feeling as he was going to have an episode of shingles. Consumer reported that on 17-MAY-2011 he experienced swollen lymph nodes in his groin and his armpit, a "low grade fever", and "the beginning of shingles lesions" on his left hip, his left buttock and one lesion on the center of his low back. Consumer reported that the lesions were not fluid filled. Consumer also reported that the injection site in his left upper arm was red, swollen and "very sore". The patient was treated with aspirin. Consumer reported that he did not have a physician for follow-up. Patient sought medical attention and spoke to an advise nurse who referred him to MSD. At the time of this report, the patient status was not recovered. Additional information has been requested.
Patient's father was sitting next to him.  Within 5 minutes of vaccination, father described that it "looked like he had a little seizure."  Paramedics were called.  Patient had a difficult time staying awake, but managed to do so.  Paramedics took vitals and preliminary diagnosis was hypotensive syncope.
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine, lot number: ER8732) via an unspecified route of administration in the right arm on 02Apr2021 at 13:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received morphine (MANUFACTURER UNKNOWN) for unknown indication and unknown date and experienced allergy. Concomitant medications included desogestrel, ethinylestradiol (PRIMERA) and progesterone (MANUFACTURER UNKNOWN) for unknown indication and unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 02Apr2021, the patient experienced sore from shot, flu like symptoms, ache and tiredness on the night of vaccination. On 08Apr2021, reported as 6 days after shot she had dizziness and vertigo. On an unspecified date in Apr2021, the patient experienced sore arm for a few days. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events sore from shot, flu like symptoms, ache, tiredness, dizziness, vertigo and sore arm were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Woke up at 2 am the next morning with one of the worst headaches I've ever had (but I don't think it was a migraine) and then vomited every hour until 9 am.  I'm totally and completely fine today.
I felt sick that evening a few hours later. Fever, headache, stimuli sensitivity to touch, noise, light. I got chills that night and when I woke up in the morning felt that my chest felt heavy, tight, and almost burning sensation. I?m not sure if I would say it hurt but definitely felt inflamed and like my heart was beating too fast and working too hard even when at rest. This peaked for about 24 hours and I felt better but the chest sensation has persisted today. It has subsided some but is still present.
COVID Breakthrough  Moderna Dose 1 1/20/21 (041L20A) Moderna Dose 2 2/17/21 (011M20A) COVID Positive 8/28/21  8/28/21: Patient very hard of hearing, when asked why in the hospital, she reports she was short of breath and was brought in for UTI. Per ER physician documentation, patient arrived from memory care unit via medic with complaints of increasing shortness of breath and dark emesis and stool.  Patient has a history of diabetes mellitus, hypertension, paroxysmal atrial fibrillation, recent right rib fracture. ER is no document that patient was diagnosed  COVID positive on 08/27/2021 and became hypoxic today.  Patient is vaccinated for COVID-19 infection. In the emergency room, she was febrile on presentation to 101.9 degrees, she was requiring 10 L of oxygen, blood pressure was 175/74 on presentation.  Patient had chest x-ray done which showed pulmonary edema. EKG normal sinus rhythm with bifascicular block. Laboratory workup revealed leukocyte esterase and nitrite positive. D-dimer elevated, CT angio negative of pulmonary embolism but revealed pneumonia superimposed on chronic interstitial changes and chronic left pleural effusion. Troponin is 0.12 patient denies chest pain, lactic acidosis of 2.3, proBNP is elevated at 13000.  Blood glucose of 242 on presentation.  CBC shows macrocytic anemia with hemoglobin of 10.4.  Patient received IV ceftriaxone, IV Lasix and dexamethasone and is being admitted to the hospitalist service.  At time of evaluation, patient lying calmly in bed, she denies complaints of chest pain or shortness of breath. Called  Memory Unit to get more information, patient has had abdominal pain and diarrhea, was diagnosed COVID positive yesterday.  Was noted to be hypoxic this morning and then transferred to the emergency room.  9/3/21: A 94-year-old lady presented to the emergency room with history of increasing shortness of breath.  She tested positive for COVID infection 1 day prior to arrival to the emergency department.  Further evaluation suggestive of pneumonia.  Patient was treated with remdesivir, dexamethasone, and empiric antibiotic therapy.  The patient's condition progressively improved.  Patient is back to her baseline. However, she still remains physically deconditioned, and will require physical conditioning via PT/OT.
Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant drugs were reported.  No Treatment information  were reported.   This case was linked to MOD-2021-294383, MOD-2021-294508 (Patient Link).
Positive swelling on left deltoid area. With reddish area on vaccination site. Patient came back to clinic (3 days after) with decreased swelling.
After receiving vaccination pts. head began to drop, he became unresponsive and was snoring, his eyes were open the entire time. I began to call his name and shake him. He was not responsive. Technician began to call 911 and as she was doing so he became to come to and he wet himself. He asked us not to call 911. The entire episode lasted less than 40 seconds.
Grandmother, called PNP on 5-21-20, Telemed visit. Skin lesion erythematous and vesicular papules on forehead and arm. No complaints of itching. No infection noted. Advised to call for signs of infection. Contagion precautions given.
less sore; started to get cold chills, like with a cold; Runny nose; Cough; felt yaky; low fever, like a 100 degree Fahrenheit; started to get cold chills, like with a cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (less sore), NASOPHARYNGITIS (started to get cold chills, like with a cold), RHINORRHOEA (Runny nose), COUGH (Cough) and VACCINATION COMPLICATION (felt yaky) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (less sore), NASOPHARYNGITIS (started to get cold chills, like with a cold), RHINORRHOEA (Runny nose), COUGH (Cough), VACCINATION COMPLICATION (felt yaky), PYREXIA (low fever, like a 100 degree Fahrenheit) and CHILLS (started to get cold chills, like with a cold). At the time of the report, PAIN IN EXTREMITY (less sore), NASOPHARYNGITIS (started to get cold chills, like with a cold), RHINORRHOEA (Runny nose), COUGH (Cough), VACCINATION COMPLICATION (felt yaky) and CHILLS (started to get cold chills, like with a cold) outcome was unknown and PYREXIA (low fever, like a 100 degree Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 100 degree fahrenheit (High) 100 degree Fahrenheit : low fever. The patient said the temperature has been the same..   No concomitant medications provided.  The patient reported that after the second dose, the patient was just fine and in the middle of the night, the patient started to experience the symptoms. Treatment information included cold medicine that helped the patient to get sleep like nightquil. The patient drunk lot's of fluids. Patient's date of birth was Oct-1985.   This case was linked to MOD-2021-310637 (Patient Link).   Reporter did not allow further contact
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020) for prophylaxis. On 4th June 2018 13:00, the patient received the 2nd dose of SHINGRIX (intramuscular). In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever, weakness, injection site pain, myalgia and injection site erythema. On an unknown date, the outcome of the fever, weakness, injection site pain, myalgia and injection site erythema were recovering/resolving. The reporter considered the fever, weakness, injection site pain, myalgia and injection site erythema to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on an unknown deltoid. The patient experienced the effects as noted at the injection site.
Patient was given Moderna vaccine and shortly after found out this lot (026C21A) is expired as of 10/24/21. Contacted Modera and they confirmed that the lot did expire. Patient did not experience and side effects at the time of this report. Awaiting on guidance from Moderna to see if dose needs to be repeated.
12 days after the injection, I noticed that the area around the injection site was really red. It spread in the following two days downwards toward my armpit. I applied hydrocortisone cream and took Benadryl. Issue resolved on day 15 with no further incident.
Fever in 1st 12 hours, for 48-72 hrs up to 105 degrees. Seizure activity 6 days later. Still having brief partial seizures.
Severely swollen upper arm and forearm of the vaccine-administered right arm. Patient states severe pain. On assesment at the pharmacy when patient showed up on 7/17/16, only the forearm was still swollen.
Injection site pain; redness; headaches; left side neck pain; shoulder pain; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 6th December 2019, refer case US2020AMR033929).   On 18th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, headache, neck pain and shoulder pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the headache, neck pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, headache, neck pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, till the time of reporting experiencing headache, neck pain and shoulder pain. The patient had injection site pain and redness and would nearly gone till the time of reporting. For the tollerence of 1st dose refer case US2020AMR033929, reported by same reporter for same patient.
No adverse effects were reported; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (intramuscular, lot# N003701, expiration date: 01-NOV-2019; dose was not reported) following a temperature excursion for prophylaxis. No adverse effects were reported in the patient. Temperature/time frame and 47 Fahrenheit to 77 Fahrenheit (9 degrees centigrade to 25 degrees centigrade) (51.6 Fahrenheit) for 42 minutes. Previous temperature excursions, 47 Fahrenheit to 77 Fahrenheit (9 degrees centigrade to 25 degrees centigrade) (57.4 Fahrenheit ) for 40 minutes.
The patient developed redness & swelling of her arm the next day. She was given steroids & BENADRYL in ED. It persisted so she was seen in our office & given Pred Pak & 7 day course of KEFLEX today.
Twin patients being vaccinated.  Two doses of IPV were administered to patient, instead of 1 to each twin.
A report was received from a health care professional on 11/14/03 concerning a vaccinee of unspecified demography who inadvertently received Fluvirin via the SC route on an unspecified date. On an unspecified date, the vaccinee received Fluvirin via the SC route. The reporter did not know whether or not the vaccinee experienced any adverse symptoms after the event. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Clent stated a few days after receiving Tdap & Varicella in the left arm and MMR and Hep B in the right arm two lymph nodes in the left side of her neck became swollen.  She subsequently had them removed.  Her physician told her it may have been caused by the Tdap.
Develop an acute case of shingles at the site of Shingrix injection Received 1st Shingrix shot LT deltoid 2/3/2020, symptoms of redness, pain and swelling started 2/7/2020, followed the next day 2/8/20 with blisters, itchiness and more pain.
Approx 5 mins p/pt left clinic started screaming took feeding screaming 1 1/2 hrs then stopped for 15mins & started for 1 more hr of screaming; fussy rest of day; pt given APAP;
Patient admitted on 2/20/22 shortly for external cephalic version for breech presentation. Patient hospitalized on 3/9/22 for labor and delivery after SROM. Baby was 7lb 12.5 oz. Postpartum course was uneventful.
Approximately 10 hours after receiving the vaccine, I felt like I had been hit with a ton of bricks. I had a fever, headache, my body ached and my skin hurt to the touch. I was exhausted but unable to sleep. The fever lasted for approximately 6 hours. The headache, body aches and skin sensitivity lasted approximately 24 hours. After the fever abated, I felt nauseous for approximately 12 hours.
One week after receiving, left upper arm became intensely itchy with redness in area approximately 4 inches by 2.5 inches That entire area also appeared swollen with a firm ? lump?
patient got prevnar 13 and later on that day she experience redness in the arm and the following day when she woke up it swollen and then the day after even more swollen
Pfizer-BioNTech COVID-19 Vaccine EUA within 6 hrs, of 2nd dose I  got weak, tired, running fever, headache, muscle & joint pain, chills - Flu-like pain and illness for approx. 24 hrs. Also injection site swelling and redness.
Dermatographia, at a much later onset than I've seen for most people, but seemingly out of nowhere, and getting more severe after I received my booster in November. I use Claritin to battle the itchiness, but the red marks cannot be avoided.