chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day after the injection patient's right arm, right index finger, middle finger and thumb felt warm, numb and tingling.  Patient applied ice to the site, took 400mg Ibuprofen which helped relieve his symptoms.  He was seen in the office for a stiff shoulder and discomfort along the median nerve.  Treatment of Ibuprofen every 8 hours for 2 to 3 days then as needed.  Shoulder stretching exercises given. Patient to follow up if no improvement.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) SQ in the abdominal region as a result of the unspecified patients being amputees. No adverse effect was reported. Additional information is not expected.
The night of July 28th, I started having trouble getting breaths in. When laying down my neck felt tight and swollen on the inside (like a bad allergic reaction) and I took 3 puffs from my father's Albuterol inhaler and then used his nebulizer (which he fortunately had as he had been reccovery from an esophagectomy since March); didn't sleep too well. Had periods where I coughed up some clear mucus over the sink after 30 minutes of coughing to breathe.  July 29th: woke up to breathing problems, used the treadmill to get my breathing together (had other experiences of breathing problems when taking depo-testosterone in the passed where using the treadmill helped). I took Mucinex, the inhaler and the nebulizer again that day. I believe I had, and also my parents had in late January to late Feburary 2020 - COVID - and Mucinex and coughing-to-breathe were what helped me daily with it. At the time, I asked my doctor and doctors about getting an Azithromycin prescription, and for some reason they said that they no longer prescribe it (which was odd). My doctor also asked if I went to Country- however, he never asked if I knew of anyone who just came back from Country (someone who was in the same business complex that we knew had returned from Country and she had encountered us when she returned). There also was a guy who was coughing near me when I took my dog walking near Shopping Center in January 2020.   I ended up sleeping with 3 pillows.   My brothers who took the shot (who do not have XXY and other mentioned problems) said I was making it up. But then again, if it wasn't for my mother who also has migraines, they wouldn't believe me when I said I was seeing flashing geometric shapes in my eyes followed by no visibility on one side for anywhere from 1-3 hours.    My mother was actually the one who had to persevere from doctor to find out I was allergic to milk, and then later that I had XXY when I was in high school (she asked a lot of doctors through my early years- and they all said she must be perverted).  I was born jaundice, and came out feet first - if this is relevant at all to my reaction, too.  July 30-Aug. 2nd ( had nebulizer each night)  I also had the normal CDC symptoms, pain in arm, chills, fever, headache (sorry 5 min mark).  Had stinging pain throughout body since then, and now have back and kidney (right-side) pain.
pt recv vax & exp petechiae & nose bleeds;pt exp petechiae & various bruises;gen petechiae on arms & legs;no true purpura bruising from minor trauma 3MAY96 950AM;no fever;plt count 2,000, hgb 12.8, WBC 9.4, 24 neut, 50 lymphs
Presented with increased difficulty in breathing, crackles.  Admitted to hospital with pneumonia.  Evaluation revealed blood clots in lungs.
EVENING OF 12/30/20, DEVELOPED BODY ACHES AND NAUSEA THAT LASTED APPROXIMATELY 12 HOURS.
Had H1N1 vaccine injection on 10/16. Since then she has experienced progressive numbness, tingling, aches, and loss of strength in her left arm (left deltoid) where she received the injection.
The arm where received injection developed hives. Also developed hives in a few other places on body.  The rash appeared the second day after the vacination and got worse on the 3rd & 4th day.
On 09-27-22, patient came in for an appointment to receive the Moderna bivalent booster. Patient was administered the Monovalent Moderna booster (NDC 80777-0275-05 dose 0.5 ml IM on the left arm). The pharmacy had just received the Moderna bivalent booster that morning and was placed in the refrigerator to be thawed out next to the other Moderna vials. The pharmacy grad intern checked in the patient and administered the vaccine, unfortunately confused the monovalent booster with the bivalent booster vial. After vaccine was administered and patient had left the pharmacy, the pharmacist looked at the vial and noticed the incorrect vaccine was administered and brought to the pharmacy grad intern's attention.   Both the pharmacist and the pharmacy grad intern referenced the CDC website for recommendations on COVID-19 vaccine administration errors and deviations, which found that the administration of a Monovalent vaccine incorrectly administered for a booster dose (if bivalent booster indicated) a patient can receive the bivalent booster after 2 months to provide protection against the Omicron variant. The pharmacy grad intern called the patient on 09-28-22 at 9:59 am and was only able to leave a message.   We are implementing a new strategy to separate the booster vials from the monovalent vaccines, also the pharmacy grad intern was coached by the pharmacist to revise her checks before administering a vaccine to a patient to ensure correct vaccine is appropriate.  On duty pharmacist is to check all vaccine vials prior to vaccination and checked for accuracy.
Increased heart rate, tight chest, dizzy more noticeable for 24 hours and then mainly night time tachycardia for 3-4 nights so far, ongoing.
Upon the delivery of Pfizer gray cap vaccine on 2/15/2022, pharmacy has kept the vaccine in the freezer (average temperature at -23.9 C) for 10 days before the administration. There were no adverse reactions reported after the administration. Pfizer has provided temperature excursion data to determine that the vaccine was still viable.
The patient was in extreme pain in her legs. this spread to her whole body. She had chills, shaking, sweating and stomach cramps. This event lasted almost 6 hours. We called the pediatricians on-call nurse and were told to start ibuprofen. The symptoms began residing about 5 hours after on-set and then by hour 6 the majority of the symptoms were gone. Patient still had body aches and chills for 12 hours more.
Feeling faint (5 minutes) Tingling of left arm and face (60 minutes) Slight swelling in throat but not severe. (10 minutes)
Cheeks red/flush warm to touch.  Itchy skin on face, neck no rash. Started within the first 45 minutes after dose was give and has not let up.
pt was leaving after 15 min waiting period and began to feel dizzy so she returned to the nurse station.  assessed pt, medical hx, took vital signs, gave juice, offered snack. observed pt for 15 min, she stated that she felt better and was ready to go home. took vital signs second time before leaving with her husband.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not provided. Treatment medication was not provided   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Redness at site, hardness at site and warmth at site. Mother told to put a cool compress at sight and take BENADRYL. She is to phone us as needed.
pt visiting relative in AZ & on 13APR92 rash appeared; also swelling & pain in joints of hand, swelling of ankle joints & swollen eyelids; seen by MD who described rash as raised, purpuric; dx hypersensitivity vasculitis;
ache all over; Chills; Head ache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (ache all over), CHILLS (Chills) and HEADACHE (Head ache) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced PAIN (ache all over), CHILLS (Chills) and HEADACHE (Head ache). At the time of the report, PAIN (ache all over), CHILLS (Chills) and HEADACHE (Head ache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant informations were reported.  No treatment informations were reported.   Reporter did not allow further contact
Rigors at hour 16, lasting approx. 2 hours; hives on day 2, currently ongoing (day 3). NO FEVER. Headaches, nausea and fatigue throughout. Blurred vision day starting day 2 and ongoing.
15 weeks pregnancy, is my second pregnancy (first was miscarriage), due date is December 22nd. The instant I got the shot I became dizzy, nauseous and overheated. I felt better after laying down. Since then I am having muscle aches, nausea, and fatigue.
High fever and chills 10 hours after 2nd dose; High fever and chills 10 hours after 2nd dose; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EK5730) via an unspecified route of administration in the left arm on 22Mar2021 at 17:45 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patients medical history was reported as none. The patient did not have allergies to medications, food, or other products. The patient did not take any concomitant medications. The patient had received unspecified other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 23Mar2021 at 09:30, the patient experienced high fever and chills 10 hours after second dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever and chills. The clinical outcome of the event fever and chills were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Reticular, macular rash over abdomen, spreading to periphery, started on 24 hrs after 1z (4 mo series). No pruritis, no pain, no breathing problems. No therapy necessary.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 17-year-old female patient of unspecified ethnicity received TREMENBA (batch/lot # M37314 and expiration date 30APR2017 on 06APR2016 4:17 PM, at 0.5 ml single dose intramuscular on left arm. The patient medical history and the patient's concomitant medications were not reported. The patient fainted "like the next day" on 07APR20156 with outcome of recovered.  Follow-up  (17MAY2016): Additional information from the contactable physician incudes age of the patient , gender, date of vaccination, onset date of the event and  outcome.
Pain at injection site, (L) axilla, chest wall, with chest tightness, pain with moving left arm.
Pentacel as the DTAP-IPV portion was given but the ActHIB was not given, no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient (unknown demographic) who received 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on 15 November 2019 (lot number UJ060AAA expiry date:04-Oct-2020) not reported via unknown route in unknown administration site was inappropriately reconstituted.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique (product preparation issue). It was reported that the Pentacel was administered and only the DTaP and IPV were given and the Hib part was not reconstituted.  It was unknown whether the patient had any adverse reactions.  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 and Module VI of the 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.
Taken to ER 2-22-06 more than 24 hours after immunizations given.R. arm tender swollen, warm and red from elbow to shoulder, temp. 97.3, Motrin given and told to continue at home. Brought to Health Dept. 8am 2-23-06 as no improvement. Arm was still swollen warm and red but child not in any distress and no fever. Parent was reassured and told to continue Motrin.
A second series of Monovalent, Novavax Vaccine was administered and required only one. First dose 10/15/2022. Second dose not required 11/22/2022.
On 7/30/22 mother states that patient had a fever of 101.2 and had a seizure (blank stare), mother called EMS. When EMS arrived patient was responsive and alert and no longer had a fever. Vitals were normal. Mother refused to go the emergency room as patient was okay after EMS arrived. Mother denied any other symptoms.
child has received each vaccine prior, but not in the current formulation (Kinrix and Proquad); cellulitis developed to right arm-seen at urgent care and put on cephalexin and oral steroids; location of cellulitis likely related to the proquad injection site
This spontaneous report has been received from a pharmacist (also reported as "Dr."), concerning to a non-pregnant female patient of unknown age. The patient's concurrent conditions included allergy to codeine. The patient's medical history was not reported, and there were no concomitant medications. On 06-JUN-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 intramuscular in the left deltoid, lot # M043424 and expiration date 06-JUN-2017 (dose and frequency were not reported) for prophylaxis (reported as "indicated by the patient's doctor"). On 07-JUN-2017 (reported as the next day), the patient came back to the pharmacist and reported a rash that was on the underarm "near the armpit and the left breast" that started "3 inches" from the injection site, but was not at the injection site. In addition, it was reported that the "rash was warm to the touch and inflamed". The patient did not sought medical attention and not received any treatment for the events. There were no laboratories performed. At the time of reporting, the patient was recovering from the rash, warm to touch and inflammation.  The causal relationship between the therapy with PNEUMOVAX 23 and the events of rash, warm to touch and inflammation was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 15-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature exucrsion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Noticed his red las extremely red and hot. The next day his arm was extremely hot and red. The MMR made him almost delirious. He was not himself. Its like his whole mind just regressed. He wouldn't get out of bed and walk. He just stared off into space. Took him to the doctor for those red hot spots, doctor prescribed an antibiotic. The rash was not going away and got worse overnight. Quit antibiotic and took him his ped. Ped says that he believes it may have been from MMR vaccine. Here we are 15 days later and my son is COVERED in bumps ( looks like measles) from his neck all down his back, in his groind. His eyes are watery, feverish. The site of injection is still extremely red.
Tested positive for covid; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid) 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 SARS-COV-2 TEST POSITIVE (Tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported.  No treatment information was provided.  Patient just tested positive for COVID-19. Patient was scheduled to get the booster on Monday, 03Jan2022. Patient cancelled the appointment and wants to know when to get the booster.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The patient tested positive for COVID-19. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The patient tested positive for COVID-19. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
vomiting - x20 (5pm-3am) fainted - 5 minutes. Respirations- were d/c But not responding, pt being floppy with no muscle tone (5 minutes) and then crying and called mama and continued vomiting.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose in 2018, refer case US2019GSK070650). On 10th April 2019, the patient received the 2nd dose of SHINGRIX. On 10th April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache and drug dose administration interval too long. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the headache and drug dose administration interval too long were unknown. It was unknown if the reporter considered the pain in arm and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose last night, but he was told he was right around 7 months, which led to drug dose administration interval too long. The caller also stated that his arm hurts and he has bad a headache. His arm was a little sore afterwards was still sore and hurting last night and this morning. The reporter clarified he has been having headaches off and on, he just went over the coast and back and goes over mountains and back to sea level. So that was why he has a headache.
Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.
Runny nose; Feel body aches; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), MYALGIA (Feel body aches) and HEADACHE (mild headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced RHINORRHOEA (Runny nose), MYALGIA (Feel body aches) and HEADACHE (mild headache). At the time of the report, RHINORRHOEA (Runny nose), MYALGIA (Feel body aches) and HEADACHE (mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment or concomitant were reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Significant follow up-Events added and Contact information updated
Patient has pain and swelling on the left arm that radiates to the back and upper neck area.
administered 1st dose 29Jun2022, dose had an expiration date of 18Jun2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 29th June 2022, the patient received the 1st dose of Havrix. On 29th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.      Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's comment: The nurse reported that the patient received an expired Havrix dose. At the time of reporting, the dose was not repeated. The Vaccine Administration Facility was same as Primary Reporter The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used.