chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath; Congested heart failure; A spontaneous report received from a consumer concerning a female patient of unknown age, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced shortness of breath and congested heart failure.  The patients medical history was not provided. No relevant concomitant medications were reported.   On 08 Mar 2021, prior  to onset of events, the patient  received their first of two planned doses of mRNA-1273 (lot# unknown) of vaccine for prophylaxis of COVID-19 infection.  On 10 Mar 2021, patient developed shortness of breath, and congested heart failure which resulted in hospitalization for 3 days.Treatment for the events included Lasix.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, shortness of breath and congested heart failure, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Further information has been requested.
Small bumps on both legs, but cheeks, and arms at injection sight that are red and itchy.  Looks as though they are ant bites.
Patient received the vaccinations in the morning of 11/9/20. Reported that by the afternoon she had a fever, that spiked at 101.5 F, and brokeout in hives over her entire body. The hives began in her right arm, which is where the Boostrix was administered.
This consumer report (initial receipt 20-May-2014) concerns a 66 year old female patient who had no pertinent medical history. Concomitant medications included propranolol and lisinopril and other unspecified medications. In October or November 2013, the patient received a influenza virus vaccine (manufacturer and batch number not provided) as it was the recommendation of the doctor. Two to three months after getting the shot, the patient developed a rash which was diagnosed as hives and skin dermatitis. She then developed heel spurs. After that, she experienced blind spots in her vision and went blind for one or two days. She was seen by an eye specialist. She then could not walk and was extremely weak. She was seen at the hospital and was diagnosed with pneumonia. She was not kept overnight. She then felt as if she had shingles but had not been diagnosed with that condition. Laboratory diagnostics included CAT scan (Computed Axial Tomography), blood work and a lung X-ray. Treatment included steroids and cephalexin. Outcome was not recovered.
Pt had come to pharmacy 8/1 and requested a MMR vaccine. My technician told them we had to order and she ordered Menveo (which she thought was MMR) when it came in the 8/3 the patient came soon after and the technician dropped it into the system . I did not realize incorrect vaccine . I administered to patient , counseling him on the MMR vaccine . When I entered it into the system i realized it was the incorrect product and contacted the patient at 10:00 PM . I explained what had happened , apologized and asked the patient if he wanted me to order the correct vaccine. He responded "yes". I also told him we would contact his doctor and disclose incident. I assured him that he would be fine . He was very understanding and not alarmed.
Rash on the abdomen.  Pen umblical region.  Zyrtec long daily
Pt vaccinated with MERUVAX developed a persistent throbbing headache, "photosensitivity", swollen & tender neck glands, cold sore on lower lip, & a rash on neck, chest & abdomen. See WORM for more details.
nausea, metallic taste, tingling tongue, dizzy. Evaluated by EMS-Cleared
aphasia; difficulty speaking; Jaw: Trismus; This is a spontaneous report from a non-contactable other healthcare professional. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 24Mar2021 (batch/lot number: ER8727) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Mar2021 during her 15 minute waiting period after the injection, the patient began to experience difficulty speaking. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Jaw: trismus present. Treatment included: no therapy. Follow up response to treatment: no change. Patient transported to ED by ambulance. Differential diagnosis: systemic reaction (hypoglycemia, hypotension, generalized rash) and red flag symptoms (CP, SOB, NVD, visual/neuro concerns). Patient with no other neuro deficits but aphasia was clearly present. AMR called to have patient brought to ED for further evaluation. Husband, will meet her there. The report was assessed as non-serious. The outcome of the events "difficulty speaking" and "trismus" was not recovered; and unknown for aphasia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The company cannot completely rule out a reasonable possibility that BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) caused the aphasia (speech disorder) and trismus due to a reportedly close drug event chronological association. Information on further evaluation would be necessary for a more meaningful medical assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
The patient came into the pharmacy two days after the vaccine administration and presented with a rash developed around the injection site. The affected area was hot to the touch. He said he noticed it the next day after vaccine administration. The patient did not complain of any other symptoms. The rash was slightly itchy and the arm was also sore. The patient was advised to apply cold compress and to Benadryl. He will continue to monitor his symptoms and was instructed to call the pharmacy if it got worse and to seek medical attention.
I woke up at 4 AM on 4/4/2023 with fever (100.4), body aches (concentrated in backs of legs and lower back). When I got up from my bed, my nose started draining. I took a home antigen test and got a positive result. I took ibuprofen, because my sinus congestion gave me a little bit of a headache. I think the ibuprofen worked, because my headache didn't get any worse, and it eventually went away. Later that afternoon, I took Sudafed, which helped with my runny nose. I called my doctor's office yesterday and asked about getting Paxlovid. He told me that I would qualify to receive it on account of my age, but I first needed to come to the clinic to have my kidneys checked to ensure they were functioning properly. At the time of this writing, I am 80% better. I slept well last night, and I woke up this morning feeling pretty decent. My voice is a little hoarse, and I now feel like I just have a mild sinus infection.
Post-vaccine visit when reviewing paperwork, determined gave polio vaccine off schedule.  Prior polio 12/14/22, 12/15/2020 and 10/01/2020.  At time of visit mother had agreed to polio vaccine along with other vaccines given.    When called to inform mother of vaccine being off schedule, father answered.  Explained to father that child had been given polio off schedule.  Father stated child died the night he received vaccination but did not say how.  Did not press for any further information.    At time of appointment, no contraindications to vaccine noted.  Mother had difficulty holding child still during vaccination; however, vaccines were still able to be given.  Child cried during vaccination but calmed down and was walking around office post vaccination.
Patient reports immediate arm pain from injection site after receiving vaccine on 8/19/21, progressing to fatigue evening of 8/19/21 and muscle/joint/back pain on Friday, 8/20/21. Monday, 8/23/21 patient is still experiencing same symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 5 months after receiving SHINGRIX, the patient experienced fever, headache, injection site warmth, injection site erythema, injection site swelling, chills and confusion. On an unknown date, the outcome of the fever, headache, injection site warmth, injection site erythema, injection site swelling, chills and confusion were recovered/resolved. It was unknown if the reporter considered the fever, headache, injection site warmth, injection site erythema, injection site swelling, chills and confusion to be related to SHINGRIX. Additional information was received as follows: The patient had confusion (she did not know who she was) and the injection site area was hot to the touch. The healthcare professional said that all the symptoms lasted 3 days and they resolved on their own.
SPOTS ON THE SKIN OF BOTH ARMS; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's past medical history included total hip replacement surgery, and concurrent conditions included back pain, alcohol use- couple of beers after work, non smoker, and chew tobacco, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 18:50 on left arm for prophylactic vaccination. Concomitant medications included baclofen for pain relief, and muscle relaxation, gabapentin, ibuprofen, and tramadol.  On 2021, the subject experienced spots on the skin of both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spots on the skin of both arms. This report was non-serious
Pericarditis, Admitted to the Hospital, NSAID and Colchicine
Patient was to receive Moderna COVID vaccine (3rd dose) but received Pfizer  Bivalent Covid for 5-11yo vaccine instead.
Had insomnia a day after my vaccination and got no more than 1 hour sleep over the course of the night. It was wide awake and unable to fall asleep. It wasnt jittery, and couldn't fall asleep.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Ew0171) via an unspecified route of administration in the right  arm on 22Apr2021 at 16:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included liraglutide (SAXENDA), bupropion (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN) all from unknown indication on an unknown date and unknown if ongoing. The patient previously received sulfamethoxazole, trimethoprim (BACTRIN) for unknown indication on unknown date and experienced drug allergy. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Er8732) via an unspecified route of administration in the left arm on 23Mar2021 at 11:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 22:30, after receiving the vaccine next day night, the patient experienced insomnia and got no more than 1 hour sleep over the course of the night. she was wide awake and unable to fall asleep. she wasn't jittery, and she could quiet her mind, but just couldn't fall asleep. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event insomnia was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Wed Feb 17. Fatique feet seem discolored at times arm seems to feel like mild pins and needles
6/2/06 received rabies (PCEC) #1 and flu vaccines. 6/9/06 received rabies (PCEC) #2 at about 14:30. At 22:00, that night, pt experienced rigors, mild urticaria/viral-like rash but no fever; all symptoms gone by next morning.
possibly got it at clinic, possibly who administered shot. Pts. daughter said the pts boyfriend denied any symptoms the whole day but that in the middle of the night the pt passed away.
sensitive to caffeine & can't drink coffee or tea anymore; visual snow; facial swelling that comes and goes; I was driving one time and I started seeing shooting stars/It felt like Alice in wonderland symptoms, like I was on mushrooms/laid me out; sleeping more than 12 hrs at a time; eye swelling to one or both eyes; It looks like I've been punched in eye, like edema; flu-like symptom; shivering; neurological issues; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (neurological issues), FOOD ALLERGY (sensitive to caffeine & can't drink coffee or tea anymore), VISUAL SNOW SYNDROME (visual snow), SWELLING FACE (facial swelling that comes and goes) and FEELING ABNORMAL (I was driving one time and I started seeing shooting stars/It felt like Alice in wonderland symptoms, like I was on mushrooms/laid me out) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced NERVOUS SYSTEM DISORDER (neurological issues). On an unknown date, the patient experienced FOOD ALLERGY (sensitive to caffeine & can't drink coffee or tea anymore), VISUAL SNOW SYNDROME (visual snow), SWELLING FACE (facial swelling that comes and goes), FEELING ABNORMAL (I was driving one time and I started seeing shooting stars/It felt like Alice in wonderland symptoms, like I was on mushrooms/laid me out), SOMNOLENCE (sleeping more than 12 hrs at a time), EYE SWELLING (eye swelling to one or both eyes), OEDEMA (It looks like I've been punched in eye, like edema), INFLUENZA LIKE ILLNESS (flu-like symptom) and CHILLS (shivering). At the time of the report, NERVOUS SYSTEM DISORDER (neurological issues) and FOOD ALLERGY (sensitive to caffeine & can't drink coffee or tea anymore) had not resolved and VISUAL SNOW SYNDROME (visual snow), SWELLING FACE (facial swelling that comes and goes), FEELING ABNORMAL (I was driving one time and I started seeing shooting stars/It felt like Alice in wonderland symptoms, like I was on mushrooms/laid me out), SOMNOLENCE (sleeping more than 12 hrs at a time), EYE SWELLING (eye swelling to one or both eyes), OEDEMA (It looks like I've been punched in eye, like edema), INFLUENZA LIKE ILLNESS (flu-like symptom) and CHILLS (shivering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high cholesterol Everything shows up normal. It did show high cholesterol..         Concomitant medication of the patient was not reported.  The patient took booster dose of Moderna vaccine on 3rd or 23rd December 2021.  The patient had seen doctors and they said there were no conditions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-513826, MOD-2022-513827 (Patient Link).
Arm Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm Soreness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm Soreness). At the time of the report, VACCINATION SITE PAIN (Arm Soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided. No concomitants were reported.
Uncontrollable vomiting @ 6:00pm, 2 (?) injunctions on 2 different anti nausea/vomiting drugs: worked well within approximately 15-30 minutes Seizures producing uncontrollable shaking; through the next 11-12 hours until I was discharged I was given intravenously multiple meds to stop seizures...including but not limited to Ativan, morphine, injectable form of Xanax, and other that I do not remember.  I got intermittent relief from shaking for maybe 30 minutes and then shaking would return and another med would be injected. Intense headache was relieved by seizure meds. Sent hom with prescription of hydroxyzine and zofran.
Not able to turn head.  Right side neck swollen to right ear. Right side: face, jaw and nose numb.  Clicking in right ear.  Numbness continues in jaw.  Able to move neck better.
WATER BLISTERS AFTER REMOVING THE BANDAGE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received band aid skin flex (form of admin, route of admin were not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient had water blisters after removing the bandage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of water blisters after removing the bandage was not reported. This report was non-serious.
Took Vivotif with food; Spontaneous report received on 17DEC2019.  A physician assistant reported that a female consumer "took Vivotif with food" (PT: Product administration error) following immunisation with Vivotif. The consumer took her doses with food. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doses with food (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.  Follow up information was received 03JAN2020.  The reporter's address, phone number, consumer's name and date of birth was provided in the follow up information.  It was updated that the consumer took three doses of Vivotif at the same time with food. The reporter could not remember the exact dates when the consumer took Vivotif doses but informed that it occurred in the week of 17December.  Company Comment: A consumer took three Vivotif doses with food (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took three Vivotif doses with food (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.
Extreme fatigue after 6p, fever, sweating, muscle aches. Symptoms lasted for nearly 24 hours.
Throat swelling, nausea, dizziness, high blood pressure right after receiving vaccine. Symptoms slowly got better until 3 days after where a headache appeared, and on the 5th day (today) it got worse. Headache feels like pressure all over, dizziness made me vomit, i have diarrhea, ringing in ears, pressure on head extends to neck and shoulders.
Has not received the 2nd/3rd doses so far; Has not received the 2nd/3rd doses so far; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 22-year-old female patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose on 19th August 2020) and Hepatitis B vaccine (received 1st dose on 08th July 2020).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis A vaccine and the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination and incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's comment: The pharmacist reported that the patient received doses in unknown facility and not sure if were doses of GlaxoSmithKline vaccines and till the time of reporting, patient has not received the second doses. The reporter asked should restart the series. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Hepatitis A vaccine and Hepatitis B vaccine, which led to incomplete course of vaccination. The case US2022124286 was identified as duplicate of this case. The case US2022124286 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Left arm deltoid injection site erythema, warm to touch, induration, pruritis, c/o pain.
pt admitted to hosp , ARF with Hypoxia secondary to COVID pneumonia; treated with steroids, ABX, dexamethasone, O2 supplementation;  worsening respiratory failure; pt was transitioned to comfort care
Unusual pain in the injection site. States never experienced before with an influenza injection. Iced the area and took anti-inflammatories.