chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is not having any adverse reaction. but first dose given 04/29/21, so the second dose was given a week early on 05/20/21
Patient received the Pfizer booster shot on Monday. Afterwards he began to have a fever, sinus infection, and could not walk without assistance due to an unsteady gate, dizziness, light-headedness, and weakness. Patient also developed slight tremors in his arms.
Mild hives 1 day after receiving immunizations. Treated with ZYRTEC and hydrocortisone cream.
Pt received dose of Covid vaccine (Moderna Spikevax) at 1:30 pm this afternoon.  About an hour later complained of not feeling well to RN.  Pt seen in presence of daughter.  Pt c/o dizziness, "disorientation", 2blurry vision and inability to read newsprint, feeling her mouth is dry and her speech is "not normal".  Denies headache, nausea, myalgias, chills, other symptoms. Did not have any symptoms following other Covid vaccines. Proceeds to talk about fear she will be unable to sleep tonight, and poor appetite.
Patient received J&J vaccine at 4:09pm on 5/11/2021. Within 3 to 4 minutes patient's girlfriend stated that the pt was having difficulty seeing. Pt evaluated and he described complete loss of vision (lasting approximately 10 seconds) that returned. Pt was seated and was instructed to move to floor and lean against wall.  Pt described numbness and tingling in both legs that resolved within 5 to 10 minutes. Pt stated he was anxious, shaking was observed, and he was hot and sweating. Vasovagal episode with loss of consciousness was immediate assessment. BP was 98/62 within 20 minutes of AE. 911 was called and EMS evalauted pt. Pt did not go to hospital AMA per EMS and pt stated he felt better. Patient was contacted on 5/12/21 at 3:25pm and he stated "I'm all good no further issues. I got a fever 8 hours after the shot. Other than that I'm all good".  Inquired about temperature and pt stated "I do not have a thermometer". Pt instructed to contact primary care but he has not seen them in 2 year (She is primary care). Pt then instructed to contact cardiologist that  he sees for his heart palpitations and heart rate control. Patient is prescribed metoprolol for this and he missed a dose the night of 5/9/21, took dose night of 5/10/21, and had shot on 5/11/21.   Patient's physician office was called and information reported to her.
Patient reported experiencing fever of 102 degrees, chills, feeling dizzy and disoriented 24 hours after receiving vaccine.  This continued for 48 hours.
I had pain at the injection site the evening of receiving the injection, which still continues, though not too bad. Walking up today at around 7 am, I felt headache, achy all over, weakness, and some fever. I decided to stay home. I lay in bed most of the day, sometimes sleeping, sometimes watching YouTube videos on my phone. I was feeling kind of cold, so I snuggled completely under the covers, head and all. I got sweaty and had to uncover my head. I changed clothes. I got up a couple of times to urinate. Once, I felt some weakness, and had to support myself with my hand on the edge of the bathroom counter. Then, this afternoon, my headache was a bit worse. I got up to hop top the bathroom. I was urinating standing up, when I started feeling weak, so I supported myself with my hand, but almost immediately, I started feeling like I was going to fall, to faint, and to vomit. I hurriedly sat down on the toilet. I was still feeling nauseated and weak, so I learned back to take pressure off my abdomen, which was feeling slightly bloated. The bathroom fan was on, so it felt rather cold, but I started getting hotter and hotter, sweating profusely. At the same time, I just sat there trying to recover, and started feeling pins and needles in my forearms, but not like they had fallen asleep, just like someone were pressing down on my arms with blunt needles. I thought I was going to have to crawl back to bed.  After a while, I started cooling off and feeling a little better. I went back to my room and changed clothes. I'm feeling warm and a bit weak and achy again, but nothing like that. I had only drunk 3 cups of water today, though I drank about 7 yesterday.
Miscommunication between the staff of the facility and the pharmacy employee about patient getting the booster at a group home visit , staff at the group home also did not know patient got a booster at a pcp visit and did not have a third dose of covid booster written on the card and the employee at the group home filled out another consent form . Spoke to the lead nurse and the patient is doing alright.
Patient is 11 years old.  Was administered the ADULT Pfizer COVID-19 vaccine in ERROR, instead of the pediatric product.  No adverse reactions / effects reported or documented.
This spontaneous report as received from a nurse practitioner refers to a 59 years old male patient who was vaccinated with a dose of PNEUMOVAX 23 (lot#H010515) on an unspecified date. Suspect secondary therapy included Tdap on the same date. On unknown date the patient developed swelling at the injection site after administration of PNEUMOVAX 23 (lot#H010515). No further details were noted on the after. The outcomes of the events was unknown. The relatedness for the events and PNEUMOVAX 23 was not reported. This is one of several reports from the same source. Additional information has been requested.
I have a lot of chronic coughing all throughout the day and at night when I'm trying to sleep at night, and I also cough up some flem with my cough
Area of induration and redness/swelling 3cm x 3cm anterior right thigh.
Patient's wife called to report that the patient has had a fever >100 degrees Fahrenheit since the morning after receiving the vaccine.
hot lump at injection site; sore arm; Upper arm itching; Hard lump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot lump at injection site), VACCINATION SITE PAIN (sore arm), VACCINATION SITE PRURITUS (Upper arm itching) and VACCINATION SITE INDURATION (Hard lump at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Upper arm itching) and VACCINATION SITE INDURATION (Hard lump at injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot lump at injection site) and VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE WARMTH (hot lump at injection site), VACCINATION SITE PRURITUS (Upper arm itching) and VACCINATION SITE INDURATION (Hard lump at injection site) outcome was unknown and VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No adverse event; Incorrect product storage; This spontaneous report was received from a medical assisstant and refers to a 4-years-old male patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 25-JUN-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen and route of administration were not reported), lot numbers reported to suffer temperature excursion were T014388, T025221 (rHA) and T027115 (rHA) and respective expiration dates 24-OCT-2021, 19-JAN-2022 and 02-FEB-2022 (It was not specified which lot was administered to the patient) administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion unknown by the reporter for an unknown timeframe; it was also unknown if there were previous temperature excursions.  No adverse symptoms were reported.  This one of several cases from the same reporter.; Sender's Comments:  US-009507513-2107USA001665: US-009507513-2106USA007465:
Few hours after PREVNAR 13, child had fever of 101 F & decreased energy. The next day, had fever of 102.5 & NBMs emesis x 1 & bump/redness noted in area of vaccine.
Patients throat feels tight and swelling, lips has a small swelling bump, patient was scared and cried and shaking afraid she is dying. Give patient 25 mg diphenhydramine (10 cc of the 12.5/5 ml) with mom consent.  Have patient sit down. I have a medic on site site to do vaccination. We continue monitor her symptoms access the condition and trying to calm the patient. Her BP was 125/99 HR 125. She was very nervous.   AFter 10 minutes, paitnet feel a little better, I give her another 25 mg Benadryl  with mother consent. Explain to mom the situation and she want her daughter to be seen at the hospital.  Patients left with mom to the nearest hospital.
Inappropriate Reconstitution Technique; Reconstituted the Menveo Lyophilized component with a non-GSK diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA859A, expiry date 31-JAN-2024) for prophylaxis.   On 14-APR-2023, the patient received Menveo. On 14-APR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate Reconstitution Technique) and incorrect dose administered (Verbatim: Reconstituted the Menveo Lyophilized component with a non-GSK diluent). The outcome of the wrong solution used in drug reconstitution and incorrect dose administered were unknown.   Additional Information: GSK Receipt Date: 17-APR-2023 The nurse manager called to inquire that how to proceed?  The reporter reported that they reconstituted the Menveo lyophilized component with a non-GlaxoSmithKline diluent and inadvertently administered to a patient.  The reporter confirmed dose was administered at their facility.  The reporter did not consent to follow-up. The patient received Menveo lyophilized component reconstituted with a non-GlaxoSmithKline diluent, which led to wrong solution used in drug reconstitution and incorrect dose administered.
pt recvd 1st Hep B vax on 2MAR92 & immed exp arm pain w/radiation & a tingling sensation down into finger tips; tingling sensation subsided & devel into an aching arm; next day exp nausea & diarrhea but had no fever;
Peri-oral edema and respiratory distress, with wheezing, within minutes. Pulse ox >95% throughout.  Child given 5mL PO diphenhydramine and 3mL albuterol nebulizer in office, then also received 0.15mg IM epinephrine and 30mg PO prednisolone in the ER.
Redness and swelling around injection site 2 days after injection.  Presumed cellulitis, treatment with Keflex.
Severe swelling from top of right sholder, down to mid forearm. Skin very sore to touch from injection to back of shoulder blade and down arm to elbow, red hot. Body aches and slight fever.
No adverse effects reported; patient was vaccinated with expired MMRII; This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.  On 10-OCT-2019, the patient was vaccinated with properly stored but expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) injection, lot number N025897, expiration date 19-SEP-2019 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (STERILE WATER) (dose, frequency, route, site of administration, lot number and expiration date were not reported) which was not expired.  No adverse effects were reported.
Severe nausea; weight loss; stomach pain; bladder infection; This is a spontaneous report from a contactable Nurse (patient). An 82-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:30 (Lot Number: EN6208) as single dose (at the age of 82-years-old) for covid-19 immunisation. Medical history included tachycardia, hypothyroidism and Covid prior vaccination (date unknown). Concomitant medications in two weeks prior to the vaccination included metoprolol succinate (TOPROL), levothyroxine sodium (LEVOXYL). The patient previously took sulfamethoxazole, trimethoprim (BACTRIUM DS) and experienced drug hypersensitivity.  Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 30Mar2021 patient experienced severe nausea, weight loss, stomach pain and bladder infection. Patient had three visits to primary care doctor (dr), one clinic visit for intravenous (iv) fluids, emergency room (ER) Visit and hospital admission. Patient was admitted for three days in response to the events (dates were not provided). Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 14Apr2021 and sars-cov-2 test (Nasal Swab) negative on 16Apr2021. Patient had not recovered from the events, at the time of the report.; Sender's Comments: Based on the available information it is unlikely that BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) contributed to events occurrence. The reported events more likely represent intercurrent medical conditions unrelated to Covid-19 vaccination. 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.
My Daughter is breaking out in hives I have pictures of it. First she started with a low grade fever then around 9pm she complained of itching. I told her to come here and see her breaking out in hives like she does when she is allergic to something. I am giving her Benadryl and taking her to the DR in the am. If the Benadryl wasn't going to work I was going to take her to the ER. I have told the people at the county before she had an allergic reaction to the chicken pox shot it couldn't be the Dtap or TDAP she just had the Tdap as well she had the DTaP before no problem. Well here we are again this time the reaction was worse.
Stabbing pain posterior L shoulder decreased range of motion x last 2 1/2 weeks no erythema, no fever.
Itching starting on upper arms at 10pm and moving to upper chest and neck by 10:30pm. Went to bed and woke up with same itching though only slight on the arms and same on the chest and neck. Skin on neck and upper chest blotchy and looks like a slight rash.
General fatigue, body aches, feeling of fever (however none), nasal congestion, headache, sore throat, cough, lung congestion, and depressed mood.
The patient noted weakness starting in the legs on January the 19th, 10 days  after receiving the first dose of the vaccine.  The weakness progressed to the point that he was able to ambulate only with assistance.   He was seen in my neurology clinic on January 28th and his evaluation suggested an ascending, painless weakness of the legs with rapidly progressive symptoms.  He  was admitted to Hospital on the same day.  His evaluation is consistent with Guillain Barre Syndrome and he has been started on plasmapheresis to treat the condition.
For about 20 hours after injection: fatigue, muscle aches, headache, lack of appetite. For about 48 hours after injection: soreness, redness, swelling in arm that got injection
Intense itching palms, soles of feet, axilla, inner forearms, wrists.  Lasting from 1/23/21 to present and has not resolved. No change in laundry detergent/soaps/lotions, no known allergies, no medication changes recently.
Sinus infection, upper respiratory infection.  1st round of treatment was a Z-pack.  Second round of treatment was 10 days of Cefdinir 300MG 2 times per day.
Child reportedly slept. 20 hours following vaccination. She also had a temperature 100-101 F. The day of the vaccination
A non-serious spontaneous report of administration to a 15 month old was received from a physician concerning a 15 month-old female. Physician stated that FLUMIST was inadvertently given to a 15 month-old. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
severe vomiting occured approximately 20 to 30 minutes after flu shot was administered.  Vomiting continued for approximately 8 hours.
DKA.  Headache, vomiting, abd pain, hyperglycemia, acidosis.
Swelling and redness and pain at Hep A injection site. Swelling began within 24 hous of injection and cleared by day 4 post injection.
Pt given full dose moderna (0.5ml) supposed to be given half dose (0.25ml)
Sudden weakness in both lower legs, unable to walk or move feet, as if my brain could not get the signal to the area. I had bad headache earlier in day. Went to ER and they evaluated for stroke and GBS. Within a few hours, some mobility returned. I could walk slowly, and I was very wobbly.  It took about 5 days for the symptoms to fully pass.
Body aches Stiffness Fatigue Nausea Foggy Extreme right arm soreness Joint pain
Swelling in my chest on the left side with pain; Swelling in my chest on the left side with pain; at times I feel I can't breathe well; tingling in my left arm,; slight fever; headache; chills; This is a Spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration on the left arm on 13Jun2021 at 01:45 PM (Lot number: EW0196) at the age of 42-year-old as single dose for COVID-19 immunization. Medication history was yes. Past drug event was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. known allergies was none. Concomitant medication was not reported.  The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 23May2021 at 12:00 PM (Lot number: EW0187) at the age of 42-year-old as single dose for COVID-19 immunization. On 13Jun2021 at 02:30 PM, the patient experienced swelling in chest on the left side with pain, at times the patient feel can't breath well, tingling in left arm, slight fever, headache and chills. No treatment was received. The outcome of events was not recovered.
My heart has been beating very strangely all day. It feels weak, fast, and off a lot of the time.
Patient's experienced swelling at injection site; redness in arm from shoulder to elbow; pain in arm.
Feel bad/'crappy'; 102 F; Bit of a cough; Achy; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on 29Mar2021, as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced feel bad/'crappy', 102 f ,bit of a cough and achy on an unspecified date.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on rapid covid test and PCR test which came back negative.The caller was asking if it was normal to have fever after vaccination.His wife had the vaccine dose on wednesday and by saturday she started feeling achy in her back; was unsure if it was the vaccine or if she did something to her back. Also added that the last vaccine his son had was Trumenba at 16 yrs of age; His son was unable to complete 3rd dose as he had every single side effect possible.The patient treatment received for adverse events was unknown.The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021414762 same reporter/drug, different patient/AE;US-PFIZER INC-2021414763 same reporter/drug, different patient/AE
pt recvd vax 24SEP92 & 27SEP92 3 days following vax pt devel herpes zoster; No further details were provided;
Pt hospitalized on 1FEB91 for diarrhea, fever & breathing difficulties; Seen in ER; While hospitalized given vax & became irritable, temp 105, hypotensive, bradyarrhythmia, & poss pneumonia & died;
24 hours of intense headache so bad that i could not touch head to pillow, stiff neck, fever 101.4, nausea, unable to stay out of bed
Malaise, fever, difficulty breathing, inability to walk, tingling in hands leading to transverse myelitis, c2-c7, tetraplegia, acute respiratory failure.  Still on life support and quadriplegic
husband received a full dose of Moderna instead of booster; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (husband received a full dose of Moderna instead of booster) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 036A21A and 036B21A) for COVID-19 vaccination.     Concomitant products included NIFEDIPINE and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Blood pressure, OXCARBAZEPINE (TRILEPTAL) for Seizure.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (husband received a full dose of Moderna instead of booster). At the time of the report, OVERDOSE (husband received a full dose of Moderna instead of booster) outcome was unknown.            No treatment medication details was provided.