chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to a multiple unspecified patients of unknown ages. On an unknown dates the patients were vaccinated with PEDVAXHIB lot # N003536, expiration date: 02-NOV-2019 for prophylaxis. On an unknown dates the patients experienced incorrect product storage and no adverse event. The reporter considered incorrect product storage and no adverse event to be not related to PEDVAXHIB. Sender's Comments: US-009507513-1709USA004394: US-009507513-1709USA004014.
Patient became lightheaded, pale, and dizzy several minutes after vaccine. She vomited into a trash can and had fainted into her chair during the minutes following the husband alerting the pharmacy team she was having a reaction (we were there to witness and aid the patient.) After vomiting and having water, the patient recovered quickly.  We monitored her one on one in the vaccine room for about 10 to 15 additional minutes and also took her blood pressure and temperature (both normal.) Patient remarked that she felt completely fine thereafter.
Pt reports having hives starting on 9/27/2023 at site of injection, along left arm and rash across face. Patient used OTC oral and topical antihistamines for treatment with success. Rash/hives are resolving.
Irritability, ...no appetite ate 9 oz of formula in following 36 hrs after vaccine. Became very dehydrated. High fever of 102.5. Vomited up the tylenol. Took to the ER, got her to have tylenol and eat some. Fever responded to tylenol but it was a minimal response.
Pt experienced itching and redness at the injection MD gave Allegra pt stayed 30 min at the office and left with no adverse effets.
Redness 13 1/2 cm x 17 1/2 cm, swelling at left deltoid, upper arm
When patient was in for his 2nd dose, reported that an hour after the first vaccination was given he felt like his heart rate was high. No measurement was ever taken to confirm it was in fact high. He also became flushed. He was wearing a sweatshirt, so when he took that off he was feeling better. This episode lasted for 5 hours. No comorbidities or other heart conditions. We asked if he was possibly dehydrated or had any caffeine that day. I determined to proceed with dose 2 under the request that he came back after 1 hour and 2 hours respectively to get vitals.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  It was reported that, the 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 27th patient of 27 adult patients described by the reporter.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 2 PM. temperature was 35. condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 09 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Woke up around 1:00AM sweating, then turned to chills.  As the morning progressed, mouth/throat was very dry and a bit hard to swallow due to dryness.  By 6:00 AM had small headache, light headed, and overall body aches.  As the day progressed, headache remained as well as light headedness.  At around 3:00PM I took my temperature and it was 100.4F (slight body aches light headed remained.
The following day after vaccine employee went to the ED for complaints of SOB, all over body aches so severe she had difficulty walking. Right arm pain and redness at site.. States had rash on inner thighs and itching.  She was off work for the rest of the week. Employee came to occ health for evaluation with the same lingering complaints on the 7/28/21..employee was a no show for her final eval at occupational health on 8/5/21. She then resigned the following day.
Pt came to our clinic to complete his COVID vaccine Pfizer series. Pt received a Moderna vaccine instead of Pfizer. Talked to mother. She stated Pt is not having any side effects.
Information has been received from a nurse practitioner (NP), via a company representative, concerning a female patient, who was vaccinated on an unknown date, with a dose of Gardasil (Lot # not provided). Subsequently, the patient developed hives and had gastrointestinal problems (unspecified). The NP instructed the patient to not pursue additional vaccinations with Gardasil. At the time of this report, it was unknown if the patient had recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
rash came & went & was raised @ times @ other times flat spots occured on legs & chest;more from area to area;
I received the 2nd shot Shingrix, extremely tired and felt terrible the whole next week, by Sat ended up in ER 103 temp, found out that I had Covid,  which never showed up on home test.   Did it weaken my immune system, i do not know when I went to ER I thought shingle vaccine was attacking my immune system.
Severe muscle pain (had to remove my shirt because it hurt my body to wear it, headache, random splitting pains in my head that make me double over at the waist and grab my head, serious pain in my right elbow, moderate pain in testicles, serious pain in middle joint of middle finger on left hand.
This case was reported by a nurse and described the occurrence of vaccine underdose in a 19-year-old female patient who received HAVRIX (batch number 4GY72, expiry date unknown). Previously administered products included HAVRIX. On 25 November 2014, the patient received the 2nd dose of HAVRIX .5 ml. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. It was unknown if the reporter considered the vaccine underdose to be related to HAVRIX. Additional information: 0.5ml of HAVRIX given to a patient who had just turned 19 year old, as the second dose in series.
Approximately 61 hours after administration, client presented to clinic with non-irritating, non-itchy rash over bilateral arms and trunk. Injection site demonstrates erythema and swelling of 35mm. Denies fever, trouble breathing. Education provided.
About 5 days after the j and j vaccine, I experienced major leg cramping on both legs and lower back pain. Ever since 5 days after, it has progressed into nerve pain and muscle spams into both legs and my toes would feel numb. Around June, I noticed my arms started to get the spams and my fingers would go numb as well. I went to see my primary doctor and he did bloodwork 2 weeks after vaccine. I had a emg dive in august because of the constant numbness in my toes. The doctor said take ibuprofen but ibuprofen never helps it. Prior to this vaccine, I was a healthy 19 old male and I loved to play baseball and basketball! Now after the vaccine I get the spams and then my legs start cramping up and my toes become numb. In my option this vaccine has changed my life. I saw a orthopedic doctor and he said the vaccine might of induced neuropathy in me so he referred me to a neurologist (finally after 8 months) I see the neurologist in January 2022!
Low fever 100.6 F, Injection site soreness,  Muscle and joint pain, lower back, legs, neck and upper body. Fatigue.
12/2021 Urgent Care gave me antibiotics  11/3/2021 Pharmacy went for Covid Test NEG. 1/5/2022 Doctors Office sent for XR Chest PA and Lateral,ECG/EKG (12 Lead) Ambulatory Office only,Respiratory PCR (STAT  FLUVID)BNP,NT-PRO 1/27/2022,USV LEGS BILAT VENOUS DVT COMPLETE 1/27/2022.Routnie Echo Complete,2/11/2022 ER Hospital POC EPOC BMP W/LACTATE & ER Staff, Phyician, MD.Type & sceen,Just in Case-LT Blue,TROPONIN,DOComplete Blood Count with auto differential,Troponin,HS Initial and 2 Hour,Comperhensive Metabolic Panel,Complete Blood Count with Auto Differential, Lipase,JUST IN CASE TUBES 5to6, Lipid Panel(Calc LDL)RTO Overnight Pulse Oximetry,  2/13/2022 NM Cardiac Imaging-MLT<SPECT ,2/14/2022 Nuclear Cardiology Test OP (PHARMACOLOGICAL).2/27/2022 USV CAROTID COMPLETE.SLEEP STUDIES 3/17/2022,Results of sleep study is needed new machine with oxygen (BI PAP), Glucose Level test in Hospital stay.Stil havel Doctors visit  04/8/2022 New Patient Office Visit, Also have appointment 4/14/2022 COMPLETE PULMONARY FUNCTION TEST, PULMONARY TESTING 4/14/2022 Follow up PULMONARY MEDICINE.Had 5 Covid Test all 5 were Negative also blood test from hospital negative for every having Covid. Also had Visiting Nurses come to the house all my issues were under control,Have not needed my Pro Air for breathing in years. Also have IBS-C. Acid Reflux. Meds, Famotidine. Amoldipine,Atorvastatin and Solifenaciin,Pro Air HFA when needed,Lactulose when needed.Was giving prescription for Pantoprazole SOD DR and sent home with oxygen.
Large lump at the injection site and redness extending halfway to the elbow for 2-3 days. Itching for another 2 days near the injection site after the lump and redness subsided.
Patient developed a syncopal episode one day following the vaccine.  Without warning, he fell to the ground, losing control of bowel and bladder, although no seizure activity noted at the time.  He transiently lost consciousness and then woke up confused and combative.  Brought to emergency room and admitted with multiple rib fractures.  Initial brain imaging was negative but 24 hours later, noted to have small hemorrhagic brain contusion in left frontal/temporal region and a small subdural hematoma.  One day later, there was not noted to be any extension of the hemorrhage/hematoma.
Pain; Ear infection has progressively gotten worse; Ear pain; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 17:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. Medical history included obesity and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. On 09Apr2021, 7 hours after second dose vaccination, the patient experienced ear pain. On 10Apr2021 at 00:00, the patient experienced pain and ear infection has progressively gotten worse, and had not responded to antibiotics. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with antibiotic drops for ear and medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ear pain, pain and ear infection has progressively gotten worse, were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Initial symptoms included fatigue, chills, fever, mild aches (quad, hip flexor), and mild headache. Required additional clothing due to chills without improved symptoms. Fever progressed to highest at 104 degrees. Required additional effort for moving in bed and short household distances. Progressed to extreme fatigue, mild nausea, and extreme dyspnea ("very deliberate breathing" "I felt like if I didn't concentrate on my breathing I would just stop breathing"). Noticed increased restlessness and increased discomfort. Took 400 mg ibuprofen and after ~30 minutes there was a gradual decrease in symptoms, particularly fever and dyspnea. Symptoms resolved after taking ibuprofen. 24 hours following initial symptoms onset, noted to have fever (101 degrees), achiness return, face was flush, and transient chills/sweats.
Chicken pox type rash on neck and trunk. Red and itchy. Started at day 7 and has continued to spread even with steroid cream.
Approx 4 hrs following immun pt had large amount of swelling occur in both lower extremities below inject site; no temp >100; Approx 14-16 hrs following immun pt had reddened rash to occur over extremities & trunk;
Patient received boost moderna vaccine on 01/28/2021. Visited the ER on 2/21/2021 for cough and tested positive for COVID-19.
Please Note: this is not an adverse effect reporting rather an administration error   The incident happened on Sunday afternoon while I was working at a retail pharmacy. This patient came to our drop-off window at around 12:40 PM to get his 2nd dose of COVID-19 vaccine without any prior appointment. They couldn't speak language well and had an interpreter to translate. They were asked by my technician whether they received their first dose of COVID-19 vaccine from Moderna since we only offer Moderna in our store. They assured her and wanted to proceed with the second dose.  After administering the dose, I discovered that he received his first dose from Pfizer from another location.  I called CDC right away asking for advise while the patient was waiting in the observation area. The on-call physician told me that it is not an issue since CDC has a fact sheet regarding this and he guided me where to find the information. I printed the fact sheet and assured patient that he is not required to take any further dose as recommended by CDC guidelines.  I observed the patient for 30 minutes for any signs or symptoms of adverse events. Except for patient being scared, nothing was observed. Patient went home without any issues.
Got ill; This is a spontaneous report from Pfizer Sponsored Program. A contactable consumer reported for a 63-year-old female patient (reporter's mother) via medical information team. A 63-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Unknown), via an unspecified route of administration on an unknown date in Jan2021 (at the age of 63-year-old) as  single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter said that patient received her first dose of the Pfizer COVID-19 vaccine in Jan2021 while living in PRIVACY and then "got ill" on an unknown date and moved to PRIVACY and she was unable to get her second dose to due age restrictions and availability and was able to get her second dose now. Reporter was wondered if her mother needed to repeat the series or just get the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
On second day I started having tightness in my chest and trouble breathing with heart flutter.  I could not lay down to sleep, Had to sleep in chair for 2 days.  Horrible headache, clogged sinus and nausea.  Put ice pack on my head off and on for a couple of days. Trouble breathing lasted 4 days and I still have headache and clogged sinus.
NO ADVERSE EVENT, JUST DUPLICATED VACCINATION.  BIVALENT BOOSTER RECEIVED 09/22/22 BY DOCTOR'S OFFICE, BUT DOCTOR'S OFFICE DIDN'T HAVE POA CONSENT, OR INFORM POA THAT PATIENT RECEIVED ON 09/22/22.  PATIENT ALSO RECEIVED FLU VACCINE THAT DAY ON 09/22/22 FROM MD'S OFFICE WITHOUT CONSENT.  PHARMACY HAD CONSENT FORM SIGNED BY POA, AND DIDN'T CATCH IN TIME...PHARMACY DID NOTICE JUST BEFORE ADMINISTERING A 2ND FLU VACCINE, SO THE ONLY ERROR WAS A DOUBLE-DOSE OF COVID BIVALENT VACCINE.  FLU VACCINE WAS THEN DESTROYED AND NOT ADMINISTERED TO PATIENT.
Pt developed urticarial rash on 6-23-11 around noon time. Pt was seen in the office around 3:35pm. On examination pt had multiple urticarial lesions on the extremities, face, ear & neck. Was sent home on PO BENADRYL with no improvement. Pt was seen in the ER on 6-23-11 at night. Was sent home on ORAPRED & BENADRYL. As pt did not improve, he was hospitalized from 6-24-11 to 6-27-11 & was placed on PO ORAPRED and PO ATARAX. Pt improved. Ped ID was consulted. Pt still on PO ORAPRED (total x 7 days) and PO ATARAX (total x 2 weeks).
Patient had a fever of 101 that evening following the vaccine, jaw and chest pain. She drove herself to the hospital due to this, worried of a possible heart attack. She is fairly fit and plays a good bit of tennis, but does doe this out in the heat. The ER advised her the reaction was due to the vaccine.
With my first vaccine, I had a delayed reaction, I received it on a Friday and was extremely tired in Tuesday and very nauseous all day Wednesday.  With my second vaccine, I became itchy at approximately 1 am, 9 hours after the vaccine, I took Benadryl and tried to sleep, when I woke up around 9 am, I had hives on my left and right wrist, my left ear and the nape of my neck and into my hairline. I took a daily antihistamine and one Benadryl when I woke up, the itchiness and hives subsided within thirty minutes but coming up on the four hour mark of the Benadryl, I am starting to get itchy again so I will continue this regimen throughout the day.
DIzziness; Bad overall feeling; Shakes; Swollen throat; Throat swelled; my arms broke out in really bad rash, but it was mostly on my forearms to my elbows; Fever; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (DIzziness), DISCOMFORT (Bad overall feeling), TREMOR (Shakes), SWELLING (Swollen throat) and PHARYNGEAL SWELLING (Throat swelled) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (It's been 10 years since the last time patient had the flu shot) and Asthma. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Asthma.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (DIzziness), DISCOMFORT (Bad overall feeling), TREMOR (Shakes), SWELLING (Swollen throat), PHARYNGEAL SWELLING (Throat swelled), RASH (my arms broke out in really bad rash, but it was mostly on my forearms to my elbows), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK, q4h. On 08-Feb-2021, RASH (my arms broke out in really bad rash, but it was mostly on my forearms to my elbows) had resolved. At the time of the report, DIZZINESS (DIzziness), SWELLING (Swollen throat), PHARYNGEAL SWELLING (Throat swelled), PYREXIA (Fever) and FATIGUE (Fatigue) had not resolved, DISCOMFORT (Bad overall feeling) was resolving and TREMOR (Shakes) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 degree f (Low) 99.9 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications Trelegy inhaler, birth control pill
1:15pm Benadryl 25mg, PO for complaints of left neck tightness and flushed feeling.  Denies shortness of breath or chest pain/tightness.   1:27pm States left neck discomfort is subsiding. 1:35pm Denies any symptoms.  12/30/2020 10:00am phone call to patient, who states no symptoms since 1:30pm on 12/29/2020.
Syncope shortly after administration of vaccines. Awake and alert after initial event. Returned to doctor's office and evaluated. Monitored prior to discharge home.
One week after receiving the Moderna Covid 19 vaccine, I developed redness, itching and some subdermal swelling at the injection site. There were no other symptoms. The reaction lasted for approximately 14 hours.