chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It has been two weeks I have taken second Pfizer shot and everything started spinning and went black, like I was going to faint; My heart started pounding; I got weird; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old patient received bnt162b2 (BNT162B2) (Lot number: EN6204) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunisation. The following information was reported: DIZZINESS (non-serious) with onset 14Apr2021, outcome "unknown", described as "It has been two weeks I have taken second Pfizer shot and everything started spinning and went black, like I was going to faint"; PALPITATIONS (non-serious) with onset 14Apr2021, outcome "unknown", described as "My heart started pounding"; FEELING ABNORMAL (non-serious) with onset 14Apr2021, outcome "unknown", described as "I got weird".  Additional information: Consumer stated, "I was not sure if I need to call you or not I was just going to, it's been two weeks exactly since I got my second Pfizer shot. It was from LOT# EN6204. And I don't know if I reached the right person but I was just I don't even know if I am at right department, but let me just tell you this morning I got weird, anyway 'I was spinning' (not clear). When confirmed if the consumer wanted to report this or have some questions, consumer stated, "I was just telling you that I think I might have had a reaction today. I am not sure if that's caused by the, it's been two weeks and I am not sure if it is caused by the vaccine." Confirmed the name if the vaccine as Pfizer COVID Vaccine, consumer stated, "Pfizer EN6204.'' Follow-up: Consumer stated, "Sure, but I hope there was not anything to follow-up. This morning, it has been two weeks I have taken second Pfizer shot and everything started spinning and went black, like I was going to faint but I didn't lose consciousness. My heart started pounding and I was very (word not clear) afterwards, I am fine now." Concomitant medication: Consumer stated, "I am taking other medications, I take vitamin C and vitamin D and I am in a wheel chair and I take stool softener." (not clarified further). Consumer stated, "No, I was just telling you in case you want to add this to you (incomplete sentence)."  Reason for delay: Daily spike of incoming calls due to COVID 19 Vaccine.  No follow-up attempts are possible. No further information is expected.
Around 430pm on the day of the shot  I start itching really bad all over my body. After the itching my face start swelling, eye lids start swelling, hives in my face arms back stomach and side.  No breathing issues.  I took kids liquid Benadryl 3 teaspoons until my wife came from the store. Then I took 2 benadryl followed by 2 more 3:30mins later.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot# unspecified) and developed a rash after vaccination. The outcome of rash was unknown. Additional information has been requested.
pt recv vax & devel vesicles on legs, arms & nose;none on trunk;
Pain in Left shoulder Nov 2021 continued through Jan 2022 it was off and on located in the left shoulder joint pain and throbbing, Mid Jan 2022 pain increased in area  and intensity keeping me from sleeping  also led to weakness in arm difficult to 1 gallon of milk. Numbness and tingling from mid neck area on left side through shoulder  down to elbow. Saw Ortho Dr. on March 3 since he repaired my slap tear shoulder back in 2017. Clinical diagnosis was cervical radiculopathy, started physical therapy March 7 2022 twice a week through March 23 2022, No improvement  in symptoms Dr. ordered MRI of neck. MRI on March 30.  MRI confirmed clinical diagnosis cervical radiculopathy. April 4 2022 nerve block injection given. Pain level as of today April 27 2022 has decreased the tingling and numbness persist.
Information has been received from a female consumer concerning her daughter, an 18 years old female without a pertinent medical history who on 31-AUG-2009 was vaccinated with her first dose of GARDASIL. There was not concomitant medication. The reporter stated that the patient had blood in her urine a month later (approximately on 30-SEP-2009) after receiving the vaccine and that this happened twice but it had not occurred again. It was also reported that on 30-SEP-2009 the patient was due for the second dose of GARDASIL. No laboratory and diagnostic test were performed. The patient did not seek medical attention. This is one of two reports from the same source. Additional information has been requested.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 11:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 11:50 AM, 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, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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.   The age of patient was provided as 21.56.  Concomitant products were not provided.  On 28 Apr 2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19 Apr 2021, vial was moved to clinic on 28 Apr 2021. 4 vials were sent to clinic. Vaccine BUD date was 19 May 2021.  On 28 Apr 2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 AM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41, 4 PM: 40.  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 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.   This case was linked to MOD22-013597 (Patient Link).
Chills; slight headache; Tiredness; stiff arm; soreness at injection site; swelling in left arm; nausea which was reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL8982, Expiration date: Unknown) via unspecified route of administration on Left arm on an 04Feb2021 at 10:47 (80-year-old vaccination) as a Dose 2, single for COVID-19 immunization. The patient medical history was reported as none. There were no concomitant medications. Vaccination Facility Type was reported as Clinic and not military facility. The patient had not history of all previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3302) via unspecified route of administration on an 14Jan2021 (80-year-old vaccination) as a Dose 1, single for COVID-19 immunization. The reporter mentioned that she took Covid-19 vaccine just to prevent from the virus. She had been having symptoms. On 05Feb2021, the patient had experienced soreness at injection site, swelling in left arm, stiff arm. On 06Feb2021, the patient had experienced tiredness, slight headache. On an unknown date in 2021, the patient had experienced nausea which was reported as worsened. On 09Feb2021, the patient had experienced chills. She was asking how long these symptoms would last. The tiredness was ongoing. If she was still and relaxed, she felt fine. When she started moving the tiredness comes back. She was unable to take her dog for a walk. She still had bouts of chills. Putting on socks or using a blanket abates it. It was not significant. It was only minor. No investigation assessment was performed. No relevant test was reported. These adverse events did not result emergency room or physician visit. The outcome of the events soreness at injection site, stiff arm was recovered on 06Feb2021, swelling in left arm on 07Feb2021 and the outcome of other events not recovered.  Follow-up attempts completed. No further information expected.
On 4-1-21 patient returned to get 2nd vaccine an informed our staff of a severe reaction to 1st dose. After waiting 15 minutes she left to go home. Once on the express way her lips & tongue sterted to swell . She proceded to go home where she took a Benadryl. Our doctor at this clinic advised her to get cleared by her PCP before 2nd dose given.
Swelling at the vaccination site; A spontaneous report was received from a female consumer of unknown age, who was also the patient, who received Moderna's COVID-19 vaccine and experienced swelling at the site.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On the night of 31 Dec 2020, the patient developed swelling of the site of the VCG vaccination they received in the remote past. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event swelling at the site was unknown.; Reporter's Comments: This case concerns a female of unknown age who had a NS event of expected Vaccination site swelling.  Event onset occurred Day 9 after the first dose of mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the Vaccination site swelling, a causal relationship cannot be excluded.
states it started w/malaise, sore joints & feeling generally bad about a wk p/vax;17FEB97 started having drenching noc sweats on 20FEB noticed lymph node size of hens egg under rt arm & one size of marble inside rt elbow;
About 8PM last night I was sitting on the couch and I went to get up and I used my left arm to push off and noticed that my left arm hurt. It hurt all night and still is hurting today. It is hurting about 4 inches from where they gave me shot. From my elbow down to my fingertips feels cold. I have coronary artery disease which means when my arm gets cold like that it means I have a blood flow issue. I have two stints and I have triple bypass surgery. The pain is constant pain in the upper arm.    I sent an email over to my primary care doctor yesterday. I was advised by Oncologist advised me to get the vaccine.
SEIZING; PASSED OUT; LIGHTHEADED; URINATED; VOMITED; NAUSEATED; This spontaneous report received from a consumer 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 not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021, around 12:30 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, after vaccination, patient waited around 30 minutes in store before heading home in a car driven by his father. After ten minutes, in the car, patient's father noticed that patient had slumped over after saying he felt lightheaded and passed out. Patient started seizing for about 30 seconds, urinated on himself and finally came to asking where he was. Then within five minutes, patient got nauseated and vomited. Once patient vomited, he started feeling better. He was able to shower with assistance once home and is now lying down feeling lightheaded and nauseated. Patient's parents continued monitor him for the next several hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from seizing, passed out, urinated, and vomited, and had not recovered from lightheaded, and nauseated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210627035-COVID-19 VACCINE AD26.COV2.S- seizing, passed out. This events is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
The next day my left eye was painful, like little ice picks going in, it was inflamed. It was difficult to see .  I had Lasik about a year ago and I called my eye Doctor because I was nervous and I went to see him and he told me it looked like a allergic reaction.  He put me on steroid drops. When I woke up Saturday morning my eye was fine, so I stopped taking the medicine.
Left eye became swollen and red, then the eyeball (sclera) started to swell and bulge out and a vessel popped causing a red spot to the white of the eye.. Was significant for several hours, then slowly subsided over the course of the day.
Headache, Myalgia, Fever, chills, night sweats Narrative:
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms.
Swelling of face, hot and prickley, could not breathe, hard time swallowing, and almost fainted - light headed
adult dose administered to a child; adult dose administered to a child; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 1-year-old male patient who received HBV (Engerix B adult) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th August 2022, the patient received the 3rd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 9th August 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comments: The Personal Assistant(PA) reported an adult dose of Engerix-B was administered to a child today (on the day of reporting). The reporter consented to follow up. Additional supportive information: The patient was given adult dose of Engerix-B instead of the pediatric dose, which led to overdose and adult product administered to child at vaccine administration.
Fever w/febrile seizure - fever started at 1300 (3-4 hours following vaccinations). Temp in ER - 102.4, seizure-like activity noted at home. Presented to ED at 18:42. Treatment - antipyretics, Outcome - good.
Been sick all day fever at 100° sleeping constantly. Body aches, stuffed up nose that I can't breath through, eyes burn, headache, cold and hot flashes off and on.  Nausea.
Shingles developed (Unsure which manufacturer----but it was Flu shot). IIV4, IM Press-free 6MO+ (this was listed on my medical records thru doctors website).
This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration, administered in the left arm on 15-Apr-2021 08:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 25-Mar-2021 08:00 AM administered in the left arm for Covid-19 immunization at the age of 38-years-old. There were no other vaccines received in four weeks. The patient did not have Covid prior vaccination. The patient experienced syncope on 16-Apr-2021 12:30 AM (00:30 military time) with outcome of unknown. No treatment was received for the adverse event. The patient was not tested for Covid post-vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported syncope cannot be excluded based on a temporal relationship.  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 RAs, Ethics Committees, and Investigators, as appropriate.
At 1327 client reported to EMT he was feeling nausea for 30 mins. EMT  did first vitals at 1329: blood pressure 160/100, pulse 65, oxygen sat 99%. EMT  did first assessment. Client reported medical history of diabetes, hypertension and unspecified thyroid condition. Current medications: Lisinopril, Metformin, and Levothyroxine.  Client reported no known allergies. PHN arrived at 1335. Client sitting upright in chair, alert and oriented x4. Client aware blood pressure is high and reported he took his medication today. Client reported only reaction to 1st Pfizer Covid vaccine was muscle pain, numbness to arm where vaccine was given and has followed up with provider. Vitals at 1339: blood pressure 160/98, pulse 68, oxygen sat 99%. Client reports nausea same and stated "I can tolerate it, I will not throw up". Client denies chest pain, shortness of breath, headache, or blurry vision. Vitals at 1349: blood pressure: 150/92, pulse 68, oxygen sat 97%. Client reports new onset of lightheadedness and nausea same. Client informed staff he wanted to leave. PHN asked client if someone could pick him up as symptoms had not resolved. Client stated " I can drive, if not I will contact someone when I am in my car". PHN  advised client to follow up with provider and gave ER precautions. Client left facility with steady gait at 1358.
Shingles. Rash, blisters, pain right shoulder, arm.  Prescribed Prednisone and Acylovir, taking Advil and Tylenol.  Today (5/10) 2nd dose of Covid-19 vaccine was refused by provider. Was told he'd have to reschedule.
Right arm pain, chills followed by joint, muscle, bone pain, headache, fever up and down from 99 to 101 degrees F.  Fatigue.  Fever was gone by 4/16/21 8am.  Right arm injection site still tender.  Other symptoms gone at this time 4/16/21 2:20pm.
I woke up at 2 am to intense chest pains. They radiated from my left shoulder blade through to my left breast.  Pain was worse when I breathed. I at first suspected indigestion, so sat on couch, took an antacid and that did not help. My husband awoke at 4 and gave me 3 baby aspirin which helped some what. Laid down for awhile, woke about 10 am to severe pain. Ended up in the emergency room at noon thinking it was a heart attack. My blood pressure was only slightly elevated and I have no history of heart problems. At the hospital all heart related tests came back okay. I was given morphine for pain and zofran.  The medicine helped to ease pain and brought my blood pressure back to normal.  I was released 4 hours later with no diagnosis for what caused the pain, the hospital told me to take Tylenol for pain as needed. When asked what caused it, they said that they didn't know. When I asked if it could have been the vaccine, they said they didn't know.
Broke out with rash consistant with active herpes zoster on right T9 dermatome with pain and neuritis
Redness swollen and bumps/lumps on both arms beginning 2 days ago.
patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
I had like allergic reaction like itching; I had like allergic reaction like itching; I feel hydrated too and I am tired; I feel dehydrated too and I am tired'; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EP7534), dose 2 via an unspecified route of administration on 16Mar2021 (Vaccination at the age of 60 years) as DOSE 2, SINGLE for covid-19 immunisation. NDC number and UPC number of COVID Vaccine: Unknown. The patient's medical history and concomitant medications were not reported. Patient previously took bnt162b2 (LOT#: Consumer stated, "EN62, looks like 31 or 51.") on 23Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient had like allergic reaction like itching (hypersensitivity) (pruritus), felt dehydrated too and was tired (fatigue) (dehydration) on an unspecified date. Outcome of the event like allergic reaction like itching (hypersensitivity) was not recovered and other events was unknown.  No follow-up attempts are needed. No further information is expected.
No adverse effects reported.; patient was administered a dose of improperly stored MMR II, ROTATEQ or PEDVAX HIB; This spontaneous report was received from a medical assistant refers to 12 month old male patient. The patient's pertinent medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent.  On 15-NOV-2019, the patient was administered with a dose (1 dosage form) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number R030808, expiration date 24-OCT-2020, anatomical location and route of administration were unknown) for prophylaxis. Other suspect therapies included haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# R000877 expiration date: 24-SEP-2020, dose number, anatomical location and route of administration were unknown) for prophylaxis (product storage error). No lot information was provided for properly stored sterile diluent used to reconstitute improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The vaccine was exposed to above 47 Fahrenheit scale (52F) for the time frame of 1 hour 15 minutes. There was previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was filed.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA003851: US-009507513-2005USA003277: US-009507513-2005USA003150: US-009507513-2005USA003276: