chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid positive after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid positive after 1st shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), METOPROLOL, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (covid positive after 1st shot). At the time of the report, SARS-COV-2 TEST POSITIVE (covid positive after 1st shot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, COVID-19: positive (Positive) covid positive.     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.   The treatment information was unknown. second dose was scheduled for second dose on 11May2021.
hives; This is a spontaneous report from a contactable consumer (patient, self-reported). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. On an unknown date patient received the second dose of the Pfizer Covid-19 vaccine 6 hours ago. Patient reports that he had hives and asked if he can take Benadryl or Claritin and if this reaction is normal. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Extreme fatigue, headache, wouldn't eat or drink because she was to tired. Elevated BP, elevated pulse and fever.- as described by daughter.  Taken to hospital to be evaluated.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in the temperature of 47F to 77F for 1 hour) doses of M-M-R II (lot #, expiration date, dose and route of administration were not reported) for prophylaxis. No adverse effect and no previous excursion were reported. The call was made because of a data logger. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA013413: US-009507513-1703USA012995:
Patients mom called our office at 8:30 am and stated the patient had hives on abdomen red raised rash, with no temp.  Tx was Calamine lotion and Benadryl.
Woke evening after the shot with personality change. Not in pain. Lasted about 1 hour. Seemed fine the next morning until after a nap woke with similar personality change but did not last as long. No fever or rash or GI symptoms. Just extremely fussy and behavior not usual. Almost angry.
approx 1/3 of the pts treated to date w/Engerix-B failed to respond or had borderline titer levels produced p/3rd dose; 60 to 70 pts have been treated to date;
Both parents tested positive the following day; Both parents tested positive the following day; This is a spontaneous report from a contactable other health care professional (Nurse). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248),via  intramuscular route of administration, administered in Arm Left on 22Jan2021 13:45 (at the age of 42-years-old) as dose 1, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248), via intramuscular route of administration, administered in Arm Left 10Feb2021 13:45 (at the age of 42-years-old) as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had been tested for Covid-19. On 13Aug2021, reported both parents tested positive the following day. The patient underwent lab tests and procedures which included Nasal Swab: positive on 13Aug2021. Treatment received for the events was unknown. The outcome of the events was resolving.
Severe headache, achy and chills. Large lump and swelling on the injection site for 7 days
Pfizer-BioNTech COVID 19 Vaccine EUA  Throbbing pain in my right back area inside - not on the skin - possibly near the kidney
I am not certain that my experience with abnormal uterine bleeding following my second Moderna COVID-19 vaccine was related to vaccination, but I thought I would put the report out there for data collection purposes. I received Dose 2 of my Moderna COVID-19 vaccine on 1/29/2021 after having received my first dose 1/3/2021. In between the two doses, I had a normal menstrual period from 1/17 - 1/21/2021.  Then I had a period from 2/23 - 2/27/2021. On 3/12/2021, when I should have been in the middle of my cycle, I started spotting and the spotting continued daily until at least 4/2/2021.
May have had a virus before had vaccine. Had a runny nose then had full blown flu with runny nose, headache, cough and stomach ache. Had low grade fever. Took 4 days after had vaccine for symptoms to occur. Dr did not give meds.
?Pfizer-BioNTech COVID-19 Vaccine EUA: patient present to clinic staing one day after vaccination experienced swollen, purple, and burning lips. Patient administered diphenhdramine and symptoms resolved over 1-2 days. Patient also reports nausea, decreased appetite. diarrhea, body aches, and frequent urination.  Patient denies shortness of breath or fever. Patient advised to continue home management.
10:30am -  Received the Vaccine Shot 11:30am- Warmth throughout face, then right had went all tingly, then numb and swollen. The numbness crept up the arm to the elbow. Then the nose started to get tingly and numb followed by the lips and gums.   12:00pm - Started to not be able to speak a sentence.  The words were coming out of my moth very jumbled even though in my mind I knew what I was trying to say. Still numb in right hand, and on right side of face.  12:10 pm- Could not see fully out of the right peripheral of my eye as well to the other symptoms of not being able to speak a full sentence. I was able to speak less words than I had about 10 min prior. Numbness in my hand went away at this time. 1:15pm- I was able to speak mostly full sentences again.  I got a pounding headache on the front to left side of my head and felt fatigues. 1:40pm- Finally able to speak full sentences again, I could feel my hand and all the parts of my face.  Felt weak, still had headache and felt nauseous and dizzy. 2:15pm- Took 1 advil, fell asleep 4:00pm- Woke up, felt weak, disoriented, still had a headache. 8:00pm- Only a small headache left and a sore arm
12JAN94 1 hr p/vax fever 103-for 36 hrs also vomiting & diarrhea
A few days after taking the vaccine her eyesight became blurry, red, cloudy and painful. Went to the eye doctor and was diagnosed with having Shingles of the eyes. Was given meds for her eyes.
3wk p/vax pt devel a rash on rt thigh;rash progressed to urticarial like lesions which coalesced & formed a plaque;pt seen by dermatologist who observed target lesions & dx erythema mult;
Abdominal pain, diarrhea, dizziness, tinnitus, vertigo, vestibular migraine with vestibular therapy. Limited work schedule.  High level of HSV1- 42.40 HSV 1 IgG Type Spec taken 21 January 2022.  SARS-COV2-SEMI-QUANT TOTAL AB 191 U/ml taken 21 December 2022 SARS-CoV-2 Spike Ab Interp - Positive taken 21 Dec 2022
Patient said she was experiencing generalized itching on her body. I told her to take 2 Benadryl tablets and then call her doctor and the call me back in about an hour. She called back at about 2:00 PM and said that her itching was almost completely gone.
began to cough; This is a spontaneous report from a contactable pharmacist reported that a 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular on 23Jan2021 12:30 at a single dose for Covid-19 immunization. The vaccine was administered at the clinic. Medical history included history of asthma attacks and has to occasionally use her epinephrine pen to aide in breathing due to a new onset of an allergy to salad dressing from an unknown date. Concomitant medication included epinephrine. On 23Jan2021 12:30, the patient began to cough. The patient was given water with no resolve to coughing. The patient went to first aid area assessed by Medic. The lungs were clear to auscultation and patient O2 saturation was 95% on RA on 23Jan2021. Patient denied any difficulty breathing. The provider evaluated patient and at 12:40 patient given 4 puffs of albuterol inhaler (patient's personal inhaler used). After reassessment/observation provider released patient home. The outcome of the event was recovered.
Headache, chills, pain in arm - took ibuprofen for the pain and headache.
COVID dose #2 given on 10FEB @1330. Notes about 1 hour after began to get HA, chills, rhinorrhea, nasal congestion, sore throat, cough, nausea, fatigue and body aches. Shortly thereafter broke out in diffuse red itchy rash of the body. Presented to the ER and was sent to FM to make appt in respiratory clinic. She denies ever having difficulty breathing, sob, wheezing or increased work of breathing. She took 2 Benadryl (50mg) and the rash resolved. Woke 11FEB with L arm tingling and L upper lip swelling. L arm tingling has resolved however lip swelling worsened throughout the day. Denies swelling of the inside of the mouth, tongue, itching or swelling in the back of the throat. Denies globus or difficulty swallowing. Denies dyspnea, wheeze or change in voice tone.
Soreness, itchy, red swelling. Large are larger than the palm of my hand. Warm to touch.
Information has been received from a physician concerning a patient,  who is a twin, who on 02-JUL-2008 was vaccinated with an oral first dose of ROTATEQ vaccine live (human-bovine). Within days of receiving the vaccination the twin experienced severe diarrhea, approximately 10 times per day. The physician reported that the twin was being  tested for rotavirus (no information was provided). No lot number was provided. No product complaint was involved. This is one of two reports form the same source. The patient's twin was administered an oral first dose of ROTATEQ vaccine live (human-bovine) and had a similar experience (WAES# 0807USA03987). Additional information has been requested
I spoke with patient again today after speaking with him last week about his inablitity to move his arm completely.  He stated he could not raise his arm above his shoulder and his fingers were still numb..  He explained to me that his arm was still sore, but only today he went into detail about how he had rotator cuff issues in this same arm.    He then explained to me that he had been seen by his PCP and they offered the same regimen that this nurse had offered (NSAIDS 600mg x 3 days and alternate cold and warm packs) I explained to him the more he uses the arm the faster it would heal.
Vaccination delivered 08/10/07. Pt called 08/14/07 to say she was experiencing "hive like" rash, was slightly pruritic and responded to topical antipruritic medication OTC, but new lesions continued to "pop-up". Pt denies activity outdoors or exposure to any new chemicals. She states she is taking 1 medication for cholesterol. Advised her to take OTC PO benadryl and report to her physician if things worsened or no improvement was seen in a couple days.
Initial misuse report received from a healthcare professional on 02 January 2014. A 11-month-old patient had received a first dose of 0.25 ml of FLUZONE QIV on 19 October 2013. It's an inappropriate dose of vaccine administered. No adverse event was reported. List of documents held by sender: none.
I started feeling very weird and could not sleep well the first night - I kept waking up with a pounding headache, but a different type of headache than I had ever felt before. I have had a constant low-grade headache since that gets worse at night.   The first night and that next day, Excedrin Migraine helped. I have been taking Ibuprofen almost every evening since then.
little sore in the same arm of injection; slight fever; A spontaneous report was received from a consumer concerning a  female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever and pain in arm.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.  On 10 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the patient developed fever and pain in arm. Treatment for the event ,was not reported.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, fever and pain in arm, was considered unknown.
On 11/17/00, the pt complained of itching of her left arm, at the lower deltoid and at which time, she noted a red, raised area approx. 7cm in diameter with little red bumps on it. It was warm to touch. She saw a physician on 11/18/00 and was treated with an "anti-inflammatory" shot and a "pill". She was given a prescription for a "steroid nose pack". The pt was not given an actual dx, but she states that she assumes the physician must have thought it was the TD injection, as they did not tell her that it wasn't the TD injection. On 11/27/00, follow-up telephone call with the pt, she states the local symptoms have resolved.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.            no concomitant and treatment drugs were provided.   This case was linked to MOD-2021-069726 (E2B Linked Report).; Sender's Comments:  MOD-2021-069726:First dose of vaccine case.
My symptoms started on Monday 06/27/2022 with what I thought were my allergies acting up. As the day went on I was getting more congested and started to cough, it was a dry cough. I woke up at 04:30AM ET on 06/28/2022 and I tested for COVID-19 and it came back negative, I tested myself on 06/29/2022 which came back with a positive test result almost immediately. I had a virtual visit on 06/30/2022 with my physician and she prescribed PAXLOVID. My first dose was that evening. I continued with congestion and pressure from the congestion, dry coughing and a slight productive cough. I finished the last PAXLOVID today, I have a little congestion but otherwise pretty good.
Pt recv vax on unknown day; on 11/24/97 pt exp rash; dx=possible ADR
9 hrs after shots pt had lip swelling on/off lasted 4hrs then resolved returned for 4hrs + resolved. Then (L) upper eyelid swelling x 4 hrs + resolved
w/in minutes p/inject of vax, pt exp a high pitched cry for a prolonged period >3 hrs; pt was was cranky & febrile for the following 2 days;
body aches; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (chills) and PYREXIA (fever) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (body aches), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (chills) and PYREXIA (fever) had not resolved. Not Provided          No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to events was not applicable.
Gave an expired Boostrix vaccine to one of her patients; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 49-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HT479, expiry date 8th August 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th August 2021, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 9th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care professional reported that she gave an expired Boostrix vaccine to one of her patients in the left deltoid, which was already expired on 8th August 2021. The reporter consented to follow up.
This spontaneous report as received from a registered nurse refers to a 6-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Fever of 102.  Head ache. Total body aches. Dizzy off balance extreme cold and sore of entire body very weak.
Upper lip numbness, bilateral midline.    Possibly associated with very minimal swelling to the upper lip. Lasted a few hours.   No other associated reaction.
FEEL SICK AFTERWARD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced feel sick afterward. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feel sick afterward was not reported. This report was non-serious.
First day with symptoms of systemic illness within 3 hours of vaccine placement.  nausea fatigue with arm pain., feverish. Pain progressively worsening with stiffness and pain up arm to left neck. Injection site is red hot and swollen. Seeking care today 02/20/2022
Pt developed shingles of her ophthalmic branch on the right side on 3/3/08.
Patient fainted post injection.  He stated that he had anxiety and felt like his blood sugar might have dropped.  EMTs checked him over and patient declined treatment.
Tdap administered on 2-11-08.  Patient contacted office on 2-12-08 stating that he had a low grade temp (99.4), body aches, chills, and swelling at site of injection (left deltoid) and some in his left axilla.  He was encouraged to take Tylenol or Ibuprofen and to apply ice to area.  He then called on 2-13-08 to state that he was feeling better.  Stated he had slept for 13 hours last night and that he no longer had any temp or body aches.  Stated he did still have some swelling in his left arm and axilla, but was going to apply ice to it during the day.  On 2-14-08, he presented to our office as he was concerned about the swelling in his left axilla and left neck.  He did have significant swelling in his left axilla and some in his left neck, both areas tender to palpation.  He also stated that his temp returned the previous evening, reaching as high as 101 degrees and that when his temp was up, he had body aches and chills.  He was seen by physician and treated with Medrol dose pack and Tylenol or Ibuprofen.
After the first dose, I had extreme pain in my left arm, had foggy brain and fatigue.  Nothing major although I did notice the onset of irregular heartbeat which is why I added Aspirin to my supplements before the 2nd dose.  The 2nd dose was a nightmare.  I am NEVER sick.  Nausea/vomiting, chills, fever, memory loss, increased tinnitus, hearing a radio that wasn't playing for 3 days mostly in the middle of the night; major fatigue, depression, and general malaise for days.
Broke out in hives across the upper chest, neck and side of cheek.  Hives also below the bra line into the upper abdominal area and on the dorsal side on the sacral area.  Confirmed with tele-nurse to take a single dose of Benadryl and to report this to this site.