chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Break through infection in which he tested positive with covid 19, this past Sunday; Break through infection in which he tested positive with covid 19, this past Sunday; Loss of taste; Low grade fever; Myalgia; congestion; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm on Mar2021 (reported as 3rd or 4th week of Mar2021) as dose 1, single and on Apr2021 (reported as 2nd week of Apr2021) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. It was reported that there was a breakthrough infection in which patient was tested positive with COVID-19, this past Sunday before the present report (29Aug2021). He did not know specific dates of when he got his COVID-19 vaccines, but he stated that his first dose was in the 3rd or 4th week of Mar2021 and the second dose was in the 2nd week of Apr2021. They did a rapid COVID test, for which he tested positive on Sunday 29Aug2021. On Thursday 26Aug2021 he started feeling sick, his twin 3rd years old school tested positive, and so it was 4 classes that were quarantined. He started feeling symptoms on this past Thursday 26Aug2021 and therefore provides his awareness date as 26Aug2021. Caller (patient) elaborated on the symptoms he experienced on Thursday 26Aug2021, he had congestion nasally, then on Friday 27Aug2021 a low grade fever. He had myalgia from 26Aug2021 having his body be sore. The congestion was done by Sunday and his nose started clearing. Caller confirmed that on Monday (30Aug2021) it was gone. Fever lasted a day and a half (28Aug2021). Regarding myalgia it was reported that he was sore and tired, just still a little sore. He added that another symptom he had was loss of taste, which started on Saturday (28Aug2021) and it was still ongoing and the same. He had no product details since he was quarantined at the moment, he didn't take his COVID card with him and it was at home, he was not going home yet for the moment. The outcome of the events was resolved on 30Aug2021 for congestion, resolved on 28Aug2021 for low grade fever, resolving for myalgia, not resolved for loss of taste and unknown for the other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Rash at vaccine site, neck and torso (front and back) Red, itchy and burning, skin intact.
Heaviness in the eyes; Dizziness; Chest pain; Rapid heart rate; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), TACHYCARDIA (Rapid heart rate), OCULAR DISCOMFORT (Heaviness in the eyes), DIZZINESS (Dizziness) and FATIGUE (fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue). On 24-Mar-2021, the patient experienced CHEST PAIN (Chest pain) and TACHYCARDIA (Rapid heart rate). On 25-Mar-2021, the patient experienced OCULAR DISCOMFORT (Heaviness in the eyes) and DIZZINESS (Dizziness). At the time of the report, CHEST PAIN (Chest pain), TACHYCARDIA (Rapid heart rate), OCULAR DISCOMFORT (Heaviness in the eyes), DIZZINESS (Dizziness) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment included unspecified anxiety medication.
Case number PHHY2011AR39627 is an initial spontaneous report received from a physician on 10 May 2011. This report concerns a male patient with unknown medical history. He was vaccinated with FLUVIRIN 2010/2011 (batch number: unknown) five days prior to the report (exact date not reported). The patient presented with 24 hours of fever and generalized pruritic erythematous reaction on unspecified date. A skin biopsy performed revealed erythema polymorphe. The outcome, seriousness and causality were not reported for the event erythema polymorphe.
Eyes became sore and red. By 6:00 PM, my right eye was blood shot on medial side. Left eye red but not as bad. Became achy and congested. By morning, eyes swollen and congested in upper sinuses. Kept clearing my throat. I suspected it was ORS reaction. My employer sent me to Employee Health Nurse. She suspected conjuctivitis and I was sent home. I tried to explain ORS but she said that my red eyes could not be related to the flu vaccine.
Two days after second Covid vaccine I had  12 hrs of the worst ?bone pain? all over my body in my life.  Lasted for 12 hours. Since then I have had migrating pain all over my body to the point  I couldn?t turn over in bed without waking  so kept trying to work with pain which caused anxiety and have had xrays, CT, LOTS of bloodwork and MRI, dexascan, and nothing shows except mild osteoarthritis and bone thinning which for a 53 year old Thats  18 years postmenopausal is not uncommon.  Nothing to explain this bazaar pain but my life has been miserable  and have been off work. Don?t know what else to do.  When I try to get in and out of a car I feel like my legs are coming off my hips yet nothing is seen on all these tests. I live with chronic pain from crohns but this has been very bad at times.
approx 40 mos p/vax pt experienced breakthrough chickenpox w/approx 100 lesions noted
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot number L013192, expiration date: 19-JAN-2017 and lot number K019372, expiration date: 16-JUL-2016, (dose was not provided). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of 54.9 degrees Fahrenheit for 2 hours and 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills, fever, site pain, redness and swelling, tiredness, nausea, headache
Nausea, fever, body aches  from about 5:30 am the day after 2nd shot lasting until the next day
On 9/26/95, pt. recv. vax.  Several hours after vax., pt. exp. prolonged, persistent inconsolable crying/screaming lasting 12 hours.sx started several hr p/vax;screams very high pitched;allerg rxn per MD dx;
p/vax 1025AM pt went to car & then returned to pay for vaccine & became SOB & c/o tightness in chest;pt placed on back & requested head stay elevated to help w/breathing;BP 182/98, P140, c/o lightheadedness;02 began;P118, resp 24;
Information has been received from a medical assistant (also reported as a registered nurse) concerning an immunocompromised female with a history of shingles who on an unspecified date was vaccinated with one dose of Zostavax. Subsequently the patient developed a "serious case of shingles and was hospitalized." The patient was reported to be hospitalized in another country and therefore the length of hospitalization was not known at the time of the report. It was reported that the patient attended the oncology clinic where the medical assistant worked, though the prescribing physician did not work in the clinic. The reason the patient attended the oncology clinic was not provided. There was no product quality complaint involved. No further information was provided. The patient;s shingled were considered serious for hospitalization. Additional information has been requested.
Left arm discomfort occurred the morning after vaccine administration. Discomfort subsided but the discomfort has returned. Arm has been sore for off and on since vaccine was administered in July.
9 month old received Kinrix; Kinrix administered instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 14-Nov-2022. Reporter's Comment:  The reporter stated that a patient was inadvertently administered a Kinrix dose today in their facility 20 minutes ago on the day of reporting in the right thigh.  The reporter also mentioned they meant to grab Pediarix but instead grabbed the Kinrix. Consented to follow up was granted. Additional Supportive Information: A 9 year old patient received Kinrix, which led to inappropriate age at vaccine administration. HCP stated they meant to grab Pediarix but instead grabbed the Kinrix, which led to wrong vaccine administered.
Woke up next day with severe bone, muscle & joint pain & headache & fatigue.  Felt like a severe fibromyalgia & RA flare.  All but fatigued had subsided in 24 hours.  Fatigue remained for 48 hours total.
Presented with hives the morning of 7/29/2023.  Did a video visit with Dr. in my office.  Pictures provided to me that are consistent with hives.  Received Benadryl 25mg twice that day.  Hives subsided a bit.  The evening of 7/29/23 though developed lip swelling.  Woke up on 7/30/23 still with hives and mom gave Claritin 10mg and the hives quickly and immediately resolved and have not returned again.
I did not experience any adverse effects to the second shot until 50 or so hours until after the shot. From then on I felt extreme exhaustion, joint pain, and muscle weakness for 9 days. So much so that on day 6 after the shot I reached out to my Doctor and scheduled a Covid PCR Test, which came back negative.  It was not until 11 days after the second shot that I felt back to "normal"   In the past few days I have noticed a scar at the site of injection. I haven't seen any information on scaring after the second shot.
Administer vaccine to the patient immediately from the fridge she doesn't put it at the room temprature; A spontaneous report was received from a nurse concerning a patient who was participating in the mRNA-1273 Emergency Use Program and experienced administer vaccine to the patient immediately from the fridge, not at room temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   Prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   A nurse called to report vaccine administered to patient immediately from the fridge, not at room temperature.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine to the patient immediately from the fridge, not room temperature, was considered resolved.  The reporter did not provide an assessment for the event, incorrect dose administered.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of out of specification product use.
Basically it was congestion with a slight cough and post nasal drip it lasted four week s and I had two rounds of antibiotics.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POTS (pre covid)" (unspecified if ongoing); "hypermobile spectrum disorder" (unspecified if ongoing); "cervical dystonia" (unspecified if ongoing); "essential tremor" (unspecified if ongoing); "panic disorder" (unspecified if ongoing); "adhd" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: Peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "known allergies: cephalexin"; Macrobid, reaction(s): "known allergies: macrobid"; Clindamycine, reaction(s): "known allergies: clindamycine"; Tetracycline, reaction(s): "known allergies: tetracycline"; Bactrim, reaction(s): "known allergies: bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment Paxlovid from 18Jan2023 to 22Jan2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
unconsolable crying per maternal hx for over 12 hrs; no other s&s;
This case was reported by a healthcare professional and described the occurrence of syncope in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included JUVEN, VITAMIN B3, LUCIDRIL, OMEGA 3 FISH OIL, LEXAPRO, AMBIEN, VITAMIN E, VITAMIN C, MAXIDEX, multivitamins plus zinc, LEUCINE, Folic Acid, BONIVA, CITRACAL and unspecified eye drops. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, 30 minutes after vaccination with FLULAVAL, the subject experienced syncope. Additionally, standing at the counter, the subject felt as though she was going to faint. She fell and fainted and hit her head as she fell. It was not reported how long the subject was out. At the time of reporting syncope was improved. The healthcare professional considered the event of syncope probably related to vaccination with FLULAVAL. A statement in the text of the report read: The cold packs were not frozen upon delivery. Tag alert indicated that the product was okay. Days later at room temperature, the Tag Alert still says okay.
Headache fever 100.0 body aches fatigue nausea; Headache fever 100.0 body aches fatigue nausea; Headache fever 100.0 body aches fatigue nausea; Headache fever 100.0 body aches fatigue nausea; Headache fever 100.0 body aches fatigue nausea; This is a spontaneous report from a contactable nurse reported that a 46-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine), intramuscular in the right arm on 17Dec2020 12:00 at single dose for immunisation. It was in the hospital where the most recent COVID-19 vaccine was administered. Medical history included Hep B chronic carrier.  She had no other vaccine/ medications in four weeks, no covid tested post vaccination, no known allergies. The patient's concomitant medications were not reported. The patient experienced headache, fever 100.0, body aches, fatigue and nausea on 20Dec2020. No treatment was given. The outcome of events was recovered on unknown date in Dec2020.  Information on the Lot/Batch has been requested.
Information has been received from a 70 year old male with sulfonamide allergy who on 24-DEC-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included simvastatin (unspecified). The reporter stated that he experienced pain at injection site after receiving the ZOSTATVAX vaccine (Oka/Merck) on 24-DEC-2008, and on the same date also had swelling on his arm. Routine labs were performed. On 27-DEC-2008 the patient recovered. Additional information has been requested.
Scalp and left shoulder infection site red, hot, burning, itching. Throat sore burning, headache same evening. Next day sneezing, runny nose, body ache. Lasting still today, 10/01/2015. Out of work on sick leave.
1 of 5 patients who recv flu vax,& w/in 1 day of vax devel malaise,stiffness,fever & congestion;addtl info 27NOV95: 5 patients,all in same company dept,had viruses around the same time of vax & all sx were attributed to viral infect;
Received her second Moderna vaccine dosage at 3:45pm today. At 3:55pm she felt flush and tachycardic, with a dry throat and tingling lips. She is unsure if this is anxiety from vaccination or a reaction. She prophylactically took ibuprofen prior to coming in for her vaccine. No history of anaphylaxis. No history of SARS-COV-2. We called for review instructing to provide 10mg cetirizine (given at 4:02pm).  Dose #1 she had experienced low grade fever, myalgias (mild) Her vital signs at 3:55pm BP 145/82;  HR 113;  SpO2 100%;  T 98 F She appears mildly flush on her face and ears. No hives or rash. No SOB, CP, N/V/D;  Vitals at 4:06 after cetirizine  BP 129/85 HR 100 SpO2 100%  Advised to take a second antihistamine if allergies continue when she gets home.
Extreme fatigue, body aches in joints comparable to the flu, nauseous, insomnia
Started Spotting (menstrual) the day after i received my vaccine, bled for 1 1/2 days, then i didn't bleed or have a period for 55 days straight, followed by a horrible and really heavy period with bad cramps and heavy bleeding.  I am not on any medication or birth control and am always very regular with my cycles.
Patient stated she was weak, pale color. Did not faint, we had her lay down on exam table, patient advised that she had not eaten that morning. Kept for 1/2 symptoms resolved after drinking some water and resting.
patchy redness swelling and warmth near Pneumovax injection site. no fever Treated with Clarinex and Zanax
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated an expired dose of ZOSTAVAX with lot # (670542/0619AA) (expiration date 26-JUL-2012) on 21-AUG-2012. No adverse symptoms reported. Additional information has been requested.
Started out as a wheal, hot and red.  Ended up after 3 days, a wheal about 10 cm, hard, hot, red and 60% of upper arm reddened, itchy, sensitive.
Tinnitus; malaise; ear pressure and it feels plugged up; you sort of sleep a day or two; tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), MALAISE (malaise), EAR DISCOMFORT (ear pressure and it feels plugged up), SOMNOLENCE (you sort of sleep a day or two) and FATIGUE (tired/fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, LISINOPRIL, ATORVASTATIN and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus), MALAISE (malaise), EAR DISCOMFORT (ear pressure and it feels plugged up), SOMNOLENCE (you sort of sleep a day or two) and FATIGUE (tired/fatigue). The patient was treated with VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) at an unspecified dose and frequency. At the time of the report, TINNITUS (Tinnitus) had not resolved and MALAISE (malaise), EAR DISCOMFORT (ear pressure and it feels plugged up), SOMNOLENCE (you sort of sleep a day or two) and FATIGUE (tired/fatigue) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  Treatment included popping of the ear to open the eustachian tube per ENT's recommendation  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-107143 (Patient Link).
This spontaneous report as received from a medical assistant refers to a 12 months old patient who on 21-JUL-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number reported as J012816, Exp. Date: 10-OCT-2015 and J009986, Exp. Date: 12-AUG-2015) .5 ml, subcutaneous and a dose of M-M-R II (lot numbers reported as J002866, Exp. Date: 12-MAR-2015 and J008154 Exp. Date: 08-JUL-2015) that were improperly stored. Doses and routes were not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
This is a spontaneous report from a contactable consumer or other non hcp (patient). A 90-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3302) via an unspecified route of administration, Anatomical Site of injection: Left shoulder on 16Jan2021 09:00 (at the age of 90-year-old) at dose 1, single, and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, anatomical site of injection: right shoulder, on 06Feb2021 09:00 (at the age of 90-year-old) at dose 2, single, both the doses for covid-19 immunisation. Medical history was reported as none (Patient History: No). Concomitant medications were not reported. Patient did not have prior vaccinations within 4 weeks. On an unspecified date in on 2021 the patient experienced Pain in my elbow where I cannot really straighten my left arm where I got the shot. This case is made valid from invalid (Product confirm as BNT162B2, case is valid now). Additional Context: Consumer stated, I had my vaccination three days ago and I have pain in my elbow where I cannot really straighten my left arm where I got the shot and I wonder what you suggest doing about it. Will you be able to tell me what I should do to take care of it. Consumer stated, It says 06Feb.That is when my next one is scheduled. Weight: Consumer stated, I am 188. Route of administration: Consumer stated, Left arm. Other medication: Consumer stated, No, just normal things. Treatment: Consumer stated, Yes, I have taken Tylenol for pain and also a pain thing, a pain stuff that I have been rubbing in it. It is Anacort or something you need to know. Or I can go find out. Only side effect was pain and stiffness in left elbow after first vaccination. Outcome of the events was unknown.  Information on the batch number has been requested.  Follow-up(22Mar2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included the following: This case is made valid from invalid (Product confirm as BNT162B2, case is valid now). Vaccine name, vaccine 1st, 2nd doses information, vaccination dates of both doses of vaccine were added.  No follow-up attempts are needed. No further information is expected.  Follow-up (10May2021): Follow-up attempts completed. No further information expected.