chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender whose medical history and concurrent conditions were not reported. Since 22-JAN-2015 the patients had been vaccinated with doses of (Oka/Merck) VARIVAX, which were exposed to temperatures outside of the recommended range (dose, route of administration and lot # were not reported). No adverse effects had been observed or reported. Additional information has been requested.
Chills, fever smashing headache, loss of appetite, body and muscular aches. Continuous for 4 +days
pt was given an expired vaccine due tolocal vaccine coordinator having incorrect manufactures expiration date listed on site
patient has been diagnosed with COVID as of 8/24/21- Cough, body aches, nasal congestion
The patient states she had pain and burning at the site of injection, with a lump and redness over the next two weeks. The pain radiated down the wrist and up to the shoulder. The patient was given Naproxen by his PCP.
He was once able to eat some of his favorite fruits but now he is allergic to them; itching; burning in tongue and throat; burning in tongue and throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: Mar2021, for COVID-19 immunization. The following information was reported: FOOD ALLERGY (non-serious), outcome "unknown", described as "He was once able to eat some of his favorite fruits but now he is allergic to them"; PRURITUS (non-serious), outcome "unknown", described as "itching"; TONGUE DISCOMFORT (non-serious), THROAT IRRITATION (non-serious), outcome "unknown" and all described as "burning in tongue and throat".  Additional information: It was reported that patient explained that he had an adverse event to the vaccine. He was once able to eat some of his favorite fruits but now he was allergic to them. Patient had reaction to Apple, Cherry, Jackfruit, birch pollen group fruits.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AE..; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported   On 07-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, administered orally, for prophylaxis (vaccination scheme, frequency, and anatomical site of injection were not reported) (lot number 1879870 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 16-OCT-2023). The administered dose of the vaccine was stored at a temperature of 34.5 degrees Fahrenheit (F), during a time frame of 1 hour and 7 minutes, as recorded by a digital data logger. There was a previous temperature excursion reported as: 66.7 degrees Fahrenheit (F), during a time frame of 13 hours and 52 minutes. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005917:MSD
Patient should have received a bivalent covid vaccine, but was instead given an original dose covid vaccine.  No harm reported by patient.
Received Influenza vaccine on 10/5/04.  Noted that the next day had swollen area at injection site.  Injection site is red and warm with induration measuring 58mm transverse and 40mm vertically.  States it was throbbing.
pt recvd vax on 4FEB93 & pt exp shaking of body 1 hr p/vax, followed by fever 101, lethargy lasting the entire afternoon & vomiting (4-5 episodes); required ER/MD visit; pt recovered;
The products were exposed to highest temperature of 54.9 degrees Fahrenheit (12.72 degrees Celsius) and lowest temperature of 40.5 degrees Fahrenheit (4.72 degrees Celsius) with no AE; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves unknown gender patient for whom it was reported the products were exposed to highest temperature of 54.9 degrees Fahrenheit (12.72 degrees Celsius) and lowest temperature of 40.5 degrees Fahrenheit (4.72 degrees Celsius) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], HIB (PRP/T) VACCINE [ActHIB], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Product storage error).  The patient medical history, medical treatment(s), vaccination(s),concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot U7328AA, expiry date: 30-Jun-2022] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ496AAA, expiry date:09-Jul-2022] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot UJ426AAA and expiry date:07-Mar-20222] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6828AB, expiry date: 09-Jan-2022] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5765BA and expiry date: 28-Aug-2022] via an unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to product storage error [Latency: on the same day].   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
About a week 4-6 days later client developed a rash with raised pimple like papules and spontaneous bruises under arms with extreme itchiness.
Post vax, pt stood up and watched sister receive IZ. While watching, pt verbalized to mother that she felt dizzy and fell immediately back and hit head on floor. Syncope. Feet elevated and head lowered after pt passed out and then awoke. Pt verbalized head and neck discomfort. EMS was called.
rash, hives, red all over, itching, tongue & lips were numb & burning from the itching, feeling of being hot, metallic taste in mouth;tx w/med;
pt recvd 2nd dose of  vax & rash broke out an both lower extremities; approx 5 mins later face broke out w/petechia; mom took pt to MD on way there approx 25 mins p/inject put back in car set & pt stiff; 19FEB93 rash & petechiat fading;
Complaint of body aches and headache, on 8/24/2012 complaint of severe headache, 8/25/2012 complaint of severe headache and slight fever.
I woke up very cold, but didn't have chills. Felt fatigues for approx. 12 hours. May have had a slight fever, but didn't have a thermometer to take measure.
pt recv vax & exp fever;pt was adm to the hosp & was found to have elevated liver enzymes;pt is reported to be improving;
Tested positive for COVID on December 23, 2022. Due to holiday schedule, had to go to ER for Paxlovid medication.
Swollen 3rd toe joints.   Activation of previous injury sites.  Back and neck pain 9/10   Bunionettes both feet , foot pain ( 6 months later )
Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL. Subsequently the patient experienced abdominal pain. Lab work showed elevated liver enzyme. The patient was sent to gastroenterologist. Subsequently, the patient recovered from abdominal pain and elevated liver enzyme. Liver enzyme have returned to within normal limits. Additional information has been requested.
2/18/12 Had swollen, red legs below knee with bumpy rash. Went to ER 2/20/12. Given diphenhydramine 12.5mg/5ml - 1/2 tsp q 4-6h.
Rapid heart rate for several hours (about 10).  Bad headache which is now a sinus headache on the right side.
This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient had been healthy prior to getting the vaccination. A day after vaccination, the patient got sick. The reporter wondered if it helped or caused illness.
Patient had eye itching and shortness of breath. Was seen in urgent care. Had vaccine on 3/28/17 presented to urgent care 4/1/17. Plan take BENADRYL.
Spider web feeling around his ears and head; Head feels like a sunburn; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY DISTURBANCE (Spider web feeling around his ears and head) and BURNING SENSATION (Head feels like a sunburn) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced SENSORY DISTURBANCE (Spider web feeling around his ears and head) and BURNING SENSATION (Head feels like a sunburn). At the time of the report, SENSORY DISTURBANCE (Spider web feeling around his ears and head) and BURNING SENSATION (Head feels like a sunburn) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-026627 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Reporter contact information updated
Heart palpitations, Head ache, Muscle spasms, tachycardia (170), high blood pressure
Patient presented to pharmacy on 10/11 with a chief complaint of pain and swelling at injection site. There is a very large bruise on the left deltoid that encompasses the injection site. Patient was referred to PCP for further treatment.
Fever 100.7 F that started 9/22 with associated muscle aches, decrease appetite, stomache pain, nausea, HA, and fatigue. Home Management included Ibuprofen.  Also indicated was a lump at the injection site of the left arm.
Interpreter used Mother stated as follows: "Vaccine given in am. At 230pm was running a fever (temperature not actually eval) felt hot, was quiet and sad, sleepy. At 1030pm was feverish, Motrin, 1 dropper was administered 15 minutes later had seizure "shaking, eyes rolling back lasted 10-15 minutes. Took child to hospital ER. Was told child had infection in nose. Child was given IV fluids. Prescribed medication 1 tsp BID for 14 days.
Red , minimally raised, across widest part of upper arm,hot to the touch,sore, slight bruise.
Her right arm swelled up for about 2 wks. It was extremely red and hard then became bruised. And was hot to the touch. Would not move it.
Moderna vaccine given to patient that is 17 years of age not 18.  Mother was "glad of vaccination with moderna" preferred it over Pfizer. No  alleged harm, doctor notified.
Fever to 102.7F, 1 hour post vax. Rash started 6 to 8 hours later to arms and legs, blanching urticarial-type subcutaneous. CNS intact.
Hives on right arm, right leg and abdomen. 2 days after vaccine given, given BENADRYL by mother, hives confirmed by their specialist. Not seen by DR at this time. Mother enc to watch for more adverse reactions and etc if needed.
itching; small plum red; This is a spontaneous report from a contactable consumer (Patient) in response to Non-HCP letter sent in cross reference case. A 51-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, in Arm Left on an unspecified date (at the age of 51-years-old) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itching and small plum red. It was reported that, patient took second vaccine he was ok so far (5 days already) only his arm left vaccine area have a small plum red and itching. Patient visited to emergency room for covid test (no results provided (as reported)). Reporting issues (side effects, complaints, etc.) with a Pfizer product. Reported issue occur after use of a Pfizer product. Outcome of the events was unknown.  Information about batch/lot number has been requested.  Follow-up attempts completed. No further information expected.
Redness, swelling, mild warmth, mild induration of left upper arm to elbow. Pt treated with 10 day course of Augmentin.
CONTRACTED COVID 19; Psoriasis flare-up; HUMIRA PEN CAUSED PAIN; SORE ARM with HUMIRA (ADALIMUMAB); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (CONTRACTED COVID 19), PSORIASIS (Psoriasis flare-up), VACCINATION SITE PAIN (HUMIRA PEN CAUSED PAIN) and PAIN IN EXTREMITY (SORE ARM with HUMIRA (ADALIMUMAB)) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) unknown. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to unknown. On an unknown date, the patient experienced COVID-19 (CONTRACTED COVID 19), PSORIASIS (Psoriasis flare-up), VACCINATION SITE PAIN (HUMIRA PEN CAUSED PAIN) and PAIN IN EXTREMITY (SORE ARM with HUMIRA (ADALIMUMAB)). At the time of the report, COVID-19 (CONTRACTED COVID 19), VACCINATION SITE PAIN (HUMIRA PEN CAUSED PAIN) and PAIN IN EXTREMITY (SORE ARM with HUMIRA (ADALIMUMAB)) had resolved and PSORIASIS (Psoriasis flare-up) outcome was unknown.            No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of PSORIASIS FLARE UP, HUMIRA PEN CAUSED PAIN, CONTRACTED COVID 19 and SORE ARM was not provided. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt was given the Monovalent pfizer vaccine instead of the BiValent. called patient to inform them
During administration of the vaccine I was noticed the needle hit my bone.  Vaccine was still administered.  Approximately, three to five minutes after vaccine was administered I became lightheaded, very nauseous, and very pale.  I had to sit down immediately.  I had temporarily had blurry vision, became extremely feverish, sweaty, I was unable to hold up my head and had to rest it on a table. About 30 minutes after onset of symptoms they began to lessen. Shortly, after that I was able to walk of the store with help. The rest of the day I was very lethargic and felt out of it as I couldn't think clearly.
Myalgias, fatigue, headache, weakness, nausea, chills, decreased appetite and easy bruising.
Administered Pfizer Covid vaccination outside of beyond use date and time. Removed from dry ice 04/16/2021 12:30pm. Dose given 04/23/2021 before 11:00 am.
10/08/21 approx 5:00 pm chills, uncontrollable shivering, headache, malaise 10/09/21 continued same with fatigue and body aches, severe left frontal headache  10/10/21 fatigue, body aches, malaise, severe left frontal headache 10/11/21 still fatigue, body ache and severe left frontal headache - called physician who recommended 600-800 mg of ibuprofen with food three times a day as needed and made physician order to stay home from work until 10/14. 10/12-13/21 fatigue and severe headaches continue, called physician again morning of 10/13 who prescribed Flexeril and Rizatriptan for the headache.  10/14/21  Back to work still taking Flexeril and Rizatriptan for headaches.  10/15/21 same 10/16/21 starting to feel better but still getting severe left frontal headache in evening. Still taking Rizatriptan to relieve symptoms.  10/17/21 same but headache less severe 10/18 to 10/22/21 all symptoms relieved except mild headaches occasionally, especially in evening and night. Only taking acetaminophen or ibuprofen as needed.
fever of 101 noted on evening of 25SEp & 26SEP;OK during day;by evening of 26SEP visibly ill (flu sx) of fever, h/a, aches & pains;27SEP still w/fever of 103 & ha/;28EP had rash & h/a;went to MD no dx & said could be r/t to MMR:small spots
flu like symptoms; pain all over the body; aches; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (pain all over the body), PAIN (aches), PYREXIA (fever) and FATIGUE (fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Janssen (Similar side effects as Moderna COVID-19 vaccine and First Booster dose) in December 2021. Past adverse reactions to the above products included Flu-like symptoms with Janssen.   On 21-Apr-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (pain all over the body), PAIN (aches), PYREXIA (fever) and FATIGUE (fatigue). On 02-Aug-2022, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (pain all over the body), PAIN (aches), PYREXIA (fever) and FATIGUE (fatigue) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had stated that he will be 56 in 2 weeks.  Concomitant medications details were not reported by the reporter.  Reportedly, patient received dose 5 of Bivalent Booster (Moderna COVID-19 Bivalent) on 06-Dec-2022 (Lot number and Expiration Date was unknown). Patient was asking that should he expect the same symptoms with the Bivalent Booster. Patient did not have his vaccination card handy. Patient had symptoms lasted for 2-4 days.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-685156 (Patient Link).
Low grade temp (<105 degrees F), erythropoiesis became papules all over next day.
Swollen arm, could not lift arm, fever in arm, chills, and aches headache terrible fatigue and malaise. Arm still swollen 3 days later and still feel awful.