chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; nasal congestion and cough; nasal congestion and cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), NASAL CONGESTION (nasal congestion and cough) and COUGH (nasal congestion and cough) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031h21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Relevant past drug history: Allergy).    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2022, the patient experienced NASAL CONGESTION (nasal congestion and cough) and COUGH (nasal congestion and cough). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), NASAL CONGESTION (nasal congestion and cough) and COUGH (nasal congestion and cough) outcome was unknown.            No concomitant medication were reported.  It was reported that 7 days after finishing treatment with Paxlovid ,Patient started having nasal congestion and a cough.He also tested positive again after having tested negative.  The device date was reported as 16-May-2022.  Company comment: This spontaneous case concerns a patient (unknown age and unknown gender) with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 5 months after mRNA-1273 vaccine, reported as third dose of the COVID  19 immunization schedules; no information about previous vaccination schedule was provided. The report stated that the patient received treatment with Paxlovid for COVID  19, and one week after finishing the treatment the patient started with nasal congestion and cough. It is also mentioned the patient tested positive after having tested negative, however, no further details regarding the type of test were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (unknown age and unknown gender) with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 5 months after mRNA-1273 vaccine, reported as third dose of the COVID  19 immunization schedules; no information about previous vaccination schedule was provided. The report stated that the patient received treatment with Paxlovid for COVID  19, and one week after finishing the treatment the patient started with nasal congestion and cough. It is also mentioned the patient tested positive after having tested negative, however, no further details regarding the type of test were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
No additional AE's reported; Improperly Stored; Administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T028308, expiration date: 20-AUG-2022; dose and route of administration were not provided). The vaccine was stored in temperature:  11.3 degrees Celsius for 15 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported. The patient was asymptomatic.  This is one of the four reports from the same reporter.; Sender's Comments:  US-009507513-2106USA005205: US-009507513-2106USA005134: US-009507513-2106USA005204:
10 h after vaccination noticed development of bad flare-up of lichen sclerosus, very painful development of lesions,  red and angry - unlike any previous flare-up, had been in remission for many months  linear confluent raised erythematous papules, right labia minora
Fever, Muscle Aches, headache started after 4 hours on Day 1 and continued on Day 2. Fully body rash and hives on Day 3 affecting left arm (not at injection site but hives/rashes mostly affected on this arm). Hives/body rash on legs, hands, torso, back, neck. Redness on face. Have NEVER experienced a rash or hives before. Completely healthy with no allergies.
Upon injection he felt a dull aching pain, had muscle soreness for 1 day. By day 2 turned into a "debilitating" pain and could not lift arm above shoulder without intense pain at injection site. Pain radiated down arm. Also reaching across body caused intense pain. Saw MD on Nov 26 diagnosed with "Impingement Syndrome" bursitis. Has nearly complete relief now following injection of cortisone into bursa.
after 4 hours of iniitial dose, had the followinig symptms on day 1...tingling lips, swollen, gums, tightening of throat, hours later, hives on face & itching  all over..took benadrly, day 2...fever of 102.9, chiils, extreme fatigue, nausea, dareahea & vomiting...took tylenol..day 3, feel better, but some stomach discomfort still and slight headache
immed p/vax in lt deltoid area became swollen (size quarter) w/drop blood;ice & pressure applied & swelling subside;disch w/quarter size area redness;
A health professional report has been received. The report concerns a 10 year old, female consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated inadvertently gave expired FLUMIST QUADRIVALENT (Preferred Term: expired drug administered) which started on 16-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
pt recv vax 29SEP96 & 30SEP96 pt exp fever & fatigue;
After 3rd vaccine, within one week, could not raise right arm higher than shoulder level or rotating movement left to right, without pain in upper shoulder joint. Pain still present.
Potential Missed Window for Vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Potential Missed Window for Vaccination) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Potential Missed Window for Vaccination). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Potential Missed Window for Vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was not given.
HPV was given due to vaccines being entered incorrectly. 07/12/16- Given left arm. 09/15/16-Given left arm. 08/08/17-Given left Deltoid.
pt recvd vax on 13oct94; initial hosp date unk; hosp transfer 20oct for streptococcal sepsis; IV atbs adm; pt stable 21oct; organism being verified by microbiology lab; serotype pending; H/O bone marrow transplant for lymphoma;
104.8 fever 24 hours after shot. Aches for about 20 hours after initial high fever. Took NyQuil and then Tylenol later.
Severe pain in the left side of his chest; Pain in calf; Had to use a cane to walk; Severe pain in the left side of hip and knee; First dose drained him; Nerve root disorder; The first dose drained him, and he made his whole right side numb; Severe pain in the left side of his temple; It feels like he had a mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke) and NERVE ROOT INJURY (Nerve root disorder) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke) (seriousness criterion medically significant). On 25-Jun-2021, the patient experienced HEADACHE (Severe pain in the left side of his temple). On 27-Jun-2021, the patient experienced HYPOAESTHESIA (The first dose drained him, and he made his whole right side numb). On 05-Jul-2021, the patient experienced NERVE ROOT INJURY (Nerve root disorder) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Severe pain in the left side of his chest), PAIN IN EXTREMITY (Pain in calf), GAIT DISTURBANCE (Had to use a cane to walk), ARTHRALGIA (Severe pain in the left side of hip and knee) and FATIGUE (First dose drained him). The patient was treated with PREDNISONE at a dose of 20 mg. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke), NERVE ROOT INJURY (Nerve root disorder), HYPOAESTHESIA (The first dose drained him, and he made his whole right side numb), CHEST PAIN (Severe pain in the left side of his chest), PAIN IN EXTREMITY (Pain in calf), GAIT DISTURBANCE (Had to use a cane to walk), ARTHRALGIA (Severe pain in the left side of hip and knee), FATIGUE (First dose drained him) and HEADACHE (Severe pain in the left side of his temple) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.
A pharmacist called in to report a drug error related to MODERNA vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of MEDICATION ERROR (A pharmacist called in to report a drug error related to MODERNA vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MEDICATION ERROR (A pharmacist called in to report a drug error related to MODERNA vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, MEDICATION ERROR (A pharmacist called in to report a drug error related to MODERNA vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MEDICATION ERROR (A pharmacist called in to report a drug error related to MODERNA vaccine).    No concomitant medication was reported.  A pharmacist called in to report a drug error related to Moderna vaccine. Verified with the caller that the vaccine was not related to any Moderna clinical trial.  No treatment information was provided.
I woke up with a sinus headache. I had slept for almost 72 hours. After the first 2 or 3 days I continued to have very mild sinus problems. I had extreme fatigue. There has been days when I'm barely able to walk across the room. I called my doctor and he told me to take Vitamin C and Zinc. I started taking 1000mg of Vitamin C and 20mg of Zinc and I have started to feel better since taking them. Nothing hurts. I don't have any pain. I just feel exhausted with mild sinus and some fatigue. It happens on and off, but I feel like I am recovering.
2 hrs after vaccines (TDaP and MENACTRA) developed rash on face, back progressed scattered on body. No resp. symptoms/cardiac or GI. Went to ER. Given BENADRYL, diagnosed with allergic reaction sent home on BENADRYL. 1/14 still with on and off hives 1/17 JCC. hives - BENADRYL daily Claritin x 2wks.
Elevated d-dimer and CRP Menstrual changes - irregular, unpredictable menses
TIA - mini stroke/transient ischemic attack. Started with loss of ability to speak/understand, weakness of left arm and leg, headache, slurring of words - 3 days in Hospital - resulted in damage to memory, confusion, weakness in left arm+leg, severe headaches - ongoing, but slightly improved after 3 weeks. Also diagnosed with acute cerebrovascular accident.
About 15 minutes after shot, I had extreme itching that lasted for about 20 minutes. I did not report it at the time since the itching stopped relatively quickly. Then various things started happening in the weeks following. Headaches, bleeding gums, nose bleeds, tingling, numbness, flank pain, centralized pain in right leg, rashes, brain fog, vision problems, hearing problems, weakness, fatigue, shaking hands, aching bones and joints, trouble walking and standing for long periods, slurred speech, stuttering. Confusion and memory problems. Depth perception problems and I have had 2 accidents while driving and that?s never happened before. One was reported to car insurance, other was not. But I definitely think my new vision problems are to blame. ER visit for flank pain, but also had many other symptoms including, numbness in legs and arms, headache, trouble speaking and brain fog.They did  a CT, fluids, steroids, pain meds and blamed flank pain and said I was dehydrated and having a panic attack and hyperventilating which I do not agree with. I do not have a history of panic attacks and/or did I feel any form of panic. Once I got the steroids is when the breathing calmed down. I went home with prescriptions for steroids. Flank pain was under control but other things kept happening. Diarrhea, fever breaks, aching bones ect. Then again a week later I admitted to ER again
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Difficulty breathing for 1/2 hour; Body numb; Extreme shaking; Nausea; Then whole body aching; Tight all over; Skin rash; Very tired in afternoons and sleep necessary at that point; Swollen around ear, neck and throat; Swollen around ear, neck and throat; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Constipation; Irregular heartbeat; Extreme acid stomach; Weakness; Vaginal bleeding (past menopause for 3 years); Ear swelling; Sharp headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Sep2021 13:00 (Batch/Lot number was not reported) at the age of 50 years as single dose for covid-19 immunisation. Medical history included known allergies: very sensitive to any medicine. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Patient had no covid prior vaccination, no covid tested post vaccination. Patient experienced sharp headache, difficulty breathing for 1/2 hour, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired in afternoons and sleep necessary at that point, swollen around ear, neck and throat, sore gums and swollen and bleeding gums, vaginal bleeding (past menopause for 3 years), constipation, irregular heartbeat, extreme acid stomach, Symptoms started about 4 hours after injection and continued all night. Nausea, weakness, acid stomach, ear swelling, heartbeat, sore gums all still continue 5 days later. Adverse event start time was on 29Sep2021 05:00 PM. Case was reported as non-serious. Treatment was received acid pills massage for tightness, pain ointm. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Woke up approximately 14 hours after receiving dose #2 with body fatigue. My large joints (e.g., hips, knees, elbows, shoulders) started to develops aches/discomfort. A hot shower helped relieve the initial discomfort, and I took 1g of APAP ~45 minutes after waking up. I then reported to work, which is an ambulatory care clinic that is working a drive-up clinic. As such, I had to work outside in ~20F weather. I had 4 layers on my upper body and 2 layers on lower body with wool socks. The cold did not bother me for the first two hours as I was able to return to a warm area between patients; however, as work became busy, I spent more time outside. The aches/discomfort in my joints progressively worsened as well as the general bodily fatigue. I took another 500mg of APAP, but it did not help much more. Eventually, the cold and body fatigue made breathing uncomfortable, and my breathing became slightly labored. Returning to the warm environment helped the symptoms not get worse, but focusing on tasks became slightly difficult. I returned home at approximately 1630, took another 1g of APAP, and proceeded to sleep from ~1730 until 0530 the next morning. I woke up feeling much better.
weak; blood pressure was 81/65 (hypotensive); pulse rate 120; fatigued; nasal congestion; chills; temperature 100.3; mild nausea; headache; felt awful; felt like passing out; This case was reported by a physician via call center representative and described the occurrence of weakness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2019, 1 days after receiving Shingrix, the patient experienced weakness, hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, headache, feels awful and felt faint. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the weakness and headache were not recovered/not resolved and the outcome of the hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, feels awful and felt faint were recovering/resolving.   It was unknown if the reporter considered the weakness, hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, headache, feels awful and felt faint to be related to Shingrix.  Additional deatils were provided as follows: The patient received Shingrix in the left deltoid. On 5th Nevember 2019 at 11:30am, the patient received vaccine and on 6th November 2019, the patient reported that felt awful and felt like passing out, weak, blood pressure was 81 and 65 (hypotensive), pulse rate 120, fatigued, chills, temperature 100.3, mild nausea, headache, nasal congestion, extremely weak. The patient had blood pressure 81 and 65, body temperature was 100.3 and pulse rate 120. The patient received Tylenol as a treatment medication. In about 6 hours after vaccination, the patient felt better with some weakness and headache. No additional information provided. The reporter consented to follow up.
Reported rash & periorbital swelling beginning 11/6/08 - Adverse reaction reported to Employee Health on 11/7/08 - referred to Nurse Practitioner at the Employee Care Center - Rx for Medrol Dose pack & Benadryl. F/U appt. with Dr. 11/10/08 Rx: Prednisone 20 mg qd X 7 days.  Reevaluated 11/17/08 & Prednisone 10 mg 6 additional tablets Rx for tapering. Referral to allergist, who thought it might be thimerosol or latex reaction.  Insert supplied and product identified as preservative and latex free.  1/5/09 Patch testing for several likely allergens conducted by Dr. Results were negative for all patch tests.
Pressure urticarial on buttocks and hands.  Also indigestion like acid reflux.
The patient experienced dizziness, light-headedness, and was nauseous. Patient stated that she was also experiencing blurred vision and abnormal hearing. She was sat down, given a cold compress, and her pulse and blood pressure were checked. The patient was also given orange juice to help raise her blood glucose.  After 20 minutes, the patient regained normal blood pressure and her nausea disappeared.  She also stated that her vision and hearing had returned to normal.
Information has been received from Sanofi Pasteur (manufacturer control # E2015-06471) on 12-JUN-2015 as a part of business agreement. Case received from an other health care professional via the Heath Authorities on 08-Jun-2015 under the reference number DK-DKMA-ADR 22988484 and DK-DKMA-EFO012034. Case is medically confirmed. Primary source was a physician. A 14-year-old female patient (weight 60 kg, height 167 cm), with no medical history reported, had received three injections of GARDASIL (batch number not reported) via intramuscular route into not reported site of administration on 22-Sep -2011 (D1), on 03-Nov-2011 (D2) and on 15-Mar-2012 (D3). on 09-Nov-2014, the patient developed visual disturbance, tiredness, headache, nauseas, dizziness, yellow eyes, red eyes, cramps in throat, legs, feet and arms, concentration impaired, severe pain in lower abdomen. In Feb-2015, the patient got stuck with thoughts, action activities. On an unspecified date, the patient developed increased liver enzymes. The patient was treated with morphine ibumetin, paracetamol, physiotherapist, psychologist and cranio sacral therapy. The following test and examinations had been performed: MRI cerebrum, lumbar puncture and blood test. The blood test showed increased liver function. At the time of reporting the outcome for increased liver function was unknown and the patient had not recovered from all the other events.
Patient was advised that she did not meet criteria for HD flu vaccine. She refused the regular flu shot. She stated that she was immunocompromised and had been told to get the HD flu vaccine by a provider. She advised that she would only take the . No adverse event to report other than HD flu vaccine was given to a person age 64 years and 8 months
Fever, aches, erythema, and swelling at injection site. Patient reported to ER getting vaccine at 11am eating seafood seafood that night (known shellfish allergy) and then having injection site redness, swelling and felling achy. Oral temp of 100 degrees noted on ER report.
Moderna COVID-19 Vaccine EUA  hives on both legs developed about a week after the shot. Not too bad but annoying and itchy. Taking Benadryl to see if that will calm it down.