chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient started breaking out with terrible hives on her arms, feet, upper body and crotch/The hives move to different parts of her body/; The hives are also red and itchy; The hives are also red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Patient started breaking out with terrible hives on her arms, feet, upper body and crotch/The hives move to different parts of her body/), PRURITUS (The hives are also red and itchy) and ERYTHEMA (The hives are also red and itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Nov-2021, the patient experienced URTICARIA (Patient started breaking out with terrible hives on her arms, feet, upper body and crotch/The hives move to different parts of her body/) and PRURITUS (The hives are also red and itchy). On an unknown date, the patient experienced ERYTHEMA (The hives are also red and itchy). At the time of the report, URTICARIA (Patient started breaking out with terrible hives on her arms, feet, upper body and crotch/The hives move to different parts of her body/), PRURITUS (The hives are also red and itchy) and ERYTHEMA (The hives are also red and itchy) outcome was unknown.            No Concomitants and Treatment medication were reported
Large erythematous raised warm lesion medial aspect of R UE - but lateral to site of injection.  +pruritus, no VZV lesion, more consistent with insect bite - responded to antihistamine.
pt recv vax 1030AM 30DEC96 & mom called 3PM reported pt was crying non-stop p/APAP;redness & swelling @ site reported by mom;MD had mom bring pt in to be evaluated;
12/02/2020 Chills/shivers -- worse in the night to morning, headache--more intense in morning day after with chills,  12/04/2020 chills subsided, headache less intense and time stronger than before. Headache still persistent. Tylenol dose taken and cold/flu (pharmacy brand) no complete relief.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On 02-MAY-2016, the patient was subcutaneously vaccinated with a 0.5 ml expired dose of M-M-R II (which had a lot # of K000738 and expiration date of 16-JAN-2016; however dosage number, therapy type and anatomical location were not reported). No concomitant medications were reported. Despite getting vaccinated with an expired dose, no adverse effects were reported. Additionally, no product quality complaint was involved. Additional information has been requested
My son tested positive; I took a home COVID-19 test but it came back negative. The next I woke up with a runny nose and headache. I waited 12 hours to take this home COVID-19 test and this one came back positive. I had a telehealth visit with my PCP and got a prescription for Paxlovid. My case was not that bad it was very mild, so I did not have to take the Paxlovid. I feel that I am 95 to 99 percent recovered.
pt recvd vax 31OCT94 1030AM & 1PM devel cold, clammy skin w/t97.2 ax; 2PM t103.3 R; 250PM T102.6R; Epi given-to ER dx febrile illness-poss viral synd, hypernatremia/chloremia, d/c ed on 1NOV; died 9NOV94;
Two days after I had a red hard raised hot lump. Treated with ice and Advil. Fully went away. Last night one week one day post I have a raised red itchy rash
36 y/o with afibrinogenemia who received first dose of Pfizer COVID vaccine on 11/12/2021 and was taking oral contraceptives at that time went on to be hospitalized on 01/04/2022  for unprovoked bilateral PE. Patient was anti-coagulated and discharged on 01/07/2022 with no further complications. Unclear if OCP with first dose of Pfizer led to hypercoagulable state.
sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) had resolved.            No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2022-445032, MOD-2022-445048 (Patient Link).
Patient given hep A #2 too early, interval too short after last dose. First dose given 5/14/18, Second dose given 10/22/18. No adverse reaction reported, just reporting med error.
shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a cold; felt hot; she couldn't sleep,; This is a spontaneous report from a contactable nurse (patient).  A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  ER8737, expiration date: 30Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left deltoid on 08Apr2021 10:30 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia. Patient stated she has had fibromyalgia for about 20 years. She said she had a fibromyalgia flare up with increased back pain, and had a Toradol 60mg intramuscular injection in her left hip on Tuesday, 06Apr2021. Concomitant medication included ketorolac tromethamine (TORADOL) for fibromyalgia from 06Apr2021. It was reported she had her first COVID-19 vaccine injection on Thursday 08Apr2021 at 10:30AM. She said that night (08Apr2021) she couldn't sleep and woke up at 3:00AM (09Apr2021) with shortness of breath, productive cough, and throat congestion. She said she had so much throat congestion, she could hardly talk. She clarified she felt like she woke up with a cold. She said she still had the productive cough, but her other symptoms went away by 8:30AM-9:00AM on 09Apr2021. She said she hadn't had a cold in 4 years. She said she read something on the internet that suggested her symptoms may be due to having the COVID-19 virus prior to getting the COVID-19 Vaccine. She said if she had the COVID-19 virus prior to getting her first COVID-19 Vaccine, she was totally asymptomatic. She said she wanted to know what she should do. Patient further reported she felt her shortness of breath was medically significant because she was mouth breathing. She clarified she felt hot during that time, and took her temperature, which was 97 degrees. She said she thought the fact she was hot was medically significant because she thought she may have a bad respiratory infection or something. The patient was not brought to the emergency room or physician's office in response to the events. The patient recovered from shortness of breath, felt hot, throat congestion on 09Apr2021; recovering from productive cough, and unknown outcome for the remaining events. The events were assessed as related with bnt162b2.
Extreme fatigue, fever and headache lasting 24 hours Day 2 painful skin surface under left breast and lt ribcage painful which lasted for 5 days. Pt stated "I felt like I had the flu 10 timesover."
Day  1 very slight swelling of arm and immediate bruising. Day  2 faint nausea and mild headache with bruising much darker.  Day 6 migraine headache and bruising starting to fade. Day 7 still had migraine headache. Axillary of same side of  body as shot became mildly  tender starting in the a.m. Day 8 still had migraine, axillary still tender, by evening arm began to swell, become bright red and itchy. Redness was located just below bruise and was 2 inches across and 3 inches down.  Later that night I began to have seizures without warning interspersed with waves of dizziness. Day9 (today) I have fatigue and dizziness.  As the day progresses the dizziness is getting better.  The fatigue  is exhausting.
Chest pain like thirty minutes ago/ chest started hurting; Mouth going completely dry i ran out of saliva; Have problem breathing; Feeling dizzy; Couldn't take like food; This is a spontaneous report from a contactable consumer (patient) reported for himself that:A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on 05Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization(Age at vaccination 36 years).  The patient medical history was not reported. The patient's concomitant medications were not reported. on 18Aug2021 After the vaccination the patient had chest pain like thirty minutes ago and he have problem breathing and started feeling dizzy wanted to faint and having children now too they are slowly going away but scary. yeah, it's all starting with his mouth going completely dry ran out of saliva then his chest started hurting and he couldn't take like food and like breath. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Per Patient she was advised has developed cellulitis from Tdap injection. Do not have any further details on what she was prescribed.
Patient was popsitive for COVID19 on 12/16/20.  Patient received Monoclonal antibody treatment at healthcare clinic on 12/17/20.  Patient received first COVID vaccine at the healthcare clinic on 01/27/21 and is now due for his second does on 02/24/21.
Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Date the vial was initially stored in the refrigerator: 31Jan2022. The vial did not undergo any temperature excursions. No treatment information provided.   This case was linked to MOD-2022-525860 (Patient Link).
Continues Twitching of right eye lower lid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 03:45 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: BLEPHAROSPASM (non-serious) with onset 02Oct2023, outcome "not recovered", described as "Continues Twitching of right eye lower lid".  Additional information: Patient had no Known allergies. Patient had no covid prior or post vaccination  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Varicella - Information has been received from aphysician concerning a male patient who on 12 Jan 1996 was vaccinated with varicella virus vaccine live On 01 Mar 2000, the patient presented with a severe case of varicella.  The physician has a concern about the lot of vaccine administered 610251/074B.  Additional information has been requested.
Patient made an appointment for a second dose for her Pfizer vaccine. The patient received the first dose on 7/21/2021, then received her second dose on 8/3/2021. Patient did not report any adverse reactions at this time.
Went to Emergency Room with very erratic heart beat. Skipped beats. Long pauses between beats. ER EKG indicated AV block 2nd degree. Was referred to local cardiologist Dr., who ordered up a 2 week heart monitor. The results showed heart block with bradycardia. Recommended pacemaker. Pacemaker was installed March 18, 2021.
pt recvd vax;devel shoulder area inflam & tendonitis next day;2 days later,worsening of sxs;tx in er w/ ibuprofen;on f/u:pt had extensive inflam of the muscles of lt arm including deltoid,trapezius;to MD 19apr c/o pain;dx as myositis;
Pt vaccinated with DTP developed high pitched unusual cry lasting 2 hrs after DTP #2.
Dizziness, unbalance. Vertigo was there occasionally the first couple days for hours or minutes, continues endlessly for now. I had a case of vertigo 8 or 9 years ago but no issues ever again with the ear or hearing or balance. After the first shot I twice thought I had a blockage or something in the ear. Tried drops, wax remover whatever you can find, nothing helped. Eventually it subsided but never gave real vertigo or long lasting balance issue. After 2nd shot was immediately an issue. Constant sweating and 99.5 fever for the 11th, 12th and 13th. 3 days straight of just sweating. Vomiting on around or just after midnight on the 13th, into the morning of the 14th. End of the 14th leading to the 15th the Veritgo has a light migraine attached. The migraine is mostly in the right eye has any migraine I've had is, comes with some light nasal pressure right at the eye socket. No issues with nasal drip or stuffy nose. Slight blurred vision which either creates the migraine or is from it. I also had migraines in the past but no more than 1 a year for the last 5 years, nothing I have medication or treatment for any longer.  This vertigo has a low grade migraine with small dot of blurred vision from one eye, my right eye. I dance with my daughter which is usually holding hands and spinning until her feet come off the ground. The first recognition that something is terribly wrong in my ear was that the moment I spin I can't rotate more than once rapidly without becoming incredibly unstably dizzy. That regardless of the vertigo, migraine or anything has been true since the 2nd shot when I spin I am at a total loss of balance.  There is constant dizziness, blurred vision, migraine
Took vaccine and immediately felt ill with body aches and weird colors around lights.   Went into Cardiac arrest 11/14/22 with no underlying health conditions and did not survive.    Was health before receiving the vaccine
Narrative:  COVID infection following COVID vaccine series completion 01/04 COVID vaccine dose #1 01/25 COVID vaccine dose #2 03/02 ED visit for headache x 3 days, treated for HTN and HA resolved 05/27 Tested for COVID due to exposure to wife who is positive for COVID, COVID test positive 06/05 Clinically resolved, no symptoms
Vaccine was given on 10/15/09. Pain and soreness began the same night and area was red and size of a baseball. On 10/16/09 began running fever of 101.9 degrees F around 5 p.m. and fever broke around 10 p.m. No fever since then, but red area on arm has gotten bigger.
A consumer report has been received. The report concerns a patient, female consumer, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced pain in back on other bones, pressure and tightness in chest, trouble breathing, pain in ribs, felt like I have fever, WBC count slightly high, weak and tired. The outcome os the event of pain in back on other bones, pressure and tightness in chest, trouble breathing, pain in ribs, felt like I have fever, WBC count slightly high, weak and tired is unknown. The report was considered to be non-serious.
Pt developed a rash on face and left arm, left thigh and left leg the following day after vaccines given.  No fever. ? allergic reaction to ibuprofen or food coloring in med vs ?viral exanthem.
Report received from a pharmacist on 12-OCT-2010 (receive via Merck WAES: 1010USA01399). A 59 year-old female patient received AFLURIA (dose 0.5cc; intramuscularly; Lot# M51908) for immunization on 11-OCT-2010 10:30. The patient had no pertinent medical history or concomitant medications. On 11-OCT-2010 10:35, five minutes after AFLURIA was administered, the patient developed itching at the site of the injection. At 11:00, the patient had inflammation including redness and itching around injection site. Within 1 hour she noted bruising, redness, swelling and the area was warm to touch. The patient notified the pharmacist of the symptoms and he evaluated the injection site on 12-OCT-2010, reporting that the symptoms were still present. On 14-OCT-2010, the patient was considered to have recovered from the events. The case was reported as non-serious. The reporter considered events possible in relation to the suspect drug, AFLURIA. The company considered events non serious and possible in relation to AFLURIA. Information derived from this AE report does not change the current safety profile of the product. Follow-up (07-Dec-2010): time of injection, time to event onset, additional adverse event (inflammation around injection site), patient outcome, date of recovery.
20SEP94 TC to mom regarding details about pt's breathing; mom reported about 915PM pt was in walker while family watching TV; one of the family members noted pt slumped over in walker, face red; mom did CPR; again pt wasn't breathing;
"COVID arm" - On or about the 8th day after the shot, right arm became swollen, warm to the touch, and red, with a diameter of about 2.5 inches.  On the 9th day after the shot, the area began to itch.  The site had been painful for the first few days after the shot,  and is still tender on this, the 10th day.
Administer Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  The vaccine was stored in the freezer.
-fever (99.2); joint & muscle aches; headache; extreme fatigue; swollen, pink arm at injection site -2 days in bed with slight fever, aches, fatigue -used 400 mg of Advil each day for 4 days -4 days after injection major side effects have subsided;  injection site still pink but not worse
No adverse effects. Vaccine was administered outside of approved age group. Father misrepresented minor's DOB on consent form to appear eligible for vaccination.
This spontaneous report as received from a nurse refers to a 68 years old male patient, who in June 2012 (also reported as December 2012), was vaccinated with a dose of 0.65 ml ZOSTAVAX (route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that in December 2012 the patient was diagnosed with shingles. It was unspecified when the adverse event began. The patient was treated with VALTREX for the adverse event. The physician saw the patient" in the last week or two" and the adverse event had resolved. The patient sought medical attention. The relatedness for the adverse event was unknown for ZOSTAVAX. Additional information has been requested.
Patient sitting in observation - blinking eyes, visible eye watering and redness - patient indicated he felt like he had eye swelling and looked at self in camera - notified staff RN
The patient experienced pain at the injection site after administration. Redness and inflammation appeared around the injection site on Saturday evening (12/15). The pain worsened and she visited the ED and was sent home and instructed to take Benadryl. She felt better on Sunday (12/16) and even better today (12/17).
received expired dose of ROTARIX; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 3T77H, expiry date 11th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 14th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 14th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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 Information: GSK Receipt Date: 19-JUL-2022. Reporter's Comments: No other symptoms reported. The reporter did not consent to follow-up. The reporter was transferred to medical information for further guidance and provided adverse event reference number to medical information agent. Additional Supportive Information: The patient received vaccine which was already expired on 11th July 2022, which led to expired vaccine used.
About 2 or so days after the first dose my right knee started to swell. It was not noticeable to me, but wearing shorts others commented on it. After the second dose the swelling in the right knee and now up into thigh was persistent and never went away. It is still happening today. I go to a lymphatic clinic for massage therapy and wear thigh high compressions everyday. I was given a lymphatic pump for lymphedema and I do manual lymphatic drainage myself at home away from the clinic everyday/night.
This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program. The consumer reported for her daughter. A female patient of an unspecified age received second single dose of TRUMENBA, on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. Previously, on an unspecified date, the patient received the first dose of meningococcal group b rlp2086. A day after vaccination, the patient experienced fever and had bruises that lasted days. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Patient got 4 shots and nearest to the Prevnar injection he had a raised scaley 2 x 3 cm rash, where a bandaid may have been.  The other areas that were covered with a bandaid did not get red.