chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Registered Nurse (R.N) concerning a 16 year old female patient with "peanuts" allergy and no pertinent medical history who on 15-JUL-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # 661766/0652X), intramuscularly. On 14-OCT-2009, the patient received the second 0.5 mL dose of GARDASIL (Lot # 657006/0188U), intramuscularly and on 23-MAR-2010, the patient was vaccinated with the third 0.5 mL dose of GARDASIL (Lot # 662299/1099Y), intramuscularly. There was no concomitant medication. It was reported that the patient developed non raised, non itching rash approximately 2 weeks after receiving each of GARDASIL doses, approximately on 30-JUL-2009, 29-OCT-2009 and 12-APR-2010. There were no laboratory diagnostic tests performed. The patient sought unspecified medical attention. It was reported that the patient recovered from the previous 2 incidences of rash but was still recovering form the rash that appeared 11 days ago. The rash appeared on her feet and hands. Follow-up information has been received from a registered nurse, concerning the 13 (previously reported as 16) year old female patient with sinus allergies and rash at time of vaccination, who received intramuscularly in the left deltoid the first and second doses of GARDASIL and in the right deltoid the third dose of GARDASIL. The nurse reported that on about August 2009, after receiving first dose of GARDASIL, the patient had mild rash on lower legs. No treatment and rash went away. After second inoculation, "approximately 4 weeks" after, on approximately 11-NOV-2009, the patient developed a slightly more severe rash in the same area. No treatment was required and rash went away. After third dose, the patient developed swollen lips and a more severe rash, 11 days after vaccination, on 03-APR-2010. The physician treated the patient with BENADRYL and steroids (unspecified). The nurse reported that the experiences required emergency room/doctor visit. No diagnostic tests were done at that time. The nurse reported that the rash was still present at the time of reporting. The nurse also reported the patient's outcome as recovered. No further information is available.
Headache, Fever, Rhinitis,fatigue,chills injection site soreness and swelling Narrative:
Immediately after getting the vaccine my arm swelled, red and a bump developed which was itchy. The provider kept me for 30 minutes. My arm hurt for over a week.
Approximately 30 - 40 minutes post vax pt developed wheals, neck pain with no problems breathing. No problems talking; no lip/oral swelling; no striation; no wheezing; pt treated with Benadryl.
Headache, extreme pain in joints and injection site. Pain lessened by day 2 with the use of ibuprofen.
Information has been received from a healthcare worker concerning a patient who on 05-FEB-2008 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 659207/1472U) instead of zoster vaccine live (Oka/Merck). This was not a case of product confusion. No product quality complaint was involved. Additional information has been requested.
A 41-year-old female patient received a tetanus booster and she experienced body aches in her joints starting that night and for 24 hours after the injection. No rash or fever occurred and she recovered completely.
Extreme nausea and vomiting. Cold sweats, chills, and severe arm pain. Unsure if fever due to broken thermometer.  Symptoms lasted approximately 24 hours.  She began to feel a bit better the day after the injection
Chills and 101 degree fever beginning 10 hours after injection. Treated with Advil. Gone after about 24 hours from start of symptoms. Vomiting 16 hours after injection. One instance, no further nausea Soreness in injected arm, beginning 4 hours after injection. Treated with Advil. Gone after about 48 hours from start of symptoms.
Pt received her first dose of the Moderna Covid19 vaccine. When her 15 minute observation period was over she stood up and began to feel nauseous and lightheaded. Pt was laid down and EMS evaluated pt. BP: 128/86, 110/84, 115/86. HR 75, oxygen saturation 99%. Pt reported feeling like the room was spinning. Pt laid down for over 30 minutes. Reported feeling well enough to go back to work. Pt was encouraged to go to the hospital for evaluation however she signed a refusal with  EMS. Pt was advised to contact her doctor. Pt was driven back to School by Police Officer.
a bad cold; cough; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A male patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was scheduled this afternoon for his 2nd dose but had a bad cold and cough. The reporter wants to know if it was ok to receive the 2nd dose. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient received  COVID- 19 (Moderna) Vaccine on 2/20. She reported for a follow up appointment with her PCP 2/22 and reported redness and swelling at the injection site. Patient's PCP diagnosed her with cellulitis and prescribed 10 days worth of Keflex for treatment.
About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both arms, hands and right legs. I first noticed my symptoms as I had been walking for about 2 miles and I felt my right leg becoming weak all of a sudden and I felt dizzy, dizzy as in feeling like collapsing. I did not collapse but felt o the verge of it all the way back to my house. I had to concentrate real hard to walk back to my neighborhood without passing out. It happens on two other walks. I have now stopped all walks since week 3 of my vaccine. Into my second dosis and it is worse. Other symptoms include feeling lethargic as if I had a serious disease tired after just washing a plate kind of fatigue. I can feel my heart beat very strongly in my right breast, in my throat or in  the back of torso by the end of the day. My arms are always numb but with different intensity, especially if I walk around a bit, with my arms facing down. I am feeling extremely dizzy as unstable and having to concentrate to walk very straight if I am out side. My legs feel like they are not reliable (never have had that feeling at my age). It is more than feeling like a zombie, it is feeling too weak to do anything and my head is sometimes spinning. The numbness can be painful as a sudden thrust in an arm ( this does not last more than a few seconds).  It has now been going on since week 3 of my first dosis and today is day 7 of my second dosis! I had 0 symptoms on the first 2 weeks of my vaccine, dosis one. Now, I don't see any progress, rather a slight worsening of all the symptoms above. It is freakish not knowing what I have, of course. One can imagine, so stress adds to the mix sometimes during the day. I would not dare to even go walk my dogs now. A short grocery store visit at the most.
After vaccine patient was sitting down but he did not feel good, he got up to say he is not feeling well on counter he passed out customer next him caught him from falling who was off duty police officer he lay him down on floor and comforted him
10/22/2021 Client woke up at 3am with throbbing pain to left deltoid. Denies any redness or swelling just pain on 10/27/2021. Client went to see Dr. So client is now waiting for an MRI to be scheduled. Client's primary doctor did not give him any pain meds. Client states " I just rub it down with alcohol but that don't help any." Client has a sling to (L) upper extremity.
Shingles; This is a spontaneous report from a contactable Nurse. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) via an unspecified route of administration as dose number unknown, single on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The Nurse reported that the patient had shingles after the vaccine on an unspecified date. The reporter assessed the event as non-serious. Outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101084524 Same reporter/drug/AE, different patient
At 3:00 PM client fellt stiffness and pain in the back of her neck.  Went up the back of head and had severe pain (headache) and frontal sinus cavities, upper teeth and pressure in her ears.  At 3:30 pm she took 650 mg of aspirin without relief.  One hour later had nausea.  She layed in bed at around 8 PM she started feeling better.  No reddness, itching, or rash at injection site.  No problems breathing.  States she had had twelve prior flu vaccines with no reactions.
local reaction, redness, swelling and warmth, patient was evaluated at 6 days post vaccination and still  had redness, swelling and warmth at vaccination site
Scattered red raised itching welts periorbital, both eyes, raised red itching pustules back of both hands. Began 3 days after vaccine, presented to clinic 7 days after vaccine.
Feel sick after they got the 2nd dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1), administration date: 03Mar2021, for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "Feel sick after they got the 2nd dose of the vaccine".  Additional information: The report was received from a Pfizer sponsored program.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12 hours after Pfizer booster shot I experienced rapid heart rate for several hours as well as the next day and I feel I am still experiencing increased heart rate intermittently. Also, feel an increased heart rate with minimal activity. I called doctors office a couple days after third Covid vaccine and was told as long as my heart rate as under 100 no further action needed.
11 days after the injection, I noticed a small patch of itchy red bumps on my side, above my hip on the left side of my body.  Over the course of the next 2 weeks, the itchy bumps developed into small vesicles which burst and began to scab over, eventually healing but leaving a small reddish purple discoloration on my skin.  I had a doctor diagnosed case of shingles approximately 24 years ago with nearly identical symptoms and sensations.  I personally believe that rash was  a recurrence of shingles.
Severe Diarrhea with abdominal cramping ongoing from 4:45 am - 10:05am.  Treated with Lopermide.
localize reaction; itching; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (localize reaction) and PRURITUS (itching) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE REACTION (localize reaction) and PRURITUS (itching). At the time of the report, VACCINATION SITE REACTION (localize reaction) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
itchiness all over my skin; red spots all over my skin and it itches; spongiotic dermatitis; a full rash all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset Mar2022, outcome "unknown", described as "a full rash all over my body"; ECZEMA (non-serious) with onset Mar2022, outcome "unknown", described as "spongiotic dermatitis"; PRURITUS (non-serious), outcome "unknown", described as "itchiness all over my skin"; RASH MACULAR (non-serious), outcome "unknown", described as "red spots all over my skin and it itches". Therapeutic measures were taken as a result of eczema, pruritus, rash, rash macular.  Additional information: Patient took the Pfizer booster shot in early Dec2021 and then started to experience itchiness all over skin, especially when they would do any exercise. In Mar, got a massage and developed a full rash all over body. The dermatologist confirmed it as spongiotic dermatitis, the patient was treated with topical corticosteroids for eczema, pruritus, rash, rash macular. The reporter informed that but the spots move from one place to another and inquired that have you heard of such a side effect of the vaccine and what is the treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
MMR 7 days ago(date uncertain- +1 or -1 day) Onset of fever this afternoon->Seen by MD 1630-> given APAP for T 104 @ 1700->seizure @ 1730(appr 1 min)generalized:T=104.3 @ 1830 INED dec /w APAP.
Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. From 08-AUG-2017 to 22-AUG-2017, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # N002202 with expiration date 04-NOV-2019; dose and route were unknown, for prophylaxis) which were exposed to temperature excursion of 9 to 25 degrees Celsius for 1 hours 34 minutes. There were no previous temperature excursions. Data logger was involved. No adverse reactions were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010242: US-009507513-1708USA010404: US-009507513-1708USA010408: US-009507513-1708USA010406: US-009507513-1708USA010407:
I received my vaccine when I was in my second trimester 18 weeks and then at 22 weeks. Uncomplicated Ivf pregnancy because of my pcos. No other medical history other than hypothyroid. Pregnancy was moving right along as normal. In late April I experienced black out of my right eye which I went to see an ophthalmologist who after doing multiple tests concluded I had a TIA.   I thought I maybe vaccine related as a friend of mine also had a TIA months after her second dose.
Patient was nauseas  but did not vomit. Had the patient lay down  and took the patients blood pressure first reading was BP 98/65, second reading was 94/62 with pulse rates of 80 and 67 respectively. Patient started to feel better after 30 minutes
SICK/FELT LIKE DYING AFTER COVID BOOSTER; FEVER AFTER COVID BOOSTER; THROWING UP AFTER COVID BOOSTER; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (SICK/FELT LIKE DYING AFTER COVID BOOSTER), PYREXIA (FEVER AFTER COVID BOOSTER) and VOMITING (THROWING UP AFTER COVID BOOSTER) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for an unknown indication and COVID-19 VACCINE for COVID-19 vaccination.    No Medical History information was reported.   In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of COVID-19 VACCINE (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In January 2022, the patient experienced MALAISE (SICK/FELT LIKE DYING AFTER COVID BOOSTER), PYREXIA (FEVER AFTER COVID BOOSTER) and VOMITING (THROWING UP AFTER COVID BOOSTER). At the time of the report, MALAISE (SICK/FELT LIKE DYING AFTER COVID BOOSTER) had not resolved and PYREXIA (FEVER AFTER COVID BOOSTER) and VOMITING (THROWING UP AFTER COVID BOOSTER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Treatment information was not provided. 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.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Medical examination determined he died of natural causes. Patient had a below knee amputation due to peripheral vascular disease. In February 2021 leading up until his death on 3/10/21 he was noted to have poor appetite and significant weight loss. Nothing else in the chart indicative of a potential cause of death.
PFIZER   PATIENT HAD SENSATION OF AIR WAY CLOSING OFF, REPORTED TO ED AND WAS GIVEN BENADRYL /DECADRON  AND FELT BETTER IN A FEW HOURS
Severe pain and reduced mobility of left arm (where injection was given). MRI on November 11 showed full-thickness tear of rotator cuff tendon. No other event on or around vaccination date could explain the tear.
10x8cm area of redness/swelling/warmth.  Tx: amoxicillin 875-125mg.
Palpitations started around 1-28-21, right sided temple pain and numbness started around March 2021, pain in ankles and legs started around May 2021.
Hives on face and arm, approx. 18 hrs /p receiving adult DT
Spouse reports high fevers, aches, severe fatigue, sweats, chills. Today fevers: 6am: 101F; 7am: 102.8F; 1:30pm: 104.7F temp max Have been taking 800-1000mg of Tylenol and alternating with Advil 600-800mg with fevers still spiking. Pt had COVID back in January of 2021, was hospitalized, treated with monoclonal antibodies, regeneron and had a very slow recovery. Also on immunosupressive Tx-rituxamab, last dose in 10/2020.
Swollen arm at injection site; swollen hands, fingers, and feet; headache (forehead); painful joint inflammation in fingers, shoulders, knees.
I was completely healthy at the time of taking the vaccine. However, about 6 hours after taking the vaccine, I have been experiencing severe chills, very high fever, headache, and a lot of weakness. It?s been 4.5 days and the same symptoms have not gone. I just don?t know what to do. I have been to the ER as I was about to faint and was having severe bone crunching chills and then to a medical facility.  I have been constantly taking pain medication
pt recvd vax;GBS w/ siadh & encephalitis;1 wk ago began tingling sensations in hands;later c/o discomfort w/ achiness,malaise & weakness;very restless that noc;to er;was observed to have some shaking on arm poss rt leg;felt sz;sodium low;
General malaise, weak. Pain at injection (PNEUMOVAX) site after 2 days. Sick to stomach.
Client given dose #2 GARDASIL, left treatment room, returned within 5 min. Stated began to feel nauseous, headache, dizzy almost immediately after left room. RTC BP 110/60, P 80 regular; c/o eye sensitivity to light, feeling of fatigue and headache while here. No apparent breathing difficulty. Seen by PCP-advised not to have dose #3 GARDASIL.
The day after 4th dose vaccination, I started feeling lightheaded and had emesis/heaving. The next morning, I was fine. Three days after vaccination, I was getting ready for bed and started getting dizzy with emesis/heaving again. I was feeling better by the next morning. A week after vaccination, I went to my PCP doctor and he thought I might have had a viral infection of the ear since ringing in my ear started before 4th dose vaccine. I was also prescribed medication for vertigo. I was referred to the ENT doctor on 5-17-2022 and she prescribed steroid shots into my right ear then prescribed Prednisone 3 tabs daily x10 days. I go for more shots into my ear next week.
arm was itchy; injection site was a red big circle the size of a softball; had the "Covid arm"; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (had the "Covid arm"), PRURITUS (arm was itchy) and INJECTION SITE ERYTHEMA (injection site was a red big circle the size of a softball) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Bee sting hypersensitivity. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PRURITUS (arm was itchy) and INJECTION SITE ERYTHEMA (injection site was a red big circle the size of a softball). On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (had the "Covid arm"). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (had the "Covid arm"), PRURITUS (arm was itchy) and INJECTION SITE ERYTHEMA (injection site was a red big circle the size of a softball) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment history was not reported.   This case was linked to MOD-2021-117516 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Patient demographic details, Past medical history, 2nd dose information, Concomitant medication details, Outcome of the event updated. On 25-Jun-2021: Follow-up received on 25-Jun-2021 and does not contain any new information