chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cesium toxicity; This spontaneous case was reported by a pharmacist and describes the occurrence of METAL POISONING (cesium toxicity) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0448A21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced METAL POISONING (cesium toxicity) (seriousness criterion medically significant). At the time of the report, METAL POISONING (cesium toxicity) outcome was unknown.        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 concomitant medication listed.   No treatment information provided.  The patient was diagnosed to have cesium toxicity 2 weeks ago and results was unknown.  Company Comment : This case concerns a 40-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of METAL POISONING (cesium toxicity). The event occurred approximately 6 months after the second dose of mRNA-1273 (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event happened after the second dose and no additional dosing is expected. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 40-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of METAL POISONING (cesium toxicity). The event occurred approximately 6 months after the second dose of mRNA-1273 (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event happened after the second dose and no additional dosing is expected. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 vaccine) is not affected by this report.
Swollen left armpit; tender left armpit; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the arm left on 30Apr2021 at 11:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid and known allergy to yellowjackets (allergy to arthropod bite).  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 09Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 07:00, the patient experienced swollen and tender left armpit. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen and tender left armpit was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
sore arm; patient received BNT162B2/ breastfeeding a 14 month old; patient received BNT162B2/ breastfeeding a 14 month old; This is a spontaneous report from a contactable consumer (patient). This consumer reported information about mother and baby. This is the mother case. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 17Dec2020 07:30 (dose number: 1) as a single dose for COVID-19 immunization. The patient's medical history included uncomplicated vaginal delivery (14 month old has no diagnosis. Was born 41 +5. Mother and baby have no issues postpartum). The patient had no known drug allergies. Concomitant medication were not reported. The patient was not pregnant at the time of vaccination and the facility where the most recent COVID-19 vaccine was administered was a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient was breastfeeding a 14 month old. The patient was not having symptoms except for a sore arm on 19Dec2020 (12:00AM). The patient did not receive any treatment for the events. The event was assessed as non-serious. The outcome of the event was not recovered.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504610 baby case
injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2019, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's wife. The patient experienced  injection site pain and no other events after receiving vaccine. This case has been linked with case US2019GSK063670, reported by the same reporter.
I did not report my 1st dose of SHINGRIX, same pharmacy, 9 weeks ago - [10-5-18] side effect same: and CDC has reported this - severe body aches - chills and fever - 12 hours plus - MOTRIN helps. I agree with CDC current description of possible side effects for folks in age 51-59. I want you to know - it is a tough few hours - MOTRIN on a full stomach help - please advise Docs, and Pharmacies to tell patients in 51-59 group to eat and have MOTRIN handy.
Smallpox immunization given 12/5/10. Came to clinic c/o raised sores on left shoulder and going down his back. Instructed to see a provider on 12/17/10. Provider given diagnosis of "mild viral illness called vaccinia". No additional treatment given. As of 12/20, sores have decreased in number, no problems noted.
Mother accompanied child stating extreme generalized pruritis and welt type rash 7 hrs after vaccinations. Mother administered Benadryl and cortisone cream. Denies throat and lung discomfort. Site of injections not red or itchy
Patient presented with a colorless swollen lump on the inside of her elbow on the left arm.  The lump was about the size of a golf ball and firm to the touch. She claimed the spot was not painful or obstructing her movements. There were no signs of swelling or redness at actual injection site, but the lump she presented with was on the same arm that she received the vaccine in. The patient claimed this was not present prior to vaccine administration. The patient was instructed to self medicate with oral diphenhydramine along with applying ice to the swollen area to reduce swelling.
2 days post vax pt developed hives on the left cheek. Within a day of this the left cheek became a little swollen. Within one week of vax the pt developed hives to the lower body and left arm. One week post onset the vaccinee experienced severe epigastric pain and elevated blood pressure, 3 days later symptoms were persisting and her lips had become swollen. Pt developed new hives which worsened; her head had swollen down to her forehead, she had a fever of 102 and chills. The following day she was not able to open her right eye and could barely open the left eye. Follow up information states the pt experienced a pruritic rash on legs and left side of face, large erythematous macular plaque on left thigh and right popleteal and lesion on shin 4 days post vax.
As per pt, she states that the next morning she had a large welt at injection sight that itched and hives to the face.
received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/number of days that have passed were 11; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/number of days that have passed were 11) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/number of days that have passed were 11). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/number of days that have passed were 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.
Sudden onset of left wrist pain,rapidly progressing to severe with associated swelling. (acute synovitis/pseudogout) Same arm as injection
Patient called pharmacy around 4pm stating that she was experiencing itching all over her body.  Patient stated she also had itching and hives at the end of her antibiody infusion.  The infusion site gave her 2 doses of iv benadryl and the itching/hives resolved over the next few days.   I advised patient to take 50mg of diphenhydramine and go to er if swelling of face or throat occurs.  Followed up with patient on 12/16/21.  Her itching resolved overnight of the 14th and she did not develop hives but has had a severe headache since the evening of 12/14.
I had been traveling and on 11/26/22, and I started to experience stomach issues. I started running a low grade fever and felt fatigued. I attributed the fatigue to jet lag. On Monday, 11/28/2022, I did a rapid test at home and it was negative. I continued to have the stomach issues. In the next couple of days, I experienced diarrhea. I did a PCR and rapid test at home on 11/30/2022, and the rapid was negative, but the PCR was positive. I reached out to my doctor on 12/01/2022 and she prescribed PAXLOVID. I started taking it on 12/01/2022 and I just finished the medication on 12/05/2022. As of today, I feel fine.
Gave patient his dose (2nd covid shot) around 12:50pm and about a minute after going over possible adverse reactions the painted said he did not feel good. He blackout but I quickly got him to lay flat on floor. During that time (about a minute) he had some jerking and wet himself a bit. I elevated his feet and called my technician just in case needed to call 911 and perform CPR/Epi but we didn't need to go that route. He loss his consciousness and quickly regained it after about a minute. I had him continue to remain laying down for 15 mins and then after patient felt comfortable I helped him back into seat inside vaccine room to monitor patient for another 20 minutes. After monitoring he was fine and left thanking me that I stayed calm to help him.
Acute facial and neck swelling. Vomiting, hives, stridor.  12/03/09 MR received for DOS 11/18/09, 11/25/09. DX: Allergic reaction.  On 11/18/09, Pt had an allergic reaction with face and arms swelling, hives, trouble breathing and vomiting.  swelling, tx: Epipen, Benadryl.  On 11/25/09, Pt experienced fever, R ear draining, and wheezing.
Pain, Itching,  redness at injection site one week after injection  No treatment - observation
Possible attenuated VZV rash noted approx 9/12/13, papulae's on erythremia base starting on chest - R arm pit and along back of R shoulder in some what ine or/dermatomal distribution.
headache; painful arm; felt lightheaded; fatigue; neckache; fever 102.3ºF; was not hungry; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (painful arm), FATIGUE (fatigue), HEADACHE (headache), NECK PAIN (neckache) and PYREXIA (fever 102.3ºF) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FAMOTIDINE for Acid reflux (esophageal), MONTELUKAST SODIUM (SINGULAIR) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Anxiety depression, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid, LIRAGLUTIDE (VICTOZA) for Weight loss, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (ATORVASTATINE ACCORD) and TRAZODONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (fatigue), NECK PAIN (neckache), PYREXIA (fever 102.3ºF) and DECREASED APPETITE (was not hungry). On 27-Jan-2021, the patient experienced DIZZINESS (felt lightheaded). On an unknown date, the patient experienced PAIN IN EXTREMITY (painful arm) and HEADACHE (headache). On 24-Jan-2021, FATIGUE (fatigue), NECK PAIN (neckache), PYREXIA (fever 102.3ºF) and DECREASED APPETITE (was not hungry) had resolved. At the time of the report, PAIN IN EXTREMITY (painful arm), HEADACHE (headache) and DIZZINESS (felt lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
I experienced boils under my left arm filled with puss and they are very painful. I also got a blood clot in my left leg.
I had my second covid vaccine on Thursday wake up Friday at 2:00 am body ache and fever Friday and Saturday.Sunday I woke up with headache and back pain I came to work today Monday I still dont feel good I still have the headache and back pain I will call employee health this morning
On 25Oct2022 tested positive for COVID-19 via a rapid test; On 25Oct2022 tested positive for COVID-19 via a rapid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 39 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Oct2022, outcome "recovering" and all described as "On 25Oct2022 tested positive for COVID-19 via a rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre syndrome in a adult female patient who received Flu trivalent vaccine for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant), tremor of hands (serious criteria hospitalization) and paralysis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was resolved with sequelae and the outcome of the tremor of hands was not recovered/not resolved and the outcome of the paralysis was unknown. It was unknown if the reporter considered the Guillain Barre syndrome, tremor of hands and paralysis to be related to Flu trivalent vaccine. Additional details were provided as follows: This case was reported by the patient for herself. The patient developed Guillain Barre Syndrome after receiving unknown flu shot when she was 16 years old. She was paralyzed, caused her to only be able to blink her eyes. She was in the hospital for two years. She stated that she had recovered but was left with tremors in her hands. The patient had denied permission to contact their physician. The reporter was unable to provide any additional information.
Localized red papules and swelling, pain for 10 days, localized fever & chills.
Patient received varicella vaccine 07/12/2001 confirmed Chicken pox-mild case 01/18/2005.
Chest pain with elevated troponin. Patient treated with corticosteroids and IVIG.
Seriousness criteria other medically significant (OMIC). Initial report received on 8/23/06 from a health care professional. A 58 year old male pt, with a past medical history of hypertension, had received an IM, left arm injection of Adacel, lot number C2556AA, on 8/11/2006. He had no illness at the time of vaccination. Eight days post vaccination, the pt developed generalized hives. He was examined by a physician four days afterwards and was treated with a Kenalog injection, oral Atarax and prednisone. At the time of this report, the pt had not recovered.
Pt was given an MMR and Varicella on 3/13/03. At that time she stated she was not pregnant and was taking birth control pills. Pt was advised to avoid pregnancy for one month and was counseled about the risks of pregnancy after MMR and Varicella. Pt is pregnant now, date of conception approx 4/5/03.
Gave patient Moderna COVID 19 vaccine.  Shortly after patient fainted.  Paramedics were called.  Patient's vitals were normal and no head trauma due to fall.
I have been extremely dizzy since waking up the morning after receiving my first dose.  Presently it is 60 hours post-injection and the dizziness has still not subsided.  I had never been prone to dizziness before I had back surgery on 1/11/2021.  However, after having the surgery, and staying in bed too long, I began to experience bouts of dizziness.  Performing the Epley maneuver made the dizziness subside.  However, it has no effect on the bouts caused by the vaccine.
1005 - Patient passed out at check-out window. He stated that he felt like he was going to pass out so the receptionist told him to sit in the floor and came to get a nurse. He was pale and said he felt hot and weak. He was offered gatorade and crackers and while a staff member went to obtain them he passed out on the floor. CPNP assessed patient and said his heart rate was low. Ammonia pad used to awaken him. He drank the gatorade and ate a cracker., Pulse ox 99% HR 44 - jls 1005 1010 - Dr called to assess patient and while he was assessing him child awoke. He was assisted from the floor to a room and sat in a chair., Pulse ox 99% HR 45 BP 70/46 - jls 1010 Pulse ox 99% HR 53 - jls 1013 1015 - Dr still in room and patient passed out again but awoke slowly with difficulty answering questions directed at him., Pulse ox 98% HR 56 - jls 1015 1016 - Patient in and out of consciousness for an additional 5-8 minutes. Dr back to room to assess patient. Oxygen 15L via non-rebreather - jls 1020, Pulse ox 99% HR 61 BP 118/76 - jls 1020 1024 - Patient awake and groggy, Blood sugar 109, Pulse ox 100% HR 58. O2 stopped per Dr - jls 1024 1053 - Patient fully alert and talking. Texting on his phone., Pule ox 98% HR 64 BP 138/80 - jls 1053 Upon check out, patient walked to desk and went light headed sliding to the ground, no head injury, color was good but MS was slow to respond, He was moved to an exam room and pulse ox was placed. Transient bradycardia and hypotension were noted (and documented above). Patient was quite drowsy with fluctuating mental status during the observation period. There was no hypoglycemia or hypoxia. Patient was observed for and eventually mental status returned to baseline. Mom was at his side the entire time. We did apply blow-by O2 for stimulation, O2 sats remained high 90's throughout observation. He denies eating breakfast this am and did not take any meds this morning. This may represent a vagal response or vaccine reaction. I would hold gardisil for now. Mom will superhydrate him today with gatorade. He is asking to go to school as he has a biology test. Mom will call with any problems.
Adm. zoster vax on 2/4/09.  Rcvd call from pt. on 4/24/09 10:16a.  She reports the following: on 3/28, she experienced pain in scalp and jaw and blurred vision.  Went to MD on 4/1; was prescribed prednisone, blood tests normal.  On 4/6 went to dermatologist; was prescribed cortisone topical ointment for "sores" which were later found to be pre-cancerous. She is having them removed in June/July.  Dermatologist believes that she has shingles as she is very itchy.  She c/o bad headaches concentrated on Rt. side and has another appt. this noon.  The itching is "tolerable" and rash is "all over crown" to include rt. and lt sides.  Her last episode of shingles was on the Rt. side.  and she reports having had headaches last time but "not like this."  Pt. also states that she is stressed because she is having polyps removed that were found on a colonoscopy on 3/5/09.  "I am under alot of stress."  Will speak to colorectal surgeon and get back with me regarding whether she wants to have that surgery or not.  Rcvd. call from pt. States that physician told her to have the surgery and "get it over with" and that might help with her stress levels and improve her condition.  Tried calling pt. today for update; no answer, no answering machine.  Will f/u at a later date.
Redness, swelling, heat. Swelling was significant to point of restricting mobility of shoulder joint. By 2100hrs increase swelling redness and heat to entire upper arm and limit mobility to arm unable to break above parallel. Patient fine otherwise. By 9/23 pt is beginning to see reduced symptoms and was completely resolved as of 9/24/17 at 1800hrs.