chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myalgia; Sore arm; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and myalgia. On an unknown date, the outcome of the pain in arm and myalgia were recovered/resolved.   It was unknown if the reporter considered the pain in arm and myalgia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The nurse reported that the patient experienced sore arm for a week, and a day of myalgia. The reporter did not agree to follow up.
urticaria onset 3 hours after vaccine, worse today. no SOB, throat swelling or other signs. Benadryl prn, prednisone x 3 days.
Starting 3/23/22: severe headache, eye pain, dehydration, heart pounding fast, shortness of breath.  Starting April 5 2022, severe leg and foot cramps, dehydration, severe diarrhea
Fever above 106.4 after vaccines given 1/9/14. After this reaction mother informed us that child had fever of 104.2 given at previous Dr. office.
contracted Covid-19 19AUG2021; contracted Covid-19 19AUG2021; This spontaneous report from a Pfizer-sponsored program, a contactable consumer reported for himself and his wife. This is for his wife. A 9-decade-old (almost 80-year-old) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient contracted COVID-19 on 19Aug2021 with outcome of recovered in Sep2021. Patient was not hospitalized for the event.  The lot number for BNT162b2 was not provided and will be requested during follow up.
6"x4" hot red swollen circle around injection site.  Fever, headache,  and arm pain
No reaction to the vaccine but I developed Cardio Arrhythmia, I am in the process of seeing a doctor.
no adverse event; The patient received a dose of improperly stored Rotateq; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and drug reactions or allergies.  On 24-FEB-2020, the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose, lot number S014947, expiration date 10-DEC-2020 for prophylaxis (route of administration was not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion below 36°F (34F) degrees Fahrenheit for 27 minutes, as recorded by a data logger. No previous temperature excursion was reported. No further adverse effect reported.
Sore arm, headache, chills, and fatigue. Tylenol (1 gram) every 6 hours. Symptoms started approximately 6 hours after injection and lasted approximately 24 hours.
inappropriate age at vaccine administration; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration). 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.   This case was linked to MOD21-069804, MOD21-069810, MOD21-069811, MOD21-069812, MOD21-069813, US-MODERNATX, INC.-MOD-2021-067198, US-MODERNATX, INC.-MOD-2021-067250 (E2B Linked Report).; Sender's Comments:  MOD21-069804: MOD21-069810: MOD21-069811: MOD21-069812: MOD21-069813: US-MODERNATX, INC.-MOD-2021-067198:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067250:Crosslinked cases
Rash in left V1 nerve distribution began at left scalp and progressed down forehead and eyelid over five days time with subsequent regional left pre-auricular lymphadenopathy.   Rash consisted of small groups of painful blisters in lines that later crusted over.   There was associated skin sensitivity to touch.  This is currently day 5 of signs and symptoms, and I began treatment with valacyclovir because of recent new blisters.
tremor; tremors that caused her to fall to the ground and flop around like a fish; hyponatremic; kidney issues; administered the vaccine into her stomach; This case was reported by a consumer via other manufacturer and described the occurrence of tremor in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included furosemide (Lasix) for product used for unknown indication.   On 16th April 2021, the patient received Shingrix. On an unknown date, the patient started Lasix at an unknown dose and frequency. On 16th April 2021, unknown after receiving Shingrix and not applicable after starting Lasix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced tremor (serious criteria hospitalization), fall (serious criteria hospitalization), hyponatremia (serious criteria hospitalization) and renal disorder (serious criteria hospitalization). The action taken with Lasix was unknown. On an unknown date, the outcome of the tremor, fall, hyponatremia, renal disorder and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the tremor, fall, hyponatremia and renal disorder to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments:  The patient's past medical history, medical treatment, vaccination and family history were not provided. The patient experienced hospitalized 5 times, tremors, tremors that cause her to fall to the ground and flop around like a fish, hyponatremic, kidney issues and physician administered the vaccine into her stomach while being treated with Furosemide and Shingrix.  Additional Supportive Information: The patient received Shingrix vaccine into her stomach, which led to vaccine administered at inappropriate site. This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively.
cold symptoms, no fever.  My grandson visited who had a runny nose.  He is 2, but his parents tested him twice for covid before visiting.  I believe I just caught his cold.
Patient vomited after 2 minutes of giving second dose of Pfizer Covid vaccine. His parents said he vomited in the past because he was afraid of needle and vaccine. Patient was responsive and answered the questions of pharmacist such as first name, last name, date of birth correctly. His chest raised up and down normally. Patient was sitting down and monitored by pharmacist for about 1 hour before he went home. He was laughing with siblings when he was sitting down for monitoring. Patient was completely fine when he left with his family.  Pharmacist called up the parents to follow up about 5 to 6 hours after incident, and the parent said the patient was completely fine.
arm left pain; Body ache severe; Fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm left pain), PAIN (Body ache severe), FATIGUE (Fatigue) and HEADACHE (headache) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced PAIN IN EXTREMITY (arm left pain), PAIN (Body ache severe), FATIGUE (Fatigue) and HEADACHE (headache).   At the time of the report, PAIN IN EXTREMITY (arm left pain), PAIN (Body ache severe), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-064095 (Patient Link).
symptoms/tests: loss of strength, weight loss, high ck levels on blood test ~9000 diagnosis: Inflammatory myositis treatment: prednisone and azathioprine
Patient had vaccine at 3pm 1/22/21 at 5pm he had chills and fatigue, at 7pm urinary retention lasting 36 hours, almost went to ER but decided not to.
Itching in the neck that does not go away with anything, I can not sleep at all due to the itching, I can not do anything this is desperate to the degree that I do not want to live like this anymore, please who can help me soon, what do I do I wait for an answer prompt, thank you.
Pt reported slight tongue "tingling" and also has a small patch of flat erythematous area on her skin about 8 minutes after the vaccine was administered. She does report the reddened area is itchy.  She denies SOB, denies airway tightness, denies chest pain.  Her vitals at 1356 hours are a HR of 66, BP of 139/74, RR of 18, Sats 100%, RR 16.  Pt took a PO benadryl at 1347 hours per her request as she had already declined further EMS care (ALS and ambulance declined).  Her Sxs resolved by 1356 hours.  She stayed a few more minutes to be sure her symptoms were completely resolved and left POV at 1407 hours.   She will follow up with her physician as soon as she leaves.  She has been notified that her symptoms could return.
my arm was red at the injection site; Cold sore; bottom right lip is swollen; fever of 102.5°F 12 hrs later; sore at the injection site; The skin on my arm, not near the injection site, was red with little tiny red discolorations; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (The skin on my arm, not near the injection site, was red with little tiny red discolorations), ORAL HERPES (Cold sore), LIP SWELLING (bottom right lip is swollen), VACCINATION SITE ERYTHEMA (my arm was red at the injection site) and PYREXIA (fever of 102.5°F 12 hrs later) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 26-Apr-2021, the patient experienced ERYTHEMA (The skin on my arm, not near the injection site, was red with little tiny red discolorations), PYREXIA (fever of 102.5°F 12 hrs later) and VACCINATION SITE PAIN (sore at the injection site). On 29-Apr-2021, the patient experienced ORAL HERPES (Cold sore) and LIP SWELLING (bottom right lip is swollen). On 30-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (my arm was red at the injection site). At the time of the report, ERYTHEMA (The skin on my arm, not near the injection site, was red with little tiny red discolorations), ORAL HERPES (Cold sore), LIP SWELLING (bottom right lip is swollen), VACCINATION SITE ERYTHEMA (my arm was red at the injection site), PYREXIA (fever of 102.5°F 12 hrs later) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown.
Tongue numbness and metallic taste began the day of the vaccine (12-1) and continued. Woke up Sarurday (12-4) with numbness in lips, tongue, cheeks. Weakness in jaws and unable to smile, unable to blink one eye at a time. Could not spit when brushing teeth, trouble eating and drinking. Eyes watering constantly. Went to Hospital Emergency room.  12-6- 21 Symptoms are still here and worse.
Anaphylactic reaction; This is a spontaneous case from the, initially reported by a nurse to Merck National Service Center (reference number SEQ19-01885) on 07-Aug-2019, concerning a female patient of unknown age.  The patient's medical history included: Sjogren's disease. On an unspecified date in 2018 (reported as last year), the patient was administered unspecified Influenza vaccine [dose, route of administration, anatomical location, batch number, and expiry date: not reported] for an unknown indication. On an unspecified date, within 4 hours after vaccination, the patient experienced an anaphylactic reaction requiring hospitalization for an unspecified time in an unspecified hospital. On unspecified date (reported as four months ago) patient had partial hysterectomy due to unknown reasons, which required five units of blood or plasma. It was reported that Afluria could not be ruled out. Therefore, the product name was filed under miscellaneous (unspecified Influenza vaccine). The outcome of the event of anaphylactic reaction was not reported. The reporter assessed the case as serious (hospitalization and life threatening).  Company comment: The patient developed anaphylactic reaction, within 4 hours after vaccination with unspecified Influenza vaccine. Chronology is plausible. Information regarding concomitant drugs was not provided. Based on provided information, causal role of the suspect product is assessed as related.; Reporter's Comments: The patient developed anaphylactic reaction, within 4 hours after vaccination with unspecified Influenza vaccine. Chronology is plausible. Information regarding concomitant drugs was not provided. Based on provided information, causal role of the suspect product is assessed as related.
7/13/18 dizziness/vertigo, nausea, headache, achy skin, lump in throat, fatigue, hoarse voice- took BENADRYL and ibuprofen. 7/14/18 fatigue, nausea, dizziness/vertigo, lump in throat, headache, BENADRYL and ibuprofen. 7/15/18 extreme dizziness/vertigo and nausea- MD provided meclizine 12mg - no results. Took ZOFRAN later in the day and nausea went away. 7/16/18 continued dizziness and vertigo, headache- ibuprofen, Vitamin A and C, saw MD who stated neurologically she was ok and symptoms appear to be slowly improving and felt they would be gone in 24-48 hours.
approx 3yrs p/vax pt exp chickenpox. pt noted as having more than 50 lesions over entire body. some lesions were pustules & some also infected
Pt was found pale, diaphoretic and clammy,  no LOC. Assisted to recumbent position on floor with BLEs elevated on chair. VS as follows: BP 109/70, HR 60, sats 94% on RA. Pt given water, snacks, cold compress applied. Pt was assisted to seated position after 3-5 mins, VS as follows: BP 115/74, HR 70, sats 96% on RA. Pt recovered within 10 mins and ambulated out of clinic in NAD after 20 min observation period.
Received injection yesterday afternoon at 11:00 pm that night noticed a rash at injection site. The rash is hot to touch and hard.  It does not itch.
Information has been received from a RN concerning a female who was vaccinated with varicella virus vaccine live. The RN reported that in Oct 2005, the pt developed chickenpox. Unspecified medical attention was sought. At the time of this report, the outcome was unk. Additional information has been requested.
Extensive Erythema Multiforme on back associated with puritis and uncomfortable.  No respiratory distress.  Epinphrine 0.3mg IM, Benadryl 50mg IM.  Triamcinolone Acentonide inj 40mg IM,  Methylprednisolone PO 4mg (654321) on consecutive days.
I know four people who had a stroke; This is a spontaneous report from a contactable consumer or other non hcp. This Consumer reported for 2 of 4 patients that.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated know four people who had a stroke on an unspecified date. The reporter if led is an ingredient used in the Pfizer COVID-19 vaccine. She received some information through an e-mail. It said to stay away from vaccinated people because the virus starts shedding. She reported that the patient had a heart attack post vaccination. This was serious it needed to addressed by doctors. The reporter mentioned that as per the e-mail 45000 people died from the vaccines. Some of the doctors are saying breastfeeding mother's are poisoning their child. This information is available on the website and written by the best doctors. The email they received contains Pfizer's number. The reporter asked if Pfizer-BioNTech COVID-19 vaccine shed the virus. She asked if breastfeeding mothers stay near vaccinated people and if that can harm the child. Reporter told children particles are used in the vaccine. Reporter also asked if any deaths reported with the Pfizer COVID-19 vaccine and if the vaccine is safe. The current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of BNT162b2. The outcome of the event was unknown.  The lot number was not provided and will be requested during follow up.
S: The patient is a nurse who works in recovery. She had a flu vaccine in her left arm a few days ago. She had noticed that where the immunization was given there has been warmth and erythema. It has felt firm. It has been sore. She says that the firmness and soreness have decreased. It does not hurt too much moving her left arm around. She denies fever, chills, nausea, vomiting, headache, shortness of breath, or facial or throat swelling. She took ibuprofen times one. She has used some heat on her left arm. O: Midway down the lateral posterior aspect of the left upper arm, there is approximately a 4-cm-diameter area of erythema. It is slightly warm. I detect no fluctuance here. There are no gross signs of infection. It is slightly tender to palpation. She expressed slight discomfort with resisted left upper extremity examination maneuvers but has full range of motion in the left upper extremity. Her lungs are clear. Her heart examination is normal. A: Local reaction status post influenza vaccination. P: We discussed that this is not an uncommon occurrence with 'flu vaccination. The are no overt signs of infection or any signs or symptoms that she has had an allergic reaction to the vaccine. I directed her for reference to again look at the influenza vaccination information sheet provided by the CDC. (1) We discussed physical modalities to do. (2) She should try to stretch her left arm. (3) We discussed some medication she can take for the next one to two days. (4) At this juncture, she is fine with being discharged to full duty. (5) I did want her to continue to watch the area for worsening signs of pain, redness, and swelling, as well as any allergic reaction type symptoms. (5) Otherwise, I will discharge her from the clinic today. She may return P.R.N.
She hasn't had her period; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMENORRHOEA (non-serious), outcome "unknown", described as "She hasn't had her period".  Additional information: Caller was a transgender and she mentioned that she got the COVID-19 shot and she hasn't had her period. Caller wants to know if this was the cause of the Pfizer COVID-19 vaccine couple years back I was a man pfizer vaccine my period was gone. Pfizer BioNTech COVID-19 vaccine. Did not get period. Transitioned from being a man.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 5/27/03 mom phoned health department stating child was very fussy for 2 weeks after receiving vaccines (first set of vaccines). S/S started about 2-3 days after immunizations. Could somewhat console, but not completely. Slight fevers. Seemed to be a little more jerky; never had jerks prior to immunizations. Not seizures. Tylenol given for treatment.
Asymmetric morbilliform eruption; This is a literature report for the following literature source(s):   A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: RASH MORBILLIFORM (hospitalization), 2 days after the suspect product(s) administration, outcome "unknown", described as "Asymmetric morbilliform eruption". The patient underwent the following laboratory tests and procedures: C-reactive protein: unremarkable; Full blood count: unremarkable; Haemodynamic test: stable; febrile: afebrile; negative; Metabolic function test: unremarkable; Physical exam: demonstrated morbilliform papules, notes: that coalesced into an erythematous plaque with sharp demarcation on his left proximal arm and trunk with fine overlying desquamation and relative sparing of the axillary vault. there was no mucosal, facial, or acral involvement; Red blood cell sedimentation rate: unremarkable.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events morbiliform rash and the use of suspect product cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
This spontaneous report as received from a 66 year old female patient with codeine allergy and antihistamines allergy refers to herself. On 16-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX. The patient reported that on 16-JUL-2013, she developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as a swollen, red, itchy area (no rash) about the size of a quarter at the injection site of the ZOSTAVAX vaccine. The patient did not seek medication attention. At the time of the report, the outcome of the events was reported as not recovered. Additional information is not expected.
Severe bone and muscle pain, severe headache, severe fatigue, severe stiffness of neck