chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (Slight fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Diagnosed with Covid) in August 2022. Concurrent medical conditions included Chronic obstructive pulmonary disease and Emphysema.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (Slight fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (Slight fever) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient stated that she has had all 3 Moderna vaccines and had with no reactions except for a slight fever and a sore arm.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-737310 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737310:Monovalent case
I am not sure if getting Shingles 5 days after my 1st dose was an adverse event or not. Today I received my 2nd dose, the person who administered the vaccine strongly recommended I report getting Shingles after receiving the COVID vaccine.
The pt noted pain in her muscle, a few days after immunization and it has persisted for 6 weeks.
Hives all over body with pruritis. swollen lips and difficulty swallowing that lasted into the vening on day of vaccine. Patient took one Benadryl and this improved. Patient went to sleep and felt better but still with hives. Patient took another Benadryl in AM and swelling to lips and difficulty swallowing improved. Patient was seen in clinic on 2/17/2021 and hives were improved, lungs were clear and no swelling  to lips was observed. Pictures taken by patient of hives and swelling to lips were reviewed
My arm is very sore at the site of the injection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 15:00 (Lot number: EL3248) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Mar2021 20:00, outcome "not recovered", described as "My arm is very sore at the site of the injection.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. List of any other medications the patient received within 2 weeks of vaccination, patient took 2 advil the week before. Patient became aware in the evening of 09Mar2021 and reported it on 10Mar2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's concurrent conditions included diabetes. No information was provided regarding the patient's concomitant medications or drug reactions/ allergies. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). The pharmacist reported that the patient, developed "redness and itching at the injection site" after receiving PNEUMOVAX 23. The outcome of injection site erythema and injection site pruritus was reported as recovered/resolved. The reporter's causality assessment was not provided.
Slight headache.  Following mid-day on 01/16/2016 hard stomach ache followed by diahrrea which has continued through 01/20/2016.  Not sufficient diahrrea to cause me to seek medical attention, but many bathroom attempts each day plus stomach ache making me uncomfortable.
Patient states stomach upset, nausea, chills the evening after Prevnar 13 injection. She states upset stomach and nausea continued 4 days.
Received first moderna vaccine on 5/10/21.  A few days after the shot, developed swelling and erythema around the injection site on left deltoid. Feels swollen and itchy at times. Believes area of erythema has gotten larger over the week.  Otherwise feeling well.  Denies fever/chills.   Appears to be injection site reaction from the Moderna vaccine. Due to evolving erythema, I was planning to prescribe keflex to err on side of caution, but patient is allergic to PCN, keflex, and clindamycin. Area marked. Patient to monitor area. Will f/u in office next week, but may cancel appointment if symptoms improve.
pt exp hives w/in 24 hrs p/vax; pt recovered; family hx of allergies;
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  Date of refrigeration was 07-May-2021   This case was linked to MOD-2021-364267 (Patient Link).
onset almost immed of lethargy; unarousable by the evening, shock, pale, low temp, limp, high pitched cry, cold clammy;
Patient received a first dose of the COVID-19 Moderna vaccine on 1/16/2021.  The patient was hospitalized at the time when the second dose was due. The patient was inadvertently scheduled for a second dose of Pfizer vaccine and received that dose on 3/12/2021. No adverse event noted by patient but this was a mixed series.
Extreme dizziness; Vomiting; Nausea; Feeling sick; Felt like falling off her bed; This spontaneous case was received on 25-Feb-2021 from other non-health professional (consumer) via Med Communication (reference number: SEQW21-00811) and concerned a 52-year-old, female patient.  The patient's concurrent condition included that the patient was diabetic. The patient's concomitant medication included unspecified medication for diabetes.  On 13-Nov-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number was P100271298 and expiry date was reported as 13-Nov-2020 (matched to expiry date of 30-Jun-2021). The patient stated that she was given the vaccine that was going to expire. The pharmacy stated that the consumer had refused the vaccine at the time, but consumer stated that she had received it.  On the same date, after receiving Afluria Quadrivalent, the patient was feeling sick and felt extreme dizziness. The patient experienced nausea, vomiting and felt 'like falling off her bed'.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  Company comment: All events are assessed as related to Afluria Quadrivalent.; Sender's Comments: All events are assessed as related to Afluria Quadrivalent.
This spontaneous report as received from a health care worker(also reported as representative) refers to unkonwn number of patients of unknown age from Vaccines for Children program. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patient was vaccinated with ROTATEQ, (therapy dates, dose strength) not reported that was improperly stored since 11-JUL-2014. No adverse effects noted. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1409USA011984 via same reporter link. Additional information is not expected as the reporter refused additional contact.
Information has been received from an unspecified reporter referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with HPV (manufacturer unknown)(lot#, strength, dosage, frequency and route unspecified). It was reported that the vaccine was causing death, permanent disability and damage to children around the world. It was ineffective and dangerous. The aluminum content far surpasses all safety levels (PQC). The outcome of the events was not reported. Additional information is not expected since there was no contact details provided.
Information has been received from a nurse practitioner referring to a 4 year old patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with M-M-R II (dose, route, lot# and expiration date were not reported) in the thigh. On an unknown date the patient experienced fever and rash due to which the patient was hospitalized. The outcome of the events was not reported. Causality assessment was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Information has been received from a certified medical assistant concerning a 66 year old female patient, with penicillin allergy and asthma, who on 05-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665401/1320Y, expire date 20-MAY-2011, route not reported), 0.5 ml in her left arm. Concomitant therapy included unspecified "asthma medications". On Sunday 07-NOV-2010, the patient was admitted to a hospital with a diagnosis of cellulitis. A diagnosis of cellulitis was considered to be immediately life-threatening and disabling by the certified medical assistant. At the time of the report, the patient was recovering. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the certified medical assistant and medical records. It was reported that on 05-NOV-2010 at 11:45 the 66 year old female patient with penicillin allergy, asthma, dyslipidemia and Gastrooesophageal reflux disease (GERD) was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y, exp 20-MAY-2011) IM into her left arm. There was no illness at time of vaccination. In the morning of 06-NOV-2010 (previously reported as 07-NOV-2010) the patient experienced redness in injection site. She became febrile and the redness increased. She had fever and elevated WBC. On 06-NOV-2010 the patient presented to the emergency room (ER) complaining of severe left arm pain and redness as well as fever at home. The erythema and swelling had extended beyond the original area and the patient was therefore admitted. CT performed on 07-NOV-2010 revealed soft tissue swelling laterally along the deltoid fascia and skin changes distally. No discrete drainable collection identified. She was started empirically on vancomycin and clindamycin. She was seen by doctor from infectious disease and doctor from pulmonary. Her symptoms were felt to be most likely as a result of a reaction to the injection itself, but cellulitis could not be ruled out. The patient was eventually changed to BACTRIM and her symptoms improved and she was cleared for discharge home on 09-NOV-2010 on the following medications: omeprazole 40 mg daily, ADVAIR 100/50 BID, montelukast sodium 10 mg daily, simvastatin 5 mg three times a week, fish oil 1 tablet daily, multivitamin daily, hormone replacement therapy and BACTRIM DS 1 tablet PO BID for 4 more days. The patient was to follow a regular diet. She was to follow up with her primary care physician as an outpatient. No further information is available.
On the 30th of Nov, I was woken out of my sleep and I felt dizzy and tried to stand up and got more dizzy and laid back down. Tried to get up again and had an incredible urge to go to the bathroom which i eventually did BM and urination. I did a corrid pulse on myself and noticed it was all over the pace, no steady normal rhythm. I took a pulse oximeter and put it on my finger to see what my pulse was actually doing and it EO2 was 92 which is abnormal for me, and pulse was irregular. I tried to take my blood pressure but can't remember what was happening with that. I called 911 because i was scared. The EMS unit came and took me to the Hospital medical center where I was taken immediately into the emergency room beds. According to what I was told, I was having a full blow atrial fibulation episode and they were very considered if i was having a stroke or TIA symptoms as well. They were going to give me medication to correct the pulse but my heart went back to normal while I was there. Because the beds were full of COVID and other patients and because i didn't have a heart attack, they discharged me to home. They put a heart monitor on me for 30 days and next week I see my cardiologist and will be getting additional blood work at the end of this week. ED DOCTOR CARDIOLOGIST) - who was at the hospital came down to see me while I was in the ER and reviewed things and oversaw things and prescribed  a drug that if used to control arithymicas and control blood pressure - which wasn't a problem for me, I do not have high blood pressure.
on 15JUN92 2 wks p/2nd dose of vax pt had lower body weakness & balance was off; lost lt eye field vision; pt was hospitalized 17JUN92 & released 19JUN92; sx felt to be an exacerbation of MS w/optic neuritis;
Broke out in a rash on my thighs on 3-7-21, continued to spread down my legs & across my stomach 3-8-21. Went to Urgent Care on 3-9-21, was give a steroid shot & topical cream. Rash continued to spread to my feet and arms. Topical cream & steroid shot did not seem to help. Rash was worse on 3-11-21. Rash cleared up by 3-17-21.
Had two separate anaphylactic reactions to polyethylene glycol. In June of 2021 received the covid vaccine and had a mild reaction that did not require treatments but is now listed as an allergy due to the same components of polyethylene glycol. Subsequent issues involving the need to use an EpiPen and or other medications to stop the reaction have been required and needed with other products related to coconut.
Took oral Typhoid 3/18 at 0400, 0800 feeling cold, shaking, generalized body aching and headache, T= 99; throat sore later, difficulty ambulating due to lack of energy; persistent dizziness, temperature rose during day; at 2030, in ER temp 103; no home care prior to ER, in ER, no care, no tests, no labs, no exam; was given Motrin x 3 tabs; released at 4AM, temp at that time = 99; on 3/19 at home lack of energy persisted, temp off/on up to 101, responded to Motrin; diarrhea and vomiting several times; missed work 3/20 due to continued symptoms; called our clinic and reported situation on 3/19; advised to d/c. Vivotif and continue home/symptomatic care.
Tingling, left arm, hand, leg and foot; first on 8-March 2021, second on 24-September 2021; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Influenza Vaccine Quadrivalent Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Covid 19 vaccine (received 1st dose of COVID in April 2021), Covid 19 vaccine (received 2nd dose of COVID in May 2021) and Shingrix (received 1st dose on 8th March 2021 in right arm, refer case US2021212569).   On 24th September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 10th September 2021, the patient received Influenza vaccine Quadrivalent unspecified season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. On 24th September 2021, unknown after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent unspecified season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced tingling. On an unknown date, the outcome of the tingling and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the tingling to be related to Shingrix, Influenza vaccine Quadrivalent unspecified season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient. The patient received 2nd dose in right deltoid at physician's office. The patient received flu vaccine 2 weeks prior to the 2nd dose of Shingrix. The reporter stated that after 2nd dose of Shingrix, developed tingling down her left arm and hand, as well as down her left leg and foot. The tingling in leg and foot has resolved. The tingling in arm and hand is unresolved. The patient received 2nd dose later than the 1st dose of Shingrix, which led to lengthening of vaccination schedule. The patient had an appointment scheduled for tomorrow with her health care professional regarding the unresolved tingling.The reporter could not provide the lot or expiration of the vaccine but stated that the physician's office administered the vaccines and would have that information.  The reporter consented to follow up with her physician. The case was linked with case US2021212569, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021212569:Same patient
Patient reports that she got the first Shingrix vaccine Friday Sept 13, 2019 around 2pm, and around 10pm suddenly got cold, "felt like I had the flu" - no energy, whole body ached, had a headache; she's not sure if she had a temp, did not check; the last symptom to resolve was the headache, which was gone around 5pm on Saturday the 14th. No N/V. She also had soreness at the injection site. She did have 3 allergy shots around noon that day, 2 in right arm, 1 in left; the Shingrix was given in the left deltoid.
3 days after receiving injection i lost my sense of smell and taste. no fever or chest congestion. taste and smell returned i 5 days 03/19/2021 woke up with vision loss i left eye. eye care assoc. diagnosis is NAION, optic neuropothy due to lack of blood flow to optic nerve damaged.
loose bowels; waves of stomach pain, starts at the top of my stomach, under the breast down to the belly button; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (waves of stomach pain, starts at the top of my stomach, under the breast down to the belly button) and DIARRHOEA (loose bowels) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029620A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (oesophageal). Concurrent medical conditions included Hiatal hernia, Blood pressure high and High cholesterol. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) and CALCIUM CARBONATE, MAGNESIUM HYDROXIDE (ROLAIDS [CALCIUM CARBONATE;MAGNESIUM HYDROXIDE]) for Acid reflux (oesophageal), LOSARTAN POTASSIUM and METOPROLOL TARTRATE for Blood pressure high, PARACETAMOL (TYLENOL) for Hiatal hernia, ROSUVASTATIN CALCIUM for High cholesterol, LEVOTHYROXINE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (waves of stomach pain, starts at the top of my stomach, under the breast down to the belly button). On 04-Feb-2021, the patient experienced DIARRHOEA (loose bowels). At the time of the report, ABDOMINAL PAIN UPPER (waves of stomach pain, starts at the top of my stomach, under the breast down to the belly button) and DIARRHOEA (loose bowels) had resolved. Not Provided          No treatment information was provided.  The patient stated that it was minor adverse event and may not have been caused by the Moderna injection, since it occurred after she received one of the injection.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received with Medical history, suspect product dosing details, Concomitant drug, and event information, reporter causality and narrative information was updated.
28nov89 pt vax hepta B. pt ex pain at inject site. 28dec89 pt vax 2nd hepta B. pt ex prolonged pain and tenderness at inject site which lasted 2 days to 1 week. pt recovered.
One day after receiving my second dose of this vaccine, I began to hear voices.  They were indistinct but persistent and very frightening. This continued until day 3.  On day 3, the voices calmed and I began to have "out-of body" feelings.  I slept as much as possible. On day 4, I woke up without any mental confusion, no voices, no out of body feeling.  Those reactions have completely gone.