chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient canceled scheduled vaccination and did not reschedule it.; Jynneos vaccine administered intradermally.; Case reference number US-BN-2022-004220 is a spontaneous case report initially received on 21-Oct-2022 via Communications (reference number: USBAV22-1759) and concerns an adult patient born in 1997.  The patient's medical history and concomitant medication details were not provided.  On 23-Sep-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at a dose of 0.1 milliliter, intradermally, at unknown anatomical location and for monkeypox prophylaxis (explicitly coded as 'Intradermal injection').  As reported, the patient was scheduled for second dose of Jynneos on 21-Oct-2022, at 1:30 PM but, the patient cancelled the appointment. The patient did not reschedule for later in the day. Since this should have been patient's second dose, he will be late for it (explicitly coded as 'Product dose omission issue').  The reporter wanted to get information regarding the storage and handling for Jynneos. They have had the vial out of the refrigerator and allowed it to sit at room temperature before administration. It was an unpunctured vial. They wanted to know if they can put it back in the fridge and for how long it will be good for if it's been taken out of the fridge.  At the time of reporting, it was unknown if the patient experienced any adverse events..  Additional information received on 21-Oct-2022 via Communications (reference number: USBAV22-1759): new information included the local case ID which is BN_2022_02599.  No further information received.; Reporter's Comments: An adult patient born in 1997 was vaccinated with the Jynneos vaccine on 23-Sep-22. The vaccine was administered intradermally, at a dose of 0.1ml which is coded as intradermal injection. Reportedly, the patient was scheduled for second dose of Jynneos on 21-Oct-22 but cancelled it and did not reschedule for later, which is considered product dose omission issue. Both events are listed per the Company conventions. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events. Intradermal injection and product dose omission issue are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: An adult patient born in 1997 was vaccinated with the Jynneos vaccine on 23-Sep-22. The vaccine was administered intradermally, at a dose of 0.1ml which is coded as intradermal injection. Reportedly, the patient was scheduled for second dose of Jynneos on 21-Oct-22 but cancelled it and did not reschedule for later, which is considered product dose omission issue. Both events are listed per the Company conventions. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events. Intradermal injection and product dose omission issue are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
Sore arm that feels weak accompanied by swollen lump on inner arm near the elbow.
Patient had large red "knot" as she called it, it was swollen and warm to touch, she said it caused pain when she moved arm/raised arm.
Information has been received from a 36 female with no pertinent medical history who on 02-JAN-2007 was vaccinated with a first dose of Gardasil. There was no concomitant medication. On 17-JAN-2007 the patient's "period started a week early" and has remained on that schedule. The patient did not seek medical attention. She reported that she would be a few days to a week late receiving her second vaccination of Gardasil because the physician's office was out of stock and had to order more. No further information is available.
She has an area measuring 3x2 inches of red, warm tissue. The area is itchy, but I am concerned with a possible cellulitis brewing.
itching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PRURITUS (itching all over the body). At the time of the report, PRURITUS (itching all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Reporter did not allow further contact
Within approximately 20 minutes of receiving shot, my eyelids began to swell (mildly) as well as my cheeks. I also immediately was overcome with fatigue and brain fog.  This lasted approximately 45 minutes.  I have no history of using facial fillers.
soreness in left arm with tingling radiating to left fingers and left side of neck. Monitored for an additional 15 minutes with no progression of symptoms. No shortness of breath, no chest pain.
Changes in menstruation cycle after both the first and second doses.  Menstruation is more painful and heavier.  The colour and smell of the blood has changed.  PMS symptoms like bloating and painful breasts are also worse.
Pinpoint red papule noted on lateral Left thigh laying over a swollen red and warm upper thigh including  the Left  knee joint as well. Associated  with limp and pain. Oral dosage of motrin given the next morning by mother was non-responsive. After two 1/2  days or oral steroids given at 1mg /kg  bid with 100 % resolution.
pt recv vax & nurse noted that pt has had 5 doses of MMR & has no detectable titer to measles;
5 days after receiving the Pfizer vaccination I ended up in the ER due to me having a miscarriage that had started approximately 4 days after the vaccination was given.; This is a spontaneous report received from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05May2021 13:00 (Batch/Lot Number: EW0171) (at age of 36 years) as DOSE 1, SINGLE for COVID-19 immunisation. Patient was pregnant at time of vaccination. Last menstrual date was on 09Apr2021. Medical history included known allergies (unspecified) and other unspecified medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other unspecified medications the patient received within 2 weeks of vaccination. 5 days after receiving the Pfizer vaccination, patient ended up in the ER due to having a miscarriage that had started approximately 4 days after the vaccination was given, on 08May2021 08:00 (as reported). The mother was 4 weeks pregnant at the onset of the event (also reported as 5 with unspecified unit). The mother was due to deliver on 14Jan2022. The mother delivered the pregnancy (as reported, pending clarification). The pregnancy resulted in spontaneous abortion. Adverse event resulted in Emergency room/department or urgent care. Treatment for event was unknown. The outcome of event was recovered on May2021.
Extremely itchy, roundish red rash with small bumps 2--3 inches around perimeter of injection site
Joint aches and pain. Also, small clusters of hives appeared occasionally over the last few days. Usually just one to three hives at a time, then they would go away and reappear in a different location. First I got one on my arm, then on my back, then on my shoulder, then on my knee... Very sporadic, and only lasted for about 10 minutes time they appeared.
The pt is a 70 yo female that presents to the ed after receiving an injection in the left deltoid.  She received her first covid vaccination today.  She reports she has "lots of allergies" to medications. She began to have some mild tingling and itching in the left hand prompting the nurse to send the pt to the ed.  No rash, symptoms have dissipated by time she is seen in the ed.  No new dyspnea or diff breathing, no throat closing sensation.   444pm  No distress, no rash, pt reports she feels better, 40mg prednisone given, home with pcp f/u as needed, return if diff breathing, rash, itching or her symptoms persist despite benadryl and otc meds. Pt and family agree with the plan, home at this time
6:30 PM onset I felt slight trembling through whole body. By 7:30 PM started uncontrollable trembling, felt very thirsty. Felt chilled throughout body. Drank about a gallon and a half of water within 20 minutes and went to bed about 10:30 PM. I felt very concerned that I was not in control of my nervous system.
10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as the day/night went on. Eventually, painful to lift. 12:30pm: Nauseous and not feeling well. Headache increasing. 7pm Migraine, chills, feeling awful, tired, muscle & joint pains, body aches, fever, left arm super painful. Slept restlessly Friday: Slept all day restlessly, chills, fever high of 102, tired, migraine, muscle  & joint pain, no appetite. Sat: Migraine, some chills, muscle, joint, arm pain. Sun: Feeling much better, joint pains, arm sore, headache.  Sun PM: Red, swelling, tingling on face around chin and mouth. - right side of face Mon: Rash on neck - right side of face Tues: Rash on torso
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 24-Jun-2022 past the BUD date 23-Jun-2021.) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination. No Medical History information was reported. On 24-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 24-Jun-2022 past the BUD date 23-Jun-2021.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 24-Jun-2022 past the BUD date 23-Jun-2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 24-Jun-2022 past the BUD date 23-Jun-2021.). Concomitant medications details were not reported by the reporter. It was reported vaccine was administered 1 day past the BUD. The event did not cause patient to seek medical care. Treatment details were not reported by the reporter.
Pt came into the pharmacy today stating that her left arm was still sore and had a hard time lifting her arm above shoulder height. She explained signs of shoulder impingement, however also stated that the spot of injection was also sore. The spot of soreness is at an appropriate injection location just above the armpit line.
"Light rash, size of a tennis ball" at SHINGRIX injection site. Appeared 2 hours after vaccination received. Resolved in 24 hours. Experienced arm soreness lasting 2 days. Denies itching, swelling, warmth, fever or joint pain.
1st dose AUG 2021, 2nd FEB 2022/no record of the second dose being received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in August 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Upon follow up, the reporter reported that, there was no documentation of the patient receiving their 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not provide demographic details from patient since they were not available. The reporter did not consent to follow-up.
Monthly facial hives - have suddenly appeared for no reason every month for the last 3 months - no new products had been introduced - same hygiene routine and food.  Disappear after a week or so.
diarrhea with blood; Extreme fatigue; Severe gastrointestinal problems; severe body aches; joint pain; Painful diarrhea; bloating; abdominal pain; chills; soreness at injection site; This is a spontaneous report from a 49-years-old male contactable consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8729), intramuscularly administered in Arm Left on 20Apr2021 10:00 as single dose and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8732) intramuscularly, administered in Arm Left on 11May2021 10:00 as single dose for covid-19 immunisation. Vaccine was administered: Workplace clinic. Concomitant medications included chlorthalidone for unknown indication and start stop date not reported. Medical history included drug allergies to Ibuprofen and codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measurements included Tylenol, rest, pepto bismol. On 12May2021 11:00, the patient experienced severe body aches, extreme fatigue, soreness at injection site, severe gastrointestinal problems, joint pain, painful diarrhea, diarrhea with blood, bloating, abdominal pain, chills. The outcome of events was not recovered.  On (17May2021) clarification was received from a Pfizer colleague with regards to the previous report received. The following was reported: Patient was self , Non- HCP, In sales.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.    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 Committees, and Investigators, as appropriate.
presents with a diagnosis of adverse effect of other viral vaccines, initial encounter.  It is of mild severity.  Patient complains of severe pain from the neck down that started 2 weeks ago, intense pain focused on the shoulders, hips and arms, Patient also complains of body ache when she wakes up. severe myalgia, polymyalgia
C/O of sharp pain and headache BP 192/104, P 72 , O2 98% RA.  Refused transferred to ED. Relative was going to drive her to the Hospital.  Was admitted at the hospital for Observation was discharged following day.   Received her second Pfizer dose on 3/9/2021, EN6206, IM RA
Within one hour of injection: tingle in tongue (resolved in 24 hours), headache, low-grade fever, fatigue (on and off for 3 days), injection site pain, red and hot injection site (resolved after 3 days). Within 12 hours of injection: lip swelling (occurred 10 hours after injection, resolved within 24 hours, note: no lip fillers). Within 48 hours of injection: swollen lypmh nodes in left armpit (resolved within 12 hours).
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site erythema (1st dose received on 21st June 2018, refer case ID US2018158177). Concomitant products included clindamycin and methotrexate. On 27th August 2018, the patient received the 2nd dose of SHINGRIX. On 28th August 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site warmth, injection site erythema, injection site pain, headache, sleepiness, fever and chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site warmth, injection site erythema, injection site pain, headache, sleepiness, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site warmth, injection site erythema, injection site pain, headache, sleepiness, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient started taking clindamycin the same day he received SHINGRIX. About 24 hours later, the patient started going between chills and fever. He has had headaches and was sleeping 12 hours a day. The patient's arm was red, swollen, painful and warm at the injection site. The swelling was about 4 to 5 inches in diameter and had been getting worse as the days go by. At the date of reporting, the nurse at the fitness center drew a circle around the swelling so he could see if it continues to get worse or was getting better. The patient denied permission to contact their physician.
Two days after vaccine I awoke with extreme dizziness and a bit nauseous. Symptoms continued for 2-3 weeks. Symptoms are slowly dissipating. Also for the first few days, shortness of breath.
Vertigo; could not work almost at all; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 35-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   The patient's past medical history included ankle fracture (surgery perfomed in 2018) and deviated septum repair (surgery perfomed in 2016). Previously administered products included TDAP with an associated reaction of product prescribing error (For tolerance of TDAP dose refer case US2022AMR091741) and Flu vaccine with an associated reaction of fatigue (For tolerance of Flu vaccine dose refer case US2022AMR091740).   On 22nd April 2022, the patient received Boostrix. In April 2022, less than a day after receiving Boostrix, the patient experienced vertigo and activities of daily living impaired. The patient was treated with dramamine (nos) (Dramamine). On an unknown date, the outcome of the vertigo and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the vertigo and activities of daily living impaired to be related to Boostrix.     Additional Information: GSK receipt date: 08-June-2022 Reporter's comment: The patient received her Boostrix vaccine approximately 1.5 months ago and about 3-6 hours afterward, patient experienced extreme vertigo. Moving her head quickly or to either side or leaning it back made it much worse, but it was also very present when just sitting and looking forward to the point she could not work almost at all because of these symptoms. They would subside or lessen in severity for an hour or two intermittently, but then return for no reason. She tried dramamine which seemed to help a little bit, but she was unable to do the Epely maneuvers because the symptoms felt so severe she could not tolerate it. She stayed in a semi reclined position as much as she could for 2-3 weeks. After 3 weeks, the symptoms lessened but were still present. At the time of reporting approximately 6-7 weeks out from the vaccine and it had improved about 90 percent or so, where it had stayed. It was still present in certain situations, but notably less severe. She was hoping to get more information about this and whether there had been any other reports of this happening. The patient was also wondering if this was something that needs exploring, because she was a bit concerned about this being permanent. The patient received oral Birth control pills (BCP) and Vitamin D. No allergies was provided, and she was in good health. Additional Supportive information: Birth control pills (BCP) and Vitamin D were not coded in field as its ingredient was NOS which would cause report failure, hence it was retained in the narrative.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR091740:Same reporter US-GLAXOSMITHKLINE-US2022AMR091741:Same reporter
2 days after being vaccinated, the pt developed a fever, wheezing, and injection site reaction that looked like necrosis at an unspecified site.
One week following vaccine:  itching, redness and hot at injection site.  Over the following week, area of redness increased in size, moving up and down my arm and reaching about 6-7 inches in diameter.   Dr. initially prescribed Benadryl, and then changed to Zyrtec.  I had taken a Benadryl prior to vaccine since I had a similar reaction to the flu shot, although not as much redness.  As of this date (2/22/21) symptoms are lessening although some redness remains.
1 1/2 hours after she had ZOSTAVAX shot she had severe itching RT back in scapula area. 3/2/10 she developed 12-16 blisters from spine around to breast with severe pain to touch. On 3/6/10 she started NEURONTIN and ATARAX via phone prescriptions. 3/23/10 areas starting to dry up as of today. Pain persists.
her son had an adverse experience with HPV vaccine; This spontaneous report was received from the patient's mother referring to her son, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis.         On an unknown date, the patient had an unspecified adverse experience (adverse event) with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) ("HPV") vaccine.      At the reporting time, the outcome of adverse event was unknown. The causality assessment was not provided.
Patient developed arm redness, swelling, and pain in the right upper arm, that was warm to touch.
This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and demographics. The nurse reported that sometime in March 2014 the patients were vaccinated with VARIVAX (Merck), subcutaneous that was improperly stored. No symptoms reported. On an unknown date the patient experienced no symptoms reported. The outcome of administered improperly stored is unknown. Additional information has been requested.