chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upper arm is swollen; upper arm is a little pink; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (upper arm is swollen) and ERYTHEMA (upper arm is a little pink) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (upper arm is swollen) and ERYTHEMA (upper arm is a little pink). At the time of the report, PERIPHERAL SWELLING (upper arm is swollen) and ERYTHEMA (upper arm is a little pink) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
muscular issue / pneumonia vaccine, which gave her similar muscular issues; This spontaneous report as received from a currently 67-year-old female patient referring to herself via Pfizer. The patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.       On an unspecified date in the past, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route, anatomical location, lot # and expiration date were not provided).         On an unknown date, the patient experienced a muscular issue (muscle disorder) gave to her by pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). By the time of report, the outcome of muscle issue was unknown.     The reporter considered muscle issue to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Developed a Lump at injection site which grew larger by March 25, and by April 29 was quite large and started oozing.
pt recvd vax 13OCT92 & 12 to 14 hrs following vax pt devel shakiness, fever, & weakness; it was also noted that devel a red raised 6 by 5 area @ the inject site which was tender to touch; By 23OCT92 the vax area had dec to 3 by 5; c/o h/a;
Menstrual cycle is late by 1 month and significant cramping and lower back pain experience days after first dose. Back pain and cramping still continues after second shot, but menstrual cycle still has not started.
Pain, redness, swelling at and around injection site, fever, nausea, headache.
Patient came in for a second Hep B dose, and was mistakenly administered a Hep A dose. Mistake was relayed to patient and correct vaccine was given.
Broke out in shingles; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received first dose of bnt162b2 (bnt162b2, PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: FC3180, expiry date: unknown), via an unspecified route of administration on 26Aug2021 as DOSE 1, SINGLE for covid-19 immunisation (age at the time of vaccination was 36 years). The patient's medical history and concomitant medications was not reported. The patient experienced broke out of shingles on 09Sep2021. It was reported that the patient called to report an adverse reaction for that she went to emergency room. She got this shot on 26th and then on Saturday, she broke out in shingles but did not know where those came from at that time, so she had to go to an emergency doctor's appointment to see what was going on, from where she got the shingles. The treatment received was valtrex 500 mg every 8 hours. The clinical outcome of the event was unknown.
This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (reaction after every vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (reaction after every vaccine). At the time of the report, IMMUNISATION REACTION (reaction after every vaccine) had resolved. The doctor told her that she has an awesome immune system, and she appreciated that her reactions lasted 24-36 hours". No treatment information was provided. This case was linked to MOD-2022-616432 (Patient Link).
Case number PHEH2014US021298 is an initial spontaneous report received from a pharmacist on 20 OCT 2014, with the follow-up information received from Quality Assurance Department (reference number: 332248) on 19 NOV 2014. This report refers to a patient of unknown age and gender. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145201) from a pre-filled syringe (PFS) on an unknown date. It was reported that while injecting the vaccine into the patient the vaccine is not  coming out of the needle instead it was running down the patient's arms. It was reported that his was the second PFS that was not manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified for the complaint. The most probable root cause is user handling. The complainant stated that vaccine leaded at the needle connection site and that the needle is self-contained in the syringe; however, Novartis do not supply syringes for this batch. It is probable that the needle was not adequately attached to the syringe.   Follow-up information received from the Quality Assurance Department  (reference number: 332248) on 19 NOV 2014: Updated batch review report.
Pt vaccinated with DTP abnormal crying lasting six hrs on 22JUN90. local reaction at injection site & local adenopathy at injection site. duration of illness was one day.
This spontaneous report as received from a 60 year old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. On 19-JUN-2013 the patient was vaccinated with ZOSTAVAX (strength, route and dose were not reported) (lot number not provided) injection for shingles prevention. Concomitant therapies included methotrexate (manufacturer unknown) shot once a week, folic acid (manufacturer unknown) and an unspecified "thyroid pill". Consumer reported that on 20-JUN-2013 "by 24 hours after", receiving ZOSTAVAX, she began to feel sick with "flu-like symptoms." Consumer also had a fever, a respiratory infection, and sinus problems including nasal inflammation. She also said she fainted 2 days after the shot, on 21-JUN-2013. Consumer went to an unspecified clinic "3 times" to seek medical attention (dates unspecified). On her visits, she had tests performed which included a chest x-ray and a sinus x-ray. On an unspecified date in 2013, patient was treated with an unspecified antibiotic shot, a cyanocobalamin B12 shot for "exhaustion" an unspecified oral antibiotic. Consumer also reported that, after receiving ZOSTAVAX, her "thyroid was low" so her physician "had to change her thyroid medicine (unspecified)." The patient is now fully recovered. She recovered on an unspecified date "at least 2 weeks" after receiving ZOSTAVAX, on approximately 03-JUL-2013. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Pediarix inadvertently administered outside of age indication. Patient was 10 years of age at the time of vaccination and Pediarix is licensed through 6 years of age.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 19-year-old female patient who received BEXSERO for prophylaxis. On 18th September 2018, the patient received the 2nd dose of BEXSERO. In September 2018, 1 day after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be related to BEXSERO. Additional details were provided as follows: The vaccine was administered elsewhere, and lot number was not available. The patient had worsening of symptoms ever since receiving 2nd dose of BEXSERO. One to two days after receiving BEXSERO the patient developed injection site redness, swelling, and a raised area about 4x4 inches. The area was also hot.
Headache, Myalgia, Arthralgia, Palpitations, Fatigue Narrative:  Other Relevant History:
Please note, no further outside facility information is available in current Medical Record other than what is listed below. No provider information is available from Hospital Patient is a 67 y.o. female presenting from the Hospital with hypoxia. She has been at Hospital x 4 months for severe MDD with melancholic and psychotic features, neurocognitive disorder and failure to thrive. She tested positive for COVID-19 on 12/31/21. The patient reports she has had some dyspnea but believes this overall has improved. She still has a cough which is productive. Reports sputum is loose. She has not visualized color. She denies sinus congestion, sore throat, lost of taste or smell. Appetite has been poor and she has not been eating much, but states she has been drinking well. Per Hospital records, she has had low grade fevers, but otherwise no vital signs changes until this morning, when she was found to have O2 saturations of 81% on room air. She was brought to hospital via EMS and sats was 86% on 2L NC, and since have been in the mid 90s on 3L NC. She denies feeling dyspneic at this time. She did not receive any treatment for COVID while at Hospital.   Original COVID-19 diagnosis was 12/31/21; had mild dyspnea (improved) and cough, and has done relatively well at facility until hypoxic PTA. On admission. CT chest "appears to have diffuse bronchiectasis w/ possible component of post-inflammatory fibrosis, and enlarged hilar lymph nodes, likely reactive; no PE" She was given from 1/12 Dexamethasone x 10 days, not a candidate for Remdesivir. QTB test negative. She was given supplemental O2 NC or HF and titrate as needed to keep O2 sat >93% and will discharged with home O2.   Discharge Disposition/Condition Disposition: Other (specify) Condition: Stable (s/sx potential problems absent or manageable)
a slight cold; goes all down to the neck; woke up with a real bad cough and a head ache; woke up with a real bad cough and a head ache; This spontaneous case was reported by an other caregiver and describes the occurrence of NASOPHARYNGITIS (a slight cold), MUSCULOSKELETAL DISCOMFORT (goes all down to the neck), COUGH (woke up with a real bad cough and a head ache) and HEADACHE (woke up with a real bad cough and a head ache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced NASOPHARYNGITIS (a slight cold), MUSCULOSKELETAL DISCOMFORT (goes all down to the neck), COUGH (woke up with a real bad cough and a head ache) and HEADACHE (woke up with a real bad cough and a head ache). At the time of the report, NASOPHARYNGITIS (a slight cold), MUSCULOSKELETAL DISCOMFORT (goes all down to the neck), COUGH (woke up with a real bad cough and a head ache) and HEADACHE (woke up with a real bad cough and a head ache) outcome was unknown.            Concomitant medication also included not listed. Treatment information was not reported.
Approx 9 hours after vaccine I developed rigors, fever, weakness, nausea, headache, joint discomfort  and as fever broke I developed diaphoresis.   Headache, nausea, weakness persisted for about 40 hours.  Headache and joint pain finally resolved after a total of 3000 mg of Tylenol over that time period.   Those was similar to side effects after my Covid booster in 2022 but only slightly more severe.
1st shot about 4/1999. 2nd shot about 5/1999. starting to have some joint problems. 3rd shot 5/2000. with in 2 weeks problems got much worse.
Fatigue; Tired; Dragging herself; Distress; Going through a difficult time; headache; sleepless night; loud screaming sounds; Having just three and half hours of sleep; Vaccination site pain; tired; nightmares/Frightening dreams; Vaccination site pain; This spontaneous case was reported by an other health professional and describes the occurrence of PAIN IN EXTREMITY (pain in arm), FATIGUE (tired), NIGHTMARE (nightmares/Frightening dreams), HEADACHE (headache) and INSOMNIA (sleepless night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin cancer. Concurrent medical conditions included Blood pressure, Bipolar disorder (she do not have episodes), Depression (she do not have episodes), Allergy and Rotator cuff tear (right shoulder). Concomitant products included TRIAMTERENE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), FATIGUE (tired), NIGHTMARE (nightmares/Frightening dreams) and PAIN IN EXTREMITY (Arm hurts). On 14-Apr-2021, the patient experienced HEADACHE (headache), INSOMNIA (sleepless night), SLEEP TERROR (loud screaming sounds) and INSOMNIA (Having just three and half hours of sleep). On 21-Apr-2021, the patient experienced STRESS (Distress) and MALAISE (Going through a difficult time). On an unknown date, the patient experienced FATIGUE (Fatigue), FATIGUE (Tired) and GAIT INABILITY (Dragging herself). At the time of the report, PAIN IN EXTREMITY (pain in arm), FATIGUE (tired), NIGHTMARE (nightmares/Frightening dreams), HEADACHE (headache), INSOMNIA (sleepless night), SLEEP TERROR (loud screaming sounds), PAIN IN EXTREMITY (Arm hurts), INSOMNIA (Having just three and half hours of sleep), FATIGUE (Fatigue), FATIGUE (Tired), GAIT INABILITY (Dragging herself), STRESS (Distress) and MALAISE (Going through a difficult time) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Swelling, pink, warm, itchy left upper arm. Patient seen on day # 3 of Sx. Administer BENADRYL q 6 hours.
Received the employee required flu vaccine on 9/20/19 at the Occupational Health Office. By 9/22/19, reactions started to occur. Reactions consisted of rash: hives, itching, redness, swelling, inflammation, and severe pain of the chest, neck, and face. From these symptoms, I was unable to sleep or function in daily life because of pain and other symptoms mentioned starting on 9/22/19. This rash and the symptoms interfered with work and then ability to wear hospital OR gowns during the scrub rotation of the Program. The gowns rubbed against the rash on my neck which further aggravated the rash.   I went to primary care doctor on 10/3/19 to get evaluated and for lab to be drawn. Labs tests showed increase in lymphocytes and eosinophils- the primary care doctor concluded an allergic reaction to something in my body.  On 10/4/19 I took the day off because of how severe the allergic reaction was. On 10/4/19 I went to the allergist first thing in the morning with the same reactions as mentioned plus had a hoarse and sore throat due to the extensive inflammation around the neck/throat area. Allergist prescribed Prednisone 40mg for 5 days and a steroid cream- Triamcinolone Acetonide Ointment 0.1% as needed for rash. Took prescribed Prednisone for 5 days, and 2 days later, rash returned: hives, itching, redness, swelling, inflammation, dryness, and severe pain of the chest, neck, and face. Side effects of Prednisone was severe (insomnia) that it was not recommended to take again along with the side effects of the steroid cream (extremely dry/painful skin). Allergist recommended patch testing to see if any chemicals or metals that may be reacting to my body. Patch testing was available after waiting 2 weeks after the last dose of Prednisone so the steroids will not interact with the results of the patch testing.  Patch testing was placed on 10/28/19, first patch test read and removed on 10/30/19, and final read on 11/1/19. Results from the patch testing showed allergic response to Thimerosal. In addition, took off work on 10/29/19 due to lack of sleep from the rash and symptoms of the rash (hives, itching, redness, swelling, inflammation, and severe pain of the chest, neck, and face).  I have been taking Benadryl and Claritin to try to ease the symptoms with little luck. I went to another allergist on 10/29/19, and he prescribed montelukast, zyrtec, and hydralazine to help with the inflammation, allergic reaction, and sleep (but with little luck, the symptoms of the effects of the flu shot still persists).   Rash has continued to this day and has spread to other areas of the body- entire face/ears, traps, upper back, and arms (starting around 10/14/19). The rash and effects of the flu shot is still currently affecting everyday life including effecting work (concentration/ coming in to work/ wearing OR scrubs and normal clothing) and ability to sleep at night. The lack of sleep interferes with work as well. As mentioned, the rash is currently still very itchy, red, swollen, dry, with inflammation, and severe pain of the chest, neck, and face.
They put it in the incorrect injection site, they put it subcutaneous; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They put it in the incorrect injection site, they put it subcutaneous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 18-Dec-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They put it in the incorrect injection site, they put it subcutaneous). On 18-Dec-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They put it in the incorrect injection site, they put it subcutaneous) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.
Patient presents to PCP office with red, swollen, left arm approximately two days after high-dose influenza vaccine injection. Of note, the injection was in the left deltoid and the swelling and redness was significantly lower than the injection site and patient also has redness at baseline. PCP was called in to examine patient and ice pack was placed on arm.
1 x 2 cm reddened area on her left lateral thigh.  There is palpable induration.  Parents use Benadryl and hydrocortisone to site.  Areas still has redness and palpable induration.
Patient was under dosed, patient was given pediatric dose of first Pfizer dose vaccination  instead  of adult dose.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gallbladder removal" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Sep2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2023) positive, notes: bright red positive. Therapeutic measures Paxlovid was taken as a result of drug ineffective, covid-19. Additional information: The patient has no known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Bell's palsy of the left side of the face. Prednisone 5 MG (21) Oral tablet therapy pack
Pt. felt run down on Friday (day after shots). No appetite and felt like she had the flu. Got a severe HA on Sat but as of Monday seems to start going away. The shot was in deltoid and rash was going around arm below that and hot to the touch.
Several months after the first dose of J&J, mensural cycle went from normal (5- 6 days in length) to anywhere from 18-35 days in length, extreme blood clots, pain, bloating, with only 2-3 days before it would start all over again. I would become light headed from all the blood loss, even passed out and fell down a flight of stairs. Massive cramping all over my body in every muscle group. Abnormal hemorrhaging would last for weeks, then stop for a couple days (2-3days) then start again. I was constantly exhausted, fatigued easily (even though I am in good health and have been a gym rat since the3 8th grade). Hemorrhaging has never stopped. I am now expecting to have a partial hysterectomy to deal with the massive amount of bleeding.
Flu-like symptoms; Sick; Felt like he was going to die; Not been able to take the second dose; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old 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, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, sickness and feeling lifeless. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the sickness and feeling lifeless were unknown.   It was unknown if the reporter considered the influenza-like symptoms, sickness and feeling lifeless to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received his 1st Shingrix shot and he became sick with flu- ike symptoms and  felt like he was going to die. The reporter did not consent to follow up. This case has been linked with US2020089530, reported by same reporter.
approx 36-48 hr p/vax pt exp growing pain in rt arm & shoulder;pain inc & spread down the arm into rt hand w/numbness in thumb & little finger, severe pain by 2AM 15JUL;saw MD 9AM treated pain w/APAP w/codeine;no arm mobility w/o pain x 3wk
No further adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions or allergies.  On 24-FEB-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot number S014947 with expiration date on 10-DEC-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine experienced temperature excursion of below 36 degrees Fahrenheit (F) (34 F) for 27 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-2002USA010005: US-009507513-2002USA009991: