chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nurse reported that several unidentified pt's received Prevnar (pneumococcal 7-valent conjugate vaccine) on (dates not specified).  It was reported that while administering Prevnar, the pt's "always scream".  Relevant medical history was not provided.  Indication for Prevnar was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose (IM).  Concomitant medications often included various other childhood immunizations.  A nurse has observed that whenever a dose of Prevnar is given in the office, "the pt's let out a scream".  Despite the sequence in which the Prevnar is given with other childhood immunizations, or the age of the child, the pt's always scream while Prevnar is being administered.  The pt's are often comforted by the end of the visit.  The nurse stated that the names and pt information was "too numerous to list".
Mother of pt reports swelling and heat of upper arm area. Mother of pt administered Tylenol and Ibuprofen. Also alternated hot and cold compresses to area.
Developed a 4x4 in erythematous, warm area with vesicles noted centrally no fever.
t100R 4 hr p/vax; while awoe pt began crying unconsolably & turned ashen pale; rechecked in ofc BP & P 84/60 & 120-144, lungs clear;
I was feeling fine until later in the evening. I got really cold with shivers that only a really warm ten minute shower helped. I started to have a massive headache and sharp random aches through my body. I took my temperature and it ranged between 99.9-101.7. I drank lots of water because I suddenly for so thirsty even though I?d already had 80+ ounces of water today. The center of my chest hurt briefly and it was hard to get comfy.
fever 16JUN92 noc of 39C; fever 17JUN92 40C given APAP; also exp rash for 1 day top of head & cheeks; 18JUN t100.1-103.8; sx gone by 19JUN92;
Patient complained of a "sting" upon injection and red and sore around the site.  Patient called 10/03/2003 at 14:00.
Approx 2hrs post vax pt devel t104, chills, disorientation; Fever not relieved by APAP; Seen @ Hosp ER 27JUN91; LT is red & swollen;
Information has been received from a registered nurse concerning a patient who on 07-NOV-2007 and 04-MAR-2008 was vaccinated PO with the first and second doses of ROTATEQ. The second dose was later than recommended. No adverse experience was related to this event. There was no product quality complaint. Additional information has been requested.
fatigue; low grade fever; headache; body aches; A spontaneous report was received from a type concerning a 51-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade fever/pyrexia, headache, body aches/pain, fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) low grade fever, headache, body aches, fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), low grade fever, headache, body aches, fatigue was unknown.; Sender's Comments:  MOD-2021-029308:Mother case
Warm, large, red, raised circular area around the injection site, about 4-5 inches in circumference. Left deltoid.
Dizziness; Tachycardia; This is a spontaneous report from a contactable other HCP. This other HCP reported for self that the 38-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID-19 Vaccine, Lot#: EL0140, Expiry Date: 31Mar2021), via an unspecified route of administration on 05Jan2021 13:15 on Deltoid, Right at single dose for covid-19 immunisation. Medical history included she did get a monthly allergy injection about 3-4 weeks prior to the COVID-19 Vaccine. She said she did not have any reaction to the allergy shot, clarifying she has always done well with her allergy shots. Concomitant medications were none.  She said she got dizzy for about 30 minutes afterwards, and then was all better. Caller asked if Pfizer has any guidance on how she should proceed with the second COVID-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance. Reported she got really dizzy approximately 10 minutes after receiving the COVID-19 Vaccine, and the dizziness lasted for about 30 minutes after that. She said the dizziness completely resolved. Reported she also got a little tachy (clarified as tachycardia) during the time period she was dizzy. She said she wasn't sure if she became tachycardic because she was worried when she became dizzy. She said the tachycardia resolved with the dizziness. No treatment was received. The events stared from 05Jan2021 and considered as Medically significant. The outcome of the events was recovered on 05Jan2021. Vaccination Facility Type was Hospital. No Vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE was require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Relevant tests was none.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of dizziness and tachycardia. 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.
low grade fever; hard lump at injection site; redness / at injection site; sore at injection site; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced low grade fever, injection site lump, injection site erythema and injection site pain. On an unknown date, the outcome of the low grade fever, injection site lump and injection site erythema were recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the low grade fever, injection site lump, injection site erythema and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received 2st dose of Shingrix and experienced low grade fever, hard lump at injection site, redness and sore at injection site. The all the symptoms were resolved after 1 week of vaccination. The reporter did not consent to follow up.
Patient claimed that after the vaccinations, he experienced double vision to the point that he was not able to drive. He then went to see an optometrist recently and was given new prescription for corrective lenses.
No reported adverse event, however, undiluted vaccine was given resulting in administration error. The patient is informed of the incident and advised.
Rash on neck and upper back, started 1-3-08 after Tdap vaccination.  Flat macules on upper chest/back.  Rash not pruritic, no histaminic flushing of cheeks.  Rash does not appear to be urticarial.
Due to my wife and daughter looking online at websites, and listening to people on social media and other loons. They have stopped speaking to me, communicating, and other things. Due to the fact that I chose to get the Covid vaccine and can't convince them that a report on that website does not actually mean its reliable data or accurate or anything of that nature what so ever. To demonstrate my point I am filling a report and the adverse event and outcome of receiving the covid vaccine was an extremely angry wife who thinks the vaccine is going to A kill me and B cause me to spread covid  and C may result in divorce.
arm hurt for a week; ran a slight fever; She thinks the vaccine was administered too high in her arm and may have hit her bone; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt for a week), PYREXIA (ran a slight fever) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She thinks the vaccine was administered too high in her arm and may have hit her bone) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     The patient's past medical history included Unconscious (patient was found unconscious due to anemia from her bleeding colon.) and Parathyroid gland operation. Concurrent medical conditions included Bleeding colon ulcer, Osteoporosis and Anemia. Concomitant products included FENTANYL for Osteoporosis.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PAIN IN EXTREMITY (arm hurt for a week), PYREXIA (ran a slight fever) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She thinks the vaccine was administered too high in her arm and may have hit her bone). In September 2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She thinks the vaccine was administered too high in her arm and may have hit her bone) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt for a week) was resolving and PYREXIA (ran a slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment to the events not reported. patient has a history of a bleeding colon and  very sick ,can't go to the bathroom like a normal person. Patient  has the bones of a 200-year-old woman after an operation on her parathyroid glands,and has bad osteoporosis. Patient had a recent event  was found unconscious due to anemia from her bleeding colon. She was given 8 pints of blood following this event. Her gastroenterologist wants to perform an operation on her where they will remove a large part of her colon and hospitalize her for almost a month. Her doctor wanted her to get the COVID-19 vaccine prior to being hospitalized.  Patient is not sure if the vaccine was given by intramuscular injection because she thinks it was administered wrong and  thinks that vaccine was administered too high in her arm and may have hit her bone.   Patient thought that after working with animals who had coronavirus her whole life. She thought she would have a natural immunity, but she does not.
fine rash appeared on face & neck 24hr p/vax;itching present;rash cleared by next AM but pt reported feeling flushed & dizzy;the flushed feeling lasted about 6hr;
I had no reactions, other than slightly sore arm, at the time of the vaccination.  Two months later, in mid- December, I experienced sudden, sharp pain in my right hip as I was walking down a flight of stairs.  X-ray reveals no broken bone(s) and no degenerative changes.  I have seen a Physical Therapist twice, and continue working with PT exercises.  I am also continuing to walk, slowly and carefully.  There has been improvement, but I continue to experience sudden sharp pain usual, fast pivots on my right leg, and when walking with a normal stride.   I have no idea if this is related to the vaccine, but there was no other apparent accident or injury prior to the pain.  So, I am reporting it in order for it to become part of the body of data, should other people be experiencing similar event(s).
Swelling and thickening of the tongue and lips, irritation to the throat and roof of mouth.  Benadryl administration on site and regime continued throughout the day at home. F/u with primary care 2 days later due to continued side effects of headache, stomach ache. Nausea and vomiting
Approximately 2 weeks post vax pt experienced a rash on his face and upper chest. About one month later the pt developed generalized rash characterized by over 50 red spots with white heads and a low grade fever. Pt was treated with Aveeno. The symptoms resolved within 48 hours.
unusual generalized twitching repeatedly over 8hr fever 103.3;no other cause for fever;
Systemic: low pulse-Mild, Systemic: Hypertension-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Nurse practitioner from Clinic said it was Vasodilation from the vaccine. Symptoms of numbness/blue around lips, fingers cold, BP was 141-76 and pulse 64 resolve in 45 minutes. EMS was called and they did full check up and patient did not need to be transported to ER.
Approximately 1200 ,Pt answered no to all pre_vaccination questions. Pt. eyes closed and head dropped to right immediately after first dosed of Moderna #0032A21A was given in his in his L deltoid.  Pt immediately came back to arousal after securing pt upright by  his shoulder. STAT call for assistance.  Onsite doctor called STAT site lead RN present Pt stated, Local Ambulance called STAT. ?Did I pass out?? ? Yes you did.?  Pt is AAOx4, color slightly pale, skin normal. Initial VS BP 48/52,P 50, R 18 and regular,,Sat 97%,  Legs elevated on chair. Pt remains alert and talking coherent. 2ND  VS 55/50, P50,R16 and regular SAT 97%. Pt remains fully AAOx4. Stated ?I was very nervous? Onsite doctor now present. 3rd manual checked VS 97/43, HR 60, R18 reg and calm, Sat 97%.  Pt says he did eat but had little to drink.  1 bottle of water given and tolerated well. Pt stated ?my visions was a little blurry and it was difficult hearing but now I am better?. Pt also denies any heart issues or syncope issues. EMT arrived approximately arrived at 1224. EMT report normal sinus rhythm, SAT 100%, all VS WNL. Pt coherent, calm and fully AAO x4.  Pt was advised by onsite voluntary doctor just for caution and further eval to go with EMT to hospital  but pt. stated ?I am ok. I do not want to go to hospital?  Refusal letter was signed by pt.  Pt also denied request to notify his Mom who pt said was waiting in car.  Pt was able to stand without assistance and ambulated to post vaccination sitting area w/o any difficulties.  Pt remained AAOx4 w/o any further issues and was D/C approximately 1pm.  Initial incident was witnessed by nurse vaccinator and report documented by this document was written by Nurse .
Given BEXSERO and MENACTRA. While giving urine sample 5 min later, developed pallor and dizziness. Improved with lying flat with feet elevated. Had not eat anything prior to visit.
pt recvd vax 320PM & 329PM pt closed eyes, head tilted forward, pt became very limp-non responsive; pupils pinpoint; no rigid skin color WNL; resp 40, P120, t97.5-02 administered by mask; transferred to hosp via ambulance; pt crying;
Folicular eczema present 48 hrs after 4 mo & 6 mo shots. No previous history of eczema. Eczema resolved with treatment using steriod cream only, to return after 6 mo shots. No fever.
Syringe-Needle malfunction when technician performing vaccination (incomplete dose). Parent wanted us to consult with patient pediatrician first to consider an additional vaccination dose.  Will be discussing with DR and utilize CDC and ACIP considerations, amount of dose was hard to estimate, likely >1/2 dose.
This spontaneous report as received from a female pharmacist via a company representative refers to herself. In April 2013, the patient was vaccinated with ZOSTAVAX, lot #, expiration date, dose and route not reported. The pharmacist reported that since receiving ZOSTAVAX in April 2013, she experiences monthly episodes of lips tingling, drying and peeling. The outcome of the events was reported as not recovered. The patient had not sought medical attention. Additional information has been requested.
Sore arm 1st Vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm 1st Vaccine dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Neurological disorder NOS and Blood pressure.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm 1st Vaccine dose). In February 2021, PAIN IN EXTREMITY (Sore arm 1st Vaccine dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include BP medicine and medicine for neurological complaints.  The patient experienced soreness of arm, which went away after couple days. No treatment information was provided.   This case was linked to MOD-2021-041291 (Patient Link).
Moderna COVID-19 Vaccine EUA,      My legs were getting sore and tired at work. I sat down to tie my shoe and noted Pitting + 3 or 4 edema to BIL Calves.  Redness , warmth in a few areas.  R leg 1" larger than L.  Then  I mentioned it to another nurse and  she said it could be side affect of Norvasc.  I spoke with my PA about it on 2/12 she D'C'd Norvasc and perscribed  Nefidepine 30 mg ER. I have not taken it yet I am monitoring my BP and it is WNL.   The edema less in calves however continues in ankles.  I have gotten MULTIPLE broken capillaries all over my legs.          Long short it has to be a reaction to vaccine.  And it continues almost 2 months after injection.   I can't wear most of my socks.  It is BAD.
RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 27 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (dose number in series )1.  It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 211A21A, expiry: unknown) dose was not reported, 1 total, administered on 27-NOV-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported. On 27-NOV-2021, the patient experienced received half dose for the booster (vaccine underdose) and off label use (dose number in series 2). HCP (from public health department) stated that there were 33 patients who received half doses (0.25ml) for their booster or 3rd dose. Most of them were patients from different locations. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed, and staff was just not made aware. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201082, 20211201228, 20211201168, 20211200752, 20211200723, 20211200769, 20211200994, 20211201179, 20211202246, 20211202379, 20211201304, 20211201362, 20211201392, 20211201443, 20211201963, 20211202161, 20211202199, 20211202207, 20211201450, 20211200717, 20211201286, 20211201304 and 20211202371.
On the morning of July 2nd, I felt I was getting a sinus infection. My ears were also hurting and I had pain all along my face in the area of my upper jaw. I thought it was a sinus infection. The next morning I felt worse and I felt like an elephant was on my chest. I took an at home test on COVID-19 home test which was positive. I had developed a sore throat also. I called my doctor who prescribed 2 medicines for me because he believed that I had a secondary infection. He gave me a z-pack and methylprednisolone. After the first day, it helped to alleviate the pressure in the chest. I felt fatigue all last week and I was unable to talk. My throat was raw. I had a really hard time talking. I still feel very nasally and I have tiredness and fatigue. I am about 3/4 of the way recovered. I still feel like I have a head cold.
Headache, Myalgia, fatigue, chills, injection site pain/arm pain Narrative:
had shingles / had the shingles vacine/Suspected vaccination failure; shingles / doctors told me to wait 1 year and get a boster shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said that double check, you could get shingles more than once.  The patient sated he/she had Shingles a few months ago from reporting date, the doctors told to wait 1 year and get a booster shot, the patient had the shingles vaccine, so did not get it nearly as bad as most people. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Increased redness, swollen and itchy feeling and pain at the area of the tetanus shot upper left arm, achy feeling in general.
patient received improperly stored VARIVAX; No adverse effect reported; This spontaneous report as received from a register nurse refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  The nurse reported that on 25-SEP-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number R019237 with expiration date 04-JUL-2020 or lot number S005078 with expiration date 19-FEB-2021(the nurse did not knew which lot number was administered to the patient) (dosage, route and anatomical location were not reported) for prophylaxis, which was exposed to temperature excursion of  -14°C to -10°C (-9.74°C) for an unknown time frame, because of data logger. There was no previous temperature excursion. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effects reported.