chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered after being reconstituted with sterile water; Administered after being reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: Reporter's Comments: The healthcare professional (HCP) reported that Hiberix was administered after being reconstituted with sterile water. No reactions was reported. The reporter consented to follow up. The vaccine administration facility was same as primary reporter PII, lot and expiration date was not provided in follow up email. Additional Supportive Information: The patients received Hiberix vaccines reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
The day after the vaccine, reported typical reactions including aches and pains, which improved the following day. The Monday after noted snoring, which was atypical but consistent with the ear infection and seasonal allergies. Sometime on midday Monday 5/24 Pt died.  Was found in his bed at approximately 6pm with rigor already set.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The patient was recommended by my physician for SHINGRIX vaccination. The patient experienced nearly every side effect. The patient did not have information about prescribing doctor's name, phone number, and address at hand. The patient had to go to a meeting but would contact again later in afternoon, at the date of reporting.
Vertigo. Woke up in the early morning with room spinning. Headache. Feeling of nausea. Happened several times throughout the day. Have "foggy head" or "brain fog" today. I have no inner ear problem.  I believe this is related to the vaccine b/c I have had covid and recovered (Jan 2020) and have struggled with brain fog ever since. It took about 7 months to clear 90%. I also have had a dull headache in the back bottom of my head for the same amount of time. I believe these are related as it has also cleared about 90% in the last 7 months.  I chose to get the vaccine to protect against the DeltaVariant and a little over 2 weeks after getting the vaccine, I have the same dull base headache I had for the past 7 months and now I have vertigo. I hope my body is just still processing the vaccine and I do not continue to have this problem.
Left Arm pain and tenderness radiating to neck accompanied by headache, sweats, nausea for 3 days
5:05PM "FEELS LIKE HEART IS RACING." DENIES ANY SHORTNESS OF BREATH, DIFFICULTY BREATHING,N/V, CHEST PAIN, DIFFICULTY SWALLOWING, SWELLING OF LIPS OR TONGUE. ALERT,ORIENTED, PINK W/D, RESP REGULAR WITH EASE. NO RASH OR HIVES NOTED.  5:25PM ALL SYMPTOMS HAVE RESOLVED PT STATES "I THINK I WAS JUAT ANXIOUS ABOUT GETTING THE SHOT".
Two days after the shot in Colorado I began to develop a rash on my right arm at the injection site.  I had flown back to North Carolina where I am on a student rotation at a hospital the day after the vaccine (Sunday 1/17).  Since then (Monday 1/18) the rash has expanded to my entire upper arm and is continuing to extend downwards.  I had swelling for about a day but that went away.  I had some swollen lymph nodes in my axilla and neck but they are no longer swollen.  Now my arm remains extremely itching and red.  I went to the ED this evening and they gave me IV Solumedrol, Pepcid, and famotidine.  The rash went away except for outside of a line of demarcation we made earlier in the day.  This morning I woke up with an intense itching in the arm.  I rubbed my hand over it (didn?t itch it) and the redness  came right back.  It is continuing to expand down my arm.
pt rcvd vax; pt devel herpes zoster & arthritis; Pt physician felt symptoms were due to vax;
1st moderna shot, 48 hr flu symptoms-achy muscles, few chills, fatigue 2nd moderna shot, 24 hr flu symptoms - same
Extreme fatigue for a week that required bed rest (felt like a bad hangover or narcolepsy) Chills
SYMPTOMS DUE TO VACCINE/ UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms due to vaccine/ unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms due to vaccine/ unspecified adverse event was not reported. This report was non-serious.
Pt seen by MD 6JAN92; had rash for 2 days that was spreading & getting worse; Hismanal prescribed;
Patient came in for his first dose of the Pfizer Covid vaccine.  He received his shot in his left arm (given @ 1:20pm on 07/29/2021).  He went to our waiting area for his 15 minutes of observation.  As soon as he sat down he start to have a reaction (1:22pm 07/29/2021).  He became unconscious.  His mother was with him and alerted the vaccinator (pharmacy technician) immediately.  Technician alerted the pharmacist/pharmacy manager.  Pharmacist ran out to check on patient.  I yelled and shook the patient.  He became alert.  He was no longer unconscious at this point.  He began sweating, his eyes kept closing.  He complained of feeling nauseated and having a headache.  Pharmacist immediately called 911.  Paramedics arrived (@ 1:40pm).  They check his vitals.  BP was 80/59. Patient then alerted the paramedics that he had to use the restroom.  He has been having diarrhea for at least the past 3 days.  Paramedics took him to the restroom.  He then was asked to have a seat outside of the restroom where his vitals were done again.  They started an IV and ran an EKG (@ 1:55pm).  Paramedics brought in stretcher and were taking him to the hospital for further observation (@2:10pm).
The mother of a 15 year old male alleges that her son received a dose of Hib in 8/91, at the age of 4 years, and subsequently developed mental retardation. In 1/87, 3/87, 9/87 and 8/91, at the ages of 2, 4 and 10 months and 4 years respectively, the child received doses of DTAP. It is alleged that, shortly after he received the vaccine doses in 1991, his language abilities, emotional affect and overall ability to function gradually regressed and deteriorated. It is alleged that he is mentally retarded; he is unable to care for himself, cannot learn to read or write, injures himself, is often hostile or violent toward others and is incapable of normal emotional interaction with others. This event was considered "Medically Important". No further information was available at the date of this report.
Menactra, Gardasil, Hep A (Vaqta) given 7/13/07. Left here, shortly after felt disjointed and blank stares. At approx 2250 came home found to have tonic-clonic approx 45 sec sz with heavy breathing and frothy. 911 called admitted x 2 nights. 7/19/07-records received: Seizure likely secondary to vasovagal reaction. After vaccine felt a bit disjointed and had a somewhat blank stare. Clonic movements, snorting and grunting, frothing at mouth. Travel to Caribbean 2 weeks prior. Headache. Neuro exam WNL. Assessment:Generalized tonic clonic seizure status post vaccines. Most likely a reaction of one of the vaccines.
On an unspecified date, the pt received a dose of Lymerix which did not go into arm. On 4/5/99 at 11:30 the pt received her third dose. 90 minutes later, she experienced severe chills, body aches, fever, fatigue and malaise. The pt went to bed. As of 9/25/00, the outcome of the events is unresolved.
KICKED MY BUTT BADLY FOR 12 HOURS; FELT LIKE GARBAGE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced kicked my butt badly for 12 hours. On APR-2021, the patient experienced felt like garbage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from kicked my butt badly for 12 hours, and felt like garbage. This report was non-serious.
Contracted transverse myelitis-acute symptoms occurring on 1-23-10, took 1 hour to cause paraplegia from first symptoms. Treated with Prednisone steroids and Physical rehabilitation.
some adverse events; Missed vaccine appointment; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (some adverse events) and PRODUCT DOSE OMISSION ISSUE (Missed vaccine appointment) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (some adverse events) and PRODUCT DOSE OMISSION ISSUE (Missed vaccine appointment). At the time of the report, ADVERSE EVENT (some adverse events) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed vaccine appointment) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Additional event reported (some adverse events).
Breakthrough COVID-19 infection. Extremely symptomatic for 2 weeks, though no hospitalization was necessary - no drop in O2 saturation. Lots of coughing, fatigue, malaise, brain fog; no fever. Probably one of the top 3 worst illnesses I've ever experienced, the other 2 being mono & pneumonia.
Following vax pt felt dizzy; instructed to lay down on exam table; lt side twitched; mom states pt has done this in the past p/stress/painful stimuli; pt recovered w/in 10-15 sec;
03/31/2022: I had a very slight scratchy cough, some chest tightness and a sore throat. I took a rapid test and PCR test on 04/01/2022. Both tests came back positive. I ended up having a severe sore throat, a cough and some wheezing. I had mild difficulty breathing, congestions and earache. I experienced headaches and did eventually lose my taste and sense of smell. I did take cough medicine and Mucinex, Tylenol and Zyrtec, Ibuprofen and Albuterol. I spoke to my doctor on 04/04/2022 and she prescribed Paxlovid. 04/08/2022 I tested positive. I took another rapid test on 04/12/2022 and it came back negative.
My knees hurt real bad; my lower legs are swollen up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, (again confirmed the name of vaccine as Pfizer Covid-19 vaccine: Consumer stated, "Yes, I had both the vaccines and one booster.")), for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, (again confirmed the name of vaccine as Pfizer Covid-19 vaccine: Consumer stated, "Yes, I had both the vaccines and one booster.")), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "My knees hurt real bad"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "my lower legs are swollen up".  Additional information: The patient was also the reporter. This report was not related to a study or programme. Covid-19 vaccine was a Pfizer product, manufacturer was unspecified. Patient characteristics, batch/lot number, NDC, UPC number and expiry date of Covid-19 vaccine was unknown. The reporter wanted to know the symptoms about the reaction to the virus shot and the side effect to the Pfizer shot. The patient had taken both the vaccines and one booster. The Patient knees hurt real bad and lower legs were swollen up and wanted to get it fixed, purchase details and other details were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash that itches; Hives are still bright and red, they are not on my face anymore or my neck, just my chest; Scalp itches something awful/back of legs itch/ankles itch/fingers itch; Redness on my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included losartan and atorvastatin for blood pressure high. The patient reported that they were having a mild, they believe reaction. They were not in anaphylactic shock, their face hasn't swollen 'up to size' (not clarified), nothing like that. They have a rash that itches, have hives on their chest, but their scalp itches something awful, the back of their legs itch, their ankles itch, and their fingers itch. They don't have any swelling, but they do have redness on their arms, well they did last night. The redness of their arms is gone, but the hives are still bright and red and they are not on their face anymore or neck, just the chest. The events occurred on 30Jan2021. The patient took antihistamine as treatment for the events. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
No symptoms reported; patient received unspecified dose of either a VARIAVX or a PROQUAD dose that was improperly stored; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not provided.        On 05-FEB-2020, the patient was vaccinated with an unspecified improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S025610 had been verified to be a valid number; expiration date 18-AUG-2021) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number S017250 had been verified to be a valid number; expiration date 01-DEC-2020); both vaccines for prophylaxis (strengths, frequencies, route of administrations, and anatomical locations were not reported). It was reported the use of properly stored sterile diluent (DILUENT MRK). It was reported the temperature excursion was at 7.5 Fahrenheit (F), for a time frame of 15 minutes, not had previous temperature excursion. It was reported that the call was due to a data logger. No symptoms reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA007010: US-009507513-2003USA007093: US-009507513-2003USA007189:
No additional adverse events.; HCP called in and reported that an expired MMR-II vaccine was administered.; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-AUG-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot #T020656, expiration date: 16-JUN-2022, (strength, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis (Expired product administered). No adverse events were reported.  .
Patient developed Rash as palpable wheals in Forehead to temporal sides, crying a lot as feeling uncomfortable 10-15 minutes after shots, however vitals stable. given 1 dose of Benadryl, ibuprofen. Recheck patient in 30 minutes, She was calm, returned to baseline. Recheck with mother of pt next day, doing well.
11/08/2014 - 4AM, Vomiting. 11/08/2014 - 11/10/2014 - Fever (101). 11/09/2014 - 4PM, Hives.
PARALYZED; WOULD HAVE DIED; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter reported that, "He know of a girl that after about a month suddenly became paralyzed and would have died if someone had not been there at the time." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the paralyzed and would have died was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220157373-covid-19 vaccine ad26.cov2.s- Paralyzed,Would have died.This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event
Friday, April 2nd, in the late afternoon, I began to feel very weak .  I had difficulty breathing throughout the night.  Saturday, April 3rd, from the moment I woke, I had difficulty focusing due to severe dizziness and extreme weakness, unable to function normally.   Shortness of breath continued and I remained in bed throughout the day.  Today, April 4th, I am stronger, but unable to physically do more than necessary because of tiring easily with the weakness.
SOME BLACK AND BLUE BRUISING AT INJECTION SITE COINCIDING WITH DIRECTION OF BANDAID THAT WAS APPLIED.  AREA IS LARGER THAN THE BANDAID AREA.  THERE WAS SOME SLIGHT SWELLING IN A WHITE AREA IN THE CENTER THAT COINCIDED WITH THE BANDAID PAD IN THE CENTER OF THE BANDAID.  NOW THE AREA IS MAINLY BLACK AND BLUE LIKE A BRUISE WHICH IS LARGER THAN THAN THE BANDAID AREA.  I DO NOT BELIEVE THIS BRUISING IS ANYTHING SERIOUS BUT I WANT TO REPORT IT DUE TO MY MYASTHENIA GRAVIS AND MEDICATIONS I AM TAKING.  OVERALL, I DO NOT BELIEVE THIS SHOULD PREVENT ME FROM RECEIVING A SECOND DOSE ON APRIL 1, 2021 AND I BELIEVE THE BLACK AND BLUE WILL EVENTUALLY SUBSIDE.
This is a spontaneous report received from a contactable consumer (Patient). A 74-year-old non pregnant female patient received first dose of BNT162B2 (COVID 19, Formulation: solution for injection, Lot number: EN6201, Expiry date: unknown) via an unspecified route of administration in right arm on 12Feb2021 at 12:00 AM as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. On 15Feb2021, the patient experienced severe muscle pain for over a week now. The patient took Ibuprofen for the event. The outcome of the event was unknown. The outcome of the events was not recovered
No adverse effect has occured and patient will be followed up on. Reported as patient is not 18 and received the Janssen Covid 19 vaccine
After the Phizer COVID-19 booster I got the expected side effects of a sore arm at the injection site, some headaches, bad muscle aches and highly sensitive and aching skin. These side effects occurred about 1 day after the injection. I had the same side effects after the 2nd dose of the Phizer vaccine. With the second dose of the vaccine the side effects went away after a couple of days. However, after the booster injection not all side effects have gone away. The injection side pain and the bad muscle aches largely went away but the skin issues remain. It has now been about 6 weeks.  The skin problem can happen anywhere on my body but it is most noticeable on my arms and legs. The legs are the most persistent. In my legs I have stinging skin pain and pins and needles feelings. The stinging at times gives the sensation of my legs being hot. The leg stinging skin is made worse by clothing touching my skin. The pins and needles feeling is worsened during hotter weather. Since the event started I have had my arms? skin badly ache and feel very sensitive to the touch along with pins and needle feelings. No visible skin rashes have been observed.
A spontaneous report from a physician was received and concerns a female patient of unspecified age who received a dose of oral VIVOTIF (batch number 3001880) on an unspecified date. The patient's medical history and concomitant medications were not provided. On an unspecified date the patient developed swelling of the ankles, abdominal pain and raised dots all over her body. At the time of this report, the outcome was unknown. The events were considered non-serious. Follow-up information received on 07.Apr.2011: 3 unsuccessful attempts were made to obtain information from the reporting physician. The case is now closed.
Her R arm is swollen, warm, painful, and erythematous. Approximately 6-7 cm in length, warm to touch, erythematous, clear demarcation of swelling. No fevers or chills, has been feeling well.