chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician. A patient of an unspecified age, gender and ethnicity received the first dose of PREVNAR 13 intramuscular in the arm on an unspecified date at 0.5 ml single. The patient medical history and concomitant medications were not reported. The patient developed a large red area where shot was given (non-serious) on an unspecified date for one week. The patient recovered from the reported event on an unspecified date. Follow-up (06Mar2015): Follow-up attempts completed. No further information expected.
PATIENT PRESENTED BACK TO PHARMACY WITH LARGE REDDENED AREA AT SITE OF INJECTION.
Pt. was given DTAP & Influenza, woke up with hives all over. No difficulty breathing, Skin - extensive hives all over. No significant local reaction at vaccine sites.
The morning after I broke out in hives on my legs after taking a run. I?ve never had hives before in my life. I took Benadryl and they went away.  On Tuesday the 2nd after a run again, I had a smaller outbreak of hives again. They went away on their own.
PT  INITIALLY INDICATED HE WAS TO RECEIVE BOOSTER DOSE (0.25ML)....PT WAS QUESTIONED OF NAME, DOB, VACCINE, AND ALSO NUMBER IS SERIES OF DOSING, PT AGREED DOSE WAS BOOSTER TO VACCINATER......UPON BILLING CYCLE REVIEW, IT WAS UNCOVERED PT WAS IN NEED OF DOSE #2. ....PT WAS CONTACTED, AND RECEIVED ADDITIONAL  0.25ML 2 HOURS LATER TO COMPLETE 2ND DOSE IN SERIES  (0.5ML)
Itchy, raised rash/welts at injection site.  The reaction occurred 8 days post injection. The raised area was circular with clear borders.
he does not feel well; muscle pain/ muscle soreness; fatigue; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (he does not feel well), MYALGIA (muscle pain/ muscle soreness) and FATIGUE (fatigue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced MALAISE (he does not feel well), MYALGIA (muscle pain/ muscle soreness) and FATIGUE (fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, MALAISE (he does not feel well), MYALGIA (muscle pain/ muscle soreness) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No relevant concomitant medications were reported.
Patient recieved the vaccine at 11:30 am on 1/21/02 in our clinic setting. She stayed about 15 minutes with no reaction. This was her first flu shot. At 5:00 pm she developed a solid, pink, itchy rash beginning at the navel spreading to her back and then to her shoulders. She went to a local walk-in center and received p.o. benadryl, IM Steriod and methylprednisolone p.o. to take at home. At 11:00 pm she felt her throat was closing up. She went to the E.R. and was treated with two benadryls and watched for 1 1/2 hours. Symptoms subsided. She was discharged from the E.R. and was to take benadryl q 6 hours for 48 hours. She was fine until 1/22/03 in the evening and her feet broke out into a rash and were itchy. She took a benadryl and it subsided. 1/23 and 1/24 she has been fine. Please let me know any thoughts you have. I told the patient I would get back to her with any feedback you have. Would you suggest any precautions with future vaccinations? I am very interested in your thoughts. Thank you.
I noticed numbness in my arm within minutes after receiving the Moderna dose 1. I didn?t think anything of it, and took two ibuprofen for the pain. The next morning, my arm felt stiff and painful. I took two more ibuprofen. Around 3 or 4 pm (just over 24 hours after initial injection), there was a red circle, about two inches in diameter around the injection site. The area was a hard, tender bump. I iced the bump for about two hours, off and on, from 6 PM to 8 PM.
Right arm was slightly sore on 2/1/19 when patient received vaccine, then very little soreness for the next two days. On 2/4 the patient reported that it was very sore and hard to lift her arm. No redness or swelling were present, no fever, headache, or chills either. She came into the pharmacy today 2/5, and the pain is still bothersome but slightly better. I counseled patient to take Acetaminophen for the next 24 hours and report to her doctor if the pain worsens.
Rash; Spots on arms and legs; Itching rash; Spots on arms and legs; Weakness; Muscle weakness/left side of body, left leg was weak on the left side, at the toes, the upper leg; Not feeling well; I threw up/ vomiting; discomfort when I eat something in my stomach; Nausea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 81-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 17Apr2021 (Batch/Lot Number: EW0169) as dose 1, single for COVID-19 immunization (at the age of 81-years-old). Medical history included osteoporosis from an unknown date and unknown if ongoing. The concomitant medications were not reported. It was reported that the patient received first dose of vaccine and patient experienced rash, spots on arms and legs, itching rash, weakness, muscle weakness/left side of body, left leg was weak on the left side, at the toes, the upper leg, not feeling well, I threw up/ vomiting, discomfort when I eat something in my stomach, nausea on Apr2021. "The patient wanted to know about the rash because she got lots of spots on her arms and her legs and she don't know if they come from the COVID19 shot. They look like circles but she don't know if they just, that they always there, but taken the COVID19 shot, it broaden our it. Just seems like Pfizer broad them to head. You know like broaden upward so she have rash to her. It look like a rash. All she has been itching today. She did not have feel the itching yesterday like this and she was so used to go out to. She just assume somebody's sting bite from the grass. She was not sure when she read this as soon as possible, did a check it and read it. That's one of thing she was calling about and the other was the weakness, the muscle weakness, not for they gave her shot but the let you know it's like and she was not feeling well. She wanted to know about the side effect as she have took the vaccine the first dose on 17Apr2021 and she had not feeling well since then but don't know if what is in this that was causing the problems, because she have a left side of her body, her left leg was weak on the left side, at the toes, the upper leg and it seems like the stomach, her stomach she threw up the first 3 days couple of days later she threw up but that's left she don't have that vomiting what she do have was discomfort a gist discomfort when she eat something in her stomach and she don't know if that's on the same basis of nausea or not but anyway there was discomfort there and she was wondering which one of the items in this vaccine is causing that. So, if it's in the vaccine then I'll know that it's bad and how long does this symptom last after we take the vaccine because she was scheduled to go and get the other one on Sunday and she don't know whether she should because she still have these side effects and if this was true side effect that was what she wanna know". The patient not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Within 2 hours of my 2nd covid injection on 6/15/2021 at 4:30pm, I had serious vertigo and had to lie down. I became almost unconscious ( I could hear what my husband was telling me but I could hardly talk, due to the lack of energy, my body was completely limp, I could not move any part of my body). I hardly slept the first night, I felt sick and couldn't eat or even drink water without feeling nauseous or vomiting. When I got up to go to the bathroom in the morning of 6/16/2021, I fainted and my husband found me unconscious in the bathroom. After I became conscious again, he brought me back to bed where I stayed all day. I couldn't lift my head without having terrible vertigo, and feeling I was going to faint again. I had a strong headache as well. The following day 6/17/2021, the symptoms started to be less strong and by 6/18/2021, the symptoms and vertigo had almost gone.
Initially received Influenza Vaccine, then went and had a PPD administered. Approximately 5 minutes later she became faint and passed out. Administered Ammonia and woke up immediately. Able to drink some juice and ate crackers.
After the 2nd dose I started noticing I was experiencing some gastrointestinal issues that were getting worse like GERD. I was burping up a lot of acid and had weird stomach issues I couldn't explain. A few weeks ago i got really sick out of nowhere and my diet or nothing had changed. I went to the ER and they gave me steroids and said I had pancolitis (inflammation all over my intestines). I went home and Took the steroids and got worse. I was pooping blood and fat and couldn't keep anything down, either throw it up or poop it out. I went back to the ER and was admitted for a week and now on heavy steroids. They said the pancolitis got worse and the steroids they gave wasn't helping.
Felt outside of my body, hazy, not myself, now I am nausous, sweaty,  for the last two days (3/21 - 3/22) Just feel yucky.  Have not gone to work.
bell's palsy; This is a spontaneous report from a contactable consumer (patient) reported for himself. This 69-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration 26Mar2021 at 13:15 (lot number: er8723) on the left arm as single dose for COVID-19 immunization. Medical history included severe arthritis. No known allergies. Concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 at 11:45 AM (lot number: en6205) on the right arm as single dose for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The patient did not have Covid prior vaccination and did not have Covid test post vaccination. The patient experienced bell's palsy on unspecified date (reported as 07Mar2021 at 01:15PM) that resulted in emergency room/department or urgent care. Treatment received including unspecified medication for the event. The outcome of the event was unknown.
12/22/21 - in the morning around 9 am or so, I noticed that the palms of my hands were extremely itchy. It was so bad that I had to put an ice pack on them to calm them down. I also applied hydrocortisone cream to them which did help. Each morning after that, the same thing was happening. But then a few days later, it wasn't only the palms of my hands, it was also the soles of my feet. My hands and feet would itch at the same time every morning. I would put an ice pack on the itchy spots and apply hydrocortisone. Then on 12/29/21 around the same time, 9 am or so, my hands and feet started itching really bad and after about an hour of that, my back started itching extremely bad. I lifted my shirt and found hives in the spot it was itching. I got in the bath to try and calm my skin. The hives on my back quickly went away and the the skin under my breasts started itching really bad and again, there were hives. I took Benadryl at this point and everything went away. I now have to take Zyrtec every day and a half to keep from getting another outbreak of hives and itching. I wait until I start feeling the itchiness to take the Zyrtec and it is every day and a half on the dot that I need to take it.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 05-FEB-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 17-DEC-2015; dosage and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt devel inj site rxn of swelling & erythema; tx: Atarax; prednisone & ceftin
Muscle pain at injection site, fatigue, became very cold without chills, fever, headache, nausea, head fog
I woke up with a sore throat, low grade fever 101.7, chills, and weak. As the day progressed, I didn?t feel well. I tested positive for COVID-19 when I went to the clinic. She then prescribed me Paxlovid. For about 2 weeks after I developed an unproductive cough.
Cellulitis around the area of Varivax (per LPN) administration warm, tender, red mass. Treated with Keflex as precaution for secondary to infection.
This spontaneous report as received from a pharmacist refers to six adult patients of unknown age and gender. The reporter stated that she administered (Merck) PROQUAD, (0.5 ml, subcutaneous, frequency was reported as once, lot# not reported) on an unspecified date to the six adult patients (inappropriate schedule). No adverse event was reported. Additional information has been requested.
Induration and erythema at IM injection site approximately 4.5 to 5 cm. Also increased warmth.
a patient received Ipol vaccine at 2 month, 4 month, 6 to 9 months and fourth dose at one year of age too early and should have been at age 4 to 6 years, No AE; Initial information received on 23-Jun-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 12 months old female patient who received a fourth dose of IPV (VERO) [IPOL] (batch number and expiry date not reported), via intramuscular route and in an unknown site of administration for prophylactic vaccination on 19-Jun-2020. The patient also received IPOL, at the age of two months, four months and six to nine month batch number and expiry date not reported), via an unknown route and site of administration for prophylactic vaccination  on an unknown date.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HIB VACCINE (HIB VACCINE) for prophylactic vaccination.  It was a case of an actual medication error case due to Inappropriate drug dose administration interval too short.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Fevers, nausea, vomiting 2-3 hrs after administration, swollen arm 2 days later. Continued fevers and vomiting for several days. Today 3/27/2023 reports fatigue, muscle weakness, joint pain she attributes to getting the vaccine.
The day after shot Covid like symptoms. The nest morning Stroke like symptoms required hospitalization for two weeks. I was wobbly and could not drink water without asperating. Symptoms still persist today..Extensive testing showed no stroke occured.  Prior to shot, I was tested for antibodies from a Covid infection 7 months ago. The antibodies where still very strong. I gave in to peer pressure and got the shot with my doctors approval.
1wk p/vax pt devel stiffness in lt elbow progressing to lt wrist then to rt arm & wrists;It has progressed to stiffness in all joints, difficulty getting out of bed;Annual follow-up dated 10/27/00 provided no additional data
FOR THE PAST TEN DAY, I HAVE BEEN STRUGGLING WITH SHORTNESS OF BREATH.
Pt states that his neck to elbow and rib cage area under his arm are all very sore with muscle ache. Had improved in the 72 hrs post injections but was still very uncomfortable.
Diverticulitis; A spontaneous report was received from a consumer concerning a unspecified age, female patient who received Moderna's COVID-19 vaccine and was hospitalized for diverticulitis.   The patient's medical history was diverticulitis.  Concomitant product use was not provided by the reporter.  On 28 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   The patient experienced diverticulitis (preexisting condition) since an unknown date due to which the patient was hospitalized on 21 Feb 2021. The vent diverticulitis was considered medically significant.  Treatment for the event included blood transfusion.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event diverticulitis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; however association is confounded by medical history of diverticulitis
Initial unsolicited report received from a consumer via other company on 3 December 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of Flu shot (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient also received XYREM as a co-suspect, on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced mononeuropathy and polyneuropathy from flu shot. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, company assessed the event of polyneuropathy as serious and important medical event. List of documents held by sender: none.
pt recvd vax & vomited, became very cranky & shakes; intermittent vomit; pt had 2 days of fever;
This patient's left arm (where the shot was given) broke out in a rash from her elbow to her shoulder. She took oral Benadryl and rubbed Cortisone cream on the rash to prevent itching. It went away in 2 1/2 days.
Pfizer.  My right hand was swollen up like a catchers- mit.  Very painful in thumb joint at a level 10.  Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2)  Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live.  Have had arthritis in this thumb but not for approximately 8 years.  Entire hand was swollen and not useable.
On 03/26/2021 medical assistant saw patient for an iz update. Medical Assistant gave patient a varicella vaccine. Medical Assistant explained that at the time of the visit the full record was not uploaded and she accidentally did not see the record on the chart. I MA supervisor talked to Medical Assistant about this incident. I retrained her on the process to follow when she has to give a vaccine. I explained that she has to double check our immunization history on chart and database, if she can not find any record in database or immunization history she had to double check the chart to see if there is an immunization record. Medical Assistant gave verbal understanding of information given and she called the patient to inform parents of the mistake and to schedule another appointment for missing vaccines.
36  year old male with hx of hypertension , asthma,  schizophrenia . he recieved  Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14  and on 4/15 he was found  by his father unresponsive then sent to the hospital.  Pt was diagnosed with  massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis ,  hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried  from massive pulmonary embolism  within 48 hours after admission.
Mother called clinic the day after 1 year vaccines (Var, MMR, Hep A) were administered to report that on the evening of the day on which the vaccines were administered, the patient "became red and developed difficulty breathing."  Mother rushed pt to the PER.  Mother was told by PER that pt had "had a reaction to the vaccine."  Mother was given a prescription for Benadryl and Prednisolone, but she did not fill prescription or give txmt because "she wasn't sure she should."  Mother told by PA at clinic, to get prescription filled and give medications as directed and to bring patient to clinic on 6/11/08 for an evaluation.  At time of this phone call (the day after reaction), mother reported patient "is better today, no respiratory problems, only small area erythema at injection site."
pt recv vax & 1/2hr devel swelling, erythema & discomfort @ site;condition progressed from shoulder to elbow;pt also had faint tingling & numbness in lips;
Joint pain, bone pain, chills, fatigue.  The joint pain and bone pain lasted 24 hours - 7 out of 10.  Lasted but to a lesser degree until 48 hours.  Chills and fatigue lasted 36 hours   Treated with Advil 2 tabs q 6 hours.
Slight swelling on right side of cheek; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Slight swelling on right side of cheek) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Slight swelling on right side of cheek). At the time of the report, SWELLING FACE (Slight swelling on right side of cheek) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
4 days after my vaccine, I was heading home when my left arm and left leg began to feel a slight tingly, I began to get light headed and naucious as well as having very deep breaths. Then I started to feel pressure in my chest. As the night persisted the pressure got worse and my breathing continued to get more shallow and deep.
30 minutes after second shot I was dizzy and very fatigued. Every day since I have had a headache, dizziness, brain fog, spacey. Today is two weeks since my second dose. My anxiety is out of control and had panic attacks for the first 5 days.
ON FEBRUARY 11, I AWOKE WITH A RUNNY NOSE WITH HEADACHE, EYE ACHE, TEOOTHACHE ON RIGHT SIDE OF MOUTH--UPPER AND LOWER.  I ALSO FELT A COLD SORE COMING ON.  I TOOK SUDAFED PE AND VALCYCLOVIR, WHICH USUALLY SOLVES THE ISSUE.  THESE SYSMPTOMS CONTINUED AND I CONTINUED WITH SUDAFED AND VALCYCLOVIR.  I SAW MY DENTIST ON FEBRUARY 11 AND WAS TOLD THERE THERE WERE NO ISSUES AND PERHAPS THE PAIN WAS CAUSED BY SINUS ISSUES.  I INCREASED THE VALCYCLOVIR TO THREE TABS A DAY RATHER THAN ONE.  THE TEETH ISSUE SPREAD TO THE LEFT SIDE OF MY  MOUTH AND  TWO MORE COLD SORES APPEARED, ANOTHER ON MY UPPER LIP AND ONE AT THE EDGE OF MY LEFT NOSTRIL.  I HAD A ZOOM MEETING WITH MY DOCTOR ON MARCH 1.  SHE INCREASED THE VALCYCLOVIR TO 1000M. THREE TIMES A DAY.  THE COLD SORES HAVE DISAPPEARED, BUT THE OTHER SYMPTOMS CONTINUE, BUT THE PAIN HAS LESSENED SOMEWHAT.  I TAKE TYLENOL WHEN THE DISCOMFORT BEGINS TO INTERFERE WITH MY DAILY LIFE.