chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning an 11 year old female with asthma, a strawberry allergy and cat allergy who on 04/13/2001 was vaccinated with a first dose of hep b vaccine IM in the right arm. Concomitant vaccination included a dose of MMR received on 04/13/2001, SC in the left arm. Concomitant therapy included montelukast sodium, fluticasone propionate, and albuterol. There was no illness at the time of vaccination. The licensed practical nurse reported that 24 hrs after the pt received the vaccinations she experienced alopecia. The licensed practical nurse reported that the client presented on 04/16/2001 with alopecia in the center of her head. The nurse reported that this was the client's first injection of hep b vaccine recombinant and MMR. In follow-up the licensed practical nurse reported that 24 hrs after vaccines, there was an abrupt onset of hair loss centrally, in a line along the sagittal suture. She report that the roots came out too and the area was 2-3cm wide and 5-6 cm long, total alopecia in that area. The licensed practical reported that as of 05/09/2001, the hair is starting to regrow. In follow-up the physician's office reported that as of 09/26/2001, the hair has regrown. No further info is available
virtually no record for review; it appears to have been unexplained crib death same day as dtp; SIDS death;
Patient came back to pharmacy reporting that she has pain/soreness in her arm next day and it has not gone away so far.
On 7/3/2022 My throat became very tight and it became very hard to talk. I believe I ran a fever of 100.5 for about two days. I also had a nasty head cold develop as well. I also had an ear ache that came along with non-severe headaches. The fever was gone and I felt pretty good by 07/13/2022, however, I still had a deep cough and a lot of congestion. I also had been taking Mucinex since the beginning as well. I reached out to my PCP office and the told me to stay well hydrated and contact them again if symptoms persisted or became worse. The nurse I did talk to said that the shots are doing their job and keeping me from getting very sick.
Left deltoid, area were 5th DTAP given. Very swollen, but to touch, painful. Child fine otherwise per mother.
Raised, itchy red bump at injection site. About 1 inch in diameter, hard to the touch. Was 26 weeks and 4 days pregnant at time of injection.
Patient experienced lazy behaviors after the vaccines.  He slept all day and all night.  When he awoke he was a different child.  He was not making sounds or smiling anymore.  He was diagnosed as autistic on Jan 3 2007.    2/5/08 Reviewed vax record & database corrected. 2/21/08 Reviewed developmental pediatrician notes of 1/3/2007 which reveal patient experienced clumsiness, frequent falls, rocking, hand slapping, hand wringing, starring, poor eye contact, poor social & play skills, unusual noises but very little speech (uses simple signs) , grossly hypotonic, severely bilaterally internally rotated feet, poor balance, delayed gross motor skills, poor protective skills.  Referred to behavioral specialist, nutritionist, parent trainer, OT/PT/ST. FINAL DX: Autism spectrum disorder.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX (batch number 9277N, expiry date unknown) for prophylaxis. On 29th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 29th January 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm and experienced arm pain since the day of injection and continues to have this pain. This was especially present when lifting the arm. The batch number of Shingrix was reported as 9Z77N, which was corrected to 9277N as per sales data sheet.
pt stated that she had no adverse reaction to the TD pt was given her TD sooner then she needed it to be. PT had her TD back in 2019 but in my system it said she was still due for it. then when i gave the pt the TD and went to put it into system it said she was given the TD vaccination back in 2019. PT was called and notified
Slight injection site pain following morning (2/6). By late evening 2/6 approx 1830 hours, my joints ached and I got very sleepy. Generally just felt worn out. Went to bed and woke up 2/7 perfectly fine. No more fatigue or aching joints, just slight injection site pain for a couple more days.
2nd dose: Fever; extreme chills; all over muscle aches; loss of taste; extreme fatigue; upset stomach; dehydrated; weakness; loss of appetite; chest tightness; feel like a panic attack; This is a spontaneous report from a contactable Other Healthcare Professional, the patient.  A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), intramuscularly on 19Jan2021 at 11:00 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient has no allergies to medications, food, or other products. Historical vaccinations include the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686) on 30Dec2020 at 19:00 intramuscularly as a single dose in the right arm for COVID-19 vaccination after which the patient experienced fatigue, muscle soreness in neck and shoulders and vaccination site pain. The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MIDOL) and ibuprofen(MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 19Jan2021 at 23:30 she began to experience fever, extreme chills, all over muscle aches, loss of taste for a day ,extreme fatigue, upset stomach, dehydrated, weakness, loss of appetite, chest tightness that would come and go making it feel almost feel like a panic attack. She further stated that she has lingering side effects such as extreme fatigue, muscle aches and chest tightness after day three of receiving this second dose that comes and goes. Currently on day seven and still have those lingering three side effects. Fatigue has been extreme at times. The patient did not receive any treatment for the events. The clinical outcomes of the events Fever, extreme chills, myalgia, loss of taste, extreme fatigue, upset stomach, dehydration, weakness, loss of appetite, chest tightness and panic attack were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107223 Same reporter, Same product, Same patient, same and different events (First Dose)
MMR/VARIVAX/PREVNAR given 6/19/18, 6/27 went to ED with febrile seizure resolved without medications.
Pfizer 3/2 and 3/23. Positive on 9/15
Beginning afternoon of Feb. 26, chills, fever of 100, fatigue for about 14 hours. Slight headache and some fatigue morning of Feb. 27. Improved and feeling back to normal by afternoon of Feb. 27. Took ibuprofen and acetaminophen alternately every 4-6 hours after the vaccination on the evening of Feb. 25, 2021.
1 of 2 pts vaxed from the same vial exp a red, hot, tender, swollen arm 18-24 hrs following vax lasting 3-4 days; no tx initiated; no culture taken & no drainage; pt recovered;
Last shot I got I had all flu symptoms for 12 hrs; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves an adult female patient who reported last shot she got she had all flu symptoms for 12 hours (influenza), while she received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) patient stated that last shot she got she had all flu symptoms for 12 hours (influenza). Weird but true.  Details of laboratory data were not reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
3/4 vaccination 3/5 I was extremely tired, lethargic, feeling really wiped out. I didn't do anything that day. This occurred on the 6th, 7th, 9th, 10th, 17th, 22nd, etc. with the extreme fatigue.   I remember the afternoon of the 22nd, I saw the doctor, every bit of energy was gone. Just not feeling well past that date but I didn't write those dates down  I rested and did not see the doctor.  *questionable if had COVID in fall 2020
Hurt in her arm after the second shot of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hurt in her arm after the second shot of vaccine) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Hurt in her arm after the second shot of vaccine). At the time of the report, PAIN IN EXTREMITY (Hurt in her arm after the second shot of vaccine) outcome was unknown.            Concomitant medications were not reported. No treatment details were reported.
6/13/11 On examination per Dr. - (Lt) deltoid mild tenderness and warmth. No significant swelling noted. 6/15/11 Exam of left deltoid mild swelling no warmth or redness, pain on palpation movement. Headache persistent and some nausea.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: en6205), on 30Mar2021 as dose 2, single (Lot number: er2613) and on 05Dec2021 as dose 3 (booster), single (Lot number: fj1621) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ADVAIR; ALBUTEROL [SALBUTAMOL]; NITROFURANTOIN. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Negative, notes: Tested negative on 07May2022 only to get sick with COVID again and test positive on 11May2022; (11May2022) positive, notes: Tested negative on 07May2022 only to get sick with COVID again and test positive on 11May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 01May2022 to 05May2022for the treatment of COVID-19. Other medication in 2 weeks included Advair, Albuterol, Nitrofurantoin and Vitamins.  No follow-up attempts are possible. No further information is expected.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  This report is for patient #2   This case was linked to MOD-2021-133518, MOD-2021-133557, MOD-2021-133558 (Patient Link).
Nasal Hemorrhage (Spontaneous) lasting around 30 minutes and again the following day.
Menveo was reconstituted with  non-GSK sterile diluent; Menveo with wrong diluent administered; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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: GSK receipt date: 21-Jul-2022 Reporter's comment: The nurse reported that a patient was administered Menveo powder after it was reconstituted with a non-GlaxoSmithKline sterile diluent. The reporter stated that the facility's office manager would had the relevant information for the adverse event report. The reporter consented to follow-up via postal.  Additional supportive information: The patient was administered Menveo powder after it was reconstituted with a non-GlaxoSmithKline sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
When going home from well visit from dr. office patient started complaining of severe headache and holding head, nausea, vomiting, weakness, achy, rash on hands, abdominal cramping.  Patient was taken to the emergency room by mother where he was treated and released.
Student c/o itching and warmth to L arm along with pain after H1N1 injection. Ice applied and mom notified. VS monitored. Cough began and student placed in supine position with feet elevated. BENADRYL given after itching and warmth noted. C/O dizziness - continued to monitor VS. C/O CP and nausea.
Myalgia, Arthralgia, NauseaVomiting, RIGHT ARM PAINAND SWELLING, CHILLS, SHOOTING PAIN IN BOTH LEGS, FATIGUE Narrative:  Other Relevant History:
Dose administered after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. On 29-Oct-2021, fourteen doses were administered. Date the vial was initially stored in the refrigerator is 16-Sep-2021. The vials did not undergo any temperature excursions.   This case was linked to MOD-2021-011631, MOD-2021-378412, MOD-2021-391847, MOD-2021-391849, MOD-2021-391850, MOD-2021-391851, MOD-2021-391852, MOD-2021-391853, MOD-2021-391854, MOD-2021-391856, MOD-2021-391857 (Patient Link).
Swollen lymph nodes under left armpit.  Bad headache  Joint pain Muscle pain Chills but no fever  Tired
losing their hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but manufacturer unknown), for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "losing their hair".  Additional information: Caller called in and said her sister and several inmates and other inmate women got the Pfizer covid-19 booster and they started losing their hair.  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.
The skin around my ring finger became very itchy. In the afternoon, (3:00) the skin on my right wrist on underside became itchy with small red bumps about the size of a silver dollar. On 10/4, The skin on the inside of my left elbow and backside of my right knee were also itchy with red blotches. I used some hydrocortisone cream 1% to relieve some of the itchiness. As of 10/8/2013 (today) all sites remain itchy with red dots and small splotches.  It hasn't gotten worse or better.
Information has been received from a RN concerning a male pt (co workers husband) who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647038/0926N). Subsequently the pt developed swelling, pain and redness at injection site. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that others had a similar experience (WAES0408USA01249, 0408USA01760 and 0408USA01761). Additional information has been requested.
Patient received vaccine.  Within 2 minutes patient became sweaty with shallow breathing.  Patient then lost consciousness and began shaking.  Time lasted a few minutes.  Provider was notified and by the time provider arrived patient was alert and conscious.  Patient was taken to an urgent care exam room for further treatment.
pt recv vax 19AUG98 & noted bumps  w/itching 28AUG98;spots were red w/scratching;from chin down lasting thru sept saw MD;hives w/itching;
The day after vaccines were given, she had swelling at injection site of Trumenba, hives on that arm, swelling of the face, hives  on arm/head/face, and throat swelling. She was given a dose pack of methylprednisolone and was feeling better the next day.
Day after vaccine, I was very sick as though I had the flu.  Had a severe headache above both eyes, was nauseous and vomited, slightly off-balance, and tired.
Developed itchiness, redness, and hard spot that was warm to touch at injection site and below as well as muscle pain in the arm as if she had been punched in the arm, first instance of this began over 1 week after injection. Seen in convenient care clinic and prescribed 7 day course of doxycyline for concern of possible abscess.
Pt was given MMR SQ in Rt arm and Tdap in Rt deltoid at 10:30 am. Minutes later pt complained of skin prickly all over. Then minutes later complained of itching all over, hands numb and tingly. Breathing felt tight. Dr came in and examined pt and observed facial swelling and hives. Nurse gave 25 mg BENADRYL IM and epi 0.3 mg and 911 was called. Pt was sent to ER.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Public Health, per guidance from the Department of Health, Centers for Disease Control and Preventio (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
Rash with raised hives 3 days. Fever 3 days. Vaginal sores for the last month, started after the 1st shot got a little better then got much worse after the second. Headaches won't go away.
breakthrough epileptic seizure after experiencing the expected 24 hours of warned side effects of 'flu-like symptoms' - intense headache, body ache, nausea/loss of appetite.
Case number PHEH2014US019976 is an initial spontaneous report from the physician received on 02 Oct 2014. This report refers to a male patient of an unknown age. His vaccination history included MMR vaccine (other manufacturer and batch number: not reported) and had an anaphylactic reaction to it and he also received varicella vaccine (other manufacturer and batch number: not reported) and had allergic reaction to it. His current condition included asthma. He was allergic to peanuts. He was vaccinated with flu shot (manufacturer and batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on an unknown date (06 years of age at the time of vaccination). On an unknown date, after vaccination he had an anaphylaxis. The outcome of the event was unknown. The seriousness and causality of the event were not reported.
Approximately 3-4 hours after receiving vaccine, lower back pain began, increasing very rapidly.  I did nothing physical that could have remotely caused this. The pain was in the lower vertebrae and also to the right-it felt like a vise was clamped around my spine and right buttock muscle.  Pain was very bad when attempting to stand up, or walk.  More a severe ache when sitting. 10 on a pain scale of 1-10.  Next morning pain reduced maybe10%; second morning pain reduced maybe 30%.
20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 13th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:Master case
Dry persistent cough that has not gone away. 3x negative covid tests. Potentially a developed allergy or remaining immune response unknown.