chrisvoncsefalvay/vaers-outcomes huggingface dataset:
recurrent migraines; 1st dose:Pfizer;2nd dose:JANSSEN; 1st dose:Pfizer;2nd dose:JANSSEN; This is a spontaneous report received from contactable reporter (Consumer). Other Case identifier(s): 20211238271(1) (Janssen).  A patient (no qualifiers provided) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single then received JANSSEN covid-19 vaccine (JANSSEN COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single both given for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient experienced recurrent migraines (dose number in series 1) when treated with PFIZER BIONTECH COVID-19 VACCINE. Event was considered as serious (medically significant). Then, the patient received the JANSSEN covid-19 vaccine as dose 2 (off label and interchange of vaccine products). The patient then had hypertrophic cardiomyopathy and partial loss of sight-also considered as serious (medically significant). Outcome of recurrent migraine was unknown.   Causality as per reporter for JANSSEN covid-19 vaccine and events of hypertrophic cardiomyopathy and partial loss of sight was Possible.   Sender comment: heart warming hypertrophic cardiomyopathy. This event(s) is considered unassessable. The events 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(s).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have swelling approximately three inches in diameter from the injection site; the injection site it is hot to the touch; my arm hurts a little bit when I move it; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 28Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Jul2021, outcome "unknown", described as "I have swelling approximately three inches in diameter from the injection site"; FEELING HOT (non-serious) with onset Jul2021, outcome "unknown", described as "the injection site it is hot to the touch"; PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "unknown", described as "my arm hurts a little bit when I move it".  No follow-up attempts are possible. No further information is expected.
Post/Tetanus Dip Adult injection, erythema, measuring 20mm diameter on R/deltoid region. Some palpable R/axillary node tenderness with full ROM.
Arm is a little sore; Felt a little achy this morning; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date).   On 20th August 2022, the patient received the 2nd dose of Shingles vaccine. On 21st August 2022, 1 days after receiving Shingles vaccine, the patient experienced pain in arm and generalized aching. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the generalized aching was unknown.   It was unknown if the reporter considered the pain in arm and generalized aching to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient got his/her vaccine yesterday. The patient experienced little sore arm and felt a achy this morning.  The patient did not had any reaction for the first one. They were not 100% effective but patient thought was  91% effective. The patient was glad that he/she now had both. The follow-up could not be possible as no contact details were available.
The patient received the incorrect vaccine. She received 0.2ml of the magenta cap formulation (ndc: 80777-0283-02) instead of receiving 0.25ml of the blue cap formulation (ndc: 80777-0282-05).
Swelling redness at injection site. Pt used ice and Benadryl to reduce reaction.
pericarditis; trouble breathing; chest pain; wheezing; palpitations; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 10Jun2021 at 13:15 (Lot Number: EW0182, unknown expiration) as dose 1, single; and on 01Jul2021 at 13:15 (Batch/Lot number was not reported) as dose 2, single, both via unspecified routes of administration in left arm at the age of 43 years old for COVID-19 immunisation.  Medical history and concomitant medications reported as none.  No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive medications within 2 weeks of vaccination. The patient experienced trouble breathing, chest pain, wheezing, palpitations - pericarditis on unspecified dates.  The events resulted in emergency room department/urgent care and doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 via nasal swab since the vaccination with negative result on 02Jul2021.  The patient had not yet recovered from the events.   Information on the lot/batch number has been requested.
hepatitis B nonresponder; Literature Report  This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 59 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 63 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
(L) arm pain, pain in injection site, pain travelling up (L) arm into neck.
Patient stated after her vaccination started a little itchy went to lunch ate cereal and than started itchy every where. Patient also received Z PEN G Benzathine after vaccination and Azithromycin right before vaccination in female wellness. Nurse gave Benadryl  and patient was monitored by nurse practitioner . Patient was put SIQ and sent with zyrtec.
Left arm 5X4  inch rounded reddened area on the upper outter Left arm.  Area reddened, swollen, itchy and tissue hardened.
HYPERVENTILATION (WHEN A PANIC ATTACK OCURRS) SLEEP TROUBLES (UNABLE TO SLEEP WITHOUT MEDICATION) LIBIDO DECREASE, BAD MEMORY (TROUBLE REMEMBERING RECENT INFORMATION-SHORT TERM MEMORY LOSS)MENOPAUSE, DEPRESSION, MIGRAINE, MOOD; (ANXIOUS, ANGRY, IRRITABLE) NUMBNESS AND TINGLING FINGERS, ABDOMEN; (BURNING SENSATION, ACID REFLUX)ANEMIA, APPETITE LOSS, VERTIGO & DIZZINESS, HIGH CHOLESTEROL, BRADYCARDIA, DIFFICULTY TO CONCENTRATE, CONSTIPATION, COSTOCHONDRITIS, THINKING ABNORMALITY, POOR TOLERANCE FOR BRIGHTS LIGHTS, BLURRED VISION, WEIGHT GAIN, WEIGHT LOSS. DX:  major depressive disorder, recurrent, moderate migraine lumbago hypercholesterolemia sensorineural hearing loss of combined types dyspepsia anxiety gastroesophageal reflux disorder vitamin B 12 deficiency. Same as I reported initially.
Adverse allergic reaction after approx 24 hours. Entire body erupted with hives that did not subside with 5ml of Benadryl. Visited Urgent Care and was administered Steroid shot. The hives went after 12 hours but another minor allergic reaction occurred after 48 hours but got controlled with another 5ml of Benadryl
apnea episode, opisthotonus;adm to hosp from ER 25MAR97;
Pt recvd DTP/HIB on 24MAR92 fever started 24MAR92 5PM t103 R, vomited APAP for fever; 26MAR92 rash & fever 101 started 27MAR92; Fever stopped 28MAR92; rash gone 31MAR92; Seen by MD, no definite dx; pt recovered & no problems w/prev immun;
she is having another knot to the right side of her neck.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8731, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in right arm on 18Apr2021 (age at time of vaccination 58 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration, administered in left arm on 27Mar2021 as dose 1, single for covid-19 immunisation. The patient reported she is having another knot to the right side of her neck on an unspecified date. Caller reports that since then she has received her second vaccine dose yesterday, 18Apr to her right arm. Caller reports that now she is having another knot to the right side of her neck. The outcome of event was unknown.  No Follow-up attempts are needed. No further information is expected.
Conuvlsions 8 hrs following immun; continued to convuls x 1 wk following-taken to ER 3x; rxn reported by mom on 5FEB92;
administered an expired dose of ACTHIB with no AE; Initial information received on 09-Aug-2021 regarding an unsolicited valid non-serious case from an other health professional and consumer/ non health care professional via Global Media information (under reference 00715879).  This case involves a 1 years old male patient who received an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) [expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) [lot number and expiration date] via unknown route in an unknown site for prophylactic vaccination.  On 09-Aug-2021, the patient received a 0.5 mL dose of suspect ACT-HIB (total, lot UJ324AA and expiration date: 14-JUN-2021] via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported that "The caller would like to know if they must revaccinate the patient as well as other instructions on how to proceed to care for the patient".  At time of reporting, the outcome was unknown for the reported event.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Pt called the pharmacy on 10/13/17 describing a "severe reaction" to one of the vaccines she received the preceding day (10/12/17). She was experiencing intense muscle pain and soreness, inability to raise her arm more than a few inches, and swelling in the deltoid (all in her right arm). I told her the reaction was due to the PNEUMOVAX 23. She had previously received a PNEUMOVAX 23 injection on 1/17/17, and should not have gotten the vaccine again on 10/12/17.
Approximately 10-12 hours after vaccine body aches & headache began, 12-24hrs added chills, sweating, sleeplessness, 24-36 very bad headache w/sensitivity to noise & light, added low fever, muscle aches, dizziness, light headed when sitting up, getting up to walk. 36-48 hours continued body aches lessened, headache lessened, nausea & dizzy w/lightheadedness. 60-72 hours diarrhea for 12 hours & stiff sore muscles, but headache lowered in pain, as with body aches, chills & sweating.
There was no excrusion from freezer; There was an excursion from their freezer/they were administered to 118 patients.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was no excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was no excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was no excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials, age, gender) and vaccine information (date of vaccination, dose number)
Received Hep B at 5 PM 7/29 within 5-10 minutes nausea, sweaty, dizziness all night. One episode of "not seeing very well" 30 minutes after vaccination.
On arrival to the emergency department, patient was hypoxic to 78% on room air.  Other vital signs are within normal limits.  He required 3 L nasal cannula to maintain O2 sats 93%.  CMP and complete blood count were unremarkable.  DR frontal and lateral chest x-ray showed faint patchy opacity at the bilateral lung base representing scattered infiltrates versus atelectasis.  He was given albuterol and dexamethasone 6 mg. Admitted to hospital medicine for acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  "
Patient had no adverse event. When patient came to receive her second dose, she admitted she falsified her birthday. False date of birth given was date. Actual patient's birthday is date. Second dose was not given since patient did not meet age requirements.
developed bilateral red eyes, itching, pain similar to 4/29/05 eye infection 2 hours after receiving both IM influenza 10/2005 and FLUMIST 10/2006.  Problems resolved after nights sleep but was present for 12 hours.  Ear pain, Red eyes, Itchy Eye lids.
Friday- fever of 101, irritability, rash on face ibuprofen and Tylenol. Saturday, fever and rash worsen. Sunday, fever up to 104 while on meds, rash worsen.
c/o sob, CP, throat tightness, tongue tingling minutes after administration of vaccine.  Vitals were within normal limits.  Alert and oriented.  Given IM benadryl and Epi. Transported to ED.
STILL WOBBLY; STILL FALLING; This spontaneous report received from a consumer concerned an 8 decade old female. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced still wobbly, and still falling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the still wobbly and still falling was not reported. This report was non-serious.
Diarrhea, nausea. Chills later on that night. Fatigue.
Pt came for Pfizer booster .The first dose was 6/29/21 2nd the dose was given 7/20/21 and booster given less than 6 months
Injection site pain and swelling at time of injection. Pain lasting several days. Severe body aches and nausea. Now 4 days out from receiving my 2nd dose and my arm still has a huge swollen knot the size of a fist. Arms is right and painful. Can physically see the knot/swelling.
Lightheaded immediately. Severe muscle cramps in legs and back from 10pm to 5am. Cold like symptoms day after.
On Monday around 1:30 in the morning I woke up with a definite urgency to go to the bathroom. After I went I still felt like I had to go and It definitely felt like I had a UTI. I have not been sexually active in months. I went to my doctor the next day and when I took the urine sample I knew without a doubt that I definitely had a UTI from all the symptoms I was having we?re by the book. It ended up coming back that I did not have a UTI but my  doctor still put me on the anabiotic?s. I then come to find out one of my coworkers who had her shot the day before me had the exact same thing happened to her and it just seemed worth reporting.
Injection site reactions with erythema and swelling; Injection site reactions with erythema and swelling; Injection site reactions with erythema and swelling; Patient's age: 0.63 years; Literature report:   This literature marketed report was received from the authors in a published literature article regarding an infant female patient, which age was reported as "0.63 years", from an initial group of 204 patients (84 female and 120 male patients; enrolled in a study, which aim  was to evaluate the safety of live virus vaccines and the characteristics of the recipient population that are associated with successful LVV post liver transplant (LT).  On an unknown date, the patient received a LT, along with an immunosuppressive regimen of Mycophenolate mofetil (MMF) (doses, routes and frequencies were not reported). It was reported that, pre-transplant, the patient was Negative for the IgG of the corresponding vaccine  On an unknown date, 4.4 years after the LT (discrepant information), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) along with varicella virus vaccine live (oka/merck)(manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis.    On an unknown date, the patient experienced an injection site reactions with erythema and swelling, following co-administration of both vaccines; that was considered a side effect from the 2 vaccinations.  At the reporting time, the outcome of vaccination site reaction, vaccination site swelling and vaccination site erythema was not reported. The authors considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck)(manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports obtained from the same literature article.; Sender's Comments:  US-009507513-2202USA001021: US-009507513-2202USA001022: US-009507513-2202USA001023:
10 h after vaccination:  extreme nausea and severe headache.  In the morning, the headache continued.
following the initial injection on my left arm, i notice later in the day (about 30 minutes later) i felt a strange sensation in the muscle area just below my left thumb on my hand.  feels like soreness on one of the nerves that is running through there.  the pain comes and goes and is not consistent through out the day.  some days there is no pain at all, but some days the pain returns randomly.  (these strange sensations went away about a month afterwards)  But then eventually it comes back every once in a while. Fast forward to the last couple of months, i started feeling the the light nerve pain again.  but this time it seems like the pain spot has moved slightly upwards my left thumb.  (there are no regular patterns as to when the pain come and go) i mentioned it to my general medicine doctor, he said to just keep an eye on it and did not provide any resolutions at all.
Small brown outline on left forearm, not the injection site; It's very tender and hasn't gone away; This spontaneous case was reported by a patient and describes the occurrence of PIGMENTATION DISORDER (Small brown outline on left forearm, not the injection site) and PAIN OF SKIN (It's very tender and hasn't gone away) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PIGMENTATION DISORDER (Small brown outline on left forearm, not the injection site) and PAIN OF SKIN (It's very tender and hasn't gone away). At the time of the report, PIGMENTATION DISORDER (Small brown outline on left forearm, not the injection site) and PAIN OF SKIN (It's very tender and hasn't gone away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non-Significant follow up appended to MOD-2021-142752
Red rash; Sore arm; not able to use the arm; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 2 days after receiving Shingrix, the patient experienced red rash, pain in arm and mobility decreased. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the red rash, pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the red rash, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: At 4 PM, the patient received Shingrix vaccine and at night of vaccination she experienced a sore arm, and she was not able to use the arm. In the morning of reporting day, 2 days after vaccination, she woke up with a red rash on her torso which was going to her neck. She took Benadryl at the time of reporting. The soreness was still present at the time of reporting. The reporter consented to follow up.
Pfizer-BioNTech COVID-19 Vaccine EUA---At Approximately 1030 PM on 2/2/21 I began having muscle aches. 2/3/21 @ 0800Am temp was 100.7. Throughout the day 2/3/21 I had a temp of >99.7 but <101, muscle aches (1day) HA(1day) and a rash on the trunk area. The fever stopped at approximately 1100PM 2/3/21.