chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reported giving a pediatric Pfizer dose to a 12 year old; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 12 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Reported giving a pediatric Pfizer dose to a 12 year old".  Additional information: The reporter clinical pharmacist had one of stores who had reported giving a pediatric Pfizer dose to a 12 year old and 16 year old and they are wanted to know if there was any direction to restart them with adult or they just go and get the second dose of the adult dose in three weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
developed Guillain-Barre' Syndrome was dx on May 5 2021 and hospitalized at neuro dept then transferred to different Hospital
PHARMACY STAFF HAD AN EXTRA DOSE OF MODERNA VACCINE ON HAND AND WAS GIVEN TO PATIENT. PATIENT DID NOT HAVE CDC RECORD ON HAND AT THE TIME PER STAFF AND TOLD STAFF HE RECEIVED THE MODERNA VACCINE. PATIENT LATER BROUGHT IN CDC CARD, INDICATING HE ACTUALLY RECEIVED PFIZER VACCINE AT A WALGREENS PHARMACY. CDC CARD WAS UPDATED TO REFLECT VACCINE GIVEN ON 03/29/2021. PER CDC GUIDELINES, PATIENT WAS NOT GIVEN A SECOND DOSE OF MODERNA VACCINE AT THIS TIME. TOLD PATIENT TO REPORT ANY ADVERSE EVENTS TO PHARMACY/PRESCRIBER AND SEEK MEDICAL ATTENTION IF SEVERE REACTIONS OCCUR.
Increased liver enzyme levels, hair loss within 2 weeks of 2nd dose. No previous familial history of autoimmune disorders Both autoimmune Hepatitis and Alopecia have been diagnosed in my daughter since her vaccinations
Left arm swollen, painful.  Caused tingling down into 4th and 5th digits of Left arm, has headache.  Afebrile.  Seen in Flight Medicine on 7 Oct 11.  Induration extends from top of elbow distally.  8 inches length x 8 inches width.  Painful, erythematous, restricts ability to raise L arm above head. Treated today with Keflex and Naprosyn for cellulitis.
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (hotness at the vaccination site), INJECTION SITE ERYTHEMA (redness at the vaccination site), INJECTION SITE PRURITUS (itchiness at the vaccination site), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included LEVOTHYROXINE, ATENOLOL, LORATADINE (CLARITINE) and SALBUTAMOL SULFATE (Pro Air INHALERIN) for an unknown indication.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced INJECTION SITE PAIN (hotness at the vaccination site), INJECTION SITE ERYTHEMA (redness at the vaccination site), INJECTION SITE PRURITUS (itchiness at the vaccination site), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain). At the time of the report, INJECTION SITE PAIN (hotness at the vaccination site), INJECTION SITE ERYTHEMA (redness at the vaccination site), INJECTION SITE PRURITUS (itchiness at the vaccination site), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included topical cream, Advil to take 2 times daily, once in the morning and once at night until hotness is gone. Antibiotics
Bad vertigo; Diarrhea; Vomiting; Chill; This is a follow-up spontaneous report from a contactable consumer (the patient). A 51-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiration date was not reported), dose 2 via an unspecified route of administration in the left arm, on 20May2021 at 08:15 (at the age of 51-year-old), as single dose for COVID-19 immunization. The patient's medical history included ongoing known allergies hive and itch from Sun light, seafood sometimes, allergies to morphine. Other medical history Fibroids. Side effects from Shingrix, Augmentin, Macrobid, Iron supplement and Vitamin B. List of other medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN-C), ergocalciferol (VIT D), tocopherol (VITAMIN E), fish oil and probiotic from an unknown date for an unknown indication. The patient's historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiration date were not reported), dose 1 via an unspecified route of administration, in the left arm, on 29Apr2021 (at the age of 51-year-old) as single dose for COVID-19 immunization. Adverse event four days after getting the 2nd dose of Pfizer vaccine on 20May2021, patient got bad vertigo, diarrhea, vomiting, and chill in the early morning on 24May2021 at 04:15. It lasted about 3 to 4 hours and then patient had been fine since that event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any treatment for events. Facility where the most recent COVID-19 vaccine was administered is reported as Other. Outcome of the events was recovered on 24May2021.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
January 26 woke with slight sore throat, dull head ache in front part of head, felt groggy, no energy all day.  took two tylenol, No clinical treatment.  January 27 ws back to normal.
7th day after injection got an itchy rash on the left arm. On the 8th day after injection developed an itchy rash all over body, pimples on my neck, rash in my mouth.  Started taking Allegra once a day on the 8th day, currently the rash is still there but much milder.
It's like eczema in skin/patches like an eczema; Itchy; little blots of red; Allergic reaction; Pain Whole Left arm; Headaches; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Deltoid Left on 03Apr2021 12:00 (Lot Number: EN6198) as 1st dose, single, and via an unspecified route of administration, administered in Deltoid Left on 24Apr2021 12:00 (Lot Number: ER8737) as 2nd dose, single for COVID-19 immunization. Medical history included Crohn's disease and immunodeficiency from an unknown date. The patient is not on other medication and doesn't take anything. On 04Apr2021, the next day after vaccination of the first dose, the patient had pain whole left arm and headaches and took Tylenol. On 05Apr2021, patient experienced it's like eczema in skin/patches like an eczema, little blots of red, that is really itchy, and allergic reaction. The patient took an antihistamine. On 25Apr2021, after the second dose, the patient again had pain whole left arm and headaches and on an unspecified date after the second dose had the same patches like an eczema not clearing still itching. Patient was still taking antihistamine. No emergency room and physician's office visit was done. The outcome of the events was not recovered.
pt called 6/10/21 reporting  swelling and redness in the arm that she received the covid vaccine.  The reaction started 6/8/21
Woke up in the middle of the night and my balance was completely "off" This only lasted for a short period of time--minute or so.
Patients guardian falsified DOB when registering for vaccination, stating the minor's DOB was 5/26/2002. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 5/26/2003 which made the vaccine a contraindication.  No known adverse reactions noted.
The next day I came down with a fever. I had aches and chills, I had a headache as well
Greatly increased tinnitus in left ear, previously was mild and intermittent, became severe and constant.  New onset right ear tinnitus, volume moderate.  I already have hearing aids,  no additional treatment is possible other than masking with other sounds.   The left ear tinnitus has remained constant ever since the booster. The volume has diminished to moderate. The right ear tinnitus has diminished to mild and intermittent.  I have great anxiety that this constant ringing will continue for the rest of my  life.
Pt received pneumococcal vaccine 12/3/04 pt called clinic with symptoms of hot spots on AM when MD spoke with pt, pt stated symptoms improved c/o sore arm Monday 12/6/04.
The night of 12/19/04 after the injection experience of cramps in legs. With in 24 hours sudden extreme weakness in arms and legs, rapid pulse, extreme fatigue, strange sensations in legs of weakness and vibration, unable to lift a tea cup without fatiguing arms, chew without fatiguing jaw, had to lean on wall in shower, or walk up stairs. Crushing fatigue for two weeks. Still symptomatic in episodes after 8 weeks, varying by the day.
I started to feel fatigued and tired so I went to bed early 2.5 hours after getting the shot. I woke up several times during the night (2:00am and 5:30am) because I did not feel well. I feel achy all over and my joints were sore. By morning (8:30) I had full blown flu symptoms including nausea, chills, joint soreness and achy all over. I felt better the second day; however, it took another day to really feel like I had gotten back to being healthy again.
onset of GBS approx 1wk p/shot;numbness in hands, feet, stomach, genitals, entire body;dizzy in face, no energy, jaw etc, GBS;
4.2 cm circular, raised, reddened . warm @ site of VARICELLA injection
Janssen COVID-19 Vaccine EUA I have been feeling interscapular pain since around 6:00pm on April 22 and the pain has continued up until now which is 4:00pm April 23. I feel it more when I curve my upper back (like in the cat position in yoga). On a scale of 1 (mild) to 5 (severe), I would say it is a 2.
Rec'd Varicella #1 and Flu #1 at 1yr check up on 12/08/17. On 12/20/17 Mom brought Pt. to office for sick O.V. and reported (L) post arm with "spot a few days after vaccines given." Provider on 12/20/17 noted oval pink, semi-firm macule app 2cm at site. No fever, warmth, tenderness or streaking. No Tx; (+) monitor.
c/o local iritation, redness, swelling, rash, itching to rt deltoid p/vax #2 22APR92 sx started 1 day p/vax admin lasted 5 days;
Patient  c/o itching, burning, headache and increased phlem in throat.    1257 BP 160/72 Pulse 70 1258 IM 50 mg Benadryl Right Arm Lot 030008 Ex 03/22 1303 BP 178/72 Pulse 62  Lungs clear no wheezing Patient stated he ate a snack at breakfast nothing since, water and banana given to patient. 1318 Bp 150/68 Lungs clear no wheezing  Patient stated phlem feeling was gone, and that itching and burning had dramatically decreased  Continued monitoring for another 20 minutes to make sure no changes.  Patient declined any higher medical assistance.  Patient declined the offer of calling family to come drive him home.  Staff offered to keep patient to monitor longer, patient declined.   Patient educated about following up with physician and what to monitor after leaving facility.   Follow up call made to patient 04/01 and 4/2  no answer VM.  Patient called back 4/3 stated he was fine with no further issues that day.
Information has been received from a physician concerning an 85-year-old male with a history of muscle ache and fatigue with the use of niacin, ezetimibe (MSD) (WAES #0712USA02106), fenofibrate (Tricor), amlodipine besylate (Norvasc), and a history of hives with an unknown agent.  On 27-Aug-2007 he was vaccinated in the left bicep with a dose of Zostavax.  Concomitant therapy included valsartan (Diovan) 160 milligrams, aspirin 81 milligrams and fexofenadine hydrochloride (Allegra) 180 milligrams.  On 29-Aug-2007 the patient developed a bruise, signs of hemorrhage, and swelling of the right hand.  There was also redness and itching on the palm of the right hand.  The patient used hydrocortisone cream and the adverse experiences improved but did not resolve.  It was unspecified if medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Nausea and my head didn?t feel. I felt out of it and couldn?t concentrate on anything.
Moderna COVID-19 Vaccine EUA 8 days after receiving my vaccine I experienced warmth, rednessness, mild itching and firmness at the injection site. At the largest, the area was approx 8 cm across. It lased for 4 days and seemed to improve with administration of steroid cream and taking claritin and benadryl. I had no other systemic effects.
an extended period; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced an extended period on an unspecified date. Patient stated to know information on irregular menses, lymphadenopathy whether vaccine can be received through oral route of administration and whether there was an improved version of vaccine that wouldn't cause any adverse reactions. The outcome of the event oligomenorrhea was unknown.  Information on lot/batch number has been requested.
First dose no side effects or symptoms, however on second dose I did. The Morning after second dose woke up sweating, fever of 102, body aches, fatigue and headache.  It is now May 15th and still continue to get headaches almost everyday and still have fatigue and body aches.
I had hives for two straight years; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown age patient who reported urticaria (I had hives for two straight years), while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.   On an unknown date, it was reported that the patient reported that non one could not get the flu from the flu shot but, sure could get the hives. He/she had hives for two straight years (urticaria) (Unknown latency) following the administration of Influenza Vaccine.   No laboratory data was reported.  Action taken was not applicable. It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Informaiton was received from an emergency medical technician (patient's mother) concerning her 15 month old daughter who on 01 NOV 2004 was vaccinated with MMR.  Concomitant therapy included a dose of PREVNAR and a dose of influenza virus vaccine.  On 01 NOV 2004 the patient developed a severe erythematous generlized rash, and fever.  It was also reported that the patient had a TB test on 01 NOV 2004.  The child was examined at the hospital but not admitted.  It was also reported that she was being treated symptomatically was recovering.  There was no product quality complaint involved.  Additional information is not expected
Moderna Covid-19 vaccine EUA - pain at injection site for 4 days, unable to sleep.  Then joint pain in left knee, right hip, both elbows that  started on  January 20th and has continued. The level of pain in the joints is a 4 , one a 1 to 10 scale.  I am unable to sit for long periods of time, I need to get up move every hour. I also have pain when walking.
2 cases of breakthrough HZ / were vaccinated with Shingrix in the past / fully vaccinated/suspected vaccination failure; 2 cases of breakthrough HZ; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient was fully vaccinated with Shingrix and during the pandemic, the patient breakthrough herpes zoster. The physician attributed that the breakthrough herpes zoster case was due to stress of the pandemic. The case resolved without issue. The reporter could not recall patient's initials, age, date of birth and when they were vaccinated. This case was considered as suspected vaccination failure as details regarding laboratory confirmation of herpes zoster and exact time to onset were unknown at the time of reporting. The reporter consented to follow up. This case has been linked with the case US2021AMR102475, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102475:same reporter, different patient (2nd patient case)
1st dose on Jul 21st 2021 never continue the series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 49-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 21-Jul-2021 with batch no. X239D and expiry date 7-Aug-2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's Comments: The pharmacist reported that now, the patient would like to continue the series. The reporter gave consent to follow up. Additional supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Within 24h of 2nd dose of vaccine experienced chills, fatigue.  3 days post vaccine (2hours after taking first dose of drospirenone) experienced itching of neck, face, hives on face, facial swelling, mild nausea/abdominal pain that resolved with BM. Facial swelling, itching, hives took 3-4 days to improve abd required oral steroids, Benadryl, zyrtec, famotidine.
numbness from hips to armpits, tingling in fingers, couldn't sleep, constipated, depression
First Covid vaccine date Jan 4th, Second Jan 22nd Unexpectedly conceived ~ Jan 14th for due date October 9th, 2021 Cysts seen on US - concern for partial molar pregnancy
This case was reported by a physician via other manufacturer and described the occurrence of injection site swelling in a 68-year-old female patient who received Tdap vaccine (batch number 45214AA?, expiry date unknown). The patient's past medical history included Sjogren's disease, hypothyroidism, Meniere's disease and hypercholesterolemia. On 7th May 2015, the patient received Tdap (intramuscular) .5 ml. On 8th May 2015, 1 days after receiving Tdap vaccine, the patient experienced injection site swelling, injection site redness, injection site itching, injection site hives, injection site pain, injection site rash and general body pain. Tdap vaccine was discontinued. In May 2015, the outcome of the injection of the injection site pain, injection site rash and general body pain were recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site redness, injection site itching and injection site hives were unknown. The reporter considered the injection site swelling to be related to Tdap vaccine. It was unknown if the reporter considered the injection site redness, injection site itching, injection site hives, injection site pain, injection site rash and general body pain to be related to Tdap vaccine. Additional details were provided as follows: The reporter stated that, the patient's left arm was very swollen, red itchy, hives from shoulder to elbow, pain and body aches. The patient had pain and rash for 3 days. The patient was not hospitalized because of events. This case was previously reported. The reported batch number for Tdap was 45214AA, which does not exist as per sales data sheet, however no clarification could be obtained.
This spontaneous report was received from a Registered Nurse via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 02-DEC-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX, lot number L025000, expiration date 06-OCT-2016, (dose, route, anatomical location and frequency were not reported), for prophylaxis. No adverse effect reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. Additional information has been requested.
Left deltoid with 3 inch X 2 inch red, swollen area. Warm to touch. Advised warm compress and Tylenol every 4 hours. Return if not better.
7pm: Uncontrollable chills, nausea, muscle aches 12 am: fever (100.4 F), restlessness, muscle aches, headache, nausea  6 am: muscle aches, headache, lethargy 12 pm: no more symptoms
Later in the day patient had swelling of gums and mouth and a rash on body. She took over the counter antihistamines. The next morning she called the pharmacy. I recommended she go to PCP but she said feeling better.
Redness at injection site. Slight swelling, warm to touch, slightly tender. Started looking like cellulitis, given Keflex 250mg/5ml 5ml tid 10 days.