chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EW0151), on 22Apr2021 as dose 2, single (Lot number: EW0175), on 21Nov2021 as dose 3 (booster), single (Lot number: 33030BD) and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "paroxysmal a-fib" (unspecified if ongoing), notes: paroxysmal a-fib; "hypertension" (unspecified if ongoing); "left atrial fascicular block" (unspecified if ongoing), notes: left atrial fascicular block; "Right bundle branch block" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. The patient received Paxlovid from 22Aug2022 to 26Aug2022 for the treatment of COVID-19.
Initial report received on 15 December 2008 from a health care professional. A 4-month-old female patient who had concurrent gastroesophagel reflux disease (GERD) and pre-existing medical condition of edema, had received a second dose of the following vaccines on 20 October 2008 at 09:00 am: ACTHIB (lot number UF529AA Sanofi Pasteur SA lot number Z1185-2) intramuscular in the left thigh; DAPTACEL (lot number C2999AA) intramuscular in the right thigh; IPOL (lot number A1109-2) subcutaneous in the left thigh; PREVNAR (manufacturer Wyeth, lot number C97892) intramuscular in the right thigh and oral "rotavirus" vaccine (manufacturer Merck, lot number 1033X). Around 13:45 pm approximately four hours after receiving the vaccinations on 20 October 2008, the patient began to experience facial swelling and had difficulty swallowing. She was taken to the emergency room where she was treated with BENADRYL and the symptoms resolved. The patient is to be evaluated by an allergist (date not provided). The patient had received the first dose of ACTHIB, DAPTACEL, IPOL, PREVNAR and rotavirus vaccine in August 2008 without any adverse events. At the time of this report, the patient had recovered. Documents held by sender: None
sore arm; Swelled like golf ball; Red arm; Flu achy symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix. On 9th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and swelling arm. In November 2019, the patient experienced influenza-like symptoms and erythema of extremities. The patient was treated with cetirizine (Claritin (Cetirizine)). On an unknown date, the outcome of the influenza-like symptoms, pain in arm, swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient noticed their arm was sore and swollen on the same day of vaccination. The symptoms worsened Swelling was like a golf ball and there was redness, so patient took Claritin. The patient also experienced some flu achy symptoms. The reporter consented to follow up.
Sickness bedridden for 3-4 days.  Symptoms I never had during my actual bout with real covid. heart palpitations, chest wheeze making breathing more labored. I had the real covid in March 2020 where I never had respiratory symptoms, tested positive for antibodies May 2020
Can feel where the shot was injected. When pressing on the spot, can feel pain at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 15:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included levonorgestrel (MIRENA) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 16Mar2021 at 08:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 07Apr2021, the patient could feel where the shot was injected. When pressing on the spot, the patient could feel pain at injection site. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event can feel where the shot was injected, when pressing on the spot, can feel pain at injection site was not resolved at the time of this report.
Given Hep A IM & Varicella SQ on 8-25-10. On 8-26-10 mother noticed varicella SQ area had red area size of silver dollar. On 8-27-10 mother noticed some swelling in Sub Q area 4x2 inch on back area of arm near where varicella shot given. Child states arm feels better today. 8-26-10 BENADRYL p.o. give by mother. Today - no tx yet. Will offer acetaminophen & cold compress & call Doctor if no relief or if gets worse.
Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt experienced mild breakthrough and looked kind of sick. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
10/02/2002 2 weeks after vaccine reported large lump on the back of her arm c/o redness and soreness. Explained to pt with RTC mild-mod reactions with vaccine. Waiver signed for 2nd Varicella vaccine. Pt declined
Initial unsolicited report received from a nurse tes on 29-Dec-2016. This case involves a 10-month-old male patient who was vaccinated with a dose of Fluzone QIV (Batch number UT5594MA, expiry date-30 June 2017, dose form and frequency not reported) intramuscularly in left thigh on 27-Dec-2016. Patient's had no pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 27-Dec-2016, the same day following the vaccination, the patient had a drooping of the face and mouth noticed by parents. The patient's parents called physician office and were advised to go to Emergency Room. The patient was diagnosed with Bell's Palsy. The patient was previously vaccinated with a dose of Fluzone QIV (batch number, expiry date, dose form, frequency, route and site of administration not reported) on 14-Oct-2016. Laboratory data and corrective treatment were not reported. The outcome of the event was reported as unknown. Upon internal review the case was considered as serious because of important medical event: Bell's palsy. List of documents held by the sender: None. Sender's Comments: This poorly documented case as patient had Bell's palsy following FLUQUADRI VACCINE. Time to onset is unknown, Clinical details- such as latency from vaccination, medical history, previous vaccination history, clinical details surrounding the event and infectious history are lacking to allow adequate medical assessment. Based on the available information the role of vaccine cannot be assessed.
Adult dose of Havrix was administered to a pediatric patient; Adult dose of Havrix was administered to a pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 19-month-old female patient who received HAV (Havrix adult) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   On 17-MAY-2023, the patient received Havrix adult. On 17-MAY-2023, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Adult dose of Havrix was administered to a pediatric patient) and overdose (Verbatim: Adult dose of Havrix was administered to a pediatric patient). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 17-MAY-2023 Medical assistant calls to report an adult dose of Havrix was administered to a pediatric patient. The reporter consented to follow up via mail. An adult dose of Havrix was administered to a pediatric patient which led to adult product administered to child and overdose.
Infantile seizures within 24 hrs. of DPT immunization. 07/17/2006-records received from Hospital: DC summary: DC DX: Infantile spasm; Seizure Disorder; Down's Syndrome. PMH: VSD, ASD and PDA. Present illness: experienced 2 seizure like events with stiffening of upper body, arms stiffen out and eyes kind of bulge.   This patient is clearly at increased risk for further epileptic seizures. If the question of seizure type persists, the patient would benefit from prolonged EEG monitoring to record her actual episodes. MRI of brain scheduled as an outpatient.
Within two weeks of receiving the MMR vax, the child stopped talking and withdrew from everyone. He also began to lash out at children and his twin sister. He stopped responding to simple commands, he is several months behind.
No fever. 4-5 rash on the site. Sites flat. Difused together (as of 04/08/2003) and scar by a bug bit spot.
I experienced tiredness, overall body aches, sneezing, cough, low grade fever. Severity was moderate and I began Paxlovid on day 3 and it kicked in 2 days later so I would say the symptoms lasted for 5 days.
client received astrazeneca covid vaccine, no reaction. Previous vaccine unavailable in the US, Janssen given as an alternative on 9/15/21
pt 2nd dose of lymerix was administered w/very short needle; pt devel 3cm circle w/central clearing which was bluish & resembled a bruise; devel a second ring below the first;
VasoVagal Reaction - Slowly slumped to floor.  Picked up and placed on exam table.  Blood Pressure 100/70 SPO2= 99%. After 20 minutes of observation, patient stated she felt fine and was released to home with Mother.
Extreme fatigue, tiredness, headaches, lack of energy, twitchy eyes ever since. Could sleep long hours.
Felt itchy on scalp & behind ears starting 4 days after vaccination (Sunday). Took some Benadryl that evening assuming it was bug bites after a hike the day prior. Didn?t report on Vsafe daily entry. The next day (Mon) felt a little less itchy til the evening. The third day (Tues) felt more itchy on scalp, ears, left shoulder & chest but did not have a rash so didn?t put it on the Vsafe check-in. Took Benadryl that night which relieved the itching & finally realized that it might be the vaccination even though it was days after the vaccination instead of dry skin or some environmental factor as it kept coming back even after Benadryl, lotion, dandruff shampo, etc. But since  I didn?t get any further Vsafe check-ins I wasn?t able to report it thru that app. Still feel a little itchy from the chest up (scalp, ears, neck, chest, back, forehead) even though it?s been 9 days after. Taking Benadryl every night has helped but it does come back.
pT DEVELOPED REDNESS AND SIGNIFICANT SWELLING IN THE THIGH WHERE SHE GOT DTAP.
Fever of 106.6 f. Seizure. Taken to ER twice. Follow up visit with pediatrician. Pediatrician stated that vaccines can not cause high fevers and seizures. ER doctors state vaccines do indeed cause high fevers which may result in seizures.
administered less than half a dose, some volume was lost; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult female patient who received Herpes zoster (Shingrix) (batch number 7P2PS, expiry date 2nd July 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 06-Apr-2022 Reporter's Comment: The nurse from her facility administered less than half a dose of Shingrix to a patient, because the patient pull the arm out during the administration, and some volume was lost. The reporter consented to follow up. Additional Supportive Information: The patient did receive less than half dose of Shingrix, which led to accidental underdose.
Rash moving all over, migrating,  intermittent, urticarial. Treated with Kenalog 40mg IM x 1, Cetirizine,
Syncope, lightheaded, nausea. Pt is pregnant at time of vaccination. Transported to ER by EMS
No additional AE/PQC was reported at time of call.; Pharmacist reporting that a dose of MMRII was inadvertently administered via intramuscular route rather than the intended subcutaneous route. No additional information provided. No additional AE/PQC was reported at time of call.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-DEC-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 0.5 ml dose, lot #W021189, expiration date: 29-MAR-2024, inadvertently administered via intramuscular route rather than the intended subcutaneous route (incorrect route of product administration) for prophylaxis (strength and dose number were not provided). No additional adverse event (AE)/product quality complaint (PQC) was reported.
About a week after my shot I began to have an itching sensation from my shoulders to my ankles.  No rash except for that caused by my scratching. The itching was not medically serious but quite uncomfortable and lasted almost two weeks.
Student was sitting with head turned towards the right as watching a video on cellphone.  Her father sitting next to student.  Was first given HPV, IM, then varicella, SQ, both on the left arm.  After shots were given,  student turned her head towards center but did not react when name was called and told "all done".   Then, trunk and neck hyperextended for about 1-2 seconds.  After which, student recovered and was fully awake, alert.  There was no cyanosis, skin was warm, no shortness of breath.  Pulse was strong and about 90/min.  Pupils, 3mm, equally reactive to light.   Student remained seated on chair and rested for about 5 mins.  Then got up and walked.  went home with father.
?Covid arm?. Red patch started the size of a quarter at injection site. Now the size of ansoftball.
flu-like symptoms; felt bad; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (Received 10 years go).   On 12th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms and feeling bad. On an unknown date, the outcome of the influenza-like symptoms and feeling bad were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's wife. On 12th August 2019, the patient had receive the 1st dose of Shingrix vaccine arin the evening and the next day when he woke up, he felt bad with flu like symptoms that lasted about 24 hours. The reporter asked if the injection was given intramuscularly and she said she assumes so. She did not have the lot number or the expiry date for the injection. The reporter consented to follow up. This case has been linked with case US2019232375 and case US2019232371, reported by the same reporter.
Bad headache, upset stomach, muscle/body pain, vomiting, dizziness, (fainted - I think.  It felt like someone suddenly pushed me down to the ground, I really though someone did that -but I live alone, no one did).  Chills, exhaustion.  Unclear thinking.  Felt like I had a fever, but I didn't check it.
Pinkish rash is now spreading down towards her elbow and the back of her arm; Rash on her arm at injection site; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Pinkish rash is now spreading down towards her elbow and the back of her arm) and VACCINATION SITE RASH (Rash on her arm at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (Rash on her arm at injection site). On 11-Feb-2021, the patient experienced RASH (Pinkish rash is now spreading down towards her elbow and the back of her arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) on 09-Feb-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Pinkish rash is now spreading down towards her elbow and the back of her arm) and VACCINATION SITE RASH (Rash on her arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  The patient stated that although recommended by pharmacist she had not yet taken the Benadryl tablets.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2021: Follow up received and added new event. On 22-Apr-2021: Follow up received and contains no new information. On 13-Jul-2021: Follow-Up received and updated primary reporter contact details.
Patient called pharmacy 10-8-18 to complain that arm (right) was still hurting after flu shot. Patient stated that arm was sore immediately after shot and discomfort has continued to increase. Currently patient states that lifting arm over head is painful. Advised patient to contact MD for additional pain relief instead of over the counter remedies.
runny nose; Dry throat; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and DRY THROAT (Dry throat) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Previously administered products included for Drug use for unknown indication: Biontech. Past adverse reactions to the above products included No adverse event with Biontech.    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 RHINORRHOEA (runny nose) and DRY THROAT (Dry throat). At the time of the report, RHINORRHOEA (runny nose) and DRY THROAT (Dry throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral test: (Positive) positive, (Positive) positive and (Positive) positive.         No concomitant medication was reported.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
in the morning of 22OCT93 pt felt hot, oral t103, body aches, h/a, stiff neck, malaise; illness subsided gradually until PM of 23OCT; morning of 24OCT 94 pt had no residual sx & felt well;
rash and a sinus infection; rash and a sinus infection; stomach stress, like in the intestine; the shoulder aches there and there is the red rash; rash on the arm and a bump red, very red; It was hot; there was just pain; appeared a red bubble, or red bump, and it was hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine), INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot) and RASH ERYTHEMATOUS (rash on the arm and a bump red, very red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), RIVAROXABAN (XARELTO), BUPROPION, TOPIRAMATE (TOPAMAX) and FUROSEMIDE for an unknown indication.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot), INJECTION SITE WARMTH (It was hot) and INJECTION SITE PAIN (there was just pain). On 02-Feb-2021, the patient experienced RASH ERYTHEMATOUS (rash on the arm and a bump red, very red). On an unknown date, the patient experienced RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine) and ARTHRALGIA (the shoulder aches there and there is the red rash). The patient was treated with AZITHROMYCIN for Sinus infection, at an unspecified dose and frequency. On 29-Jan-2021, INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot) and INJECTION SITE WARMTH (It was hot) had resolved. At the time of the report, RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine), RASH ERYTHEMATOUS (rash on the arm and a bump red, very red), ARTHRALGIA (the shoulder aches there and there is the red rash) and INJECTION SITE PAIN (there was just pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.