chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8737), in left arm and on 21Apr2021 as dose 2, single (Lot number: ER8736) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos thyroiditis in remission" (unspecified if ongoing); "elevated blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: COQ10 [UBIDECARENONE]; B COMPLEX [VITAMIN B COMPLEX]; D3; L-THEANINE; FISH OIL. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Positive Test Day 7; negative, notes: Negative tests on days 9 and 11; Asymptomatic, notes: through day 12; positive, notes: Mild symptoms beginning day 13 and positive test on day 14; negative, notes: Negative test on day 17. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
After the first dose in December I only had a sore arm. However after this second dose on 1/7 I experienced moderately severe chills, achy feelings, sore throat, and headache lasting from about 7am until I took ibuprofen at 5pm. The symptoms subsided after taking ibuprofen.
Diarrhea; Chills; Fever of 101.8; muscle pain; This is a spontaneous report from a non-contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283), intramuscular on 18Jan2021 00:45 at a single dose for COVID-19 immunisation. The patient's medical history included endometriosis and sulfa antibiotics allergy. Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 at the age of 27 years old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 19Jan2021 03:45, the patient experienced diarrhea, chills, fever of 101.8 and muscle pain. No treatment was received for these adverse events. Outcome of the events diarrhea, chills, fever of 101.8 and muscle pain was not recovered. The events diarrhea, chills, fever of 101.8 and muscle pain were considered non-serious.  No follow-up attempts are possible. No further information is expected.
PFIZER COVID VACCINE #3 GIVEN 1/17/22, LOT # 330258D; pt to hosp on 2/5/22 via EMS with SOB, non-productive cough x 2 wks; found to be positive for COVID; O2 supplementation; 2/7/22 dc'd to home; 4/24/22 pt passed away at home with COVID being one of the causes of death
Information has been received from a consumer concerning his granddaughter (a female patient of unknown age) who experienced paralysis after getting the first 0.5 ml dose of GARDASIL. Lot# was not provided. The patient was hospitalized and at the time of reporting she was still in hospital. No further information is available.
Pt reports altered mental status lasting 72 hours where she did not get up from chair or really feel aware of surrounding.
NOTE: Patient also received AFLURIA 2017-18 (Lot XT59606) simultaneously on the same left arm (higher location). Patient expressed symptoms of flushing on his face hours after receiving the vaccines. He also experienced warm sensation on his arm. He sensed he was going to get sick and bundled up for bed (jogging pants, thick socks, etc.). He woke up the next day feeling better but was experiencing a migraine which was a relieved with a dose of sumatriptan. Patient felt better/normal later that night 1/10/18.
Patient reported lightheadedness, weakness and bilateral arm numbness after standing for 30 minutes.  She received dose 2 of Moderna the day before.   She was placed in recliner, given fluids, VS as follows 100/70, 106 pulse, 99% O2.  Transported to the university health services where she continued fluid intake and rest and was discharged to home.
Tuesday am 9-11 am shot. Wednesday am awoke ill. No appetite, fussy and irritable. Didn't sense temp at first. By mid-afternoon temp. greater than 100 deg F gave Tylenol which brought temp down. Temp not taken by thermometer.
This case was reported by a physician via a sales representative and described the occurrence of extensive swelling of vaccinated limb in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of INFANRIX (unknown).  At an unspecified time after vaccination with INFANRIX, the subject experienced severe swelling in the upper arm where the vaccine was received.  This case was also associated with a pharmaceutical product complaint as the reporter is concerned that something is wrong with these vaccines and that they are holding on to them to return to agency if necessary.  At the time of reporting the outcome of the extensive swelling of the vaccinated limb was unspecified.  The reporter stated that this same event occurred in another subject.  See agency case number A0723454A for details.  Follow-up information was received on 09 May 2008 via a physician, who reported that the subject was a 4 year-old male, who received the 5th dose of INFANRIX on 18 March 2008.  Co-suspect vaccine administered on 18 March 2008 included the 4th dose of IPOL (Sanofi-Aventis).  Approximately two days after vaccination with INFANRIX and IPOL, the subject experienced severe swelling in his left upper arm through his elbow.  The reporting physician considered the event to have jeopardized the patient or required intervention.  The physician indicated that the subject received unspecified treatment and the event resolved.  The physician considered the event to be possibly related to the use of INFANRIX, and also listed this particular batch (lot #AC14B069AA) of the vaccine as a possible cause.
About 5 hours after shot, I started feeling nauseous, headache, congested, fever. Lethargic.
Pt recvd 1st dose of Recomb w/no adverse rxn; Pt recvd 2nd dose of vax & 4 hrs later exp localized redness, heat, pain, & swelling @ inject site; Also had swelling & stiffness of fingers; sx persisted for approx 24 hrs;
my left arm is THROBBING in pain! It's been awhile since I've gotten any kind of shot, so not having full mobility in my left arm is quite the shock.; MY ARM! Starting to wonder if this is normal post-vaccination soreness; This spontaneous report was received from a consumer referring on herself a female patient via company representative. As concurrent condition she had asthma and allergy issues. As concomitant therapies she used binto vitamins, allergy medications, and eucalyptus oil. There was no information about the patient's previous drug reactions or medical history.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her left arm (formulation, strength, dose, frequency, route of administration, indication, lot #, and expiration date were not reported).    On an unknown date, 1 day after the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) her arm was throbbing in pain (pain in extremity) and without full mobility (injected limb mobility decreased). Also, 2 days after the administration she still with pain in her arm.   The outcome and the causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were unknown.
Patient  was watching TV with her husband around 8 PM on 1/2/2022, when she developed tingling in her right calf.  She subsequently noticed that her right foot became numb. About 5 minutes later she developed numbness in the entire right leg, right arm, and the right side of her face. She said that her right arm and right leg were weaker, but she was able to ambulate and hold items with her hand. She also developed dizziness and palpitations. She stated that her ears were buzzing. She became more dizzy with spinning sensation when she attempted to stand up. Her husband called 911. The patient had BP 200 systolic in the ambulance. She arrived as level 1 stoke alert. CT brain/head stroke protocol did not show acute pathology, revealed 1.4 x 1 cm calcified lesion in the left basal ganglia and internal capsule, possibly representing cavernous angioma, mild chronic small vessel ischemia and volume loss.  Patient was admitted for CVA work up. MRI of the brain did not show acute pathology. ECHO showed mild LVH, no shunt. There was no events on telemonitor. Carotid US did not show flow limiting stenosis. Patient was seen by neurology. She was discharged on ASA and statin for LDL 110. She was seen by PT, OT and speech. Her right sided numbness and weakness resolved. BP normalized.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 13-NOV-2014, the patient was vaccinated with improperly stored ZOSTAVAX (19400 PFU). Concomitant medications were not provided. No adverse symptoms were reported. The temperature excursion with ZOSTAVAX was found to be supported with in-house stability data. Outcome of patient receiving improperly stored ZOSTAVAX was unknown. No product quality complaint was involved. Causality assessment was not provided. Additional information has been requested.
Onset of pain R arm evening of shot - worsened with decreased range of motion and c/o pain down arm and shoulder area, front and back over the next two weeks.  Also experienced loss of balance several times and some nausea.   Office referred her to her doctor 12/9/08.  Per MD - possible cellulitis treated with BACTRIM DS and TYLENOL.  Improving as of 12/17 and 12/19/08.
Diagnosed with shingles 15 days after first covid 19 vaccine dose; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On an unknown date the patient experienced diagnosed with shingles 15 days after first COVID-19 vaccine dose. Therapeutic measures were taken as a result of the event and included treatment with valacyclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diagnosed with shingles 15 days after first COVID-19 vaccine dose was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received her first Pfizer vaccine and was in the post vaccination room when she felt faint.  Patient described her symptoms as feeling hot, sweaty and light headed. She told her mom her symptoms and  who was familiar with her symptoms as mom herself has experienced similar symptoms post vaccination as has patient's brother.  Mom lowered patient to the floor and RN assisted her.  Patient did not respond to her name as mom called her name but responded shortly there after.  Patient sat up and was able to drink 4 ounces of orange juice and two packages of crackers.  Mom refused further medical intervention.  Mom was advised that when patient returns for her second vaccination she should have it administered in a private room where she can lie down.  Mom agreed.
Less than four hours after injection pt. developed a local cellulitis around injection site. Redness to site, Right deltoid. Warm, induration measuring 19cm x 12cm at margins. Boarders are poorly demarcated. No streaking. Tender to palpation. As of 11-7-2019 at 1445. Pt. did not attend scheduled Follow up, but was prescribed 7 days of clindamycin HCL 150mg 3x daily. On 11/22/19 pt called clinic and let staff know that symptoms resolved 3 days ago which would be 11-19-2019.
Information has been received from a pharmacist and a 71 year old female patient. The patient had no drug reactions/allergies. On 29-OCT-2014 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot # K007989, expiration date 03-SEP-2015, subcutaneous). The patient took no concomitant medication. On 02-NOV-2014 (reported as 4 days after vaccination) the patient experienced arm pain, limited movement and tingling in her left arm where the ZOSTAVAX was administered. The patient stated that the pain went from her shoulder to her wrist. The patient also experienced muscle pain and her arm was weak. The patient also had swelling and tingling in her bottom lip which began when the arm pain began. The patient developed canker sores in her mouth and she tried to treat the canker sores herself with Lysine (manufacturer and dose unspecified) which was unsuccessful. The patient also stated that she had experienced swelling of her lips multiple times on unspecified days (pertinent medical history was also reported as no). The pharmacist reported that the patient saw an unspecified cardiologist who evaluated her and confirmed that the pain and numbness was not from a cardiovascular event. The patient reported that she had seen her primary care physician on 11-DEC-2014 and was diagnosed with "a possible idiopathic shingles reaction". The physician prescribed acyclovir on the same day. No intervention was given to prevent serious criteria. The pharmacist stated that, when she saw the patient, the patient's left arm "had visibly atrophied" since the injection was given. The outcome of the events was reported as not recovered. It was also reported that the pharmacist was unsure if symptoms improved after treatment. Additional information has been requested.
Patient developed mild to moderate angioedema around mouth with swelling and redness. Some tongue swelling initially, but has resolved.
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. The administered doses were exposed to the temperature of 49.6 degrees Celsius for 1 hour and 20 minutes. There were no previous excursions. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.
Moderna that has BUD of 3/30/22 administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna that has BUD of 3/30/22 administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna that has BUD of 3/30/22 administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna that has BUD of 3/30/22 administered) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment reported  It was reported that the vial administered has an expiration of 5/20/22, and a BUD of 3/30/22 to one person this was done today which is 4/28/2022. The reported wanted to know if it was recommended for the individual to be revaccinated.
received liquid only portion; received liquid only portion; 39 year old received Shingrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 39-year-old male patient who received Herpes zoster (Shingrix) (batch number 32KA9, expiry date 11th June 2023) for prophylaxis.   On 7th March 2022, the patient received the 1st dose of Shingrix. On 7th March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The 39-year-old patient received injection of liquid AS01B only portion of the Shingrix vaccine, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration.  The vaccine was inadvertently not reconstituted prior to administration. At the time of reporting, the dose had not been repeated. The reporter consented to follow up.
pt recvd vax 16AUG93 & 26AUG93 devel a pruritic, papular, erythematous urticarial rash on trunk & legs; tx DPH & hydrocortisone cream;
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse practitioner reported that, on unspecified dates, 25 patients were inadvertently administered GARDASIL INJ (lot numbers, doses, and routes not provided), and another two vaccines, that had been improperly stored. No adverse effects were reported. This case is linked to cases MARRS# 1408USA001206 and MARRS# 1408USA001207 (same reporter link). Additional information is not expected because there was no consent to follow-up.
Seizures. Was in status epilepticus. Eventually this caused diffuse anoxic brain injury.
"Facial tics" - rapid blinking which was controllable by patient but lasted x several days.
Pt vaccinated w/DTP/IPV developed temp 100, cried 45 min constantly after receiving inject continued crying at intervals until afternoon especially when moved. Lt leg pain. Also, developed cold symptoms, possible bronchitis or pneumonia.
Patient had COVID Pfizer vaccines on 1/13/21 and 2/3/21. Known exposure to COVID and had positive COVID-19 PCR testing on 3/28/21; symptoms of runny nose and dysgeusia.
Breakthrough case admission after 4 vaccines Moderna 2/18/21 Lot# 007M20A;  Moderna 3/16/21 Lot# 015M20A;  Moderna 9/27/21 Lot# 005C21A;  Moderna 5/10/22 Lot# 057M21A
Blood pressure high; Weight loss; Injection site hives; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Blood pressure high), WEIGHT DECREASED (Weight loss), INJECTION SITE URTICARIA (Injection site hives) and COVID-19 (COVID-19) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) Citrate free. In January 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced HYPERTENSION (Blood pressure high), WEIGHT DECREASED (Weight loss) and INJECTION SITE URTICARIA (Injection site hives). At the time of the report, HYPERTENSION (Blood pressure high) and INJECTION SITE URTICARIA (Injection site hives) outcome was unknown, WEIGHT DECREASED (Weight loss) was resolving and COVID-19 (COVID-19) had resolved.            No concomitant medication were provided. No treatment medications were reported.  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.
On 10/20/15 at 8:00am patient notice large bruising on trunk, both arms, and  both legs. Appeared somewhat suddenly. Sign of first raised bruise on right fore arm appeared on Friday, October 23, 2015 morning. Morning on 10/23/15 patient when to phycisians office and had blood work done. At 1pm on 10/23/15 patient was called by doctor and told to report to emergency room immediately due to Platelets at 17,000. Blood transfusion given in ER on evening. Hospitalized for 3 days. Follow up appointment on Oct. 25 Platelets at 267000. Continuing treatment with dexamethasone every 2 weeks for 3 to 4 cycles with follow up on platelets. Dr. at cancer center is monitoring patient. It is unknown if the event is related to the vaccine administered on 10/6/15.
Vaccine administered day 1 with no adverse effects. Day 5-minor muscle pain in chest, mild fatigue continued through day 10, wife noticed rash on back and chest on day 10, doctor's visit day 10 confirmed Shingles outbreak, prescribed 10 course of Valtrax.  Rash worsened through day 15 when blisters started to dry up and redness began to subside.  No itching and very minor skin pain (primarily chest, minor on back) through day 15.  Skin/nerve pain worsened past day 15 through day 26, reduced skin/nerve pain through day 28
I had vagina blood spotting on Mon Jan 17th which was unusual because I no longer have a period so I called my GYM Dr.  I saw Dr. initially she did an ultrasound. Then I had another office visit with her, I went 3 days in a row to that office. She told me to get a hysteroscopy. I found a doctor with hysteroscopy equipment and (second Dr.) and it was performed in the office. Results showed everything was good, he said I was a 50th patient presenting with the same spotting bleeding incident that occurred just one time and he believes it's related to the vaccine and/or COVID but I never had COVID to my knowledge.
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 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankilosing Spondylitis" (unspecified if ongoing), notes: Ankilosing Spondylitis- NOT on, immuno supppresant medications. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; NALTREXONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.