chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extremely tired; This is a spontaneous report from a contactable physician (reporter's wife). A female patient of an un-specified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number/ expiry date not reported), via an unspecified route of administration on unspecified date in 2021 at dose 2, single for covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number/ expiry date: not reported), via an unspecified route of administration on unspecified date for covid-19 immunization. On an unspecified date in Feb2021 patient felt extremely tired the whole day. Reporter stated that he did have was one week after the second shot he and his wife both felt extremely tired the whole day. Patient vaccination was a week ahead of his. She only had the tiredness for 24 hours. The report was not related to any study or pro-gram. The outcome of event was recovered on an unspecified date in Feb2021.  Information on Lot/Batch number has been requested
they were really severely ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "they were really severely ill".  Additional information: Reporter's cousin and her daughter they had both shots and they had a booster shot and they were really severely ill.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 1045AM & 230PM could not read, or write & lost memory;all the above subsided completely by 6PM & has no residual neuro problems;
I was positive for COVID-19 on 05APR2023, I had a stuffy and runny nose, fever and muscle pain. I spoke with my doctor, he prescribed me paxlovid. I started feeling better about 2 days later, I feel a lot better now but I do sound nasally.
No additional AE details; Customer calling for TE evaluation on frozen products states that 7 vaccines stored outside of recommended range were administered to patients.   Names of vaccines involved (including lot/exp) VARIVAX; U010398; 4/1/2023        ?    Temperature 6°F; This spontaneous report as received from a registered nurse and an administrator, referring to a 26 years old female patient. Concomitant therapies included sterile diluent. The patient's historical condition and current condition were not reported.  It was reported that multiple patients received vaccines that underwent the temperature excursion prior to the office being aware of it, between 08-APR-2022 to 02-MAY-2022. On 27-APR-2022, the patient was vaccinated with incorrectly storge of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U010398 with expiration date: 01-APR-2023; dose, route and strength were unknown) for prophylaxis (product storage error).   Administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion below 6 Fahrenheit degrees (F) up to 14F (7.9F) for 4 hours 8 minutes 0 seconds. No previous temperature excursions reported. The reporter reported the office was unaware of the temperature excursion until she completed a data logger download on 02-MAY-2022.  No adverse events have been reported to the office at the time of the report.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA001061: US-009507513-2205USA000973:02158523 US-009507513-2205USA001202: US-009507513-2205USA001043: US-009507513-2205USA001205: US-009507513-2205USA001272:
possible late second dose of a series; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (possible late second dose of a series) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (possible late second dose of a series). At the time of the report, PRODUCT DOSE OMISSION ISSUE (possible late second dose of a series) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information was provided.
Lost his voice completely; he had some chills; He is coughing so bad/ Patient had "dry cough/ coughing has worsened; has a sore throat; headache; This is a spontaneous report from a contactable consumer. This female consumer reported for her husband (patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ET7534, NDC number and expiry date were reported as unknown) via unspecified route of administration on 06Apr2021 at 10:00 (at the age of 58-years-old) in left arm as dose 2, single for covid-19 immunisation in campus. Medical history included diabetes mellitus (diagnosed probably 20 years ago or more). Additional vaccines administered on same date of the Pfizer suspect and prior vaccinations (within 4 weeks) were reported as none. No adverse event following prior vaccinations. The patient's concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534; Expiry date: 31Jul2021) via intramuscular in left arm on 16Mar2021 for covid-19 immunisation. It was reported that the patient received the second dose on 06Apr2021. The first day on 06Apr2021, he was okay, he had some chills, but that was okay. The second day on 07Apr2021, he began to lose his voice, he had lost his voice completely. He was coughing so bad, had sore throat and dry cough. The reporter had been for the past 2 days, and she couldn't find any side effects like that, especially because he lost his voice. Coughing was worsened and sore throat had stayed about the same, he had complained about the coughing more. The adverse events did not require visit to emergency room or physician office. The reporter was planning to take the patient either to the doctor or the ER after she finishes talking to Pfizer. Relevant tests were reported as none. The patient was treated with Tylenol for chills and headache. The reporter wanted to know if the events were possible side effects of the vaccine. The clinical outcome of the events chills and headache was unknown and for all other events was not resolved.  No follow-up attempts are needed. No further information is expected.
Injection site is large and swollen a little smaller than a tennis ball and growing everyday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Aug2021 12:30 (Lot number: FD8448) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Benadryl; Niacin. Vaccination history included: Bnt162b2 (product=COVID 19 brand=Pfizer, lot number=FA7485, administration time=12:30 PM, dose number=1, vaccine location=Left arm), administration date: 25Jul2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Aug2021, outcome "not recovered", described as "Injection site is large and swollen a little smaller than a tennis ball and growing everyday". The event "injection site is large and swollen a little smaller than a tennis ball and growing everyday" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site swelling.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine, and received other medications in two weeks. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
My mom had a brain aneurysm 45 minutes after receiving her second Covid vaccine on Wednesday, March 31st, 2021.  She was rushed to Medical Center. After her CT Scan she was put on Life support that morning.  After consulting with Doctors we took her off Life Support at 4:00 pm on Friday April 2nd and she passed away 29 hours later at 9;00 pm on Saturday, April 3rd.
The patient was given IPOL after 28 days, no AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a patient (gender and age unspecified) who was administered IPV (VERO) [IPOL] after 28 days (poor quality product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 31-Jul-2020, the patient received a dose of suspect IPV (VERO) (lot number not reported, expiry date: 11-Sep-2020) via unknown route in unknown administration site for prophylactic vaccination.  The vial was opened on 02-Jul-2020 and was given to the patient on 31-Jul-2020.  It was reported that it follows a 28 day rule.  It was a case of an actual medication error due to deteriorated drug administered (latency: same day)  At the time of report, no adverse event was reported.  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 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.  There will be no information available on lot number.
passed out; fall; she felt kind of weird.; bruised and sore; bruised and sore; This is a  spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 30May2021 14:00 (Lot Number: EW8736, at vaccination age 55 years old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on 07May2021 13: 00 in left arm (LOT: EW0171) for covid-19 immunisation and had no adverse effect. The patient expected to feel the normal things like tiredness, feeling crappy, but she got her vaccine on Sunday 30May2021 at 14:00 and then the next morning 31May2021 when she woke up at 0730, she didn't know how many hours that is, she got up, she was putting her contacts in and she felt kind of weird. The next thing she knows she was passed out by her bed. Then she got up, put her other contact in, then she had to let her dogs out. She went to let her dogs out and passed out again. It was really bizarre, she never faints ever. Luckily she didn't get injured from the fall, but is bruised and sore. AE(s) did not require a visit to emergency room or physician office. The outcome of event passed out was recovered, others was unknown.
First dose: soreness at the injection site that was pretty minimal; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 02:50 (at the age of 55-years-old) (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included omeprazole (OMEPRAZOLE) taken for antacid therapy, start and stop date were not reported. The patient previously received first shingrix vaccine for immunization on 19Jun2020, second shingrix vaccine for immunization on 31Aug2020, Flu vaccine for immunization on 23Nov2020. After first dose the patient experienced soreness at the injection site that was pretty minimal on Mar2021. she states she felt fine after getting both doses of the vaccine. The patient underwent lab test of X-ray, dental 3d X-ray for nerve pain, CT scan on the face with no result. The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021893746 similar report from same reporter
Within 6 hours Fever was 101.7 Took  a combo of Aspirin 1.3 gm and Tylenol 600 mg. every 6 hours. Had a very bad night with muscle pain --- neck and shoulders. Temp did not go under 100.5 thru out the night. I finally able to sleep around 7:30 AM,  waking up at 1:35 PM.   Temp  was finally below 99.4 for the next 12 hours.  Feel weak without  an appetite.
Patient presents to our emergency department on 2/13/2021 with complaints of nausea, vomiting & diarrhea, dehydration and headache. Iv fluids administered, patient kept observation for 24+ hours.
Initially inability to move the left arm to put it into the jacket. Then bouts of labile hypertension, inability to find his word and then slurred speech and global problems moving his limbs and fine motor issues
Extreme headaches that started on 7/14/2021.  Pain begins in neck and moves upwards in top of head.
If the flu shot is supposed to make some people sick why don't we be told. I was told I would have a sore shoulder. My shoulder has not bothered me. I do not be sick I worked 6 years, no sick day out of work. So I did not expect to be sick after this shot. I have had shots before but not been sick from them. Nausea, chills, hands numb weak, too weak to work in the home. I used heating pad to warm hands head aches. I felt like staying in bed 3 days. I prayed and hoped I would be better to Bowl on Wednesday.
Patient reported extreme redness and irritation at injection site (6 in x 3 in area) red and painful.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 22-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date).    Concomitant product use was not provided by the reporter.  Staff gave patients vaccines past the use date of 18-Jun-2023.  On 22-Jun-2023, 5 doses were administered at administration site 2.   Treatment information was not provided.  This case contains information for the 25th patient out of 47 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received suspect vaccine details added, iNarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
All of a sudden started high pitched screaming in pain cry and was completely inconsolable.  We called the Dr within 5 mins and then decided to go the the ER after 30 Mins, the crying lasted 1 hour.
Received a pneumococcoal vaccine from doctor. Don't know manufacturer, lot number, route, site or number of previous doses. Fever 101F 18-24 hours after shot administered in left arm. Swelling at site of shot about 8 hours after receiving shot. Contacted physician 24 hours and was directed to come back to office after receiving shot. Patient declined to be seen 24 hours but it was suggested he take Tylenol. Fever subsided. Slept better second night (could not first night because of discomfort). 36 hours after receiving shot returned to doctor's office after calling. Given a course of treatment of 500 mg of cephalexian one capsule four times a day for a course of 8 days.
Arm was a bit sore; The patient was a bit fluish; This spontaneous case was received on 12-Oct-2020, from other non-health professional (consumer) to The Agency (reference number: SEQW20-03435) and concerned a female patient of unspecified age. At the time of this report, the patient was 59-year-old.  The patient's medical history and concomitant medications were not reported.   On an unknown date, patient was vaccinated with influenza virus vaccine polyvalent [brand not specified, indication dose, route of administration, anatomical location: not reported]. The batch number was not reported.  On an unspecified date, after receiving unspecified influenza seasonal vaccine, the patient was a bit fluish and her arm was a bit sore.  The reporter did not provide a causality assessment.  The reporter assessed this case as non-serious.  This case is linked to case number 202005139 (the same reporter).  Case updated on 27-Nov-2020: Correction made to information received on 12-Oct-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. No changes in narrative.  Company comment: A patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date, after receiving vaccine, the patient developed pain in extremity and influenza like-illness (the patient was a bit "fluish"). Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding temporal relationship, diagnostic and laboratory findings, patient's medical history and concomitant medications.; Sender's Comments: A patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date, after receiving vaccine, the patient developed pain in extremity and influenza like-illness (the patient was a bit "fluish"). Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding temporal relationship, diagnostic and laboratory findings, patient's medical history and concomitant medications.
Pt recv vax on 11/3/98; on 11/6/98 pt exp itchy, warm, discoloration of arm
about 15 minutes after getting vaccine, she felt lie head is spinning and about to faint. She reports not having eaten much today. Also says she does not remember having any other vaccinations before. She sat down and rested, ate some food and drank some water and felt slightly better.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age. On 12-FEB-2013, the patient was vaccinated with an expired MMR II (injection) (lot # 0156AA; exp. date: 01-FEB-2013 (dose and route not reported). No adverse event reported. Additional information is not expected.
Dizziness; Chills; Fever; Splitting headache; Nausea, unable to take medication due to fear of vomiting; Extreme fatigue; Slept for 16 hours; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2022, the patient received the 1st dose of Shingrix. On 5th August 2022, less than a day after receiving Shingrix, the patient experienced dizziness, chills, fever, headache, nausea, fatigue and sleepiness. On 7th August 2022, the outcome of the chills, fever and headache were recovered/resolved. On an unknown date, the outcome of the dizziness, nausea and fatigue were recovering/resolving and the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the dizziness, chills, fever, headache, nausea, fatigue and sleepiness to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: The reporter was a patient. The patient received Shingrix vaccine. The reporter stated he was feeling fine for several hours after received vaccine. The reporter reported that he experienced symptoms around 6 pm. The patient experienced dizziness, chills, fever, a splitting headache, nausea and extreme fatigue. The patient was so fatigued that the patient was slept for 16 hours on Friday night. The patient was feeling unable to took medication for symptoms due to the fear of vomiting because of the nausea. The patient had all symptoms throughout the Saturday. The reporter stated headache, fever and chills were resolved on Sunday evening. The reporter stated dizziness, fatigue and nausea were ongoing, but to a much lesser degree. The patient was feeling as through almost back to normal. The reporter did not consent to follow up.
left armpit pain.  Right armpit pain.  Pain throughout the body.  Fever of 102
Post vax, pt had fever to 101. Then 48 hours later 104. Irritable, slightly tender at site. Otherwise physical unremarkable refused to walk.
Day 1- Fever of 102 F, body aches and pains, chills, Headache Day 2- sore throat and mild aches
Mother noted symptoms of fever of 100F, runny nose, "difficulty breathing", incoordinated walking. Symptoms for 2-3 days. No ER or MD visit or evaluation.
About one hour after injection developed left facial numbness while I was on my way home. Not full numbness, but felling as if coming out of a novocaine shot. Left side chin, lips, cheek extending up to ear/eye. No sign of swelling, droop, redness. Has lasted 2 weeks + and has improved over time but not fully resolved. Now is more an occasional numb feeling mostly in L cheek/lips/corner of L eye. I grind my teeth during stressful times and grind more on my left side so was thinking it could be related to that. Sought medical attention from my doctor who felt said most likely not Bell's palsy related.
Information has been received from a 27 year old female patient with no known allergies and no pertinent medical history, who was vaccinated with the first dose of MMR II. In 1997, she received a second dose of MMR II, because when she was about to enter college, her titers were checked and found to be negative. Almost immediately after she received the vaccination, she experienced numbness in her vaccinated arm, a large cold sore on her face, and was losing vision. The patient went to her physician's office, had a spinal tap and was diagnosed with multiple sclerosis. She was given SOLUMEDROL to stop the inflammation. She was also hospitalized. The patient's numbness in her vaccinated arm, large cold sore on her face, and multiple sclerosis persisted. She was placed on interferon. Additional information has been requested.