chrisvoncsefalvay/vaers-outcomes huggingface dataset:
having symptoms of multiple sclerosis after a week and a half of the first dose of the Pfizer COVID-19 vaccine and her symptoms increased after that; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 (Lot number: ER8732) at the age of 56 years as dose 1, single and administered in arm left, administration date 17Apr2021 (Lot number: EW0161) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (medically significant) with onset 12Apr2021, outcome "not recovered", described as "having symptoms of multiple sclerosis after a week and a half of the first dose of the Pfizer COVID-19 vaccine and her symptoms increased after that". The event "having symptoms of multiple sclerosis after a week and a half of the first dose of the pfizer covid-19 vaccine and her symptoms increased after that" was evaluated at the physician office visit. Therapeutic measures were taken as a result of multiple sclerosis. The patient was "having symptoms of Multiple Sclerosis after a week and a half of the first dose of the Pfizer COVID-19 vaccine and her symptoms increased after that". Patient had her Pfizer COVID-19 vaccine in Mar2021 and Apr2021 and was "officially diagnosed with Multiple Sclerosis in Jul2021". Patient was "started with "Ocrevus" which weakens the immune system according to caller". Patient "was administered with the Ocrevus infusion last November and she is due for another infusion at the end of April". Patient and husband were concern because of the possible effect of the Ocrevus to the immune system of caller and if it would affect her getting a booster dose of the Pfizer COVID-19 vaccine. Patient asked for information on administration of the Pfizer COVID-19 vaccine with people with a weakened immune system and with people taking immunosuppressants. Patient asked if her symptoms would get worse and if Pfizer recommends a larger dose for autoimmune deficiency specifically with Multiple Sclerosis. The patient was diagnosed with Multiple Sclerosis a week after the first dose of getting the Pfizer Covid 19 vaccine, and the symptoms of Multiple Sclerosis escalated after the second dose of vaccine. No vaccinations within four weeks prior to the first administration date of the suspect vaccine.
Pfizer-BioNTech COVID 19 vaccine EUA Fever of 100.9, chills, body aches, headache, tired
Pt in for 3rd injection. Given IM (L) arm - observed pt x 15 min after inject. Upon checking out pt with LOC. Lowered pt to ground - unresponsive. 911 called - pt with short period of apnea - slow to respond to facial stimuli & smelling salts. 911 arrived - evaluated pt - transported to ER via ambulance.
This case was reported by a consumer and described the occurrence of silence in a 3 month old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On 10/19/05, on the day of the subject's birth, he received the first dose of hepatitis B vaccine. Following receipt of the first dose of hepatitis B vaccine, on 10/19/05, the subject, "had eye contact problems." The eye contact problems were ongoing at the time of initial reporting, 3/10/06. On 12/27/05, the subject received first dose of Pediarix (lot AC21B047BA). On 12/27/05, less than one day after vaccination with the first dose of Pediarix, the subject experienced hardened stools and an aversion to breast feeding. The outcome of the hardened stools and aversion to breast feeding was not reported. On 2/10/06, the subject received the second dose of Pediarix (lot AC21B053BA). On 2/10/06, less than one day after vaccination with the second dose of Pediarix, the mother of the subject reported that the subject, "went silent for the first three days. He had been babbling, but his communication diminished." At the time of initial reporting, 3/10/06, the diminished communication was ongoing. On an unspecified date, the subject experienced a fever. The outcome of the fever was not reported. Comment: Silent was assessed as medically serious (OMIC).
June 4 onset of diarrhea around 1pm.  Took OTC Kaeopectate to stop diarrhea.  Stools turned to nothing but blood.  Fatigue, abdominal pain, nausea.  Same symptoms as my daughter (she has filed a report).   Saw Dr. at PCP office on Monday, June 7th.  Blood tests requested.  Stool Sample requested.  Awaiting results. Since my daughter and myself both came down with same symptoms within 24 hours of each other we were instructed to complete this form and we have been discussing possibility of food poisoning with our PCPs.  Still have nausea, chills, abdominal pain.  Bloody stools have stopped for me.
Inject of PCV 13 given on 6/8/10 to (R) thigh.  On 6/9/10 in AM noted reddened area 3cm in size. On 6/10/10 noted very lg reddened area 8 x 9 cm with slight induration. Prescribed TYLENOL and BENADRYL. Follow-up appt. given for 6/11/10.
About 2 hours after the injection, my right ear started ringing loudly.  At 5:00 it's abating somewhat.
3 papular red lesions at site of injections a large area of diffuse erythema around upper arm.  Mild swelling with tenderness of upper arm. This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from a physician and the 64 year old female registered nurse who on 23-Feb-2007 was vaccinated SC in the right arm with a first dose of ZOSTAVAX Merck (Lot # 6564/1476F). On 23-Feb-2007, immediately after vaccination, the injection site began to get red. On 24-Feb-2007 at 18:00 (also reported as "by 25-Feb-2007), the injection site was 3" x 3" red area with three papular red lesions, these lesions were reported to be the diameter of a nickel in site. The nurse reported that she experienced discomfort from the injection site to underneath her arm. It was reported that there was still swelling and tenderness of her upper arm and that she could still fell a "thickness" at the injection site approximately 1.5" x 1.5" in diameter. The nurse stated that the experience seemed to be localized to the injection site area. Unspeciified medical attention was sought. The nurse reported that she applied BENADRYL cream and took an unspecified anthistmine. No lab or diagnostic test were performed. At the time of the report the patient was recovering. There was no product qauality complaint involved. The patient had no adverse events following prior vaccination. No further information was provided. Addtional information received indicated that the patient recovered on an unspecified date. Additional information is not expected.
p/vax pt exp flu like sx including a fever of 104, h/a & body aches;pt did not report this event until saw MD to recv second dose of vax;MD did not administer vax & advised pt to get a titer drawn;
Partial Placental Abruption that led into Pre-Term Labor and Premature delivery at 22 weeks gestation and death of infant shortly after, with no prior complications.
severe anterior uveitis, pred forte gtt, durazol gtt, timolol gtt, combigan gtt, cyclogel gtt, laser surgery
A report received from a healthcare professional on 11/08/02, concerning a 83 year old male vaccinee who experienced double vision one week after receiving Fluvirin on 10/30/2002. The vaccinee had not yet recovered at the time of reporting. There was insufficient information to determine the reporter's assessment of causality.
A report was received from a health professional on 10/15/02, concerning a 71 year old female patient who experienced injection site redness, infection and fever requiring medical intervention, after receiving Fluvirin on 10/8/02. On 10/11/02, the patient experienced redness at left arm, injection site and fever after receiving Fluvirin in the left arm on 10/8/02. On examination the left arm was red and swollen, with a streak running down her entire left arm. The patient had a temperature of 38.33 degrees C. The patient was treated with an unknown dose of oral ciprofloxacin and was sent home. At the time of this report the patient had not recovered. The reporter has assessed the relationship of study medication to the event as probable.
She got her vaccine, had the listed reactions on the paperwork.  She has had all the Pfizer vaccines and the listed normal reactions.  She woke up out of her sleep this morning with a sensation of feeling where she could not breath, she was blocked in the back of her throat with severe soreness of her uvula, and it was red when she checked it.  The uvula was very swollen and red.  It was scary, she was thinking that this was happening to her again.  She is watching, and now she has a sore throat.  This kind of feels like a reaction that she had when taking generic medications of anaphylaxis.  She is breathing a little easier but sill has the swollen, red sore throat.  She has not called her doctor, but left word with one of them and she has not called her PCP yet.
Pt presented to the ER on 6/13/2021 complaining of progressively worsening SOB, palpitations, anorexia, weakness, mental status changes, post menopausal bleeding and 2 enlarging cystic areas on her occipital and parietal scalp for the past 2 months. Pt reported post menopausal bleeding and abdominal cramping began after initial Moderna covid vaccine on 4/9/2021. She received her 2nd Moderna covid vaccine on 5/7/2021. She saw her PCP on 5/11/2021 and was referred for an outpatient ultrasound. Pt reports increased symptoms again after 2nd Moderna vaccine. She saw OB/GYN on 6/2/2021. She reported having her last menstrual period in February 2021. Then she had 3 months of amenorrhea and in end of April she had one day of heavy bleeding. After that, pt was spotting on and off for a few weeks and a heavy bleeding day in between. After evaluation, pt was found to have a complex fluid collection within the endometrial cavity, which could represent endometritis or endometrial carcinoma. Additional workup is in process.
Mother states swelling (looks like a blister on burn) on rt leg area w/a lump around shot site, no fever, vomiting, child states rt leg hurts. Seen by MD. Dx as Cellulitis from bacteria.
flu; lack of efficacy, gotten the flu vaccine but had still gotten the flu; Initial information received on 04-Dec-2019 regarding an unsolicited valid serious case received from a non-health care professional.  This case involves a female patient of unknown age who developed flu (influenza) and reported lack of efficacy (vaccination failure), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination 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 and other dosing details were not reported).  On an unknown date, the patient developed serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Also this was a case of vaccination failure.  Details of laboratory data were not reported.  Final diagnosis was influenza and vaccination failure.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient who presented with Influenza after and despite vaccination with INFLUENZA VACCINE. The time to onset is unknown. Moreover, there is no information regarding patient's condition at time of vaccination, immune status, congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Really bad ball in the hand; really sharp pain in left hand; vaccine was administered in left hand; whole day was not feeling good; stomach hurt; does not want to eat; can't get good sleep; This is a spontaneous report from a contactable consumer (patient's wife). A 39-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left hand on 18Aug2021 08:30 (Batch/Lot number was not reported, Caller did not have the patient's vaccine card and does not have this information to provide) as dose 1, single at the age of 39-year-old for COVID-19 immunisation. Medical history included COVID-19 in May2020. There were no concomitant medications. The patient experienced really sharp pain in left hand from night of 18Aug2021 and ongoing, really sharp pain in left hand was reported as worsened; really bad ball in the hand from night of 19Aug2021 and ongoing; stomach hurt, did not want to eat, can't get good sleep in 2021; whole day was not feeling good in Aug2021. He got the vaccine in the morning. At night, he started complaining that he got a sharp pain. The whole day he was not feeling good. Last night, when taking off his shirt, he got like a really bad ball in the hand. His stomach hurt and he did not want to eat. He can't really get any good sleep. The big problem was the sharp pain, lots of sharp pain. It was last night. She called right now to the pharmacy to see what was going on, if they would give some medicines or something. They gave her a paper with this number. Sharp pain in left hand: Stated he was not experiencing the pain now. He was working as a waiter. He was working in the day and at night when he came back to the house, it was really bad, at night. She thought it is coming worse. Really bad ball in the hand: It was not too big, like it covers the hand. It was the same this morning. Events did not require a visit to emergency room or physician office. No treatment received. She went to the pharmacy and asked for the vaccine. She did the paperwork and he did not tell her exactly. It got worse or something like that. It was nothing like that. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No events following prior vaccinations. No family medical history relevant to events. No relevant tests. The outcome of really sharp pain in left hand and really bad ball in the hand was not recovered. The outcome of other events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Joint pain - chest wall pain.  Joint pain is constant, not relieved by IBUPROFEN.  6/3/08 Reviewed OB/GYN medical records & vax records. FINAL DX: probable hypersensitivity to Gardisil. Vax records reveal 2nd HPV 0052Y given RUE 3/1/08.  Patient had been on Yasmin & then was switched to some other BCP.  Well for both doses.  5/27/08 reports that patient experienced constant joint pain after 1st HPV along w/chest pain.  Seen by pediatrician & dx w/chest wall pain.
Sore right arm; Couldn't sleep because of the headache/in bed the whole day, mostly trying to sleep; Fatigue/tiredness; Chills; Headache/my headache was terrible; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm), INSOMNIA (Couldn't sleep because of the headache/in bed the whole day, mostly trying to sleep), FATIGUE (Fatigue/tiredness), CHILLS (Chills) and HEADACHE (Headache/my headache was terrible) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORATADINE and FLUTICASONE for Allergy, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore right arm), INSOMNIA (Couldn't sleep because of the headache/in bed the whole day, mostly trying to sleep), FATIGUE (Fatigue/tiredness), CHILLS (Chills) and HEADACHE (Headache/my headache was terrible). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram. At the time of the report, PAIN IN EXTREMITY (Sore right arm), INSOMNIA (Couldn't sleep because of the headache/in bed the whole day, mostly trying to sleep), FATIGUE (Fatigue/tiredness), CHILLS (Chills) and HEADACHE (Headache/my headache was terrible) outcome was unknown.            Concomitant medications includes ocuvite, multivitamin, Fish Oil.   This case was linked to MOD-2021-080294 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received included no new information.
This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male pt who experienced mercury poisoning and neurodevelopmental injuries. The pt received a dose on an unspecified date. It is alleged that as a result of cumulative exposure to mercury in the thimerosal-contatining vaccne (s), the child developed "severe" neurodevelopmental injuries of mercury poisoning. No additional info was available at the time of this report.
Narrative:  Pt had seizure at home the morning of COVID vaccine dose #1, had attended his vaccination appt and received dose at 1501. At 1506, pt started seizing and pt's wife honked the car's horn to alert for assistance; EMT called and  arrived 1516. Pt started on lamotrigine for seizures and is to seen by neurology for f/u.
Case previously recorded as MA2009-4319. Initial case report received from a medical assistant via agency, on 11 NOV 2009. A 3-year-old male patient was accidentally vaccinated with FLUVIRIN (batch no. 102125P1) i.m. on 11 NOV 2009. No adverse effect was reported. Agency reference no.: NA09-007978.
I had fatigue, difficulty breathing, low oxygen level, and just not feeling good in general. My blood oxygen was low 90's and sometimes in the 80's. Then, months later I started having heart arrythmias. I contacted my doctor and was told to take Baby Aspirin. No other medications were prescribed. I am starting to feel netter now. I still have a little breathing issue but not as bad.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Vaccine received post its 30 days Expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2022 at 7:31 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 16-Feb-2022 at 7:31 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 16-Feb-2022 at 19:31:25.  No treatment information was provided by the reporter.
Hospitalized 11/6/2021; COVID-19 positive 11/6/2021; fully vaccinated  BRIEF OVERVIEW:     Admission Date: 11/6/2021 Discharge Date: 11/10/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus    HOSPITAL COURSE:  a 74-year-old female with history of breast cancer s/p lumpectomy and depression who was admitted for COVID after presenting with cough and dyspnea.  She had been having significant diarrhea and was generally weak at time of admission.  She did have 1 desaturation in the emergency department but after admission did not require any oxygen.  She received the monoclonal antibodies while inpatient.  She was evaluated by PT and OT who recommended subacute rehab. Discharge was delayed due to severe respiratory isolation but once isolation discontinued, SAR placement arranged. She remained on room air and was felt stable for discharge on 11/10. She will follow up with her PCP after discharge from SAR.
Reports sore arm that lasted more than a few days that required multiple doses of over the counter acetaminophen. Patient also iced. When pharmacy examined arm, there was a dark, yet fading, bruise ~5" down from injection area. When arriving to pharmacy 9/26/21 the bruise was in healing process and patient wasn't in pain.
pt recv vax;mom noticed rash (hive like) on arms; rash spread to diaper area then gen over entire body;was not itchy;no T elev;dph given;rash clearing but not entirely;
This spontaneous case was reported by a consumer and describes the occurrence of pruritus (both arms became itchy), peripheral swelling (swelling of both arms and chest), swelling face (puffy face) and skin mass (lumps under her face skin) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 001A21A) for COVID-19 immunization. No medical history reported. On Feb 28, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; unspecified dose. On Mar 4, 2021, patient experienced pruritus (both arms became itchy), peripheral swelling (swelling of both arms and chest), swelling face (puffy face) and skin mass (lumps under her face skin). At the time of the report, pruritus (both arms became itchy), peripheral swelling (swelling of both arms and chest), swelling face (puffy face) and skin mass (lumps under her face skin) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments.
Painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 This case was reported by a patient husband via interactive digital media. The reporter stated that, the vaccine was ten times more painful than a tetanus shot. The reporter asked is there any way you could make the shingles vaccine less painful. The reporter wife took the vaccine and she said it was ten times worse than the vaccine against tetanus. The follow-up could not be possible as no contact details were available.