chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It is still itchy and still has pink rash with dots in them. So it is definitely a rash; It is still itchy and still has pink rash with dots in them. So it is definitely a rash; She has a lump on other side of elbow now; First dose of Prevnar 13 in 2013 but before this one on 05Nov2019; Left Arm blown up after receiving; It hurt where it was put in; This is a spontaneous report from a contactable consumer.   A 74-year-old female patient received second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , on 05Nov2019 at single dose in her left arm as routine vaccination.  Concomitant medication were not reported. In 2013 patient took first dose of pneumococcal 13-val conj vaccine for immunization and she did not blow up after that one. Medical history included right arm surgery on an unspecified date in 2013 (after she received the first dose of vaccine in 2013). On 28Oct2019 a surgery in her right arm was done and she had a cast on it and she did not feel good.  She needed her left arm really bad. She was not hospitalized and it was done in a surgery center. She had a Fiberclast cast on it and 22 stiches were pulled out. She was still recovering from that and she believed this cast will be on for two weeks. She said her arms were really skinny normally, she never had heavy arms. On 05Nov2019 patient stated it hurt where vaccine was put in, her left arm got all blown up; since an unspecified date she had  rash and lump. On 07Nov2019 patient saw her doctor who told her to take diphenhydramine hydrochloride (BENADRYL). She did not take it and she went to his office. He gave her two Prednisone 20 mg each, and she took it at 2 tablets by mouth once daily. She said the swelling has gotten a little better since then. Since an unknown date she had "a lump on other side of elbow". The doctor drew it with magic marker but moved from one side to the other side of the left elbow.  She said "there was one on one side of the elbow and one on the other side of the elbow and one where biceps are.  She doesn't have any biceps." It was still itchy and still had pink rash with dots in them. So it was definitely a rash. There were about 10 dots there where the one rash was. Patient was recovering from Swelling arm; outcome of the other events was unknown.Information on batch number has been requested.
Patient presented to the ER one day post second dose of vaccine with chest pain and was diagnosed with pulmonary embolism.
The Patient received both PREVNAR 13 and FLUAD on 10/18/18. On 10/19/18 he had increased urination, a severe sinus headache and bloody nasal passages. He was able to function but had to go to the emergency room because he was so severely dehydrated. He would not give me his name so I can't look up lot numbers for any of these vaccines.
p/ pt recv vax 3/17 then 13 days later devel chickenpox breakthrough
This  patient was admitted to Hospital on 1/11/2022 pneumonia due to COVID-19. This is considered a breakthrough case
It was reported that a 2 month old female patient received an IPOL, an ActHIB, and Infanrix and a Prevnar vaccination on 3/27/01. Reportedly that same day the patient developed local swelling of the right thigh where IPOL and ActHIB were administered. Patient became irritable for three hours. Patient was treated with compresses and Tylenol. Resolved per doctor.
Information has been received from a female who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient's hair began falling out and she felt very itchy. It is unknown whether the patient sought medial attention. The current status of the patient was not reported. Additional information has been requested.
Information has been received from a health professional concerning a 25 year old Hispanic female engineer with no known drug allergies who, on an unspecified date, was vaccinated in the left gluteal muscle with a first dose of Gardasil. There was no concomitant medication. On 26 Oct 2006 the patient became flush, experienced vomiting and nausea. There was no illness at the time of vaccination. It was reported that the patient recovered the same day, 26 Oct 2006. Additional information has been requested.
Fever, chills, body ache, nausea, tiredness and fatigue for 36h, sore site of injection for 4 days
Itching, soreness, rash, lesion developed at injection site on 2/12/21
My whole body was numb for 1hr and 30 min; unsteady balance; confusion; palpitations; sob; This is a spontaneous report from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 25May2021 as dose number unknown, single for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. On unspecified date 2021, The patient experienced Later on in the day patient experienced severe side effects that was on listed patient whole body was numb for 1hour and 30 min, unsteady balance, confusion, palpitations, and sob. patients understand the sob because had asthma but otherwise perfect health. The outcome of event was unknown.  Information on the lot/batch number has been requested. ; Reporter's Comments: Reporter provided verification of contact address on 11Jun2021 CEP D #3110
Information has been received from a physician concerning a patient who on unspecified date was vaccinated with second dose of pneumococcal 23v polysaccharide vaccine (lot # unspecified). It was reported that the "patient developed a softball size lump on their arm after receiving their second shot". Unspecified medical attention was sought. No further information was available. At the time time of this report the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2008.  Information has been received from a physician concerning a patient who on unspecified date was vaccinated with second dose of PNEUMOVAX (lot # unspecified).  It was reported that the "patient developed a softball size lump on their arm after receiving their second shot".  Unspecified medical attention was sought.  No further information was available.  At the time of this report the outcome was unknown.  No additional information is available.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient states 2 days after receiving COVID Bivalent Booster, injection site formed large goosegg with the diameter of a baseball.  It is raised and elevated about 1".  It is painful to the touch.
He is dizzy, weak, and his neck is stiff and painful. His shoulders hurt. Joints are achy and stiff. Poor appetite. Used a heat pad on his neck.
Vaccine was given 12/28/2020 and it had expired 12/13/2020. No know adverse reactions to the patient.
Right after vaccine - I was running fever of 101. I called the doctor's office the next day and she said it was normal. I called the next day after that  as I still was not well. The next week, (25th of January) I went in and they were telling me they wanted me to take the second vaccine but  I felt terrible and I had ringing in ears and it felt like ears were full of fluid. And my sinuses - it felt like my head was blowing up. She put me back on Prednisone - it was tapered dose prescription. I had lingering sinus and ear problems.- He put me on antibiotic for two weeks and another tapered dose of the prednisone. I took those for two weeks and I was better. Dr.  (on Feb 19).  I had my antibodies drawn the week before I had the vaccine but I didn't get the results back until after I had taken the vaccine. I had antibodies. I would not have taken the vaccine if I would have known I had the antibodies.  I have a slight ringing in my ears right now but it's not as horrible as it was. My left ear is the worst. I think the left side of my body is the weakest part of my body. Dr. - he's a rheumatologist -  another doctor of mine - told me that he had the COVID in September and I may have gotten it from him that day that I saw him. He said it was up to me if I wanted to get the  2nd vaccine.  Note: I started taking allergy shots in February 2021  after the vaccine - allergic to dust, molds and pollens.
After receiving her flu vaccine, she stood up and felt lightheaded. She then felt flushed, had right ear pain and throat discomfort. She went to ED she was treated with BENADRYL and prednisone.
After first vaccination, my period came a week early which is does not happen at all.  With in a couple hours after my second shot, what was a light period became very heavy.  The period continued every day at varying levels from spotting to heavy for exactly 6 weeks with only a handful of days (3-5) with no bleeding during that time.   At times it was so heavy it leaked in my bed and on my couch which is abnormal.  There were several days that were heavy and also contained a lot of clumps/clots.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age might have received COMVAX, VAQTA, GARDASIL or RECOMBIVAX HB. These vaccines might have been exposed to a total of 3 possible excursion scenarios. The reporter stated she was not sure which vaccines were on hand during any given time and stated the vaccines could have experienced any combination of excursion scenarios or a total of both scenarios. Scenario 1: vaccines possible exposed to minus 2C for 63 hours. Scenario 2: vaccines possibly exposed to minus 1C for 24 hours. Scenario 3: vaccines possibly exposed to both scenarios 1 and scenario 2. These vaccines were unsupported in all scenarios. No adverse symptoms reported. At time of report, the status of patients was unknown. Additional information has been requested.
Influenza vaccination at 9:30 am. Patient noticed erythema and pain at noon (R) deltoid. Patient evaluated at 3 pm. He was noted to have a 9 cm x 6.5 cm of erythema and mild edema consistent with a local skin rxn. Pt was given 25 mg BENADRYL PO and a cool compress applied. VSS. Pt encouraged to monitor for worsening rxn, take OTC ZYRTEC and f/u dr needed.
had problems with their periods they started get them again after they had the Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "had problems with their periods they started get them again after they had the Pfizer".  Clinical Course: The patient was upset because it happened with her mother in law and two of her friends they had problems with their periods they started get them again after they had the Pfizer (further clarifications unknown split not made by CH). She also heard your CEO he is like. She was going be selfish, she was not going to get the vaccine. She will give it to everybody else and he just flew to Israel and you let him go and he was not vaccinated that's pretty bad and she did not get one not because of Pfizer her brother in law used to work for you. She didn't get because the government said we are getting involved. All government in the United States involved she knew, she didn't want part of it because they haven't done anything constructed for our country an over 80 years. So, she knew not to do it. So, she didn't want the four year old to die and also what she heard from other doctor like, he said you may as well put a damn pistol to the child head because as soon you shoot them with a vaccine not only Pfizer but any of them (not clarified) it will kill their immune system and while you are growing up, you build an immune system or any germs that comes on child's way she will have no protection against. So, she just wanted to know, how you all have no more ethics or all about the money.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sudden onset of chest pain found to have STEMI requiring urgent cardiac cath and stenting x 2
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 31-OCT-2011, the patient was vaccinated with the first dose of GARDASIL, on 13-DEC-2011,  the patient was vaccinated with the second dose of GARDASIL and on 22-MAY-2012, the patient was vaccinated with the third dose of GARDASIL (doses, route of administration, lot# and expiration dates were not reported for any of vaccines administered). On 06-OCT-2017, the patient was vaccinated with the fourth dose (an extra dose) of GARDASIL 9 (dose and route of administration were not reported) lot# N004798 and expiration date: 31-OCT-2019. No adverse effects were reported. No causality assessment was provided by the reporter.
I noticed today when I was taking a shower that the upper arm at the area of the injection site is reddened.  The size of the reddened area is approximately 4 inches by 2 1/2 inches.  The reddened area is slightly tender.  It has been 10 days since I received the vaccine.  I don't know if it is normal for the site to be reddened.
She said "maybe they gave me an expired dose" in passing.; she woke up with left leg cramping that was so bad/cramping in her left foot and lower leg and describes it as a "sharp shooting sensation".; 'a sharp, shooting sensation in her left foot and bottom part of her left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 67-years-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 10:00 (Lot number: EN6207) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "She said "maybe they gave me an expired dose" in passing."; MUSCLE SPASMS (non-serious) with onset 25Mar2021 01:00, outcome "recovering", described as "she woke up with left leg cramping that was so bad/cramping in her left foot and lower leg and describes it as a "sharp shooting sensation"."; FEELING ABNORMAL (non-serious) with onset 25Mar2021 01:00, outcome "recovering", described as "'a sharp, shooting sensation in her left foot and bottom part of her left leg". Therapeutic measures were taken as a result of muscle spasms, feeling abnormal.  Additional Information: Reporter said that she had her first PFIZER COVID-19 Vaccine on 24Mar2021 at 10:00AM. She said she was a little concerned about getting the second COVID-19 injection because that night at 1:00AM (25Mar2021), she woke up with left leg cramping that was so bad, and a sharp, shooting sensation in her left foot and bottom part of her left leg. She said the next day (26Mar2021), at 10:00AM she had the same thing happen again, but the it was not as intense as the first time. She said for 48 hours after receiving the COVID-19 Vaccine, she had experienced the left leg cramping and sharp, shooting sensation in her left foot, and bottom part of her left leg, and on Saturday (27Mar2021), she had a real short episode. She said she hadn't had any more episodes since Saturday, and hopefully wouldn't have anymore. She said the episodes had been getting less intense. She had no prior Vaccinations within 4 weeks. She had no medical History (including any illness at time of vaccination). No relevant tests were done.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 4 year old Caucasian male with no known allergies and no past medical history who on 29 JUN 2001 at 10:30 AM was vaccinated with the first dose of varicella virus vaccine live (lot #638653/1890K), in the left arm. On 30 JUL 2001 at 08:00 the patient was presented with a severe case of chicken pox. It was reported that there were more than 300 lesions all over the body, including mucous membranes. The patient also had a high fever, but the temperature was unknown. It was reported that the patient had macular papular lesions with a erythematous base, pustules, and vesicles. The affected areas were reported to be the scalp, oral mucosa, face, trunk genitalia, and extremities. It was reported that the patient recovered on 10 AUG 2001. The patient sought unspecified medical attention. There was no other information provided. Additional information has been requested.
This spontaneous report as received from a lawyer refers to a male patient of unknown age. The patient experienced mild diverticulosis, constipation, hiatal hernia, unexplained weight loss and drug administration error while on therapy with BENICAR (case # {1709USA014984}). There was no information about the patient's concurrent conditions and concomitant therapies provided. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced allergy to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The outcome the event was not provided. The reporter considered the event to be related to suspected therapy. This is one of the several reports received from the same reporter concerning the same patient. Sender's Comments: US-009507513-1709USA014984.
Case number PHEH2013US005052 is an initial spontaneous report received from a pharmacist on 27 Feb 2013. This report refers to a 31-year-old female patient. It was reported that she received only MenA of MENVEO (batch number: A110411) diluted with a sterile diluent intramuscularly on 18 Feb 2013 and did not receive MenCYW-135 liquid conjugate. No adverse event was reported after this inadvertent administration. No other information was available.
This case was reported by a healthcare professional and described the occurrence of non-seroconversion in a "few" subjects of unspecified age and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included hemodialysis. On unspecified dates the subjects received 1st dose, 2nd dose, 3rd dose and 4th dose of ENGERIX B (details unknown). The subjects experienced non-seroconversion. At an unspecified time later, the subjects received a second series of 1st dose, 2nd dose, 3rd dose and 4th dose of ENGERIX B (details unknown). The subjects experienced non-seroconversion. The healthcare professional reported that she had a few hemodialysis subjects in a few facilities who did not seroconvert after vaccination with ENGERIX B series. Even after a second series they did not seroconvert. No additional information was provided.
Rash resembling insect bites on shins and forearms starting 4-5 days after first shot.; This is a spontaneous report from a contactable consumer (Patient). A 67-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 26Feb2021 at 15:00 (at the age of 67-years-old) (Batch/Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included asthma/COPD Overlap Syndrome, seasonal and environmental allergies, sleep apnea, arthritis, rosacea and TIA. Known allergies included Tetracyclineand Latex. No other vaccine in four weeks. No covid prior vaccination and covid was not tested post vaccination. The patient's concomitant medications were not reported. On 03Mar2021, at 07:00, the patient experienced rash resembling insect bites on shins and forearms starting 4-5 days after first shot. AE resulted in Emergency room/department or urgent care. No treatment was received by the patient. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, "Her whole arm is swollen and sore/Sore upper arm/arm achy" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.
he felt very achy and tired with a sore arm; he felt very achy and tired with a sore arm; he felt very achy and tired with a sore arm; This is a spontaneous report from a contactable physician (patient) via Pfizer Sales Representative.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/Lot number unknown, via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported he felt very achy and tired with a sore arm on 21Dec2020. The events were non serious and the patient completely recovered from the events on 22Dec2020.  Information about batch/lot number has been requested.
Headache, fever, and chills lasting for about 8 hours.  Treated with ibuprofen and rest, symptoms cleared on their own.