chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 101; Swollen lymph node; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included shingles.   On 14th December 2020, the patient received Shingrix (intramuscular). On 15th December 2020, 1 days after receiving Shingrix, the patient experienced fever and enlargement of lymph nodes. The patient was treated with paracetamol (Tylenol). On 17th December 2020, the outcome of the fever was recovered/resolved. On 20th December 2020, the outcome of the enlargement of lymph nodes was recovered/resolved.   It was unknown if the reporter considered the fever and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received 2nd dose of Shingrix in the left arm. On the next day, the patient had a fever of 101 degree F which lasted for two days.  The reporter also stated that she had a swollen lymph node for five days.  The patient took Tylenol for these symptoms. The reporter did not consent to follow-up.
She had a stroke (brain hemorrhage) due to a blood clot, required surgery to correct after a three-week stay in the hospital.  She now requires physical therapy.
Fever to 103 x 24 hrs, malaise, 3-4mm lesion on tongue, sore throat, local pain, swelling and blotchy, blanching rash at injection site on deltoid as well as warmth. Pt was also short of breath at one point. Tylenol, Heat or cold, gentle range of motion exercises. F/u if not back to normal in 1 week.
The morning after getting the vaccine patient developed itchiness on her hands and scalp, then patient started to develop a rash on hand with in the hour that spread to her back. She also developed a cough and chest tightness with wheezing. Patient went to urgent care in the afternoon where they prescribed Atarax three times a day as needed.
Approximately 23 hours after 2nd Pfizer I felt very sluggish/slow. I had a 99.5 temperature and was having chills. I took 2 Advil and the event subsided.
Day 1 - site soreness and HA only. Morning of day 8 notable site soreness, itchiness. By evening pink and swollen around injection site - day 9-markedly  increased redness , swelling, discomfort at and around injection site, mild to moderate itching in affected area. I went to urgent care - provider orders P.O. keflex and told me to take an  Antihistamine if needed and refused to take the vaccine information from Me to report this.
This spontaneous report as received from a pharmacist refers to a 66 years old male patient. The patient's medical history and concurrent conditions were not reported. On 29-JUN-2016, the patient was vaccinated with ZOSTAVAX, subcutaneously (left bicep). On 05-JUL-2016, the patient experienced bruises on his abdomen and bruises on the left bicep at the injection site. The patient sought medical attention but no treatment was given for the events. The outcome and causality of the events were unknown. Additional information has been requested.
My arm stayed pretty warm; Some headache; Slight ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 89 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 26Feb2021 10:00 (Lot number: EN6205) at the age of 89 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19", stop date: 14Jan2021. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE. Date:04Feb2021, Time: 10:00, Anatomical site of injection:  arm, Route of administration: Intramuscular, Batch/lot number: EM9809, Expiration Date: 30Jun2021), administration date: 04Feb2021, when the patient was 89 years old, for Covid-19 immunization, reaction(s): "arm is pretty warm and itched quite a lot", "arm is pretty warm and itched quite a lot", "knees have bothered me, my legs have bothered me quite a bit", "knees have bothered me, my legs have bothered me quite a bit", "It is hard for me to walk", "some headache and a slight ache", "some headache and a slight ache", "arm was hurt at vaccinated sites". The following information was reported: FEELING HOT (non-serious), outcome "recovered", described as "My arm stayed pretty warm"; HEADACHE (non-serious), outcome "recovered", described as "Some headache"; PAIN (non-serious), outcome "recovered", described as "Slight ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pain; patient was given TYLENOL.  No follow-up attempts are possible. No further information is expected.
This information has been received from a physician who received the information from a consumer that provided him a link to a forum. The below information has been received by the patient's mother, from the link concerning an 18 years old healthy female who was vaccinated with the first GARDASIL dose at 18 years of age on 23-MAR-2008. Within 24 hours of the vaccine she began complaining of a terrible backache which lasted about a week. Then she started having fatigue, stomach aches, vision problems and overall body aches. She had her first seizure within a week after these symptoms. The patient was vaccinated with GARDASIL second dose on 06-MAY-2008 and the symptoms worsened and so did the full grand-mal, tonic-clonic seizures. She also started having migraines, tremors and bruising. The seizures increased to daily, sometimes more. In summer of 2008 the patient called ambulances and spent time in the hospital where they said the seizures were non-epileptic. She also had several urinary tract infection (UTI)s which she'd never had before. In July 2008, the patient had a cluster of seizures (4) and almost died on the reporter living room floor when she stopped breathing and turned blue. By the Fall of 2008 the seizures started spreading out further. The reporter felt that the symptoms were related to GARDASIL vaccine and so the patient was not vaccinated with GARDASIL third dose. As time passed, the symptoms seemed to be resolving one by one. In December 2008 the patient experienced a new symptom, bleeding gums which lasted until July 2009 and had been resolved. Her last seizure was in January of 2009, until this past weekend. In August 15, 2009 the patient had 3 seizures after time free of seizures since January 2009. By the time of this report the patient still suffered from the seizures and a severe tremor that had never gone away or lessened. The reporter indicated that the patient lost her independence, her job, her grades, her health, her freedom and had to move home. Seizures was considered to be immediately life-threatening. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax 31MAY95 & 6JUN95 pt was dx w/viral tonsillitis; pt placed on PCN; 7JUN95 pt exp a gen rash all over body;
Patient experienced flushing/redness throughout her body. Appeared to be early allergic reaction. Was given PO Benadryl and monitored for 30 minutes. s/s resolved and patient left facility in no distress.
around 8PM pt recv APAP-30min later had jerking movement of limbs;did not have loss of consciousness;later next day had another episode of same p/APAP;reporter felt that this was not from vax;exam in office was completely nl;
12x15 ovoid erythema & induration surrounding the inj site lt anterolateral thigh;no systemic signs or sx;
pt c/o pain @ inj site then shooting pain down arm, hand et neck;pt said neck had a dull ache;advised to take APAP for pain et to see MD if persists;has had flu vax q yr w/no problems;
Gave MCV-4 then HPV in right arm first then Men B third in left arm. Patient got up from exam table and stated she had a headache and sat down in an other chair. Complained of dizziness and became diaphoretic and pale. Then got up and complained of nausea. Tried to get up to go to bathroom with mother but knees gave out and mother, medical assistant and myself brought patient back to room. Had Patient lie down, and dry heaved a few times. Gave cold rag and alcohol pads to breath in to help with nausea. Had patient legs up and gave candy and soda to help. After 10min from immunization patient color improved and nausea improved.
I had the normal inflammation/swelling at the injection site 1-2 days after receiving the vaccine. Then about a week after the injection (12/04/16) I started having left eye pain/pressure and light sensitivity. A couple days later I had fever and malaise. My eye got really red and painful and extremely light sensitive. The eye doctor thought it was viral pink eye at first but it developed into a full blown iritis. About a week and a half after starting on steroids for the iritis I got a vesicular rash on my mouth/nose. I was prescribed valacyclovir for suspected shingles iritis.
LETHARGIC MORE THAN USUAL; FELT HOT LIKE FEVER/FELT WARM IN VEIN; FELT NOT VERY GOOD; TIRED; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic type 2, alcohol use (rarely), non-smoker, and ibuprofen allergy (possibly) and other pre-existing medical conditions included: the patient had no history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported and batch number: 1821286) dose was not reported, 1 total, administered on left arm on 16-MAY-2021 for prophylactic vaccination. On an unspecified date, the patient felt generally not so good, tired, lethargic more than usual, felt heat like fever, felt hot but not like boiling, warm in vein and took it easy for a day or two, patient did not feel well for a day or two so the patient rested and passed following the vaccination with first dose of covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient recovered from lethargic more than usual, felt hot like fever/felt warm in vein, felt not very good, and tired. The patient additionally received first booster of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 28-NOV-2021 for prophylactic vaccination. Age at time of vaccination 75 years old. No concomitant medications were reported.  On an unspecified date after the booster dose, the patient felt generally not so good, tired lethargic more than usual. The patient felt heat like fever, felt hot but not like boiling, warm in vein and took it easy for a day or two. The patient stated that for booster dose she felt more than the primary dose (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic more than usual, felt hot like fever/felt warm in vein, felt not very good, and tired. This report was non-serious. This case, involving the same patient is linked to 20220606162 (dose number in series 1).
PATIENT REPORTED ITCHYNESS IN THE BACK OF HER THROAT. ON THE VACCINE QUESTIONAIRE SHE NOTED SHE HAD A REACTION TO THE 1ST DOSE OF PFIZER COVID. ON SITE EMS RESPONDED AND VITALS ARE BELOW.  SHE WAS GIVEN DIPHENHYDRAMINE ORALLY AND RELEASE TO HOME.
The twitching in her eyes and head started around the second dose; 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 30 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 08Sep2021 (Lot number: EW0179) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "C-section" (unspecified if ongoing), notes: C-section  , last c section was in Jun2020.; "covid", start date: Jun2021 (unspecified if ongoing), notes: she had covid in Jun2021 and lost taste and smell at the time; "lost taste" (unspecified if ongoing), notes: she had covid in Jun2021 and lost taste and smell at the time; "smell at the time" (unspecified if ongoing), notes: she had covid in Jun2021 and lost taste and smell at the time. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:01, Batch/lot number: FA7484  , Anatomical location : injection in arm), administration date: 18Aug2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "headache". The following information was reported: MUSCLE TWITCHING (non-serious) with onset 2021, outcome "not recovered", described as "The twitching in her eyes and head started around the second dose". The event "the twitching in her eyes and head started around the second dose" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle twitching.  Additional information: patient had twitching in her eyes and head and she was asking if there can be any nerve damage or if there are people complaining of headache after the vaccine. Patient had headache every week, around 3 days a week, it is really intense, usually above or around temple, not on the temple and there is twitching in her head around the temple.Clarifies the twitching in eyes and head started a month to month and a half ago. She takes Tylenol and Ibuprofen and they are not really working which is why she thinks it is a different kind of head pain. She is thinking maybe this connected or what manifested it but she had 4 C-sections with spinal taps which could be damaging to the nerves., she went a couple of weeks ago to ER and they did a CT scan and found no tumors, nothing stood out . Confirmed she was not admitted  No follow-up attempts are possible. No further information is expected.
This case involves an unknown age and unknown gender patient who stated it doesn't work this year, with no ae while receiving vaccine influenza vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number; formulation: not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient stated it doesn't work this year, with no ae (adverse event) (vaccination failure) (unknown latency). Action taken: Not applicable. It was not reported if the patient received a corrective treatment for the event. Outcome: Unknown.; Sender's Comments: Sanofi Company Comment on 31-Dec-2021: This case involves an unknown age and unknown gender patient who stated it doesn't work this year, with no ae while receiving vaccine influenza vaccine. Further information regarding medical history, concurrent condition during vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Mom reports that the afternoon of vaccination infant had what was similar to a startle reflex but not and experienced some vomiting (not of the projectile fashion). Infant had this similar reflex 3 times since vaccination with the last occurrence including a shriek.
R deltoid 2" diameter area of erythema and warmth =cellulitis.  Keflex 250mg four times a day x 10 days.
Left arm rash, with large area of redness and warmth, which stated 14 days after 1st vaccine
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient had no pertinent medical history and no drug reactions/allergies. There were no concomitant medications. On 22-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M027552 with an expiration date: 04-February-2018 (dose, route of vaccination and anatomical location were not reported). On 23-SEP-2016, reported as about one day after receiving the vaccine, the patient experienced cellulitis, swelling and inflammation about 2 inches below the injection site. The patient sought medical attention and visited pharmacist. The patient was directed to take unspecified antihistamine medication and put ice on his arm. No lab diagnostics studies were performed. The outcome of cellulitis, inflammation and swelling was unknown. The relatedness between the events and vaccination with PNEUMOVAX 23 was not reported. Upon internal review cellulitis was determined to be medically significant. This is one of two reports from the same source. Additional information has been requested.
Fever of 102.1 on the following day, along with nausea, photosensitivity, body aches.  red swollen injection site, which on day  3 required visit with PCP and dix with cellulitis.  Red,(4inches by 4.5in) ,hot swollen,  itchy.  given  rx for Keflex.  felt well on day 5.
Urticartial skin reaction at injection site, lymphadenitis in left axilla beginning  < 48 hours after injection treatment supportive care.
Patient received a dose that was left out of the 12 hour post punctured mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose that was left out of the 12 hour post punctured mark) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 013A21A and 028I20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose that was left out of the 12 hour post punctured mark). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose that was left out of the 12 hour post punctured mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-435921 (Patient Link).
sinus infection; This is a spontaneous report from a contactable nurse reported for her husband. A 71-years-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the reported stated her husband started Augmentin today for a sinus infection. Reported was asking about concomitant use/interactions. Patient treated event with Augmentin. The outcome of the event unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
p/vax pt c/o fatigue, 10# weight loss, rash w/itching, constipation, aching joints;
pt recv vax 13JUL93 & 31JAN95 titer was less than 0.79; MD noted pt now pregnant; MD also expressed a concern about the particular lot of vax;
Tremors; I can't walk; I can't properly walk or hold myself upright; I had persecution in my muscles in my upper body and lower body; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EX3294) via an unspecified route of administration on 23Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included vortioxetine hydrobromide (TRINTELLIX). On an unspecified date in 2021, a week later patient stated that I got tremors and I can't walk, I can't properly walk or hold myself upright and I wanted to know if there are common cases like this. I can go upright, I just can't walk properly or hold myself, but I can't support my body, climb upstairs, I can't go upstairs. So I did all my testing. I got all my medical testing blood is fine, EMG, MRI, CAT Scan and I am doing a brain MRI tomorrow, but everything has come out clear and the only difference is 12Apr2021 my psychiatrist added 5mg of Trintellix and then on 23Apr2021, I have my vaccination that's the only difference that I did before I had persecution in my muscles in my upper body and lower body. Upon follow-up (24Aug2021), patient questioned do you know how many people have this adverse events, is there a place where I can read about this adverse events, how many reports do you have about people taking Pfizer's vaccine who cannot walk and which are the most common adverse events. At the time of this report, the outcome of all the events was unknown.   No follow-up attempts possible. No further information expected.  Follow up (24Aug2021): New information was received from a contactable consumer. This consumer reported in response to Non-HCP letter via telephonic follow-up activity that included addition of clinical information.  No follow-up attempts possible. No further information expected.
Sore injection site for 48 hrs; Fatigue for 48 hrs; Lower cervical and supraclavicular lymphadenopathy; This is a spontaneous report from a contactable physician (patient herself).  This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via intramuscular, on 22Dec2020 at 10:30 AM at single dose for COVID-19 immunisation.  The patient was vaccinated at hospital, age at vaccination was 39-year-old. Vaccination location was arm left. No other vaccine was received in four weeks. The patient was not pregnant.  Relevant medical history included reflux. Relevant concomitant famotidine (PEPCID) for reflux. No known allergies. The patient did not have congenital abnormality or birth defect. On 22Dec2020, after vaccination, the patient had sore injection site for 48 hrs, fatigue for 48 hrs and lower cervical and supraclavicular lymphadenopathy. Pre-vaccination and Post-vaccination tests for COVID were not performed. The patient was not treated for the events. The patient was recovering from the events.
Patient vaccinated 7 days ago and returned to site stating she had left arm swelling, redness, and itching at arm site for the past week Patient seen by medical team, vitals are stable,  refused medical transport and stated she will drive to her primary doctor Patient signed AMA form
Fatigue, malaise, mild fever and general body ache. All events resolved on their own after 3 days.
Patient states that she started with having tetany in her 3rd fingers that radiated to her 5th fingers on bil hands on Friday 10/14/22. Then on Saturday 10/15/22 she was walking carrying a crockpot and had to stop suddenly for a sudden onset of severe cramping to her bil thighs, not in the calves at all. She said she had to stop and get on her hands and knees and rub her legs for about 10 minutes to get them to loosen up so she could walk. Then on Sunday, 10/16/22, she woke up at 0300 with severe pain/cramping in her bil posterior thighs again. She had to have her spouse rub them for about 15 minutes as her legs locked and she could not move them. Patient relates that even her toes were extended and locked. She described her thighs as being "board stiff". Then this improved.
Confusion, Headache, Swelling /heaviness, pain injection site, Narrative: