chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/19-11/20- Normal fatigue, malaise after booster vaccine. Mild headache. 11/27- Intense itchiness and bumps all over scalp near bedtime. Washed my hair thinking it was just dirty, which seemed to help a little to  cool off the prickly heat coming from my scalp, but continued to itch until I went to sleep.  11/28- Scalp is still itchy, now noticing intense itching across my entire torso and realizing that I have hives. The more I itch the more seem to appear. Wracking my brain for any new foods or personal care items that may be causing this reaction but cannot think of anything. Take claritin- moderate relief.  11/28- I have some hives/swelling around my eyes and a sensation of a lump in my throat, like food is stuck and I can't swallow it down. It is slightly painful. It is helped with claritin and benadryl. No respiratory symptoms or swelling around my mouth .No fever. Hives occur in random patches throughout my body and recede, only to appear elsewhere.  11/29-  Same as 11/28, but now have pain and swelling in my left wrist,  and bilateral ankles. My left hand swells up and appears red- very similar in appearance to when I was stung by a wasp there.  A coworker suggests I take pepcid as well, and it is helpful.  11/30-12/7 (ongoing)- I have small patches of hives appear at random times and places, and seem to be extra sensitive to external irritants (necklace causes red slash marks to appear on neck, light scratching of skin produces marked raised marks as in dermatographism). Paying careful attention to what I have eaten and cannot find a correlation with symptoms. Symptoms above the shoulders are largely gone- swallow is normal and hives do not appear above the jawline.  Using gentle cleansers and moisturizing well daily.
STARTING TO NOT FEEL WELL AFTER WALKING OUT OF THE BUILDING WITH A UPSET STOMACH, THEN THROUGH OUT THE DAY I STARTED TO GET A HEADACHE AND MY ARM WAS STARTING TO HURT ALSO, THE NEXT DAY I WOKE UP WITH MY BODY HURTING AND FEELING SICK TO MY STOMACH. IT TOOK ANOTHER DAY FOR ME TO FEEL BACK TO MYSELF.
The pt experienced a slight fever, malaise, irritability, rash over entire body, some pustules, others are raised and flat. Some went to abscesses. Sibling with varicella onset of 3/14/00.
Vaccine administered at 6:40 PM. At 7:00 PM- blurred vision, right upper arm itching and mild redness distal to vaccine administration site. Generalized warm felling. Zyrtec 10mg given at 7:45 PM. All SS resolved <2 hours of office visit except blurred vision which resolved the next day.
Headache, Myalgia, Fever, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative:
By 6 pm infant very irritable " hot " temp 99.9. Mom gave Tylenol per instruction. Slept fitfully during night. 5Am crying not consolable refuses formula, no wet diaper since 5 am, 7 hours ago taking small spoons of water.
19MAR98 6PM devel fever up to 103, fever off & on 2 days never lower than 100;used motrin 1tsp q 6hr;devel rash same day & same time;fine red rash forehead, face, chest, belly;last 2 days swelling bilat neck glands;dx URI & bilat ear infect
Patient was admitted with shortness of breath, fatigue, and generalized weakness. Cough progressed. Patient required oxygen requirements via nasal cannula at 4L.
This spontaneous report was received from a nurse practitioner and refers to a 4-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 11-JAN-2018, at 2-months-old, the patient was vaccinated with the first dose of PEDVAXHIB intramuscularly, lot# N012920, expiration date 07-FEB-2020 (dose and site of administration were not reported) for prophylaxis. According to the product information the patient should receive the second dose on 11-MAR-2018, but the dose was administered on 17-APR-2018 (lot # N014944, expiration date 06-MAR-2020). No adverse reaction was reported.
Patient received TDAP (BOOSTRIX) in right arm on 9/8/16. Returned to pharmacy complaining of pain and swelling at site and upward arm 9/13/16. She said it started 9/9/16.
No symtms first day..tierd later...3rd day out symtoms at work. Head sweat which passed..queezy..light headed ..chest oain which went away after eating ..really tired body ackes
Diarrhea, fogginess, and large red, swollen, warm,painful area about 5 inches below injection site on left arm.
PATIENT HAD FINE RASH ON TRUNK & LIMBS,  HAD NO FEVER, NO MALAISE, NO LOSS OF APPETITE 2-3-DAYS POST IMMUNIZATIONS
Myalgia, Chills, Brief left side chest pain, Night sweats, Unable to sleep Narrative: Pt developed shaking chills, myalgias, brief left sided chest pain, night sweats and unable to sleep x 2 nights. Required time off work due to severity of symptoms. No known prior COVID infection.
Red rash around injection site, about 5 inches by 2 inches, warm to touch. Minor swelling.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patients concurrent condition, medical history and concomitant therapy were not provided. On an unknown date (reported as "several years ago"), the patient was vaccinated with the first dose of GARDASIL (lot number, expiration date, strength, dose, route and frequency unknown). On 03-AUG-2016, the patient was vaccinated dose two with GARDASIL 9 injection (lot number, expiration date, strength, dose, route and frequency unknown). No adverse events were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
The NP gave him my vaccine and him mine. No symptoms at time. Headache and seizures, black eye from falling, slow brain. Function
Vaccine #1: injection site pain x 2-3 days; injection site swelling, redness, extreme itch days 7-8 post.  Vaccine #2: Fever x 12 hours (100-101F before Tylenol); chills x 4 hours; body aches x 12 hours; painful arm x two days
pt recvd vax 935AM & was seen in ER 1205PM w/t103.3, P120, R28, h/a, vomiting, myalgia, chills; treated w/IV's, Compazine, APAP, Motrin; released 420PM;
hurt so much; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter asked  regarding why does it hurt so much. The reporter consented to follow up.
Approximately 20 hrs after administration of DT pt felt fuzzy & according to grandmother who witnessed the following pt c/o lightheadedness felt dizzy "Then went into a seizure" while sitting in a chair. States "shaking all over" arms legs & body - lasted "couple of minutes had t LOC.
Chest tightness/difficulty breathing. Eyes very itchy with mucus. Throat became sore.
Headache, Myalgia, Arthralgia, Fever, can't lift left arm, chills, neck pain Narrative:
The left arm shoulder slightly inflammed/swollen compared to right shoulder and slight redness at initial check.  Patient complained of vomiting day after flu shot. Not able to have full range of motion due to pain. Able to lift arm and rotate but it is painful to do so. Pain has lasted for 4 weeks. Patient said it got a little better but still painful. Has tried Tylenol and "Zyflammed OTC", as well as heat/cool pads. The alternating heat/cool has helped.
Left arm: localized cellulitis 6cmx5cm, mild swelling and tenderness.
Patient's Mom called and said pt have injection site reaction: soar arm, redness. It was reported to one of the floater pharmacist on sat 9-29-23 and patient called again on 10-2-23 and spoke with store manager and per store manager, Mom complained injection site reaction of pain, redness.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's concurrent condition, medical history and concomitant therapy was unspecified. On an unknown date the patient received a dose of M-M-R II (unspecified lot # and expiration, dosage and route not provided). Subsequently, on an unspecified date the patient developed a rash and a fever. The outcome, and the causality of the events with M-M-R II was not reported. Additional information has been requested.
Patient presented to ED on 4/9/21. Patient presented to ED and was subsequently hospitalized on 4/12/21. These are within 6 weeks of receiving COVID vaccination.
Muscular soreness throughout the body, fatigue, low grade fever, chest pain, racing heart.  Unable to go to work on the following day. Returned to work after two days.
Patient became diaphoretic and light headed 6 minutes after being injected. Patient was 'dazed'. States that he has done this before with normal venipunctures.
Information has been received from a registered nurse concerning an approximate 8-year-old patient who on 18-AUG-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved.  This is one of several reports received from the same source. Additional information has been requested.
pt recv vax MAY96 & 4 wk p/vax pt exp fever, gen malaise, jaundice, skin rash (like sunburn), & hyperthyroidism;only the hyperthyroidism was treated;
Patient presented to pharmacy 1 week after receiving the flu vaccination with prescriptions for steroid cream from Dr. Patient stated a rash started after vaccination, starting in arm pit area and moved to entire chest area.  Rash was very red, bumpy, and itchy. No changes were made to diet or medications during time period. MD office stated this was the third case of Fluzone high dose rash (1st from our pharmacy).
Information has been received from a Licensed Practical Nurse concerning an 18 year old female patient with amoxicillin and sulpha allergy who on 01-OCT-2009 was vaccinated with a first dose of GARDASIL 0.5 ml (Lot # 663453/0249Y). Concomitant therapy included a second dose of DEPO-PROVERA (manufacturer unspecified). On 04-OCT-2009 the patient woke up with dizzy spells, extreme muscle fatigue and nausea. The patient had experienced these symptoms chronically since 04-OCT-2009. The patient saw her primary care physician who pulled blood work, but all test showed no abnormalities. The primary care physician prescribed the patient prednisone (manufacturer unspecified) as treatment but the patient was still experiencing these symptoms. At the time of the report the patient had not recovered. Further information has been received from a licensed practical nurse concerning to this patient. The nurse confirmed that the patient on 01-OCT-2009 received a dose of GARDASIL and also her second dose of DEPO-PROVERA (manufacturer unspecified). The patient did not receive any concomitant vaccinations. On 20-OCT-2009, the patient contacted the physician and she complained of migraine headache, dizziness and her muscle felt sore. The patient was treated with ZOFRAN for nausea. The patient was able to go to work but stated that "it was hard to function". The patient "considered her condition to be a burden" and stated that she would not continue the therapy with GARDASIL. The patient was prescribed laboratory blood tests (blood tests unspecified). The blood test results were normal. Further follow-up has been received from a Licensed Practical Nurse concerning to this patient with amoxicillin, ROBITUSSIN allergies who was vaccinated on 01-OCT-2009 at 11:30 AM on left deltoid with a dose of GARDASIL. On 04-OCT-2009 the patient experienced dizzy spells, extreme muscle, fatigue and nauseated all the time since vaccination with GARDASIL. No abnormal blood work was performed. The primary care physician prescribed the patient prednisone (manufacturer unspecified). Additional follow up information has been received from a Licensed Nurse Practitioner concerning this patient. The nurse stated that on 04-OCT-2009, the patient woke up with a migraine, extreme nausea, dizziness and muscle fatigue. Patient saw her primary care physician and they ran test and everything was within normal limits. They gave her prednisone and treated her for an ear infection. Signs and symptoms never went away. The patient recovered from migraine, extreme nausea, dizziness and muscle fatigue on unspecified date. Additional information has been requested.
Patient called the HD today 12/01/2022 and stated on Wednesday she went to Pharmacy (did not state which one) for a Pfizer Bivalent due to the fact we did not carry that vaccine and they did not want to interchange the vaccines. After she had had the flu shot here at the HD. Patient reports that night she had a sore arm with a knot on it and by the 2nd day after she had a fever of 99.8. today her arm had heat, it itches, and the knot is spreading out flat, pink in color. denies any other symptoms and can move her arm but it is sore.  patient has not gone to the Dr but was concerned if this is normal since she has never had these symptoms before.
Nosebleed 3 hours after shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 16:30 (Lot number: FC3183) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "known allergies:Yes" (unspecified if ongoing), notes: known allergies: Yes, numerous. There were no concomitant medications. The following information was reported: EPISTAXIS (non-serious) with onset 09Sep2021 19:30, outcome "recovered" (2021), described as "Nosebleed 3 hours after shot". Therapeutic measures were not taken as a result of epistaxis.  Additional information: Numerous known allergies. No covid prior vaccination. Not tested positive for Covid post vaccination. No other vaccine in four weeks. No other medications in two weeks.  Follow-up attempts are completed. No further information is expected.
Patient  reporting today symptoms of vomiting and  diarrhea the day after receiving the  Hep B vaccine.
Approximately 6 hours after receiving injection, I started experiencing extreme fatigue and body aches.  Approximately 10 hours post injection,  body aches worsened, extreme weakness and fatigue, and starting chilling. Approximately 12 hours post injection, chilling continued and fever of 102.8*. Nausea and vomiting started about this time also. Body aches continued to worsen. Redness and hardness at injection site approximately the size of a golf ball. 20 hours post injection, fever of 102.3* , chilling and body and muscle pain continued. Nausea and Vomiting upon any movement, extreme weakness. Approximately 26 hours post injection, fever steadily decreased to 100.6*, still experiencing body and muscle pain, extreme weakness and fatigue Approximately 32 hours post injection?fever gone, still experiencing extreme fatigue and weakness, no appetite. Injection site is reddened and hot to touch and redness has grown to the size of a baseball. Tender to touch. Lymph nodes both sides of neck are swollen and tender.
This spontaneous report was received from a pharmacist via company representative. The pharmacist reported on her 72 year old father. Information regarding patient's medical history was not reported. On an unknown date the patient was vaccinated with PCV (manufacturer unknown) (lot#, expiration date, route of administration, anatomical location were not reported). Other suspect therapies administered the same day included influenza virus vaccine (manufacturer unknown). The pharmacist reported that her father died after receiving a combination of PCV (manufacturer unknown) and influenza virus vaccine (manufacturer unknown) at the same visit. On an unknown date the patient experienced pain and tightness similar to gallbladder symptoms. Then the patient was seen in the office of his unspecified physician again and determined to have an enlarged spleen. The patient was sent to an unspecified oncologist and was diagnosed as having leukemia on an unspecified date. The patient was hospitalized on an unknown date. The patient's spleen was surgically removed, as it was continuing to enlarge. The patient never fully recovered from the surgery and experienced breathing problems and died before leaving the hospital on 07-NOV-2014. The cause of death was not reported. The outcome of pain and tightness similar to gallbladder symptoms, leukemia and enlarged spleen was not reported. The events of pain and tightness similar to gallbladder symptoms, leukemia, enlarged spleen which was surgically removed and breathing problems were determined to be life-threatening by the reporter. Upon internal review the events of leukemia and enlarged spleen which required surgical removal were determined to be medically significant. The relatedness between the events and the therapy with PCV (manufacturer unknown) was not reported. Additional information is not expected since the reporter did not want to be contacted in any way regarding this report.
I noticed hives on her thighs where she had the two injections around 7pm on 3/10/17. the next morning she had hives all over her body that came and went for about 5 days.
This medically confirmed report (initial receipt 20-Jan-2014) concerns a female patient who had a medical history of mild anaemia, egg allergy (but still able to eat eggs) and had received a pneumonia vaccine when younger, and the HPV vaccine. On the 02-Jul-2012, the patient received the influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route in the right deltoid. On an unspecified date, the patient developed a serious reaction to the influenza vaccine. Outcome was not reported.
Pneumovax on 4-4-07- On 4-5-07-pain at injection site down right arm- 4-6-07- Redness and mild swelling. Shoulder bruise with red redness to mid-forearm- Benadryl cream-cold packs
Case number PHEH2012US022742 is an initial spontaneous report received from a physician on 14 Nov 2012: This report refers to a female patient of unknown age group. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date in the past. After vaccination she had a serum sickness reaction. No further information about outcome and causality was reported.
Patient received HIB 02/27/08, mom reports 4 hours later patient cried for 1 hour, then went limp for 1 minute and was weak for 30-60 minutes. 911 was called and assessed the child. Per provider probable breath holding episode.
Hives all over torso. Lasting about 30 hours.  I don?t believe that I ate or got stung by anything I am allergic to, so I am assuming this reaction is related to the vaccine.
Information has been received from a registered nurse concerning a 7-year-old female who on 24-MAR-1999 was vaccinated with the first dose of Varivax. Concomitant therapy included a first, second, third, fourth, and fifth dose of DTaP on 19-MAY-1998, 16-JUL-1998, 15-SEP-1998, 24-MAR-1999, and 28-MAR-2002, a first, second, third, and fourth dose of PedvaxHIB (manufacturer unknown) on 19-MAY-1998, 16-JUL-1998, 15-SEP-1998, and 24-MAR-1999, a first, second, third, and fourth dose of poliovirus vaccine on 19-MAY-1998, 16-JUL-1998, 24-MAR-1999, and 28-MAR-2002, and a first and second dose of MMR II (manufacturer unknown) on 24-MAR-1999 and 28-MAR-2002. Other therapy included a first, second, and third dose of hepatitis B virus vaccine (manufacturer unknown) on 24-MAR-1998, 19-MAY-1998, and 15-SEP-1998, and a 0.5 mL dose of Fluzone (Lot 3 U1172AA) on 12-DEC-2003. On 09-MAR-2006 the patient experienced breakthrough chickenpox. Subsequently, the patient recovered. No additional information is expected.
It could be related to episode of covid; It could be related to episode of covid; Diabetes; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4268250-00 (Agency).  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (cf) for psoriasis, ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "It could be related to episode of covid"; DIABETES MELLITUS (medically significant) with onset 2022, outcome "unknown", described as "Diabetes". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimubab) and BNT162B2: The reporter's causality for the event(s) of diabetes/it could be related to episode of COVID onset in 2022 and diabetes/it could be related to episode of COVID unknown onset was not provided. The reporter assessed the causality of all the events with Humira as not reported while assessed the causality of all the events with BNT162B2 as possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective(LOE) cannot be ruled out. As there is limited information in the case provided, the causal association between the event Diabetes and the suspect drug BNT162B2 assessed possibly unrelated The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Roughly 3.5 hours after injection heart rate jumped to 161 out of the blue all of a sudden; I was able to lay down in the vehicle as we were traveling from home to location and after about 5-10 minutes of laying back my HR lowered to between 100-120; arrived at ED around 6:45 and while waiting 4 hours in waiting rom area to be seen HR remained around 110-115 for the 4 hours straight and finally after about 5-6 hours it retuned to normal rate.
Patient presented to ED two days (2/2/21) after receiving dose #2 COVID-19 vaccine at  a Vaccine event reporting weakness, tired, and decreased oral intake. Vitals stable. No injection site symptoms. Receiving IV fluids and potassium replacment. Discahrged to home medically stable.