chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; Headache; Dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced pain, headache and dizziness. On an unknown date, the outcome of the pain, headache and dizziness were recovering/resolving.   It was unknown if the reporter considered the pain, headache and dizziness to be related to Shingrix.  Additional details were provided as follows: The pharmacist was the reporter and the patient. The reporter could not provide lot number or expiration date of Shingrix. The patient received 1st dose of Shingrix in left deltoid. The patient experienced pain, headache, and dizziness following dose 1 of Shingrix. The headache and dizziness started approximately 5 hours after receiving dose 1 of Shingrix. The pain was mild and dull. The headache, dizziness, and pain had improved since they started, but were not fully resolved. The reporter could not provide complete address or phone number for Pharmacy, where he received the vaccine.
Screaming that could not be stopped. Shaking. Seizure without fever, and hitting his own head for more than three weeks after shot on 3/2011. He also has had years of diagnosed but unresolved swelling and pain. However night time is often the worst. He will cry out and wake sobbing in pain. This has been almost three years of night time pain in which we have sought help at several of the specialists at hospital. Loss of muscle tone and now physical delays.
nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting worse everyday; Weakness; swollen lymph nodes in neck and groin; irregular fast heartbeats; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 01Mar2021 (Batch/Lot Number: EN6200), at single dose, for COVID-19 immunisation. Medical history included lymphadenectomy, thyroidectomy (in 2014 or 2017), COVID-19 from Feb2020 to an unknown date (not ongoing). Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation (lot# EL9269) intramuscular in left arm and experienced vaccination site swelling and azithromycin (ZITHROMAX) and experienced drug intolerance and illness. The patient experienced weakness (disability) in 2021 with outcome of not recovered, swollen lymph nodes in neck and groin (disability) in 2021 with outcome of not recovered, chest heaviness (disability) on 07Apr2021 with outcome of not recovered, fatigue (disability) in 2021 with outcome of not recovered, her quality of life was low and getting worse everyday(disability) in 2021 with outcome of unknown, chills (disability) on 07Apr2021 with outcome of unknown, nauseous (disability) on 08Apr2021 with outcome of unknown, dizziness (disability) in 2021 with outcome of not recovered, feeling unwell (disability) on 08Apr2021 with outcome of unknown, irregular fast heartbeats (disability, medically significant) in 2021 with outcome of recovered in 2021. Therapeutic measures were taken as a result of the events and included treatment with 1 Baby Aspirin. The reporter (patient) considered all these symptoms she was reporting were disabling because she had no quality of life.   No follow-up attempts are needed. No further information is expected.
Suffered severe body aches, nausea, extreme shaking/shivering. Was unable to go to work next day.
Spoke with mom on 01/19/2022 Per mom about 1 hour after leaving the clinic she notice her daughter had redness and swelling around both eyes. Then about 8:00 PM her daughter complained of a headache. Per mom she gave her some Benadryl and that it helped a little bit. On 01/19/2022 per mom has a little redness and swelling around both eyes and continues to have a headache and will give Benadryl and Ibuprofen today.
Localized reaction - 3-4 in diameter - right thigh per mom's report the morning following vaccination.  Treated with BENADRYL for 6 hr.
little stiffness after receiving the 1st dose of Moderna vaccine; has been suffering with back pain and chest pain on and off and since last night the pain was little more intense; has been suffering with back pain and chest pain on and off and since last night the pain was little more intense; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (little stiffness after receiving the 1st dose of Moderna vaccine), CHEST PAIN (has been suffering with back pain and chest pain on and off and since last night the pain was little more intense) and BACK PAIN (has been suffering with back pain and chest pain on and off and since last night the pain was little more intense) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Rheumatoid arthritis, Heart disorder, Systemic lupus erythematosus, Chest pain and Back pain. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ACETYLSALICYLIC ACID (BABY ASPIRIN) and LORATADINE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (little stiffness after receiving the 1st dose of Moderna vaccine), CHEST PAIN (has been suffering with back pain and chest pain on and off and since last night the pain was little more intense) and BACK PAIN (has been suffering with back pain and chest pain on and off and since last night the pain was little more intense). At the time of the report, MUSCULOSKELETAL STIFFNESS (little stiffness after receiving the 1st dose of Moderna vaccine) had resolved and CHEST PAIN (has been suffering with back pain and chest pain on and off and since last night the pain was little more intense) and BACK PAIN (has been suffering with back pain and chest pain on and off and since last night the pain was little more intense) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication include Keppra medicine, albuterol inhaler. No treatment medication details was reported.
This spontaneous report was received from an adult Nurse Practitioner who is the office manager via company representative regarding a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (confirmed as not GARDASIL 9) dose 1, (lot# not provided). Concomitant medications were not reported. On an unspecified date a couple of years ago in 2013, the patient experienced chronic fatigue syndrome and was hospitalized after the first dose of GARDASIL. It was reported that the treatment provider suspected that the patient had developed influenza. It was reported that the patient's parent felt that the events were attributed to the GARDASIL. The patient received no further doses of the GARDASIL. It was reported that the patient sought medical attention and treatment (unspecified) for the events. The outcome of chronic fatigue syndrome and influenza were not reported. The reporter did not provide causality assessment. Additional information is not expected as the reporter did not wish further contact.
Chills, elevated  heart rate to 138, Fever. Lasting at least 5 hours and counting
polyarthralgia, gen aches, fatigue, swelling & numbness in both hands, h/a nausea;
Five days after vaccination, started experience bloating with pain related to pressure. Bloating is very uncommon for me. While there has been somewhat of a decrease in symptoms, I have now been experiencing symptoms for 12 days at a level sufficient to interfere with sleep patterns.
a 3rd dose / was administered to a / patient. At the time of the report / patient has not reported any issues; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number DA9Rz, expiry date 30th September 2022) for prophylaxis.   On 6th July 2021, the patient received Shingrix. On 6th July 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The pharmacist reported that the patient received 3rd dose of Shingrix, which led to extra dose administered. At the time of the reporting, the patient did not report any issue. No information about 1st and 2nd dose was reported. The reporter consented to follow up.
Two hours after administration of FluMist vaccine child had a questionable 3 min generalized seizure. Child was evaluated by EMS, taken to ER eval and released. Sleep dep EEG and appt with neuro pending.
pt recv vax & devel rash;skin reveals a papular rash on trunk & extremities, but an urticarial rash over the forehead;strep screen negative;dx allergic rxn to DTP vax;mom advised to avoid further DTP vax;
IRREGULAR VAGINAL BLEEDING; MENSTRUAL CRAMPING; HORRIBLE LOW BACK PAIN LIKE BACK LABOR; CHILLS; SWELLING AT INJECTION SITE/ARM; PAIN AT INJECTION SITE/ARM; HEADACHE; NAUSEA; SPONTANEOUSLY BEGAN BLEEDING/ GOT PERIOD; This spontaneous report received from a patient concerned an adult female, age, race and ethnicity unknown. The patient's height, and weight were not reported. The patient's concurrent conditions included: perimenopausal for several years. The patient was not pregnant at the time of reporting. The patient previously received bnt 162 (Pfizer vaccine) (Dose number in series 1) on 24-MAR-2021 for prophylactic vaccination, and experienced severe reaction (dose number in series 1) and did not completed the series. The outcome of severe reaction was not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: Unknown) dose was not reported, frequency 1 total, administered on 27-DEC-2021 at 11:00 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  On 27-DEC-2021, after receiving the vaccine the patient spontaneously began to bleed and got her period, she stated it was a weird cycle not normal. On 28-DEC-2021, the patient had reactions of headache, nausea, swollen and painful injection site/arm and chills. The patient added that she was also experiencing irregular vaginal bleeding during perimenopause, along with horrible low back pain like back labor, and reports that by 14:00 on 28-DEC-2021 she had vaginal spotting which then turned into a very heavy flow, no clots, bright red, with menstrual-like cramps. On 29-DEC-2021, the patient reported that she still had the heavy flow and the same symptoms, improving slightly except for the vaginal bleeding and injection site/arm pain which she states were the same (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, chills, horrible low back pain like back labor, and menstrual cramping, and had not recovered from irregular vaginal bleeding, swelling at injection site/arm, pain at injection site/arm, and spontaneously began bleeding/ got period. This report was non-serious.
side effects of moderna vaccine on preganant ladies; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects of moderna vaccine on preganant ladies) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects of moderna vaccine on preganant ladies). At the time of the report, VACCINATION COMPLICATION (side effects of moderna vaccine on preganant ladies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were reported no treatment medications were reported   Reporter did not allow further contact
Syncope episode. Patient past out for >1 minute, awoken after using ammonia salt. Patient did not immediately remember where he was or what day of the week it was, but remembered what year it was and his name. Reported feeling hot, and that they felt like they just woke up after a night sleeping. Patient started feeling better after a few minutes and remembered where he was and what had happened up to the syncope episode.
Employee felt sick and left early on 11/2/21.  Not feeling well, stuffy nose, then loss of smell.
Muscle pain and serious fatigue. It is continuous. Every day, muscle pain in legs makes me feel like I ran a marathon, hard to climb stairs to go upstairs in my home. It is preventing me from doing any physical work or activities. Sometimes I feel like, i.e. some days and times, as if I cannot move or I am almost fainting.
The patient presented with a moderate vasovagal reaction.VS remained stable. The patient improved with oral hydration and close monitoring. The patient did have nausea at the time of discharge, though she notes this is common for her. She was discharged home with her husband as a driver.
pt recvd vax; 28sep94 exp arm infect & painful/sore, swollen & red arm; redness was from site of inject;tx ice & acetaminophen;
Injection site sore, warm and very swollen; low fever; applied cool compress, gave children's ibuprophen. Arm issue 6 days; fever 3 days. On 7/22/2011 complained of itchy red bump; applied hydrocortizone cream. More bumps appeared. Continued hydrocortizone cream at each site. Upon review of record, it appears that clinic nurse didn't examine child's immunization records and proceeded to give duplicate immunizations that were given to same child on 3/11/2010 including MMR, IPV, DTaP and Varicella. I do not know what to do about this error. I do not know what the long-or-short-term adverse affects will be.
Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache    Epi shot, Benadryl, Pepcid, prednisone
This initial spontaneous case, was received from a nurse on 07-Dec-2017, concerning a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported), which underwent temperature excursion for about 30 minutes at the lowest temperature of 34.7-degrees F on 12-November and reoccurred on 27-November through first December (unspecified year) with the lowest 27.5 degrees F. The reporter assessed the events as non-serious.
tingling in mouth and lips, some numbness followed, swelling/puffy feeling on throat under jaw, shivering. Throat and back of tongue started to feel swollen.  Started on a benedryl drip and in about 20 minutes I started feeling better, chills stopped, throat improved. After 45min to an hour I went home. Received shot around 10am, symptoms started about 20min later.  Received treatment 15 min after reporting symptoms. Took benydryl at 5pm, 9pm, 2am.  Took tylenol at 5pm. Jan 6 woke up felling like a fever and minor tingling in mouth and lips.  took benedryl at 7am.  Slept through the night without symptoms.   Taking a 25mg bendryl every 5 hours and ibprofen/tylenol alternating every 6 hours.
Swelling and redness at injection site, hard bump, tender, itchy  Tues. 1/19/2021 - 1530 - size of a quarter Thurs. 1/21/2021 - 1000 - Size of a lemon  Warm and cold compresses applied, IB Porphin
Patient arrived to the vaccination site with a friend who was also going to be vaccinated. The friend was vaccinated and the empty syringe was placed on the table, not in the sharps bin. When the patient was vaccinated, the vaccinator stuck her with the empty syringe that had been used to vaccinate the previous patient. Both patients were notified and advised to present to the Emergency Department for source testing. They did not present to the ED. Both patients have the same Primary Care Provider, who was present at the vaccination event.
Heavy period; Bad headache; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: UTMC/EN6208) via unspecified route of administration in the left arm on 22Mar2021 on 10:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since having the vaccine. The patients concomitant medications included aspirin (MANUFACTURER UNKNOWN) and prenatal vitamin (MANUFACTURER UNKNOWN) for unknown indication. On 22Mar2021, the patient experienced bad headache every late afternoon/early evening since the patient got vaccinated. The headache was so bad that ibuprofen didn't even help. Day after the vaccine, the patient experienced abnormally heavy periods with no warning. Therapeutic measure included treatment with ibuprofen for the event headache. The patient did not receive any treatment for the event of heavy period. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache and heavy periods were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recvd vax' swelling began w/in 24 hr w/ redness & pain; mild n; dx of cellulitis due to severe local rxn at TD inject site; tx w/ DPH & decloxacin began 26may94;
This spontaneous report as received from a physician refers to a 5 month old female patient. The patient did not have any relevant medical history. On 10-AUG-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J004058)0.5 ml, intramuscular. No other co suspects were reported. No concomitant therapy was reported. The physician reported that on 10-AUG-2013, the patient was accidentally administered PNEUMOVAX23. The physician reported that the patient will be revaccinate with PREVNAR13. The outcome of the patient was accidentally administered PNEUMOVAX23 was unknown. Additional information has been requested.
Arm pain for 4 months.  Nerve pain that reminded me of sciatic nerve pain. It faded away and came back a year later. I have it right now
started: 2-14-21 at approx around noon began with itching to the back. Itching has traveled to the chest. reports to have hives in addition to the itching. Used cerave itch relief moisturizing lotion. Took benadryl which helped with the area size but now has hives with blotchy areas. reports the area covers her back, both arms, and chest was a smaller area around 12inX6in. 2/17-reports the itching and rash remains but has lessened. reports taking benadryl and coricidin.  informed her she if it does not improve within 3 days to go to her PCP, verbalized understanding.
Headache, fever, uncontrollable shaking, heart rate 104, bp 140/86 called 911, ambulance ride to above Hospital. IV on route,  Kept over night in hospital. Shake stopped in about 2 hours , continued rapid heart for awhile and fever, Hospital gave him tylenol.  after about 4 hours his bp fell to 89 over 64  ... thus keeping him in hospital.   They did multi tests.   found an unknown infection in his blood.   Patient has had an elevated WBC but in hospital it was 50,000.   two weeks ago at his primary Dr.  it was 40,000.   He walks with a walker and cane, however he has lost his balance and fallen 3 time since vaccine and one of those was today.
DEVELOPED A RASH ON THE SHOULDERS, NECK AND BACK TWO DAYS AFTER VACCINE AND HAS CONTINUED FOR A FEW WEEKS NOW. SHE HAS BEEN USING TOPICAL CREAMS TO ALLEVIATE SYMPTOMS.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 (Lot number: EWO150) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS; FISH OIL; TURMERIC; MAGNE B. Other medications in two weeks: multivitamin. Past drug history included: Keflex, reaction(s): "Allergy"; Remicade, reaction(s): "Allergy"; Asacol, reaction(s): "allergy"; Azithromycin, reaction(s): "allergy". Vaccination history included: Flu vaccine, reaction(s): "allergy". The following information was reported: NEUROPATHY PERIPHERAL (disability, medically significant), PARAESTHESIA (disability) all with onset Apr2021, outcome "not recovered" and all described as "worsening of my long Covid peripheral neuropathy symptoms (paresthesias)"; MUSCLE TWITCHING (disability) with onset Apr2021, outcome "not recovered", described as "muscle twitching"; MAST CELL ACTIVATION SYNDROME (disability, medically significant) with onset Apr2021, outcome "not recovered", described as "A specialist thinks I may have mast cell activation syndrome"; HYPERSENSITIVITY (disability) with onset Apr2021, outcome "not recovered", described as "I have also developed new allergic-like reactions to many things". The events "worsening of my long covid peripheral neuropathy symptoms (paresthesias)", "worsening of my long covid peripheral neuropathy symptoms (paresthesias)", "muscle twitching", "a specialist thinks i may have mast cell activation syndrome" and "i have also developed new allergic-like reactions to many things" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (May2021) negative, notes: Nasal swab; (Oct2021) negative, notes: Nasal swab; (Nov2021) negative, notes: Nasal swab; (Dec2021) negative, notes: Nasal swab. Therapeutic measures were taken as a result of neuropathy peripheral, paraesthesia, muscle twitching, mast cell activation syndrome, hypersensitivity.  No follow-up attempts are possible. No further information is expected.
Patient received vaccine that had a refrigeration "good until" date of 11/30/2022.  Vaccine was transferred from freezer to refrigerator on 9/21/22.
10:50 am, metallic taste in mouth. 11:03 am, patient reported feeling much better. 159/62, HR 64, O2Sat 99%.
This case was reported by a consumer via another manufacturer on 14 August 2007. A patient reported that she received ADACEL (lot number not reported) and "became diabetic in a few weeks". No additional information was reported. This case was reported by a consumer via another manufacturer on 14 August 2007. SERIOUS CRITERIA OTHER-MEDICALLY SIGNIFICANT. A patient reported she received ADACEL (lot number not reported) and "became diabetic in a few weeks". No additional information was reported. A corrective version has been created using the prior receipt date in order to clarify that the reporter in this case was not a health professional. No medically significant information was added to the case.