chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female patient with insulin-dependent diabetes and no drug reactions/allergies who on 02-APR-2012, was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # not provided) and on 14-MAY-2012 was vaccinated IM with the second dose 0.5 mL dose of GARDASIL (lot # 666163/0664Z, expiration date on 18-SEP-2012). Concomitant therapy included insulin. The nurse reported that the patient was pregnant. The last menstrual period (LMP) was unknown and her estimated delivery date (EDD) was on 22-DEC-2012. Method of confirmation was unknown. The patient sought medical attention at the physician's office and she did not receive any treatment for the event. Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning the 26 year old female with diabetes, high cholesterol and a history of 2 pregnancies and 2 live births (at the week of 38 and 37 weeks) who on 02-APR-2012, was vaccinated first dose of GARDASIL (lot # 666118/1539Y) and on 14-APR-2012 was vaccinated with the second dose of GARDASIL (lot # 666163/0664Z). Concomitant therapy also included LIPITOR, LEVEMIR, metformin and vitamins (unspecified). The last menstrual period (LMP) was 17-MAR-2012 and her estimated delivery date (EDD) was on 22-DEC-2012. Estimated conception date was 30-MAR-2012. No birth defects in previous pregnancies and no infant complication in previous pregnancies. Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning the 26 year old female with diabetes, smoking of 1/2 pack per day, and a history of 2 pregnancies and 2 male babies (one at the week of 38 weeks (on 17-FEB-2009) with weight of 6 lbs 8ozs and 36 weeks (on 13-JAN-2012) with weight of 5 lbs 13ozs) who on 14-MAY-2012 was vaccinated with the second dose of GARDASIL (lot # reported as M0664Z). On 08-DEC-2012, the patient delivered a live birth via cesarean section. The mother and infant experience no complications during the delivery. The male infant was normal, no congenital anomalies, with weight of 6 lbs 7ozs and length of 19 1/2. Upon internal review, cesarean section was considered as a medically significant event. Additional information is not expected.
Pt. received 2nd Jap. Enceph. on 2/12/08.  On 2/14/08 called stated arm sore with occ. tingling in fingers.  Advise to F/U with PCP.  2/16/08 much better, no pain PCP-no intervent.
Week after 1st vaccine arm hot swollen, hives, itchy and red.  Had to take antihistamine and Advil.   Arm felt a tingling sensation as if numb.
Pt began vomiting 4 hrs post immun w/intermittent vomiting for subsequent 8 hr; Pain in deltoid x 5 days; felt hot to mom, temp not measured;
Got COVID shot around noon on 8/31, by 4 PM could not keep eyes open, was very tired, fell asleep, husband said was running really high fever, not responsive, sweat through all the sheets, in the morning when woke up, felt like she had a weighted suit on her body, couldn't lift limbs, was difficult to breath, heart was pounding hard. Drank some water and ate something but after 45 minutes would barely move her tongue, felt like strings were connected to her jaw, had tingling in hands and feet which she still has, couldn't swallow. Husband took her to the ER. When there they said her BP was a little elevated and said heart rate was irregular, had to wait a few hours, they finally tried to do some tests, couldn't do the neurological tests, they gave her antihistamines to help her swallow, they didn't have beds available to do IV, was extremely nauseous, still could not move. After about 20 minutes she sate in waiting room for 4 hours. Just went home and has been fatigued since then, can't eat. Able to talk and move and shower but still has tingling in hands and feet. Family history of guillane barre and bells palsy.
10/27/99 pt vax w/ 1st pneumococcal vax 23 polyvalent. 10/28, 9:00 the deltoid area - sore. 14:00 area - red, swollen. Pt exp shakes at 15:30. 20:00, pt exp chest discomfort, chills, fever. Dr. diag severe inject site cellulitis.
Pt became nauseated and stated his throat was swelling able to speak in full sentences stats r/a 97% b/p 156/102 fsbs 117 rr 12 tempt 97.1 denies any pain was given a 25mg p.o. Benadryl about 10min vomited up water about 8oz of water, PA assessed pt lungs were clear, and after the vomiting felt he should be transported to the ED Mother transported to ED pt stable upon transport
This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL lot # K005083, expiry date 04-NOV-2016 and lot # K010215, expiry date 05-MAY-2017 (dose, route and site of administration were not reported). There were no known side effects reported. The vaccines experienced temperature excursion of maximum temperature of 22.7 degrees Celsius for 3 hours 48 minutes and minimum temperature of 0.2 degrees Celsius for 31 hours 1 minute. This is one of several reports received from the same source. Additional information has been requested.
Pruritic rash (entire body) X few days was ill 3-4 days after flu shot.
her arm started to swell; 3 painful bumps at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (her arm started to swell) and VACCINATION SITE MASS (3 painful bumps at site of injection) in a 41-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) , while the parent received the product for COVID-19 vaccination.     No relevant history reported.  Concomitant product exposures included IRON, VITAMIN D [VITAMIN D NOS] and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 09-Mar-2021, the parent received first 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 18-Mar-2021, the adult was diagnosed with VACCINATION SITE SWELLING (her arm started to swell) and VACCINATION SITE MASS (3 painful bumps at site of injection). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, VACCINATION SITE SWELLING (her arm started to swell) and VACCINATION SITE MASS (3 painful bumps at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
He took his vaccine and his arm was a little sore right afterwards.  His arm hurts more today and is having trouble lifting the arm.  He has chills, fatigue, diarrhea, nausea, muscle pain, fever, headache.  He has not taken anything for his symptoms, just wanting to sleep.     He is allergic to the flu vaccine and he told them that before the vaccine and they assured him that he was ok to get this.  He probably will not get the 2nd vaccine.
Shot received at 1pm. At 6 pm, started to experince severe chills, body aches and temp of 99.5. Of note, I have had covid in the past(March). I get antibodies tested regularly as I am in a study; antibodies still present. My symptoms following this vaccine were more severe than my covid symptoms.
Patient is a 26-year-old male  with history of idiopathic urticaria, COVID-19 positive October 2019 here for PCM follow-up after going to urgent care on 25 March 2021 for hypersensitivity reaction.  Patient who has received his Moderna vaccination on 4 March 2021 around 10:00 for reporting Symptoms of headache, muscle ache, chills And left shoulder pain 4 hours after his vaccination.  Patient reported For waking up the next day with watery non bloody diarrhea and diffuse Rash with pruritus.  He also reported for feeling winded when talking long sentences.  Patient woke up on 24 March with a blister on the flat surface of his tongue that raised concern For him to go to urgent care the next day.
Patient went to ER with breathing difficulties. Had fluid buildup in lower legs and fluid on lungs. Was diagnosed by ER Dr. with Congestive Heart Failure (CHF).  This was a new and first time diagnoses as patient sees a heart specialist each year.  With treatment patient was slowly getting better. Upon second dose 01/20/2021 patient got worse again. Eventually had to go on Oxygen. With treatment patient is slowly getting over symptoms of CHF.
received the first dose of the COVID-19 vaccine on 22Dec2020/tested positive after taking the first dose; received the first dose of the COVID-19 vaccine on 22Dec2020/tested positive after taking the first dose; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 22Dec2020 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that the pharmacist understood that the undiluted vials could be stored up to 120 hours in the refrigerator. She mentioned that their vials are already close to 120 hours stored in the refrigerator. She also knows that if you draw it up in a syringe, the vaccine has a 6-hr viability. She wanted to know if the vial expires after 120 hours or it would mean an additional 6 hours on top of the 120 hours. It was reported that "The allowable time in the refrigerator (5 days or 120 hours), starts when the vaccine is removed from storage under ultra-low temperatures. From the point of dilution, the vaccine may be stored at 2 degrees C to 30 degrees C for up to 6 hours." also shared extended stabiilty information of diluted vials". It was then reported that the patient received the first dose of the COVID-19 vaccine on 22Dec2020. However, the patient tested positive after taking the first dose. The pharmacist asked if the patient should be revaccinated with first dose and then wait for the another 2 weeks for the second dose. Pharmacist further asked if not, is it ok giving it at 8 days after the 21 day-interval, how to proceed, and dose the Regulatory recommendations included people who had COVID-19. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported "tested positive after taking the first dose".
Double vision; has to have a walker to be able to walk; feel like legs just fell up under; This case was reported by a pharmacist via call center representative and described the occurrence of double vision in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received Shingrix. In May 2022, less than 2 weeks after receiving Shingrix, the patient experienced double vision, walking difficulty and lower extremities weakness of. On an unknown date, the outcome of the double vision, walking difficulty and lower extremities weakness of were not recovered/not resolved.   It was unknown if the reporter considered the double vision, walking difficulty and lower extremities weakness of to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-MAY-2022 Reporter's Comment: The reporting pharmacist had a patient who received Shingrix in last week before day of reporting. The patient was experiencing double vision, he had to have a walker to be able to walk. The patient stated, his legs just felt like his legs just fell up under him. The reporter looked up some of the side effects and looks like it could be some of the symptoms. The reporter told the patient that he/she would give all this message to call them back. The reporter requested to contact patient and let him know further course of action and also to give him/her a call. The reporter consented to follow up.
pt with trouble swallowing at 35 mins s/p vax. she wasimmediately transferred to ED and RN accepted pt and sign out. Dr.  notified beforehand.
VBT Positive COVID-19 test 05/22/2021. Symptomatic- Shortness of breath, Transferred to another facility for further workup.
This spontaneous report was received from a medical assistant, who referred to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 20-MAR-2017 and 20-APR-2017, the patient was vaccinated with GARDASIL 9 dose 1 and dose 2 respectively, lot# M037770 and expiration date: 01-JUN-2019 (route of administration was not reported) for prophylaxis. On 23-AUG-2017, the patient received the third dose of GARDASIL 9 lot# M033583 and expiration date: 14-APR-2019 (route of administration was not reported) for prophylaxis. The medical assistant reported that, on 23-AUG-2017, the patient received dose of GARDASIL 9 outside of the recommended dosing schedule. No adverse effects were reported. No product quality complaint was involved.
Patient experienced symptoms of hypoglycemia immediately after receiving the Moderna vaccine. The patient stated she took insulin and had a small meal before receiving the immunization. She believed she did not eat enough for the dose of insulin received. The patient given orange juice and monitored for symptoms. We used a blood glucose meter to check her blood sugar. Patient's blood sugar returned to normal. Patient able to return to normal daily activities.
Donor c/o nausea and vomiting 20-30 mins. after Tetanus inj. This lasted all night and today c/o N/V.
Severe muscle aches  Diarrhea  Headaches  Feverish  Nauseous Left arm super sore Sore throat
Pts right arm became red and swollen.  Swelling extended to wrist, elbow and under arm. Pts arm doubled in size. Pt was seen by covering physician and then primary doctor on 11/06.
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 06-DEC-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date reported and established as 05-OCT-2022; dose, route of administration, and anatomical site of vaccination were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 53 minutes; above 9 degrees C (9.6C) for a time frame of 34 minutes; above 9 degrees C (9.5C) for a time frame of 23 minutes; and above 9 degrees C (8.5C) for a time frame of 9 minutes. It was reported that no had previous temperature excursion. No additional adverse effects reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Pfizer-BioNTECH COVID -19 vaccine reconstituted with 1.7 ml of 0.9 ml NS instead of 1.8 ml.  As a result    only 5 doses  were obtained for adminstration.
Red swollen arm from injection site halfway down and turning into  underarm - length of swelling  about 12 inches .  Painful, burning, keeping me awake at night.  Accompanied by Pain in left underarm lymph node area.  This is day 7 of this adverse event (today is 23-Mar 2021) and most severe day of reaction thus far
After 9 days after taking booster shot, I started getting hives all over my body. This is 4th day I have been on antihistamines. The hives and itching will not go away.
sneezed; runny nose; arm began to feel sore; couldn't sleep; kidney stones; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 10Mar2021 at 13:00 as a single dose for COVID-19 immunization.  Medical history included family history of lymphoma and back problems/pain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that on the evening of the day of the vaccination, 10Mar2021, the patient's arm began to feel sore and she couldn't sleep due to the discomfort. The patient took ibuprofen to help the pain and it lasted for about three days. She also reported that on 14Mar2021, the patient had a very runny nose on the 4th day and says she sneezed 80-100 times. The patient said her friend took the vaccine and reported sneezing, as well. The patient took Tylenol before the vaccine. The patient added that she has back problems/pain and regularly takes 1-2 ibuprofen a day and was told by someone that she should not take ibuprofen because it could interfere with the vaccine. The patient wanted to know if this was true. The patient also reported that she has kidney stones on Mar2021 and was "screaming and hollering yesterday" because of the pain. She takes hydrangea root to break down the kidney stones and ibuprofen. She added that they've had 5 or 6 people around here lost and 2 cousins lost (died) to lymphoma and multiple people in her family have died from lymphoma. She was concerned the vaccine could cause lymphoma. The outcome of the event arm began to feel sore and couldn't sleep was recovered on Mar2021. The outcome of the other events was unknown.   Information on the lot/batch number has been requested.
Sever dermatitis to the body left arm chest stomach flank, resulting in hyper pigmentation
Severe eczema, Food allergies to eggs and peanuts, Food sensitivities to milk, gluten, coconut oil, cashews, almonds.
Chills, high fever, headache, and muscle pain.  The chills subsided on the second day.  The fever rose to 103.3 on the second day  No side effects after the second day.
Later the day after the vaccine I started to get soreness in the injection site arm. I took Aleve and went to bed. Woke up and it was the arm was really hurting as if the rotor cuff area was hurting real bad when I tried to move the arm. I didn't use the arm and took anti-inflammatories for about 2 days until the symptoms subsided on their on. I was a little tired during this time but otherwise nothing else.
5 minutes of vertigo; lightheaded; Initial information was received on 15-Sep-2021 regarding an unsolicited valid non-serious case from consumer/non healthcare professional via call center via Agency (Reference number- 00770195). This case involves Elderly female patient who experienced lightheaded (dizziness) and 5 minutes of vertigo (vertigo) when received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious lightheaded (dizziness) and 5 minutes of vertigo (vertigo) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "Caller would like to know if the vaccine is available in the area and if the vaccine is 3 or 4 strain. Caller did not want to give any other information besides her name. Caller stated that she will give that information to the person she is being transferred to. The caller wanted to know if she can get a "regular" flu shot that is four strains and not three strains. She would like to know if "quad" is always four. She would like to know if the "senior" flu shot is "double". The caller states that she didn't feel her last flu vaccine when it was administered so she wants to go back to "her" at Rite Aid. She states that she doesn't want to fill out any paperwork but she got the "senior" vaccine once "many, many years ago" and she got a little lightheaded and had 5 minutes of vertigo that was not bad. She states that she is going to try and not get the "senior" flu vaccine even though she is about to be 72. She states that she will try to have the regular one (vaccine) and then wait 4 weeks until the antibodies form and she is safe from the flu and then she will get the booster from Pfizer for COVID 19. She states that in February and March we were told that if you had the Pfizer vaccine you were 94-95% covered for COVID but then a month or two ago we were told we were 80% covered or lower and then yesterday it came out that we don't need the booster so fast and she said it was a little disconcerting with all the backtracking. She states that she doesn't want the flu or COVID."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  The event outcome was unknown for dizziness.  On an unknown date, the patient recovered from vertigo.  There will be no information available on the batch number for this case.
About 8 minutes after adminesitering the Moderna vaccine patient started feeling dizzy, light headed, sweating and his ears were ringing. I asked if he wanted me to call the ambulance and he said yes. I gave patient a bottle of water and Orange Juice (confirmed non diabetic). It seemed like he was having an anxiety or panic attack. EMT came in and took him to the hospital, at that time he said he started feeling better.
Ct was to receive 0.1cc PPD for TB skin test on 8/16/04 instead Ct. received Adult Td 0.5cc ID in left forearm. Mother of Ct. reports redness/swelling/pain in forearm-followed up with MD, now both arms painful, to continue MD follow up.
Around 830pm rashes started on my body then to upper extremities, neck and head. Went urgent care and received a steroid shot. I was also taking Benadryl 50mg orally. Rashes lasted for 6 days.
This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 69-year-old male patient who received SHINGRIX. In February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site burning, malaise, nausea, vomiting, fever and chills. On an unknown date, the patient experienced sweating. On an unknown date, the outcome of the injection site burning, malaise, nausea, vomiting, fever, chills and sweating were recovered/resolved. The reporter considered the injection site burning, malaise, nausea, vomiting, fever, chills and sweating to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported the following adverse reactions after SHINGRIX that was administered on the left arm approximately 1.5 months before the reporting date. The events occurred that night after the injection, lasted for about 30 to 40 minutes and then stated he could tell it was getting better about an hour later. The patient requested to remain anonymous and was reluctant to answer some questions.
10 - 17 hours after: vaccine: frequent urination 7 times overnight, full bladder 17/18 hrs after vaccine: - severe headache, body aches, chills, fever 103.8, unable to sleep, frequent urination continued, 1-2 times per hour, full bladder. 34 hrs after: body aches, chills, and frequent urination subside. Body can?t cool down, really hot no matter what. Fever starts to drop. Sweat profusely overnight - soaking wet sheets.  42 hours after: severe headache still persists, fever down to 100.6, profuse sweat continues through day.  Injection site hot, hard, and tender.