chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fluctuations of blood pressure; aches and pains/achy; sore joints; sore ribcage; feeling cold; dizzy; not feeling like herself; This is a spontaneous report from a contactable consumer. This 80-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6207) via an unspecified route of administration on 22Mar2021 (at 80-year-old), as dose 1, single on left arm for COVID-19 immunization. The patient's medical history included high blood pressure, caller says that this was diagnosed 12-15 years ago, maybe longer. The said that she had not had any other recent vaccinations or started any new medications, but she was prescribed something a couple weeks ago that she took one of and did not like how she felt so she had not taken any more of that, which was at least three weeks ago. Caller provides no further details about this medication. On an unknown date in Mar2021 after she had received the first dose of Pfizer's COVID vaccine she experienced fluctuations of blood pressure, which she does take medication for blood pressure. She stated that she had aches and pains and sore joints, sore ribcage which she says was very unusual, and she felt like she had reached for something and twisted or pulled a muscle or something, she felt cold, She asked if she should be concerned about her next injection. She stated she felt achy and dizzy. She says that she was advised by her doctor's office since she felt she had some kind of reaction to let Pfizer know. She says two or three days after getting the injection she started not feeling like herself, she was achy and her joints in her hands ached which was not usual and then she felt it in her shoulders. She says her blood pressure fluctuated more than usual, which she does have high blood pressure that was well controlled by medication, at least the last 5 months since her husband passed away. She says she went through a lot of stress, and it has not been an issue, then it kind of fluctuated a lot last week. She mentioned that her height was 5 feet 8 inches, and when she was last measured she was 5 feet 7.5 inches, she shrunk half an inch before she got the vaccine, which she knows because she had a bone scan a couple months ago. She says she was quite active, she lives alone and does housework and drives. She says she has not treated the achiness, though she had considered taking Tylenol if she couldn't sleep but she did sleep. The event outcome was unknown.  No follow-up attempts were possible. No further information was expected.
Fever TMax 102 F,  chills, myalgia, R arm intense pain, but no acute inflammation in area of injection
No additional adverse events.; On 29-APR-2020 an improperly stored VARIVAX was administered to a patient.; This spontaneous report as received from  a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided.   On 29-APR-2020,  the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S025913 has been verified to be a valid lot number, expiration date reported as  20-AUG-2021), for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported.   Administered dose of vaccine experienced the temperature excursion of -14 Celsius degrees to -10 Celsius degrees (-11.2 Celsius degrees)  for 9 hours and 58 minutes and  of -9 Celsius degrees to 8 Celsius degrees   (3 Celsius degrees)  for 13  hours and 35 minutes. Data logger was not involved. There were no previous excursions reported.
Couldn't sleep; Fever; Body aches; A spontaneous report was received from consumer concerning a female patient with unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events insomnia, pyrexia and pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in unspecified location  for prophylaxis of COVID-19 infection.  On unknown date, The patient experienced the events could not sleep, fever(not anymore) and pain (not terrible).  Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On date the outcome of the events could not sleep, fever and pain was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
There was not a adverse reaction.  The doctor pulled out a 11th dose and administered it, not realizing it was an eleventh dose from the vial. The individual is fine and has not exhibited any adverse reactions what so ever.
pt recv vax & devel dystonic rxn w/focal myoclonus of head & upper extremities;this condition was dx by MD as being permanent;tx botulism toxoid to dec pt tremors;
On Monday night, 4/12, I noticed and felt a painful lump behind my right ear and tenderness near the area and further out. I visited Wellstar ENT on Tuesday, 4/13, for it to be examined. The cause of the lump was unknown but an antibiotic was prescribed as a precaution. By Wednesday morning, 4/13, shingles rash and sores appeared right below the area on the right side of my neck. As the days progressed more sores appeared and the pain increased. While attending another appointment (GYN) on Friday, 4/16, I was diagnosed with shingles.  VALACYCLOVIR HCL , 1 GRAM, tablets were prescribed., to be taken three times a day for seven days.
Woke up at 1:45am Tuesday morning to vomit.  Vomited again at 3:30 am 08/10/21.  Has had headaches, one stomach ache, and been extremely tired since.
Information has been received from a public health nurse concerning an adult female pt who was vaccinated with a second dose of Pneumococcal 23v polysaccharide vaccine. It was noted that the date of the first dose is unknown. Subsequently the pt experienced redness and severe swelling at the injection site, which resolved with no treatment. The adverse event improved and the pt recovered. No further information was available regarding the adverse event. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
CHILD UNDERAGE FOR VACCINE.  CHILD DOB REPORTED AS 10/30/2008 ON CONSENT. SYSTEM LISTED DATE OF BIRTH AS 10/30/2011. CHILD RECEIVED VACCINES ON 08/6/2021 AND 08/27/2021 (LOT #EW0177)
8 year old patient who took 1 oral dosage instead of injectable and he didn't tolerate it; 8 year old patient who took 1 oral dosage instead of injectable; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 8 years old patient who was vaccinated with a dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] lot number not reported via oral route.  The patients medical history and concomitant medications were not reported.  It was an actual medication error due to inappropriate route of vaccination (8 year old patient who took 1 oral dosage instead of injectable).  On unknown date,  patient experienced an adverse event following vaccination. It was reported as an 8 year old patient who took 1 oral dosage last Wednesday, and he didn't tolerate it.  No lab data or corrective treatment provided.  Patient's outcome for adverse event NOS was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
skin stings; Sore arm; fatigue for 2-3 days; slight headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number F49L5, expiry date 12th January 2021) for prophylaxis.   On 25th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, fatigue, headache and stinging skin. On an unknown date, the outcome of the pain in arm, fatigue and headache were recovered/resolved and the outcome of the stinging skin was recovering/resolving.   It was unknown if the reporter considered the pain in arm, fatigue, headache and stinging skin to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix on the left arm. The patient experienced sore arm and fatigue for 2 to 3 days and slight headache presented on and off for 1 to 2 days. The stinging was a little better than day before reporting yesterday. This case has been linked with case US2020019154 (husband's case), reported by same reporter.
FEVER, NAUSEA, HEADACHE, EXTREME LETHARGY. The feelings were so severe that she was unable to work for 2 days following the vaccination, and she was still feeling lethargic 4 days later. Tmax >102F.
hard lump at injection site; hard lump at injection site; swelling right arm; soreness right arm; warmth at injection site; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date 6th December 2021) for prophylaxis.   On 28th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th September 2019, less than a day after receiving Shingrix, the patient experienced swelling arm, pain in arm and injection site warmth. On an unknown date, the patient experienced injection site lump and injection site induration. On an unknown date, the outcome of the swelling arm, pain in arm, injection site warmth, injection site lump and injection site induration were recovering/resolving.   It was unknown if the reporter considered the swelling arm, pain in arm, injection site warmth, injection site lump and injection site induration to be related to Shingrix.  Additional details were provided as follows: The reporter was a patient.  The patient received Shingrix in her right arm.  After receiving the vaccine, she developed swelling and soreness in the right arm, warmth at the injection site and less than 3 weeks, had a hard lump at the injection site. The patient consented to follow up and also provided her physician's address.
Swelling around injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments:  The caller stated that the patient had a lot of swelling around injection site.  The caller was not sure if other vaccines were given with this product.  The caller stated this was all the information the Nurse gave her. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022137214:Same reporter
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. On unknown dates the patient were vaccinated with improperly stored GARDASIL 9 lot # L023230, expiration date: 28-JUL-2017, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Hydrocele developed in right testicle on evening of vaccination and proceeded to get worse over time, and as of filing this report, is causing me the most pain it ever has.  Testicle is abnormally large/swollen and very painful even when laying down.  No damage was done to my testicles prior to or after receiving the vaccine.  The  sudden appearance of this hydrocele is extremely abnormal and arose shorty after vaccination.
Since the last shot on 4/9/2021 I have had an outbreak of herpes 4/14/21, shocking pain in my feet 5/2021 and Shingles 2 times June and July and now I'm being told I have rheumatoid arthritis which I never had before.
I had a sore throat for 3 days and severity was medium, runny nose, nausea. Fatigue lasted 8 days and was mild and required me to have daily naps. My doctor prescribed PAXLOVID 5 days.
Pt reported itchy arm at injection site which spread to entire right arm, back, and neck.  Dose of 10 ml oral benedryl administered at 1322 at a dose of 12.5mg/5ml.  Pt reported burning of throat and chest and a dose of Epinephrine via EpiPen was given into right thigh at 1323.   911 was called at 1331 after pt reported throat burning turning into a feeling of throat constriction.   A second dose of EpiPen was administered into the left thigh at 1341 and the ambulance arrived to bring pt to hospital at 1344.
Swollen lymph nodes in left breast that turned into mastitis after first vaccine. Had to go on antibiotics. Very sore arm for 3 days. Tired for 2 days.  Swollen lymph nodes and plugged milk ducts in left breast again after second vaccine. Had ultrasound to document. Extreme fatigue and low grade fever for 5 days. Stayed in bed. Pain at injection site and a red rash developed. Lasted a week. Huge inflammatory response in joints mostly in hips. Lasted for several weeks. Extremely painful. Doctor said I should report.
Patient reported erythema and pain to right shoulder after getting PNEUMOVAX 23. Had seasonal influenza in left arm same day. No fever or spread. Tx with MOTRIN & ice.
Information has been received from a registered nurse and a physician concerning a 48 year old female with an unknown medical history and unknown allergies who on 10/6/05 was vaccinated SC in the left arm with a second 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot # 650649/0790P). On 10/6/05, the patient reported that she had developed local severe swelling from left shoulder to below elbow, redness, pain, fever of 101 and vomiting. The client presented to the doctor office the same day and was treated with methylprednisolone acetate, 80 mg IM and ketorolac tromethamine , 60 mg IM. The nurse reported that the patient's fever decreased and the client was recovering. The nurse reported that the patient received a first dose of pneumococcal 23v polysaccharide vaccine three years prior to second. Local severe swelling from left shoulder to below elbow, redness, pain, fever of 101 and vomiting were considered to be other important medical events (OMIC) and disabling by the reporter. Additional information has been requested.
hives - mild without target lesions or mucosal involvement. Patient also on D6 of sulfa-medication. Supportive treatment (OTC benadryl) advised.
Currently have not had a regular period since having the Moderna vaccine, I do have a IUD (have had for years) and would still have monthly period symptoms, cramping, bleeding, pms, etc. Since I have had the vaccine I do not have any of these symptoms and haven't had any bleeding to date.
No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered nurse concerning to patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 23-DEC-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (dose, frequency, lot # and expiration date were not provided) for prophylaxis. On 24-FEB-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose (unspecified), orally (frequency not provided; lot # 1660112, expiration date 18-OCT-2020), for prophylaxis. The temperature excursion was called by the digital data logger. There were multiple temperature excursions below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 minutes (reported as hours). No previous temperature excursions were reported. No additional adverse effects were reported.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2003USA005892: US-009507513-2003USA005842: US-009507513-2003USA005917:
Client left health dept and in car about 10 mins started sneezing and coughing. Went to restaurant and ate outside but continued sneezing and coughing with eyes watery. Got home about 2:45-3pm and took 20 minute nap. Woke up and chest was tight, throat was tight, eyes swollen, face and ears itchy. Father was home with her. Called health dept and closed, called PCP office and instructed to go to ER. Drove to ER in about 10 minutes and arrived about 4-4:30pm. Seen immediately. Given IV Benadryl, Epi Pen x1. States she felt better immediately. Observed x 2hours. Discharged home with Benadryl OTC to take on 8/8/14 and prescription for Prednisone 20 mg 3 tabs daily for 3 days, Epi Pen for use as needed. Today she feels fine but little tired from Benadryl. Had HA when first work up today but since gone.
Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on 01May2021 at 11:15 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. It was unknown if the patient was diagnosed with COVID-19, prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021, the patient experienced headache and sore arm. The clinical outcome of the events headache and sore arm was recovered on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Pt fainted in chair after receiving vaccination. Moved to cot.  Mom & sister present.   4:15PM Pt eating crackers, Juice & sitting up.  Color returned to face. 4:25PM Left w/o assistance with mom & sister.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-JAN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K006681, expiration date on 21-OCT-2015 (dose and route were not provided). There was no concomitant medication described. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
H/A head is pounding, Chills shivering, took hours to warm up, nausea, 102.4temp,  took Tylenol. This AM still have H/A, sore arm, 98.8 temp. Pain in right upper arm.
Mom reports the AM after shot, arm red, swollen and noted welts to arm and on back. By the PM welts gone. No respiratory difficulty.
Infection due to SARS COIVD , acute viral respiratory, feeling ill, achy, coughing, sever fatigue.  Severe covid after having to be vaccinated on 1/5/2022 and 2/22/2022.
been asleep for the bulk of the day; pain; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (been asleep for the bulk of the day), PAIN (pain) and HEADACHE (headache) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (been asleep for the bulk of the day), PAIN (pain) and HEADACHE (headache). At the time of the report, SOMNOLENCE (been asleep for the bulk of the day) outcome was unknown and PAIN (pain) and HEADACHE (headache) had not resolved.            No concomitant medications were reported  No treatment drugs were reported  Consent to follow up unknown
Warm to the touch, erythematous, 6cm axial length, 3.5 cm width. Light pink, irregular border. No purulence.
7/6/16 - 5pm - 1st dose - Felt dizzy but not much. 7/8/16 at 1pm - 2nd dose - headache after 2 hrs; last eaten at 10am, nausea. 7/10/16 at 10am - empty, stomach - ate 12pm - HA at 12pm, fever 99.9 (3pm) - took ADVIL 600 mg at 3:30pm felt fine, 7pm felt tired; fever returned, achy, HA, and diarrhea. 7/11/16 - 3rd dose HA and felt worse.
Information has been received from a medical assistant concerning a 48 year old female with depression, anxiety and chronic back pain and allergic to LEVAQUIN and unspecified narcotic who on 27-JUN-2008 was vaccinated with ZOSTAVAX by subcutaneous injection (lot number and injection site not reported). Concomitant therapy included XANAX, ATIVAN, and LORTAB. On 28-JUN-2008 the patient developed a cough, cold like symptoms, numbness from the left arm to the hand, ache and pain, and headache. On 30-JUN-2008, it was reported that the patient was "being seen at the office today with a chief complaint of overall aches. Other symptoms have not resolved." Additional information has been requested.
Pt dx'd with chickenpox. Pt had chickenpox vaccine on 2/6/99. Not yet recovered as of 11/01/00.
This spontaneous report as received from a Certified Medical Assistant refers to a female patient of unknown age. The reporter stated that the patient received her first dose of GARDASIL (route, lot number and expiration date not reported) on 04-SEP-2008 and her second dose of GARDASIL (route, lot number and expiration date not reported) on 26-JUN-2013 and at the time of report on 26-SEP-2013 she came to the office to receive her third dose of GARDASIL (route, lot number and expiration date not reported). No adverse symptoms were reported. Additional information has been requested.
Breakthrough COVID infection leading to hospitalization. Symptoms beginning 4/30/22 including: cough, SOB, fatigue, and nausea.