chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported feeling lightheaded. Vitals were within normal limits.; This is a spontaneous report from a contactable pharmacist. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via an intramuscular route of administration in the arm left on 19Apr2021(at the age of 45-year-old) as a single dose for COVID-19 immunisation. The medical history included gastric sleeve three years ago and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an intramuscular route of administration in the left arm on 29Mar2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, the patient felt lightheaded. It was reported that the patient's vitals were within the normal limits. On 19Apr2021, the patient underwent vital signs measurements and were within normal limits. The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event felt lightheaded was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Patient had  general malaise. Onsite EMS was called vitals BP 146/91  99% O2 HR 85.  Patient refused evaluation or care. Released to go home against medical advise.
Received first vaccine on 01/28/2021 as Moderna Received second vaccine on 02/25/2021 as Pfizer
Right deltoid erythema 6x7 cm + warm and tender. Unable to move right shoulder above head.
Left rotator soreness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration in the left arm on 18Dec2020 at 09:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and thyroid cancer. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received concomitant medications which were not specified within two weeks of vaccination for unknown indication on unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced left rotator soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left rotator soreness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recv vax; hyperthermia 7jul95; T up to 104.4 R;
Patient Instructions will continue to observe and will recheck at the next exam visit Discussion Notes This breast tissue development is most likely from the maternal hormones that developed during mom's pregnancy. the breast tissue should gradually go away
dizziness 20 minutes after shot; chest pain and dizziness 24 hours after shot.
Patient with 2 Pfizer vaccinations, last dose 02/23/2, who admitted to hospital with complications partially attributed to COVID and a positive COVID PCR.  Provider d/c note below:  "88 YO female who presented to the hospital for evaluation of progressive weakness, nausea and vomiting.  The patient is accompanied by her daughter.  The patient lives with her daughter.  She apparently is very healthy.  Has not seen any physician in a long while and is only on Claritin and multivitamin.  She ambulates without any assistive device.  She was in her usual state of health until about 2 days ago when she started experiencing some chest discomfort on the right side radiating to the right arm, cough, productive of clear sputum without any blood.  No hemoptysis.  She also notes that the cough seems to be worse at night.  In fact, the patient recalls that she probably has been coughing for more than 2 days.  She then started becoming weak, feeling lightheaded and according to the daughter, looks wobbly with her gait.  She has not had a falls.  She has not had any syncope.  The daughter tried her on over-the-counter medications including Alka-Seltzer for what she thought was possibly an upper respiratory cold but with her progressive weakness, she ended "
feel like theres something heavy on my lungs when i ay down; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (feel like theres something heavy on my lungs when i ay down) in a  patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUNG DISORDER (feel like theres something heavy on my lungs when i ay down). At the time of the report, LUNG DISORDER (feel like theres something heavy on my lungs when i ay down) had not resolved.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown.       No concomitant medication were provided.  It was reported that patient got first dose few days ago and still felt like there was something heavy on lungs when patient lay down.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Upon internal review on 26-Sep-2022, significant correction was performed to update Patient country, obtain drug country and drug authorization country of suspect vaccine, reporter and Agency causality and Narrative.
Information has been received from a registered nurse concerning a female patient between the age of 19 and 39 years who between 23-OCT-2006 and 27-OCT-2006 was vaccinated subcutaneously with a dose of Pneumovax 23 (lot #654981/0674F).  Subsequently, in October 2006, the patient developed swelling and warmth in the vaccinated arm.  Unspecified medical attention was sought and the patient was treated with unspecified antibiotics.  At the time of report, the patient was recovering.  The nurse requested a lot check for lot number 0674F.  No product quality complaint was involved.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Site: Pain at Injection Site-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Pt reports having swelling bubble under armpit that may be a lymph node after getting vaccination day before. states first 2 shots did not cause any swelling, but this shot did. pt states that painful, let pt know to use ice or ibuprofen/tylenol and if not resolved or getting better in 3 days to contact MD
This case was reported by a consumer and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, dizziness, headache, fever and nausea. On an unknown date, the outcome of the influenza-like symptoms, dizziness, headache, fever and nausea were unknown. It was unknown if the reporter considered the influenza-like symptoms, dizziness, headache, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The insurance plan told to reporter that she can pay for SHINGRIX at pharmacy and take it to her doctor's office at hospital across the street from the pharmacy to get injection at her doctor's office. The reporter's doctor agreed and the reporter did not had to have an appointment. They said her to come to office and nurse would do injection as soon the reporter got the medicine. The patient experienced flu like symptoms, dizziness, headache, fever and nausea after the 1st shot at pharmacy so she did not want to sit in a pharmacy with those symptoms again. The patient was so glad that she thought that she could get injection at doctor's office especially since the patient also read that the pharmacist often missed the deltoid muscle. Today, the patient called to verify that pharmacy would sell her the medicine through insurance and explained that she would be taking it across the street to get injection at her doctor's office at the hospital clinic. The pharmacist said that they could not sell it to the patient as she could get in an accident driving across street or medicine could get hot. So the patient was not going to let the pharmacist inject so may had to be forced into not getting the 2nd  shot because of fear of getting it again at pharmacist. The patient asked that why drug plan and her doctor planned to do work. The pharmacist said they had to do injection that they are not allowed to sell her the medicine to take to her doctor. The patient inquired what can be done to get shot from doctor's office if pharmacists refused to sell it.
On 5/27/00, the pt received her 1st dose of Lymerix. Within days of the injection, she experienced mild flu symptoms, back pain, and "bad" joint pain. The reporter noted that the pt needed treatment by a chiropractor 5 times in 2 weeks due to severe back pain. The most recent information received on 6/12/2000, reported the outcome of the events as resolving.
BLURRED VISION; VOMITING; WEAKNESS; CHILLS; HEADACHE; FEVER; FATIGUE; STOMACH PAINS; POOR SLEEP; ABDOMINAL BLOATING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced stomach pains. On APR-2021, the subject experienced poor sleep. On APR-2021, the subject experienced abdominal bloating. On APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced blurred vision. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) No major abnormalities in blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, vomiting, weakness, chills, and fever on 13-APR-2021, and had not recovered from headache, fatigue, poor sleep, stomach pains, and abdominal bloating. This report was non-serious.
This spontaneous report was received from a consumer via a company representative, and refers to her 3 year old female child. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-DEC-2018 (reported as 8 days ago), the patient received PROQUAD injection (the reporter assumed that the administered dose was 0.5 mL) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. It was reported that a sterile diluent was used. On an unspecified date in December 2018, the patient experienced bruising and petechiae. On follow up, the patient appeared to have idiopathic thrombocytopenia (ITP) on her presentation. Complete blood count (CBC) with differential, performed in December 2018, showed a platelet of 9 (units not provided), but all other cell lines were normal. By the time of the report, the outcome of idiopathic thrombocytopenia was not reported. In addition, the relatedness between the event and PROQUAD was reported as possibly related.
Had no taste; Coughing up phlegm; No appetite; Urinary tract infection/urinating frequently; Aches; Fever; Chills; Nauseous; Headache; A Spontaneous report was received from a 61-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection/urinating frequently, headache, coughing up phlegm, had no taste, aches, fever, chills, nauseous and no appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) in left arm for prophylaxis of COVID-19 infection.   On Saturday night 06 Mar 2021 or Sunday 07 Mar 2021, after receiving the vaccine patient developed fever, headache, chills, aches, no appetite, nauseous and he urinated frequently. The patient had been to his physician on 08-MAR-2021 and was prescribed antibiotics for urinary tract infection. On 08 Mar 2021, the patient started experiencing coughing up phlegm and he had no taste.  Action taken with mRNA-1273 in response to events was unknown.  The outcome of events urinary tract infection/urinating frequently, headache, coughing up phlegm, had no taste, aches, fever, chills, nauseous and no appetite 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 events, a causal relationship cannot be excluded.
Pt vitals stable prior to vaccination. Per father consent form was signed and confirmation was established that patient had never had an allergic reaction or side effect to vaccinations in the past.  Pt was administered vaccines at approximately 11:15, after 10 minutes at about 11:25 patient experienced some nausea, dizziness and lightheadedness. Patient experienced possible vasovagal syncope, Patient was placed in a supine position as she was able to take deep breaths of alcohol pads, patient did not lose consciousness and remained oriented to self, place and time. Patient responded to instructions and Vital signs at time of episode was BP: 100/62 Pulse 69 O2 98%. Pt denies Shortness of breath, chest pain, chest pressure, throat closure, or chest wheezing. Patient progressively improved as she stated dizziness and lightheadedness resolved at approximately 11:40 with 98% 02 and 100 pulse rate. At 1130 the blood pressure was improved at 110/72. Pt improved and was able to drink water and denied any further issues. patient was monitored for over an hour for additional side effects and/or symptoms.
patient got this vaccine 2 weeks ago and had wanted a flu shot but she was given another covid shot
Rash, fever, dystonia, nerve pain, headache, back pain, leg and arm numbness, muscle spasms, muscle pain.
Case number PHEH2014US003812 is an initial spontaneous report received from a consumer (parents) on 21 FEB 2014. This report refers to a 14 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: unknown), intramuscularly on an unknown date in JAN 2014. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
This spontaneous report as received from a physician via two company representatives refers to a female patient of unknown age. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M000592, route of administration reported as "intramuscular or subcutaneous injection", (dose, strength and expiry date were not reported). On an unknown date, the patient experienced "injection site swelling after being administered PNEUMOVAX 23". No treatment was given for the event. No lab diagnostics studies were performed. The outcome of injection site swelling was reported as recovered, on an unknown date. The patient sought medical attention by contacting doctor's office. The relatedness between the event and PNEUMOVAX 23 was not reported. The physician requested a lot check. Additional information has been requested.
feeling really crappy; This case was reported by a other health professional via other manufacturer and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The reporter was a pharmacy student. The patient had no medical history. The reporter contacted to inquire regarding the patient that had a bad reaction to the Shingrix vaccine and was wondering about if the patient could take COVID vaccine. The patient received Shingrix vaccine and reported feeling really crappy. The reporter consented to follow-up.
chills, t104.7 R MD dx febrile rxn to immun; pt taken to ER;
Inconsolable crying began at 7:30am on 3-22-07 and lasted at least 12 hours
Had immunization on 5/26/09, had episodic spells of rhythmic movements of arms and legs followed by lethargic episodes. Baby felt cold to mother during the night. No spells on 5/27/09. Again had seizure type symptoms on 5/28/09 in the afternoon - Mother reports  no fevers. Child was seen in clinic on 5/29/09 by Dr. Baby breastfeeds and takes some solids. No more seizures - since Thursday. Mother has seizure disorder and takes TOPAMAX. Dr. notified neurologist and was told if seizures last > 5 minutes parents should bring child to ER and EEG maybe needed.
Eye pain on the right side; Soreness in the armpit; Bad headache; Tired; Achy; Whole arm turned red/spread far on my whole arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), EYE PAIN (Eye pain on the right side), ERYTHEMA (Whole arm turned red/spread far on my whole arm), AXILLARY PAIN (Soreness in the armpit) and HEADACHE (Bad headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 044A21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS] and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced ERYTHEMA (Whole arm turned red/spread far on my whole arm). On 20-Nov-2021, the patient experienced PAIN (Achy) and FATIGUE (Tired). On 23-Nov-2021, the patient experienced HEADACHE (Bad headache). On 24-Nov-2021, the patient experienced EYE PAIN (Eye pain on the right side) and AXILLARY PAIN (Soreness in the armpit). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) for Headache, at a dose of 1 dosage form. At the time of the report, PAIN (Achy) and FATIGUE (Tired) had resolved, EYE PAIN (Eye pain on the right side) and AXILLARY PAIN (Soreness in the armpit) outcome was unknown, ERYTHEMA (Whole arm turned red/spread far on my whole arm) was resolving and HEADACHE (Bad headache) had not resolved.            The patient said they had a severe reaction. The patient received the Moderna COVID-19 booster vaccine on 19-Nov-2021. After receiving the vaccine, their whole arm turned red where they got the shot. The patient said it spread far on their whole arm and by 20-Nov-2021, Saturday they felt achy and tired. On 21-Nov/22-Nov-2021, it went back to normal. On 23-Nov-2021, the patient got a bad headache and took Motrin. On 24-Nov-2021, the patient woke up with a headache and characterized it as a headache with eye pain on the right side. The patient does have soreness in the armpit where they got the shot as well. Reportedly, the redness was going away and the was their main concern.   This case was linked to MOD-2021-396560, MOD-2021-395909 (Patient Link).
Friday 1/21: fatigue, weakness, brain fog. Difficulty completing everyday tasks.  Saturday 1/22: Weakness, fatigue, brain fog. Sunday 1/23: Weakness, brain fog, dizziness, high blood pressure (172/120), difficulty standing up, walking, talking, and using hands.  No treatment, no known cause
Experiencing burning in area where vaccine was given. Also experiencing burning in other areas of body i.e. knee, leg, arm.
Pt recvd Hep B vax & exp dizziness, malaise, diaphoresis & paresthesia; No further details were provided;
The client reported that her legs felt heavy at 4:52 PM. The client denied any itchiness, shortness of breath, or swelling. Vitals obtained at 4:53 PM were as follows: automatic BP 188/107, HR 74, O2 98%. Repeat manual BP obtained at 4:56 PM was 146/80. The client denied any current symptoms and stated her legs felt relaxed. Repeat vitals obtained at 5:01PM were as follows: BP 136/86, HR 72, O2 98%. The client denied any current symptoms. Repeat vitals obtained at 5:11 PM were as follows: BP 136/88, HR 71, O2 98%. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 5:21PM ambulating with a steady gait unassisted.
Pt received IDV, DTAP and MMRII on 7/22/16 frig temp were out of range. 33 degrees being the low. According to S.P. IPV was not stable. Pt will get IPV in Sept 2016 with Flu.
Client was given vaccinations on 5/3/06. On 5/15/06 she called and reported on 5/8/06 she became dizzy. On 5/9/06 she had tingling in her left hand going up to her head. She indicated that the use of her left hand was now greatly diminished.  She indicated she was seen by her physician and was told she had mercury poisioning.