chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a multiple unspecified number of patients of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reported stated that improperly stored doses of PNEUMOVAX 23, lot number M029680, expiration date 17-JAN-2018 (dose, route, and anatomical location were not reported), were administered to the multiple unspecified number of patients on unspecified dates, for prophylaxis. The vaccines were exposed to a range of temperature of more than 8 degrees Celsius but less than 25 degrees Celsius for 1 hour and 30 minutes due to a data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007056: US-009507513-1702USA001638:
The patient came into the pharmacy 1/22/18 saying he has a rash on his arm from the shot. He lifted his sleeve and there was a red, warm cellulitis reaction starting approximately 1 inch below injection site, travelling all the way down his arm to the elbow. He said it didn't hurt so he wasn't worried about it. I encouraged him to call and follow up with his doctor.
I had a small stroke 7 days after the vaccine. They did a million tests and found no cause other than the vaccine time correlation...I?m a healthy 32 year old.
After receiving the 2nd dose she had a sore arm. When she caught covid she had cold like symptoms. She had a very low fever, runny nose, and a little bit of a cough. She said her smell was a little off as well. During coivd she had a flare up of bacterial vaginosis. She was prescribed metronidazole for it.
About 2:30am the next morning after the vaccine I was woken up to a slight painful tightness in my chest I went to Care Urgent but nothing was done and I was released.  This persisted for about 8hrs and finally went away.  My shoulder joint was painful  the next day which caused me to have to use a heating pad for about a day or so and my arm at the injection site was sore for a few days also.
Pt dx with cellulitis to right upper arm. Pt hospitalized. 8/2/07-records received for DOS 7/18-7/23/07- DX: Right arm cellulitis. C/O fever, chills, temp 103.1. Erythema, induration at injection site.
Child had extensive erythema right thigh/ increased warmth/ induration around 36 hours after DTAP injection. No alteration of consciousness. No fever. Parents very upset.
fever and vomiting 1 day after, then 2 days later with tingling/numbness of both hands, resolved within 24 hours.
A 34 year old, male patient (with a history of having many flu vaccine dose in the past) developed a "black ring around the needle injection site" immediately after he received an intramuscular, injection of Fluzone (lot number U2195AA) in the right deltoid on 03 November 2006. The RN who administered the vaccine reported seeing the adverse event. The patient had no pain. The nurse reported there was no sign of the "black dot" several hours later. One type of syringe, a B-D Safety Glide syringe, was used with a B-D 23 Gauge (lot number 604873) needle. Abco alcohol swipes out of "Mashbills, TW" were used. It was not known if the black marks appeared mostly at the first or second dose of the vial or more towards the end of the vial. It was not known low long the mark lasted. This has not been seen with any other product vial. There were 4 RN's vaccinating. This has not happened in the past years. Out of 50-60 doses given, she has een this 10-15 times. The patient were unaware, with no complaints. Follow-up information received on 05 February 2007. The reporter was not sure if the black mark occurred with the first or later doses. The black mark would go away after a few hours. No other known event occurred.
PATIENT CAME TO THE PHARMACY TODAY 9-19-22 AND WANTED US TO REPORT THAT SHE HAD ABOUT 20 OR SO NOSEBLEEDS AFTER HAVING THESE VACCINATIONS THE NEXT DAY. SHE SAID SHE NEVER HAS NOSEBLEEDS AND HER DOCTOR COULDN'T REPORT IT.
Sore arm for 3 weeks, hot to touch during that time, painful, red for 1 week, difficult lift arm at times
Fever, chills, body aches, arm soreness, headache less than 24 hours after injection lasted 3 days. The rash presented 3 days after injection. Warm to touch. Red, lumpy itches slightly, arm is still somewhat sore.
Patient reports following his 2nd moderna vaccination he about 1 week later experienced facial paralysis, went to ER and they informed he had a Bell's Palsy. Patient is unsure if related to vaccine, has not had prior Bell's Palsy
Dizziness after 12 hours, nausea day 2, diarrhea day 3 and excessive gas day 4.
Tingling whole left leg after first shot; Numb whole left leg  after first shot; Light flashing vision after first shot; Headache on & off after first shot; Left arm hurt after first shot; Pain in the lymph node left armpit after first shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (Tingling whole left leg after first shot), HYPOAESTHESIA (Numb whole left leg  after first shot), PHOTOPSIA (Light flashing vision after first shot), HEADACHE (Headache on & off after first shot) and VACCINATION SITE PAIN (Left arm hurt after first shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PARAESTHESIA (Tingling whole left leg after first shot), HYPOAESTHESIA (Numb whole left leg  after first shot), PHOTOPSIA (Light flashing vision after first shot), HEADACHE (Headache on & off after first shot), VACCINATION SITE PAIN (Left arm hurt after first shot) and LYMPH NODE PAIN (Pain in the lymph node left armpit after first shot). On 03-Apr-2021, PARAESTHESIA (Tingling whole left leg after first shot), HYPOAESTHESIA (Numb whole left leg  after first shot), PHOTOPSIA (Light flashing vision after first shot), HEADACHE (Headache on & off after first shot), VACCINATION SITE PAIN (Left arm hurt after first shot) and LYMPH NODE PAIN (Pain in the lymph node left armpit after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter.   This case was linked to MOD-2021-413029 (Patient Link).
After booster shot on 12/27/2021, patient reported "heart palpitations and increasing size in my lymph nodes in my armpit, elbow, and left breast. The injection site(left deltoid) is also warm, red, and swollen to the touch. The size in pain in my lymph nodes on the left side have gotten so bad I have limited mobility in that arm. The pain in my left breast wakes me up at night" that "seem to be increasingly worse with each vaccine [she] has received" and "had similar side effects after [her] second dose as well" which was on 2/4/2021
Pt. was diagnosed w/ shingles 3 days after receiving ZOSTAVAX.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX. On 24th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional information was received as follows: This case was not previously reported to anyone. The patient received the vaccine on the left arm. The patient experienced consistent arm pain for 1-2 days after receiving the SHINGRIX vaccination. The arm pain was resolving and at the reporting time he experienced intermittent arm pain. The arm pain did not occur every day. The patient had denied permission to contact their physician. The reporter did not want to be contacted regarding this adverse event. The reporter did not provide his birth date.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Tachycardia-Mild, Additional Details: EMT was called.
Fever, chills, fatigue, loss of appetite, swollen lymph node in left armpit, sore arm at injection site. Fatigue lasting 3 days, headaches lasting 4 days, extremely thirsty, nauseous
Swelling - Erythema - Hyperthermia extending from shoulder and midway down arm.
Severe muscle pain; This spontaneous case was reported by a non-health professional and describes the occurrence of MYALGIA (Severe muscle pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (Severe muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (Severe muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received her first shot of the Moderna COVID-19 vaccine on 10March2021 and their second shot on 28April2021 and ever since have been experiencing severe muscle pain.  The pain is not going away.  Patient is not on any concomitant medication.  Treatment taken include Tylenol for severe muscle pain
Numbness/tingling feeling in hands, legs, and arms, headaches. Healthcare provider diagnosed symptoms as a panic attack.
Information has been received from a health professional concerning a 59 year old female patient with seasonal allergies and a history of nicotine dependence who on 06-NOV-2007, was vaccinated IM into the left arm with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot# 655501/1035F). Concomitant therapy included influenza virus vaccine (unspecified) also administered into the left arm, triamcinolone acetonide (NASACORT AQ) and varenicline tartrate (CHANTIX). The next morning (reported as 06-NOV-2007), the patient experienced severe pain at the injection site, overall body aches and swollen glands. The patient was treated with acetaminophen (+) hydrocodone bitartrate (LORTAB) and cool compresses to the sites. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chickenpox and sore throat. The pts sibling had a similar reaction.
(R) parotitis. No fever, no rash. Presented with enlargement (R) cheek on exam. No enlargement at (R) parotid gland area.
This spontaneous report was received from a pharmacist referring to a 66 year old female patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # N003993 with expiration date 20-OCT-2018, intramuscularly in the left deltoid, for prophylaxis (dose was not reported). On 28-FEB-2018, the patient experienced tingling in her left arm down to her fingertips. No treatment was given for the event and no laboratory/diagnostic tests were performed. At the time of reporting, the outcome of paraesthesia was reported as not recovered. The causality assessment between paraesthesia and PNEUMOVAX 23 was not reported.
projectile vomiting, aches all over, chills, head cold, cough, fever
PSYCHOLOGICALLY UNPLEASANT, PANIC, FEAR AND SUICIDAL THOUGHT.
Tongue swelling and tingling- first noticed at 6 am upon waking up .  Called employee health around 11am, instructed to go to ER.  Went , received steroid treatment around 12:45 pm , returned to work.  Received  a 5 day dose pak to take at home
Besides achy joints and an achy arm at the injection site the next morning, the most concerning  problem began about 33 hours after the booster shot was administered. During intercourse, just before the moment of climax, a sudden, throbbing headache began in my left temple and travelled up to the top of my head.  I had not experienced this before the booster shot. It happened again day 3 and day 7, each time just before the moment of climax. There were no other sexual encounters where a headache did not happen. On day 4, I experienced a headache while passenger on a motorcycle rideBesides achy joints and an achy arm at the injection site the next morning, the most concerning  problem began about 33 hours after the booster shot was administered. During intercourse, just before the moment of climax, a sudden, throbbing headache began in my left temple and travelled up to the top of my head.  I had not experienced this before the booster shot. It happened again day 3 and day 7 (with fast heartbeat lasting an hour), each time just before the moment of climax. There were no other sexual encounters where a headache did not happen. On day 4, I experienced a headache while passenger on a motorcycle ride and then a sudden ,throbbing headache in the left temple as I climbed my stairs to the 2nd floor. On the 8th day, I experienced a burning sensation from temple to temple across my scalp, fast heartbeat, numb tongue, and nausea, all new symptoms. I went to the E.R. and had a CT Scan, EKG, and MRI, all normal.
About 5 minutes after getting the shot I had a strong metallic taste in my mouth and some lightheadedness. It only lasted a minute or two. Later that day I felt off as if I was coming down with something. During the night I developed a high fever of 101.5 , extreme sweats, extreme muscle aches and chills, brain fog and exhaustion. A slight headache, and achy arm.  That evening 4/7/21 I had an episode of vertigo while sitting in bed getting ready for sleep. Everything spun and I fell backwards. The fever sweats and chills lasted about 24 hours. The aches, pains, and brain fog lasted about 3 days. The vertigo episodes happened about 2-4 times a day for 3 or 4 days. After the original 4 days I still experience 2-4 episodes of lightheaded/ dizziness per day (but not severe spins). I have also felt some sporadic tingling in my head and hands since getting the dose. I am still fighting periods of extreme exhaustion and some brain fog off and on. It has been 11 days since my second vaccine dose.
next day I had the chills no fever, major headache, I ached all over no one could even touch me... I week later I had a possiable heart attack...went to the doctor. had to wait till 4-14- to see a cardio doctor was advised not to get the 2nd shot
PATIENT RECEIVED A SECOND DOSE OF FLUZONE HD WITHIN A YEAR DUE TO MISCOMMUNICATION FROM PATIENT TO STAFF DESPITE MULTIPLE ATTEMPT TO VERIFY THE VACCINE THE PATIENT WANTS THAT DAY. UPON CLARIFICATION AFTER ADMINISTRATION AND PATIENT ALREADY WENT HOME, PATIENT ORIGINALLY WANTED A COVID BOOSTER SHOT BUT FAILED TO COMMUNICATE IT CLEARLY WHEN ASKED BY PHARMACY STAFF. THE MEDICATION ERROR WAS DISCOVERED UPON THIRD-PARTY REJECTION FROM INSURANCE PLAN SAYING THAT THE PATIENT GOT A DOSE OF FLUZONE HD ALREADY ONE MONTH PRIOR. PATIENT WAS CONTACTED AND THE ISSUE WAS REVIEWED WITH THE PATIENT. PATIENT IS AWARE OF THE ERROR AND REPORTS NO ADVERSE EFFECTS THUS FAR. PATIENT AND PATIENT'S FAMILY MEMBER ARE AWARE OF THE MEDICATION ERROR.
Idiopathic intracranial hypertension (IIH)  Tingling in arm, face, legs Low heart rate Pain in joints, hands toes, knees
Itching, redness, hot, and sore to touch around site of injection on upper left arm. Intensified later in day, sought med. care. Diagnosis: cellulitis. Red spot now swollen, hard and 3 in. in diameter. CBC and blood cultures were taken at dr. office. Began Keflex 500 mg. twice a day for 7 days. First dose: 8:00PM on 3/6 and used hot compress as directed by dr. office.  3/7-general body aches and malaise. No fever.  3/8, advised by internist to go to urgent care. Red/purple spot now 6 in. in diameter Diagnosis: more likely to be allergic reaction to vaccine. Given 60 mg. Prednisone by mouth in office, directed to continue Keflex, and take 50 mg. Benadryl every 6 hrs. through 3/9. Use cold compress.  Red/purple itchy spot reduced in size by 3/11 but reaction still visable and itching.
Patient was dx'd with covid on 7/31/2021. She was short of breathe, weak, dehydrated, developed a cough.
positive for a week almost 10 days now; positive for a week almost 10 days now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for a week almost 10 days now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: i am positive for a week almost 10 days now. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was on paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
redness at injection site; tenderness at injection site; mild headache; mild nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA, VACCINATION SITE PAIN, HEADACHE, and NAUSEA in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D3 and MAGNESIUM for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA, VACCINATION SITE PAIN, HEADACHE, and NAUSEA. On 28-Apr-2021, VACCINATION SITE ERYTHEMA and VACCINATION SITE PAIN had resolved. At the time of the report, HEADACHE had not resolved and NAUSEA had resolved. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No laboratory data was provided. No treatment information was provided.   This case was linked to MOD21-084080. Sender's Comments:  MOD21-084080.
Topic: Acute Illness >> Mar 15, 2021  8:16 AM  Reporter wrote: PCP    Does the pt have current symptoms of illness? Yes  Date symptoms started: over the weekend   1.    Does the patient have a fever (subjective or confirmed)? Yes, between 100 and 100.6 2.    Does the patient have a new onset of cough? Yes 3.    Does the patient have a new onset of shortness of breath? No 4.    Additional symptoms: body aches, fatigue   The pt received the first dose of the COVID-19 vaccine on 3/6/2021.  The pt inquired whether the pt's wife should also be tested.  The pt's wife is a pt of the practice.  The pt's wife only has a slight cough.  The pt is currently receiving treatments for prostate cancer.
High fever,dizzy,wheezing,shortness of breath,hives,hoarseness,pounding heart,and I was in the hospital from the 18th. thru the 20th.
pt recvd vax c/o nausea, appeared pale, body rigid w/eyes rolled back; pt lost consciousness for approx 15 seconds; VS stable; pt became alert & responsive w/o treatment;
Approx 4 hours after having the shot BOTH times; 1st time ache all over, bad headache; no appetite, very weak...stayed in bed for approx 30 hours 2nd dosage:  approx 4 hours after shot; bad headache, no appetite, very weak  lasted longer still in bed on following Sunday 2/28 (shot on 2/25) headache would come and go; was told to make sure someone stayed with me since I had had reaction with first shot and warned me thatif I had reaction to 1 would have for 2nd...No one to stay
ingredient in the vaccine is making her knees feel better; sore arm; This is a spontaneous report from a contactable consumer or other non hcp. An 81-year-old female patient received an unknown dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Jun2021 (at age of 81-year-old) as single dose for COVID-19 immunization. The patient medical history included "she has been having problem with her knees for quite some time". The patients concomitant medications were not reported. The patient mentioned that she has lots of medical problems and is taking lots of medication but still decided to get the vaccine yesterday. She experienced a sore arm, but so far feels okay. She has also stated that she has been having problem with her knees for quite some time. She wants to know what ingredient in the vaccine is making her knees feel better or is it just a combination of other factors. She said that "Everyone who gets the vaccine is a guinea pig. As a guinea pig, I want to know and that her physician probably did not know any of the ingredients of the vaccine". The outcome of events was unknown.  Information on the lot/batch number has been requested.
12-22-09 Complained arm left deltoid pain and bump. 12-24-09 Vomit and abdominal pain. ER visit 12/24/09. IVF and IV pain med. 1-17-10 Vomit and abdominal pain.
Patient came to pharmacy to get their second dose of Pfizer covid vaccine. They were asked how the first dose went and the patient stated "it was fine, just a sore arm, but I am nervous about the second dose." They were asked if they had any questions about the second dose and responded no. Patient tensed up when given the injection in their left deltoid muscle but was fine immediately after the injection. Patient was instructed to sit in covid vaccine recovery area for 15 minutes after the dose. A couple minutes later, technican said that patient was seizing, so pharmacist went to check on patient. Patient was on floor at the time, with legs straight out, but left arm and waterbottle curved underneath her torso. She was lying on her right ear and their was a noticeable "goose egg" on her forehead (Larger than a quarter). Patient was initially unresponsive the first couple of seconds, but quickly responded and could speak to us. She kept saying her head hurt, but she said her arm was okay (we asked since it was convoluted at a weird angle) and her neck or back didn't hurt (didn't seem like any spinal damage,etc, so she could move). Her mother, who was in wine& spirits I believe (right next to pharmacy), came over within 30 seconds and started stroking her back and thought she would be okay, that she just kept complaining of her head hurting. By this time, a member of management came and had called 911. She didn't want to move and was both scared and crying. We kept telling her to take deep breaths, that she is okay and not bothering anyone, we just want to make sure she is okay. She started to calm down but kept saying her head hurt, but not mentioning any other symptoms. The ambulance arrived to evaluate her head injury afterwards and she was able to stand and walk to her car with her mom with their assistance.