chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sleepy; Sore arm; Feels achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Sore arm), PAIN (Feels achy) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Sore arm), PAIN (Feels achy) and FATIGUE (Tired). At the time of the report, SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Sore arm), PAIN (Feels achy) and FATIGUE (Tired) outcome was unknown.         Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.
adult dose of havrix was given to an 11 year old; adult dose of havrix was given to an 11 year old; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old female patient who received HAV (Havrix adult) (batch number J95H7, expiry date 31st May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the child patient received dose of Havrix adult which led to overdose and adult product administered to child. The nurse was wondering what adverse events or side effects they should be on the lookout for. The reporter consented to follow up.
6/23/09 0935 Upon rising client stated "feeling dizzy, laid client down B/P 108/80 P64, R14, skin w/d appropriate for race, c/o legs feeling week", able to lift leg up/down, move foot back/forth, able to feel sensation of touch upon lower extremeties bi-laterally, zero pain, denied problems breathing, A/O x3, client talking/laughing with siter, PEARLA intact, encouraged mom/client to follow-up with provider, client ambulated out of facility with steady gait.
pt recv vax & exp sleepiness & severe h/a some time p/vax;reporter suspected an encephalopathy;
05/28 Second dose of vaccine 06/01 Knee cramps and pain. 06/02 Acupuncture was performed, and the pain was no longer felt after acupuncture. But two hours later the knee continued to ache. He will recover in about two weeks.  06/16 I started to have a headache in the morning, and then my dizziness continued until now. The headaches had previously only occurred on the day of the second dose and the next day. Chiropractic, acupuncture, and massage have not worked. I'm waiting for an MRI.
3 hrs. after receiving 0.25mg Influenza IM patient vomited 3 times in 1 hr. Pt. was given sips of Pedialyte.
Patient recieved Flumist three days prior to being deployed. He developed headache, fever and chill and a target shaped rash on his thigh while in transit. He also developed Bells Palsy and elevated liver enzymes and was treated for Lyme Disease with doxycycline. He was also treated with steroids for the Bells Palsy. His symptoms resolved.  7/15/08 Reviewed medical records & vax records. FINAL DX: Lyme disease, Bell's palsy Records reveal patient experienced severe HA, pain w/rash to left inner thigh x 9 days, posterior neck pain, fever & chills.  Seen in ER on 10/23/2007.  Tick bite on left thigh previously.  Exam revealed blanching erythematous circular lesion medial left thigh.  Dx w/Lyme disese & tx w/antibiotics.  10/31/2007 w/fever, chills, myalgias, HA cough.  Noted Bell's palsy s/s x 1 day which worsened.  Tx w/steroids.  Seen 11/07 w/Bells's palsy unable to fully close left eye, left facial weakness.  Symptoms resolved & LFTs returned to WNL by 3/2008.
Patient experienced only chills; Fever; Soreness in her arms; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Patient experienced only chills), PYREXIA (Fever) and MYALGIA (Soreness in her arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (Patient experienced only chills), PYREXIA (Fever) and MYALGIA (Soreness in her arms). At the time of the report, CHILLS (Patient experienced only chills), PYREXIA (Fever) and MYALGIA (Soreness in her arms) had not resolved.            Patient states that she had extreme symptoms worse than when she had COVID-19 for 2 days after getting the first dose.  The action taken with response to the drug is not applicable.  No concomitant medication was reported.  It was not reported if the patient was received any corrective treatment for the event.   This case was linked to MOD-2021-030492 (Patient Link).
Injection site pain, inability to raise arm above shoulder height or lift more than 4 pounds or pull open a door or put on and off shirt without increase in pain and it has not gotten any better in the weeks that have followed. The pain and limited range of motion and use has not improved.
pt recv vax 6DEC96 & 6DEC96 pt exp edema of the lt arm;7DEC96 pt exp erythema of the lt arm & flu like sx;It was noted that the pt was afeb;
11/20/21-COVID-19 RESULT Detected Abnormal    Nothing else listed.
Initial unsolicited report received from non-healthcare professional (office staff) on 15 June 2015. Five patients (approximately) (age and gender not reported), whose medical history and concomitant medication were not reported, had received a dose of  PENTACEL (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. On unspecified date post-vaccination, the patients experienced red, swollen leg down to the ankle, reddish rash, the injection site seems to be very sensitive to the touch, and also the patients were incredibly irritable; more than usual. It was reported that, all the patients received Pentacel vaccine from the same lot number.  Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none. Follow up information received from a non-healthcare professional on 4 August 2015. Case is linked to case 2015SA117517, 2015SA117518, 2015SA117519 and 2015SA117520 (same reporter). Coding of event swollen leg down to the ankle was updated. Documents held by sender: none.
In March, 1999 and May, 1999, the vaccinee received her 1st and 2nd dose of Lymerix, respectively. Following the 2nd dose, the vaccinee experienced what she described as severe disabling joint pain all over her body. This pain then localized in her back, neck, knees, elbows, fingers and jaw. The pain tends to get progressively worse as the day goes on. When it is bad in her knees, she has difficulty walking by the end of the day. On days that the pain strikes her elbows, she had difficulty lifting by day's end. Due to the extreme fatigue she has experienced, she is forced to go to bed by 19:00. This case is considered serious because the events are disabling. As of 2/1/00, the outcome of the events is unknown.
Pt had mild chills and fever (starting 10/25/00 and resolving quickly). On 11/2/00, she developed body aches, fatigue and fever. By 11/5/00, a rash was spreading to most areas of her body. The fever and rash lasted approx. 1 week. Joint pain in knees and hands, started a few days before 11/3/00, which she continued to have. Other symptoms; cough, lasting 3-4 weeks, pain in ears, chest congestion and lymph node swelling.
Information has been received from a physician and the mother of a 24 month old female who was vaccinated with PEDVAXHIB (OMPC).  Subsequently the patient developed serum sickness, reportedly due to the administration.  At the time of the report, it was unknown, if the patient recovered.  Additional information has been requested.
Itching, no hives, no redness. She took BENADRYL (it helped some). Lasted 3 1/2 days.
Onset of deep, what feels like, bone pain 5 days post vaccination. I had regular muscle tenderness 1 day post vaccination, that only lasted 1 day, but this feels much different. Still experiencing this discomfort. No other injury that would have caused this pain.
Patient reports 7 weeks prior to her 1st dose of pfizer she received a cosmetic filler in her face. on 5/4 the location where the filler was placed began to swell to the size "of a ping pong ball." As of today (5/21) it has still not resolved. Patient is taking oral prednisone.
Patient became very lethargic, mucous membranes became pale (Lips and Conjunctiva of eyes)  color left her face, speech became slurred, eyes closed. Cold skin, pt reports feeling dizzy, light headed. Nauseous, tingling and numb sensation in the arms. Slow/shallow respirations.
tiredness/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness/fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (tiredness/fatigue). At the time of the report, FATIGUE (tiredness/fatigue) had not resolved.            No concomitant medications reported.  No treatment medications provided by the reporter.   Action taken with mRNA-1273 in response to event was not applicable.
She reported back to the pharmacy after receiving her vaccine stating that underneath her arm was itchy (approx. 10-15 mins post vaccination). She reported the itchiness to be under her left arm (closer to the armpit). She said the itchiness was no where near the actual injection site and it was only on the bottom half of the top part of her arm. She denied any other symptoms and I advised her to take Benadryl. She contacted her PCP office when she got home and the provider on call told her that she does not need to take Benadryl because she takes a maintenance allergy medication already. He told her to take the Benadryl only if the itchiness gets worse. I called her about 4 hours later and she said that about 90% of the itchiness has resolved. I called a second time 2-3 hours later to follow up again and she said she is completely fine.
Cough; Running nose; sore throat; Lots of phlegm; A lot of congestion; Sinus problem; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), COUGH (Cough), RHINORRHOEA (Running nose), OROPHARYNGEAL PAIN (sore throat) and PRODUCTIVE COUGH (Lots of phlegm) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Fever). On 27-Mar-2021, the patient experienced COUGH (Cough), RHINORRHOEA (Running nose), OROPHARYNGEAL PAIN (sore throat), PRODUCTIVE COUGH (Lots of phlegm), NASAL CONGESTION (A lot of congestion) and SINUSITIS (Sinus problem). At the time of the report, PYREXIA (Fever), COUGH (Cough), RHINORRHOEA (Running nose), OROPHARYNGEAL PAIN (sore throat), PRODUCTIVE COUGH (Lots of phlegm), NASAL CONGESTION (A lot of congestion) and SINUSITIS (Sinus problem) outcome was unknown. Not Provided          no concomitant medications are provided. treatment to the events not reported.   This case was linked to MOD-2021-089374 (Patient Link).
This spontaneous report was received from a physician via company representatives, and refers to a patient (encounter key# 3733771) of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 28-MAR-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" with lot number J009689 and expiration date of 28-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) degrees (15.5 Celsius) (highest recorded temperature) for a total of 888 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
I was doing light yard work in the sun, them in the 70s, became dizzy and could not stand, fell backward to the ground, tried to get up and became nauseated, had the dry heaves so I laid down on my side.  Every time I opened my eyes the area began spinning again.  I had a fever and sweated heavily for about 1 hour.  I took two aspirin with a glass of water.  I had a short nap, lying on the ground, when I woke up the fever was gone and I started having chills.  After about 30 min, my dizziness was less, but I still could not walk.  I started sitting up and scooting backward into the house, which took about 30 min to get into the house.   I  laid on the floor, was still having chills, so covered up with many blankets. About 8pm, 5 hours after first getting dizzy, the chills were gone and I was able to get up and get in bed.   About 10 pm I took 2 asprins and went to sleep.I had to get up
Rash to my trunk, back that is now spreading up my neck and to my shoulders and upper arms.  It is not raised, no papule, appears blanch able, itches off and on and irritated.  It was there when I woke up this morning and is worse this evening after work.  I have tried loratadine PO.
Within minutes following injection, pt began to complain of itching at injection site. Then developed erythema & edema. Reaction remained localized. BENADRYL administered. Symptoms subsided by following day, was able to resume normal activity.
Patient had redness and swelling around elbow area with red nodule on inside of elbow. She stated the area was feverish.
Dizziness, nausa, shakiness increasing since 4th dose of Imovax received 2/17/09. Recommended use of aspirin on regular basis.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date between 08-OCT-2016 and 11-OCT-2016, the patients were vaccinated with improperly stored unspecified dose of PNEUMOVAX23 (dosing details were not reported) (lot # M018766, expiry date: 15-OCT-2017 and lot # M032635, expiry date: 05-MAY-2018) for prophylaxis which was stored at temperature of 1 degree centigrade for 4 hours as worst. There were no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Lot number M032635 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent). On 30-NOV-2016, it was reported that a call was placed to the medical assistant, but he/she was unable to provide any further information. Additional information has been requested. Sender's Comments: US-009507513-1610USA005738: US-009507513-1610USA007903: MERCK 1610USA007902: Mfr number.
Approximately 4.5 hours after injection my upper body around my ribs and back felt as if there was a band tightening. There was a lot of stress and pressure and inflammation in my upper body especially near the base of my heart. My heart beat was rapid and I was short of breath. The event lasted approximately 25 minutes.
lost all feeling in my left hand; getting migraines 1-2x a week; more tired than I used to be; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5398, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 at 13:00 hours as dose 2, single (at the age of 41-years-old) for covid-19 immunisation at Clinic/ Administration facility. Medical history included ongoing migraine (got one every year or so), tired and known allergies to shellfish from an unknown date and unknown if ongoing. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications within 2 weeks of vaccination. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246, Expiration date and NDC number was not reported), via an unspecified route of administration, administered in left arm on 15Jan2021 at 13:00 hours as dose 1, single (at the age of 41-years-old) for covid-19 immunisation. Patient was not diagnosed with COVID-19, prior to vaccination. On 01Mar2021, since her second vaccine, patient had pain and stiffness in her left hand that feels like what she imagines was arthritis to feel like, getting migraines 1-2x a week (previously she got one every year or so), and she was more tired than she used to be. On Jun2021, when she flew via airplane, patient lost all feeling in her left hand and it had hurt much more since then. Patient considered all the events serious (disabling/incapacitating). Patient went to doctor or other healthcare professional office/clinic visit for disability or permanent damage. Patient had been tested for COVID-19 by nasal swab, Sofia Antigen on 12Jul2021 and result was negative. Therapeutic measures were taken as a result Imatrex for migraines Motrin for hand. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Red patch about 4 inches by 4 inches on upper left shoulder near injection site, and two or three  red dots in skin
Swelling at injection site with NO redness. Soreness at injection site. Weakness in injection arm (left).
This spontaneous report received from a patient concerned a 51 year old female. 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 not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced severe brown line in the white part of eye. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe brown line in the white part of eye, and the outcome of headache was not reported. This report was non-serious.
Information has been received from a consumer concerning an 84 year old female patient with arthritis and no known drug reactions or allergies who on 22-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665300/1314Y) injection instead of "flu shot". It was reported that the patient upper arm became red, hot and swollen on 23-SEP-2010. The patient did not seek medical attention. At the time of this report, the outcome of the patient was unknown. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got shingles from the shingles shot the next day after second dose. Additional Supportive Information: The follow up would not possible as no contact details were available.
This case was reported by a healthcare professional and described the occurrence of injection site rash in a "few" elderly subjects of unspecified gender, all greater than 65-years-old, who were vaccinated with Flulaval (GlaxoSmithKline).  In September 2007, the subjects received the first doses of Flulaval (.5 ml, unknown, administered in either the right or left arm).  The reporter indicated that the vaccines were administered with 5/8 inch needles (it was noted that the Center for Disease Control recommends 1 to 1.5 inch needles to prevent seepage into tissues).  At an unspecified time after vaccination with Flulaval, the subjects experienced rashes around the injection sites and/or injection site burning.  Those subject who contacted the medical office were instructed to apply cold compresses to the affected areas; the three or four subjects had not re-contacted the medical office at the time of this report.  At the time of reporting the events were resolved.
w/in 2 hrs of vax began high pitched screaming for +/- 10 hrs, t103; spoke w/MD was given Ibuprofen but was not seen;