chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I just got progressively tired; Headache a still a bit. It is still affecting my eyesight; Headache a still a bit. It is still affecting my eyesight; Injection site is very sore; I am freezing, I have the chills on badly.; Fever over 100; Severe muscle aches; Pains in my joint; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on 20Mar2021 (age at vaccination: 68 years), as a dose 1, single for COVID-19 immunization. The patient's medical history includes asthma (Start: Unspecified Stop: Unspecified). The patient concomitant medications include levothyroxine sodium (Synthroid) (Start: Unspecified Stop: Unspecified), montelukast sodium (singulair) for asthma (Start: Unspecified Stop: Unspecified), pitavastatin calcium (livalo) (Start: Unspecified Stop: Unspecified). On an unspecified date in Mar2021, later in the night, the patient got severe headache, chills and the patent have fever over 100. Reportedly the patient muscles and joints ache like crazy and her headache was so bad, it was affecting patient eyesight. Reportedly the patient felt tired when they gave her injection. The patient was fine yesterday. It was reported that 3 hours afterwards the patient walked out of there at 10:45. The patient stayed there for 15 minutes and then just got progressively tired, and at about 7 O'clock late night, I started getting the chills. the patient was freezing and cannot get warm. Reportedly the patient was freezing and have the chills on badly. Patient heated blanket around her. The injection site was very sore. It was reported that the patient had a Covid-19 first dose yesterday. The patient did not receive the treatment because the patient was told to not take any kind of Aspirin or Ibuprofen because it has an adverse effect on the needle and the patient dont not know what to do. That why the patient was calling. Outcome of the event was unknown.  No follow-up attempts are possible. information about batch/ lot number cannot be obtained.
A report from health professional via medical rep concerns a 3 year old, male patient. No information regarding relevant history, concomitant disease and concomitant medications was provided. The patient was administered FLUMIST Quadrivalent (intranasal), 0.2mL on 01-Oct-2015. The patient experienced a bloody nose after the administration. As treatment the staff applied pressure to his nose and the event resolved. The patient recovered from bloody nose on 01-Oct-2015. The company physician assessed bloody nose to be non serious.
I felt awful for 2 -3 days after the second vaccine shot (weak, muscle fatigue, joint pains, nausea, cold sweats, racing heartbeat, just overall exhaustion). I felt a little bit better day 4 and went back to my normal activities, but then felt awful again on Monday. I have had some "good days" where I just feel weak and tired, but other days are worse and I have to stay in bed from weakness.
4/10/21 around 11:00am onset of body/joint aches, chills , headache. Fever 103 at 1700. 4/11/21 continued aches, migraine like headache, stated she didn't feel well and husband witnessed her pass out and "slumped over" on dining table. States she "came to" within a minute. Since then has continued to have daily migraines with associated nausea.
This spontaneous report as received from a physician and from a support services director via two company representatives refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 09-JAN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II injection (lot# J003625, expiry date 22-MAR-2015, albumin status HSA; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified) concerning a refrigerator. The excursion lasted for 48 hours with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator and/or in the freezer. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse practitioner concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot# unknown) injection. The nurse practitioner reported that on an unspecified date the patient developed total body hives after receiving a dose of Gardasil. Medical attention was sought. The patient was put on a high dose of steroids (unspecified therapy) to decrease the inflammation of the hives. The outcome of the hives was not reported. No further adverse event information. Additional information has been requested.
GARDASIL admin. 2/12/18 (L) arm. Day 1 pain. Day 2-4 large local rash plum size photo taken. Not reported until 4/12/18. Declined 2nd due to rash after first injection.
Area 3"x2" at injection site, red, swollen, itchy, moderately painful.
throat and face swelling, headache rate 10/10, nausea, vomiting and diaphoretic-Was seen in the emergency room and was given Toradol, Benedryl, Pepcid
Two days after dose 4 I started having pain and tingling from shoulders, upper back and neck.  It would subside and then flare up again. When it flared up it was brutal. On my right should I am still having tingling and weakness. I did see the orthopedic surgeon and he did me a cortisone shot if not better in the next week I will be seeing him again.
Sore knots in left supraclavicular region-possibly/probably lymph nodes Began Tuesday following injection (12/7) and have continued to current date (12/10).  Knots not present in right supraclavicular region
15 hours after vaccine had severe chills, 101.2 fever, pounding headache. Lasted for about 5 hours severely, then off & on for the next 11 hours. Experienced extreme fatigue.
Patient received the Covid-19 vaccine. She reports symptoms of dizziness, high heart rate, sweaty.  1145:  Patient states she feels like she has a sensation of swelling, itchy legs.  Patient is requesting Benadryl.   1147 Benadryl 25mg given by RN.  Phone call made to patient's son to come to the clinic to accompany patient home.   1217  Patient states she feels much better, slight dizziness.   1244  Patient's son arrived.  Patient states she feels better and wanted to walk herself out of the clinic.  Patient will contact her PCP if she has anymore questions or concerns.     Vitals taken: 1135:  158/98 120 96% RA 16R 1142:  162/98 110  99% 2L 18R 1152:  160/92  83  98% 2L 18R 1244:  150/80  108  98% RA 18R Treatment/intervention patient was given:  25mg Benadryl PO
The day after flu shot was given, I had dry heaves, severe migraine that lasted all day and into the evening.  That afternoon went to ER.  Was given Toradol injection for headache which took an hour or so before the headache started to get better.
Nurse did hit a capillary and I bled immediately after injection- enough where it ran down my arm and went onto floor. I felt pretty okay except for the feeling of my arm hot and fuzzy and fuzzy fingers on my left hand until my "leave time' of 10:03 am. I stayed a little longer, and was home by 10:30 when I became extremely nauseous, dry heaving, left side of face numb. Headache started at 10:40. Tried calling medical facility but was on hold for soo long- no one answered so since I don't have insurance I decided to just rest and drink fluids. By 11:40 my face was back to normal, no longer nauseous but extremely lethargic and was the rest of the day. The following day I felt ok -slight swelling on my arm at injection site and a bruise that I still have.
Approx 1 min post vaccine given little white splotches appeared the skin became pink then red and traveled down legs turning purpleinto both feet. Pt crying and wouldn't stop. Provider called into room. Benadryl ordered and given. Color returned to normal. Pt stopped crying. No resp distress ntoed.
Reporting varicella with many lesions and in the eye; is to see ophthamologist. Placed on Zovirax 800mg qid X 5 days. Under present care. (2nd Varivax given on 4/24/98; lot 1578E/SC/Deltoid)
fever of 101 degrees Fahrenheit; she felt bad and exhausted; she felt bad and exhausted; she slept for 18 hours; her legs are really weak; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101 degrees Fahrenheit), MALAISE (she felt bad and exhausted), FATIGUE (she felt bad and exhausted), HYPERSOMNIA (she slept for 18 hours) and MUSCULAR WEAKNESS (her legs are really weak) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 antibody test positive (Treated with Remdesivir.) on 05-Feb-2021 and Weakness generalised.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (fever of 101 degrees Fahrenheit), MALAISE (she felt bad and exhausted), FATIGUE (she felt bad and exhausted), HYPERSOMNIA (she slept for 18 hours) and MUSCULAR WEAKNESS (her legs are really weak). The patient was treated with REMDESIVIR at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 101 degrees Fahrenheit), MALAISE (she felt bad and exhausted), FATIGUE (she felt bad and exhausted), HYPERSOMNIA (she slept for 18 hours) and MUSCULAR WEAKNESS (her legs are really weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were included.
The patient reports that he has been experiencing pain of the left shoulder which radiates to the left elbow, provoked by movement of the left shoulder and left upper extremity, especially with shoulder abduction. He is not able to qualify the pain when asked. He states that symptoms began 8 days after he received a second dose of the Moderna COVID-19 vaccine, which was administered into the left upper extremity. He states that it is difficult to abduct the left upper extremity due to exacerbation of pain, but he denies any actual weakness, numbness, or paresthesias of the left upper extremity.
Seen for check-up in office on (F) 6/27/14. Rec'd 4 mo immunizations. Mom reports s/s reaction began 6/28/14 and include: Edema, erythema, warmth and induration at site on (RT) thigh. Seen for s/s on 6/30/14 and tx'd with KEFLEX (250/5) - SIG: 1/2 tsp po BID x 10 days.
patient received the Moderna Covid 19 vaccine on 1/23/2021 around 5:45pm  wife called management today and reported that he had collapsed and passed away today around noon
pt recv vax 14JUN94 & same day pt was irritable & felt feverish; 15JUN94 0300hr cont to cry since 2000 hr on 14JUN95; pt would scream, as if in pain; only breast feed for brief periods of time,t105.6, fussy/agitated/crying, full fontanelle
Pt went to ED for urticaria rash to chest, back, and face.  Given IV fluids Benadryl 12.5mg, Pepcid 10mh, and solumedrol 30mg IV.  Transferred to Hospital at 5:33 PM via ambulance per ED doctor.
INJECTION SITE PAIN - DELTOID (UNKNOWN IF IT WAS RIGHT OR LEFT SIDE); MILD FEVER; This spontaneous report received from a patient via a company representative concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the patient experienced injection site pain - deltoid (unknown if it was right or left side). On MAR-2021, the patient experienced mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain - deltoid (unknown if it was right or left side), and mild fever. This report was non-serious.
After years of remission from RA, recurrence of disease which has become highly active and has been difficult to get under control even with prednisone and now adalimumab.
August 29, 2021 patient with NO HISTORY OF SEIZURES had a seizure in the Emergency Room of Hospital.  Patient was treated with Keppra for seizure.  On August 31, 2021 patient had another seizure and died.
My feet went nub 40 minutes after and then it became progressively worse over the next 10 days. I went to the Dr. to find out what was wrong and they did some tests. I ended up going to the Neurologist who performed some tests that shows that my muscles were working but not my nerves. My legs are still experiencing issues (stairs are super hard and almost impossible, walking a quarter mile is still difficult because I become extremely exhausted which is not normal for me, and your left leg has to be dragged because it gets tired. I'm still dealing with the issues caused by the Moderna vaccine (working with a Neurologist on a continual basis).
This case is linked to case number 2013-08216 (same reporter and same product for different patient). Initial report received from a healthcare professional on 30 July 2013. A male patient, whose medical history and concomitant medications were not reported, had received pre-exposure Rabies vaccine series with IMOVAX Rabies vaccine (lot number: D1101 for 2 doses and lot number B0292 (lot not valid) for 1 dose, (dose number, route and anatomical site of administration not reported), June 2010 date not specified. On an unspecified date of July 2013, the patient had undergone titer level test and was found titers less than 0.1. Other laboratory details and corrective treatments were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second day: 101 fever, chills, terrible fatigue and a red rash over entire body.
Pt. called to report injection site pain, swelling and redness apx 3 " diameter. Complained of "temp" unknown reading x 2 days. Improved by 11-7-11 down to quarter sized area of swelling and redness.
pain in all bones jaw, neck, shoulders, hips and feet; arm inflammation; sluggish/ could not get out of bed; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd September 2021, 8 hrs after receiving Shingrix, the patient experienced fever and sluggishness. On 24th September 2021, the patient experienced inflammation localized. On 27th September 2021, the patient experienced bone pain. The patient was treated with paracetamol (Tylenol). On 25th September 2021, the outcome of the fever, inflammation localized and sluggishness were recovered/resolved. On an unknown date, the outcome of the bone pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, sluggishness and bone pain to be related to Shingrix. The reporter considered the inflammation localized to be related to Shingrix.  Additional details provided were as follows: The case was reported by the patient. The patient received her 2nd dose of Shingrix vaccine on her left arm, that night she had a high fever that resolved on 25th September 2021, in the morning.  The patient felt sluggish from 23rd September 2021 and was resolved on 25th September 2021.  On 24th September 2021, 1 day after vaccination, the patient's left arm was inflamed and resolved on 25th September 2021.  On 27th September 2021, 4 days after vaccination, upon rising, she had pain in all her bones including her jaw, neck, shoulders, hips and feet.  On a pain scale she was at an 8 or 9.  The patient could not get out of bed.  The patient went to her health care professional (HCP) on 19th October 2021 because her bones were still painful.  The took bloodwork and urinalysis and it showed inflammation.  HCP felt the inflammation was from the Shingrix vaccine and that the caller should report it to the company.  HCP advised her to take Tylenol for pain.  The pain was getting better, pain scale at a 5 or 6 now, but not resolved. The reporter did not consent to follow-up also did not give permission to contact HCP.
Rash at injection site, severe itching, mild pain, swelling of arm and hard round area within muscle
Felt tired; Twitches and crumples in shoulder, twitches and crumples below scapula, now it's in her leg and stuff; it got worst and it's scaring me; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (Twitches and crumples in shoulder, twitches and crumples below scapula, now it's in her leg and stuff), CONDITION AGGRAVATED (it got worst and it's scaring me) and FATIGUE (Felt tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 042L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Erythromycin), Drug allergy (Sulfa) and Dry eye. Concomitant products included VITAMINS NOS for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced MUSCLE TWITCHING (Twitches and crumples in shoulder, twitches and crumples below scapula, now it's in her leg and stuff) and CONDITION AGGRAVATED (it got worst and it's scaring me). On an unknown date, the patient experienced FATIGUE (Felt tired). At the time of the report, MUSCLE TWITCHING (Twitches and crumples in shoulder, twitches and crumples below scapula, now it's in her leg and stuff) and CONDITION AGGRAVATED (it got worst and it's scaring me) had not resolved and FATIGUE (Felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood work all fine.         Patient have allergies to Avalak. Other concomitant medication included Eye drugs for dry eye.  Bood work all fine, no other symptoms than cramping and twitching. No treatment medication was reported.   This case was linked to MOD-2022-650931 (Patient Link).
SWEATING; OTHER SYMPTOMS; CHILLS; FEVER; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not allergic to the J&J Vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sweating, other symptoms, chills, fever, and severe headache. Laboratory data (dates unspecified) included: Lab test (NR: not provided) No sinus blood clots were found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, other symptoms, chills, fever, and severe headache. This report was non-serious. This case, from the same reporter is linked to 20210950596 and 20210949900.
Case number PHEH2015US026905, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 22 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there had not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Patient had severe muscle pain in the injection arm.  Was unable to move the arm. Patient saw physician who prescribe anti-inflammatory medication.  As of 10/28/11 still has some tenderness at injection site.
My daughter received 2 vaccines on 9/16, MMR and Varicella, and 2 more vaccines on 9/20 Tdap and Polio. On 9/23 she began developing several pimple-like bumps on her body. For the next 3 days more bumps were forming. On 9/25 she developed a fever of 103 and headache. The next day 9/26 a rash developed on many parts of her body, and a few round bruises formed on her skin. I took her to the ER that night, bloodwork was performed. Doctor stated all was normal, besides a fever and rash. The next morning most of her body was covered in hives. I took her to a pediatric urgent care, doctor confirmed some pox spots and rash and hives. Stated that it appears to be a vaccine reaction.
Pain spreading to back left shoulder, down the left arm, and left side of torso. Very Painful ache for 24 hours. Some improvement with movement.  Continued pain, especially at night, gradually improving after  5 days.   Range of motion in left shoulder  limited for first 3 days of symptoms.  Also, left breast tenderness for the 5 days.
This case was received from Pfizer, Inc (manufacturer report# 2016505408) on 14-NOV-2016. Information had been received from a nurse who was reporting on two patients who received the PREVNAR 13 shot and experienced severe arm pain. One of the patients was given prednisone and her arm pain had resolved (see MARRS# 1612USA004838). The other patient who received the PREVNAR 13 on 01-JUN-2016 has continued arm pain with limited mobility of that arm. The reporter clarified that the patients received PNEUMOVAX23. On 01-JUN-2016, a 68 year old female patient with arthritis and vitamin D deficiency received PNEUMOVAX23 (lot# L019836, expiration date 24-MAR-2017) 0.5 ml injected in right deltoid as preventative for pneumonia. On 27-APR-2016, patient had received Tdap vaccination in left deltoid. Concomitant medications included TOULEO 30 units at bedtime injected subcutaneously for diabetes (October 2015 - ongoing), metformin 1 gram twice daily for diabetes (start date unknown - ongoing) and losartan 50mg once daily for blood pressure high (start date unknown - ongoing). In August 2016, patient came to the doctor's office and reported that she has had arm pain since she received the PNEUMOVAX23 and it rated a 10/10 on the pain scale. The arm pain and limited mobility of the arm started right after receiving PNEUMOVAX23 on 01-JUN-2016. Patient also came back to the doctor's office in October 2016 and on 25-OCT-2016 to have a Duplex performed to check for blood clots because of the pain and swelling in her arm, but it came back normal. Onset of swelling arm was unknown. The outcome of severe arm pain, swelling arm and limited mobility of arm was reported as persisting. This is one of two reports from the same reporter. Additional information has been requested.