chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches and pains; cramps to her earlobes; inability to touch her head due to sensitivity; "it was bad!"; headache; muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches and pains), MUSCLE SPASMS (cramps to her earlobes), HYPERAESTHESIA (inability to touch her head due to sensitivity), FEELING ABNORMAL ("it was bad!") and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (body aches and pains), MUSCLE SPASMS (cramps to her earlobes), HYPERAESTHESIA (inability to touch her head due to sensitivity), FEELING ABNORMAL ("it was bad!"), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 25-Mar-2021, PAIN (body aches and pains), MUSCLE SPASMS (cramps to her earlobes), HYPERAESTHESIA (inability to touch her head due to sensitivity), FEELING ABNORMAL ("it was bad!"), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included used an icepack for her head.   This case was linked to MOD-2021-131999, MOD-2021-131999 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Batch number Updated, Concomitant medications added.
Sick to her stomach; Having diarrhea; Severe muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to her stomach), DIARRHOEA (Having diarrhea) and MYALGIA (Severe muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Sick to her stomach), DIARRHOEA (Having diarrhea) and MYALGIA (Severe muscle pain). At the time of the report, ABDOMINAL DISCOMFORT (Sick to her stomach), DIARRHOEA (Having diarrhea) and MYALGIA (Severe muscle pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment details not reported by the reporter.
warts on hands; This spontaneous report was received from a physician, referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, frequency, route, lot# and expiration date were unknown) for prophylaxis (also reported as vaccination).  On an unknown date, the patient developed warts on hands. The outcome of warts on hands was unknown.  The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Body aches (especially in the neck, back, and face),; Chills; Low-grade fever (about 99-101); Headache; Mild flu; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 11:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypothyroidism. The patient was allergic to penicillin and lamotrigine. Concomitant medications included lithium (MANUFACTURER UNKNOWN), ethinylestradiol; ferrous fumarate; norethisterone acetate (LO LOESTRIN FE), levothyroxine (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  On 31Mar2021 at 23:30 the patient experienced body aches (especially in the neck, back, and face), chills, low-grade fever (about 99-101) and headache. The patient felt it was like a mild flu but it was bad enough and had to miss the class in the university. Therapeutic measures were taken for the reported event and included treatment with mostly acetaminophen (TYLENOL) and some ibuprofen (MANUFACTURER UNKNOWN). The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events general body pain, chills, fever, headache and mild flu were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Patients letter states: day after injection given, injection site very sore. 4 days after injection, shoulder and upper arm became painful and stiff. 6 days later there was discoloration of area around left elbow including lower and upper forearm. Went to Dr. on Sept. 16 and believes the injection caused a hemorrhage that still pains him as of Sept. 24.
Felt bad; Not feeling well; tested positive for COVID; Diagnosed with Covid; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program Pfizer First Connect. This female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient took the COVID-19 vaccine last Tuesday on the 05Jan2021, after she took it she felt bad in that evening, she was not feeling well. Patient tested COVID positive and diagnosed with COVID on an unspecified date in Jan2021. Patient inquired that can she still get the second dose that was supposed to have on 26th. The outcome of event was unknown.  Information on the lot/batch number has been requested.
l cannot raise my left arm above my left should because the place of injection is painful; muscle weakness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 17:00 (at the age of 52-years-old) as a single dose for COVID-19immunisation. The patient did not have any relevant medical history. The patient had no known allergies to any medications, food or other products. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), ezetimibe, simvastatin (VYTORIN) and curcuma longa rhizome (TURMERIC SUPPLEMENT) for unknown indication and on unknown date within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 09Mar2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced that he cannot raise his left arm above his left shoulder because of the place of injection which was painful and had muscle weakness. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the events he cannot raise his left arm above his left shoulder because of the place of injection which was painful and muscle weakness was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
MODERNA COVID VACCINE DOSE #3 GIVEN 11/5/21, LOT #071F; pt to ED with increasing SOb, chills; given Solumedrol, continuous Nebs; positive for COVID; given ABX, Remdesivir; pt's condition worsened; status became DNR; worsening respiratory status requiring ICU and O2 supplementation with facemask and vasopressors; status changed to comfort care and pt passed away in the hospital
Felt nauseous after shit 25 mins in but think that may be due to empty stomach.. really hot also at the same time. The next evening (day after injection) slight itching started. Woke up in the middle of the night itching (face) and today (2 days after) full body itching. Not sever but annoyingly.
57 y.o. female  who presents to the ED with an allergic reaction to the Moderna COVID-19 vaccine.  She had symptoms of lightheadedness and dizziness and thickening in her throat.  I did not see any angioedema on her uvula or lips.  She points to her throat feeling slightly tight.  She was given epinephrine with improvement as well as Benadryl and steroids.  She is given a prescription for steroids and is instructed to premedicate with Benadryl and steroids prior to her next vaccination which she should coordinate with employee health.  An EpiPen was also prescribed for her as needed.  She is to return for any worsening.
Initial report was received on 14 May 2013 from a health care professional. An adolescent female (name and date of birth not reported) had received MENACTRA (lot number, route, site and date of administration not reported) and unspecified amount of time later developed increasing tics since vaccine up to "100/day". No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
irritation in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (irritation in left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, GABAPENTIN, ALPRAZOLAM, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D3, CHONDROITIN SULFATE SODIUM, COLECALCIFEROL, GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (GLUCOSAMINE CHONDROITIN WITH VITAMIN D3 EXTRA STRENGTH PREMIUM FORMULA) and DICLOFENAC for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE IRRITATION (irritation in left arm). At the time of the report, VACCINATION SITE IRRITATION (irritation in left arm) outcome was unknown. Not Provided      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.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077942 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077942:2 nd dose
Received at approximately 12 noon on November 2, 2002.  Approximately 14 hours later had shaking chills with a temperature of 100 degrees (oral).  In AM, took shower with a resulting increase in pulse to 120 bpm.  Achey all over and a feeling of exhaustion.  Chills again approximately 34 hours after immunization.   AM of 2nd day, November 4th,  felt ok - no fever, chills or achiness.  Left arm has a raised red area approximately 2 inches in circumference.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. Concurrent medical conditions included arthritis.  On 27th March 2018 14:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th March 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved. The reporter considered the injection site pain and injection site erythema to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient received the SHINGRIX vaccine about 2 months before the date of reporting in left arm. The health care professional called the patient to remind them that it was time for their booster dose and the patient told the health care professional that when they received the vaccine, that it was the most pain they ever experienced from a vaccine. They had pain and redness at the injection site which started hours later that day and lasted for about 4 to 5 days. The patient called the pharmacy on 31st March 2018 and spoke to the pharmacist on duty (this was a different health care professional than the reporter spoke to) and the pharmacist just advised the patient on how to manage the injection site reaction. The patient experienced a constant, dull, aching pain at the injection site which started after the initial pain went away (about 4 to 5 days after vaccination) and they are still experiencing this constant, dull, aching pain 2 months later. The patient compared this pain to a toothache. The patient reported that they also have arthritis but this pain was completely different.
Fever, chills, terrible migraine all day - no medication helped, body aches, exhaustion, SHINGLES.  I was out of work for 2 weeks.
On May 4th, 2021 there was a sudden onset of extreme pain, whether sitting up or laying down on the joint in ball of left foot. There was noticeable swelling. I was unsure of how this happened. Intense pain. I went to urgent care and all of the x-rays were normal. I couldn't walk normally. I was told it could be gout, even though I did not fall in any of the categories for that. It slowly healed over the next few weeks. Over the next month I just was super careful. I went to a sports podiatrist who told me that I had extreme inflammation in two areas of my joint in the ball of my foot. There was an abnormal uptake of inflammation in the area. The pain always seemed to be in the morning.
Moderate injection site pain occurred within 4 hours, fever, chills, headache and nausea occurred after 16 hours. Extreme fatigue  occurred after 20 hours for a duration of 24 hours.  Acetaminophen was used at onset of fever and every 6-8  hours thereafter.  Medication effective at reducing fever and headache,  only mildly effective at reducing injection site pain.
9/10/21-Chicken pox (he is vaccinated against Varicella) he developed small red bumps which progressed into fluid filled blisters covering his body. 11/22/21- He developed symptoms consistent with Alpha Gal allergy (ate beef for dinner had shortness of breath, difficulty breathing and severe stomach pain about 3 hrs after ingesting). Lab test confirmed this. He had been able to eat beef with no problem up until that point. I believe the Covid vaccine may have triggered this allergy to express itself from his tick bite from 2015. That is the only tick bite he ever had.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 08-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J009689, expiry date: 29-JAN-2015, dose/frequency: as recommended in the prescribing information, intramuscular). Pertinent medical history and concomitant medications were unspecified by reporter. On 09-SEP-2014, the patient experienced hives, pain, swelling and pinkless below the injection site and difficulty raising her arm after receiving PNEUMOVAX 23. The patient did not seek any medical attention. The outcome of the events was unknown. The causality was unknown. No further adverse event information was provided. Additional information has been requested.
body aches; Chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No newinformation.; Sender'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.
Lightheaded and dizzy; This is a spontaneous report from a contactable other HCP (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 17Dec2020 03:15 pm at single dose for COVID-19 immunization. Vaccine location was left arm and it was the first dose. None medical history. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient experienced lightheaded and dizzy at 17Dec2020 12:00 pm with outcome of recovered with sequelae. The adverse event (AE) resulted in emergency room/department or urgent care. The event was reported as non-serious. The action taken in response to the event for bnt162b2 was not applicable.  Information on lot/batch number has been requested.
On 5/14/02, red rash around injection site (not sure which side); Benadryl given. On 5/17/02, cheeks bright red, red spots on trunk, forearms (wrist and elbows) red "look burned". On 5/20/02, went to MD and MD not sure if rxn to IZ but thinks so, possible. On 5/23/02, spots on legs, continued redness on arms; cheeks clear. No fever. No pain. No other symptoms. Continues to have rash.
Had severe body aches m, fever, headache, progressed into dizziness and "foggy memory", started to have some chest pain. Felt as if I was intoxicated, lasted the whole day. Woke up the next morning and still felt "out of it" and weak but thought it would get better, went to work (im a nurse). Started having continous vomiting, shortness of breath and chest pain at work. As well as severe tremors. I was taken to the hospital, given fluids and my QT was prolonged with my heart which i have never had before . Was given iv magnesium and waited for my heart rhythm to improve. Was told not to take anymore of my prescribed medications or nausea medications and follow up with my pcp the next day. Im still feeling horrible, nausea, body aches, low grade fever and I am 72 hours out. Now I have huge hospital bill to pay, can't work currently because I still feel bad and my heart has a weird rhythm. Hoping this helps as if this was what I was expecting I would have never got it.
Cramping of the stomach; fever over 101; This spontaneous case was reported by a non-health professional and describes the occurrence of ABDOMINAL PAIN UPPER (Cramping of the stomach) and PYREXIA (fever over 101) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (For crushed both heels.) from 15-Apr-2021 to 16-Apr-2021. Concurrent medical conditions included Diabetic (Type 1).    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Cramping of the stomach) and PYREXIA (fever over 101). At the time of the report, ABDOMINAL PAIN UPPER (Cramping of the stomach) and PYREXIA (fever over 101) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medication was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-089712 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089712:
Mild tenderness to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Mild tenderness to the touch at the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE PAIN (Mild tenderness to the touch at the injection site). At the time of the report, INJECTION SITE PAIN (Mild tenderness to the touch at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
pt recv vax 14SEP98 & 15SEP98 pt exp localized rxn on lt leg described as red & swollen treated w/ATB therapy;
13:04 RRT Called for pt complaining of itchiness, pain of the throat.     13:06 Vs 155/103 85 HR 85  99% on room air.   13:07 Cetirizine HCL 10mg PO for allergy symptoms   13:09 VS 163/95 HR 76 98% Room Air. Clear lung sounds. Heart tone strong regular rhythm. Strong upper and lower extremities strength. A/0X4. Clear speech.   13:14 pt complain of left ear pain 6/10. Clear speech, no sign of facial drooping. 81mg Asprin PO given for left ear pain.   13:17 VS 150/70 71HR 99% on room air.   13:21 called 911 for pt ear pain and throat symptoms not improving. Airway is intact. No sign of distress or no difficulty breathing. Clear lung sounds.   13:27 pt state throat symptoms improving. Left ear pain 6/10. VS 140/60 71HR 98% on room air.   13:34 Ear pain 5/10. Airway intact no sign of distress or difficulty breathing.   13:38 Ambulance arrived. No change in pt condition.   13:45 VS 148/71 72HR 100% on room air. Left ear pain 3/10. Pt state throat symptoms are improving. Airway intact, no sign of distress or no difficulty breathing.   13:47 pt left to ER by ambulance in stable condition and with all belongings.
This spontaneous report was received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse practitioner informed that since 24-OCT-2014 the patients were vaccinated with improperly stored (Merck) PROQUAD injection (lot number, expiration date, dosage and route were not reported). No adverse effected were noted. This is one of several reports from the same source. Additional information has been requested.