chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; fever 100 F; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (fever 100 F) and HEADACHE (mild headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (Body aches), PYREXIA (fever 100 F) and HEADACHE (mild headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Apr-2021, PAIN (Body aches), PYREXIA (fever 100 F) and HEADACHE (mild headache) had resolved.            No concomitant medications reported by investigator
B/L hand, elbow, and chest with several 1-2mm coalescing erythematous papules with (+) TTP.
HA, nausea, chills, vomiting, treated /w Tylenol
Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I had chills. Moved to the clinic area. While under observation, symptoms increased. Tongue was reported to be swelling on right side. In retrospect, believe this was lymph nodes.Administered 2 doses together of Benadryl. Oxygen level and blood pressure remained strong. Hands turned bright red and itched. Left at 2:30. Took Benadryl and Tylenol at 3:00. Rashes and itchy throat continued for 48 hours as well as chills and aches. Overall outcome, positive health returned. Lack of energy. Bit of brain fog still remain.
pt recv vax & contracted pertussis 2wk ago about 23OCT96;pt was immunized 1JUN97, 3UAG87, 7OCT87 & 21OCT88 & 5th dose 1992;positive blood test & cult were not reported;@ the time pt was being treated for URI w/ATB;pt coughing, v;
acute right frontal lobe CVA (stoke) consisting of LUE weakness and facial droop (left side) - treatment with ASA / plavix. Outcome: stable discharge from facility after improvement in symptoms x 2 days
First dose given 27APRIL2021 and asking for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose given 27APRIL2021 and asking for second dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose given 27APRIL2021 and asking for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose given 27APRIL2021 and asking for second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
because of elbow pain it is hard to sleep at night; numbness in fingers of same arm; pain that moved down to the elbow of injected arm; This spontaneous case was reported by a pharmacist and describes the occurrence of INSOMNIA (because of elbow pain it is hard to sleep at night), HYPOAESTHESIA (numbness in fingers of same arm) and ARTHRALGIA (pain that moved down to the elbow of injected arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Oct-2021, 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 experienced INSOMNIA (because of elbow pain it is hard to sleep at night), HYPOAESTHESIA (numbness in fingers of same arm) and ARTHRALGIA (pain that moved down to the elbow of injected arm). At the time of the report, INSOMNIA (because of elbow pain it is hard to sleep at night), HYPOAESTHESIA (numbness in fingers of same arm) and ARTHRALGIA (pain that moved down to the elbow of injected arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient had used heating pad as treatment.
Very large bruise in the injected area, with heat coming from area, chills, small area rash on arm. Treatment: Advil and rest with blankets with no fever.  11/30/15 area still has a knot but minimal in size now.
Chills, shaking, tachycardia, headache, weakness, insomnia for about 16 hours after onset
The child is awake, alert, anxious. Skin is warm and dry. She has urticaria on her extremities over the left proximal thigh and mostly the left upper extremity on the volar aspect of the upper arm. Pupils are equal and reactive. Conjuctivae are not injected. Membranes are moist. Posterior pharynx is clear. No evidence of angioedma. Neck is supple. Respirations are clear. No rales or wheezes. Diagnosis: Urticaria, allergic reaction.
Narrative: Admission Date: Sep 23,2021 Discharge: Sep 8,2021 Condition of patient at discharge: deceased Acute hypoxic respiratory failure secondary to COVID-19 complicated by COPD on home O2. 73 year old male PMHx of COPD (on 3.5-4L NC baseline), HFpEF, saddle pulmonary embolism (s/p IVC filter), OSA, HTN, gout, and hyperlipidemia, presented to the Emergency Dept with dyspnea, found to be COVID+ (8/23) and worsening acute hypoxic respiratory failure despite being vaccinated with Janssen (J&J) vaccine on 5/11/2021. Patient treated for Covid (see treatment meds), pneumonia (vancomycin and Zosyn) and C. difficile (oral vancomycin) while hospitalized. Continued to require high flow nasal cannula and unable to wean off. Discussions had with family and patient for comfort care only with morphine for air hunger. Patient unfortunately passed away on 9/8/21.
I was feeling okay before the vaccine. I had the shot on my left shoulder, I took tylenol prior to receiving the vaccine. I immediately felt tingling sensation on my left arm and 3fingers (pinky, ring and pointer). Few minutes after I felt the same way on my left cheek, did not progress, so after 30minutes I was released from the observation area. I went home, ate breakfast and went to sleep on my unaffected side. I woke up in the afternoon not feeling the pins and needles anymore but I am still feeling the pressure, however I noticed that my left ear is warm and red as well. The following day, still feeling the pressure but gone for the rest of the day. However, I am still feeling the tingling sensation both in my left arm/fingers and left face once in a while for a few minutes, but will go away, it comes and goes until to this date. Our Emp Health advised me to seek medical clearance before i could get the second dose. I am schedule to see my MD this week.
4 inch area of induration appeared in r arm. Skin or arm was not affected (no redness, warmth or drainage).
Within 30 minutes of the injection she developed forceful, involuntary muscle contractions to her abdomen and B. hands.  Had less severe muscle contractions to jaw.  She has had similar reactions to compazine and to influenza vaccines.
Patient felt light headed and hot. She then c/o scratchiness in her throat and a little shortness of breath. Patient was administered Benadryl 50mg  IVP and was monitored at the site of vaccination. She refused transport. She stated that she felt much better.
Case number PHEH2016US023382, is an initial spontaneous report received from a nurse on 13 Sep 2016. This case refers to a 33 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly into left arm on 01 Feb 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this administration error.
No adverse event occurred Patient was given Moderna booster 2.5 ml in which was recently expired. Contacted manufacturer response was: The vaccine administered on April 4 & 5, 2022 from lot number 059H21A maintained the activity necessary to  protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
Vertigo with dizziness and emesis.  Went to the ER because of inability to stand.  Was discharged after 31 hours.  Went to PT, which was not successful.  Went to my GP and was prescribed prednisone, meclizine, and ondansetron.  I continue to experience episodes of dizziness.
Nausea,  heavy vomiting back to back, severe stomach pain, sweating, chills,  severely elevated blood pressure above 200.   Sickness lasted from 3/18 -3/25.  No solid food until 3/25.
Pt received Covid 19 vaccination at 17:73 hours.  At approximately 18:12  hours PT began walking to the bathroom because she was not feeling well. staff noticed PT was sitting down in a chair complaining of shortness of breath and chest pain. Once notified of the situation, I alerted EMS staff and Fire Rescue to respond. PT began feeling light headed. PT was laid down on the floor and was becoming unconscious. EMS crew administered Epi to PT right deltoid. PT was administered oxygen as well. PT condition began to improve but was still not alert to surroundings or commands. Fire/Rescue responded on scene to assess patients condition. PT was treated by Fire/Rescue and was transported to .
Started as a small red spot about the size of a quarter within a day or so, then started to expand around a week in. Now 2 weeks and still there:  3x3 inch hive like lesion in the area of the injection
Smell and taste  changed to constant metallic burnt coffee smell and taste in mouth.  There all the time. Has. It gone away and has been four weeks. Very frustrating as it effects taste of all food.
Severe symptoms began 07/18-07/19 included a severe fever,  with quivering and shaking, my head felt like it would explode. I took four Advil PMs and it knocked me out for the rest of the evening. The following day I was able to shower and then went back to sleep. I took more Advil PMs and then I slept through the night. My fever broke by that evening and I took another shower and then felt good enough to get up and get dressed and go about my day. I was not feeling well but I was mobile. I was still suffering from head and chest congestion and total exhaustion. These symptoms lasted until about 07/24 to 07/25. I did not get up to normal daily function until about the second week of August. On the 27thth of September started to come down with symptoms of a head and chest cold and congestion began. On the 9th of October, congestion began to loosen up and I was able to clear the phlegm from my lungs. I went to my physician on the 12th of October and was given medication for Pneumonia. I am now feeling better and improving with the medication.
SEVERE CHILLS, FATIGUE, HEADACHE, FELT LIKE A HAD A FEVER BUT I DID NOT REGISTER A FEVER
Patient had blood in stool for 3 days following vaccine. Onset of blood in stool was 2.5 hours following vaccine and was not associated with any fussiness or any other notable symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old male patient who received Hepatitis B vaccine. Previously administered products included hepatitis B (dose 1) and hepatitis B (dose 2). On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information received: Pharmacist reporting a patient received two Hepatitis B vaccines (manufacturer unknown) from a different facility two years ago, but did not receive the third of three in the series.
body aches; chills; headache; sore throat; swollen glands; stuffy nose; runny nose,; ear infection; pink eye; This spontaneous report was received from a consumer and refers to a currently 22-year-old female patient. The patient's medical history, concomitant medications and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, formulation, route of administration, injection site, lot number and expiration date were not reported) for prophylaxis (reported as "vaccine"). Immediately after the vaccination, the patient experienced body aches, chills, headache, sore throat, swollen glands, stuffy nose, runny nose and ear infection. It was reported, that the patient was prescribed with unspecified antibiotics for ear infection. On an unknown date reported as "then" the patient experienced pinkeye. The outcome of all events was unknown.  The relatedness between all of the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
Covid-Hospitalization; Covid-Hospitalization; This is a spontaneous report from a non-contactable other health care professional. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications included ocrelizumab (OCREVUS). The patient experienced Covid-Hospitalization. The patient underwent laboratory tests and procedures which included Covid-19 test shows positive on an unspecified date in 2021. The outcome of the event was unknown.   No further information was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and the suspect drug.
Pt recvd vax & pt devel rt brachial plexitis, also referred to as neuralgic anyothropy, autoimmune deficiency, & permanent nerve damage to rt upper extremity;
I started with a cold, and I went to a virtual visit. I received a prescription for Zpac and 6-day prescription of Prednisone. I didn't get better after that. On December 29, 2023, I did another virtual visit and received another prescription for Prednisone Medrol pack. I was still sick after that. On January 6, 2023, I went to see my primary doctor where I received a steroid shot and referral for a pulmonary doctor. On January 18, 2023, I saw a pulmonary doctor and received another prescription for more steroids and Augmentin, and I also received a chest x-ray that day.  The chest x-ray showed I had a collapsed lung. During this time, I was taking breathing treatments with Albuterol, Atrovent, and Brio. Then on February 23, I went back to Pulmonary doctor who sent me to the urgent care who did a chest x-ray again. The doctor told me my lungs looked worse than before and prescribed me more Prednisone, and Augmentin. On March 1, 2023, I called the doctor because I had pleurisy, which he prescribed me pain medication for it.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Information regarding the patient's pertinent medical history was not provided. On 04-MAR-2014 the patient was indicated to received ZOSTAVAX, but inadvertently received VARIVAX 1350 U, 0.5 ml, subcutaneously. Lot number was unknown. No adverse effect was reported. Additional information has been requested.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: face start drooping once swelling went away per patient
10OCT TD given w/in 12hr of vax hard, raised area & soreness to site;14OCT rash to lt arm, 6" wide, 4" above elbow, up to shoulder;17OCT very red, hot to lt arm, nauseous, unsure if fever;urticaria to lt arm;seen by MD dx cellulitis;
Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Pt self reported anaphylactic reaction.  Unknown time course and severity.  Pt did not seek any known treatment.
Pain, erythema, swelling at injection site. Swelling spreading to upper arm and down to elbow. Fevers as high as 101.4. Headaches.
Itchy, sore when touched, hot, red and swollen.  Lasted 2 days went away for 1 day then returned for 3 days and reduced in severity.
This spontaneous report as received from a healthcare worker refers to a 9 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L011846, expiration date 16-JUN-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
04/03/23 presents to ED for "fatigue, falls, cough". PMHx of "Waldenstrom's macroglobulinemia, SIADH, atrial fibrillation, and obstructive sleep apnea"
the pain localization varies in the arm (after second dose); pain from the shoulder all the way down into the hand (after second dose); Tired for a week (after first dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the pain localization varies in the arm (after second dose)), FATIGUE (Tired for a week (after first dose)) and ARTHRALGIA (pain from the shoulder all the way down into the hand (after second dose)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included DULOXETINE HYDROCHLORIDE, LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), AMLODIPINE BESILATE, OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]), FAMOTIDINE (FAMOTIDINE ACID REDUCER), HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]), METOPROLOL SUCCINATE, GABAPENTIN, MONTELUKAST, ALPRAZOLAM (XANAX SR), VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced FATIGUE (Tired for a week (after first dose)). On an unknown date, the patient experienced PAIN IN EXTREMITY (the pain localization varies in the arm (after second dose)) and ARTHRALGIA (pain from the shoulder all the way down into the hand (after second dose)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (the pain localization varies in the arm (after second dose)) and ARTHRALGIA (pain from the shoulder all the way down into the hand (after second dose)) outcome was unknown and FATIGUE (Tired for a week (after first dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication butrotion-HclXl tab 300mg 1/night is used.   This case was linked to MOD-2021-314900.
Inconsolable crying x 6 hours - 2 hours after receiving vaccines. (+) 2cm induration right ant thigh.
acheing, throbbing  and  bruising around injection site. never pregnant for 1 week
Was really sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Was really sick). The outcome of the sickness was recovered/resolved (duration 4 days).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient's sister/brother interactive digital media. The reporter stated that his/her sister had it very bad. The patient got the Shingles booster last week and she was really sick for about 4 days. The reporter guessed that it was better than being in pain a few months as shingles was the worst  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Approximately 10 hours after receiving vaccine, experienced nausea, headache, fatigue, chills, and fever (100*F) for the next 8 hours.
Fever, chills, headache, dizziness. All lasted for about 24 hours. Was treated at home with Tylenol
Vaccine administered 7/9/15. Within a couple days large, swollen bruised area today 7/14/15 looks much better, resolving.
severe diarrhea (3 or so very loose stools a day or more); This is a spontaneous report received from a contactable consumer (patient). A 62-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Apr2021 (two weeks before the report) at single dose for COVID-19 immunisation at the age of 62-year-old. Medical history and concomitant medications were unknown. The patient received vaccine two weeks before the report (Apr2021), since then he has been experiencing what he described as severe diarrhea (3 or so very loose stools a day or more). The outcome of the event was unknown. No follow-up attempts are needed. Information on the lot/batch number has been requested. No further information is expected.
PFizer vaccine was administered after being discovered that the vaccines were kept in the freezer for 11 days longer than the two week standard time.  Patient was notified and given the option for additional dose.
On 11/15/15, patient got the Flu and Pneumonia shots. He slept ok but a week later he had a reaction to the shots and he went to the ER.