chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day of injection a left arm very sore. began at 11:45 pmChills, Feverish body warm, Headache,Ached all over especially hands and feet joints nausea  second day eruption to Right inner mid thigh, red ring and pustuale painful and itchy found the area because I wnet to scratch it I have pictures tylenol then pharmacist recommended ibuprophrn,  Third day  headaches still achy no fever pus broke on eruption very red I have picture . Painful arm and site of eruption and itchy all over Painful and itchy Saw Dr did blood work Took ibuprophen and antihistamine.
Sat 5-10-08 red with cluster of blisters, itches & burns always.  Thur-started getting worse called Dr made appt for 5-16-08.  Tx generic for ZOVARAX & generic for VICODIN VZV culture done.
Swelling started Tuesday and redness on Wednesday. Movement OK rash on tricept and wrap to breast on front probable shingles due to location of rash (no rash on deltoid).
Information has been received from a physician concerning a male child with no pertinent medical history and no drug allergies who on 29-DEC-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot # not reported). Subsequently the patient developed a generalized/chickenpox like rash after vaccination. The patient called the office to report the rash on 08-JAN-2009. As of 08-JAN-2009, the patient was not recovered. Additional information is not expected.
5/3/99 lt thigh lateral side mildly edematous & soft to touch small scabbed area where child scratched child stated d/t itching;tiny red papule to lt medial thigh;papules;edema to thigh;
This is a spontaneous case, initially received on 12-Dec-2017, from other health professional (pharmacist), concerning a 27-year-old, adult female patient. The patient did not have medical history. The patient's concomitant medications were not reported. On 30-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 195246 and expiry date: 30-Jun-2018). After administration of FLUCELVAX (reported as a few months ago), the patient had limited mobility ever since the shot. It was reported that, her arm was hurting and she had trouble in lifting anything. Patient suspected that it might be a nerve or tendon reaction and complained of pain (like a shooting pain) and limited mobility when she moved her arm up and down. On 31-Oct-2017, the patient started feeling pain and later it got worse. The reporter stated that, the patient did not receive any medication to treat the events. The outcome of the events was not recovered (reported as ongoing). The reporter assessed the events as non-serious. Follow-up received on 08-Feb-2018: This case was considered lost to follow-up since the reporter could not be contacted for further information after the attempt made in 30 days.
I felt ill two days following the injection: congestion, runny nose, lethargic, sluggish. I then went into preterm labor at 32 weeks gestation and delivered 5lbs 4 oz via emergency c-section. This was my first pregnancy.
Adverse reaction occurred after the patient was discharged from clinic and went home. States she had difficulty breathing and rash on her neck. She was taken to the emergency room by family and treated. Reaction resolved after treatment. She also states she took Ibuprofen 5-10 minutes before reaction occurred. Hospital records show Pt. walked in to ER at 1315 with difficulty breathing, difficulty swallowing, chest tightness, wheezing and rash over throat and neck. She was treated with 25mg of IV Benadryl, 125mg of IV Prednisone and 20 mg of IV Famotidine.
Post vaccination return of CRPS/RSD related numbness and burning in each site where history of CRPS.  Have not been on any medications for the CRPS for over 2 years with minimal to no exacerbation of CRPS events. I have a long history of flair ups with insults to my body (e.g. post accident, post surgery, extensive dental work).  The numbness and burning started to return within 2 hours of injection to the right side of my face and my right hand.  Then these symptoms started to return to other locations on my body throughout the week (lower back, left knee and right ankle).  The only site that has subsided 1 week post injection is my right hand though all symptoms have not resolved there either.  The burning in my lower back got so bad on Thursday that I had issues sitting and scheduled an appointment with Dr. for Monday 3/1/21. Telehealth visit with Dr. this AM and returning to medication to treat CRPS/RSD till episode resolved.
Redness to face/arms, Itching to body Shortness of breath, Feeling it move to my mouth, throat, nose, so far some symptoms have lasted 3 days
This case was reported in a literature article and described the occurrence of failure to thrive in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included combined immunodeficiency syndrome (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed failure to thrive. Serious criteria included GSK medically significant. The outcome of failure to thrive was unknown. The investigator considered that there was a reasonable possibility that the failure to thrive may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence failure to thrive of in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had severe combined immunodeficiency disease (SCID). No information on patient's medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed failure to thrive. The treatment was unknown. The outcome of the event was not provided. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB" This is 1 of the 11 valid cases reported in this literature article. The article corresponding to this case is not available for submission due to copyright restriction.
Mom reports pt with hard red area 2 1/2 inch in diameter. Fever of 104.0. Advised to give benadryl and tylenol along with use of warm compress at the site.
Sore arm at injection site (intense); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Feb2021 15:45 (Lot number: EM9809) at the age of 56 years as dos e 1, single for covid-19 immunisation. Relevant medical history included: "herpes" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; VALACYCLOVIR [VALACICLOVIR]; DICLOFENAC SODIUM. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Sore arm at injection site (intense)".  Additional information: The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to Pfizer COVID-19 vaccine. The patient has no history of COVID-19 infection. The patient was not tested for COVID-19 post-vaccination.   No follow-up attempts are possible. No further information is expected.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: Pain and Neuropathy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Pt states they are experiencing tingling sensations and pain in joints
Muscle soreness and tenderness to touch around collar area.  Extends around neck to collar bone and down to scapula area.
Arm soreness/ at injection site / started getting sore after / it felt like a flu shot; Arm /stiffness; This case was reported by a consumer via licensee and described the occurrence of injection site pain in a 49-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 VACCINE) (batch number EN6204, expiry date June 2021) for prophylaxis.   The patient's past medical history included covid-19 (Family History) (patient's mother passed away on 15th March 2021 and she was fighting Covid). Previously administered products included Pneumonia vaccine (2 or 3 years ago from the date of reporting at the age of 46 years). Concurrent medical conditions included asthma.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On 13th March 2021 09:30, the patient received COVID 19 VACCINE. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain and injection site movement impairment. On an unknown date, the outcome of the injection site pain and injection site movement impairment were unknown.   It was unknown if the reporter considered the injection site pain and injection site movement impairment to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient had reported for herself. The age at vaccination was not reported. After receiving Flu vaccine arounf 12 or 1 PM, the patient had soreness and stiffness at the injection site. The patient was getting sore after the vaccine and it felf lke a Flu shot. On 13th March 2021 09:30, the patient received COVID 19 VACCINE. in left arm.
I am now on my 9th day straight of severe Vertigo.  I have no other adverse symptoms outside of this.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding patient's concomitant medications, concurrent conditions or medical history. On or about 17-OCT-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported), to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unspecified date, the patient experienced shingles (Herpes zoster) and on or about 16-SEP-2015, was treated by a physician at a convenient care. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (Vaccination failure) and suffered serious physical, emotional, and economic damages (Emotional distress), as a result of patient's injuries on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (Emotional distress) (Pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (Condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.
increase in temp. 103.3 at 730 PM on the 7/20/2018. Tylenol broke fever. Child recovered "per mom" by 330 on 7-21-2018.
sore throat; headache; fever; body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 antibody test positive since January 2021.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.            no concomitant and  treatment drugs were provided.   Reporter did not allow further contact
PT HAD REACTION TO SPIKEVAX: YDAY HE HAD PAIN ON RIGHT SIDE OF FACE THAT RESEMBLED TRIGEMINAL NEURALGIA AND TODAY ITS ON LEFT SIDE BELOW TEETH TO BOTTOM OF JAW SHARP PAIN AND FATIGUE AND FEVER AND PERSON GAVE HIM SHOT BUT WAS GIVEN THREE FINGER LENGTHS BELOW AND PT CONFIRMED IN MUSCLE--FOUND ARTICLES WITH THIS ADR --has reached to doctor for consult.
Very painful administration.  Seemed too high on the shoulder. I was seated- nurse administering was standing.  Could not lift my arm by that evening.  Severe pain.  Urgent care on November 30.  Course of steroids- could then lift arm halfway.  No effect on pain.  High density ultrasound 12/08/2020 showed 2 tears- moderate fluid in bursa.  Never had a shoulder issue before. EVER.  Without steroids ROM decreased again.  Severe pain persists. Messaging MD for cortisone injection.
On October 19 2021, Patient received approximately 0.3mL of undiluted contents of the Pfizer-BioNTech COVID-19 vaccine vial equating to roughly 135mcg. Patient has reported arm soreness at 24hours after the dose and which resolved until 48 hours after the dose. Starting at 48 hours after the dose was given, patient expresses slight fatigue.
Blood blisters in mouth; Rash on upper body that looks like measles but without the itching; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (Blood blisters in mouth), RASH MORBILLIFORM (Rash on upper body that looks like measles but without the itching) and ASTHENIA (Weakness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL MUCOSAL BLISTERING (Blood blisters in mouth), RASH MORBILLIFORM (Rash on upper body that looks like measles but without the itching) and ASTHENIA (Weakness). At the time of the report, ORAL MUCOSAL BLISTERING (Blood blisters in mouth) and RASH MORBILLIFORM (Rash on upper body that looks like measles but without the itching) had not resolved and ASTHENIA (Weakness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient received their first dose of Moderna vaccine and on an unknown date experienced weakness which resolved on an unknown date.  Reportedly, the patient also developed blood blisters in their mouth and rash on upper body that looks like measles but without the itching. Both these symptoms were still ongoing.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-079485 (Patient Link).
Patient woke up on the morning of 11/17/18 to find a golf ball sized red welt on her left arm and a hard nodule under the skin the size of a marble where the injection was given. The red welt was warm and her arm was sore (#2 out of 10 on a 1-10 scale). The welt grew in size in the next 24 hours, then started to decrease after that. Patient called in to the pharmcy on 11/19/18 to let us know of the reaction. Pharmacist told patient to watch it and if the redness grew in size or if she developed a fever she should go be seen by a doctor. The patient was also recommended to call her doctor to inform them of the reaction. The pharmacy checked back in with the patient on 11/20 and she said that the redness had reduced but it was still a little sore. Overall she was feeling better.
Body ache; Low grade fever; Head ache; This is spontaneous report from contactable consumer. A 53-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on 24Mar2021 at 18:30, (at the age of 53 years old), as a single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history and concomitant medication were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration, on 03Mar2021 at 19:15, (at the age of 53 years old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 25Mar2021 at 13:00, the patient experienced low grade fever, headache and body ache. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No therapeutic measures were taken as a result of the events. The clinical outcome of fever, headache and body ache were recovered on an unknown date in Mar2021.   Information about lot/batch number cannot be obtained. No further information expected.
Pt rec'd 1st dose of Hep B on 1/11/02. Pt went to beach for weekend and upon return on (1/13/02) he reported to mother that a rash on face, chest and back began to appear on (1/2/02). Mother took pt to Dr. on 1/14/02 and is having blood work done this afternoon.
Symptoms of anxiety, hand and face skin tingling, and mild SOB began at 2:50 PM.  Patient stated she had a history of anxiety.  BP 132/94, Pulse 124, O2: 98% (measured with finger pulse oximeter).  At 3:12 symptoms progressed to blue lips, cramping of hands, complaint of "weight on the chest", EMS was called.   Pulse was 112, O2 was 98%.  No rashes, swelling, or nausea noted.  Had patient lie down on a yoga mat and helped her with anxiety reduction strategies, gave her sips of water.  Transferred to EMS at 3:26 PM.  Patient was evaluated, recovered, and released on-site.
Information has been received from a pharmacist concerning a female with a history of liver transplant, salsa allergy and aspirin allergy who began experiencing two menstrual periods each month after receiving two doses of GARDASIL vaccine (yeast) (lot#'s not reported). The patient sought unspecified medical attention in the physician's office. The dates of the GARDASIL vaccine (yeast) injections were not provided and the onset of adverse symptoms was not specified. No other symptoms or treatments were reported and no other information was available. The patient has not recovered. Additional information has been requested.
SORE ARM; SORE THROAT; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and sulfa allergy. The patient experienced drug allergy when treated with codeine, and streptomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, once a total administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and sore throat. This report was non-serious.
Pt recvd vax 18JUL94; mom gave pt APAP a/vax admin, by 7PM pt had fever, was irritable & screaming; fever 102; pt usually a good sleeper, was up that noc several times crying & screaming;
Immediate pain in injection site, felt the vaccine travel through left side of body, when it reach my neck, I felt a tightening around my throat and I could not swallow.  The length of time it took to reach this point was within 5 minutes or so of the shot.  Paramedics came and checked my vitals, which were normal.  Eventually, tightness loosened and I felt better.  The next day, there was a knot in my throat/neck that subsided by afternoon.  It felt like I was punched in the throat.  I also had dry mouth for about 24 hours.  In addition, I felt muscle and joint aches  for six days.
Redness at injection site; Rash on back and stomach; A spontaneous report was received from a consumer (nurse) concerning a 57-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a rash on back and stomach and redness at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020, approximately seven days prior to the onset of the events, the patient received her first of two doses of mRNA-1273(Batch Number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient developed a rash on back and stomach. On 06 Jan 2021, patient developed redness at injection site.  Treatment details for event rash on back and stomach included hydrocortisone cream. No treatment information was provided for injection site redness.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event rash on back and stomach was considered resolved. The outcome of the event redness at injection site was not reported.; Reporter'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.
High fever, body aches, chest pains, back pain, fatigue, sweating, chills, shortness of breath, over sleeping, left arm pain.