chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lymphadenopathy erythematous nodular eruption of bilateral thighs to be treated with clobetasol 0.05% ointment BID for 2-3 weeks.
Redness, itching, heat, and small hardened area at injection site. Started 7-8 days post injection.
Pain in left arm. Several days later, chest pain, pain on left side of back. Left wrist pain. All would come and go. January 7, bottom lip began tingling and left side of face went numb. Taken to medical center and admitted.
Received MMR for a negative Rubella titre on 4/14/06. Reported rash on body on 4/27/06.
Initial unsolicited report received from a nurse on 25 May 2018. This case involves a male child (age not reported) patient who was vaccinated with QUADRACEL (batch number C5248AA, expiry date, route and site of administration were not reported) were not reported on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, post vaccination patient experienced left arm hot red swollen more than 3 inches diameter bumpy itchy. Relevant lab investigations and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Incorrect pfizer covid vaccine was administered. Patient received the 10mcg/0.2ml concentrations. No adverse events or outcomes, to this day, have been reported.
I had severe pain from my buttocks down to my foot. There is pain behind my right back and side of my leg. The pain spreads out to the outer side. The pain is absolutely intense. I have never experienced anything like this in my life. It is difficult for me to even sit down. I contacted a doctor, through my insurance, and they contacted me back. I thought it was Bursitis, but when the doctor contacted me, she told me that she believes I have sciatica. I was advised to take one gabapentin at breakfast, one at lunch and two before bedtime. I'm also taking ALEVE to help with the pain. I am unable to see my doctor in person until December 22, 2022. The pain has decreased minimally due to the amount of gabapentin and ALEVE I am currently taking.
My right arm presented with a large round lump that was red, irritated and bumpy.  The following day, it continued to grow to the size of a baseball.  It was warm to the touch and sensitive. As of today, the swelling has gone down significantly (although it's still swollen) it is still visibly red, however, no longer sensitive to the touch.
Off and on low grade fever (99.9 to 100.4) , especially at night going on 72 hours plus, with severe headache, body aches, joint aches, fatigue, chills and just an overall feeling of unwellness. The reason I am reporting is this was the first dose and it is not getting better and I am in day 4 now.
low grade temp, cranky PM of 7JUN93; by AM of 8JUN had bilateral parotid & submandibular swelling w/drooling & tenderness;
loss of sensation in limbs; Dizziness; chills; unstability walking; uneven breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jun2021 13:00 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: SENSORY LOSS (non-serious) with onset 22Jun2021 15:30, outcome "not recovered", described as "loss of sensation in limbs"; DIZZINESS (non-serious) with onset 22Jun2021 15:30, outcome "not recovered", described as "Dizziness"; CHILLS (non-serious) with onset 22Jun2021 15:30, outcome "not recovered", described as "chills"; WALKING DISABILITY (non-serious) with onset 22Jun2021 15:30, outcome "not recovered", described as "unstability walking"; IRREGULAR BREATHING (non-serious) with onset 22Jun2021 15:30, outcome "not recovered", described as "uneven breath". Therapeutic measures were not taken as a result of sensory loss, dizziness, chills, walking disability, irregular breathing.  Additional information: Facility type vaccine was reported as pharmacy or drug Store. COVID prior vaccination was reported as no. COVID not tested post vaccination. There were no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called with bruised, itchy and inflamed inject site. She mostly complained about injection site being itchy. She did bleed after the injection and was advised she may bruise. Injection was on 11/10/23 and all symptoms continue until today, 11/13/23, when she called to report.
body is cold; Occasionally some nauseous sensation but didn't throw up; Eyes feel so tired; hard to concentrate; it bother my sleep; first dose on 19Dec2020, second dose on 06Jan2021; heaviness in the head when I woke up next day; some hot/spicy sensation around eyes area; didn't even have good appetite during lunch time on day 2; sever headache started at night of day one; This is a spontaneous report from a contactable Other HCP (patient).  A 33-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EK9231), on 06Jan2021 14:30 via an unspecified route of administration in the left arm at single dose COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) on 19Dec2020 09:45 in the left arm at single dose for COVID-19 immunisation. On 06Jan2021 at 23:00, started at night of day one, the patient experienced severe headache. The patient experienced also heaviness in the head when she woke up next day (07Jan2021) and had some hot/spicy sensation around eyes area (07Jan2021). The patient needed to take paracetamol (TYLENOL) to get some relieve and she did not even have good appetite during lunch time on day 2 (07Jan2021). On unspecified date the patient had no fever and her body was cold; occasionally some nauseous sensation but didn't throw up. Eyes feel so tired and hard to concentrate. Hopefully those symptoms go away soon as days pass since it bothered patient sleep. The patient had a doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The patient took also guaifenesin (MUCINEX). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
2-3 days after receiving injection developed left trapezius contraction pain - headache and left arm pain. Muscle relaxants/anti-inflammatory.
Developed lumps in lower abdomen/groin along with swollen lymph nodes in this area. Soon after developed severe adrenal insufficiency- body stopped producing cortisol (had adrenal crisis before being diagnosed), with no found cause. Imaging of lumps is still inconclusive (they are still there), adrenal insufficiency is currently being treated with a steroid.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 19-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10pk-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 80 hours with the lowest recorded temperature of 30 Fahrenheit degree. The total cumulative excursion time of the second time was 1172 hours with the lowest recorded temperature of -3 Celsius degree. The total cumulative excursion time of the third time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the fourth time was 88 hours with the highest recorded temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Vaccination adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Reporter wanted to know who they contact if he had a potential adverse event to report. Dosage text reported as Unknown. No treatment medication was provided.   Reporter did not allow further contact
My symptoms started on Friday May 13th 2022, I was flying home and started sniffling. I had runny nose, chills and fatigue. I took a home rapid test on 05/14/22 which was positive. I called doctor and they prescribed me Paxlovid, started taking on same day. My symptoms have gradually gotten much better. Now I have fatigue and metallic taste in my mouth.
Presented with SOB, afib; Dx Covid PNA; Labs: D-dimer 1.94 CRP 12.9, Ferritin 2757.5; Tx:  Decadron, Remdesivir, Vit C, Lovenox, Singulair, Zinc;  Supplemental O2 from 2-5 LPM; Remained on 5 LPM O2 at d/c
This spontaneous report as received from a physician refers to a 3 years old patient. On an unknown date the patient was vaccinated with a dose of ROTATEQ (lot# not reported), oral liquid, orally. On an unknown date the patient experienced contracted rotavirus after received the ROTATEQ. The patient sought medical attention with physician and was prescribed PEDIALYTE Solution. Not lab diagnostic studies were performed. The patient was recovered and the AE improved due to the virus and symptoms subsiding on its own. This is one of several cases received from the same reporter. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA headache first day, immediate itching and redness and lump at injection site, nausea and shortness of breath, tenderness on injection site, arm soreness it is now day 9 since my 1st shot, and everything else has gone away except for the redness, itchiness, and the lump size which has progressively gotten worse not cleared up in 7 to 10 days
This spontaneous report as received from a registered nurse refer to an unspecified number of patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot# K040164 with expiration date 20-FEB-2018 (dose and route of administration were not reported). Temperature and time frame of excursion were reported as 49.8 Fahrenheit (F) and 33.4 F for an unspecified amount of time. The vaccine had also previous temperature excursion of 48.1 for 1 hour and 15 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Redness and itchness starting 2 days after vaccine, on the 3rd day redness spread down her arm to her wrist and patient went to urgent care.  They said it was cellulitis and gave keflex and triamcinolone cream.  Resolved it in 2 days.
4 month old male patient received a expired dose of Pentacel, no AE.; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a four month old male patient who was vaccinated with an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PALIVIZUMAB (SYNAGIS).  On 14-Oct-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ061AA, U6137AA and expiry date: 04-Oct-2020, 04-Oct-2020) via an intramuscular route at an unknown administration site (reported left) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Persistent intermittent HA.  No prior hx of HA and no other aggrevating factors other than vaccine.  Also new arthralgias.
A few hours post vaccine child became irritable and developed lacy edematous rash to forehead.
Next morning, minor pain and swelling after daily exercise, approximately 10:30 AM.  Swelling subsided slightly 3 hours later, but minor swelling and minor pain remain.  No treatment.
Red round rash around site, slightly raised, sometimes itchy.  Still there as of today 1/31/2021
severe swelling of her left arm; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  An elderly female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COVID-19 VACCINE taken for covid-19 immunisation as dose number unknown, single. The following information was reported: PERIPHERAL SWELLING (medically significant) with onset 2021, outcome "unknown", described as "severe swelling of her left arm". Therapeutic measures were taken as a result of peripheral swelling.  Clinical course: Pfizer employee stated, "So, the doctor told me that the almost immediately started to swell up in left arm and she went to provider who administered her a steroid (Treatment) to reduce the swelling and then a year and half ago. And it was not that bad, so because of that she looked like to take her shingle shot. she was eligible for her single shot (Further clarification unknown, hence captured as unspecified shingle shot), so it created a level of fear in her, she did take her COVID shot (Manufacturer name not clarified hence left unchecked in tab) and the shingle shot, she was due for but she said I haven't done it again, you know because she got very bad experience and little scared." It was reported that No, it was administered a year and half ago. No, we do not have the Lot#." She did take her COVID shot and shingle shot, she was due for but she said I haven't done it again, because she got very bad experience and little scared. Patient had no known allergies. She shared that when she was over 65, so she got her Prevnar 13, she had an unusual reaction immediately, mean it is listed in the packaging insert, she had a very severe swelling of her left arm, after almost immediately, after getting you know the Prevnar 13.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events and The suspected drug cannot be ruled out.
3.5" round,red, indurated, tender macule on Left Lateral thigh at site of DTaP. No fever or other systemic Sx's. Cellulitis treated with Keflex. (MMR was given in opposite leg of reaction)
Pt reports that 30 minutes after receiving his second dose of Moderna vaccine he began vomiting. He states there were blood streaks in the vomit. He did not initially seek medical attention. He was seen in our office last month for a routine office visit.  That is when he informed of the reaction.
Severe vomiting starting at 2am -5:30am Hard time breathing Hands tingling and then eventually could not use hands Went to ER and received  anti nausea medication       3 days later still complaining of hard time with deep breathing- pain in chest
Initial misuse report received on 11-Oct-2013 from a health care professional. A female patient, age, medical history and concomitant medications were not reported, received a dose of ADACEL through IM (lot number C4181AA and site of vaccination was not reported) on 11-Oct-2013. It was reported that a patient exposed to ADACEL during pregnancy. As of 11-Oct-2013, Patient did not have any adverse events. List of documents held by sender: none.
shooting pain lt arm when raise arm & cannot lay on arm;cont take motrin;pain lasted x 4 days;
July 2021 I just started waking up in the middle of night with extreme shortness of breath. I had difficulty with inspiration, difficulty exercising, and I had really bad fatigue. I also had chest tightness. October 31 2020 is when I had caught Covid before the vaccine. When I went to the doctor they prescribed me a dose of oral steroids, and I was put on 2 inhalers.
100.3 degree fever; Severe headache; Diarrhea; Soreness near teeth; Pain at injection site; Swollen lymph nodes in neck and armpit aggravated; Swollen lymph nodes in neck and armpit aggravated a pinched nerve in ''my'' shoulder on the same side; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female 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 22Apr2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included elongated bone at base of neck that often results in pinched nerves. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pills (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for birth control. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 01Apr2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021, the patient experienced 100.3 degree fever, severe headache, diarrhea, soreness near teeth, pain at injection site and swollen lymph nodes in neck and armpit aggravated a pinched nerve in my shoulder on the same side that she received the shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events 100.3 degree fever, severe headache, diarrhea, soreness near teeth, pain at injection site and swollen lymph nodes in neck and armpit aggravated a pinched nerve in my shoulder was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flu-like symptoms; muscle ache; headache; shivering; tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On 1st February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd February 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, headache, shivering and tiredness. The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). On an unknown date, the outcome of the influenza-like symptoms, muscle pain, headache, shivering and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, headache, shivering and tiredness to be related to Shingrix.  Additional deatils were provided as follows: The patient received Shingrix in the left arm. The reporter stated that by 2nd February 2020 after vaccination, the patient experienced flu-like symptoms which includes muscle ache, tiredness, headache and shivering who has been going on. The opatient received Tylenol and Advil as a treatment mediaction. No additional information provided. The reporter consented to follow up.
I have an IUD, have not had a period in 3 years. As of Wednesday 2/9/22, I started spotting, on Tuesday 2/15 seen by my GYN to make sure everything was okay, IUD still in place. The cramping and bleeding have never been so bad in my life. I want to throw up from the pain.
Narrative:  Patient received first Pfizer COVID-19 vaccination in late October 2021 and PCP reported "He reports receiving covid 19 vaccine on 10/14/2021 w/diarrhea, fatigue, abdominal pain, symptoms improving since receiving the vaccine. He reports he previously had Covid one year ago with same symptoms. Is resting and drinking fluids/PediaLyte. Patient received second Pfizer COVID-19 vaccination middle November 2021 and a message to PCP was sent saying, "I got the second COVID vaccination on Tuesday. I haven't been to work since. I'm very tired, have bad diarrhea, headache, and chills / hot flashes. I'm going to try to find an urgent care this morning. I will send you a copy of the record of treatment. I saw you after the first injection with the same complaints. I wish you would enter into my record that I have these negative effects so that I may avoid both flu and COVID vaccinations in the future. They are not consistent with my crohn's disease and my reduce immune system from years of taking high dose corticoids."
Patient has a history of syncope; vaccine was administered without incident.  Pt was advised to wait 15 minutes in store.  After 15 minutes, pt walked to vehicle and became unresponsive.  Medical clinical staff responded to scene.  Pt stated unable to get out of vehicle and into wheelchair to be evaluated inside.  EMS was called.
pt recv vax 5DEC97 & same day devel a swollen, red area @ the inj site;31DEC97 pt was hosp for 5 days w/h/a & a stiff neck;
lightheadedness when standing up, heachache, upper back stiffnesss, hot and cold sweats, vomiting