chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headaches started the day after COVID vaccine #2.  Headaches were reported as severe.  Pt having 5-7 headache days per week lasting 2 months.  As of today (4/11/22) they have subsided to be relatively mild.
This spontaneous report received from a parent concerned a 30 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced was not feeling well. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and was not feeling well was not reported. This report was non-serious.
pt recv vax & arm ached;pt noticed sunken place;pt described it as a big hole w/nothing left but skin over the bone;pt stated it just ached;MD said ti was SC fat atrophy from inj site post flu vax;;residula is a dimple post inf lt deltoid;
Patient received 2nd dose of COVID vaccination just prior to ER admission. After receiving the vaccine, she developed difficulty swallowing, difficulty breathing, and the feeling of swelling in her pharynx. She took a claritin after her symptoms developed (prior to presenting to ER). In the ER, she was given methylprednisolone, famotidine, and diphenhydramine. Her symptoms resolved. She was sent home with prescriptions for prn prednisone (10 mg po) and diphenhydramine (50 mg po).   Also of note, patient did not she had hives after receiving her first COVID vaccine.
Pt had swelling at right arm injection site, 2x normal size plus pain in to right pectoral. Vomiting, nausea and chills.
Was advised by health department that patient had received 3rd shot at a pharmacy before returning to our pharmacy for her 3rd. After looking at our system and the patient's vaccination card we determined that patient had only received 2 shots and was due to receive her third. She did not disclose that she had already received a 3rd shot.
Fatigue; headache; foot pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 at 10:00 as dose 2, single (Lot number: EN6200) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number=EL9264; Administration time: 10:00 AM; Anatomical location: left arm), administration date: 27Jan2021, when the patient was 70-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Feb2021, outcome "not recovered"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "not recovered", described as "foot pain"; HEADACHE (non-serious) with onset Feb2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fatigue, headache, pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. No known allergies were reported.
body aches, ha, fever, injection site very hot, swollen, painful, could not even get out of bed x 3 days.
Patient mom notified staff that patient went to ER on 7/4/18 for rash and ongoing fever. Fever started on 6/29/18. Vaccines given 6/26/18. T99.6 on 6/29/18, T102.1 on 6/30/18. Mom reports fussiness, lethargy. Eating and drinking ok. Rash presented on 7/4/18. Rash on trunk, limbs, face and scalp.
Body hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body hurts). At the time of the report, MYALGIA (Body hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up document received on 26-MAY-2021 contains non significant information
itchy at injection site/ It was hurting; itchy at injection site/ It was hurting; This morning he was tired.; He had headache.; Early this morning, his arm at the injection site was swollen./It is swelled; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (itchy at injection site/ It was hurting), VACCINATION SITE SWELLING (Early this morning, his arm at the injection site was swollen./It is swelled), VACCINATION SITE PRURITUS (itchy at injection site/ It was hurting), FATIGUE (This morning he was tired.) and HEADACHE (He had headache.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced VACCINATION SITE SWELLING (Early this morning, his arm at the injection site was swollen./It is swelled), FATIGUE (This morning he was tired.) and HEADACHE (He had headache.). On an unknown date, the patient experienced VACCINATION SITE PAIN (itchy at injection site/ It was hurting) and VACCINATION SITE PRURITUS (itchy at injection site/ It was hurting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency; IBUPROFEN (ADVILCAPS) at an unspecified dose and frequency and DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (itchy at injection site/ It was hurting), VACCINATION SITE SWELLING (Early this morning, his arm at the injection site was swollen./It is swelled), VACCINATION SITE PRURITUS (itchy at injection site/ It was hurting), FATIGUE (This morning he was tired.) and HEADACHE (He had headache.) outcome was unknown.        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.   concomitant medications include Blood Pressure Medicine, Heart Medicine  treatment medications include Tylenol, Advil, Benadryl
pt recvd vax;exp local swelling;w/in 48 hrs pt devel T 106 & became septic;to hosp & blood culture confirmed growth of E.coli; tx w/ unspecified atb; pt fine at time of rpt;
feeling better like old self before being diagnosed with fifth persons syndrome; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) and ERYTHEMA INFECTIOSUM (feeling better like old self before being diagnosed with fifth persons syndrome) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concomitant products included DIAZEPAM, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) and CANNABIS for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (muscle pain). On 28-Apr-2021, the patient experienced ERYTHEMA INFECTIOSUM (feeling better like old self before being diagnosed with fifth persons syndrome). On 28-Apr-2021, MYALGIA (muscle pain) had resolved. On 08-May-2021, ERYTHEMA INFECTIOSUM (feeling better like old self before being diagnosed with fifth persons syndrome) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medicine : Pain medicine.
This spontaneous report as received from a certified Medical assistant regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On 06-SEP-2016, the patients were vaccinated with improperly stored ZOSTAVAX lot # M019646/ expiration date-18-JUL-2017. No adverse event was reported. No concomitant medication was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt Reports - 1s day : dizziness  -2nd day: c/o chills, body aches. Also c/o of  Left Rib pain radiating left side, to side & back.  Also developed Bilateral shoulder Pain Rt > Lt & Knee pain.  -post 2 weeks: worsening joint Pain, hard to walk, stiffness.  c/o weakness (Rt arm) (Per Patient) -currantly: wrist, fingers, hips, knees, ankles, shoulder Pain past week sx's better not significant
administered a Pentacel to a patient that had never had one and was beyond the age limit; Initial information received on 26-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient (age and gender unknown) who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, expiry date not reported via unknown route in unknown administration site.  It was an actual medication error due inappropriate age at vaccine administration.  It was reported that the doctor had questions regarding administering a Pentacel to a patient that had never had one and was beyond the age limit.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on batch number was requested for this case.  List of documents held by sender: none.
17MAR92 fever, vomitting x 4-5; 18MAR92 pale & weak; 19MAR92 tongue started to swell; couldn't talk properly tongue became chaffed, gums seemed puffy; 22MAR92 started running mild temp-lips are chapped;
My minor child experienced a negative response to the COVID-19 vaccination. The 2nd vaccination was worse than the first. She received it at Medical Center. Department of Medicine. A  significant incapacity that caused a  substantial disruption of the ability to conduct normal life functions formation of circular patches of skin. Person in Charge of COVID-19 Immunization Clinic.
Per 12/20/21 email:  "I had my booster Thursday afternoon. Friday I woke up with achiness and a little nausea, which isn?t abnormal considering how I reacted to the second vaccine. However, Saturday morning I had swelling in my arm as well as my armpit into my chest. It feels like someone stuck a knife in my armpit for lack of a better description and I still have it today"
This spontaneous report as received from a medical assistant refers to an a patient of unknown age and gender. No information on patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported.  The medical assistant reported that the patient received GARDASIL 9 outside the recommended series schedule. The patient was vaccinated with GARDASIL 9 on following dates: the first dose, lot # L018351, expiration date: 11-AUG-2017 on 10-MAR-2016, the second dose, lot # L026602, expiration date: 19-OCT-2017 on 18-JUL-2016; the third dose, lot # L026602, expiration date: 19-OCT-2017 on 18-AUG-2016 (dose and route of administration were not reported). No adverse effects were reported.  Additional information has been requested.
PT REC'D VACCINE X2- ONCE ON 7/13/11 AND THE 2ND TIME ON 7/14/11 BY THIS NURSE. IT WAS ORDERED FOR 7/14 AND IT WAS GIVEN THE DAY BEFORE.
Patient received a ZOSTAVAX vaccine on 1/9/12 in her right arm and on 1/11/12 she noticed her injection site was red and inflamed an area the size of an orange.
Arm hurt at injection site; Face was on fire; Face was red; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN (Face was on fire), ERYTHEMA (Face was red) and VACCINATION SITE PAIN (Arm hurt at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced THERMAL BURN (Face was on fire) and ERYTHEMA (Face was red). On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, THERMAL BURN (Face was on fire), ERYTHEMA (Face was red) and VACCINATION SITE PAIN (Arm hurt at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.; 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.
Shot was given in the left arm. That day I had normal soreness in my arm. However, it has been three weeks now and the soreness continues. I have trouble raising my arm and fully extending it. It continually feels like the muscle is sore and when I go to bed I have trouble finding a position for the arm that does not hurt. I have not sought any treatment yet. I am just hoping that it will get better over time.
Information has been received from a healthcare worker (medical assistant) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On multiple unspecified dates, unspecified doses of RECOMBIVAX HB which were improperly stored under 70 F for 38 hours were administered to multiple unspecified patients (incorrect product storage). The lot # of the RECOMBIVAX HB included: L019298 with expiration date 22-JUN-2017; L045117 with expiration date 06-OCT-2018; L027733 with expiration date 13-SEP-2017; L048849 with expiration date 04-FEB-2018 and L039660 with expiration date 04-FEB-2018. There was no previous temperature excursion. No adverse event was reported. This one of several reports received from the same reporter. Additional information has been requested.
Patient became short of breath and very anxious. She self administered her own albuterol inhaler, shortly after becoming short of breath. She was taken to exam room where she received 0.3 mg Epinephrine IM into her right thigh. She was tachycardic in the 150s but was normotensive and satting 100% on room air. Approximately 5 minutes after receiving Epi, her breathing slowed down and symptoms began to fade. She was transported via ambulance per protocol.
COVID arm; red spots around injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE ERYTHEMA (red spots around injection site) 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 historical condition was reported).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE ERYTHEMA (red spots around injection site). At the time of the report, VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE ERYTHEMA (red spots around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Patient reports generalized acute muscle ache; swollen glands in neck and occiput on 10/06/2012. Effects reported to PCP 10/16/2012; no treatment provided. Patient reports muscle aches resolving but swollen glands persist as of 10/18/2012.
Muscle pain site of injection, muscle fatigue, Tricep and bicep reduction, upper body pain across shoulder blades, loss of strength in upper body
Headache, nausea, chills, dizziness, exhaustion, body aches, thought process diminished, excessive urination....for over a week
Pt was sitting in office check-out area, stated she felt "her hands go numb", "saw spots then blacked out". Remembers opening eyes as she heard her name being called and saw herself lying on floor. Pt was assisted to nearby chair where she proceeded to faint again. Was carried to exam room #2 until EMS arrived. BP 80's/50's at this time. Discharge home from Dr. office.
Skin rash/redness at injection site and in axilla on side of injection; Skin rash/redness at injection site and in axilla on side of injection; Skin rash/redness at injection site and in axilla on side of injection; This is a spontaneous report from a contactable other healthcare professional reported for a female patient. A 28-year-old female patient receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided), intramuscular (anatomical location: arm left) on 19Jan2021 at 13:00 at SINGLE DOSE for covid-19 immunization. Patient's medical history included birth control. Concomitant medications included ethinylestradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) as birth control, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluticasone nasal spray, and probiotics.  The patient previously took first dose of bnt162b2 (lot number: EH9899; expiration date not reported), intramuscular (anatomical location: left arm) on 29Dec2020 at 09:30 am for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior vaccination. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The patient has no allergies to medications, food, or other products. Facility where the most recent COVID-19 vaccine was administered was reported as workplace clinic. It was also reported that patient was not pregnant at the time of vaccination. On 20Jan2021 at 07:00, the patient experienced skin rash/redness at injection site and in axilla on side of injection. It was reported that no treatment was provided for the events. The events were assessed as non-serious. Outcome of the events was recovering.
This is a spontaneous report from a contactable consumer reported for herself. A 85-year-old female patient of an unknown race/ethnicity received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose on 19Sep2017 for immunization. The first day the patient experienced sore arm, the second day she has a stiff neck, and the third day all her joints from where her neck joins her head down to her toes were awful and hurting, and they are still bothering her. The patient was diagnosed with rheumatoid arthritis, and a blood test was done. The patient was in excellent health prior to this shot. The outcome of the events was reported as unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected. Pfizer is Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Patient got second dose on 05-04-2021. She came on 05-19-2021 and complained of shortness of breath and trouble breathing since her second dose. She said she didn't have side effects from the first dose. She only started having shortness of breath immediately after her second dose. She said she has difficulty breathing at rest, but when she walks it goes away. Patient has a history of asthma and uses proair as needed to help with her breathing. Advised her to go see a doctor immediately. Patient said she does not currently have a Primary Care Provider, so advised her to go to the nearest urgent care/ER for further evaluation.