chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost immediatley after receiving vaccine patient experienced intense itching and burning at injection site and within 30 minutes swelling started as well. Reports soreness, and hardness, and swelling. Patient examined it visually at home and circled reaction with a pen at 1:39 pm and site was around 2 inches by 3 inches large.  By 11am 12/21/21 patient came back to pharmacy to report reaction and area of reaction was around the same size but had shifted down about one inch on arm. Patient still reports heat, swelling and itching from reaction site but that it is slightly more mild than yesterday. She hasn't taken any medications for symptoms.
off breathing patterns; Headache; Chills/shivering; body aches; extreme thirst; weak; high temperature; This is a spontaneous report from a contactable healthcare professional (patient). A 19-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ez3249), intramuscular at the left arm on 25Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Type 1 diabetes and hypothyroidism. Concomitant medication included insulin. The patient previously took the first dose of BNT162B2 on 04Jan2021 intramuscular on the left arm for COVID-19 immunization. The patient experienced off breathing patterns, headache, chills/shivering, body aches, extreme thirst, weak, and high temperature on 26Jan2021 12:00. The patient did not receive any treatment for the events. The outcome of the events was recovered with sequel.
Right deltoid-red with mild induration 100x130cm. Benadryl/ cool compress
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 11-year-old female patient who received MENVEO (batch number M16130, expiry date 21st July 2018) for prophylaxis. Previously administered products included INFANRIX with an associated reaction of injection site swelling (for details regarding adverse event, refer case US2018115052). Concomitant products included loratadine and melatonin. On 15th May 2018, the patient received MENVEO. On 15th May 2018, immediately after receiving MENVEO, the patient experienced injection site swelling and injection site itching. In May 2018, the patient experienced headache, rash lips, rash and skin discoloration. The patient was treated with ibuprofen, paracetamol (Tylenol), benadryl (nos) (Benadryl) and famotidine (Pepcid). On an unknown date, the outcome of the injection site swelling, injection site itching, headache, rash lips and rash were recovered/resolved and the outcome of the skin discoloration was unknown. The reporter considered the injection site swelling, injection site itching, headache, rash lips, rash and skin discoloration to be related to MENVEO. Additional information was reported as follows: This case was reported by the mother of the patient. The patient received a dose of MENVEO and immediately experienced swelling in arm at site of injection along with itchiness. Caller stated that the patient was given Benadryl and Pepcid right away due to similar reaction with INFANRIX from 2015. The caller reported that swelling was about 3.5 inches around injection site and that 18 hours later patient experienced spots on face and lips that were purple in color. The caller reported that the patient experienced headache as well that Tylenol and ibuprofen did not resolve. Caller reports that events resolved 2 weeks later. Vaccine administration facility information was not obtained during phone consultation. Reporter called back at 2:01 inquiring if the pictures that were associated with the adverse event reports had been received. The sender informed the reporter that he/she would send a follow up and if more information was required she would be contacted by the safety department.
20 Sep--developed rib pain and went to ED; pain was sig 6/10; now a 2/10; cardiac eval neg; dx'ed w/ costochondritis.
About 14 hours after my shot I started to experience cramping in the chest.  It felt almost like I had swallowed something and couldn't get it down.  The cramping was on the front and back of my ribs and lasted for about an hour and a half.  It was never difficult to breathe, but it was painful and disconcerting.  After using my albuterol a couple of times and doing some stretching the cramping subsided.  I had other normal reactions such as chills, tiredness, and fatigue as well.
it is like a cold he can not get rid off; Chest congestion; sore throat; head congestion; flu like symptoms; headache that were coming and going.; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle soreness), HEADACHE, HEAD DISCOMFORT, INFLUENZA LIKE ILLNESS, and OROPHARYNGEAL PAIN (sore throat) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced MYALGIA (muscle soreness). On 03-Apr-2021, the patient experienced HEADACHE. On 05-Apr-2021, the patient experienced HEAD DISCOMFORT/CONGESTION and INFLUENZA LIKE ILLNESS. On 06-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 07-Apr-2021, the patient experienced CHEST DISCOMFORT/ CONGESTION. On an unknown date, the patient experienced NASOPHARYNGITIS (it is like a cold he can not get rid off). The patient was treated with FUROSEMIDE at a dose of 40 mg four times per day; CARVEDILOL at a dose of 3.125 mg twice a day; LOSARTAN at a dose of 50 mg four times per day; ATORVASTATIN at a dose of 40 mg four times per day; BABY ASPIRIN at an unspecified dose and frequency; NAPROXEN SODIUM at a dose of 500 mg once a day; LANSOPRAZOLE at a dose of 20 mg four times per day; FISH OIL at an unspecified dose and frequency; VITAMIN E at an unspecified dose and frequency; MAGNESIUM at an unspecified dose and frequency; CALCIUM at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and VITAMIN D2 at an unspecified dose and frequency. On 02-Apr-2021, MYALGIA (muscle soreness) outcome was unknown. At the time of the report, HEADACHE, HEAD DISCOMFORT/ CONGESTION, INFLUENZA LIKE ILLNESS, OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT/ CONGESTION and NASOPHARYNGITIS (it is like a cold he can not get rid off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-083383 (Patient Link).   Most recent FOLLOW-UP information incorporated above included, On 22-Jul-2021 No significant follow up information received regarding the 1st dose
Pain in arm that radiates down to the wrist, hand, fingers. Tingling and numbers in hand/fingers that has lasted continuously since the shot was administered.
Mother states pt ran low-grade fever night of/day after shots, treated w/ OTC TYLENOL and MOTRIN. Pt has been guarding/favoring right thigh despite medication, warm compresses, and muscle massage. Pt is unable to tolerate bending leg to play, and drags leg when walking.
Sx onset 7/21 with nasal congestion & HA (thought she was starting with sinus infection). Lost taste and smell on 7/24. Works in a facility. We do not have the lot number.
Febrile Seizure lasted 60 seconds self-resolved,seen in ED dxed with Bilateral Otitis Media treated with Amoxicillin
Severe arm pain, (9-10/10) with movement and loss of range of motion.
Sore arm; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness) and HEADACHE (Headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness) and HEADACHE (Headache). On 21-Mar-2021, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness) and HEADACHE (Headache) had resolved.            Concomitant medications included Hormone IUD. No treatment information provided.   This case was linked to MOD-2021-081308 (E2B Linked Report).; Sender's Comments:  MOD-2021-081308:for 2nd dose
Red elevated rash 5-6 cm diameter on injection site with slight pruritis . Appeared on day 8 post vaccination
I don?t have my card on me at the moment. I can put the lot number later. I?m having redness/swelling which has slowly increased since getting the vaccine on Friday 1/15/21. It?s about three inches by three inches on my right deltoid.
Received Td in LD on 3/29/04. Mother of patient called 4/1/04 complained of redness, swelling of left upper arm. Mother also stated swollen lymph node under left arm. Patient complained of rib pain on left side on 3/30/2004.
Extreme Temp requiring visit to ER,T 106 @ home- T 105 @ ER.  6Feb91 child doing well. No new fever or problems per nurse. Pertussis rxn
Taking Paxlovid for Covid 19 positive results; Taking Paxlovid for Covid 19 positive results; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2021 at 12:00 as dose 1, single (Lot number: EW0179), in left arm and on 15Jun2021 at 12:00 as dose 2, single (Lot number: EW0178) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stage 3C metastatic melanoma" (unspecified if ongoing), notes: Stage 3C metastatic melanoma. Concomitant medication(s) included: AMLODIPINE, start date: 01Mar2022, stop date: 11Apr2022. Past drug history included: Codeine, reaction(s): "Allergy_Codeine"; Aspirin, reaction(s): "Allergy_Aspirin"; Epinephrine, reaction(s): "Allergy_Epinephrine"; Morphine, reaction(s): "Allergy_Morphine". The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Apr2022 at 01:00, outcome "unknown", COVID-19 (medically significant) with onset 12Apr2022 at 01:00, outcome "not recovered" and all described as "Taking Paxlovid for Covid 19 positive results". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient was taking Paxlovid for Covid 19 positive results. After one dose, Extreme dizziness, lightheaded, dry mouth and metal taste in her mouth. Cannot sleep due to extreme body aches. Patient had allergies with codeine, aspirin, all stimulants, epinephrine, morphine, most pain relievers.
Patient came in for Covid-19 Vaccine with reviewing vaccine card with drawing up 2nd Dose. Patient was administered .50 mL of Moderna Vaccine for 2nd Dose. The Patient had already received 2nd Dose at a pharmacy in 02/2022. Patient should have received Booster Vaccine after 5 mos of primary series administration.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of erythema (received 1st dose, refer case US2019036988). In February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a month after receiving SHINGRIX, the patient experienced erythema and vaccine administered at inappropriate site. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the erythema was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose within the past 2 weeks, but she insisted that it be injected in her buttock instead of her arm, which led to vaccine administered at inappropriate site. She had redness as big as a cantaloupe on her rear end after the 2nd dose. The reporter consented to follow up. Emergency room (ER) visit was required.
It felt a little numb on the part that was injected; I kept filling the medicine drip from my nose and since then I have been having really bad cough; I kept filling the medicine drip from  my nose and since then I have been having really bad cough; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Dec2020 at a  single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient stated that she believed she had a little bit side effects on the vaccine in Dec2020. She took the vaccine about maybe more than a week ago and yesterday it felt a little numb on the part that was injected and she kept "filling the medicine" drip from her nose and since then she had been having really bad cough. The patient stated that for her cough, she took natural stuffs (unspecified). Outcome of the events was unknown.  Information on the batch/lot number has been requested.
1 day after vaccination, patient developed rapid heartbeat and a feeling of tightness in his chest. He has no history of high blood pressure or cardiac problems. Patient was encouraged to contact his MD for evaluation.
Rigors and dyspnea for about 5 minutes.  Oximeter was at 77% on RA for 1 - 2 min before coming to normal.
Tachycardia withut chest pain, to a rate 120 bpm. On a previous occasion, BUT just reported to me today, Patient states he had runs of tachycardia up to 170 bpm, at time of first Modern injection. Tachycardia  to rate of 170  associated with first and only Moderna injection of COVID vaccine.).
Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness). At the time of the report, VACCINATION SITE PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-024076 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-024076:same reporter , different patient.(MOD21-037456)
Received flu shot 9/2/15. I expected normal pain at injection site, however, my shoulder is in excruciating pain when I lift it above my head reach back in back pocket.  I believe the pharmacist administered the injection too high in Deltoid.
About 24 hours later I lost complete control below my waist. I had no control over my legs or bladder. It seemed to resolve itself in about 4-5 days but then reoccurred with the second dose as well and I am now still having residual effects from that.
Child had received a dose on 11/16/2009 according to the state registry.  the clinic staff were not told
the nurse diluted vial of Menactra with sterile water before administering/No AE; Based on the information received on 26-Apr-2019, the report previously considered as non-valid became valid: the patients initials and date of birth was reported.  Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a patient (age at revaccination was 12 years), who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number, Exp. Date, route and administration site not reported) on an unspecified date. It was reported that It was reported that the nurse diluted vial of vaccine with sterile water before administering.   Information on the batch number was requested.  It was an actual medication error case due to inappropriate reconstitution technique.   It was reported that the patient did not have any reaction.  corrective action: the patient was revaccinated on 26-Apr-2019 (dosing details and lot number not reported).  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.  List of documents held by sender: none.  Additional information received on 26-Apr-2019 received from other healthcare professional.  The date of birth of the patient was reported.  Information regarding dose restart (corrective action) and adverse event (no reaction) was reported.  The corresponding fields and narrative were updated accordingly.
Gradual onset of diffuse myalgias followed by sudden onset severe and uncontrollable shivering, possible fever.
A small amount of vaccine exuded form vaccination site upon needle withdrawal. Vaccination lead was called to evaluate. Determined that patient received greater than half of the dose, therefore per CDC Guidelines, no further action was taken.
This spontaneous report as received from a health professional refers to a 14 day old patient (gender unknown). No concurrent condition, medical history or allergy/drug reactions were reported. On 12-JUN-2015, the patient was vaccinated with VAQTA 25/0.5 (units unknown) once, intramuscular (lot # and expiry date unspecified). No adverse effects were noted. No product quality complaint (PQC) was involved. The outcome of the event was unknown. Additional information has been requested.
Patient received Covid Monovalent for 3rd dose.  Should have rec'd Covid Bivalent.  No treatment given.  No adverse outcome.
HR at 11:30 and it was 104; This is a spontaneous report from a contactable consumer (reported for herself).  A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 26Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included Afib (atrial fibrillation) from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination and reporting. Concomitant medications included apixaban (5 mg tab) at 5 mg, and atorvastatin calcium (10 mg tab) at 10 mg; both reported as other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient checked her HR (heart rate) at 11:30 and it was 104, and at 12:30 it had come down to 90. No treatments received in response to the event reported. The event was reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "HR at 11:30 and it was 104" was recovering.   Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable consumer who reported for herself. A female patient of an unspecified age received PREVNAR 13, on an unspecified date at 0.5 ml single for immunisation. Concomitant medications were not reported.  The patient had allergy to iodine.  On an unknown date she experienced hoarseness and paralyzed vocal cord. She had three months of speech therapy and nothing was working. The final outcome of both the events was unknown.
allergic type rash appeared approx 6 hrs p/pt recvd 15 mo immun series; rash covered entire body like a sunburn states mom; taken to ER given DPH-rash;
BODY RASH STARTED ON LEFT ARM AND  SPREAD ON TORSO AND DOWN THE ARM, UNDERNEATH THE ARMS, TOWARDS THE BREAST AND WHOLE BACK THEN GOING DOWN TO LEGS, INNER THIGHS AND TUMMY; BODY ACHES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lyme disease, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced body aches. On 10-AUG-2021, the patient experienced body rash started on left arm and spread on torso and down the arm, underneath the arms, towards the breast and whole back then going down to legs, inner thighs and tummy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 10-AUG-2021, and had not recovered from body rash started on left arm and spread on torso and down the arm, underneath the arms, towards the breast and whole back then going down to legs, inner thighs and tummy. This report was non-serious.
Information has been received from a registered nurse concerning a 67 year old female patient, who on Nov 18, 2002 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot#643251/045M). Concomitant vaccination included a dose of influenza virus vaccine in the left arm. On Nov 20,2002 the patient called the doctor's office reporting that she had developed a rash from her elbow to her shoulder on her right arm. No other symptoms were reported. The patient was expected to be seen at the doctor's office. Subsequently, the patient fully recovered. The reporter indicated that two other patients (WAES0212USA01991 and 0212USA01970) received pneumococcal vaccine 23 polyvalent from the same lot and also experienced "worse than usual local reactions". The reporter also noted that "This office has given (pneumococcal vaccine 23 polyvalent) for over 10 years and we have never had the type of reactions that these 3 (and subsequent) patients experienced" (WAES0303USA00344). The reporter stated that she was "uncomfortable using the rest of the vial or other vials from the same lot". The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the center for evaluation and research and was released. Additional information is not expected.
Red, swollen, itchy and warm seen 5-10-08 given KEFLEX.
On Sunday the 15th I took a home a COVID-19 test because I was not feeling well, it came back negative. I went to the doctor the next day, I was tested for both the flu A & B and COVID-19, I tested posted for influenza B and COVID-19. I was given TAMIFLU and LAGEVRIO molnupiravir. I am still having some fatigue, mental fog, a cough, I will occasionally run a low-grade fever, other than that I have recovered. I feel the vaccine kept me out of the hospital. I was sick for two weeks and had one of the worst coughs I have ever had in my life.