chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From the physician Urgent Care note on 1/1/10-This 66 y/o female presents with-c/o immunization site pain on bilateral deltoids. Had pneumococcal on right and Tetanus on left. Right deltoid is tender to touch 4/10, but no inflammation, hardness or swelling noted. Left site has a 1-inch slightly reddened circle w/ 1cm area that is hard to touch, tender, has been keeping pt wake tonight. She applied LANACANE lotion on it earlier and took TYLENOL yesterday for the pain, but nothing recently. Here to check as bothers her sleep and hasn't had this reaction before. Extremities-1 areas of light pink injection b/l deltoids 1 cm area that is mildly firm but no circumscribed fluctuant mass nor heat, its mildly tender, strength intact with grip, normal limb muscle bulk UEs. From the physician Urgent Care note on 1/3/10- she was seen here 2 days ago with an apparent inflammatory reaction to tetanus vaccine. She has been NSAID's a local care, but still has pain and swelling of the left arm and wrist. Pain is from the shoulder down to the wrist. There is some stiffness noted. She has no chills or fever and no other complaints. The right arm is fine. Plan-start prednisone, 40mg po now and in AM, 20mg po daily x3 and 10mg po daily x3. From Domicilliary physician note 1/4/10-LABS-BMP, CBC, PT/INR, ESR have been unremarkable. Complement C3/C4 panel was sent out and is pending. From nursing note 1/4/10-A. Today the injection site on the left deltoid is slightly red, there is about a 2cm swelling noted at the area that is quite tender to the touch. Patient states her left wrist was swollen also, and both are getting better with the steroids. From Domicilliary physician note 1/8/10-Patient presents with chief complaint of urine smelling funny and looking darker. From Domicilliary physician note 1/11/10-Patient presents with chief complaint of allergic reaction to CIPRO. Says last night she began to itch and to have throat swelling. She chose not to go to facility, but decided to self treat with diphenhydramine- 3 doses 100mg po each, approx 4 hours apart. Reports my throat felt like is was swelling, my skin got red and I began itching. No current symptoms other than mild itch. Note her multiple allergies, all self reported below. From Domicilliary physician note 1/28/10-Patient was placed on a low-dose steroid taper and symptoms resolved without sequelae. Treatment drugs used: Prednisone dose: 21.25 units: mg freq: every day route: PO.
This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. A 5-year-old patient (gender unknown) received a dose of PREVNAR 13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient developed a Streptococcus pneumoniae infection and died. It is unknown if an autopsy was performed. No further information was provided.
no adverse effect reported; a patient received an expired dose of M-M-R II; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.  On 17-OCT-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin) (M-M-R II), lot # N026828, expiration date 27-SEP-2019, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects were reported.
Patient says 3 days following vaccine he experienced muscle twitching that resulted in paralysis of his amputated lower limbs, resulting in surgery.
Local swelling of right thigh with redness, non-tender seen 2 days after KINRIX (DTaP, IPVS administered in right thigh. Cool compress and Benadryl orally.
Headache; A little bit dizzy; So tired / extremely tired; Started to get the chills; Little pain at the injection site with certain moves of the arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (A little bit dizzy), FATIGUE (So tired / extremely tired), CHILLS (Started to get the chills), VACCINATION SITE PAIN (Little pain at the injection site with certain moves of the arm) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A.) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (took Imodium for the therapy.).    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced VACCINATION SITE PAIN (Little pain at the injection site with certain moves of the arm). On 16-May-2021, the patient experienced DIZZINESS (A little bit dizzy). 16-May-2021, the patient experienced FATIGUE (So tired / extremely tired) and CHILLS (Started to get the chills). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, DIZZINESS (A little bit dizzy), FATIGUE (So tired / extremely tired), CHILLS (Started to get the chills), VACCINATION SITE PAIN (Little pain at the injection site with certain moves of the arm) and HEADACHE (Headache) outcome was unknown.            No treatment medications provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Additional info received on 17-MAY-2021: New events updated.
pt recv vax 20FEB98 & started running temp 101 to 103 same evening;given APAP & temp slowly came down;24FEB98 temp was about 100-spotty red rash appeared on face 24FEB98 * 25FEB98;it spread to trunk & arms & lightly on legs;refusing solid;
chills; body aches; Not feeling well; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and VACCINATION COMPLICATION (Not feeling well) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PYREXIA (fever) and VACCINATION COMPLICATION (Not feeling well). On an unknown date, the patient experienced CHILLS (chills) and MYALGIA (body aches). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and VACCINATION COMPLICATION (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.  No concomitant medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: adverse event updated
Injection site started hurting within minutes of injection.  Wihtin 30 minutes, large bump on arm, hot to touch, red bumpy rash, itchy and painful.  Rash/itchyness/pain continued for 12 days.  At day 28, skin around injection site still discolored.  I took photos.
depression; headache; arthritic pain in entire body/muscle, joint pain, body aches; muscle, joint pain, body aches; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression), HEADACHE (headache), ARTHRALGIA (arthritic pain in entire body/muscle, joint pain, body aches) and MYALGIA (muscle, joint pain, body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DEPRESSION (depression), HEADACHE (headache), ARTHRALGIA (arthritic pain in entire body/muscle, joint pain, body aches) and MYALGIA (muscle, joint pain, body aches). At the time of the report, DEPRESSION (depression), HEADACHE (headache), ARTHRALGIA (arthritic pain in entire body/muscle, joint pain, body aches) and MYALGIA (muscle, joint pain, body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: updated events tab - outcome (resolved), event duration, declined for further follow up.
Patient said she experienced mid-back pain that felt like the kidneys. She went to the emergency room where they determined it was a side effect of the vaccine and she was told to take Tylenol. She was instructed to have the pharmacy report the adverse event.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 80-year-old female patient who received Shingrix for prophylaxis. In July 2018, the patient received the 1st dose of Shingrix (intramuscular). In July 2018, 1 day after receiving Shingrix, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but it could be 79 or 80 years. The patient received 1st dose of Shingrix on left deltoid. The next day after receiving Shingrix, the patient experienced intense itching with redness but no hives and no pain on her arm where she received the vaccination. No additional details were available.
he took the first shot and didn't feel good after, but a couple of days later he was okay; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: ER6208) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, start date: 2006. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "he took the first shot and didn't feel good after, but a couple of days later he was okay". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197965 Same reporter/drug, different patients;US-PFIZER INC-202201201522 same reporter/drug, different patient/event;
seizure; sore arm; A spontaneous report was received from a consumer, concerning a 67-years old male patient, who received Moderna's COVID-19 vaccine and experienced seizure and sore arm.  The patient's medical history included brain tumor removed. No relevant concomitant product was reported.  On 06 Ma 2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (lot number 036A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day patient experienced sore arm for couple of days.  On 12 Mar 2021, 6 days after the first shot, the patient experienced seizure. The patient was hospitalized for a night and laboratory tests were performed. There was no indication of stroke and everything else came back inconclusive.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event sore arm was resolved on 08 Mar 2021 and the outcome of the event seizure was unknown; 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.
skin painful to touch even the slightest touch hurt; Chills; temperature spiked 102 degree; muscles and joint hurts; muscles and joint hurts; Cold; felt fatigued and slept most of the day; slight body aches; Swelling and redness at injection site; Swelling and redness at injection site; felt fatigued and slept most of the day; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number EN6203) via intramuscular on 25Feb2021 12:30 PM (age at vaccination was 41 years) as DOSE 2, SINGLE for COVID-19 Immunisation at hospital. The patient's medical history and concomitant medication were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number Ek4176) via intramuscular in right bicep on 03Feb2021 12:30 PM as DOSE 1, SINGLE for COVID-19 immunisation at hospital and nine days after my first dose I experienced redness and swelling at injection site. I treated it with over the counter Benadryl cream the first day. I also took Benadryl over the counter medicine that night. The redness and swelling was still there on day 10. I treated it with over the counter cortisone cream. The redness and swelling had cleared up by day 11. The patient experienced few hours after receiving the vaccine, cold on 25Feb2021, on the next day she woke up feeling fine but with slight body aches, around 10:45 am she started to experience chills and then her muscles and joint hurts, she also experienced her skin painful to touch even the slightest touch hurt, her temperature spiked 102 degree on 26Feb2021. She also felt fatigued and slept most of the day. She had redness and swelling at the injection site. Patient underwent lab tests and procedure of body temperature and resulted into 102 degree on 26Feb2021 and 99.6 on 27Feb2021. She took children's liquid Tylenol throughout the day and evening for fever. The next day the fever broke bout her temperature remained around 99.6 degree throughout the day. By Sunday 28Feb2021 her temperature was back to normal. She did not have any covid like symptoms and felt completely fine. She treated redness and swelling at the injection site with cortisone 5(over the counter cream). The redness and swelling was gone by Monday (01Mar2021) afternoon. If this information help with future vaccine development please feel free to contact. The outcome of events cold, chills, muscles and joint hurts, skin painful to touch even the slightest touch hurt, fever, fatigue and slept most of the day was recovered on 28Feb2021 and outcome of redness and swelling at the injection site was recovered on 01Mar2021.  Follow-up attempts were completed. No further information was expected.
Intense headache for 72 hours immediately after vaccine, hot/sweaty immediately after vaccine then again when NSAIDs wore off that night and into next day, extremely painful arm for 72 hours, muscle very hard at injection site for 72 hours, bruise still present at injection site 6 days post (never bruised for vaccine before)
Patient received vaccine beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days). In September 2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vials were in refrigerator for over 30 days. From 24-Aug-2021 the vials were stored in the refrigerator, which were administered on 27-Sep-2021 and 29-Sep-2021. It was stated that the vial did not undergo temperature excursions.  No concomitant medications were reported.  No treatment information was reported.
Patient noted to have left shoulder redness, + induration 6 days after vaccination. Patient was treated in ER; diagnosed with Cellulitis. Treated with antibiotics.
100.4 degree fever at 4am after dose accompanied by chills, sweats, and headache nausea at 2pm on 2/6
Burning sensation; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route in the left arm on 01Mar2021(at the age of 36 years-old) as a single dose for COVID-19 immunisation. Medical history included SLE, Von Willebrands type 1, hellp syndrome, elevated liver enzymes. Concomitant medications included hydroxychloroquine (PLAQUENIL) 1 tablet daily, for unknown indication within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested positive for COVID-19 since having the vaccine. On 02Mar2021, the patient experienced burning sensation. The patient did not feel pain but was unable to correlate to eating, sleeping, activity, etc. The patient reported burning sensation was continually occurring multiple times a day only on left side of body, mainly upper back down through legs- both front and back side. The patient reported occasional burning sensation in left arm from injection site down. The patient was receiving treatment with medical team at clinic. The clinical outcome burning sensation was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist concerning a 68 year old female with no known allergies, who on 25-AUG-2010 was vaccinated with a dose of PNEUMOVAX 23, 0.5 mL intramuscularly into the right arm. In approximately 2007, the patient was vaccinated with the first dose of PNEUMOVAX 23 prior to her 65th birthday. Concomitant therapy included FLUVIRIN into the left arm. On 25-AUG-2010, the patient called the pharmacy later that evening to report that her right arm hurt and that she was developing a small bruise at the injection site and a larger area, warm to the touch, red, swollen, and painful, located approximately four inches below the injection site on her right arm. Pharmacist reported that he suggested the patient take ibuprofen and apply cold compresses to the arm. Pharmacist also reported that the patient tolerated well the injection of FLUVIRIN. At the time of this report the patient had not recovered. No laboratory or diagnostic tests were performed. The patient sought medical attention calling pharmacy. Additional information has been requested.
NAUSEA, VOMITING, DIAHREA, HEADACHES, BODY ACHES, FEVER.  GIVEN TYLENOL.
COVID-19 Vaccine EUA  got J&J vaccine shot @ 2:00pm on Wed, April,7th woke up approx. 2:00am in trembling chills , woke up again @ 7:00a with fever , nagiated and feeling a flu like symtoms, headache , sore bones , been out of work two days now and starting to feel a little better but not anywhere near normal yet and don't have any alergies or alergic to anything.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX approximately 5 years ago in 2007. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient had shingles infection an unspecified number of times on unspecified number of dates. No treatment information was reported. It was unknown if the patient sought medical attention. The outcome of shingles infection was unknown. The relatedness for shingles infection was not provided for ZOSTAVAX. Additional information has been requested.
Extreme soreness in arm. Swollen glands under arm. Eye twitching-severe over 3 weeks.
Swelling in right arm; Painful injection site / site soreness; Hot injection site; Red injection site; Itchy / itchiness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and FLUAD .5 ml. On 17th September 2019, 1 hr after receiving Shingrix, the patient experienced swelling arm, injection site pain, injection site warmth, injection site erythema and pruritus. On 8th October 2019, the outcome of the swelling arm was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were recovered/resolved and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, injection site pain, injection site warmth, injection site erythema and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient received a flu vaccine, Fluad at the same time. The reporter stated that an hour later she started to have swelling in her right arm and a red, hot, painful injection site on her right arm, and she was itchy.  The reporter stated that all the symptoms except for the itchiness and some site soreness "when you press on it." persist at this time. The patient stated that all other symptoms resolved within "one and a half weeks" from 17th September 2019. The reporter does not have vaccine information for this adverse event. The reporter consent to healthcare professional follow up.
Pt received PNEUMOVAX and FLUVIRIN in right arm. Over the next couple of days rash spread throughout upper arm. After a couple of days started taking BENADRYL and rash has improved. Still has rash.
Mild chills the day after. Muscle aches day 2 (mild). Diarrhea day 3 (mild). Injection site swollen and red and sore (mild)
Malaise, Fever, Chills, Severe weakness, nausea, gastrointestinal upset. Unable to do anything except huddle in chair under blanket! 36 hours. Resolved over time. The worst reaction I have had from a vaccination in my life.
15 year old patient was given pediatric (5-11 year old ) dose . Patients mother was notified. Patient will receive 12 year old and above dose in 21 days. Patient tolerated vaccine with no adverse effects
Tiredness; Weakness; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), ASTHENIA (Weakness) and DIZZINESS (Dizziness) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness), ASTHENIA (Weakness) and DIZZINESS (Dizziness). At the time of the report, FATIGUE (Tiredness), ASTHENIA (Weakness) and DIZZINESS (Dizziness) outcome was unknown.            No concomitant medication nor treatment information provided by reporter.